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

Tsunekazu Mizushima, Hiroshi Tamagawa, Chu Matsuda, Kohei Murata, Mutsumi Fukunaga, Hirofumi Ota, Junichi Hasegawa, Masaki Tsujie, Takayuki Fukuzaki, Taishi Hata, Ichiro Takemasa, Masataka Ikeda, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)152-158
Number of pages7
JournalOncology (Switzerland)
Volume89
Issue number3
DOIs
Publication statusPublished - Jan 1 2015
Externally publishedYes

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Tegafur
Uracil
Leucovorin
Colorectal Neoplasms
Confidence Intervals
Therapeutics
Information Services
Neutropenia
Disease-Free Survival
Bevacizumab
Safety
Survival
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

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. / Mizushima, Tsunekazu; Tamagawa, Hiroshi; Matsuda, Chu; Murata, Kohei; Fukunaga, Mutsumi; Ota, Hirofumi; Hasegawa, Junichi; Tsujie, Masaki; Fukuzaki, Takayuki; Hata, Taishi; Takemasa, Ichiro; Ikeda, Masataka; Yamamoto, Hirofumi; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki.

In: Oncology (Switzerland), Vol. 89, No. 3, 01.01.2015, p. 152-158.

Research output: Contribution to journalArticle

Mizushima, T, Tamagawa, H, Matsuda, C, Murata, K, Fukunaga, M, Ota, H, Hasegawa, J, Tsujie, M, Fukuzaki, T, Hata, T, Takemasa, I, Ikeda, M, Yamamoto, H, Sekimoto, M, Nezu, R, Doki, Y & Mori, M 2015, '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', Oncology (Switzerland), vol. 89, no. 3, pp. 152-158. https://doi.org/10.1159/000381718
Mizushima, Tsunekazu ; Tamagawa, Hiroshi ; Matsuda, Chu ; Murata, Kohei ; Fukunaga, Mutsumi ; Ota, Hirofumi ; Hasegawa, Junichi ; Tsujie, Masaki ; Fukuzaki, Takayuki ; Hata, Taishi ; Takemasa, Ichiro ; Ikeda, Masataka ; Yamamoto, Hirofumi ; Sekimoto, Mitsugu ; Nezu, Riichiro ; Doki, Yuichiro ; Mori, Masaki. / 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. In: Oncology (Switzerland). 2015 ; Vol. 89, No. 3. pp. 152-158.
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abstract = "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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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

PY - 2015/1/1

Y1 - 2015/1/1

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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