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FDA OKs Guselkumab for Crohn’s Disease
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The approval marks the fourth indication for guselkumab, which was approved for moderate to severe plaque psoriasis in 2017, active psoriatic arthritis in 2020, and moderately to severely active ulcerative colitis in 2024.
Guselkumab is the first and only interleukin-23 (IL-23) inhibitor that offers both subcutaneous (SC) and intravenous (IV) induction options for CD, the company said in a news release.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, director of the Inflammatory Bowel Disease Unit at the University of Calgary, Calgary, Alberta, Canada, said in the release.
“The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers not available before,” said Panaccione.
The FDA nod in CD was based on positive results from three phase 3 trials evaluating guselkumab in more than 1300 patients with moderately to severely active CD who failed or were intolerant to corticosteroids, immunomodulators, or biologics.
The GRAVITI trial showed that guselkumab as SC induction and maintenance therapy was superior to placebo in clinical remission as well as endoscopic response and remission and deep remission.
Results from GALAXI 2 and GALAXI 3 showed that guselkumab was superior to ustekinumab (Stelara) on all pooled endoscopic endpoints.
Guselkumab is the only IL-23 inhibitor to demonstrate “clinical remission and endoscopic response, both at 1 year, with a fully subcutaneous induction regimen,” the company said.
The recommended SC induction dose of guselkumab is 400 mg (given as two consecutive injections of 200 mg each, dispensed in one induction pack) at weeks 0, 4 and 8. The drug is also available in a 200 mg prefilled syringe. For the IV induction option, 200 mg IV infusions are administered at weeks 0, 4, and 8.
The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter.
Use of the lowest effective recommended dosage to maintain therapeutic response is recommended.
Full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
WATS-3D Biopsy Increases Detection of Barrett’s Esophagus in GERD
, new research showed.
Compared with forceps biopsies (FB) alone, the addition of WATS-3D led to confirmation of BE in an additional one fifth of patients, roughly doubled dysplasia diagnoses, and influenced clinical management in the majority of patients.
“The big take-home point here is that the use of WATS-3D brushing along with conventional biopsies increases the likelihood that intestinal metaplasia will be identified,” first author Nicholas Shaheen, MD, MPH, AGAF, with the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine at Chapel Hill, North Carolina, told GI & Hepatology News.
“Almost 20% of patients who harbor BE were only identified by WATS-3D and might have otherwise gone undiagnosed had only forceps biopsies been performed,” Shaheen said.
The study was published in The American Journal of Gastroenterology.
Beyond Traditional Biopsies
BE develops as a complication of chronic GERD and is the chief precursor to esophageal adenocarcinoma. Early detection of BE and dysplasia is crucial to enable timely intervention.
The current gold standard for BE screening involves upper endoscopy with FB following the Seattle protocol, which consists of four-quadrant biopsies from every 1-2 cm of areas of columnar-lined epithelium (CLE) to confirm the presence of intestinal metaplasia. However, this protocol is prone to sampling errors and high false-negative rates, leading to repeat endoscopy, the study team pointed out.
WATS-3D (CDx Diagnostics) is a complementary technique designed to improve diagnostic yield by using brush biopsy to sample more tissue than routine biopsies.
WATS-3D has been shown to increase detection of dysplasia in patients with BE undergoing surveillance for BE, but less is known about the value of WATS-3D for BE screening in a community-based cohort of patients with GERD.
To investigate, Shaheen and colleagues studied 23,933 consecutive patients enrolled in a prospective observational registry assessing the utility of WATS-3D in the screening of symptomatic GERD patients for BE.
Patients had both WATS-3D and FB in the same endoscopic session. No patient had a history of BE, intestinal metaplasia or dysplasia in esophageal mucosa, or esophageal surgery, endoscopic ablation or endoscopic mucosal resection prior to enrollment.
Overall, 6829 patients (29%) met endoscopic criteria for BE (≥ 1 cm esophageal CLE with accompanying biopsies showing intestinal metaplasia).
Of these, 2878 (42%) had intestinal metaplasia identified by either FB or WATS-3D, but 19.3% had their BE diagnosis confirmed solely on the basis of WATS-3D findings.
Among patients who fulfilled the endoscopic criteria for BE, the adjunctive yield of WATS-3D was 76.5% and the absolute yield was 18.1%.
Of the 240 (1.0%) patients with dysplasia, 107 (45%) were found solely by WATS-3D.
‘Clinically Valuable Adjunct’
Among patients with positive WATS-3D but negative FB results, clinical management changed in 90.7% of cases, mostly involving initiation or modification of surveillance and proton pump inhibitor therapy.
These results suggest that WATS-3D is a “clinically valuable adjunct” to FB for the diagnosis of BE when used as a screening tool in symptomatic GERD patients and particularly in patients with endoscopic evidence of > 1 cm esophageal columnar-lined epithelium, the study team wrote.
Adjunctive use of WATS-3D when BE is suspected “may save endoscopies and lead to quicker, more accurate diagnoses,” they added.
The investigators said a limitation of the study is the lack of central pathology review, potentially leading to diagnostic variability. They also noted that over half of the detected dysplasia cases were crypt dysplasia or indefinite for dysplasia, raising concerns about clinical significance.
Reached for comment, Philip O. Katz, MD, AGAF, professor of medicine and director of the GI Function Laboratories, Weill Cornell Medicine in New York, said he’s been using WATS for more than a decade as an adjunct to standard biopsy in patients undergoing screening and surveillance for BE and finds it clinically helpful in managing his patients.
This new study provides “further information that WATS added to biopsy that has been traditionally done with the Seattle protocol increases the yield of intestinal metaplasia and likely dysplasia in patients being screened for Barrett’s,” Katz, who wasn’t involved in the study, told GI & Hepatology News.
Funding for the study was provided by CDx Diagnostics. Shaheen and several coauthors disclosed relationships with the company. Katz disclosed relationships (consultant/advisor) for Phathom Pharmaceuticals and Sebella.
A version of this article appeared on Medscape.com.
, new research showed.
Compared with forceps biopsies (FB) alone, the addition of WATS-3D led to confirmation of BE in an additional one fifth of patients, roughly doubled dysplasia diagnoses, and influenced clinical management in the majority of patients.
“The big take-home point here is that the use of WATS-3D brushing along with conventional biopsies increases the likelihood that intestinal metaplasia will be identified,” first author Nicholas Shaheen, MD, MPH, AGAF, with the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine at Chapel Hill, North Carolina, told GI & Hepatology News.
“Almost 20% of patients who harbor BE were only identified by WATS-3D and might have otherwise gone undiagnosed had only forceps biopsies been performed,” Shaheen said.
The study was published in The American Journal of Gastroenterology.
Beyond Traditional Biopsies
BE develops as a complication of chronic GERD and is the chief precursor to esophageal adenocarcinoma. Early detection of BE and dysplasia is crucial to enable timely intervention.
The current gold standard for BE screening involves upper endoscopy with FB following the Seattle protocol, which consists of four-quadrant biopsies from every 1-2 cm of areas of columnar-lined epithelium (CLE) to confirm the presence of intestinal metaplasia. However, this protocol is prone to sampling errors and high false-negative rates, leading to repeat endoscopy, the study team pointed out.
