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)

Autor: 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
Přispěvatelé: 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.
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: British Journal of Cancer
Popis: 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.
Databáze: OpenAIRE