TY - JOUR
T1 - Preplanned safety analysis of the JFMC37-0801 trial
T2 - a randomized phase III study of six months versus twelve months of capecitabine as adjuvant chemotherapy for stage III colon cancer
AU - Suto, Takeshi
AU - Ishiguro, Megumi
AU - Hamada, Chikuma
AU - Kunieda, Katsuyuki
AU - Masuko, Hiroyuki
AU - Kondo, Ken
AU - Ishida, Hideyuki
AU - Nishimura, Genichi
AU - Sasaki, Kazuaki
AU - Morita, Takayuki
AU - Hazama, Shoichi
AU - Maeda, Koutarou
AU - Mishima, Hideyuki
AU - Ike, Hideyuki
AU - Sadahiro, Sotaro
AU - Sugihara, Kenichi
AU - Okajima, Masazumi
AU - Saji, Shigetoyo
AU - Sakamoto, Junichi
AU - Tomita, Naohiro
N1 - Publisher Copyright:
© 2017, The Author(s).
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Background: Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis. Methods: Patients aged 20–79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m2/day on days 1–14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated. Results: A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation. Conclusions: Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable. Trial registration: UMIN-CTR, UMIN000001367.
AB - Background: Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis. Methods: Patients aged 20–79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m2/day on days 1–14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated. Results: A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation. Conclusions: Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable. Trial registration: UMIN-CTR, UMIN000001367.
KW - Adjuvant chemotherapy
KW - Adverse events
KW - Capecitabine
KW - Colon cancer
KW - Hand-foot syndrome
KW - Treatment duration
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U2 - 10.1007/s10147-016-1083-9
DO - 10.1007/s10147-016-1083-9
M3 - Article
C2 - 28078540
AN - SCOPUS:85009290193
SN - 1341-9625
VL - 22
SP - 494
EP - 504
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 3
ER -