WATS-3D (CDx Diagnostics) is a complementary technique designed to improve diagnostic yield by using brush biopsy to sample more tissue than routine biopsies.
WATS-3D has been shown to increase detection of dysplasia in patients with BE undergoing surveillance for BE, but less is known about the value of WATS-3D for BE screening in a community-based cohort of patients with GERD.
To investigate, Shaheen and colleagues studied 23,933 consecutive patients enrolled in a prospective observational registry assessing the utility of WATS-3D in the screening of symptomatic GERD patients for BE.
Patients had both WATS-3D and FB in the same endoscopic session. No patient had a history of BE, intestinal metaplasia or dysplasia in esophageal mucosa, or esophageal surgery, endoscopic ablation or endoscopic mucosal resection prior to enrollment.
Overall, 6829 patients (29%) met endoscopic criteria for BE (≥ 1 cm esophageal CLE with accompanying biopsies showing intestinal metaplasia).
Of these, 2878 (42%) had intestinal metaplasia identified by either FB or WATS-3D, but 19.3% had their BE diagnosis confirmed solely on the basis of WATS-3D findings.
Among patients who fulfilled the endoscopic criteria for BE, the adjunctive yield of WATS-3D was 76.5% and the absolute yield was 18.1%.
Of the 240 (1.0%) patients with dysplasia, 107 (45%) were found solely by WATS-3D.
‘Clinically Valuable Adjunct’
Among patients with positive WATS-3D but negative FB results, clinical management changed in 90.7% of cases, mostly involving initiation or modification of surveillance and proton pump inhibitor therapy.
These results suggest that WATS-3D is a “clinically valuable adjunct” to FB for the diagnosis of BE when used as a screening tool in symptomatic GERD patients and particularly in patients with endoscopic evidence of > 1 cm esophageal columnar-lined epithelium, the study team wrote.
Adjunctive use of WATS-3D when BE is suspected “may save endoscopies and lead to quicker, more accurate diagnoses,” they added.
The investigators said a limitation of the study is the lack of central pathology review, potentially leading to diagnostic variability. They also noted that over half of the detected dysplasia cases were crypt dysplasia or indefinite for dysplasia, raising concerns about clinical significance.
Reached for comment, Philip O. Katz, MD, AGAF, professor of medicine and director of the GI Function Laboratories, Weill Cornell Medicine in New York, said he’s been using WATS for more than a decade as an adjunct to standard biopsy in patients undergoing screening and surveillance for BE and finds it clinically helpful in managing his patients.
This new study provides “further information that WATS added to biopsy that has been traditionally done with the Seattle protocol increases the yield of intestinal metaplasia and likely dysplasia in patients being screened for Barrett’s,” Katz, who wasn’t involved in the study, told GI & Hepatology News.
Funding for the study was provided by CDx Diagnostics. Shaheen and several coauthors disclosed relationships with the company. Katz disclosed relationships (consultant/advisor) for Phathom Pharmaceuticals and Sebella.
A version of this article appeared on Medscape.com.
, new research showed.
Compared with forceps biopsies (FB) alone, the addition of WATS-3D led to confirmation of BE in an additional one fifth of patients, roughly doubled dysplasia diagnoses, and influenced clinical management in the majority of patients.
“The big take-home point here is that the use of WATS-3D brushing along with conventional biopsies increases the likelihood that intestinal metaplasia will be identified,” first author Nicholas Shaheen, MD, MPH, AGAF, with the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine at Chapel Hill, North Carolina, told GI & Hepatology News.
“Almost 20% of patients who harbor BE were only identified by WATS-3D and might have otherwise gone undiagnosed had only forceps biopsies been performed,” Shaheen said.
The study was published in The American Journal of Gastroenterology.
Beyond Traditional Biopsies
BE develops as a complication of chronic GERD and is the chief precursor to esophageal adenocarcinoma. Early detection of BE and dysplasia is crucial to enable timely intervention.
The current gold standard for BE screening involves upper endoscopy with FB following the Seattle protocol, which consists of four-quadrant biopsies from every 1-2 cm of areas of columnar-lined epithelium (CLE) to confirm the presence of intestinal metaplasia. However, this protocol is prone to sampling errors and high false-negative rates, leading to repeat endoscopy, the study team pointed out.
WATS-3D (CDx Diagnostics) is a complementary technique designed to improve diagnostic yield by using brush biopsy to sample more tissue than routine biopsies.
WATS-3D has been shown to increase detection of dysplasia in patients with BE undergoing surveillance for BE, but less is known about the value of WATS-3D for BE screening in a community-based cohort of patients with GERD.
To investigate, Shaheen and colleagues studied 23,933 consecutive patients enrolled in a prospective observational registry assessing the utility of WATS-3D in the screening of symptomatic GERD patients for BE.
Patients had both WATS-3D and FB in the same endoscopic session. No patient had a history of BE, intestinal metaplasia or dysplasia in esophageal mucosa, or esophageal surgery, endoscopic ablation or endoscopic mucosal resection prior to enrollment.
Overall, 6829 patients (29%) met endoscopic criteria for BE (≥ 1 cm esophageal CLE with accompanying biopsies showing intestinal metaplasia).
Of these, 2878 (42%) had intestinal metaplasia identified by either FB or WATS-3D, but 19.3% had their BE diagnosis confirmed solely on the basis of WATS-3D findings.
Among patients who fulfilled the endoscopic criteria for BE, the adjunctive yield of WATS-3D was 76.5% and the absolute yield was 18.1%.
Of the 240 (1.0%) patients with dysplasia, 107 (45%) were found solely by WATS-3D.
‘Clinically Valuable Adjunct’
Among patients with positive WATS-3D but negative FB results, clinical management changed in 90.7% of cases, mostly involving initiation or modification of surveillance and proton pump inhibitor therapy.
These results suggest that WATS-3D is a “clinically valuable adjunct” to FB for the diagnosis of BE when used as a screening tool in symptomatic GERD patients and particularly in patients with endoscopic evidence of > 1 cm esophageal columnar-lined epithelium, the study team wrote.
Adjunctive use of WATS-3D when BE is suspected “may save endoscopies and lead to quicker, more accurate diagnoses,” they added.
The investigators said a limitation of the study is the lack of central pathology review, potentially leading to diagnostic variability. They also noted that over half of the detected dysplasia cases were crypt dysplasia or indefinite for dysplasia, raising concerns about clinical significance.
Reached for comment, Philip O. Katz, MD, AGAF, professor of medicine and director of the GI Function Laboratories, Weill Cornell Medicine in New York, said he’s been using WATS for more than a decade as an adjunct to standard biopsy in patients undergoing screening and surveillance for BE and finds it clinically helpful in managing his patients.
This new study provides “further information that WATS added to biopsy that has been traditionally done with the Seattle protocol increases the yield of intestinal metaplasia and likely dysplasia in patients being screened for Barrett’s,” Katz, who wasn’t involved in the study, told GI & Hepatology News.
