[Phase I / II study of XELOX plus bevacizumab in Japanese patients with metastatic colorectal cancer(JO19380)]

Gan To Kagaku Ryoho. 2011 Apr;38(4):561-9.
[Article in Japanese]

Abstract

FOLFOX plus Bevacizumab (BEV) is one of he 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 same in Europe and United States. XELOX + BEV is recommended as 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 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 become 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 significant first-line therapy for colorectal cancer based on that report.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bevacizumab
  • Capecitabine
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / therapeutic use
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives
  • Fluorouracil / therapeutic use
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Neoplasm Metastasis / drug therapy
  • Oxaloacetates

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Oxaloacetates
  • Deoxycytidine
  • Bevacizumab
  • Capecitabine
  • Fluorouracil

Supplementary concepts

  • XELOX