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Phase I study of daily S-1 combined with weekly irinotecan in patients with advanced non-small cell lung cancer

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Abstract

Background

S-1 is a novel oral fluorouracil prodrug active against non-small cell lung cancer (NSCLC). To determine the feasibility of S-1 combined with weekly irinotecan for patients with advanced NSCLC, we performed a phase I study to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of irinotecan.

Methods

Patients with advanced NSCLC received S-1 (80 mg/m2) on days 1–14 and irinotecan (50–80 mg/m2) on days 1, 8, and 15 of each 28-day cycle. Three to six patients were treated with each dose of irinotecan, with the MTD defined as the dose at which dose-limiting toxicity (DLT) appeared in 33% of patients.

Results

At doses of 50–70 mg/m2, no patients experienced any DLT, whereas, at a dose of 80 mg/m2, two of four patients experienced DLTs. Two patients experienced grade 3 toxicities — neutropenia and diarrhea.

Conclusion

The MTD of weekly irinotecan was 80 mg/m2, making its RD for phase II trials 70 mg/m2.

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Authors and Affiliations

  1. Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirosemachi, Aoba-ku, Sendai, Miyagi, 980-0873, Japan

    Osamu Ishimoto, Yoshihiro Honda & Shunichi Sugawara

  2. Fukushima Medical University, Fukushima, Japan

    Takashi Ishida & Mitsuru Munakata

Authors
  1. Osamu Ishimoto
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  2. Takashi Ishida
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  3. Yoshihiro Honda
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  4. Mitsuru Munakata
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  5. Shunichi Sugawara
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Corresponding author

Correspondence to Shunichi Sugawara.

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Ishimoto, O., Ishida, T., Honda, Y. et al. Phase I study of daily S-1 combined with weekly irinotecan in patients with advanced non-small cell lung cancer. Int J Clin Oncol 14, 43–47 (2009). https://doi.org/10.1007/s10147-008-0796-9

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  • DOI: https://doi.org/10.1007/s10147-008-0796-9

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