1. 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)
- Author
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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., and Ardizzoni, A.
- Subjects
Adult ,Male ,medicine.medical_specialty ,Cancer Research ,Lung Neoplasms ,triplet ,medicine.medical_treatment ,non-small cell lung cancer (NSCLC) ,cisplatin ,Vinorelbine ,chemotherapy ,Vinblastine ,Gastroenterology ,Deoxycytidine ,Disease-Free Survival ,doublet ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,Clinical Studies ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Ifosfamide ,Stage (cooking) ,Aged ,Neoplasm Staging ,Cisplatin ,Chemotherapy ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,Middle Aged ,medicine.disease ,Gemcitabine ,Surgery ,Lung Neoplasm ,Oncology ,Toxicity ,Female ,business ,medicine.drug ,Human - 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.
- Published
- 2012