An early phase II trial of S-1 in Japanese patients with cytokine-refractory metastatic renal cell carcinoma |
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Authors: | Seiji Naito Taiji Tsukamoto Michiyuki Usami Hiroyuki Fujimoto Hideyuki Akaza |
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Institution: | 1. Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan 2. Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan 3. Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan 4. Urology Division, National Cancer Center Hospital, Tokyo, Japan 5. Department of Urology and Andrology, Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba, Ibaraki, Japan
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Abstract: | Purpose S-1, an oral anticancer agent, contains tegafur (FT), 5-chloro-2,4-dihydroxypyridine (CDHP), and potassium oxonate (Oxo) at a molar ratio of FT:CDHP:Oxo = 1:0.4:1. The aim of this trial was to investigate the efficacy and safety of S-1 in Japanese patients with cytokine-refractory metastatic renal cell carcinoma (RCC). Methods We conducted a non-randomized, open-label trial in Japanese patients with metastatic RCC who had received nephrectomy and had failed cytokine-based immunotherapy. The primary endpoint was response rate. S-1 40–60 mg based on the body surface area was administered twice daily (80–120 mg/day) for 4 consecutive weeks, followed by a 2-week rest period; cycles were repeated every 6 weeks. Patients continued treatment until disease progression, unacceptable toxicity, or withdrawal of consent. Results A total of 20 eligible patients were enrolled. Among these, 3 patients had partial response, yielding objective response rate of 15%; 13 patients had no change; 4 patients had progressive disease. The median time-to-progression and median overall survival were 12.0 and 25.7 months, respectively. The initial adverse event was generally mild to moderate in severity. The most common grade 3/4 drug-related hematological and non-hematological adverse events were neutropenia (20.0%) and anorexia (20.0%), respectively. Conclusions S-1 is active and well tolerated for the treatment of cytokine-refractory metastatic RCC. |
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