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
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)
UR - http://www.scopus.com/inward/record.url?scp=84903816270&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84903816270&partnerID=8YFLogxK
U2 - 10.1007/s00280-014-2461-5
DO - 10.1007/s00280-014-2461-5
M3 - Article
C2 - 24744162
AN - SCOPUS:84903816270
SN - 0344-5704
VL - 73
SP - 1253
EP - 1261
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 6
ER -