Abstract 96P
Background
For colorectal cancer, irinotecan-based therapy is recommended after failure of oxaliplatin-based therapy. Liposomal irinotecan is a new formulation of irinotecan that reduces toxicity and improves efficacy. This study aimed to explore the efficacy and safety of liposomal irinotecan + 5-FU/LV + bevacizumab in the second-line treatment of metastatic colorectal cancer.
Methods
This is a multi-center, open-label, single-arm clinical trial enrolling patients with metastatic colon or rectal adenocarcinoma who had received first-line oxaliplatin-based therapy. All eligible subjects received liposomal irinotecan + 5-FU + LV + bevacizumab until disease progression, intolerance, or withdrawal of informed consent. The primary endpoint is objective response rate (ORR), and secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results
As of June 19, 2024, a total of 41 subjects had been enrolled. Among them, 22 were male (53.7%) and 19 were female (46.3%). The median age was 57 years (30.0-76.0 years), and 68.3% of patients had ≥2 metastatic lesions. The study included 13 cases of left colon cancer, 13 cases of right colon cancer, and 15 cases of rectal cancer. Nineteen subjects underwent at least once imaging evaluation, and the number of patients achieved partial response and stable disease were 4 and 12, respectively. The ORR was 21.1% (95% CI: 9.1%∼51.2%), and the DCR was 84.2% (95% CI: 60.4%∼96.6%). Disease progression and death occurred in 5 and 2 subjects, and the median PFS and OS were not reached. Treatment-related adverse events (TRAEs) occurred in 31 patients (75.6%), and 16 patients (39.0%) experienced ≥3 grade AEs. The most common (incidence ≥ 10%) ≥ 3 grade AEs included: neutropenia (17.1%), leucopenia (17.1%), and diarrhea (12.2%). No unexpected adverse events and grade 5 TRAE occurred.
Conclusions
The results showed that irinotecan liposome + 5-FU/LV + bevacizumab has great efficacy and controllable safety in the second-line treatment of metastatic colorectal cancer, and is worthy for further treatment and follow-up.
Clinical trial identification
NCT06184698.
Editorial acknowledgement
Legal entity responsible for the study
The Fourth Hospital of Hebei Medical University.
Funding
CSPC Ouyi Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.