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Disease characteristics and real-world treatment pathways of BRAF V600E-mutant metastatic colorectal cancer patients: Analysis of 120 patients enrolled in the BERING CRC study
Associated with a poor prognosis, there is an increased medical need for BRAFV600E-mutant metastatic colorectal cancer (mCRC) patients for improved therapeutic approaches. Upon completion of the BEACON CRC-trial, targeted treatment (TT) with encorafenib plus cetuximab (E+C) after prior systemic therapy is now regarded as a standard of care for these patients. Since clinical data from controlled clinical trials is limited and based on a selected patient population, the non-interventional study (NIS) BERINGCRC aims to observe a broader patient population in current clinical practice.
BERINGCRC is the first NIS evaluating clinical practices in the use of E+C after prior systemic therapy according to the approved respective Summary of Product Characteristics (SmPC) in BRAFV600E-mutant mCRC patients in Germany, Austria, and Switzerland. BERINGCRC is ongoing and aims to enroll up to 300 patients from 126 sites. For the present analysis, disease characteristics and treatment data of the first 120 patients were collected at 56 sites across Germany, Austria, and Switzerland between 09/2020 and 11/2022. Consistent with BEACON CRC, adjuvant systemic therapy with relapse ≤ 6 months was counted as metastatic 1st-line treatment. The primary endpoint is the 1-year overall survival rate. Secondary endpoints include efficacy, QoL, and tolerability of E+C.
A total of 120 patients was included in this analysis. Median age was 66.4 years (range 31 to 88) and approximately half of the patients (51.7%) were male. 68 patients (56.7%) were documented with right-sided tumors and for 60.0% of the patients stage IV disease was noted when the primary diagnosis was established. In the metastatic setting, main sites of metastasis were liver, peritoneum, and lung (50.8%, 32.5%, and 20.8% of the patients, respectively), with 13.3% of the patients presenting with ≥ 3 metastatic sites. For 30.8% of the patients, an ECOG performance status (PS) of 0 was documented at baseline (ECOG PS 1: 46.7%; ECOG PS 2: 8.3%; ECOG PS 3: 1.7%; Not done/missing: 12.5%). Evaluable treatment details were documented in 103 patients. Treatment in adjuvant setting was reported for 33 patients (32.0%). Thirty one (93.9%) of these patients received chemotherapy alone. Early relapse in adjuvant setting was documented for 15 of them (45.5%). In first line, 9 (8.7%) were documented with E+C treatment directly following adjuvant therapy. Another 48.5% of the patients received chemotherapy alone, for 39.8% chemotherapy was combined with targeted therapy, 1.0% received immunotherapy, and 1.0% received targeted therapy alone. In second line, 69.9% of the patients with documented treatment received E+C, 9.7% were treated with chemotherapy alone, and 11.7% with chemotherapy + targeted therapy. An initial bi-weekly cetuximab dosing was reported for 8.7% of the patients treated with E+C.
In line with previous findings on BRAFV600E-mutant mCRC patients, the number of patients with right-sided tumors was relatively high. However, compared to literature, synchronous metastases were reported considerably more often in this NIS. Compared to the pivotal study BEACON CRC, BERINGCRC patients were notably older and less patients were documented with ECOG PS 0.
NCT04673955.
Editorial support was provided by Andreas Zähringer, Freiburg.
The authors.
Pierre Fabre Pharma GmbH, Freiburg, Germany.
G. Prager: Advisory / Consultancy: Merck, Roche, Amgen, Sanofi, Lilly, Bayer, Servier, CECOG, MSD, BMS, Pierre Fabre, Incyte, Novartis; AstraZeneca. F. Reichenbach: Full / Part-time employment: Pierre Fabre Pharma GmbH. D. Arnold: Honoraria (self): Merck, Sharp and Dome; GlaxoSmithKline; Gilead, Merck Serono, Boston Scientific, Bristol-Meyer Squibb, Pierre Fabre Pharma, Servier, Astra Zeneca, Lilly, Sanofi (Genzyme); Honoraria (Institution): Merck, Sharp and Dome, Terumo, Merck Serono, Boston Scientific, Bristol, Meyer Squibb, Pierre Fabre Pharma, Servier, OncoLytics; Advisory / Consultancy: Merck, Sharp and Dome, Gilead, Merck Serono, Boston Scientific, Bristol, Meyer Squibb, Pierre Fabre Pharma, Servier, Roche; Research grant / Funding (self): OncoLytics. A. Vogel: Honoraria (self): AstraZeneca, Amgen, BeiGene, Böhringer Mannheim, BMS, BTG, Daichi-Sankyo, EISAI, GSK, Imaging Equipment Ltd (AAA), Incyte, Ipsen, Jiangsu Hengrui Medicines MSD, PierreFabre, Roche, Servier, Sirtex, Tahio, Terumo; Advisory / Consultancy: AstraZeneca, Amgen, BeiGene, Böhringer Mannheim, BMS, BTG, Daichi-Sankyo, EISAI, Incyte, Ipsen, MSD, PierreFabre, Roche, Servier, Sirtex, Tahio, Terumo. S. Stintzing: Honoraria (self): AMGEN, Pierre-Fabre, Merck KGaA; Advisory / Consultancy: AMGEN, Pierre-Fabre, Merck KGaA; Research grant / Funding (institution): Roche, Pierre-Fabre, Merck KGaA; Travel / Accommodation / Expenses: Amgen, Pierre-Fabre, Merck KgaA. All other authors have declared no conflicts of interest.
