Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer (JO19380): Evaluation of long-term treatment cases

Atsushi Sato, Toshihiko Doi, Narikazu Boku, Ken Kato, Yoshito Komatsu, Kensei Yamaguchi, Kei Muro, Yasuo Hamamoto, Wasaburo Koizumi, Nobuyuki Mizunuma, Hiroya Takiuchi

Research output: Contribution to journalReview article

Abstract

FOLFOX plus Bevacizumab (BEV) is one of the current standard treatments for unresectable colorectal cancer. In Europe and the United States, XELOX is a regimen which replaced 5-FU/LV of FOLFOX with capecitabine (XEL), an oral prodrug of fluorouracil. Benefits of XELOX and FOLFOX are reported to be the same in Europe and the United States. XELOX+BEV is recommended as a treatment option in various guidelines. However, the safety and effectiveness data were from overseas, and unconfirmed in Japan. Therefore, we carried out a JO19380 study to evaluate the effectiveness and safety of XELOX+BEV on Japanese patients in a domestic phase I / II clinical trial. A total of 64 patients were registered in this study. The response rate was 72%, the progression free survival was 11 months, and the median survival time was 27.4 months with XELOX+ BEV. The common grade 3/4 toxicities were sensory neurotoxicity (17%) and neutropenia (16%). The effectiveness and safety equivalents of overseas reports were confirmed in Japanese patients. They suggested that XELOX+BEV has the potential to becom one of the standard treatments for unresectable colorectal cancer in Japan. In the trial, long-term disease control with XEL+BEV was reported in patients who discontinued oxaliplatin because of adverse events. Continuous treatment with XEL+BEV after XELOX+BEV is considered to be a significant first-line therapy for colorectal cancer based on that report.

Original languageEnglish
Pages (from-to)561-569
Number of pages9
JournalJapanese Journal of Cancer and Chemotherapy
Volume38
Issue number4
Publication statusPublished - 2011 Jan 1
Externally publishedYes

Fingerprint

Colorectal Neoplasms
oxaliplatin
Therapeutics
Safety
Fluorouracil
Japan
Phase II Clinical Trials
Clinical Trials, Phase I
XELOX
Bevacizumab
Prodrugs
Neutropenia
Disease-Free Survival
Guidelines
Survival

Keywords

  • Long-term treatment
  • Unresectable colorectal cancer

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer (JO19380) : Evaluation of long-term treatment cases. / Sato, Atsushi; Doi, Toshihiko; Boku, Narikazu; Kato, Ken; Komatsu, Yoshito; Yamaguchi, Kensei; Muro, Kei; Hamamoto, Yasuo; Koizumi, Wasaburo; Mizunuma, Nobuyuki; Takiuchi, Hiroya.

In: Japanese Journal of Cancer and Chemotherapy, Vol. 38, No. 4, 01.01.2011, p. 561-569.

Research output: Contribution to journalReview article

Sato, A, Doi, T, Boku, N, Kato, K, Komatsu, Y, Yamaguchi, K, Muro, K, Hamamoto, Y, Koizumi, W, Mizunuma, N & Takiuchi, H 2011, 'Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer (JO19380): Evaluation of long-term treatment cases', Japanese Journal of Cancer and Chemotherapy, vol. 38, no. 4, pp. 561-569.
Sato, Atsushi ; Doi, Toshihiko ; Boku, Narikazu ; Kato, Ken ; Komatsu, Yoshito ; Yamaguchi, Kensei ; Muro, Kei ; Hamamoto, Yasuo ; Koizumi, Wasaburo ; Mizunuma, Nobuyuki ; Takiuchi, Hiroya. / Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer (JO19380) : Evaluation of long-term treatment cases. In: Japanese Journal of Cancer and Chemotherapy. 2011 ; Vol. 38, No. 4. pp. 561-569.
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AU - Komatsu, Yoshito

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