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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Fast-track catheter management offers little benefit after benign hysterectomy
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
REPORTING FROM SGS 2018
Key clinical point: Fast-track catheter management after surgery improves dwell time, but not other outcomes.
Major finding: Catheter dwell times were 650 versus 1,196 minutes with fast-track and conventional management, respectively.
Study details: A prospective, randomized study of 200 women.
Disclosures: Dr. Lang reported having no disclosures.
Source: Lang P et al. SGS 2018, Oral Poster 20.
Study: No increased risk of serious AEs with combined urogyn/gyn onc surgery
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
REPORTING FROM SGS 2018
Key clinical point: Concurrent urogynecologic/gynecologic oncology surgery does not increase the risk of serious adverse events.
Major finding: Concurrent surgery patients had more grade 2 complications (44% vs. 19%).
Study details: A retrospective study of 108 cases and 216 matched controls.
Disclosures: Dr. Davidson and Dr. Noone each reported having no disclosures.
Source: Davidson ER et al. SGS 2018, Oral Presentation 13.
Checkpoint inhibition less toxic than antiangiogenic therapy in NSCLC
ORLANDO – , a systematic review and meta-analysis suggests.
In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.
For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.
The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.
The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.
Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.
“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.
This study was supported by the China Medical University Beigang Hospital.
sworcester@frontlinemedcom.com
SOURCE: Hsu C et al. NCCN poster 13
ORLANDO – , a systematic review and meta-analysis suggests.
In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.
For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.
The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.
The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.
Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.
“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.
This study was supported by the China Medical University Beigang Hospital.
sworcester@frontlinemedcom.com
SOURCE: Hsu C et al. NCCN poster 13
ORLANDO – , a systematic review and meta-analysis suggests.
In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.
For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.
The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.
The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.
Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.
“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.
This study was supported by the China Medical University Beigang Hospital.
sworcester@frontlinemedcom.com
SOURCE: Hsu C et al. NCCN poster 13
REPORTING FROM THE NCCN ANNUAL CONFERENCE
Key clinical point: Checkpoint blockade appears less toxic than antiangiogenic therapies in advanced NSCLC
Major finding: Less toxicity was seen with first-line nivolumab or pembrolizumab vs. sorafenib + platinum doublets (odds ratios, 0.08 and 0.12, respectively).
Study details: A systematic review and meta-analysis of 37 trials involving 16,810 patients.
Disclosures: The study was supported by the China Medical University Beigang Hospital.
Source: Hsu C et al. NCCN poster 13.
HDAC inhibition may boost immune therapy efficacy in breast cancer
ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.
Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Responses were seen in all 3 DL1 patients, 12 of 14 DL2 patients, 3 of 4 DL3 patients, and 2 of 9 (with 4 pending first restaging) DL4 patients. Dose-limiting toxicities included one case of pneumonitis at DL2 and an allergic reaction in one DL4 patient, said Dr. Connolly of Johns Hopkins University, Baltimore.
The most common treatment-associated adverse events occurring in 6 or more patients included anemia, fatigue, neutropenia, nausea, and rash, with each occurring in 12 to 22 patients, including grade 3 anemia in 7 patients, grade 3 fatigue in 4 patients, and grade 3 neutropenia in 5 patients. Grade 4 adverse events included lymphopenia in one patient and elevated lipase in one patient, she said.
Possible immune-related adverse events included hypothyroidism in 2 DL2 patients and 3 DL3 patients, hyperthyroidism in 1 DL3 patient, colitis in 1 DL2 and 1 DL3 patient, pneumonitis in 4 DL2 patients, rash in 10 DL2-DL4 patients, and meningoencephalitis and myasthenia gravis in 1 DL3 patient.
Study participants were adults with a mean age of 60 years with metastatic or unresectable solid tumors for which standard treatments did not exist or were no longer effective, or for which treatment with anti–programmed cell death ligand1/cytotoxic T-lymphocyte antigen 4 treatment was appropriate. All had good performance status and adequate organ and pulmonary function, less than 30% liver involvement, and any brain metastases were stable. Those with active autoimmune disease or a history of autoimmune disease that might recur were excluded, as were patients treated within 14 days of enrollment.
“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”
There may be other mechanisms for this activity as well, she noted.
The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.
“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.
Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.
These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.
The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.
However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.
Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.
This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures
SOURCE: Connolly RM et al. NCCN, Poster 3.
ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.
Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Responses were seen in all 3 DL1 patients, 12 of 14 DL2 patients, 3 of 4 DL3 patients, and 2 of 9 (with 4 pending first restaging) DL4 patients. Dose-limiting toxicities included one case of pneumonitis at DL2 and an allergic reaction in one DL4 patient, said Dr. Connolly of Johns Hopkins University, Baltimore.
The most common treatment-associated adverse events occurring in 6 or more patients included anemia, fatigue, neutropenia, nausea, and rash, with each occurring in 12 to 22 patients, including grade 3 anemia in 7 patients, grade 3 fatigue in 4 patients, and grade 3 neutropenia in 5 patients. Grade 4 adverse events included lymphopenia in one patient and elevated lipase in one patient, she said.
Possible immune-related adverse events included hypothyroidism in 2 DL2 patients and 3 DL3 patients, hyperthyroidism in 1 DL3 patient, colitis in 1 DL2 and 1 DL3 patient, pneumonitis in 4 DL2 patients, rash in 10 DL2-DL4 patients, and meningoencephalitis and myasthenia gravis in 1 DL3 patient.
Study participants were adults with a mean age of 60 years with metastatic or unresectable solid tumors for which standard treatments did not exist or were no longer effective, or for which treatment with anti–programmed cell death ligand1/cytotoxic T-lymphocyte antigen 4 treatment was appropriate. All had good performance status and adequate organ and pulmonary function, less than 30% liver involvement, and any brain metastases were stable. Those with active autoimmune disease or a history of autoimmune disease that might recur were excluded, as were patients treated within 14 days of enrollment.
“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”
There may be other mechanisms for this activity as well, she noted.
The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.
“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.
Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.
These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.
The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.
However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.
Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.
This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures
SOURCE: Connolly RM et al. NCCN, Poster 3.
ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.
Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Responses were seen in all 3 DL1 patients, 12 of 14 DL2 patients, 3 of 4 DL3 patients, and 2 of 9 (with 4 pending first restaging) DL4 patients. Dose-limiting toxicities included one case of pneumonitis at DL2 and an allergic reaction in one DL4 patient, said Dr. Connolly of Johns Hopkins University, Baltimore.
The most common treatment-associated adverse events occurring in 6 or more patients included anemia, fatigue, neutropenia, nausea, and rash, with each occurring in 12 to 22 patients, including grade 3 anemia in 7 patients, grade 3 fatigue in 4 patients, and grade 3 neutropenia in 5 patients. Grade 4 adverse events included lymphopenia in one patient and elevated lipase in one patient, she said.
Possible immune-related adverse events included hypothyroidism in 2 DL2 patients and 3 DL3 patients, hyperthyroidism in 1 DL3 patient, colitis in 1 DL2 and 1 DL3 patient, pneumonitis in 4 DL2 patients, rash in 10 DL2-DL4 patients, and meningoencephalitis and myasthenia gravis in 1 DL3 patient.
Study participants were adults with a mean age of 60 years with metastatic or unresectable solid tumors for which standard treatments did not exist or were no longer effective, or for which treatment with anti–programmed cell death ligand1/cytotoxic T-lymphocyte antigen 4 treatment was appropriate. All had good performance status and adequate organ and pulmonary function, less than 30% liver involvement, and any brain metastases were stable. Those with active autoimmune disease or a history of autoimmune disease that might recur were excluded, as were patients treated within 14 days of enrollment.
“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”
There may be other mechanisms for this activity as well, she noted.
The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.
“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.
Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.
These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.
The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.
However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.
Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.
This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures
SOURCE: Connolly RM et al. NCCN, Poster 3.
REPORTING FROM THE NCCN ANNUAL CONFERENCE
Key clinical point:
Major finding: Three patients had a partial response, 12 had stable disease, 5 progressed.
Study details: A phase 1 dose-expansion study involving 30 patients.
Disclosures: This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, and by a V Foundation award. Dr. Connolly reported having no disclosures.
Source: Connolly RM et al. NCCN, Poster 3.
Sling revisions: pain as indication linked with SUI recurrence
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
REPORTING FROM SGS 2018
Key clinical point: Sling revisions for pain may increase the risk of postoperative stress urinary incontinence recurrence.
Major finding: The recurrent SUI rate after revision was 39.5% overall vs. 70% among those with pain as an indication.
Study details: A retrospective cohort study of 129 women.
Disclosures: Dr. Cramer reported having no disclosures.
Source: Cramer MS et al. SGS 2018, Oral Presentation 04.
CBC data can predict immunotherapy responses in NSCLC
ORLANDO – Information readily available on complete blood count can help predict response to immunotherapy and outcomes in patients with advanced non–small cell lung cancer, according to findings from a review of 157 cases.
