Phase 2 trial of liposomal irinotecan plus fluoruracil and bevacizumab as second-line treatment in advanced colorectal cancer

Cohort A of a multicenter phase 2 trial in China evaluated liposomal irinotecan (Lipo-IRI) combined with fluorouracil and bevacizumab as second-line treatment for advanced colorectal cancer (CRC). The cohort included 53 patients with relapsed or metastatic CRC after first-line therapy. The primary endpoint was objective response rate (ORR). Among 46 efficacy-evaluable patients, the comfirmed ORR was 21.7% (95% CI 10.9-36.4). With a median follow-up of 5.5 months, the median progression-free survival was 7.4 months (95% CI 4.9-NR). Grade ≥ 3 treatment-related adverse events occurred in 18.9% of patients, most commonly decreased neutrophil count (7.5%). The authors conclude that Lipo-IRI combined with fluorouracil and bevacizumab showed promising efficacy and manageable safety as second-line treatment for advanced CRC.