Baseline characteristics of patients enrolled in the BERING CRC study: A European real-world study in BRAF V600E-mutant metastatic colorectal cancer.
Authors: Stintzing Sebastian , Hübner Gerdt , Schröder Jan , Forstbauer Helmut , Kisro Jens , Welslau Manfred , Müller-Huesmann Harald , Bürkle Dieter , Krammer-Steiner Beate , von der Heyde Eyck , Reichenbach Frank , Arnold Dirk , Fritsch Ralph M , Gerger Armin , Hegewisch-Becker Susanna , Vogel Arndt , Wagner Anna Dorothea , Winder Thomas , Koeberle Dieter , Prager Gerald 
Published: June 2022

e15584

Background: BRAF V600E-mutant metastatic colorectal cancer (mCRC) is characterized by a poor prognosis and limited clinical data. Based on results from the phase 3 BEACON CRC trial, targeted treatment with encorafenib plus cetuximab (E+C) represents a newly approved standard of care for these patients (pts) upon systemic therapy. As data from controlled clinical trials are based on a selected patient population, the non-interventional study (NIS) BERING CRC observes a broader patient population under real-world conditions. Methods: BERING CRC is the first NIS to investigate the real-world use of E+C in BRAF V600E-mutant metastatic colorectal cancer upon systemic treatment in Germany, Austria, and Switzerland. For the present baseline analysis, disease characteristics and treatment data of the initial 40 pts were documented prospectively in 27 sites across Germany and Austria between 09/2020 and 08/2021. As BERING-CRC is ongoing, the study aims to enroll up to 500 pts from 96 German, Austrian, and Swiss sites. The study observes pts treated according to the approval as given in the respective Summary of Product Characteristics (SmPC). The primary objective is to analyze the 1-year overall survival rate. Secondary endpoints include efficacy, quality of life and tolerability of E+C. Data are analyzed descriptively using standard summary statistics. Results: 40 pts were included in this baseline analysis. The median age was 68 years (range 34-88) and 38% were female. 26 pts (65%) were documented with right-sided tumors and for 63% stage IV disease was noted at initial diagnosis. In the metastatic setting, the main sites of metastasis were liver, peritoneum, and lung (55%, 40%, 33% of pts, respectively), with 20% of pts having ≥ 3 organs involved. For 38% of pts, an ECOG performance status (PS) of 0 was documented at baseline assessment (60% ECOG PS 1 or 2). Adjuvant treatment was reported for 8 pts and 88% received chemotherapy alone in this setting. 3 pts (8%) were documented with E+C treatment directly following adjuvant therapy and half of all pts with documented first-line treatment received chemotherapy alone (CT), for 42% chemotherapy was combined with targeted therapy (CT+TT). In second-line, 74% of pts with documented treatment received E+C (9% CT, 17% CT+TT). Bi-weekly cetuximab dosing was reported for 11% of pts treated with E+C. Conclusions: While the high number of pts with right-sided tumors was in line with previous findings on BRAF V600E-mutant mCRC pts, considerably more pts were male in this initial real-world cohort and synchronous metastasis was reported markedly more often. As complementation to previous controlled clinical trial data, pts enrolled to date in BERING-CRC were notably older and presented with higher ECOG PS compared to the pivotal study. Clinical trial information: NCT04673955.