An alternative and perhaps more readily grasped way of expressing the QALY results is that patients undergoing laparoscopic hysterectomy enjoyed an additional 0.85 QALY, or roughly 1 extra month of life in perfect health over a 5-year time period, Dr. Siedhoff explained.
The decision analysis didn’t include the well-established facts that laparoscopic hysterectomy entails less postoperative pain, a shorter average hospital length of stay, and faster return to daily activities.
Dr. Siedhoff was quick to assert that the true incidence of occult leiomyosarcoma in women undergoing surgery for presumed fibroids is unknown. An American College of Obstetricians and Gynecologist’s position statement issued earlier this year quoted an estimate of 1 in 500. The FDA cited a figure of 1 in 350. But when the North Carolina researchers examined the 10 studies published during 1990-2013, upon which the FDA based its estimate, the investigators felt compelled to reject 6 of them because of poor quality. For example, several studies included morcellation in patients with preoperative known or suspected sarcoma, even though morcellation should absolutely never be done in that situation. Based upon a weighted analysis of the remaining four highest-quality studies, the investigators came up with an estimate of 12 cases/10,000 women.
Noting that the largest of the studies in the FDA analysis included just 1,584 women with 2 cases of leiomyosarcoma, Dr. Siedhoff said, “I think it’s important to point out that really important decisions are being made on awfully small numerators and denominators. The truth of the matter is we have no idea what the true number is. It could be twice as high as our estimate or half as low.”
He admitted that he has been personally affected by the rancorous tone of recent public debate regarding morcellation safety, in which the procedure’s defenders often are demonized.
“It’s been confusing to me why in the Wall Street Journal they talk about these evil doctors who want to use this technique, as if it somehow benefits us. It’s not easier to do laparoscopic surgery, and it’s certainly not easier to morcellate tissue. The only reason that we’re talking about this is because we care about the outcomes for our patients,” the gynecologic surgeon said at the meeting presented by the Society of Laparoendoscopic Surgeons and affiliated societies. “One of the things that has been most difficult about all this,” he continued, “is the way that the information has moved from some very vocal people who feel strongly about this issue to the level of the lay person that you see in the elevator, or worse yet, your own patient. I think it’s almost like a game of telephone, so that by the time it gets down to a person who’s not a surgeon, the message is ‘morcellation causes cancer.’”Not only is the true prevalence of occult malignancy in women undergoing laparoscopic surgery for removal of fibroids unclear, but the data on the adverse impact of morcellation in this situation is sketchy as well. To date, it consists of two single-center retrospective studies. The more recent report, from Brigham and Women’s Hospital, involved 19 patients who underwent morcellation and 39 who had a total abdominal hysterectomy, all found to have leiomyosarcoma. The cancer recurrence rate was significantly higher in women who had morcellation, by a margin of 74% to 51%. However, there was no significant difference in overall survival (Cancer 2014 [doi:10.1002/cncr.28844]).
In contrast, an earlier Korean study involving a consecutive series comprised of 25 patients with occult leiomyosarcoma who underwent morcellation and 31 with total abdominal hysterectomy found a significant difference in 5-year overall survival: 46% in the morcellation group, and what Dr. Siedhoff deemed an unusually favorable 73% in the total abdominal hysterectomy patients (Gynecol. Oncol. 2011;122:255-9).
There is a great unmet need for a reliable preoperative method to distinguish leiomyosarcomas from benign fibroids. Imaging is of limited value. Endometrial biopsy is rarely positive. No biomarkers have been identified. Clinical factors that increase the likelihood of leiomyosarcoma include rapid growth, African American ethnicity, older age, a history of pelvic radiation, and the presence of the retinoblastoma gene.
In his own practice, Dr. Siedhoff sometimes uses specimen retrieval bags when performing morcellation, but finds the currently available versions to be cumbersome and a challenge to work with. Besides, he noted, there is to date no evidence that they are actually effective in reducing leiomyosarcoma recurrence risk. He was a member of an AAGL task force which in May issued a position statement on morcellation, which noted, “Use of morcellation within specimen retrieval pouches for containment of benign or malignant uterine tissue requires significant skill and experience, and use of specimen retrieval pouches should be further investigated for safety and outcomes in a controlled setting.”