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Journal of Clinical Oncology, Vol 17, Issue 11 (November), 1999: 3522-3530
© 1999 American Society for Clinical Oncology

Gemcitabine and Cisplatin Versus Mitomycin, Ifosfamide, and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Randomized Phase III Study of the Italian Lung Cancer Project

L. Crinò, G. V. Scagliotti, S. Ricci, F. De Marinis, M. Rinaldi, C. Gridelli, A. Ceribelli, R. Bianco, M. Marangolo, F. Di Costanzo, M. Sassi, S. Barni, A. Ravaioli, V. Adamo, L. Portalone, G. Cruciani, A. Masotti, G. Ferrara, F. Gozzelino, M. Tonato

From the Department of Medical Oncology, Policlinico Hospital, Perugia; Department of Clinical and Biological Sciences, University of Torino, Torino; Department of Medical Oncology, S Chiara Hospital, Pisa; Department of Pneumology III, Forlanini Hospital, Department of Medical Oncology II, Regina Elena Institute, Department of Medical Oncology I, Regina Elena Institute, and Department of Pneumology VIII, Forlanini Hospital, Rome; Department of Medical Oncology B, National Cancer Institute "G Pascale" and Department of Endocrinology and Molecular and Clinical Oncology, Federico II University, Naples; Department of Medical Oncology, S Maria delle Croci Hospital, and Department of Medical Oncology, Umberto I Hospital, Lugo, Ravenna; Department of Medical Oncology, S Maria Hospital, Terni; Department of Medical Oncology, S Maria Hospital, Reggio Emilia; Department of Radiation Oncology, S Gerardo Hospital, Monza; Department of Medical Oncology, Infermi Hospital, Rimini; Department of Medical Oncology, University of Messina, Messina; Department of Pneumology, Civile Maggiore Hospital, Verona; Department of Pneumology I, "Vincenzo Cervello" Hospital, Palermo; and Department of Pneumology, Infermi Hospital, Biella, Italy.

Address reprint requests to Giorgio V. Scagliotti, MD, University of Torino, Department of Clinical and Biological Sciences, Azienda Ospedaliera S Luigi, Regione Gonzole n. 10, 10043 Orbassano, Torino, Italy; email scagliotti{at}ihnet.it

PURPOSE: To compare gemcitabine and cisplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) chemotherapy in patients with stage IIIB (limited to T4 for pleural effusion and N3 for supraclavicular lymph nodes) or stage IV non–small-cell lung cancer (NSCLC). The end points were the evaluation of quality of life (QoL), response rates, survival, and toxicity.

PATIENTS AND METHODS: Three hundred seven patients were randomized to receive either gemcitabine 1,000 mg/m2 on days 1, 8, and 15 plus cisplatin 100 mg/m2 on day 2, every 28 days, or mitomycin 6 mg/m2, ifosfamide 3,000 mg/m2, and mesna on day 1 plus cisplatin 100 mg/m2 on day 2, every 28 days. The whole-blood cell count was repeated on day 1 in both arms and weekly in the GC arm before each gemcitabine administration.

RESULTS: No major differences in changes in QoL were observed between the two treatment arms. The objective response rate was 38% in the GC arm compared with 26% in the MIC arm (P = .029). The median survival time was 8.6 months in the GC arm and 9.6 months in the MIC arm (P = .877, log-rank test). Grade 3 and 4 thrombocytopenia was significantly worse in the GC arm (64% v 28%, P < .001), whereas grade 3 and 4 alopecia was reported more commonly in the MIC arm (39% v 12%, P < .001).

CONCLUSION: We report an increased response rate without changes in QoL and a similar overall survival, time to progression, and time to treatment failure for the GC when compared with the MIC regimen in the treatment of advanced NSCLC.


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