TRIBE Reports Improved Metastatic CRC OS for FOLFOXIRI Plus Bevacizumab

Median overall survival is significantly longer for metastatic colorectal cancer patients treated with bevacizumab in combination with FOLFOXIRI than with FOLFIRI

medwireNews: Metastatic colorectal cancer (CRC) patients derive an overall survival benefit from first-line FOLFOXIRI plus bevacizumab compared with FOLFIRI plus bevacizumab, phase III trial findings indicate.

The primary analysis of the TRIBE trial showed that progression-free survival was significantly longer and the overall response rate significantly higher with the FOLFOXIRI than the FOLFIRI regimen in this patient population, explain the investigators.

And in light of these updated findings, they recommend that FOLFOXIRI plus bevacizumab be considered as a therapeutic option for patients with metastatic CRC with characteristics similar to the study’s inclusion criteria – such as an ECOG performance status of 2 or less for patients aged between 18 and 70 years and of 0 for those between 71 and 75 years old, measurable disease as per the RECIST criteria, and adequate bone marrow, liver and renal function.

After a median follow-up of 48.1 months, median OS was 29.8 months for the 252 participants randomly assigned to receive open-label FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin and irinotecan) together with bevacizumab. This was significantly longer than the OS of 25.8 months recorded in the 256 patients treated with FOLFIRI (fluorouracil, leucovorin and irinotecan) plus bevacizumab.

The RAS and BRAF mutational status was evaluable in 181 of FOLFOXIRI-treated patients and in 176 of those given FOLFIRI. And the efficacy findings stratified for mutational status were broadly in line with the main analysis, making allowances for the lower statistical power, say Alfredo Falcone, from the University Hospital of Pisa in Italy, and colleagues.

They add that the interaction analysis showed no significant difference in treatment effect across all molecular subgroups.

The researchers also report that an identical 76% of patients who progressed in either group went on to receive second-line therapy, which they say allays concerns regarding the efficacy and feasibility of subsequent lines of treatment for patients given FOLFOXIRI plus bevacizumab, a regimen that contains a high number of active agents.

“The present findings show that the intensification of the upfront chemotherapy backbone positively affects patients’ prognosis; the advantage provided by FOLFOXIRI plus bevacizumab in RECIST response and progression-free survival translated into a consistent improvement in overall survival”, the team concludes in The Lancet Oncology:

References

Cremolini C, Loupakis F, Antoniotti C, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol 2015; Advance online publication 31 August. doi:10.1016/S1470-2045(15)00122-9

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