Real-World Data of Patients with BRAF V600E-Mutated Metastatic Colorectal Cancer Treated with Trifluridine/Tipiracil
Year: 2024
Type: article
Study design: Observational Study
Abstract: Background: For patients with refractory metastatic colorectal cancer (mCRC), trifluridine/tipiracil (FTD–TPI) has been associated with a significant improvement in overall survival (OS). However, data are lacking regarding the activity of FTD–TPI in patients with BRAF-mutated mCRC. Methods: This retrospective, multicenter, international cohort included patients with BRAF-mutated mCRC treated with FTD–TPI in a real-life setting in Spain and Italy. Survival analysis was performed using Kaplan–Meier methods and Cox proportional hazard models and according to established prognostic groups: good prognosis characteristics (GPC; < 3 metastatic sites and time from metastases to FTD–TPI ≥ 18 months) and poor prognosis characteristics (PPC; ≥ 3 metastatic sites or time from metastases to FTD–TPI < 18 months). Results: In the 26 patients included, the median age was 61 years, 13 (50%) were female, and 20 (77%) had an Eastern Cooperative Oncology Group (ECOG) performance status of 1. Fourteen (56%) patients had right-sided tumors, six (23%) had microsatellite instability tumors, and thirteen (50%) had liver metastases. Median progression-free survival was 2.3 months (95% CI 2.0–3.2), and median OS (mOS) was 6.6 months (95% CI 4.4–12.0). mOS was 7.6 vs. 4.2 months (HR 1.64, 95% CI 0.65–4.10, p = 0.3) for GPC and PPC patients, respectively. Exploratory analyses identified ECOG as the only feature associated with survival. The most frequent grade 3–4 adverse events were neutropenia (8%), anemia (8%), and asthenia (4%). Conclusions: Patients with BRAF mutant mCRC achieved modest benefits with FTD–TPI; however, patients with GPC and ECOG 0 achieved longer OS compared with those with PPC or ECOG 1–2, thus warranting further exploration in prospective cohorts.
Source: Cancers
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,296
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Celgene, Array BioPharma, Taiho Pharmaceutical, Exelixis, Les Laboratories Pierre Fabre, BeiGene, NuCana, Seagen, Servier, Novartis Farmacéutica, PharmaMar, Menarini Group, Genentech, Takeda Oncology, Daiichi Sankyo Europe, Cilag
OpenAlex ID: W4405333686
