(Colorectal Cancer) Subgroup Analysis Results of FOLFOXIRI + Avastin
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- August 14, 2019
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At the ESMO World Congress on Gastrointestinal Cancer held in Barcelona, Spain from July 3–6, 2019, Chiara Cremolini presented subgroup analysis results from the TRIBE2 Phase III clinical trial evaluating the efficacy and safety of FOLFOXIRI plus bevacizumab (Avastin) as both first-line and re-induction second-line treatment in colorectal cancer patients.
The TRIBE2 Phase III trial randomized colorectal cancer patients 1:1 to:
- FOLFOXIRI group: First-line FOLFOXIRI + bevacizumab; following first progression, second-line re-induction with FOLFOXIRI + bevacizumab
- FOLFOX/FOLFIRI group: First-line FOLFOX + bevacizumab; following first progression, second-line FOLFIRI + bevacizumab
Primary endpoint: second progression-free survival (PFS2); secondary endpoint: first progression-free survival (PFS1).
Patient Characteristics:
| Parameter | FOLFOXIRI | FOLFOX/FOLFIRI |
|---|---|---|
| Median age | 60 yrs (33–75) | 61 yrs (30–75) |
| ECOG PS 0 | 86% | 85% |
| Right-sided primary tumor | 38% | 38% |
| Liver-only metastases | 32% | 29% |
| RAS mutation positive | 63% | 65% |
| BRAF mutation positive | 10% | 10% |
Results:
Consistent with ESMO 2018 and ASCO 2019 data, the FOLFOXIRI group demonstrated significant improvements in primary endpoint PFS2, as well as objective response rate, complete resection rate, and overall survival.
The subgroup analysis of PFS2 showed overall superiority of the FOLFOXIRI group over the FOLFOX/FOLFIRI group. In the subgroup of patients with right-sided and/or RAS mutation, BRAF mutation, and ECOG PS 0 (N=470), median PFS2 was 19.8 months in the FOLFOXIRI group versus 16.1 months in the FOLFOX/FOLFIRI group (hazard ratio 0.68 in favor of FOLFOXIRI).
Based on the TRIBE2 trial results, Chiara Cremolini concluded that FOLFOXIRI + bevacizumab significantly improved PFS2 in patients with right-sided and/or RAS mutation, BRAF mutation, and ECOG PS 0.
Source: Updated results of TRIBE2, a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable mCRC (WCGC 2019, Abstract #LBA-007)
#ColorectalCancer
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