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A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer: A Japanese experience

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Abstract

Purpose

This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer.

Methods

A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment.

Results

Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%–35.0%). The median PFS was 5.6 months (95% CI, 4.1–7.0 months) and the median OS was 19.6 months (95% CI, 11.4–24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable.

Conclusion

The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.

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Authors and Affiliations

  1. Department of Surgery, Kurume University School of Medicine, Kurume, Japan

    Yutaka Ogata & Kazuo Shirouzu

  2. Department of Medical Informatics, Kyushu University Hospital, Fukuoka, Japan

    Shoji Tokunaga

  3. Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

    Yasunori Emi, Eiji Oki, Hiroshi Saeki, Ken Shirabe, Yoshihiro Kakeji & Yoshihiko Maehara

  4. Department of Surgery, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan

    Hirofumi Hasegawa

  5. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan

    Noriaki Sadanaga

  6. Division of Digestive and General Surgery, Faculty of Medicine, University of the Ryukyus, Okinawa, Japan

    Hironori Samura

  7. Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

    Fumihiko Fujita

  8. Department of Surgery, Social Insurance Tagawa Hospital, Tagawa, Fukuoka, Japan

    Takaho Tanaka

  9. Department of Surgical Oncology and Digestive Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan

    Masaki Kitazono

  10. Department of Surgery, Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Hiroshima, Japan

    Manabu Yamamoto

  11. Department of Clinical Oncology, Saiseikai Kumamoto General Hospital, Kumamoto, Japan

    Tatsuma Morikita

  12. Department of Surgery I, Oita University Faculty of Medicine, Oita, Japan

    Masafumi Inomata

Authors
  1. Yutaka Ogata
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  2. Shoji Tokunaga
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  3. Yasunori Emi
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  4. Eiji Oki
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  5. Hiroshi Saeki
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  6. Ken Shirabe
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  7. Hirofumi Hasegawa
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  8. Noriaki Sadanaga
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  9. Hironori Samura
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  10. Fumihiko Fujita
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  11. Takaho Tanaka
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  12. Masaki Kitazono
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  13. Manabu Yamamoto
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  14. Tatsuma Morikita
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  15. Masafumi Inomata
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  16. Yoshihiro Kakeji
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  17. Kazuo Shirouzu
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  18. Yoshihiko Maehara
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Kyushu Study Group of Clinical Cancer (KSCC)

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Ogata, Y., Tokunaga, S., Emi, Y. et al. A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer: A Japanese experience. Surg Today 41, 84–90 (2011). https://doi.org/10.1007/s00595-010-4418-6

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  • DOI: https://doi.org/10.1007/s00595-010-4418-6

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