Phase II trial of intraperitoneal cisplatin and mitoxantrone in patients with persistent ovarian cancer

Objective. The aim of this study was to determine the feasibility and effic acy of intraperitoneal cisplatin and mitoxantrone in patients with very sma ll-volume residual disease at second-look surgery after completion of prima ry platinum-based intravenous chemotherapy, Patients and methods, Between February 1992 and February 1994, 42 patients were treated with up to five cycles of intraperitoneal cisplatin (100 mg/m( 2))/mitoxantrone (10 mg/m(2)). Patients were evaluated for surgically defin ed response rate and followed for progression-free (PFS) and overall surviv al (OS) using an intention-to-treat analysis, and grouped according to dise ase volume at initiation of treatment. Results. The mean age of all patients was 48.5 years. Thirty patients (71%) were Stage III at diagnosis; 18 patients (43%) had microscopic disease at the initiation of IP therapy, and 24 patients (57%) had macroscopic disease . Twenty-eight patients completed three or more cycles of protocol therapy, and 14 patients were changed to standard intravenous therapy after receivi ng fewer than three cycles of treatment secondary to catheter-related probl ems (12 patients), cisplatin ototoxicity (1 patient), or withdrawal from st udy (1 patient). Using an intention-to-treat analysis, the median PFS was 2 2.5 months, and the median OS of all patients (N = 42) was 47 months (6-72 months) with a median follow-up of 62.7 months. When grouped according to s ize of disease at initiation of treatment, the OS has not been reached at 6 2.7 months of follow-up in patients (N = 18) with microscopic disease. Conclusions. (1) The combination of LP mitoxantrone and cisplatin has an un acceptable catheter failure rate due to mitoxantrone toxicity; (2) PFS and OS is longer in patients with microscopic rather than macroscopic residual disease; and (3) intraperitoneal platinum-based chemotherapy in patients wi th very small-volume residual disease may result in improved survival, (C) 1999 Academic Press.