The TRIBE study showed that FOLFOXIRI plus bevacizumab therapy is an effective treatment for metastatic colorectal cancer (mCRC). This study aimed to determine the safety and effectiveness of FOLFOXIRI therapy as a first-line treatment.
We retrospectively collected data of patients with mCRC treated with FOLFOXIRI from March 2014 to December 2017 in two centres.
Fifty-five patients were enrolled in this study (median age, 60 years; males 25, females 30). The tumour location was classified as right and left in 15 and 40 patients, respectively. Twenty-nine and twenty-six patients had RAS wild-type disease and mutation-type disease, respectively. Anti-VEGF and anti-EGFR antibodies were used in 38 and 17 patients, respectively. The most common grade 3 or 4 adverse event was neutropenia (51%). Skin toxicities and hypomagnesaemia showed a statistically higher frequency among patients with anti-EGFR antibodies (P < 0.001 and P = 0.039, respectively). The overall response rate (ORR) was 67% (complete response [CR], 7 patients; partial response [PR], 30 patients; not evaluated [NE], 1 patient), and the disease control rate was 96% (stable disease, 16 patients). The median progression free survival (mPFS) was 11.0 (0.43 − 45.3) months and the median overall survival (mOS) was 41.9 (1.00 − 45.3) months. In FOLFOXIRI plus anti-VEGF antibodies, the ORR was 55% (CR, 5 patients; PR 16 patients), and in FOLFOXIRI plus anti-EGFR antibodies, the ORR was 94% (CR, 2 patients; PR, 14 patients; NE, 1 patient) (P = 0.271). With a median follow up of 18.4 months, mPFS and mOS were not significantly different in patients with anti-EGFR antibodies or anti-VEGF antibodies (hazard ratio [HR], 3.12 [0.883 − 11.0]; P = 0.143 and P = 0.063, respectively). Twelve patients had progressive disease (PD) during the induction phase. In these patients, mOS was significantly poorer (13.2 months versus 41.9 months; HR, 23.3 [6.77 − 80.1]; P < 0.001).
FOLFOXIRI plus molecular target therapy showed impressive results for patients with mCRC. The response rate was significantly higher in patients with anti-EGFR antibodies, although skin toxicities and hypomagnesaemia tend to occur in these patients.
Clinical trial identification
Legal entity responsible for the study
Kobe City Medical Center General Hospital.
Has not received any funding.
All authors have declared no conflicts of interest.