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Surgery Today

, 41:1610 | Cite as

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

  • Hideo Baba
  • Naoko Hayashi
  • Yasunori Emi
  • Yoshihiro Kakeji
  • Akinori Egashira
  • Eiji Oki
  • Ken Shirabe
  • Tetsuo Toyama
  • Takefumi Ohga
  • Manabu Yamamoto
  • Hirofumi Hasegawa
  • Fumiko Kohakura
  • Hidefumi Higashi
  • Kiyoshi Niwa
  • Fumihiko Fujita
  • Yutaka Ogata
  • Shunji Kohnoe
  • Masafumi Inomata
  • Hironori Samura
  • Shoji Tokunaga
  • Yoshihiko Maehara
  • Kyushu Study Group of Clinical Cancer (KSCC)
Original Article

Abstract

Purpose

This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer.

Methods

Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred.

Results

Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%–48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1–9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1–40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients.

Conclusion

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

Key words

FOLFOX4 Oxaliplatin Colorectal cancer First-line chemotherapy 

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Copyright information

© Springer 2011

Authors and Affiliations

  • Hideo Baba
    • 1
  • Naoko Hayashi
    • 1
  • Yasunori Emi
    • 2
  • Yoshihiro Kakeji
    • 2
  • Akinori Egashira
    • 2
  • Eiji Oki
    • 2
  • Ken Shirabe
    • 2
  • Tetsuo Toyama
    • 3
  • Takefumi Ohga
    • 4
  • Manabu Yamamoto
    • 5
  • Hirofumi Hasegawa
    • 6
  • Fumiko Kohakura
    • 7
  • Hidefumi Higashi
    • 8
  • Kiyoshi Niwa
    • 9
  • Fumihiko Fujita
    • 10
  • Yutaka Ogata
    • 11
  • Shunji Kohnoe
    • 12
  • Masafumi Inomata
    • 13
  • Hironori Samura
    • 14
  • Shoji Tokunaga
    • 15
  • Yoshihiko Maehara
    • 2
  • Kyushu Study Group of Clinical Cancer (KSCC)
  1. 1.Department of Gastroenterological Surgery, Graduate School of Medical SciencesKumamoto UniversityKumamotoJapan
  2. 2.Department of Surgery and Science, Graduate School of Medical ScienceKyushu UniversityFukuokaJapan
  3. 3.Department of SurgeryNakagami HospitalOkinawaJapan
  4. 4.Department of SurgerySaiseikai Fukuoka General HospitalFukuokaJapan
  5. 5.Department of SurgeryHiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalHiroshimaJapan
  6. 6.Department of SurgeryKyusyu Central Hospital of the Mutual Aid Association of Public School TeachersFukuokaJapan
  7. 7.Department of Surgery, and Gastroenterological Internal MedicineUrasoe General HospitalOkinawaJapan
  8. 8.Department of SurgeryNippon Steel Yawata Memorial HospitalFukuokaJapan
  9. 9.Department of SurgerySameshima HospitalKagoshimaJapan
  10. 10.Department of SurgeryNagasaki University Graduate School of Biomedical SciencesNagasakiJapan
  11. 11.Department of SurgeryKurume University School of MedicineFukuokaJapan
  12. 12.Department of General SurgeryFukuoka Dental CollegeFukuokaJapan
  13. 13.Department of Surgery 1Oita University Faculty of MedicineOitaJapan
  14. 14.Division of Digestive and General Surgery, Faculty of MedicineUniversity of the RyukyusOkinawaJapan
  15. 15.Department of Medical InformaticsKyushu University HospitalFukuokaJapan

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