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Phase II study of first-line chemotherapy with uracil-tegafur plus oral leucovorin in elderly (≥75 years) Japanese patients with metastatic colorectal cancer: SGOSG-CR0501 study

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Abstract

Background

Oral uracil-tegafur and leucovorin (UFT/LV) therapy for elderly patients with metastatic colorectal cancer (mCRC) requires careful handling in Western countries because of a high incidence (≥20 %) of grade 3 diarrhea. However, its efficacy and safety for elderly Asian patients have not been investigated.

Methods

In this multicenter cooperative phase II study, the eligibility criteria were: age of 75 years or older, no prior chemotherapy, and histologically confirmed colorectal cancer with one or more measurable lesions. UFT 300 mg/m2/day and LV 75 mg/day were administered orally for 28 days followed by a 7-day rest period.

Results

Twenty-one patients were enrolled in this study (prior to study termination after approval of bevacizumab), and all patients were eligible for efficacy and safety analysis. The median age was 79 years (range, 75–83 years). The majority of patients (95 %) had ECOG Performance Status 0 or 1. The overall response rate was 33 % (95 % confidence interval [CI], 18–53 %). The median progression-free and overall survivals were 5.3 months (95 % CI 4.0–7.9 months) and 18 months (95 % CI 13–21 months), respectively. Grade 3 or greater adverse events included anorexia (10 %), diarrhea (10 %), and leukopenia (5 %). These results were compatible with those seen in Japanese patients in a previous bridging study between Japan and the US, in which patients under 75 years old were evaluated.

Conclusions

UFT/LV therapy was safe and feasible in elderly Japanese patients with mCRC, and further study of UFT/LV therapy in combination with bevacizumab is warranted.

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Acknowledgments

We thank all of the participating patients, their family members, and the researchers. We are deeply grateful to Dr. K. Araki and Dr. N. Kobayashi for helping this study as the safety monitoring committee members.

Conflict of interest

Ichinosuke Hyodo and Toshikazu Moriwaki received a research grant from Taiho Pharmaceutical Co. Ltd.; Tomohiro Nishina, Minoru Mizuta, Akihito Tsuji, Ryohei Watanabe, Ikuo Takahashi, Yuji Watanabe, Toshikazu Moriwaki, Takashi Maeba and Ichinosuke Hyodo received lecture fees from Taiho Pharmaceutical Co. Ltd.

Author information

Author notes

  1. Akihito Tsuji

    Present address: Kobe City Medical Center General Hospital, Kobe, Japan

Authors and Affiliations

  1. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, Matsuyama, Ehime, 791-0280, Japan

    Toshihiko Matsumoto & Tomohiro Nishina

  2. Mitoyo General Hospital, Himehama, Toyohama-cho, Kanonji, Kagawa, 769-1695, Japan

    Minoru Mizuta

  3. Kochi Health Sciences Center, Ike, Kochi, Kochi, 781-8555, Japan

    Akihito Tsuji

  4. Matsuyama-shimin Hospital, Ootemachi, Matsuyama, Ehime, 790-0067, Japan

    Ryouhei Watanabe

  5. Matsuyama Red Cross Hospital, Bunkyo-cho, Matsuyama, Ehime, 790-8524, Japan

    Ikuo Takahashi

  6. Ehime University School of Medicine, Shitsukawa, Toon, Ehime, 791-0295, Japan

    Yuji Watanabe

  7. University of Tsukuba, Tennodai, Tsukuba, Ibaraki, 305-0006, Japan

    Toshikazu Moriwaki & Ichinosuke Hyodo

  8. Social Insurance Ritsurin Hospital, Ritsurin-cho, Takamatsu, Kagawa, 760-007, Japan

    Takashi Maeba

Authors
  1. Toshihiko Matsumoto
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  2. Tomohiro Nishina
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  10. Ichinosuke Hyodo
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Corresponding author

Correspondence to Tomohiro Nishina.

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Matsumoto, T., Nishina, T., Mizuta, M. et al. Phase II study of first-line chemotherapy with uracil-tegafur plus oral leucovorin in elderly (≥75 years) Japanese patients with metastatic colorectal cancer: SGOSG-CR0501 study. Int J Clin Oncol 20, 111–116 (2015). https://doi.org/10.1007/s10147-014-0675-5

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  • DOI: https://doi.org/10.1007/s10147-014-0675-5

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