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Laparoscopy vs Laparotomy for Endometrial Cancer Staging: The Lap2 Report
Abstract & Commentary
By Robert L. Coleman, MD, Professor, University of Texas; M.D. Anderson Cancer Center, Houston, Portland, is Associate Editor for OB/GYN Clinical Alert.
Dr. Coleman is a consultant to GlaxoSmithKline, Eli Lilly Co., Abbott Laboratories, Sanofi-Aventis, and Pfizer, and serves on the speakers bureau for GlaxoSmithKline, Eli Lilly Co., and OrthoBiotech.
Synopsis: Laparoscopic surgical staging for clinical stage I-IIA uterine cancer is feasible and safe, providing staging information on par with laparotomy and a superior profile relative to complications and hospital stay.
Source: Walker JL, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study Lap 2. J Clin Oncol 2009;27:5331-5336.
Endometrial cancer is the most common gynecologic malignancy and most often presents with corpus-limited disease. The principle aspect of initial care is organ removal, which may be approached surgically via the vagina or abdomen, or endoscopically. The latter two are preferred given the ability also to evaluate for extra-uterine disease in the abdomen and pelvis, as well as the retroperitoneum (surgical staging).
A formal phase III randomized surgical trial was conducted by the Gynecologic Oncology Group to assess the safety and feasibility of laparoscopic surgical staging relative to laparotomy. Eligible patients had clinical stage I-IIA uterine cancer and were randomly assigned 2:1 to laparoscopy vs laparotomy. The main study endpoints were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes.
In the current report, the latter 3 variables are not discussed due to immature data (survival and recurrence patterns) or are reported elsewhere (quality of life). Overall, 1248 of 1682 patients randomized to laparoscopy had the procedure completed without conversion to laparotomy (74%). The primary reason for conversion was poor visibility (54% of the 246 conversions). Laparoscopy was associated with significantly fewer moderate-to-severe postoperative adverse events (14% vs 21%; P < 0.0001), including ileus, and fewer hospital days (percentage greater than 2 days: 52% vs 94%; P < 0.0001), but was associated with a higher rate of noncompliance in removing paraortic lymph nodes (8% vs 4%; P < 0.0001) and longer operative times (204 vs 130 minutes; P < 0.001). However, there were similar rates of intraoperative complications, percentage of patients identified with positive nodes, and stage distribution. The authors conclude the laparoscopic approach is safe and feasible with noted improvements in short-term outcomes. Survival data are pending.
While endoscopic removal of the uterus has been performed for some time, the ability and utility of endoscopic surgical staging for endometrial cancer was launched when surgical dissection of the retroperitoneum became feasible. In the two decades since these initial reports, hundreds of papers have appeared in the literature highlighting improvements in surgical technique; patient selection; new, improved, or modified instrumentation; short- and long-term outcomes; and most recently, the introduction of robotics. Nearly all of these reports have come from a relatively limited number of highly skilled surgeons, developing referral or speciality practices and providing education to trainees and novices, who continually push the surgical envelope. Since the majority of endometrial surgical staging cases in this country are not reported in research studies, metrics of safety and feasibility of the laparoscopic approach are difficult to quantify.
Recognizing this important limitation, the Gynecologic Oncology Group launched a randomized clinical trial to initially describe the complications of the endoscopic route in members of this cooperative group without formal restrictions on surgical skill. Later, the protocol was expanded to describe outcomes as a non-inferiority design; these data are still maturing. However, for those who routinely offer the endoscopic approach for disease-limited endometrial cancer, the results of this initial summary are not surprising, and are validating with the exception of conversion rates. While it would be expected that case volume increases would reduce conversion to laparotomy due to surgical skill, it is likely that this acquired acumen also stretched patient selection to older, more obese, and more medically diverse patients, keeping the conversion rate higher than expected. Indeed, over half of the conversion cases were due to surgical field exposure. The recent introduction of robotics will likely have a positive effect on these issues as optics, motility degrees of freedom, and surgeon comfort are all substantially improved with these machines. Ultimately, long-term survival data for the two approaches must be equivalent or better to cement this surgical approach, despite the obvious bias to preferentially offer the procedure. Fortunately, those data will be available in the coming years.