Journal of Clinical Oncology, Vol 21, Issue 17
(September), 2003: 3207-3213
© 2003 American Society for Clinical Oncology
Cisplatin Plus Gemcitabine Versus a Cisplatin-Based Triplet Versus Nonplatinum Sequential Doublets in Advanced Non–Small-Cell Lung Cancer: A Spanish Lung Cancer Group Phase III Randomized Trial
V. Alberola,
C. Camps,
M. Provencio,
D. Isla,
R. Rosell,
C. Vadell,
I. Bover,
A. Ruiz-Casado,
P. Azagra,
U. Jiménez,
J.L. González-Larriba,
P. Diz,
F. Cardenal,
A. Artal,
A. Carrato,
S. Morales,
J.J. Sánchez,
R. de las Peñas,
E. Felip,
G. López-Vivanco
From the Division of Medical Oncology, Arnau de Vilanova Hospital; Division of Medical Oncology, General University Hospital, Valencia; Division of Medical Oncology, Puerta de Hierro Hospital; Division of Medical Oncology, La Princesa Hospital; Division of Medical Oncology, San Carlos University Hospital; Preventive Medicine Department, Autonomous University, Madrid; Division of Medical Oncology, University Hospital, Zaragoza; Division of Medical Oncology, Germans Trias i Pujol Hospital, Badalona; Division of Medical Oncology, Mar Hospital; Division of Medical Oncology, Durán i Reynals Hospital; Division of Medical Oncology, Valle de Hebrón Hospital, Barcelona; Division of Medical Oncology, San Juan Hospital, Reus; Division of Medical Oncology, Arquitecto Marcide Hospital, El Ferrol; Division of Medical Oncology, León Hospital, León; Division of Medical Oncology, Miguel Servet Hospital, Zaragoza; Division of Medical Oncology, Elche University Hospital, Alicante; Division of Medical Oncology, Arnau de Vilanova Hospital, Lérida; Division of Medical Oncology, Provincial Hospital, Castellón; and Division of Medical Oncology, Cruces Hospital, Bilbao, Spain.
Address reprint requests to Vicente Alberola Candel, MD, Hospital Arnau de Vilanova, San Clemente 12, 46015 Valencia, Spain; email: alberola_vicara{at}gva.es or Rafael Rosell, MD, Institut Catala d’Oncologia, Hospital Germans Trias i Pujol, Ctra Canyet, Sln, 08916 Budalona, Barcelona, Spain; e-mail: rrosell{at}ns.hugtip.scs.es.
Purpose: To compare the survival benefit obtained with cisplatin plus gemcitabine, a cisplatin-based triplet, and nonplatinum sequential doublets in advanced non–small-cell lung cancer (NSCLC).
Patients and Methods: Stage IIIB to IV NSCLC patients were randomly assigned to receive cisplatin 100 mg/m2 day 1 plus gemcitabine 1,250 mg/m2 days 1 and 8, every 3 weeks for six cycles (CG); cisplatin 100 mg/m2 day 1 plus gemcitabine 1,000 mg/m2 and vinorelbine 25 mg/m2 days 1 and 8, every 3 weeks for six cycles (CGV); or gemcitabine 1,000 mg/m2 plus vinorelbine 30 mg/m2 days 1 and 8, every 3 weeks for three cycles, followed by vinorelbine 30 mg/m2 days 1 and 8 plus ifosfamide 3 g/m2 day 1, every 3 weeks for three cycles (GV–VI).
Results: Five hundred fifty-seven patients were assigned to treatment (182 CG, 188 CGV, 187 GV–VI). Response rates were significantly inferior for the nonplatinum sequential doublet (CG, 42%; CGV, 41%; GV–VI, 27%; CG v GV–VI, P = .003). No differences in median survival or time to progression were observed. Toxicity was higher for the triplet: grade 3 to 4 neutropenia (GC, 32%; CGV, 57%; GV–VI, 27%; P < .05); neutropenic fever (CG, 4%; CGV, 19%; GV–VI, 5%; P < .0001); grade 3 to 4 thrombocytopenia (CG, 19%; CGV, 23%; GV–VI, 3%; P = .0001); and grade 3 to 4 emesis (GC, 22%; GCV, 32%; GV–VI, 6%; P < .0001).
Conclusion: On the basis of these results, CG remains a standard regimen for first-line treatment of advanced NSCLC.
Preliminary results of this study were presented at the 37th Annual Meeting of the American Society of Clinical Oncology in San Francisco, CA, May 12–15, 2001.
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