Specifically, absolute monocyte count of 0.63 or greater and absolute neutrophil count/absolute lymphocyte count of 5.9 or greater at baseline were significantly associated with poor progression-free survival (hazard ratios, 1.50 and 1.61, respectively) and overall survival (HRs, 1.71 and 1.87, respectively) in patients treated with anti–programmed death-1 (PD-1) antibodies, Aixa E. Soyano, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Additionally, absolute neutrophil count of at least 7.5 and myeloid to lymphoid ratio of at least 11.3 at baseline were associated with poor overall survival (HRs, 1.86 and 2.31, respectively), according to Dr. Soyano of the Mayo Clinic, Jacksonville, Fla.
“The potential predictive value of these readily available biomarkers might help with risk stratification and treatment strategies,” she and her colleagues wrote.
Cases included in the review involved advanced non–small cell lung cancer (NSCLC) patients with a median age of 66 years who were treated with nivolumab or pembrolizumab at the Mayo Clinic from January 2010 to April 2017. Most (91%) were white, 4.5% were African American, 1.9% were Asian, 0.6% were native Hawaiian/Pacific Islander, and 1.9% were other ethnicities. Slightly more than half (53%) were men, and diagnoses included adenocarcinoma (69%), squamous disease (29%) and other (3%). Half had one prior line of chemotherapy, 22% had two prior lines, and 10% had three or more prior lines. The majority (72%) had Eastern Cooperative Oncology Group performance status of 1 or 2, and 34% had CNS disease.
Pembrolizumab was given intravenously at a dose of 2 mg/kg every 21 days (11 patients), and nivolumab was given intravenously at a dose of 3 mg/kg every 14 days (146 patients). Clinical response was assessed every 8-12 weeks by CT of the chest, abdomen and pelvis, and also – in some cases – by brain MRI.
The findings are notable because, although combination chemotherapy with a platinum-based doublet has, for the last decade, been the backbone of initial systemic therapy for patients whose tumor does not have driver mutations, monoclonal antibodies targeting PD-1 or its ligand PD-L1 have shown improvements in progression-free survival and overall survival in certain patients with metastatic or locally advanced lung cancer, the investigators explained.
Prior studies in melanoma patients treated with immunotherapy targeting the cytotoxic T-lymphocyte antigen 4 pathway and PD-1/PD-L1 pathways have identified predictive or prognostic hematological markers of outcomes. However, data with respect to hematologic markers in lung cancer are sparse, and given the high cost, significant immune-related side effects, and rapidly expanding number of indications for immunotherapy in NSCLC, there is a need for reliable biomarkers to help predict response and outcomes, they said.
In a separate presentation at the NCCN conference, John A. Thompson, MD, of the Fred Hutchinson Cancer Research Center, Seattle, noted that some progress has been made in the area of predicting response to immune checkpoint inhibitors in NSCLC patients. Namely, the value of tumor PD-L1 expression and tumor mutation burden for predicting outcomes was highlighted in a recent study by Rizvi et al., who concluded that “the incorporation of both TMB [tumor mutation burden] and PD-L1 expression into multivariable predictive models should result in greater predictive power.” .
“This is a first step in our evolution and our progress toward a better biomarker. I think when we add in other factors like gene expression, we may be able to develop an even more robust biomarker that will help us select appropriate patients for therapy,” he said.
Dr. Soyano and her colleagues noted, however, that these measures, as well as tumor infiltrating immune cells, which have also been shown to have predictive value, require special testing and/or processing.
Furthermore, the optimal cutoff with PD-L1 expression is debatable, they said.
CBC data is more readily available, and also appears to have predictive and prognostic value, they said, concluding that the findings warrant further investigation in a larger, prospective study.
The authors reported having no disclosures.
sworcester@frontlinemedcom.com
SOURCE: Soyano A et al. NCCN Poster 075.
ORLANDO – Information readily available on complete blood count can help predict response to immunotherapy and outcomes in patients with advanced non–small cell lung cancer, according to findings from a review of 157 cases.
Specifically, absolute monocyte count of 0.63 or greater and absolute neutrophil count/absolute lymphocyte count of 5.9 or greater at baseline were significantly associated with poor progression-free survival (hazard ratios, 1.50 and 1.61, respectively) and overall survival (HRs, 1.71 and 1.87, respectively) in patients treated with anti–programmed death-1 (PD-1) antibodies, Aixa E. Soyano, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Additionally, absolute neutrophil count of at least 7.5 and myeloid to lymphoid ratio of at least 11.3 at baseline were associated with poor overall survival (HRs, 1.86 and 2.31, respectively), according to Dr. Soyano of the Mayo Clinic, Jacksonville, Fla.
