Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osakasayama, Osaka 589-8511, Japan.
DNA Chip Research Inc., 1-15-1, Kaigan, Minato-ku, Tokyo 105-0022, Japan.
Future Oncol. 2023 Jun;19(17):1165-1174. doi: 10.2217/fon-2023-0209. Epub 2023 Jun 13.
For 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 -mutated mCRC patients and investigated biomarkers for response and resistance by collecting blood samples before and after treatment. UMIN000045530 (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051983).
对于 V600E 突变型转移性结直肠癌（mCRC），BEACON 三期试验显示，与基于伊立替康的化疗联合抗 EGFR 抗体相比，西妥昔单抗（抗 EGFR 抗体）、恩考芬尼（BRAF 抑制剂）和比美替尼（MEK 抑制剂）三联疗法以及西妥昔单抗和恩考芬尼二联疗法在生存方面具有获益。这两种方案在日本都是标准治疗方法，但仍缺乏明确的预测疗效和选择治疗的生物标志物。这些方案耐药的机制也需要紧急探索，以进一步改进治疗方法。这项前瞻性观察性/转化研究评估了西妥昔单抗和恩考芬尼联合或不联合比美替尼治疗 V600E 突变型 mCRC 患者的真实临床结局，并通过在治疗前后采集血样，研究了反应和耐药的生物标志物。UMIN000045530（https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051983）。
