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LARCs are underutilized, even where Zika risk is high
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Of women surveyed who were using contraception, 20.6% were using a highly effective long-acting reversible contraceptive.
Data source: A population-based survey of 3,175 women in Los Angeles County who had previously given birth.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Cervical cancer screening adherence drops after HPV vaccination
SAN DIEGO – Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.
In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).
The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.
The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.
Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.
In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.
Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.
Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.
Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.
The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.
The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.
The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.
Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.
[email protected]
On Twitter @karioakes
SAN DIEGO – Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.
In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).
The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.
The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.
Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.
In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.
Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.
Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.
Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.
The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.
The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.
The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.
Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.
[email protected]
On Twitter @karioakes
SAN DIEGO – Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.
In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).
The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.
The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.
Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.
In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.
Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.
Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.
Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.
The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.
The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.
The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.
Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: The odds ratio for adherence after immunization compared to before was 0.19 (95% confidence interval, 0.08-0.49).
Data source: Retrospective chart review of 495 women who received at least two Pap smears during the period from 2006 to 2010.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Continuing tamoxifen costs less, performs better in ER+ breast cancer
AT ACOG 2017
SAN DIEGO – Continuation of tamoxifen for an additional 5 years is a cost-effective strategy that does not increase all-cause mortality for premenopausal women with estrogen receptor–positive breast cancer, based on an analysis using sophisticated computational modeling techniques.
“For premenopausal women with an early estrogen receptor–positive breast cancer who have completed 5 years of tamoxifen as initial treatment, another 5 years of tamoxifen is preferable to ovarian ablation with an aromatase inhibitor as extended endocrine treatment,” Janice Kwon, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
The researchers sought to answer a key clinical question: “What is the optimal endocrine strategy for premenopausal women who have completed 5 years of tamoxifen? Another 5 years of tamoxifen? An aromatase inhibitor preceded by ovarian ablation? Or no further treatment?”
Dr. Kwon and her coinvestigators used a Markov Monte Carlo simulation to project adverse events that would occur with each of the three treatments in a hypothetical cohort of 18,000 premenopausal women with estrogen receptor–positive breast cancer. They also conducted sensitivity analyses to ascertain the point at which a given treatment would become cost effective. The investigators used a time horizon of 40 years in the Monte Carlo simulation, which uses repeated random sampling of a large data set to model the probability of a variety of outcomes. The primary outcome measure used to compare the three treatment strategies was the incremental cost-effectiveness ratio (ICER).
For the no further treatment strategy, the average costs were $1,074, for an average life expectancy gain of 16.69 years. Compared with this strategy, 5 more years of tamoxifen would cost $3,550 for an average life expectancy gain of 17.31 years, yielding an ICER of $4,042. The strategy of performing a bilateral salpingo-oophorectomy (BSO), followed by 5 years of aromatase inhibitor therapy, was more costly at $14,312 and yielded a shorter life expectancy gain at an average of 17.06 years, eliminating it as a feasible strategy in the ICER analysis.
Using the Monte Carlo simulation to assess treatment-related mortality, Dr. Kwon and her colleagues found that no further treatment would result in the most deaths from breast cancer, at 7,358. For this, and each of the other two strategies, the investigators also modeled deaths from other causes and from early BSO, using the Nurses’ Health Study hazard ratios. No further treatment would result in 5,878 deaths from other causes and none from early BSO, for a total of 13,236.
Another 5 years of tamoxifen, the model showed, would result in 6,227 deaths from breast cancer, 6,330 from other causes, and none from BSO, for a total of 12,557.
The BSO–aromatase inhibitor strategy was modeled to have the fewest deaths from breast cancer (5,504) and from other causes (5,834) but would result in an additional 1,897 deaths from the early BSO. The BSO–aromatase inhibitor strategy thus resulted in a virtually identical number of deaths over a 40-year period as no treatment at all, at 13,235.
An aromatase inhibitor is frequently considered as a treatment strategy for women with estrogen receptor–positive breast cancer. However, using an aromatase inhibitor is predicated on the patient being menopausal, so ovarian ablation is recommended for patients who have, or who may have, intact ovarian function.
Nearly 3 decades’ worth of data from the Nurses’ Health Study showed an overall hazard ratio of 1.41 for premenopausal oophorectomy without hormone therapy, said Dr. Kwon of the gynecologic oncology division at the University of British Columbia, Vancouver. Increased rates of osteoporosis, stroke, and coronary heart disease contributed to the increased risk, with 80% of the excess deaths occurring within 15 years of oophorectomy. The analysis yielded a number needed to harm for the procedure of eight.
The study’s results have also been substantiated by a recent meta-analysis, said Dr. Kwon, that also saw “fewer disease-free events but more deaths with aromatase inhibitor versus tamoxifen” (Breast Cancer Res Treat. 2017;161:185-90). However, she said, the long-term outcomes of breast cancer over many decades are unknown, and the analysis did not include costs for treatment of recurrent breast cancer.
No external funding sources were reported, and Dr. Kwon reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT ACOG 2017
SAN DIEGO – Continuation of tamoxifen for an additional 5 years is a cost-effective strategy that does not increase all-cause mortality for premenopausal women with estrogen receptor–positive breast cancer, based on an analysis using sophisticated computational modeling techniques.
“For premenopausal women with an early estrogen receptor–positive breast cancer who have completed 5 years of tamoxifen as initial treatment, another 5 years of tamoxifen is preferable to ovarian ablation with an aromatase inhibitor as extended endocrine treatment,” Janice Kwon, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
The researchers sought to answer a key clinical question: “What is the optimal endocrine strategy for premenopausal women who have completed 5 years of tamoxifen? Another 5 years of tamoxifen? An aromatase inhibitor preceded by ovarian ablation? Or no further treatment?”
Dr. Kwon and her coinvestigators used a Markov Monte Carlo simulation to project adverse events that would occur with each of the three treatments in a hypothetical cohort of 18,000 premenopausal women with estrogen receptor–positive breast cancer. They also conducted sensitivity analyses to ascertain the point at which a given treatment would become cost effective. The investigators used a time horizon of 40 years in the Monte Carlo simulation, which uses repeated random sampling of a large data set to model the probability of a variety of outcomes. The primary outcome measure used to compare the three treatment strategies was the incremental cost-effectiveness ratio (ICER).
