# Patients with Colorectal Cancer and BRAFV600E-Mutation in Argentina: A Real-World Study—The EMOGI-CRC01 Study

## TL;DR

This study examines real-world treatment outcomes for BRAF-mutated colorectal cancer patients in Argentina, highlighting limited access to costly drugs and varied treatment approaches.

## Contribution

The study presents the largest real-world cohort of BRAFV600E-mutated CRC in Latin America, emphasizing treatment disparities in low-middle-income countries.

## Key findings

- Median progression-free survival in first-line treatment was 9 months.
- Only 26% of patients received BRAF inhibitors in second-line treatment, with a 10.5% overall response rate.
- Treatment heterogeneity was observed due to limited access to high-cost drugs.

## Abstract

BRAF-mutated colorectal cancer is an aggressive entity related with poor prognoses and limited data in Latin America, reflecting gaps in research and practice. The EMOGI-CRC01 study analyzed 161 patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) across ten oncology centers in Argentina. The median age was 58.5 years, and 93.8% of patients received first-line treatment, mostly doublet chemotherapy plus anti-VEGF. With a median follow-up of 23 months, the progression-free survival (PFS) was 9 months. In second-line treatment, only 26% received BRAF inhibitors, with median PFS 5.2 months (95% CI 4.9—NR) and the overall response rate (ORR) was 10.5%. Real-world studies are essential to understand the barriers. Our study highlights treatment heterogeneity due to limited access to high-cost drugs, especially in the second-line setting.

Background/Objectives: The BRAF-mutation is a poor prognostic factor in colorectal cancer (CRC). There is a need for real-world data in low-middle-income countries regarding clinical characteristics, outcomes, and treatment strategies. This study aims to describe progression-free survival (PFS) and in the first- and second-line setting and sequences of treatment regimens. Methods: We retrospectively analyze patients from ten oncology centers in Argentina, diagnosed with BRAFV600E-mutated advanced CRC between January 2014 and July 2023. Results: A total of 161 patients with metastatic CRC and BRAFV600E-mutation. The median age was 58.5 (IQR 47–69), and 21.7% were MMR-deficient (dMMR). Of these patients, 93.8% received first-line treatment. With a median follow-up of 23 months (95% CI 16.5–33.4 months), the median PFS was 9 months (95% CI 7.4–10.5 months). The most common regimen in first line setting was doublet chemotherapy plus anti-VEGF for 49% of the patients. Twenty-six percent of the patients received BRAF inhibitors in the second-line setting, with a median PFS of 5.2 months (95% CI 4.9—NR); the overall response rate (ORR) was 10.5%. Conclusions: This study represents, to the best of our knowledge, the largest published real-world cohort of BRAFV600E-mutated CRC in Latin America. The heterogeneity of the treatments reflects the existence of barriers to access to high-cost drugs in our country. Cooperative efforts are needed to understand the particular characteristics of this subgroup of patients.