Funding for the study was provided by CDx Diagnostics. Shaheen and several coauthors disclosed relationships with the company. Katz disclosed relationships (consultant/advisor) for Phathom Pharmaceuticals and Sebella.
A version of this article appeared on Medscape.com.
Intensive Nutrition Therapy Improves Outcomes in Alcohol-Related ACLF
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
In a randomized controlled trial, compared with standard care, dietitian-supported, intensive nutritional therapy improved survival, reduced frailty, and lowered hospitalization rates in men with alcohol-related ACLF.
The study, performed by a team from the Postgraduate Institute of Medical Education and Research, Chandigarh, India, was published in Clinical Gastroenterology and Hepatology.
ACLF related to alcohol use is associated with poor outcomes due to poor nutritional intake and frailty. Frail patients with ACLF face higher morbidity, mortality, and hospitalization rates than their nonfrail counterparts. However, research on the role of structured nutritional interventions in improving these outcomes is limited.
Patal Giri, MBBS, MD, and colleagues enrolled 70 men with alcohol-related ACLF and frailty (liver frailty index [LFI] > 4.5) in a single-center, open-label study. Half were randomly allocated to an intervention group receiving outpatient intensive nutrition therapy (OINT) plus standard medical treatment (SMT) and half to a control group receiving SMT alone for 3 months.
The intervention group received a monitored high-calorie, high-protein, and salt-restricted diet as prescribed by a dedicated senior liver dietitian. The control group received regular nutritional recommendations and were managed for the ACLF-associated complications, without intervention or guidance by the study team.
After 3 months follow-up, overall survival (the primary outcome) was significantly improved in the OINT group compared with the control group (91.4% vs 57.1%), “suggesting that the improvement in nutrition status is associated with better survival,” the study team noted. Three patients died in the OINT group vs 15 in the SMT group.
OINT also led to a significant improvement in frailty, with LFI scores decreasing by an average of 0.93 in the intervention group vs 0.33 in the control group; 97% of patients improved from frail to prefrail status in the OINT group, whereas only 20% of patients improved in the SMT group.
The mean change in LFI of 0.93 with OINT is “well above the substantially clinically important difference” (change of 0.8) established in a previous study, the authors noted.
Significant improvements in weight and body mass index were also observed in the OINT group relative to the control group.
Liver disease severity, including model for end-stage liver disease (MELD) scores, showed greater improvement in the OINT group than in the control group (−8.7 vs −6.3 points from baseline to 3 months).
During the follow-up period, fewer patients in the intervention group than in the control group required a hospital stay (17% vs 45.7%).
Limitations of the study include the single-center design and the short follow-up period of 3 months, which limits long-term outcome assessment. Further, the study only included patients meeting Asia Pacific Association for Study of Liver criteria for ACLF, which does not include the patients with organ failure as defined by European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria. Patients with ACLF who had more severe disease (MELD score > 30 or AARC > 10) were also not included.
Despite these limitations, the authors said their study showed that “dietician-monitored goal-directed nutrition therapy is very important in the management of patients with alcohol-related ACLF along with SMT.”
Confirmatory Data
Reached for comment, Katherine Patton, MEd, RD, a registered dietitian with the Center for Human Nutrition at Cleveland Clinic, Cleveland, Ohio, said it’s well known that the ACLF patient population has a “very high rate of morbidity and mortality and their quality of life tends to be poor due to their frailty. It is also fairly well-known that proper nutrition therapy can improve outcomes, however barriers to adequate nutrition include decreased appetite, nausea, pain, altered taste, and early satiety from ascites.”
“Hepatologists are likely stressing the importance of adequate protein energy intake and doctors may refer patients to an outpatient dietitian, but it is up to the patient to make that appointment and act on the recommendations,” Patton told GI & Hepatology News.
“If a dietitian works in the same clinic as the hepatologist and patients can be referred and seen the same day, this is ideal. During a hospital admission, protein/calorie intake can be more closely monitored and encouraged by a multi-disciplinary team,” Patton explained.
She cautioned that “the average patient is not familiar with how to apply general calorie and protein goals to their everyday eating habits. This study amplifies the role of a dietitian and what consistent education and resources can do to improve a patient’s quality of life and survival.”
This study had no specific funding. The authors have declared no relevant conflicts of interest. Patton had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
VA Shake-up Disrupts Mental Health Services for Some US Veterans
SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.
Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.
“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.
“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.
After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.
The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.
It also faces complex problems.
“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.
The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.
Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.
The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.
They spoke on the condition of anonymity, because they were not authorized to speak with the media.
STAFFING SHORTAGES
A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.
“There’s no way to take a scalpel and do it appropriately that quickly,” he said.
VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.
He did not specify how many support staff for these providers had been affected.
Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.
The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.
Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.
The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”
‘THE MOOD IS SO LOW’
In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.
The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.
He did not directly address questions about why mental health providers needed to return to the office.
“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.
In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.
The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.
“People are calling out sick. People are ill with stress and worry. The mood is so low.”
A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.
VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.
“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”
The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.
Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.
They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.
“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”
Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”
(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)
SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.
Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.
“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.
“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.
After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.
The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.
It also faces complex problems.
“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.
The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.
Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.
The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.
They spoke on the condition of anonymity, because they were not authorized to speak with the media.
STAFFING SHORTAGES
A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.
“There’s no way to take a scalpel and do it appropriately that quickly,” he said.
VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.
He did not specify how many support staff for these providers had been affected.
Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.
The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.
Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.
The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”
‘THE MOOD IS SO LOW’
In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.
The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.
He did not directly address questions about why mental health providers needed to return to the office.
“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.
In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.
The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.
“People are calling out sick. People are ill with stress and worry. The mood is so low.”
A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.
VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.
“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”
The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.
Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.
They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.
“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”
Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”
(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)
SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.
Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.
“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.
“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.
After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.
The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.
It also faces complex problems.
“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.
The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.
Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.
The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.
They spoke on the condition of anonymity, because they were not authorized to speak with the media.
STAFFING SHORTAGES
A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.
“There’s no way to take a scalpel and do it appropriately that quickly,” he said.
VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.
He did not specify how many support staff for these providers had been affected.
Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.
The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.
Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.
The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”
‘THE MOOD IS SO LOW’
In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.
The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.
He did not directly address questions about why mental health providers needed to return to the office.
“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.
In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.
The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.
“People are calling out sick. People are ill with stress and worry. The mood is so low.”
A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.
VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.
“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”
The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.
Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.
They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.
“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”
Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”
(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)
Do Patients With Intermediate-Risk Cervical Cancer Need Adjuvant Chemotherapy?
New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group.
Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention.
The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.
The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations.
“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.
The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.
Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated.
This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history.
The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).
If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?
Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.
What Is the History of Adjuvant Treatment in Cervical Cancer?
Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.
“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”
That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said.
Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia.
“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.
“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”
Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?
“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.
Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.
“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.
What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?
For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.
“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.
“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”
Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?
All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.
Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.
“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.
Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?
For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”
Agustí Garcia said her study results can help “refine” clinical practice.
“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said.
“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”
Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.
A version of this article first appeared on Medscape.com.
New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group.
Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention.
The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.
