Liposomal irinotecan and capecitabine plus bevacizumab as second‐line therapy in metastatic colorectal cancer: A multicenter, single‐arm study

BACKGROUND: Liposomal irinotecan, characterized by its favorable pharmacologic properties and reduced systemic toxicity compared to irinotecan, has demonstrated superior therapeutic potential. This multicenter, single-arm study was conducted to evaluate the efficacy and safety of liposomal irinotecan, capecitabine, and bevacizumab as a second-line treatment for metastatic colorectal cancer (mCRC). METHODS: , twice daily, d1-10), and bevacizumab (5 mg/kg, d1). The primary endpoint was progression-free survival. Secondary endpoints included objective response rate, disease control rate, duration of response, overall survival, and safety. RESULTS: Between March 2024 and July 2024, 63 patients were enrolled, with a median age of 60.0 years (range: 37.0-79.0). Among the patients who received at least one tumor assessment, the objective response rate and disease control rate were 22.9% (11/48; 95% CI, 12.0-37.3) and 89.6% (43/48; 95% CI, 77.3-96.5), respectively. With a median follow-up of 16.2 months (range: 0.5-28.5), the median progression-free survival was 8.1 months (95% CI, 7.3-8.9), and the median overall survival was 19.5 months (95% CI, 15.2-23.8). The most common grade 3 to 4 adverse events were diarrhea (12.7%), neutropenia (11.1%), and fatigue (6.3%). CONCLUSIONS: The combination of liposomal irinotecan, capecitabine, and bevacizumab demonstrated promising antitumor activity and a manageable safety profile in patients with mCRC who had failed first-line oxaliplatin-based therapy. These results suggested that this regimen is a clinically feasible second-line treatment option for mCRC.