Study provides cancer risk estimates among women undergoing morcellation

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com

An estimated 1 in 370 women who undergo electric power morcellation during a minimally invasive hysterectomy have uterine cancer, with the risk of cancer and endometrial hyperplasia markedly increasing with age, according to an analysis using an insurance database of more than 500 U.S. hospitals.

The estimate, published online in JAMA on July 22, is close to the Food and Drug Administration’s estimate that about 1 in 350 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma and is higher than historical estimates provided in the literature. The FDA’s estimate, first reported when the agency issued a safety communication in April discouraging the use of laparoscopic power morcellators (LPMs) during a hysterectomy or myomectomy because of the risk of disseminating cancerous tissue and upstaging disease, was based on 9 U.S. and international studies of women treated from 1983 to 2011. The risk of an unsuspected leiomyosarcoma was about 1 in 500.

But unlike the FDA analysis, the most recent analysis, conducted by Dr. Jason Wright and his associates at Columbia University, New York, specifically addressed the risk associated with morcellation. The estimate was based on the records of 232,882 women who underwent a minimally invasive hysterectomy from 2006 to 2012 obtained from a database that represents about 15% of U.S. hospitalizations. Morcellators were used in almost 16% (36,470) of the women, and there were 99 cases of uterine cancers, for a prevalence of 27/10,000 – about one in 370.

Among the women who underwent morcellation, the strongest risk factor for abnormal pathology, either for cancer or any of the precancerous changes, was advanced age. Compared with women under age 40 years, the prevalence ratio for uterine malignancy was 1.42 among those aged 40-44 and 2.55 for those aged 45-49, increasing to 4.97 among those aged 50-54 years, 19.37 among those aged 55-59 years, 21.36 among those aged 60-64 years – and 35.97 among those aged 65 and older.

The researchers also identified cases of endometrial hyperplasia, other gynecologic cancers, and smooth muscle tumors of uncertain malignant potential. The risk of endometrial hyperplasia also increased significantly with age, compared with women under age 40, with prevalence ratios of 1.17 among those aged 40-44 (not statistically significant) and 1.71 among those aged 45-49, to 4.07 among those aged 50-54 years, to 10.21 among those aged 65 years and older. The results are reported in a research letter (doi:10.1001/jama.2014.9005)

Despite the availability of power morcellators for 20 years, "few studies have described the prevalence of unexpected pathology at the time of hysterectomy," Dr. Wright and his associates wrote. While the analysis had limitations, including the lack of long-term follow-up and not being able to verify the pathology results, they concluded that patients who may be undergoing morcellation "should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure."

One of the strengths and unique aspects of this study was being able to identify a large population of women who specifically had morcellation and a hysterectomy, providing a population-based estimate of the prevalence of cancer in this group, Dr. Wright said in an interview. This is slightly different than other estimates and studies, which were not specific to morcellation, including those that looked at the incidence of sarcoma among women who had a hysterectomy. "We could not separate out epithelial endometrial cancers from uterine sarcomas, so this is an estimate of any malignancy within the uterus," so "probably a high proportion of women who underwent morcellation underwent the procedure for fibroid uterus, so the chance of sarcomas is probably higher in these patients than in the general population."

The study did not allow evaluation of whether the use of morcellation increased the risk of dissemination of cancer, which "certainly warrants further study," added Dr. Wright, chief of the division of gynecologic oncology at Columbia.

The lack of data has been one of the major problems surrounding morcellation, with very few studies specifically looking at data that can be used to help guide patients and clinicians. Dr. Wright and his associates hope that their results can help guide patients and clinicians.

"There’s undoubtedly a risk of cancer and precancerous changes in women who undergo morcellation ... and [patients and clinicians] need to weigh that risk," he said. "But certainly morcellation may allow some women to undergo a minimally invasive surgery who otherwise require laparotomy, and the complications and recovery are much easier with minimally invasive surgery, when it’s feasible."

Dr. Charles E. Miller, director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., described these data as "compelling," with well-presented information that stratifies risk by age that can be used to help properly counsel patients.

The marked difference in risk among women under age 40 is particularly important, he said. Dr. Miller performs about 250 morcellations per year and has had only one patient with a sarcoma, a woman in her mid-40s, which he said reflects the younger age of his patients.

"If we can better identify age groups where that risk is higher and do the treatment that is appropriate in that age group, then I think we’ve come a long, long way," he said in an interview. There are always outliers, and unfortunately, women in younger age groups develop sarcomas, but there are also the risks of more invasive surgery that should be considered, he added.

"There’s always going to be risk, and there’s always going to be decision making with surgery," and while there is a need for better ways to identify those patients at risk, currently, "all we can hang our hat on now is stratifying [risk] with age," Dr. Miller said.

On July 10-11, the FDA held a meeting of its Obstetrics and Gynecology Devices panel, to review the safety of LPMs during uterine surgery for fibroids, Among the questions the panel was asked was whether there were characteristics of patients – such as age, physical exam findings, and imaging test results – that could help identify patients who might be at a higher risk of a sarcoma.

The FDA is currently reviewing the safety of LPMs in women undergoing surgery for presumably benign fibroids, an issue that has received widespread attention this year and resulted in the FDA’s safety communication in April – largely due to the case of Dr. Amy Reed, an anesthesiologist who was diagnosed with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at age 40 last year. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are leading a campaign to highlight these risks, including a petition on change.org calling for a halt to morcellation during minimally invasive and robotic-assisted hysterectomy and myomectomy.

The authors of the JAMA report had no disclosures. Dr. Wright and one of the other authors, are recipients of National Cancer Institute (NCI) grants; another author is a recipient of an NCI fellowship. Dr. Miller disclosed that he is a consultant to Ethicon Endo-Surgery. Ethicon is a morcellator manufacturer.

emechcatie@frontlinemedcom.com