The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations.
“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.
The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.
Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated.
This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history.
The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).
If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?
Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.
What Is the History of Adjuvant Treatment in Cervical Cancer?
Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.
“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”
That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said.
Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia.
“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.
“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”
Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?
“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.
Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.
“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.
What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?
For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.
“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.
“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”
Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?
All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.
Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.
“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.
Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?
For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”
Agustí Garcia said her study results can help “refine” clinical practice.
“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said.
“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”
Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.
A version of this article first appeared on Medscape.com.
New findings on radiation plus adjuvant chemotherapy in patients with intermediate-risk cervical cancer seem to spell the end for the dual therapy in this group.
Results from a phase 3 clinical trial of 316 women who’d had radical hysterectomies found that adjuvant chemotherapy as treatment for their early-stage, intermediate-risk cervical carcinoma did not improve outcomes but did increase toxicity. The results were the inverse of the study’s intention.
The NRG-GOG 0263 (NCT01101451) study failed to reach its endpoint of improving recurrence-free survival through the addition of cisplatin chemotherapy, confirming instead that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative in this cohort. The results were presented during a plenary session of the Society of Gynecologic Oncology Annual Meeting on Women’s Cancers in Seattle, Washington.
The current standard of care in this cohort is for radiotherapy alone, although the National Comprehensive Cancer Network (NCCN) guidelines place adjuvant chemotherapy in category 2B recommendations.
“Perhaps the NCCN guidelines will have to change what it says here,” Andrew Berchuck, MD, chief of gynecologic oncology and professor of obstetrics and gynecology at Duke University School of Medicine in Durham, North Carolina, told this news organization. Berchuck was not involved in the clinical trial.
The National Cancer Institute lists adjuvant chemotherapy first in its guidelines for this group.
Another study published online this month in JAMA Oncology concluded that morbidity in these patients could be reduced if the use of chemoradiotherapy were de-escalated.
This population-based cohort study of 1116 women, conducted by Núria Agustí Garcia, MD, postdoctoral fellow at The University of Texas MD Anderson Cancer Center in Houston, and colleagues, found no significant overall survival benefit of adjuvant chemotherapy in intermediate-risk cervical cancer, and that when it was given, patients tended to have larger tumors and nonsquamous cell history.
The 5-year survival rate in patients who received chemoradiotherapy was 87%, compared with an 87% 5-year survival rate in those who received radiotherapy alone (hazard ratio = 0.85; 95% CI, 0.59-1.23; P =.38).
If the standard of care in this cohort is radiation only, and outcomes are not better in adjuvant treatment, then why is there a controversy at all, and why are some investigators such as Agustí Garcia attempting to clarify adjuvant treatment’s effects?
Experts say it’s because of the history of adjuvant chemotherapy in more advanced cervical cancer and the extrapolations clinicians made when treating patients with intermediate risk.
What Is the History of Adjuvant Treatment in Cervical Cancer?
Concomitant therapies in intermediate-risk cervical cancer began in the late 1990s, at a time when it was found effective in more advanced disease, according to Berchuck, who also was not involved in the population study.
“Say back then, you had a stage IIIb cervical cancer. With external radiation alone, followed by brachytherapy internally, the cure rate for something like that would have been maybe 50 or 60%,” Berchuck said in an interview. “Adding cisplatin improved the cure rate by about 15%.”
That cisplatin improved survival rates in advanced disease, led to using it in less advanced cases, according to Berchuck. “The idea here was that if the pathology report indicated a larger tumor involving the lymphatics, the risk of recurrence went up to about 20%, so by adding chemo to postsurgical radiotherapy, you could improve things more than with just radiation alone,” Berchuck said.
Studies of adjuvant chemotherapy in advanced cervical cancers confused the matter, according to Agustí Garcia.
“The theoretical benefit of adding chemotherapy to radiotherapy for patients with intermediate-risk cervical cancer has been extrapolated from studies on locally advanced or high-risk cases, for example, those with parametrial or lymph node metastases,” Agustí Garcia said in an interview.
“However, before its implementation, there was no solid evidence supporting this approach in intermediate-risk patients,” she said. “The oncologic behavior of this subgroup may differ, and in the absence of parametrial or lymph node metastasis, chemotherapy may not be necessary.”
Do Both Studies Suggest That Radiotherapy Has Become More Effective Recently?
“Probably. Modern radiation techniques, such as IMRT [intensity-modulated radiation therapy] and IGRT [image-guided radiation therapy] are more effective than historical techniques,” said Amer Karam, MD, a clinical professor of obstetrics and gynecology at Stanford University in Palo Alto, California. Karam was not involved in either study mentioned previously.
Agustí Garcia said that while it’s true radiotherapy techniques have improved, these advancements primarily impact morbidity rather than survival outcomes.
“The lack of survival benefit from concomitant chemotherapy in intermediate-risk patients suggests that such benefit may never have existed in this subgroup,” she said.
What Explains Why Overall Survival Did Not Significantly Differ Between Patients Who Received Radiotherapy Alone and Those Who Received Chemoradiotherapy?
For Karam, there is a question as to whether chemosensitization mechanisms in radiation therapy, such as reactive oxygen species, inhibition of DNA repair, modulating tumor microenvironment, and cell cycle arrest — all used to induce apoptosis — are as efficacious as once thought.
“Also, systemic chemosensitization may not be as effective at controlling systemic disease beyond the pelvis and radiation field,” he said.
“Radiation is extremely effective in cervical cancer,” said Berchuck. “When you’re giving radiation in a situation like this where there is none, to only microscopic disease, it makes sense that radiation could be effective by itself.”
Why in the JAMA Oncology Study Were Larger Tumor Size and Nonsquamous Histology Associated With the Use of Chemoradiotherapy?
All experts agreed this is likely because this subgroup of patients with larger tumors is typically seen as being at higher risk for recurrence. This might be due to what Karam called an “unfavorable histology” and certain tumor characteristics, including depth of invasion.
Yet Agustí Garcia said, in her study, even after propensity score matching, adjuvant chemotherapy did not demonstrate any survival benefit in this subgroup.
“The importance of performing propensity score matching in our analysis was to ensure that populations with comparable baseline recurrence and death risks were being evaluated fairly,” she told this news organization.
Do These Findings Change Clinical Practice for Intermediate-Risk Cervical Cancer Treatment?
For Karam, the new evidence in intermediate-risk cervical cancer confirms rather than changes clinical practice. “The standard of care was radiation therapy alone, which is now confirmed, based on the results of GOG 263,” Karam said. “The standard of care for these patients will remain the same.”
Agustí Garcia said her study results can help “refine” clinical practice.
“The results suggest that adjuvant therapy could be safely de-escalated in intermediate-risk cervical cancer,” Agustí Garcia said.
“We should avoid chemotherapy when there is no evidence-based benefit, reserving its use for locally advanced or high-risk cases, refining clinical guidelines to ensure treatment recommendations are based on higher-quality evidence, thereby standardizing care and reducing overtreatment,” she continued. “Current guidelines lack consensus and rely on lower-quality evidence.”
