Final results of a phase II study of S-1 in patients with cytokine-refractory metastatic renal cell carcinoma

Seiji Naito, Katsunori Tatsugami, Nobuo Shinohara, Yoshihiko Tomita, Atsushi Mizokami, Masato Fujisawa, Katsuyoshi Hashine, Masaharu Nishikido, Masayuki Nakagawa, Taiji Tsukamoto, Hideyuki Akaza

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Objective: A planned primary analysis of a Phase II study of S-1 demonstrated that the drug was active and tolerable in Japanese patients with cytokine-refractory metastatic renal cell carcinoma. Furthermore, pharmacogenomic analysis suggested that low expression of thymidylate synthase mRNA may have been associated with clinical outcome in terms of overall response rate and progression-free survival. Here, we report the results of the final analysis assessing the efficacy and safety of S-1 including overall survival. Methods: Patients with renal cell carcinoma were eligible if they had had at least one regimen of cytokine for metastatic disease. S-1 was orally administered on Days 1-28 of a 42-day cycle until disease progression. The primary endpoint was the overall response rate, and the secondary endpoint included progression-free survival, overall survival and safety. Results: A total of 45 patients were treated with S-1 and were fully assessable for efficacy and safety. At the final analysis, a response was seen in 11 patients (overall response rate, 24.4%; 95% confidence interval: 12.9-39.5%), including two patients who achieved a complete response. The final median progression-free and overall survival were 9.2 and 42.8 months, respectively. The safety profile of S-1 was favorable. It was suggested that there was no relation between overall survival and the expression level of thymidylate synthase. Conclusion: This final analysis confirms that S-1 treatment is effective and safe in patients with cytokine-refractory renal cell carcinoma.

Original languageEnglish
Article numberhyt185
Pages (from-to)122-126
Number of pages5
JournalJapanese journal of clinical oncology
Issue number2
Publication statusPublished - Feb 2014

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research


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