Upfront modified FOLFOXIRI plus panitumumab for RAS/BRAF wild-type mCRC: final results of the multicenter phase 3 TRIPLETE study

The phase 3 TRIPLETE study, at 57 centers in Italy, compared first-line mFOLFOX plus panitumumab (control group; n=217) versus mFOLFOXIRI plus panitumumab (experimental group; n=218) for patients with unresectable RAS/BRAF wild-type metastatic colorectal cancer (mCRC). Final results of TRIPLETE have now been published. The median follow-up was 60.2 months (IQR 49.3-70.0). The median overall survival was 41.1 months in the experimental group versus 33.3 months in the control group (HR 0.79; p=0.049). Overall survival outcomes favored the experimental group regardless of clinical features. There were no differences between the groups for the endpoints objective response rate,, early tumor shrinkage rate, depth of response, no residual tumor resection rate, and progression-free survival. Among patients alive at the time of disease progression, the median postprogression survival was 24.6 and 17.7 months for the experimental and control groups, respectively (HR 0.79; p=0.062). The authors conclude that upfront mFOLFOXIRI plus panitumumab significantly improved overall survival compared with mFOLFOX plus panitumumab in patients with RAS/BRAF wild-type mCRC.