“The potential predictive value of these readily available biomarkers might help with risk stratification and treatment strategies,” she and her colleagues wrote.
Cases included in the review involved advanced non–small cell lung cancer (NSCLC) patients with a median age of 66 years who were treated with nivolumab or pembrolizumab at the Mayo Clinic from January 2010 to April 2017. Most (91%) were white, 4.5% were African American, 1.9% were Asian, 0.6% were native Hawaiian/Pacific Islander, and 1.9% were other ethnicities. Slightly more than half (53%) were men, and diagnoses included adenocarcinoma (69%), squamous disease (29%) and other (3%). Half had one prior line of chemotherapy, 22% had two prior lines, and 10% had three or more prior lines. The majority (72%) had Eastern Cooperative Oncology Group performance status of 1 or 2, and 34% had CNS disease.
Pembrolizumab was given intravenously at a dose of 2 mg/kg every 21 days (11 patients), and nivolumab was given intravenously at a dose of 3 mg/kg every 14 days (146 patients). Clinical response was assessed every 8-12 weeks by CT of the chest, abdomen and pelvis, and also – in some cases – by brain MRI.
The findings are notable because, although combination chemotherapy with a platinum-based doublet has, for the last decade, been the backbone of initial systemic therapy for patients whose tumor does not have driver mutations, monoclonal antibodies targeting PD-1 or its ligand PD-L1 have shown improvements in progression-free survival and overall survival in certain patients with metastatic or locally advanced lung cancer, the investigators explained.
Prior studies in melanoma patients treated with immunotherapy targeting the cytotoxic T-lymphocyte antigen 4 pathway and PD-1/PD-L1 pathways have identified predictive or prognostic hematological markers of outcomes. However, data with respect to hematologic markers in lung cancer are sparse, and given the high cost, significant immune-related side effects, and rapidly expanding number of indications for immunotherapy in NSCLC, there is a need for reliable biomarkers to help predict response and outcomes, they said.
In a separate presentation at the NCCN conference, John A. Thompson, MD, of the Fred Hutchinson Cancer Research Center, Seattle, noted that some progress has been made in the area of predicting response to immune checkpoint inhibitors in NSCLC patients. Namely, the value of tumor PD-L1 expression and tumor mutation burden for predicting outcomes was highlighted in a recent study by Rizvi et al., who concluded that “the incorporation of both TMB [tumor mutation burden] and PD-L1 expression into multivariable predictive models should result in greater predictive power.” .
“This is a first step in our evolution and our progress toward a better biomarker. I think when we add in other factors like gene expression, we may be able to develop an even more robust biomarker that will help us select appropriate patients for therapy,” he said.
Dr. Soyano and her colleagues noted, however, that these measures, as well as tumor infiltrating immune cells, which have also been shown to have predictive value, require special testing and/or processing.
Furthermore, the optimal cutoff with PD-L1 expression is debatable, they said.
CBC data is more readily available, and also appears to have predictive and prognostic value, they said, concluding that the findings warrant further investigation in a larger, prospective study.
The authors reported having no disclosures.
sworcester@frontlinemedcom.com
SOURCE: Soyano A et al. NCCN Poster 075.
ORLANDO – Information readily available on complete blood count can help predict response to immunotherapy and outcomes in patients with advanced non–small cell lung cancer, according to findings from a review of 157 cases.
Specifically, absolute monocyte count of 0.63 or greater and absolute neutrophil count/absolute lymphocyte count of 5.9 or greater at baseline were significantly associated with poor progression-free survival (hazard ratios, 1.50 and 1.61, respectively) and overall survival (HRs, 1.71 and 1.87, respectively) in patients treated with anti–programmed death-1 (PD-1) antibodies, Aixa E. Soyano, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.
Additionally, absolute neutrophil count of at least 7.5 and myeloid to lymphoid ratio of at least 11.3 at baseline were associated with poor overall survival (HRs, 1.86 and 2.31, respectively), according to Dr. Soyano of the Mayo Clinic, Jacksonville, Fla.
“The potential predictive value of these readily available biomarkers might help with risk stratification and treatment strategies,” she and her colleagues wrote.
