Journal of Clinical Oncology, Vol 20, Issue 21
(November), 2002: 4285-4291
© 2002 American Society for Clinical Oncology
Phase III Randomized Trial Comparing Three Platinum-Based Doublets in Advanced Non–Small-Cell Lung Cancer
By G.V. Scagliotti,
F. De Marinis,
M. Rinaldi,
L. Crinò,
C. Gridelli,
S. Ricci,
E. Matano,
C. Boni,
M. Marangolo,
G. Failla,
G. Altavilla,
V. Adamo,
A. Ceribelli,
M. Clerici,
F. Di Costanzo,
L. Frontini,
M. Tonato for the Italian Lung Cancer Project
From the Department of Clinical and Biological Sciences, University of Torino, Turin; Division of Pneumo-Oncology V, C. Forlanini Hospital, Division of Medical Oncology B, Regina Elena Institute, and Division of Medical Oncology A, Regina Elena Institute, Rome; Division of Medical Oncology, Bellaria Hospital, Bologna; Division of Medical Oncology B, National Cancer Institute "G. Pascale" and Department of Endocrinology and Molecular and Clinical Oncology, Federico II University, Naples; Division of Medical Oncology, S. Chiara Hospital, Pisa; Division of Medical Oncology, S. Maria Hospital, Reggio Emilia; Division of Medical Oncology, S. Maria delle Croci Hospital, Ravenna; Division of Medical Oncology, S. Luigi and S. Curro Hospital, Catania; Department of Medical Oncology, University of Messina, Messina; Division of Medical Oncology, S. Giuseppe Hospital and Division of Medical Oncology, L. Sacco Hospital, Milan; Division of Medical Oncology, S. Maria Hospital, Terni; and Division of Medical Oncology, Policlinico Hospital, Perugia, Italy.
Address reprint requests to Giorgio V. Scagliotti, MD, University of Turin, Department of Clinical and Biological Sciences, Azienda Ospedaliera S Luigi, Regione Gonzole 10, 10043 Orbassano, Torino, Italy; email: scagliotti{at}ihnet.it
PURPOSE: To evaluate whether two commonly used newer platinum-based regimens offer any advantage over vinorelbine-cisplatin (reference regimen) in response rate for patients with advanced non–small-cell lung cancer (NSCLC).
PATIENTS AND METHODS: Chemotherapy-naive patients were randomized to receive gemcitabine 1,250 mg/m2 days 1 and 8 plus cisplatin 75 mg/m2 day 2 every 21 days (GC arm), or paclitaxel 225 mg/m2 (3-hour infusion) then carboplatin (area under the concentration-time curve of 6 mg/mL·min), both on day 1 every 21 days (PCb arm), or vinorelbine 25 mg/m2/wk for 12 weeks then every other week plus cisplatin 100 mg/m2 day 1 every 28 days (VC arm).
RESULTS: Six hundred twelve patients were randomized to treatment (205 GC, 204 PCb, and 203 VC). Overall response rates for the GC (30%) and PCb (32%) arms were not significantly different from that of the VC arm (30%). There were no differences in overall survival, time to disease progression, or time to treatment failure. Median survival for the GC, PCb, and VC groups was 9.8, 9.9, and 9.5 months, respectively. Neutropenia was significantly higher on the VC arm (GC 17% or PCb 35% v VC 43% of cycles, P < .001), as was thrombocytopenia on the GC arm (GC 16% v VC 0.1% of cycles, P < .001). Alopecia and peripheral neurotoxicity were most common on the PCb arm, as was nausea/vomiting on the VC arm (P < .05).
CONCLUSION: Efficacy end points were not significantly different between experimental and reference arms, although toxicities showed differences. These findings suggest that chemotherapy in NSCLC has reached a therapeutic plateau.
Presented in part at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.
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