A phase ii study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer

Tsunekazu Mizushima, Yoshito Ide, Kohei Murata, Ichiro Ohashi, Keigo Yasumasa, Mutsumi Fukunaga, Hiroyoshi Takemoto, Hiroshi Tamagawa, Junichi Hasegawa, Taishi Hata, Ichiro Takemasa, Masataka Ikeda, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objective: Combined chemotherapy with S-1 and irinotecan (IRIS) for metastatic colorectal cancer has been reported to be effective and safe. However, there are only a few studies on the effects of adding bevacizumab to IRIS. We conducted a clinical study to evaluate the efficacy and safety of IRIS plus bevacizumab as first-line therapy for metastatic colorectal cancer. Methods: Forty metastatic colorectal cancer patients were enrolled in this phase II study. All patients received irinotecan (80 mg/m2) and bevacizumab (7 mg/kg) on days 1 and 15 and S-1 (40-60 mg twice daily) on days 1-21 of a 5-week repeated cycle. Results: The response rate was 47.4% [95% confidence interval (CI) 31.5-63.2], progression-free survival was 11.9 months (95% CI 9.4-16.8), and overall survival was 23.4 months (95% CI 19.0-inf). The only grade 3 hematological toxicity was neutropenia (16%) and the incidences of grade 3 nonhematological toxicity were low at <10%, other than diarrhea (10.9%). Conclusion: In this clinical study, we revealed IRIS plus bevacizumab to be a promising first-line regimen for metastatic colorectal cancer with a low incidence of serious toxicities, in which favorable response rates and extension of survival time can be expected.

Original languageEnglish
Pages (from-to)317-322
Number of pages6
JournalOncology (Switzerland)
Volume85
Issue number6
DOIs
Publication statusPublished - Dec 1 2013
Externally publishedYes

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irinotecan
Colonic Neoplasms
Colorectal Neoplasms
Drug Therapy
Confidence Intervals
Incidence
Neutropenia
Disease-Free Survival
Diarrhea
Survival Rate
Safety
Survival
Bevacizumab

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

A phase ii study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer. / Mizushima, Tsunekazu; Ide, Yoshito; Murata, Kohei; Ohashi, Ichiro; Yasumasa, Keigo; Fukunaga, Mutsumi; Takemoto, Hiroyoshi; Tamagawa, Hiroshi; Hasegawa, Junichi; Hata, Taishi; Takemasa, Ichiro; Ikeda, Masataka; Yamamoto, Hirofumi; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki.

In: Oncology (Switzerland), Vol. 85, No. 6, 01.12.2013, p. 317-322.

Research output: Contribution to journalArticle

Mizushima, T, Ide, Y, Murata, K, Ohashi, I, Yasumasa, K, Fukunaga, M, Takemoto, H, Tamagawa, H, Hasegawa, J, Hata, T, Takemasa, I, Ikeda, M, Yamamoto, H, Sekimoto, M, Nezu, R, Doki, Y & Mori, M 2013, 'A phase ii study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer', Oncology (Switzerland), vol. 85, no. 6, pp. 317-322. https://doi.org/10.1159/000356018
Mizushima, Tsunekazu ; Ide, Yoshito ; Murata, Kohei ; Ohashi, Ichiro ; Yasumasa, Keigo ; Fukunaga, Mutsumi ; Takemoto, Hiroyoshi ; Tamagawa, Hiroshi ; Hasegawa, Junichi ; Hata, Taishi ; Takemasa, Ichiro ; Ikeda, Masataka ; Yamamoto, Hirofumi ; Sekimoto, Mitsugu ; Nezu, Riichiro ; Doki, Yuichiro ; Mori, Masaki. / A phase ii study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer. In: Oncology (Switzerland). 2013 ; Vol. 85, No. 6. pp. 317-322.
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abstract = "Objective: Combined chemotherapy with S-1 and irinotecan (IRIS) for metastatic colorectal cancer has been reported to be effective and safe. However, there are only a few studies on the effects of adding bevacizumab to IRIS. We conducted a clinical study to evaluate the efficacy and safety of IRIS plus bevacizumab as first-line therapy for metastatic colorectal cancer. Methods: Forty metastatic colorectal cancer patients were enrolled in this phase II study. All patients received irinotecan (80 mg/m2) and bevacizumab (7 mg/kg) on days 1 and 15 and S-1 (40-60 mg twice daily) on days 1-21 of a 5-week repeated cycle. Results: The response rate was 47.4{\%} [95{\%} confidence interval (CI) 31.5-63.2], progression-free survival was 11.9 months (95{\%} CI 9.4-16.8), and overall survival was 23.4 months (95{\%} CI 19.0-inf). The only grade 3 hematological toxicity was neutropenia (16{\%}) and the incidences of grade 3 nonhematological toxicity were low at <10{\%}, other than diarrhea (10.9{\%}). Conclusion: In this clinical study, we revealed IRIS plus bevacizumab to be a promising first-line regimen for metastatic colorectal cancer with a low incidence of serious toxicities, in which favorable response rates and extension of survival time can be expected.",
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T1 - A phase ii study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus Bevacizumab in Patients with Metastatic Colon Cancer