Agustí Garcia reported grants from Fundación Alfonso Martín Escudero. Berchuck has no disclosures. Karam reported royalties from UpToDate and that he is a speaker for AstraZeneca.
A version of this article first appeared on Medscape.com.
Can Adjuvant Immunotherapy Boost Survival Outcomes in Advanced Nasopharyngeal Cancer?
TOPLINE:
Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.
METHODOLOGY:
- About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
- Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
- Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
- The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.
TAKEAWAY:
- Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
- The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
- Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
- The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.
IN PRACTICE:
“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.
“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.
SOURCE:
The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.
LIMITATIONS:
The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.
DISCLOSURES:
The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.
METHODOLOGY:
- About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
- Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
- Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
- The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.
TAKEAWAY:
- Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
- The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
- Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
- The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.
IN PRACTICE:
“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.
“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.
SOURCE:
The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.
LIMITATIONS:
The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.
DISCLOSURES:
The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Adjuvant therapy with camrelizumab significantly improved 3-year event-free survival in patients with locoregionally advanced nasopharyngeal carcinoma compared with observation, according to findings from the phase 3 DIPPER trial.
METHODOLOGY:
- About 20%-30% of patients with locoregionally advanced nasopharyngeal carcinoma experience disease relapse after definitive chemoradiotherapy. Camrelizumab plus chemotherapy can improve progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, but its effectiveness as adjuvant therapy in locoregionally advanced disease remains unclear.
- Researchers conducted the randomized phase 3 DIPPER trial at 11 centers in China, enrolling 450 patients with T4N1M0 or T1-4N2-3M0 nasopharyngeal carcinoma who had completed induction-concurrent chemoradiotherapy.
- Participants were randomly assigned to receive either adjuvant camrelizumab (200 mg intravenously every 3 weeks for 12 cycles; n = 226) or observation (n = 224). The median follow-up duration was 39 months.
- The primary endpoint was event-free survival, defined as freedom from distant metastasis, locoregional relapse, or death due to any cause; secondary endpoints included distant metastasis–free survival, locoregional relapse–free survival, overall survival, and safety.
TAKEAWAY:
- Patients who received camrelizumab had a higher 3-year event-free survival rate than those who underwent observation (86.9% vs 77.3%; stratified hazard ratio [HR], 0.56; P = .01).
- The 3-year distant metastasis–free survival was also higher in the camrelizumab group (92.4% vs 84.5%; stratified HR, 0.54; P = .04).
- Patients in the camrelizumab group had higher locoregional relapse–free survival at 3 years than those in the observation group (92.8% vs 87.0%; stratified HR, 0.53; P = .046). However, the difference in overall survival between the groups was not significant.
- The safety analysis included 426 patients; 97.1% of those who received camrelizumab experienced at least one adverse event of any grade, the most common being reactive capillary endothelial proliferation compared with 85.5% of those in the observation group. Further, 11.2% of patients taking camrelizumab reported grade 3 or 4 events, including leukopenia and neutropenia compared with 3% in the observation group.
IN PRACTICE:
“The DIPPER trial demonstrated that adjuvant camrelizumab following induction-concurrent chemoradiotherapy significantly improved event-free survival by 9.6% with a favorable safety profile in patients with locoregionally advanced [nasopharyngeal carcinoma],” the authors wrote.
“If survival is eventually proven to be improved with induction chemoimmunotherapy, can we begin asking about de-escalation of chemoradiotherapy” for patients with nasopharyngeal carcinoma? “This question is exceptionally important, given the significant long-term consequences of radiotherapy on survivors,” the author of an accompanying editorial wrote.
SOURCE:
The study was led by Ye-Lin Liang, MD, Sun Yat-sen University Cancer Center in Guangzhou, China, and was published online in JAMA.
LIMITATIONS:
The study included patients from an endemic region where nasopharyngeal carcinoma is predominantly linked to Epstein-Barr virus infection, potentially affecting the generalizability of the findings to nonendemic populations. The open-label design may have introduced bias. Additionally, combined positive scores for programmed cell death ligand 1 (PD-L1) were unavailable for some patients, potentially affecting the analysis of the correlation between PD-L1 expression and clinical outcomes.
DISCLOSURES:
The study was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project, National Natural Science Foundation of China, Guangzhou Municipal Health Commission, Key Area Research and Development Program of Guangdong Province, Overseas Expertise Introduction Project for Discipline Innovation, and Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. The authors reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
OK to Skip Pelvic Lymph Node Dissection in Cervical Cancer?
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.
Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.
Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.
Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2025.
Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.
It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.
The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).
The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.
“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.
Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was < 1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.
Overall, about 3.85% of patients (n = 16) in the biopsy-only group had a recurrence compared with 6.24% (n = 26) in the pelvic lymphadenectomy group at a median follow-up of 50 months.
But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.
The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], 0.61; P = .12). However, the 3-year overall survival was significantly higher in biopsy-only group — 100% vs 97.8% in the lymphadenectomy group (HR, 0.21; P = .007). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.
As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (10.1% vs 2.4%), as well as longer operating time and more blood loss.
Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.
Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.
Although quality of life data was not presented in the trial, patients who skipped pelvic lymphadenectomy had fewer adverse events, “which is very important for our patients,” Thaker added.
This study had no commercial funding. Liu and Thaker had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM SGO 2025
3D Total Body Photography Shown to Decrease Biopsies, Improve Dx of Nonmelanoma Skin Cancers
ORLANDO, Fla. — A study of automated three-dimensional total-body photography (3D TBP) found that it improved “hit” rates of positive malignant biopsies and reduced unnecessary biopsies of skin lesions but left unanswered questions about the practicality of its widespread use and cost-effectiveness.
“We did observe improved biopsy practices and outcomes,” said Jordan Phillipps, MD, a dermatology resident at Mayo Clinic in Jacksonville, Florida, who reported the results of the study during a late-breaker session at the American Academy of Dermatology (AAD) 2025 Annual Meeting.
“We observed reduced unnecessary biopsies, which was driven by benign and premalignant, particularly actinic keratosis, lesions,” Phillipps said. “We observed improved malignancy detection, which was profoundly driven by nonmelanoma skin cancers.”
Study Design and Results
The retrospective study included 410 adult patients who had at least two sessions with the Vectra WB360 3D TBP imaging system at a dedicated 3D imaging clinic at Mayo Clinic in Rochester, Minnesota Patient eligibility for the 3D clinic requires a previous melanoma diagnosis. All study participants also underwent dermoscopy, Phillipps said. Their average age was 51.6 years, and 53% were women.
The study accounted for 5981 total patient encounters, including 1150 dedicated Vectra imaging sessions, Phillipps said. In this group, 3006 biopsies were performed, of which 56% were benign, 32% were malignant, and 12% were premalignant. The study also separately evaluated lesion type, focusing on keratinocytic and pigmented lesions.
Most of the keratinocytic lesions were nonmelanoma skin cancers, he said, whereas the pigmented lesions were mostly benign.
“The intervention did significantly reduce biopsies per encounter by 35%, and this was driven by benign lesions and premalignant lesions, particularly actinic keratosis lesions,” Phillipps said.
