Abstract
Purpose
To determine the dose-limiting toxicity (DLT) and activity of combination with docetaxel and S-1 on unresectable gastric cancer.
Patients and methods
Docetaxel was administered intravenously on day 1 and S-1 was administered orally on days 1–14, every 3 weeks. Doses of each drug in phase I study were docetaxel 60–75 mg/m2 and S-1 60–80 mg/m2. A phase II study was conducted with the recommended dose (RD) based on phase I.
Results
Sixty-five patients (median age 54 years) were enrolled. The DLTs were neutropenia with fever or stomatitis. The RD was docetaxel 75 mg/m2 and S-1 60 mg/m2. Two patients (aged 66 and 64 years) developed septic shock during the initial part of phase II study. A phase I study at lower dose (docetaxel 60 mg/m2 and S-1 80 mg/m2) was conducted for patients older than 60 years, and this dose was determined as the RD for these patients. In the phase II study, frequent grade 3/4 toxicities were neutropenia (47%) and febrile neutropenia (26%). The overall response rate was 50% (95% CI, 35–66%) and median survival was 15.3 months (95% CI, 10.0–20.6 months).
Conclusions
Combination with docetaxel and S-1 was active against advanced gastric cancer and gave manageable toxicities.
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Acknowledgments
We thank Hyeri Cha Ph.D. and Sung-Ho Beck M.D. for helpful discussions and Sun Hwa Lim for help in preparing the manuscript.
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Supported in part by a grant from the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (0412_CR01_0704_0001).
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Zang, D.Y., Yang, D.H., Lee, H.W. et al. Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer with consideration to age. Cancer Chemother Pharmacol 63, 509–516 (2009). https://doi.org/10.1007/s00280-008-0768-9
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DOI: https://doi.org/10.1007/s00280-008-0768-9