Liposomal irinotecan and capecitabine plus bevacizumab as second‐line therapy in metastatic colorectal cancer: A multicenter, single‐arm study
Dan Su, Changzheng Li, Tongsen Zheng, Jiebing Tang, Guangyu Wang, Huiting Xu, Xiaodong Wang, Zhengwen Cai, Chao Liu, Yanqiao ZhangABSTRACT
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
Patients with histologically confirmed mCRC who had progressed following first‐line oxaliplatin‐based chemotherapy were enrolled in this study. The treatment regimen was liposomal irinotecan (70 mg/m 2 , d1), capecitabine (1000 mg/m 2 , 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.