Randomized trial of systematic lymphadenectomy (LY) vs nodal sampling (SA) at second look surgery (SLS) in ovarian cancer patients: Final results

5068 Background: The role of systematic pelvic and para-aortic lymphadenectomy at SLS in ovarian cancer patients has not been addressed by randomized clinical trials (RCTs). We conducted a RCT to determine whether LY improves progression-free (PFS) and overall survival (OS) compared with SA. Methods: From January 1991 through December 1999, 303 eligible patients (i.e. patients with FIGO stage I-IV epithelial ovarian carcinoma at up front surgery and in complete remission after primary debulking surgery and first line chemotherapy) were randomly assigned to undergo LY (N = 156) or SA (N = 147) at the end of SLS. Survival was analyzed using a Cox multivariable regression analysis. All statistical tests were two-sided. Results: Median operating time was longer and the percentage of patients requiring blood transfusions was higher in the LY arm than the SA (240 vs 135 min., P < .001, and 30% vs 10%, P < .001, respectively). In the LY arm and SA arm the median number of removed nodes and the percentages of patients with nodal involvement was statistically different (44 vs 8, P < .0001, and 24% vs 13%, P = 0.018, respectively). At a median follow-up of 59 months, 156 events (i.e., recurrences or deaths) were observed, and 98 patients had died. The 5-year progression-free and overall survival was 41% and 65% for LY, 49% and 61% for SA, respectively. The risk for first event (hazard ratio [HR] = 1.11, 95% CI = 0.81 to 1.53; P = .50) and death (HR = 0.79, 95% CI = 0.53 to 1.18; P = .24) after adjustment for residual tumor at first surgery was not significantly different between the two arms. Conclusions: Although LY at SLS seemed to improve overall survival, this survival gain (21% decrease in the hazard of death) was not statistically significant and therefore the routine use of LY at SLS for ovarian cancer is not supported by this RCT. No significant financial relationships to disclose.