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01.06.2014 | Original Article | Ausgabe 6/2014 Open Access

Cancer Chemotherapy and Pharmacology 6/2014

Safety analysis of two different regimens of uracil–tegafur plus leucovorin as adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III trial comparing 6 with 18 months of treatment: JFMC33-0502 trial

Cancer Chemotherapy and Pharmacology > Ausgabe 6/2014
Takashi Tsuchiya, Sotaro Sadahiro, Kazuaki Sasaki, Ken Kondo, Kenji Katsumata, Genichi Nishimura, Yoshihiro Kakeji, Hideo Baba, Takayuki Morita, Keiji Koda, Seiji Sato, Junji Matsuoka, Yoshiyuki Yamaguchi, Hisashi Usuki, Chikuma Hamada, Susumu Kodaira, Shigetoyo Saji
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Electronic supplementary material

The online version of this article (doi:10.​1007/​s00280-014-2461-5) contains supplementary material, which is available to authorized users.



The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil–tegafur (UFT) plus leucovorin in patients with stage IIB or III colon cancer. We report the interim results of preplanned safety analyses.


Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT (300 mg/m2) plus leucovorin (75 mg/day) for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five courses) or for 18 months (study group, 5 days of treatment followed by a 2-day rest, 15 courses). Treatment status and safety were evaluated.


A total of 1,071 patients were enrolled, and 1,063 were included in safety analyses. Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % in the study group. Treatment completion rate in the study group at 18 months was 56.0 %. The overall incidence of adverse events (AEs) was 75.3 % in the control group and 77.6 % in the study group. The incidences of grade 3 or higher AEs were low in both groups. During the first 6 months, the incidences of the subjective AEs were significantly lower in the study group.


Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy. In particular, 5 days of treatment followed by a 2-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than 6 months.

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