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CDC: Improvement in breast cancer mortality slower among black women
Breast cancer mortality rates decreased for both white and black women from 2000 to 2014, but the decrease was slower for black women, according to a report by investigators with the Centers for Disease Control and Prevention.
The mortality rate decreased an average of 1.9% per year for white women, compared with an average decrease of 1.5% per year for black women, in an analysis of data from United States Cancer Statistics (USCS). Between 2010 and 2014, breast cancer mortality was 41% higher among black women (29.2 deaths per 100,000 people) than among white women (20.6 deaths per 100,000 population), reported Lisa C. Richardson, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 14;65[40]:1093-8).
Between 1999 and 2004, mortality rates decreased only for white woman older than 50 years.
USCS includes incidence data from the CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program, and mortality data from the National Vital Statistics System.
“When combined with population-based approaches to increase knowledge of family history of cancer, increase physical activity, promote a healthy diet to maintain a healthy bodyweight, and increase screening for breast cancer, targeted treatment interventions could reduce racial disparities in breast cancer,” the investigators said. “A fuller understanding of [breast cancer’s] exact mechanisms might lead to more tailored interventions that could decrease mortality disparities.”
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
Breast cancer mortality rates decreased for both white and black women from 2000 to 2014, but the decrease was slower for black women, according to a report by investigators with the Centers for Disease Control and Prevention.
The mortality rate decreased an average of 1.9% per year for white women, compared with an average decrease of 1.5% per year for black women, in an analysis of data from United States Cancer Statistics (USCS). Between 2010 and 2014, breast cancer mortality was 41% higher among black women (29.2 deaths per 100,000 people) than among white women (20.6 deaths per 100,000 population), reported Lisa C. Richardson, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 14;65[40]:1093-8).
Between 1999 and 2004, mortality rates decreased only for white woman older than 50 years.
USCS includes incidence data from the CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program, and mortality data from the National Vital Statistics System.
“When combined with population-based approaches to increase knowledge of family history of cancer, increase physical activity, promote a healthy diet to maintain a healthy bodyweight, and increase screening for breast cancer, targeted treatment interventions could reduce racial disparities in breast cancer,” the investigators said. “A fuller understanding of [breast cancer’s] exact mechanisms might lead to more tailored interventions that could decrease mortality disparities.”
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
Breast cancer mortality rates decreased for both white and black women from 2000 to 2014, but the decrease was slower for black women, according to a report by investigators with the Centers for Disease Control and Prevention.
The mortality rate decreased an average of 1.9% per year for white women, compared with an average decrease of 1.5% per year for black women, in an analysis of data from United States Cancer Statistics (USCS). Between 2010 and 2014, breast cancer mortality was 41% higher among black women (29.2 deaths per 100,000 people) than among white women (20.6 deaths per 100,000 population), reported Lisa C. Richardson, MD, and her associates at the CDC’s National Center for Chronic Disease Prevention and Health Promotion (MMWR. 2016 Oct 14;65[40]:1093-8).
Between 1999 and 2004, mortality rates decreased only for white woman older than 50 years.
USCS includes incidence data from the CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program, and mortality data from the National Vital Statistics System.
“When combined with population-based approaches to increase knowledge of family history of cancer, increase physical activity, promote a healthy diet to maintain a healthy bodyweight, and increase screening for breast cancer, targeted treatment interventions could reduce racial disparities in breast cancer,” the investigators said. “A fuller understanding of [breast cancer’s] exact mechanisms might lead to more tailored interventions that could decrease mortality disparities.”
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
Key clinical point:
Major finding: The mortality rate decreased an average of 1.9% per year for white women, compared with an average decrease of 1.5% per year for black women.
Data source: United States Cancer Statistics (USCS).
Disclosures: The CDC supported this study.
Laparoscopy comparable to open staging for uterine papillary serous cancer
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
BOSTON – Laparoscopic staging of patients with uterine papillary serous carcinoma is a safe alternative to open staging and may offer some advantages, according to findings presented at the annual Minimally Invasive Surgery Week.
“Traditionally, serous papillary cancer has been treated different than the other endometrial cancers, the reason being is that it tends to behave more like ovarian cancer,” Jeanette Voice, MD, of Richmond University Medical Center in Staten Island, N.Y., said at the meeting, which was held by the Society for Laparoendoscopic Surgeons. “Patients with serous papillary cancer tend to be older [so] these patients may benefit from a less invasive surgical approach.”
Dr. Voice and her coinvestigators conducted an 8-year retrospective study of laparoscopic and open-staged cases treated from March 2007 through May 2015. Initially, 59 patients with pathology-confirmed uterine papillary serous carcinoma were identified over that time period, and were divided into two cohorts: one receiving open surgery (37 patients) and one receiving laparoscopic surgery (22 patients).
Median age, body mass index, and prior abdominal surgery rate were not significantly different between the two cohorts.
