Annals of Oncology 6:347-353, 1995
© 1995 European Society for Medical Oncology
research-article |
Chemotherapy of advanced non-small-cell lung cancer: A comparison of three active regimens. A randomized trial of the Italian Oncology Group for Clinical Research (G.O.I.R.C.)
1Medical Oncology Division, Policlinico Hospital Perugia
2Medical Oncology Service, S. Bortolo Hospital Vicenza
3Medical Oncology Division I, Istituto Regina Elena Roma
4Medical Oncology, University ‘La Sapienza’ Roma
5Oncology Service, Hospital of Piacenza
6Medical Oncology Division, Arcispedale S. Anna Ferrara
7Oncology Service, S. Maria Hospital Temi
8Medical Oncology Service, Hospital of Reggio Emilia
9Pneumology Division, Silvestrini Hospital Perugia
10Medical Statistics Unit, Institute of Internal and Vascular Medicine, University of Perugia Italy
Correspondence to: Dr. L. Crinò, Divisione di Oncologia Medica, Policlinico Monteluce, 06122 Perugia, Italy
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 TUB 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 evalable 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.
advanced NSCLC, cisplatin-based chemotherapy
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