Cases included in the review involved advanced non–small cell lung cancer (NSCLC) patients with a median age of 66 years who were treated with nivolumab or pembrolizumab at the Mayo Clinic from January 2010 to April 2017. Most (91%) were white, 4.5% were African American, 1.9% were Asian, 0.6% were native Hawaiian/Pacific Islander, and 1.9% were other ethnicities. Slightly more than half (53%) were men, and diagnoses included adenocarcinoma (69%), squamous disease (29%) and other (3%). Half had one prior line of chemotherapy, 22% had two prior lines, and 10% had three or more prior lines. The majority (72%) had Eastern Cooperative Oncology Group performance status of 1 or 2, and 34% had CNS disease.
Pembrolizumab was given intravenously at a dose of 2 mg/kg every 21 days (11 patients), and nivolumab was given intravenously at a dose of 3 mg/kg every 14 days (146 patients). Clinical response was assessed every 8-12 weeks by CT of the chest, abdomen and pelvis, and also – in some cases – by brain MRI.
The findings are notable because, although combination chemotherapy with a platinum-based doublet has, for the last decade, been the backbone of initial systemic therapy for patients whose tumor does not have driver mutations, monoclonal antibodies targeting PD-1 or its ligand PD-L1 have shown improvements in progression-free survival and overall survival in certain patients with metastatic or locally advanced lung cancer, the investigators explained.
Prior studies in melanoma patients treated with immunotherapy targeting the cytotoxic T-lymphocyte antigen 4 pathway and PD-1/PD-L1 pathways have identified predictive or prognostic hematological markers of outcomes. However, data with respect to hematologic markers in lung cancer are sparse, and given the high cost, significant immune-related side effects, and rapidly expanding number of indications for immunotherapy in NSCLC, there is a need for reliable biomarkers to help predict response and outcomes, they said.
In a separate presentation at the NCCN conference, John A. Thompson, MD, of the Fred Hutchinson Cancer Research Center, Seattle, noted that some progress has been made in the area of predicting response to immune checkpoint inhibitors in NSCLC patients. Namely, the value of tumor PD-L1 expression and tumor mutation burden for predicting outcomes was highlighted in a recent study by Rizvi et al., who concluded that “the incorporation of both TMB [tumor mutation burden] and PD-L1 expression into multivariable predictive models should result in greater predictive power.” .
“This is a first step in our evolution and our progress toward a better biomarker. I think when we add in other factors like gene expression, we may be able to develop an even more robust biomarker that will help us select appropriate patients for therapy,” he said.
Dr. Soyano and her colleagues noted, however, that these measures, as well as tumor infiltrating immune cells, which have also been shown to have predictive value, require special testing and/or processing.
Furthermore, the optimal cutoff with PD-L1 expression is debatable, they said.
CBC data is more readily available, and also appears to have predictive and prognostic value, they said, concluding that the findings warrant further investigation in a larger, prospective study.
The authors reported having no disclosures.
sworcester@frontlinemedcom.com
SOURCE: Soyano A et al. NCCN Poster 075.
REPORTING FROM THE NCCN ANNUAL CONFERENCE
Key clinical point:
Major finding: Hazard ratios for progression-free survival were 1.50 and 1.61 with absolute monocyte count of 0.63 or greater, absolute neutrophil count/absolute lymphocyte of 5.9 or greater at baseline.
Study details: A review of 157 NSCLC cases.
Disclosures: The authors reported having no disclosures.
Source: Soyano AE et al. NCCN poster 075.
Xenon imaging could detect lung involvement after HSCT
SALT LAKE CITY – Hyperpolarized xenon-129 magnetic resonance imaging, or 129Xe MRI, showed strong promise for revealing early lung ventilation deficits in pediatric hematopoietic stem cell transplant (HSCT) patients in a proof-of-concept study.
The use of hyperpolarized xenon gas in this setting remains investigational, but is emerging as a safe non-ionizing approach for mapping and quantifying regional airway obstruction in the pediatric population. It has been shown to be more sensitive to early disease than the current clinical gold standard of measuring forced expiratory volume in 1 second (FEV1) by spirometry, Laura L. Walkup, PhD, said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The 129Xe MRI provides regional information that spirometry cannot, allowing for a targeted approach to planned procedures such as bronchoscopy, said Dr. Walkup of Cincinnati Children’s Hospital Medical Center.
“We hypothesized that hyperpolarized 129Xe MRI would be sensitive to lung abnormalities in the pediatric HSCT population,” she said.
Of 13 patients aged 6-13 years (mean, 10 years) who were enrolled in the study and underwent 129XeMRI, 9 also completed spirometry successfully, and the average FEV1 in those patients was 83% of the predicted value.
