TRESBIEN (OGSG 2101): encorafenib, binimetinib and cetuximab for early recurrent stage II/III BRAF V600E-mutated colorectal cancer.
Shogen BokuHironaga SatakeTakashi OhtaSeiichiro MitaniKentaro KawakamiYozo SuzukiToshihiko MatsumotoTetsuji TerazawaEiki YamazakiHiroko HasegawaTatsuki IkomaMamoru UemuraToshifumi YamaguchiAtsushi NaitoYasunobu IshizukaYukinori KurokawaDaisuke SakaiHisato KawakamiToshio ShimokawaToshimasa TsujinakaTakeshi KatoTaroh SatohYoshinori KagawaPublished in: Future oncology (London, England) (2022)
The BRAF V600E mutation accounts for approximately 5% of colorectal cancer (CRC) cases and is an extremely poor prognostic factor. However, there are no clear recommendations regarding first-line therapy for patients with early recurrent BRAF V600E-mutated CRC, during or after adjuvant chemotherapy. Recently, a novel combination of encorafenib, binimetinib and cetuximab, showed a higher response rate than standard chemotherapy in patients with BRAF V600E-mutated CRC. Here we describe our plan for the TRESBIEN study (OGSG 2101), which is an open-label, multicenter, single-arm, phase II study designed to evaluate whether encorafenib, binimetinib and cetuximab are effective for patients with early recurrent BRAF V600E-mutated colorectal cancer, during or after adjuvant chemotherapy. The planned number of subjects is 25.