A Phase II Trial of Intraperitoneal Cisplatin and Etoposide as Consolidation Therapy in Patients with Stage II–IV Epithelial Ovarian Cancer Following Negative Surgical Assessment

Abstract

Purpose.To determine the efficacy of three courses of intraperitoneal (ip) cisplatin (CDDP) and etoposide (VP-16) as consolidation therapy following pathologically negative second-look surgical reassessment for Stage IIC–IV epithelial ovarian cancer (EOC).Patients and Methods.Between September 1988 and April 1996, 40 patients were treated with three cycles of ip CDDP (100 mg/m2)/VP-16 (200 mg/m2) as consolidation therapy. Survival was compared to that of a group of 46 contemporaneous patients undergoing observation only.Results.Median age of the 36 eligible patients was 52 years (range 30–70 years). Stage distribution was II (3), III (31), and IV (2); histologic grade was 1 (2), 2 (7), 3 (25), and not recorded (2); and residual disease at completion of initial surgery was none/microscopic in 13/36 (36%) patients. Median age of the 46 patients who did not receive consolidation was 52 years (range, 27–80 years); stage distribution was II (18), III (26), and IV (2); histologic grade was 1 (5), 2 (12), 3 (28), and not recorded (1). With a median follow-up of 36 months in both groups, 14/36 (39%) of the protocol group have recurred compared with 25/46 (54%) of those undergoing observation alone. Median disease-free survival (DFS) for the observed patients is 28.5 months and has not been reached in the consolidation group. Disease-free survival distribution between the two groups was compared using the log-rank test and was found to be significant (P= 0.03). Multivariate analysis revealed that the only significant predictor of improved DFS was protocol treatment (P< 0.01).Conclusion.Intraperitoneal consolidation with CDDP/VP-16 following negative second-look reassessment in patients with advanced EOC resulted in a significant increase in DFS compared to nonprotocol patients treated concurrently who underwent observation alone.