OBJECTIVES: There is a high unmet need for more effective and tolerable therapies among patients with metastatic colorectal cancer (mCRC). The study objective was to evaluate biomarker prevalence, demographic and clinical characteristics, and treatment patterns by line of therapy (LOT) among mCRC patients who had undergone next-generation sequencing (NGS).

METHODS: This retrospective observational analysis employed the AACR Project GENIE-Biopharma Collaborative database. Eligible mCRC patients were ≥18 years and had undergone NGS testing between January 1, 2015 and December 31, 2017. Descriptive statistics were used to describe biomarker prevalence, patient characteristics and treatment patterns.

RESULTS: Among 827 mCRC patients, 48.7% had RAS mutations, 6.9% had BRAF mutation, 5.0% had MSI-H/dMMR, 1.6% had HER2 amplification, 1.5% had HER2 mutation, 0.8% had POLE mutation, 0.1% had NTRK fusion, while no ROS1 fusion were identified. Majority of the patients were male (56.5%) and White (79.0%), with a median (IQR) age of 54 (46, 64) years. Over half (58.0%) of patients were initially diagnosed with stage IV CRC, and 79.9% had adenocarcinoma. The most prevalent site of metastasis was liver (44.0%). Nearly 89% of patients received first-line therapy (1L), 63% received second-line (2L), 35% received third-line (3L), and 14% received fourth-line and beyond (4L+). For 1L, the most common therapy was FOLFOX-based therapy (58.5%) followed by FOLFIRI-based therapy (20.9%), in 2L (FOLFOX 16.0%, FOLFORI 46.2%), 3L (22.0%, 26.8%), and 4L+ (24.6%, 19.5%). Increasing usage of TAS-102 was observed in later LOTs with 10.7% for 3L and 12.7% for 4L+.

CONCLUSIONS: Nearly 16% of mCRC patients have a potentially actionable biomarker (BRAF, MSI-H/dMMR, HER2, NTRK). Reported biomarkers here were similar for BRAF and RAS compared to published literature. Real-world treatment patterns indicate mCRC patients often use FOLFOX- or FOLFIRI-based therapy with substantial recycling of chemotherapies in relapsed/refractory setting.