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Randomized trial of the efficacy of adjuvant chemotherapy for colon cancer with combination therapy incorporating the oral pyrimidine 1-hexylcarbamoyl-5-fluorouracil

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Abstract

Background and aims

The purpose of the present trial was to clarify the efficacy of postoperative adjuvant chemotherapy including an oral fluoropyrimidine anticancer drug, the 1-hexylcarbamoyl-5-fluorouracil (HCFU), for the treatment of colon cancer.

Method

Patients with clinical stage Dukes’ B and C colon cancer, who had been treated surgically, were assigned to a chemotherapy group treated with mitomycin C, 5-fluorouracil (5-FU), and HCFU and to a control group that received no postoperative adjuvant chemotherapy.

Results

Of the 1,001 patients registered for the study, 17 (1.7%) were ineligible. The incidence of toxicity was significantly higher in the chemotherapy group than in the control group. However, there were few severe side effects and no deaths related to the treatment. Overall survival showed no significant difference between the groups. The disease-free survival or the recurrence-free intervals was significantly higher in the chemotherapy group than in the control group. The incidence of hepatic recurrence was significantly (P=0.003) lower in the chemotherapy group than in the control group.

Conclusion

The results of this study demonstrated the efficacy of adjuvant chemotherapy for colon cancer, i.e., combined chemotherapy that included the 5-FU oral anticancer drug HCFU.

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Author information

Authors and Affiliations

  1. Department of Surgery, School of Medicine, Kitasato University, 1-15-1, Kitasato, Sagamihara, Kanagawa, 228-8555, Japan

    Masahiko Watanabe

  2. Department of Surgery, School of Medicine, Keio University, Tokyo, Japan

    Susumu Kodaira

  3. Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan

    Takashi Takahashi & Takeshi Tominaga

  4. Department of Surgery, National Cancer Center Hospital, Tokyo, Japan

    Keiichi Hojo

  5. Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Aichi, Japan

    Tomoyuki Kato

  6. Department of Surgery, School of Medicine, The University of Tokushima, Tokushima, Japan

    Kazufumi Kunitomo

  7. First Department of Surgery, School of Medicine, Kurume University, Fukuoka, Japan

    Hiroharu Isomoto

  8. Department of Biostatistics, School of Health and Nursing, University of Tokyo, Tokyo, Japan

    Yasuo Ohashi

  9. Kinki University School of Medicine, Osaka, Japan

    Masayuki Yasutomi

Authors
  1. Masahiko Watanabe
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  2. Susumu Kodaira
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  3. Takashi Takahashi
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  4. Takeshi Tominaga
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  5. Keiichi Hojo
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  6. Tomoyuki Kato
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  7. Kazufumi Kunitomo
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  8. Hiroharu Isomoto
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  9. Yasuo Ohashi
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  10. Masayuki Yasutomi
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Corresponding author

Correspondence to Masahiko Watanabe.

Additional information

On behalf of the members of the Japanese Foundation for Multidisciplinary Treatment of Cancer, JFMC15-8901

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Watanabe, M., Kodaira, S., Takahashi, T. et al. Randomized trial of the efficacy of adjuvant chemotherapy for colon cancer with combination therapy incorporating the oral pyrimidine 1-hexylcarbamoyl-5-fluorouracil. Langenbecks Arch Surg 391, 330–337 (2006). https://doi.org/10.1007/s00423-006-0044-6

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  • DOI: https://doi.org/10.1007/s00423-006-0044-6

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