Patients with pretreated BRAF V600E-mutant metastatic colorectal cancer receiving a triplet targeted therapy regimen had prolonged quality of life (QoL) compared with those treated with a regimen of irinotecan plus cetuximab or FOLFIRI plus cetuximab, according to an analysis of QoL findings from the phase 3 BEACON CRC trial that were presented at the 2020 Gastrointestinal Cancers Symposium in San Francisco, California.1
In this multicenter, open-label, 3-arm phase 3 study of patients with advanced BRAF V600E-mutant colorectal cancer who had progressive disease following treatment with 1 or 2 prior regimens in the metastatic setting (BEACON CRC; ClinicalTrials.gov Identifier: NCT02928224), patients were randomly assigned in a 1:1:1 ratio to receive triplet therapy with BRAF inhibitor encorafenib, the anti-EGFR antibody cetuximab and the MEK inhibitor binimetinib (224 individuals); doublet therapy with encorafenib plus cetuximab (220 individuals), or irinotecan plus cetuximab or FOLFIRI plus cetuximab (control group; 221 individuals).
Both OS and objective response rate (ORR) comparing the triplet therapy arm with the control arm were primary study endpoints, with secondary study endpoints including a comparison of the QoL of patients in all 3 study arms.
Previously reported efficacy and safety results from the BEACON CRC study showed that both OS and ORR were significantly improved in patients treated with the triplet regimen compared with the control group, and that the rates of grade 3 or higher adverse events were similar in those 2 arms.2
These QoL assessments from patients enrolled in BEACON CRC were collected using 4 validated QoL measures. Specifically, QoL assessments focused on the time to deterioration in QoL variables between study arms using a prespecified change in QoL score to represent deterioration that was considered to be representative of a clinically meaningful QoL change.1
Using 2 different quality of life measures, the risk of QoL deterioration was reduced by 45% (hazard ratio [HR], 0.55; 95% CI, 0.43-0.70) and 44%, (HR, 0.56; 95% CI, 0.44-0.71) respectively, when patients receiving triplet therapy were compared with those in the control arm. Similar findings were observed when the doublet therapy arm was compared with the control arm, and when QoL assessments were made using the other 2 QoL assessment tools. However, no significant differences in QoL were detected when the triplet and doublet therapy arms were compared.1
Lead study author, Scott Kopetz, MD, PhD, FACP, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, Houston, said in a press release: “The findings highlight that with these novel targeted therapy regimens, not only was disease controlled longer, but patient-reported QoL was maintained longer.”3
Disclosures: This study was sponsored by Pfizer, Inc. Some of the study authors reported financial relationships with pharmaceutical and medical device companies. For a full list of disclosures, please refer to the study abstract.
- Kopetz S, Grothey A, Van Cutsem E, et al. Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC). J Clin Oncol. 2020;38(suppl 4):Abstract 8.
- Kopetz S, Grothey A, Yaeger R, et al. Encorafenib, binimetinib, and cetuximab in BRAF V600E–mutated colorectal cancer. N Engl J Med. 2019;381(17):1632-1643.
- 2020 Gastrointestinal Cancers Symposium. New drug combinations maintain quality of life for patients with colorectal and liver cancer [press release]. Published January 21, 2020. Accessed January 24, 2020.
This article originally appeared on Cancer Therapy Advisor