1068 Cisplatin 120mg/m2 vs. carboplatin 500mg/m2 in combination with mitomycin c and vindesin; a randomized phase III study in 164 patients with stage IIIB and IV squamous-cell bronhogenic carcinoma

Autor: Davorin Radosavljevic, Siniša Radulović, V. Kovcin, S. Kovacević, E. Elezar, L. Mitrović, Svetislav Jelić, Z. Ristović
Rok vydání: 1995
Předmět:
Zdroj: European Journal of Cancer. 31:S223
ISSN: 0959-8049
DOI: 10.1016/0959-8049(95)96315-5
Popis: A randomized phase III study of Cisplatin vs. Carboplatin in 1:4 ration in patients with stage IIIb and IV squamous cell bronhogenic carcinoma, in combination with Mitomycin C and Vindesin was performed in 164 patients. The study is still open and accrual of new patients is planed to be stopped by July 1995. The arm A received Cisplatin 120 mg/m2, Mitomycin C 8 mg/m2 and Vindesine 3 mg/m2. The arm B received Carboplatin 500 mg/m2 with the same dosage of Mitomycin C and Vindesine per cycle. Chemotherapy was applied until signs of progressive disease, 6 cycles at most. Both arms were well balanced regarding age, sex, clinical stage, histological grade and performance status. 84 patients were randomized to the Cisplatin group (83 evaluable for activity) and 80 to the Carboplatin group (76 evaluable for activity). In the Cisplatin group there were 2.41% CR, 30.12% PR, 43.37% SD, 24.10% PD, RR 32.53%, mean time to progression 4.21 ± 3.09 months, median 3.43; mean overall survival 6.72 ± 3.69 months, median 6. In the Carboplatin group there were 5.26 CR, 30.26% PR, 43.24% SD, 21.05% PD, RR 35.72%; mean time to progression 5.01 ± 3.27 months, median 4.40; mean overall survival 7.65 ± 5.26 months, median 6. The Carboplatin arm displayed a higher incidence of grade III/IV hematological toxicity, while the Cisplatin regimen was more emetogenic and nephrotoxic. Carboplatin substituting Cisplatin in the regimen seems to be associated with a similar activity and a longer interval to progression not affecting the overall survival.
Databáze: OpenAIRE
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