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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)

Authors :
Mara A. Cafferata
A Bagnulo
F. Grossi
F. Zanelli
R. Labianca
Elizabeth H. Baldini
Tiziana Prochilo
F Recchia
Manlio Mencoboni
C. Caroti
C Pennucci
E. Matano
Corrado Boni
F. Di Costanzo
Domenico Germano
G Marini
Marcello Tiseo
Andrea Ardizzoni
C. Barone
Luca Boni
Boni, C.
Tiseo, M
Boni, L.
Baldini, E.
Recchia, F.
Barone, C.
Grossi, F.
Germano, D.
Matano, E.
Marini, G.
Labianca, R.
Di Costanzo, F.
Bagnulo, A.
Pennucci, C.
Caroti, C.
Mencoboni, M.
Zanelli, F.
Prochilo, T.
Cafferata, M.A.
Ardizzoni, A.
Source :
British Journal of Cancer
Publication Year :
2012

Abstract

BACKGROUND: The FAST is a 2 × 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. © 2012 Cancer Research UK. All rights reserved.

Details

Language :
English
Database :
OpenAIRE
Journal :
British Journal of Cancer
Accession number :
edsair.doi.dedup.....33b29d1f07838b41759d1f46f368b4c3