INTRAPERITONEAL CARBOPLATIN WITH OR WITHOUT INTERFERON-ALPHA IN ADVANCED OVARIAN-CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE AT 2ND LOOK - A PROSPECTIVE RANDOMIZED TRIAL OF 111 PATIENTS

From June 1990 to October 1994, 111 advanced ovarian cancer patients w ith minimal (less than 2 cm) residual disease after platinum-based fro nt-line chemotherapy and second-look laparotomy entered a cooperative randomized study aimed at evaluating the effectiveness and the toxicit y of the addition of interferon-alpha 2 to carboplatin, both intraperi toneally (ip) administered. Patients were randomized to receive either 3 courses of ip Carboplatin 400 mg/m(2) Day 1 q 28 days (54 pts) (CBD CA) or ip interferon-alpha 25 x 10(6) U Day 1 + ip carboplatin 400 mg/ m(2) Day 2 q 28 days (57 pts) (CBDCA + IFN). Patients treated with int erferon experienced more severe (WHO grade 3-4) leukopenia (28% vs 17. 1%) and anemia (14% vs 4.2%). Fever (P = 0.000) and flu-like syndrome (P = 0.02) were significantly more frequent in the combination arm. No difference in gastroenteric, neurologic, or renal toxicity was observ ed. At a median follow-up time of 13 months (range 1-72) 71 patients s howed a disease progression (31 CBDCA, 40 CBDCA + IFN) and 44 patients died (21 CBDCA, 23 CBDCA + IFN). Median progression-free survival was 11 months in the CBDCA group and 10 months in the CBDCA + IFN arm. Me dian survival was 22 and 29 months in CBDCA and CBDCA + IFN arm, respe ctively. In conclusion, intraperitoneal interferon-alpha does not seem to improve the results achievable with intraperitoneal carboplatin in this subset of patients, while the toxicity and the costs of the comb ination are consistently higher than with chemotherapy alone. (C) 1997 Academic Press.