Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer: Results of a west Japan oncology group study

Isamu Okamoto, Hiroshige Yoshioka, Satoshi Morita, Masahiko Ando, Koji Takeda, Takashi Seto, Nobuyuki Yamamoto, Hideo Saka, Kazuhiro Asami, Tomonori Hirashima, Shinzoh Kudoh, Miyako Satouchi, Norihiko Ikeda, Yasuo Iwamoto, Toshiyuki Sawa, Masaki Miyazaki, Kenji Tamura, Takayasu Kurata, Masahiro Fukuoka, Kazuhiko Nakagawa

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Purpose: The primary goal of this open-label, multicenter, randomized phase III trial was to determine whether treatment with carboplatin plus the oral fluoropyrimidine derivative S-1 was noninferior versus that with carboplatin plus paclitaxel with regard to overall survival (OS) in chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: A total of 564 patients were randomly assigned to receive either carboplatin (area under the curve, 5) on day 1 plus oral S-1 (40 mg/m 2 twice per day) on days 1 to 14 or carboplatin (area under the curve, 6) plus paclitaxel (200 mg/m 2) on day 1 every 21 days. Results: At the planned interim analysis, with a total of 268 death events available, the study passed the O'Brien-Fleming boundary of 0.0080 for a positive result and noninferiority of carboplatin and S-1 compared with carboplatin and paclitaxel was confirmed for OS (hazard ratio, 0.928; 99.2% CI, 0.671 to 1.283). Median OS was 15.2 months in the carboplatin and S-1 arm and 13.3 months in the carboplatin and paclitaxel arm, with 1-year survival rates of 57.3% and 55.5%, respectively. Rates of leukopenia or neutropenia of grade 3/4, febrile neutropenia, alopecia, and neuropathy were more frequent in the carboplatin and paclitaxel arm, whereas thrombocytopenia, nausea, vomiting, and diarrhea were more common in the carboplatin and S-1 arm. The carboplatin and S-1 arm had significantly more dose delays than the carboplatin and paclitaxel arm. Conclusion: Oral S-1 with carboplatin was noninferior in terms of OS compared with carboplatin and paclitaxel in patients with advanced NSCLC, and is thus a valid treatment option.

Original languageEnglish
Pages (from-to)5240-5246
Number of pages7
JournalJournal of Clinical Oncology
Issue number36
Publication statusPublished - Dec 20 2010
Externally publishedYes


All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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