TY - JOUR
T1 - Phase II study of oral tegafur/uracil and leucovorin plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic colorectal cancer
AU - Mizushima, Tsunekazu
AU - Tamagawa, Hiroshi
AU - Matsuda, Chu
AU - Murata, Kohei
AU - Fukunaga, Mutsumi
AU - Ota, Hirofumi
AU - Hasegawa, Junichi
AU - Tsujie, Masaki
AU - Fukuzaki, Takayuki
AU - Hata, Taishi
AU - Takemasa, Ichiro
AU - Ikeda, Masataka
AU - Yamamoto, Hirofumi
AU - Sekimoto, Mitsugu
AU - Nezu, Riichiro
AU - Doki, Yuichiro
AU - Mori, Masaki
N1 - Publisher Copyright:
© 2015 S. Karger AG, Basel.
PY - 2015/8/21
Y1 - 2015/8/21
N2 - Background/Objective: Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there are few studies on the combination of bevacizumab with UFT/LV. This clinical study evaluated the efficacy and safety of UFT/LV plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic CRC. Methods: Forty patients with advanced or metastatic CRC aged ≥75 years were enrolled in this multicenter, open-label, single-arm phase II study. All patients received oral UFT (300-600 mg) and LV (50 mg) twice daily on days 1-21 and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle (University Hospital Medical Information Network No. UMIN000003447). Results: The median follow-up period was 14.7 months. The response rate was 20.0% [95% confidence interval (CI): 9.1-35.6], median progression-free survival was 8.9 months (95% CI: 5.3-11), and median overall survival was 21.7 months (95% CI: 13.7-23.4). The only grade 3 hematological toxicity was neutropenia (3.0%), and the incidence rates of grade 3 nonhematological toxicity were low at ≤10%. Conclusion: UFT/LV plus bevacizumab is a promising first-line regimen for elderly patients with advanced or metastatic CRC. The combination is well tolerated and efficacious.
AB - Background/Objective: Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there are few studies on the combination of bevacizumab with UFT/LV. This clinical study evaluated the efficacy and safety of UFT/LV plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic CRC. Methods: Forty patients with advanced or metastatic CRC aged ≥75 years were enrolled in this multicenter, open-label, single-arm phase II study. All patients received oral UFT (300-600 mg) and LV (50 mg) twice daily on days 1-21 and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle (University Hospital Medical Information Network No. UMIN000003447). Results: The median follow-up period was 14.7 months. The response rate was 20.0% [95% confidence interval (CI): 9.1-35.6], median progression-free survival was 8.9 months (95% CI: 5.3-11), and median overall survival was 21.7 months (95% CI: 13.7-23.4). The only grade 3 hematological toxicity was neutropenia (3.0%), and the incidence rates of grade 3 nonhematological toxicity were low at ≤10%. Conclusion: UFT/LV plus bevacizumab is a promising first-line regimen for elderly patients with advanced or metastatic CRC. The combination is well tolerated and efficacious.
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U2 - 10.1159/000381718
DO - 10.1159/000381718
M3 - Article
C2 - 25967649
AN - SCOPUS:84942199513
VL - 89
SP - 152
EP - 158
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 3
ER -