AU - Mizushima, Tsunekazu

AU - Ide, Yoshito

AU - Murata, Kohei

AU - Ohashi, Ichiro

AU - Yasumasa, Keigo

AU - Fukunaga, Mutsumi

AU - Takemoto, Hiroyoshi

AU - Tamagawa, Hiroshi

AU - Hasegawa, Junichi

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 - 2013/12/1

Y1 - 2013/12/1

N2 - Objective: Combined chemotherapy with S-1 and irinotecan (IRIS) for metastatic colorectal cancer has been reported to be effective and safe. However, there are only a few studies on the effects of adding bevacizumab to IRIS. We conducted a clinical study to evaluate the efficacy and safety of IRIS plus bevacizumab as first-line therapy for metastatic colorectal cancer. Methods: Forty metastatic colorectal cancer patients were enrolled in this phase II study. All patients received irinotecan (80 mg/m2) and bevacizumab (7 mg/kg) on days 1 and 15 and S-1 (40-60 mg twice daily) on days 1-21 of a 5-week repeated cycle. Results: The response rate was 47.4% [95% confidence interval (CI) 31.5-63.2], progression-free survival was 11.9 months (95% CI 9.4-16.8), and overall survival was 23.4 months (95% CI 19.0-inf). The only grade 3 hematological toxicity was neutropenia (16%) and the incidences of grade 3 nonhematological toxicity were low at <10%, other than diarrhea (10.9%). Conclusion: In this clinical study, we revealed IRIS plus bevacizumab to be a promising first-line regimen for metastatic colorectal cancer with a low incidence of serious toxicities, in which favorable response rates and extension of survival time can be expected.

AB - Objective: Combined chemotherapy with S-1 and irinotecan (IRIS) for metastatic colorectal cancer has been reported to be effective and safe. However, there are only a few studies on the effects of adding bevacizumab to IRIS. We conducted a clinical study to evaluate the efficacy and safety of IRIS plus bevacizumab as first-line therapy for metastatic colorectal cancer. Methods: Forty metastatic colorectal cancer patients were enrolled in this phase II study. All patients received irinotecan (80 mg/m2) and bevacizumab (7 mg/kg) on days 1 and 15 and S-1 (40-60 mg twice daily) on days 1-21 of a 5-week repeated cycle. Results: The response rate was 47.4% [95% confidence interval (CI) 31.5-63.2], progression-free survival was 11.9 months (95% CI 9.4-16.8), and overall survival was 23.4 months (95% CI 19.0-inf). The only grade 3 hematological toxicity was neutropenia (16%) and the incidences of grade 3 nonhematological toxicity were low at <10%, other than diarrhea (10.9%). Conclusion: In this clinical study, we revealed IRIS plus bevacizumab to be a promising first-line regimen for metastatic colorectal cancer with a low incidence of serious toxicities, in which favorable response rates and extension of survival time can be expected.

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