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.

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) / 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.. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - 106:4(2012), pp. 658-665. [10.1038/bjc.2011.606]

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)

Tiseo M.;
2012-01-01

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.
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) / 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.. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - 106:4(2012), pp. 658-665. [10.1038/bjc.2011.606]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2862167
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