In terms of intraoperative factors, median operative times for the open and laparoscopic cohorts were similar: 196 minutes versus 216 minutes, respectively (P = .561). Similarly, the number of pelvic lymph node dissections and rate of omentectomy were also not significantly different: 18 nodes (open) versus 16 nodes (laparoscopic) (P = .96), and 100% (open) versus 91% (laparoscopic) (P = .08).
However, laparoscopic patients had more favorable median estimated blood loss (310 mL versus 175 mL, P = .048) and shorter hospital stays (4 days versus 1 day, P less than .042).
Laparoscopic patients also achieved more robust debulking to zero centimeter residual disease, with 90.5% of patients achieving it versus 65.7% of those in the open surgery cohort, but the difference was not statistically significant (P = .1).
In terms of postoperative adjuvant therapy – brachytherapy, external beam radiation, and chemotherapy – there were no significant differences in outcomes between the two cohorts. Recurrence rates were also similar, with nine recurrences in the open cohort and eight recurrences in the laparoscopic cohort. The estimated 36-month progression-free survival rates were “almost identical,” with 55.3% in the open cohort versus 53.3% in the laparoscopic (P = .727), according to Dr. Voice.
Postoperative complications were more common in the open surgery cohort (29.7%), compared with 13.6% in the laparoscopic cohort, but no statistically significant difference was found between them (P = .16).
Dr. Voice did not report information on financial disclosures.
AT MINIMALLY INVASIVE SURGERY WEEK
Key clinical point:
Major finding: Laparoscopic patients had lower median estimated blood loss (310 mL v. 175 mL, P = .048) and shorter hospital stays (4 days v. 1 day, P less than .042).
Data source: Retrospective review of data on 59 open and laparoscopic patients over 8 years.
Disclosures: Dr. Voice did not report information on financial disclosures.
PD-L1 positivity correlated with pembrolizumab response in advanced melanoma
Programmed death ligand–1 expression correlated positively and significantly with pembrolizumab response in advanced melanoma, based on an analysis of 405 patients from the international, multicohort, open-label phase I KEYNOTE-001 trial.
Among patients for whom 33%-65% of tumor cells expressed PD-L1, the objective rate of response was 57%, but the rate was only 8% among patients whose specimens did not express PD-L1, Adil Daud, MD, of the University of California, San Francisco, and associates reported. Taken together, the findings suggest that melanoma is most likely to respond to pembrolizumab when specimens show at least 10% positivity, the investigators reported (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.67.2477).
Among the 405 patients who also were evaluable for tumor response, the overall objective response rate was 33% (95% confidence interval, 28%-37%). Grouping patients based on the melanoma scoring system for PD-L1 expression showed that PD-L1 positivity correlated significantly with the objective response rate (P less than .001). Furthermore, a higher PD-L1 melanoma score correlated significantly with both progression-free survival (hazard ratio, 0.76; 95% CI, 0.7-0.82) and overall survival (HR, 0.76; 95% CI, 0.69-0.83), with P values less than .001 for each association.
Median progression-free survival was 5.6 months in PD-L1–positive patients and 2.8 months in PD-L1–negative patients, while median overall survival was 30 months in PD-L1–positive patients and 12.6 months in PD-L1–negative patients, the researchers reported. “The high prevalence of PD-L1 positivity observed in this study, along with the durable responses observed in PD-L1–negative tumors, suggest that pembrolizumab treatment should not be limited to patients with PD-L1–positive tumors,” they concluded. “Ongoing clinical trials with correlative studies will further delineate the role of PD-L1 expression in melanoma.”
Merck sponsored the trial. Dr. Daud disclosed ties to Merck, OncoSec, Novartis, Genentech, Bristol-Myers Squibb, and Array BioPharma.
Programmed death ligand–1 expression correlated positively and significantly with pembrolizumab response in advanced melanoma, based on an analysis of 405 patients from the international, multicohort, open-label phase I KEYNOTE-001 trial.
Among patients for whom 33%-65% of tumor cells expressed PD-L1, the objective rate of response was 57%, but the rate was only 8% among patients whose specimens did not express PD-L1, Adil Daud, MD, of the University of California, San Francisco, and associates reported. Taken together, the findings suggest that melanoma is most likely to respond to pembrolizumab when specimens show at least 10% positivity, the investigators reported (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.67.2477).
Among the 405 patients who also were evaluable for tumor response, the overall objective response rate was 33% (95% confidence interval, 28%-37%). Grouping patients based on the melanoma scoring system for PD-L1 expression showed that PD-L1 positivity correlated significantly with the objective response rate (P less than .001). Furthermore, a higher PD-L1 melanoma score correlated significantly with both progression-free survival (hazard ratio, 0.76; 95% CI, 0.7-0.82) and overall survival (HR, 0.76; 95% CI, 0.69-0.83), with P values less than .001 for each association.
