Abstract
Purpose
FOLFOXIRI is a standard treatment for unresectable colorectal cancer (CRC) liver metastases. However, limited data exists on its safety and effectiveness in low-to-middle income countries (LMICs). This prospective study addresses this gap in a Vietnamese LMIC setting.
Methods
We enrolled 92 patients with unresectable CRC liver metastases between 2022 and 2023. All patients received FOLFOXIRI every two weeks, with routine G-CSF prophylaxis to prevent neutropenia. A multidisciplinary team (MDT) assessed diagnoses and treatment responses. Outcomes were R0/R1 resection rate, progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse events (AEs), and recurrence-free survival (RFS) for surgical patients.
Results
The median patient age was 56 years, with a male predominance (70.7%). The primary tumors were located in the left colon (42.4%), rectum (37%) and right colon (20.7%). Thirty-two patients (34.8%) experienced severe (grade 3 or higher) AEs, with thrombocytopenia (13.1%) and anemia (9.8%) being the most frequent. Most patients (72/87, 82.9%) achieved a partial response. The ORR and DCR were 85.1% and 95.4%, respectively. Fifty-seven patients (62%) achieved resectability, and 54 (58.7%) underwent radical surgery. The R0/R1 resection rate was 88.9%. The median PFS and OS for all patients were 13 and 22 months, respectively. The median RFS of surgical patients was 14 months.
Conclusions
FOLFOXIRI improves the response rates, R0/R1 resection rates, and survivals for patients with CRC liver metastases. Future research is neccessary to improve prognosis of patients while minimizing toxicities.
Trial registration number:
NCT05362825 dated 5th May 2022