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Phase II tailored S-1 regimen study of first-line chemotherapy in elderly patients with advanced and recurrent non-small cell lung cancer

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Abstract

Purpose

We investigated the efficacy and toxicity of a novel oral 5-fluorouracil (5-FU) formulation (S-1), administered according to a tailored dose regimen.

Methods

S-1 was administered orally for 28 days, followed by 14 days of no treatment, in 23 patients who received a tailored dose of S-1, adjusted on the basis of individual creatinine clearance and body surface area. In 8 of the patients, pharmacokinetic study was performed on the 6 points on 7th day after S-1 administration.

Results

Of the 23 patients enrolled in this study, 2 (8.7 %) had a partial response and 14 (60.9 %) had stable disease. The disease control rate was 69.6 % (16/23) (95 % confidence interval, 50.8–88.4 %). Grade 3/4 hematologic and non-hematologic toxicities were minor. In the pharmacokinetic study group, the maximum plasma concentration (C max) and the area under the plasma concentration curve of 5-FU at all 6 points after administration of the tailored S-1 dose regimen were similar to the values reported in a previous study describing cancer patients with normal renal function who received a standard dose of S-1 (80 mg/m2/day).

Conclusions

Our results suggest that tailored S-1 monotherapy is safe and therapeutically useful as first-line treatment for elderly patients with advanced and recurrent non-small cell lung cancer.

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Acknowledgments

We are indebted to the physicians and all other co-medical staff who contributed to this study. We thank J Patrick Barron of the International Medical Communications Centre of Tokyo Medical University (Tokyo, Japan) for his review of this report. We particularly thank Dr. T. Shimokawa who statistically supported.

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Authors and Affiliations

  1. Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-chou, Tennoji-ku, Osaka, 543-0035, Japan

    Takayuki Shiroyama, Kiyoshi Komuta, Suguru Yamamoto, Seigo Minami, Yoshitaka Ogata & Kouhei Okafuji

  2. Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, Osaka, Japan

    Takashi Kijima, Isao Tachibana & Atsushi Kumanogoh

  3. Department of Pulmonary Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Fumio Imamura

  4. Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan

    Tomonori Hirashima & Ichiro Kawase

Authors
  1. Takayuki Shiroyama
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  2. Takashi Kijima
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  3. Kiyoshi Komuta
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  4. Suguru Yamamoto
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  5. Seigo Minami
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  7. Kouhei Okafuji
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  8. Fumio Imamura
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  9. Tomonori Hirashima
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  11. Ichiro Kawase
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Corresponding author

Correspondence to Takayuki Shiroyama.

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Shiroyama, T., Kijima, T., Komuta, K. et al. Phase II tailored S-1 regimen study of first-line chemotherapy in elderly patients with advanced and recurrent non-small cell lung cancer. Cancer Chemother Pharmacol 70, 783–789 (2012). https://doi.org/10.1007/s00280-012-1958-z

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  • DOI: https://doi.org/10.1007/s00280-012-1958-z

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