Ventilation deficits were apparent on the 129Xe MRI imaging in 8 of the 13 subjects and varied in regional distribution. The whole-lung 129Xe ventilation defect percentage for the HSCT group was 14%, which was significantly greater than the approximately 6% ventilation defect percentage in a cohort of age-matched controls, Dr. Walkup said, noting that ventilation deficits were seen in three of four subjects who were unable to complete reliable spirometry.
“So those are lung abnormalities that may have otherwise gone undetected,” she said, adding that hyperpolarized xenon gas also highlighted the wide individual variation in ventilation, even among cases with similar FEV1 percentages.
The findings are notable, because pulmonary complications such as bronchiolitis obliterans are a major source of morbidity and mortality in the pediatric HSCT population, and an accurate and early diagnostic tool identifying the location and severity of suspected obstructive lung pathology following HSCT is desperately needed, she said.
The HSCT patients in the current study included four boys and nine girls. Isotopically-enriched xenon gas (86% 129Xe) was hyperpolarized using a commercial polarizer and images were acquired during a breath hold of up to 16 seconds and up to 1 L of xenon gas. Conventional anatomic MR images also were acquired.
The 129Xe ventilation was quantified using a less than 60% mean whole-lung 129Xe signal threshold, and was compared to FEV1 percentage predicted as measured via spirometry.
The procedure was well tolerated by all patients, Dr. Walkup said, noting that no patients withdrew from the study, and all were able to maintain the required breath hold.
Drops in blood oxygen saturation level did occur, but were transient and resolved within 10-30 seconds of normal breathing. Further, there were no changes in heart rate during imaging, and any side effects related to xenon, such as tingling in extremities, dizziness, or euphoria, were also quickly resolved with normal breathing, she said.
“There were no serious adverse events related to the study ... these results are in good agreement with previously published safety assessments of xenon in kids and in adults, and at our institution we routinely perform xenon imaging in children as young as age 6,” she added.
The findings, which are consistent with those seen in studies of other conditions such as cystic fibrosis, asthma, and chronic obstructive pulmonary disease, suggest that 129Xe MRI is an emerging modality with strong translational potential for detecting early pulmonary involvement following HSCT, she said.
“The real power of the xenon MRI is the spatial information that it provides; we can use that information to plan targeted procedures like bronchoscopy and biopsies ... and since it is non-ionizing, it may be used serially to assess disease progression or response to an intervention,” Dr. Walkup said.
She noted, however, that because it is not yet approved by the Food and Drug Administration, and because it requires specialized expertise and hardware, it is available at only a handful of centers worldwide.
There is a long way to go before the technology will be widely clinically implemented, but work is ongoing at Cincinnati Children’s Hospital to determine how xenon MRI may play a role in pulmonary screening of patients, she said.
Dr. Walkup reported having no financial disclosures.
SOURCE: Walkup L et al. 2018 BMT Tandem Meetings Abstract 56.
SALT LAKE CITY – Hyperpolarized xenon-129 magnetic resonance imaging, or 129Xe MRI, showed strong promise for revealing early lung ventilation deficits in pediatric hematopoietic stem cell transplant (HSCT) patients in a proof-of-concept study.
The use of hyperpolarized xenon gas in this setting remains investigational, but is emerging as a safe non-ionizing approach for mapping and quantifying regional airway obstruction in the pediatric population. It has been shown to be more sensitive to early disease than the current clinical gold standard of measuring forced expiratory volume in 1 second (FEV1) by spirometry, Laura L. Walkup, PhD, said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The 129Xe MRI provides regional information that spirometry cannot, allowing for a targeted approach to planned procedures such as bronchoscopy, said Dr. Walkup of Cincinnati Children’s Hospital Medical Center.
“We hypothesized that hyperpolarized 129Xe MRI would be sensitive to lung abnormalities in the pediatric HSCT population,” she said.
Of 13 patients aged 6-13 years (mean, 10 years) who were enrolled in the study and underwent 129XeMRI, 9 also completed spirometry successfully, and the average FEV1 in those patients was 83% of the predicted value.
Ventilation deficits were apparent on the 129Xe MRI imaging in 8 of the 13 subjects and varied in regional distribution. The whole-lung 129Xe ventilation defect percentage for the HSCT group was 14%, which was significantly greater than the approximately 6% ventilation defect percentage in a cohort of age-matched controls, Dr. Walkup said, noting that ventilation deficits were seen in three of four subjects who were unable to complete reliable spirometry.
“So those are lung abnormalities that may have otherwise gone undetected,” she said, adding that hyperpolarized xenon gas also highlighted the wide individual variation in ventilation, even among cases with similar FEV1 percentages.
The findings are notable, because pulmonary complications such as bronchiolitis obliterans are a major source of morbidity and mortality in the pediatric HSCT population, and an accurate and early diagnostic tool identifying the location and severity of suspected obstructive lung pathology following HSCT is desperately needed, she said.
The HSCT patients in the current study included four boys and nine girls. Isotopically-enriched xenon gas (86% 129Xe) was hyperpolarized using a commercial polarizer and images were acquired during a breath hold of up to 16 seconds and up to 1 L of xenon gas. Conventional anatomic MR images also were acquired.
The 129Xe ventilation was quantified using a less than 60% mean whole-lung 129Xe signal threshold, and was compared to FEV1 percentage predicted as measured via spirometry.
The procedure was well tolerated by all patients, Dr. Walkup said, noting that no patients withdrew from the study, and all were able to maintain the required breath hold.
Drops in blood oxygen saturation level did occur, but were transient and resolved within 10-30 seconds of normal breathing. Further, there were no changes in heart rate during imaging, and any side effects related to xenon, such as tingling in extremities, dizziness, or euphoria, were also quickly resolved with normal breathing, she said.
“There were no serious adverse events related to the study ... these results are in good agreement with previously published safety assessments of xenon in kids and in adults, and at our institution we routinely perform xenon imaging in children as young as age 6,” she added.
The findings, which are consistent with those seen in studies of other conditions such as cystic fibrosis, asthma, and chronic obstructive pulmonary disease, suggest that 129Xe MRI is an emerging modality with strong translational potential for detecting early pulmonary involvement following HSCT, she said.
“The real power of the xenon MRI is the spatial information that it provides; we can use that information to plan targeted procedures like bronchoscopy and biopsies ... and since it is non-ionizing, it may be used serially to assess disease progression or response to an intervention,” Dr. Walkup said.
She noted, however, that because it is not yet approved by the Food and Drug Administration, and because it requires specialized expertise and hardware, it is available at only a handful of centers worldwide.
There is a long way to go before the technology will be widely clinically implemented, but work is ongoing at Cincinnati Children’s Hospital to determine how xenon MRI may play a role in pulmonary screening of patients, she said.
Dr. Walkup reported having no financial disclosures.
SOURCE: Walkup L et al. 2018 BMT Tandem Meetings Abstract 56.
SALT LAKE CITY – Hyperpolarized xenon-129 magnetic resonance imaging, or 129Xe MRI, showed strong promise for revealing early lung ventilation deficits in pediatric hematopoietic stem cell transplant (HSCT) patients in a proof-of-concept study.
The use of hyperpolarized xenon gas in this setting remains investigational, but is emerging as a safe non-ionizing approach for mapping and quantifying regional airway obstruction in the pediatric population. It has been shown to be more sensitive to early disease than the current clinical gold standard of measuring forced expiratory volume in 1 second (FEV1) by spirometry, Laura L. Walkup, PhD, said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The 129Xe MRI provides regional information that spirometry cannot, allowing for a targeted approach to planned procedures such as bronchoscopy, said Dr. Walkup of Cincinnati Children’s Hospital Medical Center.
“We hypothesized that hyperpolarized 129Xe MRI would be sensitive to lung abnormalities in the pediatric HSCT population,” she said.
Of 13 patients aged 6-13 years (mean, 10 years) who were enrolled in the study and underwent 129XeMRI, 9 also completed spirometry successfully, and the average FEV1 in those patients was 83% of the predicted value.
Ventilation deficits were apparent on the 129Xe MRI imaging in 8 of the 13 subjects and varied in regional distribution. The whole-lung 129Xe ventilation defect percentage for the HSCT group was 14%, which was significantly greater than the approximately 6% ventilation defect percentage in a cohort of age-matched controls, Dr. Walkup said, noting that ventilation deficits were seen in three of four subjects who were unable to complete reliable spirometry.
“So those are lung abnormalities that may have otherwise gone undetected,” she said, adding that hyperpolarized xenon gas also highlighted the wide individual variation in ventilation, even among cases with similar FEV1 percentages.
The findings are notable, because pulmonary complications such as bronchiolitis obliterans are a major source of morbidity and mortality in the pediatric HSCT population, and an accurate and early diagnostic tool identifying the location and severity of suspected obstructive lung pathology following HSCT is desperately needed, she said.