For the no further treatment strategy, the average costs were $1,074, for an average life expectancy gain of 16.69 years. Compared with this strategy, 5 more years of tamoxifen would cost $3,550 for an average life expectancy gain of 17.31 years, yielding an ICER of $4,042. The strategy of performing a bilateral salpingo-oophorectomy (BSO), followed by 5 years of aromatase inhibitor therapy, was more costly at $14,312 and yielded a shorter life expectancy gain at an average of 17.06 years, eliminating it as a feasible strategy in the ICER analysis.
Using the Monte Carlo simulation to assess treatment-related mortality, Dr. Kwon and her colleagues found that no further treatment would result in the most deaths from breast cancer, at 7,358. For this, and each of the other two strategies, the investigators also modeled deaths from other causes and from early BSO, using the Nurses’ Health Study hazard ratios. No further treatment would result in 5,878 deaths from other causes and none from early BSO, for a total of 13,236.
Another 5 years of tamoxifen, the model showed, would result in 6,227 deaths from breast cancer, 6,330 from other causes, and none from BSO, for a total of 12,557.
The BSO–aromatase inhibitor strategy was modeled to have the fewest deaths from breast cancer (5,504) and from other causes (5,834) but would result in an additional 1,897 deaths from the early BSO. The BSO–aromatase inhibitor strategy thus resulted in a virtually identical number of deaths over a 40-year period as no treatment at all, at 13,235.
An aromatase inhibitor is frequently considered as a treatment strategy for women with estrogen receptor–positive breast cancer. However, using an aromatase inhibitor is predicated on the patient being menopausal, so ovarian ablation is recommended for patients who have, or who may have, intact ovarian function.
Nearly 3 decades’ worth of data from the Nurses’ Health Study showed an overall hazard ratio of 1.41 for premenopausal oophorectomy without hormone therapy, said Dr. Kwon of the gynecologic oncology division at the University of British Columbia, Vancouver. Increased rates of osteoporosis, stroke, and coronary heart disease contributed to the increased risk, with 80% of the excess deaths occurring within 15 years of oophorectomy. The analysis yielded a number needed to harm for the procedure of eight.
The study’s results have also been substantiated by a recent meta-analysis, said Dr. Kwon, that also saw “fewer disease-free events but more deaths with aromatase inhibitor versus tamoxifen” (Breast Cancer Res Treat. 2017;161:185-90). However, she said, the long-term outcomes of breast cancer over many decades are unknown, and the analysis did not include costs for treatment of recurrent breast cancer.
No external funding sources were reported, and Dr. Kwon reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT ACOG 2017
SAN DIEGO – Continuation of tamoxifen for an additional 5 years is a cost-effective strategy that does not increase all-cause mortality for premenopausal women with estrogen receptor–positive breast cancer, based on an analysis using sophisticated computational modeling techniques.
“For premenopausal women with an early estrogen receptor–positive breast cancer who have completed 5 years of tamoxifen as initial treatment, another 5 years of tamoxifen is preferable to ovarian ablation with an aromatase inhibitor as extended endocrine treatment,” Janice Kwon, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
The researchers sought to answer a key clinical question: “What is the optimal endocrine strategy for premenopausal women who have completed 5 years of tamoxifen? Another 5 years of tamoxifen? An aromatase inhibitor preceded by ovarian ablation? Or no further treatment?”
Dr. Kwon and her coinvestigators used a Markov Monte Carlo simulation to project adverse events that would occur with each of the three treatments in a hypothetical cohort of 18,000 premenopausal women with estrogen receptor–positive breast cancer. They also conducted sensitivity analyses to ascertain the point at which a given treatment would become cost effective. The investigators used a time horizon of 40 years in the Monte Carlo simulation, which uses repeated random sampling of a large data set to model the probability of a variety of outcomes. The primary outcome measure used to compare the three treatment strategies was the incremental cost-effectiveness ratio (ICER).
For the no further treatment strategy, the average costs were $1,074, for an average life expectancy gain of 16.69 years. Compared with this strategy, 5 more years of tamoxifen would cost $3,550 for an average life expectancy gain of 17.31 years, yielding an ICER of $4,042. The strategy of performing a bilateral salpingo-oophorectomy (BSO), followed by 5 years of aromatase inhibitor therapy, was more costly at $14,312 and yielded a shorter life expectancy gain at an average of 17.06 years, eliminating it as a feasible strategy in the ICER analysis.
Using the Monte Carlo simulation to assess treatment-related mortality, Dr. Kwon and her colleagues found that no further treatment would result in the most deaths from breast cancer, at 7,358. For this, and each of the other two strategies, the investigators also modeled deaths from other causes and from early BSO, using the Nurses’ Health Study hazard ratios. No further treatment would result in 5,878 deaths from other causes and none from early BSO, for a total of 13,236.
Another 5 years of tamoxifen, the model showed, would result in 6,227 deaths from breast cancer, 6,330 from other causes, and none from BSO, for a total of 12,557.
The BSO–aromatase inhibitor strategy was modeled to have the fewest deaths from breast cancer (5,504) and from other causes (5,834) but would result in an additional 1,897 deaths from the early BSO. The BSO–aromatase inhibitor strategy thus resulted in a virtually identical number of deaths over a 40-year period as no treatment at all, at 13,235.
An aromatase inhibitor is frequently considered as a treatment strategy for women with estrogen receptor–positive breast cancer. However, using an aromatase inhibitor is predicated on the patient being menopausal, so ovarian ablation is recommended for patients who have, or who may have, intact ovarian function.
Nearly 3 decades’ worth of data from the Nurses’ Health Study showed an overall hazard ratio of 1.41 for premenopausal oophorectomy without hormone therapy, said Dr. Kwon of the gynecologic oncology division at the University of British Columbia, Vancouver. Increased rates of osteoporosis, stroke, and coronary heart disease contributed to the increased risk, with 80% of the excess deaths occurring within 15 years of oophorectomy. The analysis yielded a number needed to harm for the procedure of eight.
The study’s results have also been substantiated by a recent meta-analysis, said Dr. Kwon, that also saw “fewer disease-free events but more deaths with aromatase inhibitor versus tamoxifen” (Breast Cancer Res Treat. 2017;161:185-90). However, she said, the long-term outcomes of breast cancer over many decades are unknown, and the analysis did not include costs for treatment of recurrent breast cancer.
No external funding sources were reported, and Dr. Kwon reported having no relevant financial disclosures.
[email protected]
On Twitter @karioakes
Key clinical point:
Major finding: Continuation of tamoxifen for 5 more years resulted in 678 fewer deaths than did receipt of an aromatase inhibitor and oophorectomy in a hypothetical cohort of 18,000 women.
Data source: Monte Carlo simulation and sensitivity analysis of a hypothetical cohort of 18,000 premenopausal women with estrogen receptor–positive breast cancer.
Disclosures: No external funding sources were reported, and the researchers reported having no relevant financial disclosures.
FDA okays pembrolizumab for certain solid tumors with common biomarker
In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.
Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.
Patients who are eligible for pembrolizumab under this approval are those whose solid tumors have progressed despite earlier treatment and who lack other treatment options; pembrolizumab was also approved for colorectal cancer patients whose cancers have progressed after treatment with some chemotherapy drugs.
Pembrolizumab received priority review from the FDA and was approved on the basis of five uncontrolled single-arm clinical trials. There were a total of 149 patients enrolled in the trials, and 15 different cancer types were represented. Colorectal and other gastrointestinal cancers and endometrial cancers were the most common types in the studies. Of the 149 patients, 39.6% had a complete or partial response, and of these responders, 78% had a response lasting at least 6 months.
Fatigue is a common side effect of pembrolizumab; anorexia, peripheral edema, rash, pruritis, hyperlipidemia, and electrolyte disturbances are also common. Because of the drug’s mechanism of action, it can cause immune-mediated side effects, such as pneumonitis, hepatitis, nephritis, and endocrinopathies.
Pembrolizumab is given as an intravenous infusion, usually once every 3 weeks. It targets the programmed death-1/programmed death-ligand 1 (PD-1/PDL-1) pathway to boost the immune system’s ability to target and kill cancer cells.
“This is an important first for the cancer community,” said Dr. Pazdur, who is also acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The clinical trials were sponsored by Merck & Co., which markets Keytruda.
[email protected]
On Twitter @karioakes
In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.
Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.
Patients who are eligible for pembrolizumab under this approval are those whose solid tumors have progressed despite earlier treatment and who lack other treatment options; pembrolizumab was also approved for colorectal cancer patients whose cancers have progressed after treatment with some chemotherapy drugs.
Pembrolizumab received priority review from the FDA and was approved on the basis of five uncontrolled single-arm clinical trials. There were a total of 149 patients enrolled in the trials, and 15 different cancer types were represented. Colorectal and other gastrointestinal cancers and endometrial cancers were the most common types in the studies. Of the 149 patients, 39.6% had a complete or partial response, and of these responders, 78% had a response lasting at least 6 months.
Fatigue is a common side effect of pembrolizumab; anorexia, peripheral edema, rash, pruritis, hyperlipidemia, and electrolyte disturbances are also common. Because of the drug’s mechanism of action, it can cause immune-mediated side effects, such as pneumonitis, hepatitis, nephritis, and endocrinopathies.
Pembrolizumab is given as an intravenous infusion, usually once every 3 weeks. It targets the programmed death-1/programmed death-ligand 1 (PD-1/PDL-1) pathway to boost the immune system’s ability to target and kill cancer cells.
“This is an important first for the cancer community,” said Dr. Pazdur, who is also acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The clinical trials were sponsored by Merck & Co., which markets Keytruda.
[email protected]
On Twitter @karioakes
In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.
Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.
Patients who are eligible for pembrolizumab under this approval are those whose solid tumors have progressed despite earlier treatment and who lack other treatment options; pembrolizumab was also approved for colorectal cancer patients whose cancers have progressed after treatment with some chemotherapy drugs.
Pembrolizumab received priority review from the FDA and was approved on the basis of five uncontrolled single-arm clinical trials. There were a total of 149 patients enrolled in the trials, and 15 different cancer types were represented. Colorectal and other gastrointestinal cancers and endometrial cancers were the most common types in the studies. Of the 149 patients, 39.6% had a complete or partial response, and of these responders, 78% had a response lasting at least 6 months.
Fatigue is a common side effect of pembrolizumab; anorexia, peripheral edema, rash, pruritis, hyperlipidemia, and electrolyte disturbances are also common. Because of the drug’s mechanism of action, it can cause immune-mediated side effects, such as pneumonitis, hepatitis, nephritis, and endocrinopathies.
Pembrolizumab is given as an intravenous infusion, usually once every 3 weeks. It targets the programmed death-1/programmed death-ligand 1 (PD-1/PDL-1) pathway to boost the immune system’s ability to target and kill cancer cells.
“This is an important first for the cancer community,” said Dr. Pazdur, who is also acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. The clinical trials were sponsored by Merck & Co., which markets Keytruda.
[email protected]
On Twitter @karioakes
Postcesarean outpatient opioid needs predicted by inpatient use
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – The amount of pain medication a women requires in the hospital after a cesarean delivery was an accurate predictor of postdischarge needs, and could provide guidance to tailor home prescriptions, reducing the amount of unused opioids left after recovery, according to a new study.
Jenna Emerson, MD, and her colleagues also found that more than half of the opioid medications prescribed for home postcesarean use went untaken, and that one in five women used no opioid medication after leaving the hospital.
The prospective cohort study, one of two awarded the Donald F. Richardson Prize at the meeting, looked at how much opioid medication was used by women while they were inpatients, and also asked women to keep track of how much medication they used at home, to see if one could predict the other.
The pilot study enrolled 100 women who had a postdelivery inpatient stay of less than 8 days, who spoke English, and who had given birth to a live viable infant. The study’s statistical analysis looked for relationships not only between inpatient and outpatient use of opioids, but also between patient characteristics and level of opioid use in the hospital and at home.
A total of 76 women completed follow-up, said Dr. Emerson, who is a fourth-year ob.gyn. resident at Brown University, Providence, R.I. One patient was excluded because she was on high opioid doses for addiction treatment before delivery, and her postdelivery opioid requirements represented a clear outlier in the data.
The investigators used medical record data to determine opioid requirements as inpatients after cesarean delivery. For standardization of different strengths of opioids, use was expressed by using Mean Morphine Equivalents (MME). Baseline patient demographic characteristics and comorbidities were also obtained from medical record review.
Patients were asked to track their home opioid use for 2 weeks postdischarge, and also received a follow-up phone call at the end of their first 2 weeks at home.
Inpatient opioid use was divided into tertiles according to low (less than 40 MME), medium (41-70 MME), and high (greater than 70 MME) use. Overall, the group’s mean opioid use in the final 24 hours before discharge was 59 MME, an amount Dr. Emerson said was equivalent to about eight tablets of oxycodone/acetaminophen or 12 tablets of hydrocodone/acetaminophen.
Most patients (89%) went home with a prescription for oxycodone/acetaminophen, and the mean number of pills prescribed per patient was 35. For the original group of 100 patients, this meant that prescriptions were written for 3,150 oxycodone/acetaminophen tablets, 162 hydrocodone/acetaminophen tablets, and 139 oxycodone tablets.
Home use over the first 2 weeks postdischarge was a mean 126 MME, or the equivalent of about 17 oxycodone/acetaminophen tablets. A total of 39% of women reported they had used less than half of their opioid medication; 21% had used all or required more opioids, and 20% had used at least half of their opioids. One in five patients (20%) had not taken a single opioid tablet after discharge from the hospital, and only 2 of the 75 women were still using opioids at the time of the 2-week follow-up call, Dr. Emerson said.
This means there was a total of 1,538 tablets of unused prescription opioid medication left in the homes of the 75 women included in the final analysis, Dr. Emerson said.
When the investigators compared inpatient and outpatient opioid use, they found that 26 women (34.7%) had been in the lowest tertile of inpatient opioid use. These women also had the lowest mean MME at home, using 53 MME in the first 2 weeks post discharge. The middle tertile for inpatient use used a mean 111 MME at home, while the highest used 195 MME (analysis of variance P less than .001).
Higher outpatient opioid use was seen in patients with a history of psychiatric comorbidities (MME 172 vs. 103 for no psychiatric comorbidities; P = .046). Other factors associated with numerically higher use that did not reach statistical significance included breastfeeding status (MME 197 for no breastfeeding, 112 for breastfeeding; P = .068) and insurance status (MME 154 for public, 95 for private; P = .058).
Patients’ mean age was 30.3 years; 63% of participants were Caucasian, 5% were black, and 19% identified their ethnicity as Hispanic. Patients were about evenly divided between having public and private insurance, and most (72%) had some post-high school education. Just 5% had a prior history of drug use or abuse, and about half (49%) were having a repeat cesarean delivery. Three quarters were breastfeeding their infants.
Unused opioid prescriptions are a significant contributor to the pool of opioids available for diversion and recent work has shown that up to 23% of opioids prescribed are used for “nonmedical” purposes, Dr. Emerson said. Since cesarean deliveries are the most commonly performed major surgery in the United States, the opportunity to reduce the number of opioids available for diversion is significant, she said.
“Opioid prescription use after cesarean delivery should be tailored to patient needs,” she said, calling for larger studies to validate and expand on the findings.
Dr. Emerson reported having no outside sources of funding and no relevant financial disclosures.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Inpatient opioid use by tertile was highly associated with outpatient opioid use by tertile (P less than .001).
Data source: A prospective cohort study of 75 women with cesarean deliveries of live viable infants.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Despite CVD risk, few internists screen for prior preeclampsia
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.
Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).
“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.
The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.
Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.
Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.
In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.
In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.
Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).
A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).
When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.
The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.
Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Of 89 women who received well-woman exams, 21 were asked about prior preeclampsia, while 88 were asked about diabetes and smoking, and 89, about hypertension (P = .0002).
Data source: A retrospective record review of 89 women receiving well-woman exams in the year after the American College of Obstetricians and Gynecologists issued CVD screening guidelines for prior preeclampsia.
Disclosures: The study authors reported having no outside sources of funding and no conflicts of interest.
Changing gloves before closure cut wound-related cesarean complications
SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.
Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.
Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .
Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.
Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.
The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.
The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.
A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.
Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.
Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).
The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.
There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.
The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.
Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.
Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .
Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.
Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.
The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.
The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.
A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.
Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.
Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).
The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.
There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.
The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.
Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.
Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .
Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.
Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.
The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.
The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.
A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.
Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.
Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).
The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.
There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.
The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
Key clinical point:
Major finding: The number needed to treat to see benefit from glove changing was 14; the cost per procedure was about $5.
Data source: A randomized controlled trial of 553 patients undergoing nonemergent cesarean delivery.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Roux-en-Y bests sleeve gastrectomy for weight loss
AT ENDO 2017
ORLANDO – Roux-en-Y gastric bypass resulted in greater weight loss than sleeve gastrectomy in a study that followed more than 700 patients, an effect that was sustained over time.
However, surgical complications were more common than with sleeve gastrectomy, and patients were more likely to have an extended hospital stay.
The study, conducted by Corey Lager, MD, and his collaborators at the University of Michigan Medical Center, Ann Arbor, looked at 5-year outcomes for 380 patients who had Roux-en-Y gastric bypass (RYGB), compared with those for 336 patients who received sleeve gastrectomy (SG).
Specific outcomes examined included the amount of absolute weight loss and excess body weight loss over the 5-year study period, whether obesity-related comorbidities resolved, and the type and number of complications seen with each procedure.
Sleeve gastrectomy is becoming increasingly popular, even as RYGB and adjustable gastric banding procedures have become more and more rare, Dr. Lager said at the annual meeting of the Endocrine Society. Duodenal switch procedures have continued to represent a very small proportion of surgical weight loss surgeries. Of the four, SG accounted for nearly 80% of the procedures performed in 2013; RYGB, which accounted for about 60% of procedures in 2006, fell to about 30% of procedures by 2013.
The investigators conducted a retrospective analysis of patients undergoing RYGB or SG from January 2008 to November 2013. Patients were seen annually in postoperative follow-up, so the study was able to track body mass index (BMI), weight, excess body weight loss, hemoglobin A1c levels, blood pressure, and serum lipid and vitamin levels over the 5-year period. Additionally, the study captured 30-day postoperative complications for each procedure.
Although about 80% of patients undergoing each procedure were female and baseline lab values and characteristics were similar in many respects, patients undergoing sleeve gastrectomy had higher body weight (mean, 143 kg) and BMI (mean, 50 kg/m2), compared with those who received RYGB (weight, 133 kg; BMI, 47; P less than .001 for both). The average age in both groups was about 45 years.
Sleeve gastrectomy patients were less likely to continue for the full 5 years of follow-up. Of 336 SG patients originally enrolled, 93 had 5-year data. Of the 380 RYGB patients, 188 returned for the 5-year follow-up.
At all time points, the RYGB patients had significantly more total weight loss than the SG patients (P less than .05); the initial weight loss for RYGB patients approached 28% of body weight at year 1, compared with about 23% for the SG patients. By the end of the 5-year period, RYGB patients had maintained about a 24% weight loss, compared with almost 20% for the SG group.
This pattern was mirrored for BMI in each cohort: At year 1, the RYGB patients were down about 14 points, compared with about 12 points for the SG group. By year 5, the difference had narrowed so that each group had lost a mean of between 11 and 12 points from their original BMI, but the difference was still statistically significant (P less than .05).
The final measure of weight loss was excess body weight lost, and again, RYGB patients lost significantly more of their excess body weight at all time points than did the SG patients. At the end of the first year, RYGB had lost more than 65% of their excess body weight, compared with about 48% for the SG patients. By 5 years, the SG patients had regained enough weight that their net excess weight loss was a little less than 40%, while the RYGB patients’ regain put them at about 55% excess weight loss by the end of the study period.
In terms of biomarkers, systolic blood pressure did not differ significantly between the three groups except at study year 3, though the RYGB group had numerically slightly lower systolic blood pressures at all time points. Total cholesterol was lower at 1, 2, 4, and 5 years after surgery for the RYGB group.
Sleeve gastrectomy, as expected, had lower rates of grade I surgical complications, including hemorrhage and infection. Also, the SG patients had fewer postsurgical emergency department visits and a shorter length of stay.
The study results were consistent with those of a 2016 meta-analysis that favored RYGB in terms of excess weight lost, readmission for diabetes-related complications, and resolution of hypertension (Obes Surg. 2016 Feb;26[2]:429-42).
Although this was a large study, it was limited by its retrospective nature and by the lack of randomization, said Dr. Lager. Retaining patients for long-term follow-up was also an issue: Of the original 719 patients, 507 were followed at 3 years and 281 at 5 years, so a significant number weren’t tracked for the full 5 years.
Dr. Lager reported no conflicts of interest, and the study had no outside sources of funding.
[email protected]
On Twitter @karioakes
AT ENDO 2017
ORLANDO – Roux-en-Y gastric bypass resulted in greater weight loss than sleeve gastrectomy in a study that followed more than 700 patients, an effect that was sustained over time.
However, surgical complications were more common than with sleeve gastrectomy, and patients were more likely to have an extended hospital stay.
The study, conducted by Corey Lager, MD, and his collaborators at the University of Michigan Medical Center, Ann Arbor, looked at 5-year outcomes for 380 patients who had Roux-en-Y gastric bypass (RYGB), compared with those for 336 patients who received sleeve gastrectomy (SG).
Specific outcomes examined included the amount of absolute weight loss and excess body weight loss over the 5-year study period, whether obesity-related comorbidities resolved, and the type and number of complications seen with each procedure.
Sleeve gastrectomy is becoming increasingly popular, even as RYGB and adjustable gastric banding procedures have become more and more rare, Dr. Lager said at the annual meeting of the Endocrine Society. Duodenal switch procedures have continued to represent a very small proportion of surgical weight loss surgeries. Of the four, SG accounted for nearly 80% of the procedures performed in 2013; RYGB, which accounted for about 60% of procedures in 2006, fell to about 30% of procedures by 2013.
The investigators conducted a retrospective analysis of patients undergoing RYGB or SG from January 2008 to November 2013. Patients were seen annually in postoperative follow-up, so the study was able to track body mass index (BMI), weight, excess body weight loss, hemoglobin A1c levels, blood pressure, and serum lipid and vitamin levels over the 5-year period. Additionally, the study captured 30-day postoperative complications for each procedure.
Although about 80% of patients undergoing each procedure were female and baseline lab values and characteristics were similar in many respects, patients undergoing sleeve gastrectomy had higher body weight (mean, 143 kg) and BMI (mean, 50 kg/m2), compared with those who received RYGB (weight, 133 kg; BMI, 47; P less than .001 for both). The average age in both groups was about 45 years.
Sleeve gastrectomy patients were less likely to continue for the full 5 years of follow-up. Of 336 SG patients originally enrolled, 93 had 5-year data. Of the 380 RYGB patients, 188 returned for the 5-year follow-up.
At all time points, the RYGB patients had significantly more total weight loss than the SG patients (P less than .05); the initial weight loss for RYGB patients approached 28% of body weight at year 1, compared with about 23% for the SG patients. By the end of the 5-year period, RYGB patients had maintained about a 24% weight loss, compared with almost 20% for the SG group.
This pattern was mirrored for BMI in each cohort: At year 1, the RYGB patients were down about 14 points, compared with about 12 points for the SG group. By year 5, the difference had narrowed so that each group had lost a mean of between 11 and 12 points from their original BMI, but the difference was still statistically significant (P less than .05).
The final measure of weight loss was excess body weight lost, and again, RYGB patients lost significantly more of their excess body weight at all time points than did the SG patients. At the end of the first year, RYGB had lost more than 65% of their excess body weight, compared with about 48% for the SG patients. By 5 years, the SG patients had regained enough weight that their net excess weight loss was a little less than 40%, while the RYGB patients’ regain put them at about 55% excess weight loss by the end of the study period.
In terms of biomarkers, systolic blood pressure did not differ significantly between the three groups except at study year 3, though the RYGB group had numerically slightly lower systolic blood pressures at all time points. Total cholesterol was lower at 1, 2, 4, and 5 years after surgery for the RYGB group.
Sleeve gastrectomy, as expected, had lower rates of grade I surgical complications, including hemorrhage and infection. Also, the SG patients had fewer postsurgical emergency department visits and a shorter length of stay.
The study results were consistent with those of a 2016 meta-analysis that favored RYGB in terms of excess weight lost, readmission for diabetes-related complications, and resolution of hypertension (Obes Surg. 2016 Feb;26[2]:429-42).
Although this was a large study, it was limited by its retrospective nature and by the lack of randomization, said Dr. Lager. Retaining patients for long-term follow-up was also an issue: Of the original 719 patients, 507 were followed at 3 years and 281 at 5 years, so a significant number weren’t tracked for the full 5 years.
Dr. Lager reported no conflicts of interest, and the study had no outside sources of funding.
[email protected]
On Twitter @karioakes
AT ENDO 2017
ORLANDO – Roux-en-Y gastric bypass resulted in greater weight loss than sleeve gastrectomy in a study that followed more than 700 patients, an effect that was sustained over time.
However, surgical complications were more common than with sleeve gastrectomy, and patients were more likely to have an extended hospital stay.
The study, conducted by Corey Lager, MD, and his collaborators at the University of Michigan Medical Center, Ann Arbor, looked at 5-year outcomes for 380 patients who had Roux-en-Y gastric bypass (RYGB), compared with those for 336 patients who received sleeve gastrectomy (SG).
Specific outcomes examined included the amount of absolute weight loss and excess body weight loss over the 5-year study period, whether obesity-related comorbidities resolved, and the type and number of complications seen with each procedure.
Sleeve gastrectomy is becoming increasingly popular, even as RYGB and adjustable gastric banding procedures have become more and more rare, Dr. Lager said at the annual meeting of the Endocrine Society. Duodenal switch procedures have continued to represent a very small proportion of surgical weight loss surgeries. Of the four, SG accounted for nearly 80% of the procedures performed in 2013; RYGB, which accounted for about 60% of procedures in 2006, fell to about 30% of procedures by 2013.
The investigators conducted a retrospective analysis of patients undergoing RYGB or SG from January 2008 to November 2013. Patients were seen annually in postoperative follow-up, so the study was able to track body mass index (BMI), weight, excess body weight loss, hemoglobin A1c levels, blood pressure, and serum lipid and vitamin levels over the 5-year period. Additionally, the study captured 30-day postoperative complications for each procedure.
Although about 80% of patients undergoing each procedure were female and baseline lab values and characteristics were similar in many respects, patients undergoing sleeve gastrectomy had higher body weight (mean, 143 kg) and BMI (mean, 50 kg/m2), compared with those who received RYGB (weight, 133 kg; BMI, 47; P less than .001 for both). The average age in both groups was about 45 years.
Sleeve gastrectomy patients were less likely to continue for the full 5 years of follow-up. Of 336 SG patients originally enrolled, 93 had 5-year data. Of the 380 RYGB patients, 188 returned for the 5-year follow-up.
At all time points, the RYGB patients had significantly more total weight loss than the SG patients (P less than .05); the initial weight loss for RYGB patients approached 28% of body weight at year 1, compared with about 23% for the SG patients. By the end of the 5-year period, RYGB patients had maintained about a 24% weight loss, compared with almost 20% for the SG group.
This pattern was mirrored for BMI in each cohort: At year 1, the RYGB patients were down about 14 points, compared with about 12 points for the SG group. By year 5, the difference had narrowed so that each group had lost a mean of between 11 and 12 points from their original BMI, but the difference was still statistically significant (P less than .05).
The final measure of weight loss was excess body weight lost, and again, RYGB patients lost significantly more of their excess body weight at all time points than did the SG patients. At the end of the first year, RYGB had lost more than 65% of their excess body weight, compared with about 48% for the SG patients. By 5 years, the SG patients had regained enough weight that their net excess weight loss was a little less than 40%, while the RYGB patients’ regain put them at about 55% excess weight loss by the end of the study period.
In terms of biomarkers, systolic blood pressure did not differ significantly between the three groups except at study year 3, though the RYGB group had numerically slightly lower systolic blood pressures at all time points. Total cholesterol was lower at 1, 2, 4, and 5 years after surgery for the RYGB group.
Sleeve gastrectomy, as expected, had lower rates of grade I surgical complications, including hemorrhage and infection. Also, the SG patients had fewer postsurgical emergency department visits and a shorter length of stay.
The study results were consistent with those of a 2016 meta-analysis that favored RYGB in terms of excess weight lost, readmission for diabetes-related complications, and resolution of hypertension (Obes Surg. 2016 Feb;26[2]:429-42).
Although this was a large study, it was limited by its retrospective nature and by the lack of randomization, said Dr. Lager. Retaining patients for long-term follow-up was also an issue: Of the original 719 patients, 507 were followed at 3 years and 281 at 5 years, so a significant number weren’t tracked for the full 5 years.
Dr. Lager reported no conflicts of interest, and the study had no outside sources of funding.
[email protected]
On Twitter @karioakes
Key clinical point:
Major finding: At 5 years post surgery, Roux-en-Y recipients had kept off 25% of their body weight, compared with 20% for sleeve gastrectomy patients (P less than .05).
Data source: Longitudinal follow-up of 716 patients who had one of two surgical procedures for weight loss.
Disclosures: None of the study authors reported relevant disclosures, and no external source of funding was reported.
Lower limb compression halved epidural-associated hypotension
SAN DIEGO – Use of sequential compression devices reduced by half cases of epidural-associated hypotension in laboring women in a small real-world, randomized controlled trial.
The results showed that patients who received sequential compression devices (SCD) and kept them on for at least an hour after epidural analgesia placement had half the hypotension of patients who had no lower limb compression (33.3% vs. 66.7%; P .022).
“Lower limb compression using SCDs significantly decreased the incidence of maternal hypotension in laboring patients receiving epidural anesthesia,” said Margaret Steinmetz, MD, a third-year resident at the State University of New York at Buffalo.
The study, which was presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, was a multisite, randomized controlled trial that used a randomized block design to assign women to three groups. The control group received no intervention; the remainder of patients received either thromboembolic deterrent (TED) stockings or sequential compression devices (SCDs) set to intermittent compression and applied before receiving epidural anesthesia.
The facilities’ usual protocols were followed both for epidural placement and for patient management, except for the lower limb compression and the study’s timed blood pressure checks.
Pregnant women who were at term and had requested epidural anesthesia were included if they had a singleton pregnancy; no history of hypertension, cardiovascular disease; and no contraindication to lower limb compression.
Hypotension – defined as at least one decrease in either systolic or diastolic blood pressure of more than 20% from baseline – was tracked by obtaining sequential blood pressure readings. A baseline was established with an average of three readings obtained before epidural placement. Following the epidural bolus, blood pressures were measured at minutes 1, 5, 15, 30, 45, and 60.
The investigators used an intention-to-treat analysis, meaning that they included patients allocated to each group whether or not they actually received lower limb compression. Patients with missing data were excluded.
A total of 82 patients were randomized:
- 28 to the control arm (no lower limb compression); 1 had missing data.
- 26 to receive TEDs (6 of whom did not don the stockings); 5 were excluded from analysis because of missing data or no epidural placement.
- 28 patients to receive SCDs (8 of whom did not have SCDs applied); 5 were excluded from analysis because of missing data or no epidural placement.
While the SCDs cut the incidence of hypotension in half, compared with no compression, women in the TEDs group saw an intermediate result, with a 52.4% incidence of hypotension.
Dr. Steinmetz noted that knee-high TEDs were used. The choice was made in part because the labor and delivery nursing staff were not enthusiastic about the prospect of placing thigh-high TEDs on a woman in labor, she added.
Patient age, mean body mass index, and gestational age did not differ significantly between the study arms. Logistic regression analysis performed to control for clinical site, method of delivery, gestational age, and maternal age and body mass index did not affect the analysis, Dr. Steinmetz added.
Older data showed that about 30% of women getting epidurals in labor experience hypotension, though Dr. Steinmetz said that she believes that the 66.7% seen in this study is probably closer to an accurate estimate.
SUNY Buffalo is looking at changing the labor and delivery protocol to include lower limb compression with epidurals, Dr. Steinmetz said, adding “When I’m on labor and delivery, I definitely encourage the placement of SCDs.”
Some facilities also use lower limb compression to reduce hypotension when patients receive regional anesthesia for cesarean deliveries. Dr. Steinmetz said that there are studies that support that practice, but the literature is not conclusive. Still, it makes sense in this setting too, she said. “C-section patients sit up, they get their spinal, then we lay them down and put in a Foley, and they’re vomiting as we put in the Foley because they’re hypotensive from that spinal. ... For me, myself, when I go into practice in 2 months, yes; I will be wanting to do this.”
Dr. Steinmetz reported no relevant disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – Use of sequential compression devices reduced by half cases of epidural-associated hypotension in laboring women in a small real-world, randomized controlled trial.
The results showed that patients who received sequential compression devices (SCD) and kept them on for at least an hour after epidural analgesia placement had half the hypotension of patients who had no lower limb compression (33.3% vs. 66.7%; P .022).
“Lower limb compression using SCDs significantly decreased the incidence of maternal hypotension in laboring patients receiving epidural anesthesia,” said Margaret Steinmetz, MD, a third-year resident at the State University of New York at Buffalo.
The study, which was presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, was a multisite, randomized controlled trial that used a randomized block design to assign women to three groups. The control group received no intervention; the remainder of patients received either thromboembolic deterrent (TED) stockings or sequential compression devices (SCDs) set to intermittent compression and applied before receiving epidural anesthesia.
The facilities’ usual protocols were followed both for epidural placement and for patient management, except for the lower limb compression and the study’s timed blood pressure checks.
Pregnant women who were at term and had requested epidural anesthesia were included if they had a singleton pregnancy; no history of hypertension, cardiovascular disease; and no contraindication to lower limb compression.
Hypotension – defined as at least one decrease in either systolic or diastolic blood pressure of more than 20% from baseline – was tracked by obtaining sequential blood pressure readings. A baseline was established with an average of three readings obtained before epidural placement. Following the epidural bolus, blood pressures were measured at minutes 1, 5, 15, 30, 45, and 60.
The investigators used an intention-to-treat analysis, meaning that they included patients allocated to each group whether or not they actually received lower limb compression. Patients with missing data were excluded.
A total of 82 patients were randomized:
- 28 to the control arm (no lower limb compression); 1 had missing data.
- 26 to receive TEDs (6 of whom did not don the stockings); 5 were excluded from analysis because of missing data or no epidural placement.
- 28 patients to receive SCDs (8 of whom did not have SCDs applied); 5 were excluded from analysis because of missing data or no epidural placement.
While the SCDs cut the incidence of hypotension in half, compared with no compression, women in the TEDs group saw an intermediate result, with a 52.4% incidence of hypotension.
Dr. Steinmetz noted that knee-high TEDs were used. The choice was made in part because the labor and delivery nursing staff were not enthusiastic about the prospect of placing thigh-high TEDs on a woman in labor, she added.
Patient age, mean body mass index, and gestational age did not differ significantly between the study arms. Logistic regression analysis performed to control for clinical site, method of delivery, gestational age, and maternal age and body mass index did not affect the analysis, Dr. Steinmetz added.
Older data showed that about 30% of women getting epidurals in labor experience hypotension, though Dr. Steinmetz said that she believes that the 66.7% seen in this study is probably closer to an accurate estimate.
SUNY Buffalo is looking at changing the labor and delivery protocol to include lower limb compression with epidurals, Dr. Steinmetz said, adding “When I’m on labor and delivery, I definitely encourage the placement of SCDs.”
Some facilities also use lower limb compression to reduce hypotension when patients receive regional anesthesia for cesarean deliveries. Dr. Steinmetz said that there are studies that support that practice, but the literature is not conclusive. Still, it makes sense in this setting too, she said. “C-section patients sit up, they get their spinal, then we lay them down and put in a Foley, and they’re vomiting as we put in the Foley because they’re hypotensive from that spinal. ... For me, myself, when I go into practice in 2 months, yes; I will be wanting to do this.”
Dr. Steinmetz reported no relevant disclosures.
[email protected]
On Twitter @karioakes
SAN DIEGO – Use of sequential compression devices reduced by half cases of epidural-associated hypotension in laboring women in a small real-world, randomized controlled trial.
The results showed that patients who received sequential compression devices (SCD) and kept them on for at least an hour after epidural analgesia placement had half the hypotension of patients who had no lower limb compression (33.3% vs. 66.7%; P .022).
“Lower limb compression using SCDs significantly decreased the incidence of maternal hypotension in laboring patients receiving epidural anesthesia,” said Margaret Steinmetz, MD, a third-year resident at the State University of New York at Buffalo.
The study, which was presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, was a multisite, randomized controlled trial that used a randomized block design to assign women to three groups. The control group received no intervention; the remainder of patients received either thromboembolic deterrent (TED) stockings or sequential compression devices (SCDs) set to intermittent compression and applied before receiving epidural anesthesia.
The facilities’ usual protocols were followed both for epidural placement and for patient management, except for the lower limb compression and the study’s timed blood pressure checks.
Pregnant women who were at term and had requested epidural anesthesia were included if they had a singleton pregnancy; no history of hypertension, cardiovascular disease; and no contraindication to lower limb compression.
Hypotension – defined as at least one decrease in either systolic or diastolic blood pressure of more than 20% from baseline – was tracked by obtaining sequential blood pressure readings. A baseline was established with an average of three readings obtained before epidural placement. Following the epidural bolus, blood pressures were measured at minutes 1, 5, 15, 30, 45, and 60.
The investigators used an intention-to-treat analysis, meaning that they included patients allocated to each group whether or not they actually received lower limb compression. Patients with missing data were excluded.
A total of 82 patients were randomized:
- 28 to the control arm (no lower limb compression); 1 had missing data.
- 26 to receive TEDs (6 of whom did not don the stockings); 5 were excluded from analysis because of missing data or no epidural placement.
- 28 patients to receive SCDs (8 of whom did not have SCDs applied); 5 were excluded from analysis because of missing data or no epidural placement.
While the SCDs cut the incidence of hypotension in half, compared with no compression, women in the TEDs group saw an intermediate result, with a 52.4% incidence of hypotension.
Dr. Steinmetz noted that knee-high TEDs were used. The choice was made in part because the labor and delivery nursing staff were not enthusiastic about the prospect of placing thigh-high TEDs on a woman in labor, she added.
Patient age, mean body mass index, and gestational age did not differ significantly between the study arms. Logistic regression analysis performed to control for clinical site, method of delivery, gestational age, and maternal age and body mass index did not affect the analysis, Dr. Steinmetz added.
Older data showed that about 30% of women getting epidurals in labor experience hypotension, though Dr. Steinmetz said that she believes that the 66.7% seen in this study is probably closer to an accurate estimate.
SUNY Buffalo is looking at changing the labor and delivery protocol to include lower limb compression with epidurals, Dr. Steinmetz said, adding “When I’m on labor and delivery, I definitely encourage the placement of SCDs.”
Some facilities also use lower limb compression to reduce hypotension when patients receive regional anesthesia for cesarean deliveries. Dr. Steinmetz said that there are studies that support that practice, but the literature is not conclusive. Still, it makes sense in this setting too, she said. “C-section patients sit up, they get their spinal, then we lay them down and put in a Foley, and they’re vomiting as we put in the Foley because they’re hypotensive from that spinal. ... For me, myself, when I go into practice in 2 months, yes; I will be wanting to do this.”
Dr. Steinmetz reported no relevant disclosures.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: The rate of hypotension for women in labor who received epidurals was 66.7% with no lower limb compression, compared with 33.3% when sequential compression devices were used (P –.02).
Data source: Multisite randomized controlled trial of 82 patients who received epidurals while in labor.
Disclosures: The study authors reported no outside sources of funding, and reported no conflicts of interest.
Early-stage HL patients fare well 10 years after lower-intensity regimens
Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.
The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).
Trials in favorable HL
Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).
Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.
Trials in unfavorable HL
The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.
Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPPbaseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.
Following the HD11 cohort longitudinally showed that BEACOPPbaseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).
Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.
To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPPescalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.
The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.
Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.
[email protected]
On Twitter @karioakes
Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.
The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).
Trials in favorable HL
Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).
Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.
Trials in unfavorable HL
The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.
Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPPbaseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.
Following the HD11 cohort longitudinally showed that BEACOPPbaseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).
Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.
To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPPescalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.
The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.
Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.
[email protected]
On Twitter @karioakes
Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.
The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).
Trials in favorable HL
Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).
Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.
Trials in unfavorable HL
The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.
Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPPbaseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.
Following the HD11 cohort longitudinally showed that BEACOPPbaseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).
Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.
To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPPescalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.
The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.
Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.
[email protected]
On Twitter @karioakes
FROM JCO
Key clinical point:
Major finding: Early-stage favorable HL patients had identical progression-free survival, whether they received a more or less intense chemotherapy and radiation regimen (10-year PFS, 87% in each arm).
Data source: Long-term follow-up data from 4,276 patients in four arms of the German Hodgkin Study Group trials.
Disclosures: Several study authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.