Treatment De-escalation Not Effective in Metastatic CRC

Treatment de-escalation was not effective in patients with previously untreated, metastatic colorectal cancer (CRC) in the phase 3 ERMES study, according to researchers. They reported these findings in the Journal of Clinical Oncology.

The ERMES trial (ClincalTrials.gov identifier: NCT02484833) enrolled patients with previously untreated, metastatic, RAS/BRAF wild-type CRC.

The patients were randomly assigned to receive treatment with fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus cetuximab until disease progression or FOLFIRI plus cetuximab for 8 cycles followed by cetuximab maintenance (de-escalated treatment).

There were 154 patients in the prolonged FOLFIRI/cetuximab arm and 183 patients in the de-escalated arm who received treatment per protocol. The median follow-up for the per-protocol population was 22.4 months.

The study’s primary endpoint was not met, as progression-free survival (PFS) with de-escalated treatment was not noninferior to PFS with FOLFIRI/cetuximab until progression. The median PFS was 10.0 months with de-escalated treatment and 12.2 months with FOLFIRI/cetuximab until progression (hazard ratio [HR], 1.30; 95% CI, 1.03-1.64; P for noninferiority =.43).

The median overall survival was not significantly different between the arms. It was 35.7 months with de-escalated treatment and 30.7 months with FOLFIRI/cetuximab until progression (HR, 0.79; 95% CI, 0.59-1.06; P =.119).

The rate of grade 3-4 adverse events (AEs) was similar between the arms overall but lower in the de-escalated treatment arm during the maintenance phase. The overall rate of grade 3-4 AEs was 50.3% with de-escalated treatment and 52% with FOLFIRI/cetuximab until progression. The rate of grade 3-4 AEs in the maintenance phase was 20.2% and 35.1%, respectively.

Based on these results, the researchers concluded that, in this patient population, FOLFIRI/cetuximab should be continued until disease progression or intolerance.

Disclosures: This study was supported by Merck Serono S.p.A. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor