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Good pregnancy outcomes after laparoscopic radiofrequency ablation for fibroids
VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.
The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.
The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.
There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.
Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.
The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.
The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.
There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).
Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.
VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.
The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.
The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.
There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.
Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.
The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.
The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.
There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).
Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.
VANCOUVER – A retrospective analysis of women who became pregnant after undergoing laparoscopic radiofrequency ablation (Lap-RFA) of symptomatic myomas found no evidence that the procedure negatively impacted pregnancy or birth outcomes, according to Jay Berman, MD.
The procedure is a minimally invasive alternative to myomectomy, hysterectomy, and other surgical techniques, with minimal scarring and quick recovery. But the pivotal trials excluded women who were planning to become pregnant, and the Food and Drug Administration recommends against its use in women planning a future pregnancy because of the lack of safety and efficacy data in that population.
The procedure, which gained FDA approval in 2016, combines laparoscopic ultrasound with targeted radiofrequency to heat fibroids, which then shrink over the next few months. “There have been a lot of questions from infertility specialists regarding whether Lap-RFA can be applied to their patients because there’s very little scarring and a quick return to work. It’s really a very nice outpatient procedure for dealing with fibroids,” Dr. Berman said in an interview.
There is natural concern, however, because clinicians are uncomfortable exposing women to a pregnancy risk. “I think there’s concern from many gynecologists and reproductive endocrinologists on the pregnancy outcomes following fibroid therapy, whatever that happens to be – traditional open laparoscopic myomectomy, robotic myomectomy, all of those kinds of therapies. We were interested in looking at pregnancy outcomes following [RFA for fibroids] and whether or not C-sections would need to be recommended, similar to what you see following myomectomy, where if you enter the cavity or go through more than half of the myometrium, you recommend a C-section for that patient in subsequent pregnancies,” said Dr. Berman, who is a professor of obstetrics and gynecology at Wayne State University, Detroit.
Early case studies, mostly done in Mexico and Guatemala, found the uteri of women to be normal following Lap-RFA, he said.
The results of this study are encouraging, but are far from the final word, as the data are retrospective and small. Acessa, which provided statistical analysis for the current work, is planning a prospective study. “I don’t think there’s enough to say that the labeling should be changed, but we’re moving in that direction. There needs to be a lot more information,” Dr. Berman said at the meeting sponsored by AAGL.
The study combined data from two randomized, controlled trials in the United States and Germany; six cohort studies in the United States, Germany, and Latin America; and commercial procedures performed in the United States. The researchers relied on standardized case reports that focused primarily on maternal and infant safety, and the mode of delivery. They collected data from 38 women (mean age, 36 years) who had fibroids types 1-6 that were of a maximum 0.2-13 cm in diameter. In 19 cases, it was 5.5 cm or smaller. The number of fibroids treated ranged from 1 to 31; 19 women had one or two fibroids treated.
There were a total of 43 pregnancies, 32 of which resulted in full-term live births (74%) and there was 1 preterm birth (2.3%). All infants were healthy, and there 19 vaginal births and 13 C-sections. The reasons for the C-sections were previous C-sections or obstetric indications, such as unusual bleeding, nonprogression of labor, or abnormal fetal heartbeat. There were eight spontaneous abortions (19%) and one therapeutic abortion (2.3%), and one pregnancy was ongoing (2.3%).
Dr. Berman has been a consultant for Acessa Health, Bayer, Boston Scientific, Medtronic, and Abbvie. He has been on the speakers bureau for Acessa, Merck, Boston Scientific, Medtronic, Abbvie, and Lupin. He has performed contracted research for Acessa, Bayer, Allergan, and Obseva.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Cannabis frequently is used for endometriosis pain
VANCOUVER, B.C. – with over a third reporting either current or past use, according to a new survey.
The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.
Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”
To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.
About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.
Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.
The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.
Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.
Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.
But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.
That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.
Dr. Reinert has no financial disclosures.
VANCOUVER, B.C. – with over a third reporting either current or past use, according to a new survey.
The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.
Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”
To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.
About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.
Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.
The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.
Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.
Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.
But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.
That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.
Dr. Reinert has no financial disclosures.
VANCOUVER, B.C. – with over a third reporting either current or past use, according to a new survey.
The finding comes as more and more companies are marketing CBD-containing products to women, with unsubstantiated claims about efficacy, according to Anna Reinert, MD, who presented the research at a meeting sponsored by AAGL.
Women self-reported that marijuana use was moderately effective, while the median value for CBD corresponded to “slightly effective.”
To investigate use patterns, Dr. Reinert and colleagues created a questionnaire with 55-75 questions, which followed a branching logic tree. Topics included pain history, demographics, and experience with marijuana and CBD for the purpose of controlling pelvic pain. The survey was sent to two populations: an endometriosis association mailing list, and patients at a chronic pain center in Phoenix.
About 24,500 surveys were sent out; 366 were received and analyzed. The response rate was much different between the two populations, at 1% in the endometriosis association and 16% of the clinic population. Dr. Reinert attributed the low response rate in the association sample to the continuing stigma surrounding marijuana use, citing much higher response rates to other surveys sent out by the association around the same time.
Overall, 63% of respondents said they had never used marijuana; 37% reported past or present use; 65% said they had never used CBD; and 35% reported past or present use. About 45% of marijuana users reported that its use was very effective, and 25% said it was moderately effective. About 22% of CBD users said it was very effective, and about 33% said it was moderately effective. The median values lay in the moderately effective range for marijuana, and in the slightly effective range for CBD.
The findings suggest a need for more research into the potential benefit and limitations of cannabis for pelvic pain from endometriosis, said Dr. Reinert, an obstetrician/gynecologist the University of Southern California, Los Angeles.
Until this study, evidence of efficacy of marijuana for this indication has been sparse. A report from the National Academy of Sciences showed that there is evidence that cannabis and cannabinoids have a therapeutic effect on chronic pain in adults (National Academies Press (US) 2017 Jan 12), but the report made no mention of gynecological applications. Despite this lack of evidence, surveys have shown that women of reproductive age use marijuana, and an analysis by the Ameritox Laboratory in a pain management population found that 13% of women and 19% of men tested positive for marijuana in their urine.
Still, “there is not research looking at marijuana for women with chronic health pain,” Dr. Reinert said at the meeting.
But that doesn’t stop companies from developing CBD vaginal suppositories and marketing them for menstrual pelvic discomfort, pain during sex, and other issues. Lay press articles often boost these claims, although some skeptical takes address the lack of evidence. Still, “there’s a lot on the more positive side,” she said.
That leads to a lot of interest among patients in using marijuana or CBD for symptom relief, which is part of the reason that Dr. Reinert’s team decided to examine its use and perceived efficacy. Another reason is that there is some biological basis to believe that cannabis could be helpful. There is some evidence that women with endometriosis have changes in their endocannabinoid system (Cannabis Cannabinoid Res. 2017;2:72-80), and there are clinical trials examining the impact of non-CBD, non-tetrahydrocannabinol (THC) endocannabinoid ligands.
Dr. Reinert has no financial disclosures.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Ultrasound distinguishes early, late-stage endometriosis
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
REPORTING FROM THE AAGL GLOBAL CONGRESS
Depression linked to persistent opioid use after hysterectomy
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Opioid reduction works after minimally invasive gynecologic surgery
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Surgical staging improves cervical cancer outcomes
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
REPORTING FROM THE AAGL GLOBAL CONGRESS