[A prospective randomized trial comparing mitomycin C and vindesine and cisplatin versus pirarubicin and vindesine and cisplatin in the treatment of advanced non-small cell lung cancer].

BACKGROUND: To evaluate the response, adverse effects and survival of MVP regimen and TVP regimen. METHODS: Sixty six patients with advanced non-small cell lung cancer were randomized into two groups:MVP arm (32 patients, mitomycin C 6-8 mg/m² d1, vindesine 2-3 mg/m² d1 and d8, cisplatin 70-80 mg/m² d1) and TVP arm (34 patients, pirarubicin 40-50 mg/m² d1, vindesine and cisplatin were the same as arm MVP). Characteristics of the patients were similar in two arms. All patients received two to four cycles of chemotherapy. RESULTS: The overall responses were 34% (11/32) in the MVP arm and 56% (19/34) in the TVP arm. There were 1 complete response, 10 partial responses in the MVP arm and 1 complete response, 18 partial responses in the TVP arm. TVP regimen appeared to have a higher objective response, but no statistically significant difference in the response was observed between two regimens (Chi-square=2.269, P=0.132). Main side effects were hematological toxicities. Grade III+IV hematological toxicities were significantly higher in the patients of arm TVP than arm MVP, especially neutropenia (79% vs 44%, Chi-square=7.458, P=0.006). Median survival time was 12 months vs 8 months, and 1-, 2-, 3-year survival rates were 53% vs 24% (Chi-square=4.943, P=0.026), 17% vs 6%, 6% vs 0, for arm TVP and arm MVP, respectively.. CONCLUSIONS: MVP regimen has a lower response rate and longer survival time but less hematological toxicities than TVP regimen. The results suggest MVP regimen is a safe and active regimen for advanced non-small cell lung cancer.