The BEETS (JACCRO CC-18) trial: an observational and translational study of BRAF-mutated metastatic colorectal cancer

Author:

Inagaki Chiaki1ORCID,Matoba Ryo2,Yuki Satoshi3ORCID,Shiozawa Manabu4,Tsuji Akihito5,Inoue Eisuke6ORCID,Muro Kei7ORCID,Ichikawa Wataru8ORCID,Fujii Masashi9ORCID,Sunakawa Yu10ORCID

Affiliation:

1. Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osakasayama, Osaka 589-8511, Japan

2. DNA Chip Research Inc., 1-15-1, Kaigan, Minato-ku, Tokyo 105-0022, Japan

3. Department of Gastroenterology & Hepatology, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido 060-8648, Japan

4. Department of Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa 241-8515, Japan

5. Department of Clinical Oncology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

6. Showa University Research Administration Center, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan

7. Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan

8. Division of Medical Oncology, Showa University Fujigaoka Hospital, 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa 227-8501, Japan

9. Japan Clinical Cancer Research Organization (JACCRO), 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051, Japan

10. Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

Abstract

For BRAF V600E-mutated metastatic colorectal cancer (mCRC), the BEACON phase 3 trial showed survival benefit of triplet therapy with cetuximab (anti-EGFR antibody), encorafenib (BRAF inhibitor) and binimetinib (MEK inhibitor) as well as doublet therapy with cetuximab and encorafenib over irinotecan-based chemotherapy plus anti-EGFR antibody. Both regimens are standards of care in Japan, but definite biomarkers for predicting efficacy and selecting treatment remain lacking. The mechanisms underlying resistance to these regimens also warrant urgent exploration to further evolve treatment. This prospective observational/translational study evaluated real-word clinical outcomes with cetuximab and encorafenib with or without binimetinib for BRAF-mutated mCRC patients and investigated biomarkers for response and resistance by collecting blood samples before and after treatment. Clinical Trial Registration: UMIN000045530 ( https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051983 )

Funder

Ono Pharmaceutical

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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