Surgical staging of uterine cancer: Randomized phase III trial of laparoscopy vs laparotomy—A Gynecologic Oncology Group Study (GOG): Preliminary results

Abstract

5010 Background: Feasibility of laparoscopy has been demonstrated, but the toxicity, staging, and survival has not been adequately compared to the traditional open approach. A randomized Phase III trial of 2616 patients was conducted by the GOG from 5/1996 to 9/2005. QOL and complications of surgery were previously reported at SGO. FIGO pathologic staging is the basis of this report. Methods: Clinical Stage I-IIA uterine cancer were eligible, consenting to either technique. The randomization procedures yielded two on laparoscopy arm for every one on the laparotomy arm. Scope participants were required to undergo laparotomy if the complete surgical staging was not feasible, or for resection of cancer. The staging results include: FIGO surgical stage, peritoneal cytology, number of nodes per site, and percent positive nodes at each location: right pelvic, left pelvic, right para-aortic, left para-aortic. Results: 2616 were randomized, 403 were excluded for this analysis: 84 ineligible, 76 sarcoma, 198 incomplete data, 45 were stage IV, leaving 2213 evaluable for lymph node staging of endometrial carcinoma (781 open:1432 scope). Conversion to laparotomy from laparoscopy occurred in 23.7%. Positive or suspicious cytology was found in 5.6% of laparotomy and 7.8% of laparoscopy participants (p = 0.055 n.s.). Pelvic nodes were documented (R 98.8% vs 98.9%, L 98.5% vs 98.1% n.s.) and positive pelvics (any positive 8.8% vs 8.7%; R 5.5% vs 5.8%; L 6.9% vs 6.1% n.s.) were similar. Laparoscopic surgical staging cases were less likely to have para-aortic nodes sampled (L 91.3% vs 85.0% p < 0.001; R 96.0% vs 92.5% P = 0.001), but positve nodes were no different (any positive PA 5.0% vs 4.5%; R 4.1%, 3.4%; L 2.3%, 2.7% n.s.). Final FIGO Staging results (III A: 5.5% vs 5.7% n.s.& IIIC: 9.3% vs 9.5% n.s.) were the same by randomization arm. Conclusion: These results demonstrate that laparoscopic surgical staging of endometrial cancer can be completed in 76.3%. No difference in postive cytology, node positivity rate, or FIGO stage could be attributed to the laparoscopic approach. Conversion to laparotomy is advised when incomplete staging results would yield inadequate information for treatment planning. NCI Funding: UO1CA65221, CA 27469. No significant financial relationships to disclose.