BACKGROUND:Cisplatin-based chemotherapy is generally considered the most active treatment for advanced non-small-cell lung cancer. The combination of cisplatin and etoposide had for some time been the standard treatment at our center. Of the other active regimens, cisplatin in combination with mitomycin-C, vindesine or ifosfamide (MVP or MIC) showed the highest response rates. We decided to perform a comparative trial of the three 'best' regimens in order to define a possible standard regimen in advanced NSCLC. MATERIALS AND METHODS:From May 1989 to April 1992, 393 consecutive, previously untreated NSCLC patients, stages IIIB and IV, were randomized to receive either cisplatin (120 mg/sqm day 1) + etoposide (100 mg/sqm days 1-3) every 3 weeks (PE) or cisplatin (120 mg/sqm every 4 weeks) + mitomycin-C (8 mg/sqm days 1-29-71) + vindesine (3 mg/sqm days 1-8-15-22) (MVP) or cisplatin (120 mg/sqm day 1) + mitomycin-C (6 mg/sqm day 1) + ifosfamide (3 mg/sqm day 2) every 3 weeks (MIC). Of these, 382 were evaluable for survival and 360 for response. RESULTS:Response rates were statistically higher for both MIC (40%) and MVP (36%) than for the PE arm (23%). Survival estimates analyzed by the log-rank test showed a significant benefit (p < 0.04) for patients treated with three-drug regimens (MVP; MIC) as compared to those in the PE arm. The main toxicity was myelosuppression; thrombocytopenia WHO grade 3-4 was worse in the MIC arm; nephrotoxicity grade 3-4 was also more frequent in the MIC arm. CONCLUSIONS: A three-drug cisplatin-based regimen (MVP; MIC) should be considered as reference treatment in NSCLC.
RCT Entities:
BACKGROUND:Cisplatin-based chemotherapy is generally considered the most active treatment for advanced non-small-cell lung cancer. The combination of cisplatin and etoposide had for some time been the standard treatment at our center. Of the other active regimens, cisplatin in combination with mitomycin-C, vindesine or ifosfamide (MVP or MIC) showed the highest response rates. We decided to perform a comparative trial of the three 'best' regimens in order to define a possible standard regimen in advanced NSCLC. MATERIALS AND METHODS: From May 1989 to April 1992, 393 consecutive, previously untreated NSCLCpatients, stages IIIB and IV, were randomized to receive either cisplatin (120 mg/sqm day 1) + etoposide (100 mg/sqm days 1-3) every 3 weeks (PE) or cisplatin (120 mg/sqm every 4 weeks) + mitomycin-C (8 mg/sqm days 1-29-71) + vindesine (3 mg/sqm days 1-8-15-22) (MVP) or cisplatin (120 mg/sqm day 1) + mitomycin-C (6 mg/sqm day 1) + ifosfamide (3 mg/sqm day 2) every 3 weeks (MIC). Of these, 382 were evaluable for survival and 360 for response. RESULTS: Response rates were statistically higher for both MIC (40%) and MVP (36%) than for the PE arm (23%). Survival estimates analyzed by the log-rank test showed a significant benefit (p < 0.04) for patients treated with three-drug regimens (MVP; MIC) as compared to those in the PE arm. The main toxicity was myelosuppression; thrombocytopenia WHO grade 3-4 was worse in the MIC arm; nephrotoxicity grade 3-4 was also more frequent in the MIC arm. CONCLUSIONS: A three-drug cisplatin-based regimen (MVP; MIC) should be considered as reference treatment in NSCLC.
Authors: P Comella; G Frasci; G De Cataldis; N Panza; R Cioffi; C Curcio; M Belli; A Bianco; G Ianniello; L Maiorino; M Della Vittoria; J Perchard; G Comella Journal: Br J Cancer Date: 1996-12 Impact factor: 7.640
Authors: E Baldini; C Tibaldi; A Ardizzoni; F Salvati; A Antilli; L Portalone; S Barbera; F Romano; F De Marinis; M R Migliorino; M A Noseda; U Borghini; M Crippa; G Ferrara; M Raimondi; M Fioretti; M Bandera; M C Pennucci; G Galeasso; G C Cacciani; G Lepidini; G Sunseri; C Lanfranco; M Rinaldi; R Rosso Journal: Br J Cancer Date: 1998-06 Impact factor: 7.640