The HSCT patients in the current study included four boys and nine girls. Isotopically-enriched xenon gas (86% 129Xe) was hyperpolarized using a commercial polarizer and images were acquired during a breath hold of up to 16 seconds and up to 1 L of xenon gas. Conventional anatomic MR images also were acquired.
The 129Xe ventilation was quantified using a less than 60% mean whole-lung 129Xe signal threshold, and was compared to FEV1 percentage predicted as measured via spirometry.
The procedure was well tolerated by all patients, Dr. Walkup said, noting that no patients withdrew from the study, and all were able to maintain the required breath hold.
Drops in blood oxygen saturation level did occur, but were transient and resolved within 10-30 seconds of normal breathing. Further, there were no changes in heart rate during imaging, and any side effects related to xenon, such as tingling in extremities, dizziness, or euphoria, were also quickly resolved with normal breathing, she said.
“There were no serious adverse events related to the study ... these results are in good agreement with previously published safety assessments of xenon in kids and in adults, and at our institution we routinely perform xenon imaging in children as young as age 6,” she added.
The findings, which are consistent with those seen in studies of other conditions such as cystic fibrosis, asthma, and chronic obstructive pulmonary disease, suggest that 129Xe MRI is an emerging modality with strong translational potential for detecting early pulmonary involvement following HSCT, she said.
“The real power of the xenon MRI is the spatial information that it provides; we can use that information to plan targeted procedures like bronchoscopy and biopsies ... and since it is non-ionizing, it may be used serially to assess disease progression or response to an intervention,” Dr. Walkup said.
She noted, however, that because it is not yet approved by the Food and Drug Administration, and because it requires specialized expertise and hardware, it is available at only a handful of centers worldwide.
There is a long way to go before the technology will be widely clinically implemented, but work is ongoing at Cincinnati Children’s Hospital to determine how xenon MRI may play a role in pulmonary screening of patients, she said.
Dr. Walkup reported having no financial disclosures.
SOURCE: Walkup L et al. 2018 BMT Tandem Meetings Abstract 56.
REPORTING FROM THE 2018 BMT TANDEM MEETINGS
Key clinical point: Hyperpolarized 129Xe MRI shows promise for revealing lung ventilation deficits in pediatric HSCT patients.
Major finding: The whole-lung 129Xe ventilation defect percentage was 14% for HSCT group versus 6% for controls; deficits were seen in three of four subjects who were who were unable to complete reliable spirometry.
Study details: A proof-of-concept study involving 13 children.
Disclosures: Dr. Walkup reported having no financial disclosures.
Source: Walkup L et al. 2018 BMT Tandem Meetings. Abstract 56.
Survey: Litigation fears drive response to FDA power morcellator warnings
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
REPORTING FROM SGS 2018
Key clinical point: Litigation fears drove decline in power morcellation after FDA warning.
Study details: A survey of 126 physicians.
Disclosures: Dr. Taylor reported having no disclosures.
Source: Taylor GB et al. SGS 2018, Oral Poster 19.
High MIH case volume may up risk for adverse events in women with large uteri
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
sworcester@frontlinemedcom.com
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
sworcester@frontlinemedcom.com
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
sworcester@frontlinemedcom.com
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
REPORTING FROM SGS 2018
Key clinical point: High case volume may increase risk for adverse events during minimally invasive hysterectomy with large uteri.
Major finding: MIH volume, estimated blood loss, and operative time were associated with intraoperative adverse events (odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (ORs, 1.3, 1.4, and 1.9, respectively).
Study details: A retrospective cohort study of 763 women.
Disclosures: Dr. Bretschneider reported having no relevant disclosures.
Source: Bretschneider C et al. SGS 2018, Oral Poster 12.
Laparoscopic hysterectomy safest even for markedly enlarged uteri
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
sworcester@frontlinemedcom.com
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
sworcester@frontlinemedcom.com
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
sworcester@frontlinemedcom.com
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
REPORTING FROM SGS 2018
Key clinical point: Laparoscopic hysterectomy can and should be offered to women with uteri over 500 g.
Major finding: The odds ratios for complications after laparoscopic, abdominal, and vaginal hysterectomy for uteri over 500 g were 1.61, 2.16, and 2.57, respectively.
Study details: A secondary analysis of a nationwide cohort of 27,167 women.
Disclosures: Dr. Louie has received consulting fees from Teleflex.
Source: Louie M et al. SGS 2018, Oral Poster 06.