Phase I study of daily S-1 combined with weekly irinotecan in patients with advanced non-small cell lung cancer |
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Authors: | Osamu Ishimoto Takashi Ishida Yoshihiro Honda Mitsuru Munakata Shunichi Sugawara |
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Affiliation: | (1) Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirosemachi, Aoba-ku, Sendai, Miyagi 980-0873, Japan;(2) Fukushima Medical University, Fukushima, Japan |
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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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Keywords: | Irinotecan Weekly S-1 Phase I trial Non-small cell lung cancer |
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