A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (bix study)

Yasuo Hamamoto, Tatsuro Yamaguchi, Tomohiro Nishina, Kentaro Yamazaki, Takashi Ura, Takako Nakajima, Ayumu Goto, Ken Shimada, Norisuke Nakayama, Junichi Sakamoto, Satoshi Morita, Yasuhide Yamada

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Abstract

Background. Capecitabine is used mainly with oxaliplatin to treat metastatic colorectal cancer (mCRC). Results from capecitabine plus irinotecan (XELIRI) with or without bevacizumab (BV) have been reported in Europe but not in Japan. Consequently, the safety and efficacy of XELIRI plus BV in Japanese patients with mCRC were assessed in a single-arm phase II study.

Methods. Eligible patients had had prior chemotherapy containing BV for mCRC and wild-type or heterozygous UGT1A1. Therapy in each 21-day treatment cycle consisted of capecitabine (800 mg/m2 twice daily on days 1-15), irinotecan (200 mg/m2 on day 1), and BV (7.5 mg/kg on day 1). The primary endpoint was dose-limiting toxicity in phase I and progression-free survival (PFS) in phase II.

Results. A total of 34 patients (6 in phase I, 28 in phase II) were enrolled from May 2010 to June 2011. Baseline characteristics included a median age of 60 years (range: 22-74 years) for 24 men and 10 women. No dose-limiting toxicities appeared in phase I. Median PFS was 240 days (95% confidence interval: 179-311 days). Overall response rate was 18.1%, and the disease-control rate was 90.9%.The incidence of adverse events frequently associated with irinotecan and capecitabine were neutropenia (any grade, 55.9%; grade 3 or 4, 11.8%), diarrhea (any grade, 50%; grade 3 or 4, 5.9%), and hand-foot syndrome (any grade, 61.8%; grade 3 or 4, 5.9%).

Conclusion. Our results suggest that XELIRI plus BV is well tolerated and effective as a second-line treatment for mCRC in Japanese patients. This regimen could be especially appropriate for patients resistant to oxaliplatin-based regimens.

Original languageEnglish
Pages (from-to)1131-1132
Number of pages2
JournalOncologist
Volume19
Issue number11
DOIs
Publication statusPublished - 2014 Jan 1

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irinotecan
oxaliplatin
Colorectal Neoplasms
Drug Therapy
Disease-Free Survival
Hand-Foot Syndrome
Neutropenia
Diarrhea
Japan
Therapeutics
Bevacizumab
Confidence Intervals
Safety
Capecitabine
Incidence

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (bix study). / Hamamoto, Yasuo; Yamaguchi, Tatsuro; Nishina, Tomohiro; Yamazaki, Kentaro; Ura, Takashi; Nakajima, Takako; Goto, Ayumu; Shimada, Ken; Nakayama, Norisuke; Sakamoto, Junichi; Morita, Satoshi; Yamada, Yasuhide.

In: Oncologist, Vol. 19, No. 11, 01.01.2014, p. 1131-1132.

Research output: Contribution to journalArticle

Hamamoto, Y, Yamaguchi, T, Nishina, T, Yamazaki, K, Ura, T, Nakajima, T, Goto, A, Shimada, K, Nakayama, N, Sakamoto, J, Morita, S & Yamada, Y 2014, 'A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (bix study)', Oncologist, vol. 19, no. 11, pp. 1131-1132. https://doi.org/10.1634/theoncologist.2014-0159
Hamamoto, Yasuo ; Yamaguchi, Tatsuro ; Nishina, Tomohiro ; Yamazaki, Kentaro ; Ura, Takashi ; Nakajima, Takako ; Goto, Ayumu ; Shimada, Ken ; Nakayama, Norisuke ; Sakamoto, Junichi ; Morita, Satoshi ; Yamada, Yasuhide. / A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (bix study). In: Oncologist. 2014 ; Vol. 19, No. 11. pp. 1131-1132.
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abstract = "Background. Capecitabine is used mainly with oxaliplatin to treat metastatic colorectal cancer (mCRC). Results from capecitabine plus irinotecan (XELIRI) with or without bevacizumab (BV) have been reported in Europe but not in Japan. Consequently, the safety and efficacy of XELIRI plus BV in Japanese patients with mCRC were assessed in a single-arm phase II study.Methods. Eligible patients had had prior chemotherapy containing BV for mCRC and wild-type or heterozygous UGT1A1. Therapy in each 21-day treatment cycle consisted of capecitabine (800 mg/m2 twice daily on days 1-15), irinotecan (200 mg/m2 on day 1), and BV (7.5 mg/kg on day 1). The primary endpoint was dose-limiting toxicity in phase I and progression-free survival (PFS) in phase II.Results. A total of 34 patients (6 in phase I, 28 in phase II) were enrolled from May 2010 to June 2011. Baseline characteristics included a median age of 60 years (range: 22-74 years) for 24 men and 10 women. No dose-limiting toxicities appeared in phase I. Median PFS was 240 days (95{\%} confidence interval: 179-311 days). Overall response rate was 18.1{\%}, and the disease-control rate was 90.9{\%}.The incidence of adverse events frequently associated with irinotecan and capecitabine were neutropenia (any grade, 55.9{\%}; grade 3 or 4, 11.8{\%}), diarrhea (any grade, 50{\%}; grade 3 or 4, 5.9{\%}), and hand-foot syndrome (any grade, 61.8{\%}; grade 3 or 4, 5.9{\%}).Conclusion. Our results suggest that XELIRI plus BV is well tolerated and effective as a second-line treatment for mCRC in Japanese patients. This regimen could be especially appropriate for patients resistant to oxaliplatin-based regimens.",
author = "Yasuo Hamamoto and Tatsuro Yamaguchi and Tomohiro Nishina and Kentaro Yamazaki and Takashi Ura and Takako Nakajima and Ayumu Goto and Ken Shimada and Norisuke Nakayama and Junichi Sakamoto and Satoshi Morita and Yasuhide Yamada",
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T1 - A phase I/II study of XELIRI plus bevacizumab as second-line chemotherapy for Japanese patients with metastatic colorectal cancer (bix study)

