Improved QOL Observed in Patients with CRC Treated with Triplet and Doublet Regimen

In the BEACON colorectal cancer (CRC) study, patients with BRAF V600E-mutant metastatic CRC whose disease had progressed after 1 or 2 prior regimens treated with encorafenib (Braftovi) and cetuximab (Erbitux) with or without binimetinib (Mektovi) demonstrated substantial improvements in patient-reported quality of life assessments over the current standard of care, according to an abstract published in the Journal of Clinical Oncology.¹

The findings will be presented at the 2020 Gastrointestinal Cancers Symposium, taking place January 23-25 in San Francisco, California.

“The findings highlight that with these novel targeted therapy regimens, not only was disease controlled longer, but patient-reported quality of life was maintained longer,” lead author Scott Kopetz, MD, PhD, FACP, professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, said in a press release.²

The open-label, phase III trial included a cohort of 655 patients randomized to receive either the triplet (n = 224), doublet (n = 220), or standard of care control (n = 221) regimen. Those who the received the standard of care regimen were treated with one of two regimens, consisting of irinotecan (Onivyde) plus cetuximab or FOLFIRI (leucovorin, calcium folinate, fluorouracil, and irinotecan) with cetuximab. 

Efficacy data was published previously in the New England Journal of Medicine. The median overall survival was 9.0 and 8.4 months with the triplet and doublet targeted treatments, compared to 5.4 months in the control group of patients. 

Researchers will report on the quality of life of the participants at the symposium, which was a secondary endpoint of the study. Using four validated measurement tools (European Organisation for Research and Treatment of Cancer [EORTC] QOL Questionnaire, Functional Assessment of Cancer Therapy, EuroQol 5D 5L, and the Patient Global Impression of Change), quality of life was assessed at baseline and after every treatment cycle.

Notably, the researchers observed the time to 10% or greater deterioration between the study arms, which is thought to illustrate a clinically meaningful deterioration in quality of life. Patients who received the triplet had a roughly 44% (HR 0.56; 95% CI, 0.44-0.71) to 45% (HR 0.55; 95% CI, 0.43-0.70) reduction in the risk of quality of life deterioration compared to the patients in the standard of care group, based on 2 of the measures. The participants treated with the doublet had a roughly 43% (HR 0.57; 95% CI, 0.45-0.72) to 46% (HR 0.54; 95% CI, 0.43-0.69) reduction in risk. Similar results were observed with the EuroQol 5D 5L and Patient Global Impression of Change. No significant differences were seen in quality of life for patients in the triplet and doublet groups. 

According to the American Cancer Society, the lifetime risk of developing colorectal cancer is about 4.4% in men and 4.1% in women.³ The disease is the third leading cause of cancer-related deaths in men and women in the US, the second most common cause when men and women are combined. 

References:

1. Kopetz S, Grothey A, Cutsem EV, et al. Encorafenib plus cetuximab with or without binimetinib for BRAFV600E-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. NCT02928224.

2. New Drug Combinations Maintain Quality of Life for Patients With Colorectal and Liver Cancers [news release]. Alexandria, Virginia. Published January 21, 2020. asco.org/about-asco/press-center/news-releases/new-drug-combinations-maintain-quality-life-patients. Accessed January 22, 2020.

3. American Cancer Society. Key Statistics for Colorectal Cancer. American Cancer Society website. Published January 8, 2020. cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Accessed January 22, 2020.