TY - JOUR
T1 - 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
T2 - JFMC33-0502 trial
AU - Tsuchiya, Takashi
AU - Sadahiro, Sotaro
AU - Sasaki, Kazuaki
AU - Kondo, Ken
AU - Katsumata, Kenji
AU - Nishimura, Genichi
AU - Kakeji, Yoshihiro
AU - Baba, Hideo
AU - Morita, Takayuki
AU - Koda, Keiji
AU - Sato, Seiji
AU - Matsuoka, Junji
AU - Yamaguchi, Yoshiyuki
AU - Usuki, Hisashi
AU - Hamada, Chikuma
AU - Kodaira, Susumu
AU - Saji, Shigetoyo
N1 - Funding Information:
Conflict of interest Yoshihiro Kakeji has received honoraria from taiho Pharmaceutical Co., ltd, tokyo, Japan. Chikuma Hamada has served on the advisory board and received research funding from taiho Pharmaceutical. the other authors have declared no conflict of interest.
PY - 2014/6
Y1 - 2014/6
N2 - Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Adjuvant chemotherapy
KW - Colon cancer
KW - Leucovorin
KW - Treatment duration
KW - Uracil-tegafur (UFT)
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U2 - 10.1007/s00280-014-2461-5
DO - 10.1007/s00280-014-2461-5
M3 - Article
C2 - 24744162
AN - SCOPUS:84903816270
VL - 73
SP - 1253
EP - 1261
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 6
ER -