CRYSTAL (NCT00154102) study and post hoc analyses: Efficacy results* in KRAS and RAS wild-type mCRC1-3
The CRYSTAL study may not be adequately powered, nor error-controlled, for subgroup analyses. Treatment differences observed in the RAS wild-type subpopulation cannot be regarded as statistically significant. The analyses described here were exploratory.
Limitations of the RAS post hoc analysis data: Only 65% of patients with KRAS wild-type tumors were evaluable for RAS status.3 RAS wild-type subpopulation data presented may not be representative of the label population.
- The main outcome measure in the all-randomized patient population was progression-free survival (PFS) assessed by an independent review committee (IRC)1
CRYSTAL regimen vs FOLFIRI alone
- In all-randomized patients, overall survival (OS) was not significantly different at the planned, final analysis based on 838 events (HR=0.93 [95% CI: 0.8-1.1]; P=0.327)1
- Limitations of Use: ERBITUX is not indicated for treatment of RAS-mutant colorectal cancer or when the results of the RAS mutation tests are unknown
§Criteria for objective response rate (ORR)4
- The ORR is the sum of the rate of partial response and the rate of complete response
- Partial response: ≥50% decrease in the sum of the products of the longest diameter and the greatest perpendicular diameter of all index lesions compared to baseline, by 2 observations not less than 4 weeks apart, and no evidence of progressive disease
- Complete response: disappearance of all measurable lesions by 2 observations no less than 4 weeks apart, without the appearance of any new lesions