Previous studies of automated TBP have been hampered by small study populations, he said, and this is one of the largest studies of the Vectra WB360 device. “Nonmelanoma skin cancers are underreported,” Phillipps said, noting that most studies focus on melanoma and pigmented lesions. “Our aim was to assess the effect of Vectra implementation on biopsy practice and outcomes,” he explained.
For malignant lesions, the investigators observed an improvement in malignancy detection, a modest 1.6% increase in hit rates of positive malignant biopsies, and a modest 1.3% decrease in the number needed to biopsy, he said.
A subgroup analysis of pigmented and keratinocytic lesions demonstrated that improved malignancy detection is “profoundly driven by nonmelanoma skin cancers” of 71% per biopsy, Phillipps said, along with “sizable” increases in the hit rate (+17%) and a reduction in the number of biopsies (–14%).
Melanoma detection decreased by 62% per biopsy. Phillipps said the reduction was probably because of the study methodology, specifically the eligibility requirement of having had a previous melanoma diagnosis. “These patients typically develop only one primary melanoma,” Phillipps said. To test this, the investigators compared melanoma hit rates with a matched, unexposed cohort that did not have Vectra imaging. They found that the hit rates were similar. “So this was reassuring that we weren’t missing any melanomas,” Phillipps said.
The results also showed improved efficacy for detecting severely dysplastic nevi, for which the hit rate increased by 16% and the number needed to biopsy decreased by 13%. “Actinic keratoses lesions were biopsied less,” he said, noting a 50% decrease. Both benign keratinocytic lesions, predominantly seborrheic keratosis and benign lichenoid keratosis, and benign pigmented (benign nevi) lesions were biopsied less.
Limitations and Questions
The highly selective nature of the patient population was a limitation of the study, Phillipps noted, along with financial and logistical challenges that impede the generalizability of the findings. Overall, he said, the study emphasized that 3D TBP is effective in skin cancer screening and diagnosis, notably beyond pigmented lesions.
Kristina Callis Duffin, MD, MS, chair of dermatology at The University of Utah, Salt Lake City, Utah, called the findings “exciting” but noted that the study did not compare results to the gold standard of clinician-performed skin screenings. “That absolutely would be the important way to do it, through a randomized trial,” she said, “but that’s a hard study to do.”
The cost-effectiveness of total-body imaging also needs to be evaluated, Duffin said. “You really have to look at a number of factors in terms of protection compared to a human gold standard, the rates of biopsies,” she said. “There are a lot of things to unpack; that cost-effectiveness has to be balanced with a more accurate diagnosis and reduction of morbidity with multiple biopsies.”
Phillipps reported no relevant financial relationships. Duffin disclosed financial relationships with AbbVie, Alumis, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, FIDE, Janssen Pharmaceuticals, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
ORLANDO, Fla. — A study of automated three-dimensional total-body photography (3D TBP) found that it improved “hit” rates of positive malignant biopsies and reduced unnecessary biopsies of skin lesions but left unanswered questions about the practicality of its widespread use and cost-effectiveness.
“We did observe improved biopsy practices and outcomes,” said Jordan Phillipps, MD, a dermatology resident at Mayo Clinic in Jacksonville, Florida, who reported the results of the study during a late-breaker session at the American Academy of Dermatology (AAD) 2025 Annual Meeting.
“We observed reduced unnecessary biopsies, which was driven by benign and premalignant, particularly actinic keratosis, lesions,” Phillipps said. “We observed improved malignancy detection, which was profoundly driven by nonmelanoma skin cancers.”
Study Design and Results
The retrospective study included 410 adult patients who had at least two sessions with the Vectra WB360 3D TBP imaging system at a dedicated 3D imaging clinic at Mayo Clinic in Rochester, Minnesota Patient eligibility for the 3D clinic requires a previous melanoma diagnosis. All study participants also underwent dermoscopy, Phillipps said. Their average age was 51.6 years, and 53% were women.
The study accounted for 5981 total patient encounters, including 1150 dedicated Vectra imaging sessions, Phillipps said. In this group, 3006 biopsies were performed, of which 56% were benign, 32% were malignant, and 12% were premalignant. The study also separately evaluated lesion type, focusing on keratinocytic and pigmented lesions.
Most of the keratinocytic lesions were nonmelanoma skin cancers, he said, whereas the pigmented lesions were mostly benign.
“The intervention did significantly reduce biopsies per encounter by 35%, and this was driven by benign lesions and premalignant lesions, particularly actinic keratosis lesions,” Phillipps said.
Previous studies of automated TBP have been hampered by small study populations, he said, and this is one of the largest studies of the Vectra WB360 device. “Nonmelanoma skin cancers are underreported,” Phillipps said, noting that most studies focus on melanoma and pigmented lesions. “Our aim was to assess the effect of Vectra implementation on biopsy practice and outcomes,” he explained.
For malignant lesions, the investigators observed an improvement in malignancy detection, a modest 1.6% increase in hit rates of positive malignant biopsies, and a modest 1.3% decrease in the number needed to biopsy, he said.
A subgroup analysis of pigmented and keratinocytic lesions demonstrated that improved malignancy detection is “profoundly driven by nonmelanoma skin cancers” of 71% per biopsy, Phillipps said, along with “sizable” increases in the hit rate (+17%) and a reduction in the number of biopsies (–14%).
Melanoma detection decreased by 62% per biopsy. Phillipps said the reduction was probably because of the study methodology, specifically the eligibility requirement of having had a previous melanoma diagnosis. “These patients typically develop only one primary melanoma,” Phillipps said. To test this, the investigators compared melanoma hit rates with a matched, unexposed cohort that did not have Vectra imaging. They found that the hit rates were similar. “So this was reassuring that we weren’t missing any melanomas,” Phillipps said.
The results also showed improved efficacy for detecting severely dysplastic nevi, for which the hit rate increased by 16% and the number needed to biopsy decreased by 13%. “Actinic keratoses lesions were biopsied less,” he said, noting a 50% decrease. Both benign keratinocytic lesions, predominantly seborrheic keratosis and benign lichenoid keratosis, and benign pigmented (benign nevi) lesions were biopsied less.
Limitations and Questions
The highly selective nature of the patient population was a limitation of the study, Phillipps noted, along with financial and logistical challenges that impede the generalizability of the findings. Overall, he said, the study emphasized that 3D TBP is effective in skin cancer screening and diagnosis, notably beyond pigmented lesions.
Kristina Callis Duffin, MD, MS, chair of dermatology at The University of Utah, Salt Lake City, Utah, called the findings “exciting” but noted that the study did not compare results to the gold standard of clinician-performed skin screenings. “That absolutely would be the important way to do it, through a randomized trial,” she said, “but that’s a hard study to do.”
The cost-effectiveness of total-body imaging also needs to be evaluated, Duffin said. “You really have to look at a number of factors in terms of protection compared to a human gold standard, the rates of biopsies,” she said. “There are a lot of things to unpack; that cost-effectiveness has to be balanced with a more accurate diagnosis and reduction of morbidity with multiple biopsies.”
