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Triplets versus doublets, with or without cisplatin, in the first-line treatment of stage IIIB-IV non-small cell lung cancer (NSCLC) patients: A multicenter randomised factorial trial (FAST)

By C. Boni, M Tiseo, L. Boni, E. Baldini, F. Recchia, C. Barone, F. Grossi, D. Germano, E. Matano, G. Marini, R. Labianca, F. Di Costanzo, A. Bagnulo, C. Pennucci, C. Caroti, M. Mencoboni, F. Zanelli, T. Prochilo, M.A. Cafferata and A. Ardizzoni

Abstract

BACKGROUND: The FAST is a 2 7 2 factorial trial addressing two questions: (1) the role of replacing cisplatin (P) with a non-platinum agent, vinorelbine (N), and (2) the role of adding a third agent, ifosfamide (I), in a doublet based on gemcitabine (G). METHODS: A total of 433 stage IIIB-IV non-small cell lung cancer (NSCLC) patients were randomised to one of four arms: gemcitabine-cisplatin (GP), gemcitabine-vinorelbine, gemcitabine-ifosfamide- cisplatin or gemcitabine-ifosfamide-vinorelbine. Two comparisons were performed: N- vs P-containing regimens and I-triplets vs non-I doublets. RESULTS: For N- vs P-containing regimens, adjusted overall survival was 9.7 vs 11.3 months (P=0.044), progression-free survival was 4.9 vs 6.4 months (P=0.020) and response rate was 24% vs 31% (P=0.124), respectively. No statistically significant difference was observed between doublets and triplets. Grade 3-4 haematological toxicity was significantly more frequent in P-containing therapy; grade 3-4 leucopenia was significantly more common in triplets. Concerning non-haematological toxicity, grade 3-4 nausea-vomiting was significantly increased in P-containing regimens. CONCLUSIONS: This trial provides evidence of a slight survival superiority of GP-containing regimens over platinum-free N-containing chemotherapy. This trial also confirms that the addition of a third chemotherapy agent (I) to a standard G-based doublet does not improve treatment outcome. \ua9 2012 Cancer Research UK. All rights reserved

Topics: chemotherapy, cisplatin, doublet, non-small cell lung cancer (NSCLC), triplet, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Deoxycytidine, Disease-Free Survival, Female, Humans, Ifosfamide, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Vinblastine, Oncology, Cancer Research
Publisher: 'Springer Science and Business Media LLC'
Year: 2012
DOI identifier: 10.1038/bjc.2011.606
OAI identifier: oai:cris.unibo.it:11585/592460
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