Phase II trial of cetuximab plus irinotecan for oxaliplatin- and irinotecan-based chemotherapy-refractory patients with advanced and/or metastatic colorectal cancer: Evaluation of efficacy and safety based on kras mutation status (T-CORE0801)

Hiroshi Soeda, Hideki Shimodaira, Makio Gamoh, Hideaki Ando, Hideki Isobe, Takeshi Suto, Shin Takahashi, Yuichi Kakudo, Kenji Amagai, Takahiro Mori, Mika Watanabe, Takuhiro Yamaguchi, Shunsuke Kato, Chikashi Ishioka

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

Abstract

Background: Mutations in the KRAS gene have been identified as negative predictors of response to anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapy by patients with metastatic colorectal cancer (mCRC). However, it has been based on the study of mainly Caucasian mCRC patients. This prospective study investigated the relationship between the mutation status of EGFR-related genes including KRAS and the response rate (RR) to cetuximab plus irinotecan therapy in Japanese mCRC patients. Methods: Samples taken from 43 chemotherapy-refractory mCRC patients who had undergone cetuximab plus irinotecan therapy at 11 medical centers in Japan were subjected to direct DNA sequencing to determine the KRAS, BRAF, PIK3CA, NRAS, and AKT1 mutation status. The clinical outcome after the treatment was evaluated for each mutation status. Results:KRAS mutations were detected in 31.7% of 41 eligible patients. The RR to cetuximab plus irinotecan therapy was found to be 17.9 and 0% in the KRAS wild-type and mutant subgroups, respectively. Conclusion: Despite the identification of a lower-than-expected RR to treatment by the KRAS wild-type subgroup, KRAS mutation status appears to be a useful predictive marker of response to cetuximab plus irinotecan therapy in Japanese mCRC patients.

Original languageEnglish
Pages (from-to)7-20
Number of pages14
JournalOncology (Switzerland)
Volume87
Issue number1
DOIs
Publication statusPublished - 2014 Jul

Keywords

  • Cetuximab
  • Colorectal carcinoma
  • Epidermal growth factor receptor
  • KRAS

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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