A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients

Satoshi Yoda, Kenzo Soejima, Hiroyuki Yasuda, Katsuhiko Naoki, Ichiro Kawada, Hideo Watanabe, Ichiro Nakachi, Ryosuke Satomi, Sohei Nakayama, Sinnosuke Ikemura, Hideki Terai, Takashi Sato, Maiko Morosawa, Koichiro Asano

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)


Background: This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment. Methods: Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade ≥3 neutropenia with fever over 38°C, grade ≥3 thrombocytopenia, or grade ≥3 major nonhematological toxicities. Results: Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose. Conclusion: The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m 2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.

Original languageEnglish
Pages (from-to)717-722
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Issue number3
Publication statusPublished - 2011 Mar


  • Irinotecan
  • Non-small cell lung cancer
  • Phase I trial
  • S-1
  • Second line

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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