Median progression-free survival was 5.6 months in PD-L1–positive patients and 2.8 months in PD-L1–negative patients, while median overall survival was 30 months in PD-L1–positive patients and 12.6 months in PD-L1–negative patients, the researchers reported. “The high prevalence of PD-L1 positivity observed in this study, along with the durable responses observed in PD-L1–negative tumors, suggest that pembrolizumab treatment should not be limited to patients with PD-L1–positive tumors,” they concluded. “Ongoing clinical trials with correlative studies will further delineate the role of PD-L1 expression in melanoma.”
Merck sponsored the trial. Dr. Daud disclosed ties to Merck, OncoSec, Novartis, Genentech, Bristol-Myers Squibb, and Array BioPharma.
Programmed death ligand–1 expression correlated positively and significantly with pembrolizumab response in advanced melanoma, based on an analysis of 405 patients from the international, multicohort, open-label phase I KEYNOTE-001 trial.
Among patients for whom 33%-65% of tumor cells expressed PD-L1, the objective rate of response was 57%, but the rate was only 8% among patients whose specimens did not express PD-L1, Adil Daud, MD, of the University of California, San Francisco, and associates reported. Taken together, the findings suggest that melanoma is most likely to respond to pembrolizumab when specimens show at least 10% positivity, the investigators reported (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.67.2477).
Among the 405 patients who also were evaluable for tumor response, the overall objective response rate was 33% (95% confidence interval, 28%-37%). Grouping patients based on the melanoma scoring system for PD-L1 expression showed that PD-L1 positivity correlated significantly with the objective response rate (P less than .001). Furthermore, a higher PD-L1 melanoma score correlated significantly with both progression-free survival (hazard ratio, 0.76; 95% CI, 0.7-0.82) and overall survival (HR, 0.76; 95% CI, 0.69-0.83), with P values less than .001 for each association.
Median progression-free survival was 5.6 months in PD-L1–positive patients and 2.8 months in PD-L1–negative patients, while median overall survival was 30 months in PD-L1–positive patients and 12.6 months in PD-L1–negative patients, the researchers reported. “The high prevalence of PD-L1 positivity observed in this study, along with the durable responses observed in PD-L1–negative tumors, suggest that pembrolizumab treatment should not be limited to patients with PD-L1–positive tumors,” they concluded. “Ongoing clinical trials with correlative studies will further delineate the role of PD-L1 expression in melanoma.”
Merck sponsored the trial. Dr. Daud disclosed ties to Merck, OncoSec, Novartis, Genentech, Bristol-Myers Squibb, and Array BioPharma.
Key clinical point: PD-L1 expression correlates with pembrolizumab response in advanced melanoma.
Major finding: Higher levels of PD-L1 staining correlated positively with tumor response (P less than .001).
Data source: Analyses of 405 patients from KEYNOTE-001, an international, multicohort, open-label phase I trial of pembrolizumab in advanced melanoma.
Disclosures: Merck sponsored the trial. Dr. Daud disclosed ties to Merck, OncoSec, Novartis, Genentech, Bristol-Myers Squibb, and Array BioPharma.
Registry helps track pelvic organ prolapse outcomes in the U.S.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
AT PFD WEEK 2016
Pembrolizumab boosts response but not survival in small study of advanced NSCLC
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
Key clinical point: Adding pembrolizumab to platinum-based chemotherapy for upfront therapy of advanced NSCLC nearly doubled response rates.
Major finding: The overall response rate in the pembrolizumab/chemo group was 55% vs. 29% for chemotherapy alone (P = .0016)
Data source: Phase II randomized, open-label trial in 123 patients with untreated stage IIIB or IV nonsquamous NSCLC.
Disclosures: The study was funded by Merck, Sharp, and Dohme. Dr. Langer disclosed research funding from the company. Dr. Soria disclosed financial relationships (consulting/honoraria, research funding) with several companies, but not Merck.
Surgical Risks From Systemic Psoriasis Therapies
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
Scalp Psoriasis: Weighing Treatment Options
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Pharmacists urge more focus on kidney disease indicator
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
AT THE ANNUAL MEETING OF AADE
STIM1 long-term follow-up confirms imatinib discontinuation safety
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: The rate of molecular recurrence-free survival overall was 43% at 24 months, 40% at 18 months, and 38% at 60 months.
Data source: Long-term follow-up of 100 patients from the STIM1 trial.
Disclosures: STIM1 was supported by grants from the French Ministry of Health Programme Hospitalier de Recherche and by the Institut National du Cancer. Dr. Etienne reported financial relationships with Novartis, Bristol-Myers Squibb, and ARIAD Pharmaceuticals. Coauthors reported relationships with several pharmaceutical companies.
2016 Pediatric Hospital Medicine Award Winners Announced
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”