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Annals of Oncology Advance Access originally published online on November 1, 2006
Annals of Oncology 2007 18(2):317-323; doi:10.1093/annonc/mdl377
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© 2006 European Society for Medical Oncology

lung cancer

Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan

Y Ohe1,*, Y Ohashi2, K Kubota3, T Tamura1, K Nakagawa4, S Negoro5, Y Nishiwaki3, N Saijo3, Y Ariyoshi6, M Fukuoka4 and For the FACS Cooperative Group

1 Department of Internal Medicine, National Cancer Center Hospital, Tokyo
2 Department of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, The University of Tokyo, Tokyo
3 Thoracic Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba
4 Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Osaka
5 Department of Thoracic Oncology, Hyogo Medical Center for Adults, Akashi, Hyogo
6 Aichi Cancer Center Aichi Hospital, Okazaki, Aichi, Japan

* Correspondence to: Dr Y. Ohe, Department of Internal Medicine, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Tel: +81-3-3542-2511; Fax: x+81-3-3542-7006; E-mail: yohe{at}ncc.go.jp

Background: To compare the efficacy and toxicity of three platinum-based combination regimens against cisplatin plus irinotecan (IP) in patients with untreated advanced non-small-cell lung cancer (NSCLC) by a non-inferiority design.

Patients and methods: A total of 602 patients were randomly assigned to one of four regimens: cisplatin 80 mg/m2 on day 1 plus irinotecan 60 mg/m2 on days 1, 8, 15 every 4 weeks (IP) carboplatin AUC 6.0 min x mg/mL (area under the concentration–time curve) on day 1 plus paclitaxel 200 mg/m2 on day 1 every 3 weeks (TC); cisplatin 80 mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1, 8 every 3 weeks (GP); and cisplatin 80 mg/m2 on day 1 plus vinorelbine 25 mg/m2 on days 1, 8 every 3 weeks (NP).

Results: The response rate, median survival time, and 1-year survival rate were 31.0%, 13.9 months, 59.2%, respectively, in IP; 32.4%, 12.3 months, 51.0% in TC; 30.1%, 14.0 months, 59.6% in GP; and 33.1%, 11.4 months, 48.3% in NP. No statistically significant differences were found in response rate or overall survival, but the non-inferiority of none of the experimental regimens could be confirmed. All the four regimens were well tolerated.

Conclusion: The four regimens have similar efficacy and different toxicity profiles, and they can be used to treat advanced NSCLC patients.

Key words: carboplatin, cisplatin, gemcitabine, irinotecan, non-small-cell lung cancer, paclitaxel, randomized phase III study, vinorelbine

Received for publication May 16, 2006. Revision received August 13, 2006. Accepted for publication August 30, 2006.


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