Upfront FOLFOXIRI Plus Bevacizumab in Metastatic Colorectal Cancer: TRIBE2 Trial Update
Posted: Monday, June 29, 2020
Based upon the results of the previous phase III TRIBE study on metastatic colorectal cancer, Chiara Cremolini MD, of Tuscan Tumor Institute, Pisa, Italy, and colleagues compared a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of modified FOLFOX6 and FOLFIRI doublets, in combination with bevacizumab. This upfront strategy with FOLFOXIRI plus bevacizumab appears to be an optimal therapeutic option for this patient population. The updated data were published in The Lancet Oncology.
The updated study (TRIBE2) was an open-label, multicenter, randomized phase III trial that enrolled 679 patients with metastatic colorectal cancer recruited from 58 Italian oncology units. They all had histologically confirmed, unresectable, previously treated metastatic colorectal adenocarcinoma. Half of the patients were randomly assigned to the control group; they received first-line modified FOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) plus bevacizumab followed by FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab after disease progression. The other half were the experimental group; they received FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab followed by a reintroduction of the same regimen after disease progression.
At a median follow-up of 35.9 months, the progression-free survival was 84% in the control group and 77% in the experimental group. During first-line treatment, the most frequent grade 3 or 4 adverse events were diarrhea and hypertension. Of the 570 patients alive at the time of first disease progression, 88% of the control group and 82% of the experimental group received further treatment.
“Our results suggest that upfront exposure to FOLFOXIRI plus bevacizumab followed by the reinduction of the same regimen leads to improved survival outcomes when compared with a preplanned sequential strategy of three cytotoxic drugs across two subsequent lines of therapy in the treatment of patients with metastatic colorectal,” the study authors concluded.
Disclosure: The authors reported no conflicts of interest.