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FOLFIRI plus bevacizumab as a first-line treatment for Japanese patients with metastatic colorectal cancer: a JACCRO CC-03 multicenter phase II study

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Abstract

Purpose

The purpose of this multicenter phase II study was to evaluate the efficacy and safety of a combination of irinotecan, 5-fluorouracil (5-FU), and leucovorin (FOLFIRI) plus bevacizumab as first-line chemotherapy in Japanese patients with metastatic colorectal cancer.

Methods

Patients with metastatic colorectal cancer were eligible for enrollment. On day 1 of a 14-day cycle, patients received bevacizumab 5 mg/kg, irinotecan 150 mg/m2, and l-leucovorin 200 mg/m2 as an intravenous infusion, followed by 5-FU 400 mg/m2 as an intravenous bolus and then 5-FU 2,400 mg/m2 as an 46-h intravenous infusion. This treatment cycle was repeated. The primary endpoint was progression-free survival (PFS).

Results

We enrolled 40 patients, but one withdrew consent before starting treatment. The remaining 39 patients received a total of 509 cycles of FOLFIRI plus bevacizumab (median 11 per patient; range 1–30). The median PFS was 11.5 months, the median overall survival (OS) was 22.0 months, and the 1-year OS rate was 81.8 %. All 39 patients had adverse events. Grade 3 or 4 neutropenia and stomatitis occurred in 21 (53.9 %) and 4 (10.3 %) patients, respectively.

Conclusion

Our results suggest that FOLFIRI plus bevacizumab is a clinically effective regimen with a manageable toxicity profile as first-line chemotherapy in patients with metastatic colorectal cancer.

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Acknowledgments

We are grateful to W. Koizumi, Y. Shimada, and S. Maetani for their kind advice and to T. Sasaki, H. Takahashi, and A. Kawano, who served on the independent review committee. We also thank S. Koyama and Y. Kakehashi for their data management. This study has been presented in part at the 9th Annual Meeting of the Japanese Society of Medical Oncology, Yokohama, Japan, 2011. This study was supported by the Japan Clinical Cancer Research Organization (JACCRO). The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript.

Conflict of interest

The authors declared that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Digestive Surgery, Nihon University School of Medicine, 30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan

    Mitsugu Kochi, Ken Hagiwara & Masashi Fujii

  2. Department of Surgery, Hakodate Goryokaku Hospital, 38-3, Goryokaku-cho, Hakodate, Hokkaido, 040-8611, Japan

    Yuji Akiyama

  3. Department of Surgery, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

    Tatsuya Aoki

  4. Department of Surgical Oncology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan

    Takao Takahashi

  5. Department of Clinical Oncology, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan

    Katsuji Hironaka

  6. Department of Surgery, Midori Municipal Hospital, 1-77 Shiomigaoka, Midori-ku, Nagoya, Aichi, 458-0037, Japan

    Futoshi Teranishi

  7. Department of Regenerative Surgery, Fukushima Medical University, 1 Hikarigaoka, Fukushima, 960-1295, Japan

    Fumihiko Osuka

  8. Division of Biostatistics, Kitasato University School of Pharmaceutical Sciences, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan

    Masahiro Takeuchi

  9. Japan Clinical Cancer Research Organization, 7F Ginza Wing Bldg, 1-14-5 Ginza, Chuo-ku, Tokyo, 104-0061, Japan

    Toshifusa Nakajima

Authors
  1. Mitsugu Kochi
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  2. Yuji Akiyama
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  3. Tatsuya Aoki
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  4. Ken Hagiwara
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  5. Takao Takahashi
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  6. Katsuji Hironaka
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  7. Futoshi Teranishi
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  8. Fumihiko Osuka
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  9. Masahiro Takeuchi
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  10. Masashi Fujii
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  11. Toshifusa Nakajima
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Corresponding author

Correspondence to Mitsugu Kochi.

Appendix

Appendix

The following investigators participated in the study: Mitsugu Kochi, Ken Hagiwara (Nihon University School of Medicine, Tokyo, Japan); Akinori Takagane, (Hakodate Goryokaku Hospital, Hokkaido, Japan); Tatsuya Aoki (Tokyo Medical University Hospital, Tokyo, Japan); Takao Takahashi (Department of Surgical Oncology, Gifu University Graduate School of Medicine); Katsuji Hironaka (Department of Clinical Oncology, Kawasaki Medical School); Futoshi Teranishi (Midori Municipal Hospital, Aichi, Japan); and Fumihiko Osuka (Fukushima Medical University, Fukushima, Japan).

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Kochi, M., Akiyama, Y., Aoki, T. et al. FOLFIRI plus bevacizumab as a first-line treatment for Japanese patients with metastatic colorectal cancer: a JACCRO CC-03 multicenter phase II study. Cancer Chemother Pharmacol 72, 1097–1102 (2013). https://doi.org/10.1007/s00280-013-2292-9

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  • DOI: https://doi.org/10.1007/s00280-013-2292-9

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