AU - Hamamoto, Yasuo

AU - Yamaguchi, Tatsuro

AU - Nishina, Tomohiro

AU - Yamazaki, Kentaro

AU - Ura, Takashi

AU - Nakajima, Takako

AU - Goto, Ayumu

AU - Shimada, Ken

AU - Nakayama, Norisuke

AU - Sakamoto, Junichi

AU - Morita, Satoshi

AU - Yamada, Yasuhide

PY - 2014/1/1

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N2 - Background. Capecitabine is used mainly with oxaliplatin to treat metastatic colorectal cancer (mCRC). Results from capecitabine plus irinotecan (XELIRI) with or without bevacizumab (BV) have been reported in Europe but not in Japan. Consequently, the safety and efficacy of XELIRI plus BV in Japanese patients with mCRC were assessed in a single-arm phase II study.Methods. Eligible patients had had prior chemotherapy containing BV for mCRC and wild-type or heterozygous UGT1A1. Therapy in each 21-day treatment cycle consisted of capecitabine (800 mg/m2 twice daily on days 1-15), irinotecan (200 mg/m2 on day 1), and BV (7.5 mg/kg on day 1). The primary endpoint was dose-limiting toxicity in phase I and progression-free survival (PFS) in phase II.Results. A total of 34 patients (6 in phase I, 28 in phase II) were enrolled from May 2010 to June 2011. Baseline characteristics included a median age of 60 years (range: 22-74 years) for 24 men and 10 women. No dose-limiting toxicities appeared in phase I. Median PFS was 240 days (95% confidence interval: 179-311 days). Overall response rate was 18.1%, and the disease-control rate was 90.9%.The incidence of adverse events frequently associated with irinotecan and capecitabine were neutropenia (any grade, 55.9%; grade 3 or 4, 11.8%), diarrhea (any grade, 50%; grade 3 or 4, 5.9%), and hand-foot syndrome (any grade, 61.8%; grade 3 or 4, 5.9%).Conclusion. Our results suggest that XELIRI plus BV is well tolerated and effective as a second-line treatment for mCRC in Japanese patients. This regimen could be especially appropriate for patients resistant to oxaliplatin-based regimens.

AB - Background. Capecitabine is used mainly with oxaliplatin to treat metastatic colorectal cancer (mCRC). Results from capecitabine plus irinotecan (XELIRI) with or without bevacizumab (BV) have been reported in Europe but not in Japan. Consequently, the safety and efficacy of XELIRI plus BV in Japanese patients with mCRC were assessed in a single-arm phase II study.Methods. Eligible patients had had prior chemotherapy containing BV for mCRC and wild-type or heterozygous UGT1A1. Therapy in each 21-day treatment cycle consisted of capecitabine (800 mg/m2 twice daily on days 1-15), irinotecan (200 mg/m2 on day 1), and BV (7.5 mg/kg on day 1). The primary endpoint was dose-limiting toxicity in phase I and progression-free survival (PFS) in phase II.Results. A total of 34 patients (6 in phase I, 28 in phase II) were enrolled from May 2010 to June 2011. Baseline characteristics included a median age of 60 years (range: 22-74 years) for 24 men and 10 women. No dose-limiting toxicities appeared in phase I. Median PFS was 240 days (95% confidence interval: 179-311 days). Overall response rate was 18.1%, and the disease-control rate was 90.9%.The incidence of adverse events frequently associated with irinotecan and capecitabine were neutropenia (any grade, 55.9%; grade 3 or 4, 11.8%), diarrhea (any grade, 50%; grade 3 or 4, 5.9%), and hand-foot syndrome (any grade, 61.8%; grade 3 or 4, 5.9%).Conclusion. Our results suggest that XELIRI plus BV is well tolerated and effective as a second-line treatment for mCRC in Japanese patients. This regimen could be especially appropriate for patients resistant to oxaliplatin-based regimens.

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