title: Intraperitoneal carboplatin with or without interferon-alpha in advanced ovarian cancer patients with minimal residual disease at second look: a prospective randomized trial of 111 patients. G.O.N.O. Gruppo Oncologic Nord Ovest.
abstract: From June 1990 to October 1994, 111 advanced ovarian cancer patients with minimal (less than 2 cm) residual disease after platinum-based front-line chemotherapy and second-look laparotomy entered a cooperative randomized study aimed at evaluating the effectiveness and the toxicity of the addition of interferon-alpha2 to carboplatin, both intraperitoneally (ip) administered. Patients were randomized to receive either 3 courses of ip Carboplatin 400 mg/m2 Day 1 q 28 days (54 pts) (CBDCA) or ip interferon-alpha 25 x 10(6) U Day 1 + ip carboplatin 400 mg/m2 Day 2 q 28 days (57 pts) (CBDCA + IFN). Patients treated with interferon 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 observed. At a median follow-up time of 13 months (range 1-72) 71 patients showed 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. Median survival was 22 and 29 months in CBDCA and CBDCA + IFN arm, respectively. 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 combination are consistently higher than with chemotherapy alone.
authors.affiliation: National Institute for Cancer Research and Cooperative Centers of the G.O.N.O. (North West Oncology Group).
authors.forename: M
authors.initials: M
authors.lastname: Bruzzone
authors.forename: A
authors.initials: A
authors.lastname: Rubagotti
authors.forename: A
authors.initials: A
authors.lastname: Gadducci
authors.forename: E
authors.initials: E
authors.lastname: Catsafados
authors.forename: G
authors.initials: G
authors.lastname: Foglia
authors.forename: I
authors.initials: I
authors.lastname: Brunetti
authors.forename: P G
authors.initials: PG
authors.lastname: Giannessi
authors.forename: F
authors.initials: F
authors.lastname: Carnino
authors.forename: L
authors.initials: L
authors.lastname: Iskra
authors.forename: R
authors.initials: R
authors.lastname: Rosso
authors.forename: A
authors.initials: A
authors.lastname: Martoni
authors.forename: F
authors.initials: F
authors.lastname: Pannuti
authors.forename: V
authors.initials: V
authors.lastname: De Lisi
authors.forename: R
authors.initials: R
authors.lastname: Maltoni
authors.forename: R
authors.initials: R
authors.lastname: Ridolfi
authors.forename: S
authors.initials: S
authors.lastname: Mammoliti
authors.forename: L
authors.initials: L
authors.lastname: Gallo
authors.forename: F
authors.initials: F
authors.lastname: Boccardo
authors.forename: N
authors.initials: N
authors.lastname: Ragni
authors.forename: P F
authors.initials: PF
authors.lastname: Conte
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D016190:Carboplatin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007274:Injections, Intraperitoneal; D016898:Interferon-alpha / Q000008:administration & dosage*; D007813:Laparotomy; D008875:Middle Aged; D009367:Neoplasm Staging; D018365:Neoplasm, Residual; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D012086:Reoperation
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha; D016190:Carboplatin