Intraperitoneal cisplatin versus no further treatment: 8-year results of EORTC 55875, a randomized phase III study in ovarian cancer patients with a pathologically complete remission after platinum-based intravenous chemotherapy.

摘要: First-line intravenous chemotherapy (CT) following debulking surgery is associated with prolonged survival, in particular patients who achieve a pathological complete remission (pCR) at second-look but whom high rate of relapses still occurs. Between 1988 and 1997, 153 pCR platinum-based CT were randomized between four courses intraperitoneal cisplatin (P) (90 mg/m2 every 3 weeks) or observation. Overall survival (OS) was the primary endpoint, while progression-free (PFS) secondary endpoint. This intent-to-treat analysis includes 16 not eligible 17 had protocol violations. The two groups well balanced terms age (median = 55 years), performance status (78% P.S. O), FIGO stage (96% III), histology (serous 66%), grade (2 80%), residuum before (>1 cm 40%). Intraperitoneal delivered mainly through catheters (Port-a-Cath 61% Tenckhoff 25%). Side effects included vomiting [> =grade 2 (82%)], rise serum creatinine (14%)], abdominal pain [grade 1-2 (38%)], neurotoxicity 2-3 (15%)]. After median follow-up 8 years, 80 (52%) have progressed no difference pattern relapse 75 (49%) died; respective hazard ratios for PFS OS 95% CI are 0.89 (0.59-1.33) 0.82 (0.52-1.29). These results suggestive treatment benefit do support change clinical practice. Other trials reviewed briefly discussed.