Phillipps reported no relevant financial relationships. Duffin disclosed financial relationships with AbbVie, Alumis, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, FIDE, Janssen Pharmaceuticals, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
ORLANDO, Fla. — A study of automated three-dimensional total-body photography (3D TBP) found that it improved “hit” rates of positive malignant biopsies and reduced unnecessary biopsies of skin lesions but left unanswered questions about the practicality of its widespread use and cost-effectiveness.
“We did observe improved biopsy practices and outcomes,” said Jordan Phillipps, MD, a dermatology resident at Mayo Clinic in Jacksonville, Florida, who reported the results of the study during a late-breaker session at the American Academy of Dermatology (AAD) 2025 Annual Meeting.
“We observed reduced unnecessary biopsies, which was driven by benign and premalignant, particularly actinic keratosis, lesions,” Phillipps said. “We observed improved malignancy detection, which was profoundly driven by nonmelanoma skin cancers.”
Study Design and Results
The retrospective study included 410 adult patients who had at least two sessions with the Vectra WB360 3D TBP imaging system at a dedicated 3D imaging clinic at Mayo Clinic in Rochester, Minnesota Patient eligibility for the 3D clinic requires a previous melanoma diagnosis. All study participants also underwent dermoscopy, Phillipps said. Their average age was 51.6 years, and 53% were women.
The study accounted for 5981 total patient encounters, including 1150 dedicated Vectra imaging sessions, Phillipps said. In this group, 3006 biopsies were performed, of which 56% were benign, 32% were malignant, and 12% were premalignant. The study also separately evaluated lesion type, focusing on keratinocytic and pigmented lesions.
Most of the keratinocytic lesions were nonmelanoma skin cancers, he said, whereas the pigmented lesions were mostly benign.
“The intervention did significantly reduce biopsies per encounter by 35%, and this was driven by benign lesions and premalignant lesions, particularly actinic keratosis lesions,” Phillipps said.
Previous studies of automated TBP have been hampered by small study populations, he said, and this is one of the largest studies of the Vectra WB360 device. “Nonmelanoma skin cancers are underreported,” Phillipps said, noting that most studies focus on melanoma and pigmented lesions. “Our aim was to assess the effect of Vectra implementation on biopsy practice and outcomes,” he explained.
For malignant lesions, the investigators observed an improvement in malignancy detection, a modest 1.6% increase in hit rates of positive malignant biopsies, and a modest 1.3% decrease in the number needed to biopsy, he said.
A subgroup analysis of pigmented and keratinocytic lesions demonstrated that improved malignancy detection is “profoundly driven by nonmelanoma skin cancers” of 71% per biopsy, Phillipps said, along with “sizable” increases in the hit rate (+17%) and a reduction in the number of biopsies (–14%).
Melanoma detection decreased by 62% per biopsy. Phillipps said the reduction was probably because of the study methodology, specifically the eligibility requirement of having had a previous melanoma diagnosis. “These patients typically develop only one primary melanoma,” Phillipps said. To test this, the investigators compared melanoma hit rates with a matched, unexposed cohort that did not have Vectra imaging. They found that the hit rates were similar. “So this was reassuring that we weren’t missing any melanomas,” Phillipps said.
The results also showed improved efficacy for detecting severely dysplastic nevi, for which the hit rate increased by 16% and the number needed to biopsy decreased by 13%. “Actinic keratoses lesions were biopsied less,” he said, noting a 50% decrease. Both benign keratinocytic lesions, predominantly seborrheic keratosis and benign lichenoid keratosis, and benign pigmented (benign nevi) lesions were biopsied less.
Limitations and Questions
The highly selective nature of the patient population was a limitation of the study, Phillipps noted, along with financial and logistical challenges that impede the generalizability of the findings. Overall, he said, the study emphasized that 3D TBP is effective in skin cancer screening and diagnosis, notably beyond pigmented lesions.
Kristina Callis Duffin, MD, MS, chair of dermatology at The University of Utah, Salt Lake City, Utah, called the findings “exciting” but noted that the study did not compare results to the gold standard of clinician-performed skin screenings. “That absolutely would be the important way to do it, through a randomized trial,” she said, “but that’s a hard study to do.”
The cost-effectiveness of total-body imaging also needs to be evaluated, Duffin said. “You really have to look at a number of factors in terms of protection compared to a human gold standard, the rates of biopsies,” she said. “There are a lot of things to unpack; that cost-effectiveness has to be balanced with a more accurate diagnosis and reduction of morbidity with multiple biopsies.”
Phillipps reported no relevant financial relationships. Duffin disclosed financial relationships with AbbVie, Alumis, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, FIDE, Janssen Pharmaceuticals, Novartis, and Pfizer.
A version of this article first appeared on Medscape.com.
FROM AAD 2025
ACG Issues First Guidance on Diagnosis and Management of Gastric Premalignant Conditions
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
including atrophic gastritis, gastric intestinal metaplasia, dysplasia, and certain gastric epithelial polyps, all of which have an increased risk of progressing to gastric cancer.
The guideline was published online in The American Journal of Gastroenterology.
GPMCs are “common in gastroenterology practices, but in the US, at least, we’ve not had concrete guidance,” first author Douglas Morgan, MD, MPH, AGAF, Division of Gastroenterology, The University of Alabama at Birmingham, noted in an interview.
With these guidelines, we hope there “will be a paradigm shift to finally establish surveillance in the stomach, much like we’ve been doing for decades in the colon and the esophagus,” Morgan said.
Gastric cancer is a common cancer in the United States with disproportionately higher incidence rates in immigrants from countries with a high incidence of gastric cancer and certain non-White populations.
In addition, the 5-year survival rate in the United States for gastric cancer is 36%, which falls short of global standards and is driven by the fact that only a small percentage of these cancers are diagnosed in the early, curable stage.
These guidelines will help address this marked disparity and the burden on minority and marginalized populations, the guideline authors wrote. “The overarching goals are to reduce [gastric cancer] incidence in the United States, increase the detection of early-stage disease (early gastric cancer), and to significantly increase the 5-year survival rates in the near term.”
Key Recommendations
The guideline includes recommendations on endoscopic surveillance for high-risk patients, the performance of high-quality endoscopy and image-enhanced endoscopy (IEE) for diagnosis and surveillance, GPMC histology criteria and reporting, endoscopic treatment of dysplasia, the role of Helicobacter pylori eradication, general risk reduction measures, and the management of autoimmune gastritis and gastric epithelial polyps.
In terms of screening, the guidelines recommend against routine upper endoscopy screening for gastric cancer and GPMC in the general US population (low quality of evidence; conditional recommendation).
They also noted that there is “insufficient” direct US evidence to make a recommendation on opportunistic endoscopy screening for gastric cancer and GPMC in patients deemed at high risk based on race/ethnicity and family history. In addition, they recommend against the use of noninvasive biomarkers for screening or surveillance of GPMC or gastric cancer.
In terms of endoscopic and histologic diagnosis of GPMC, high-quality endoscopic evaluation is crucial to detect premalignant conditions or gastric cancer, the authors said. This includes adequate mucosal cleansing and insufflation, and photodocumentation of anatomic landmarks, as well as use of high-definition white light endoscopy (HDWLE) and IEE.
