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A phase II study of S-1 monotherapy as second-line treatment for advanced non-small cell lung cancer

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Abstract

Purpose

To assess the efficacy and toxicity of an oral anticancer fluoropyrimidine derivative, S-1, for previously treated patients with advanced non-small cell lung cancer (NSCLC).

Patients and methods

Patients with advanced (clinical stage IIIB-IV) NSCLC who had previously received one platinum-based chemotherapy were enrolled. S-1 was administered orally at the dosage decided by using the nomogram based on patient BSA b.i.d. for 28 consecutive days, repeated every 6 weeks.

Results

Between August 2005 and July 2007, 50 patients were entered into this study. Six patients achieved partial response (PR), and the overall response rate of eligible patients was 12.5% (6/48) (95% confidence interval (95%CI), 3.1–21.9%). Disease control rate was 39.6% (19/48) (95%CI, 25.7–53.4%). Median progression-free survival was 2.5 months. Median survival time was 8.2 months, and 1-year survival rate was 29.6%. No grade 4 toxicities were encountered. Grade 3 hematological toxicities comprised neutropenia in one patient (2.1%) and anemia in one patient (2.1%). Grade 3 non-hematological toxicities were observed in only five patients (10.4%). Treatment-related death did not occur.

Conclusion

S-1 is an active and well-tolerated monotherapy for second-line treatment of advanced NSCLC.

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Authors and Affiliations

  1. Division of Respirology and Allergology, Department of Internal Medicine, School of Medicine, Fujita Health University, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi, 470-1192, Japan

    Yoshitaka Totani, Yuji Saito, Masamichi Hayashi, Toshihiko Tada, Yasuo Kohashi, Yuki Mieno, Atsushi Kato, Hiromi Imizu, Yukiko Yoneda, Tami Hoshino, Yasuhiro Uchiyama, Yasuo Takeuchi, Mitsushi Okazawa & Hiroki Sakakibara

Authors
  1. Yoshitaka Totani
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  2. Yuji Saito
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  3. Masamichi Hayashi
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  4. Toshihiko Tada
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  5. Yasuo Kohashi
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  6. Yuki Mieno
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  7. Atsushi Kato
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  8. Hiromi Imizu
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  9. Yukiko Yoneda
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  10. Tami Hoshino
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  11. Yasuhiro Uchiyama
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  12. Yasuo Takeuchi
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  13. Mitsushi Okazawa
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  14. Hiroki Sakakibara
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Correspondence to Yoshitaka Totani.

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Totani, Y., Saito, Y., Hayashi, M. et al. A phase II study of S-1 monotherapy as second-line treatment for advanced non-small cell lung cancer. Cancer Chemother Pharmacol 64, 1181–1185 (2009). https://doi.org/10.1007/s00280-009-0981-1

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  • DOI: https://doi.org/10.1007/s00280-009-0981-1

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