Systematic gastric biopsies should follow the updated Sydney protocol, with at least two separate containers for antrum/incisura and corpus biopsies. Histology should document the subtype of gastric intestinal metaplasia — incomplete, complete, or mixed — and severity and extent of atrophic gastritis and metaplasia.
Morgan emphasized the importance of coordination between the gastroenterologist and pathologist. “Several of these measures are not routinely reported, so we need to be in conversations with our collaborating pathologists,” he told this news organization.
In terms of GPMC surveillance, the authors suggest surveillance endoscopy every 3 years in high-risk patients with gastric intestinal metaplasia who meet one of the following criteria: High-risk histology (incomplete vs complete subtype, extending into the corpus); family history of gastric cancer in a first-degree relative; foreign-born individuals from high-gastric cancer incidence nations; or high-risk race/ethnicity (East Asian, Latino/a, Black, American Indian, or Alaska Native).
Individuals with multiple risk factors for gastric cancer may be considered for shorter than 3-year intervals.
Low-risk gastric intestinal metaplasia (limited to antrum, mild atrophy, and complete gastric intestinal metaplasia subtype) does not require routine endoscopic surveillance.
In terms of endoscopic management of dysplastic GPMC, endoscopic resection is suggested for dysplasia with visible margins. If dysplasia is not visible, repeat endoscopy with HDWLE and IEE by an experienced endoscopist is advised.
In patients appropriate for endoscopic resection of dysplasia, particularly endoscopic submucosal dissection, referral to a high-volume center with appropriate expertise in the diagnosis and therapeutic resection of gastric neoplasia is strongly recommended.
In patients with confirmed complete resection of dysplasia, endoscopic surveillance is also strongly recommended. Surveillance examinations should be performed by an experienced endoscopist using HDWLE and IEE, with biopsies according to the systematic biopsy protocol in addition to targeted biopsies.
In terms of nonendoscopic GPMC management, testing for H pylori (and eradication treatment if possible) is strongly recommended for patients with GPMC and those with a history of resected early gastric cancer.
Aspirin, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or antioxidants are not recommended for patients with GPMC for the purpose of preventing gastric cancer.
In patients with autoimmune gastritis, testing for H pylori with a nonserological test, eradication treatment if positive, and posttreatment testing to confirm eradication is advised.
There is not enough evidence to make a formal recommendation on endoscopic surveillance in those with autoimmune gastritis; surveillance should be individualized, considering the risk for neuroendocrine tumors and possibly gastric cancer.
In terms of gastric epithelial polyps, endoscopic resection of all gastric adenomas is recommended, regardless of size, to exclude or prevent dysplasia and early gastric cancer. Adenomas that are not amenable to endoscopic resection should be referred for surgical resection, if clinically appropriate.
Morgan noted that the ACG GPMC guideline aligns with the updated ACG/American Society for Gastrointestinal Endoscopy upper endoscopy quality indicators released earlier this year.
Implementation of the ACG GPMC guideline and “change in clinical practice will require concrete targets and include training and quality initiatives,” the authors said.
This research received no commercial support. Morgan disclosed research support from Panbela Therapeutics, Thorne, and American Molecular Laboratories.
A version of this article first appeared on Medscape.com.
AI-Enhanced Echocardiography: A Game-Changer for Opportunistic Liver Disease Detection?
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.
An AI algorithm called EchoNet-Liver demonstrated strong performance for detecting cirrhosis and steatotic liver disease (SLD) from routinely acquired transthoracic echocardiography studies containing subcostal images of the liver, the developers reported in NEJM AI.
“We hope that this algorithm enables physicians to opportunistically screen for chronic liver disease to identify asymptomatic and undiagnosed patients, thus enabling us to treat comorbidities relevant to the patient’s cardiovascular and noncardiovascular health,” Alan C. Kwan, MD, assistant professor, Department of Cardiology, Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, told this news organization.
Harnessing Echo to Reveal Liver Trouble
CLD affects over 1.5 billion people globally, with many cases remaining undiagnosed due to the asymptomatic nature of early disease and a lack of routine screening. Traditional diagnostic methods such as liver function tests, ultrasonography, and MRI are often limited by cost, availability, and patient access.
Echocardiography is a commonly performed imaging study that incidentally captures images of the liver but is not utilized for liver disease assessment.
EchoNet-Liver is an AI algorithm that can identify high-quality subcostal images from full echocardiography studies and detect the presence of cirrhosis and SLD.
Kwan and colleagues trained it using nearly 1.6 million echocardiogram videos from 66,922 studies and 24,276 adult patients at Cedars-Sinai Medical Center (CSMC). The model predictions were compared with diagnoses from clinical evaluations of paired abdominal ultrasound or MRI studies. External validation studies were conducted using similar data from Stanford Health Care.
In the “held-out” CSMC ultrasound dataset, EchoNet-Liver detected cirrhosis with an area under the receiver operating characteristic curve (AUROC) of 0.837 (95% CI, 0.828-0.848) and SLD with an AUROC of 0.799 (95% CI, 0.788-0.811).
The algorithm showed a sensitivity of 69.6% and a specificity of 84.6% for detecting cirrhosis, and a sensitivity of 74.1% and a specificity of 72.0% for detecting SLD.
In the Stanford Health Care external-validation test ultrasound cohort, the model detected cirrhosis with an AUROC of 0.830 (95% CI, 0.799-0.859) and SLD with an AUROC of 0.769 (95% CI, 0.733-0.813), with sensitivity and specificity of 80.0% and 70.9%, respectively, for cirrhosis and 66.7% and 78.0%, respectively, for SLD.
In the CSMC MRI-paired cohort, EchoNet-Liver detected cirrhosis with an AUROC of 0.704 (95% CI, 0.699-0.708) and SLD with an AUROC of 0.725 (95% CI, 0.707-0.762).
Identifying Subclinical Liver Disease to Improve Outcomes
“Across diverse populations and disease definitions, deep-learning-enhanced echocardiography enabled high-throughput, automated detection of CLD, which could enable opportunistic screening for asymptomatic liver disease,” the authors wrote.
“By improving the diagnosis of subclinical CLD, we may be able to limit or reverse disease progression and improve care by triaging patients toward appropriate clinical and diagnostic management,” they said.
By way of limitations, the researchers noted that the tool was developed using a cohort of patients who had both abdominal ultrasound and echocardiography within 30 days, and thus probably had a higher prevalence of liver disease compared with the general population receiving echocardiography. The true clinical utility of EchoNet-Liver will depend on whether its application to a general echocardiography population can efficiently detect undiagnosed CLD, they cautioned.
“While we developed this algorithm based on clinical data, the application within the clinic would typically require FDA approval, which we have not yet applied for,” Kwan told this news organization.
“We plan to prospectively validate this algorithm at multiple sites to ensure that application of this algorithm improves patient care without causing excess diagnostic testing, thus providing value to patients and the healthcare system as a whole,” Kwan said.
Funding was provided in part by KAKENHI (Japan Society for the Promotion of Science). Kwan reported receiving consulting fees from InVision.
A version of this article first appeared on Medscape.com.