Opdivo (nivolumab) not only improves survival but it also maintains, and can even improve, health-related quality of life in patients with advanced melanoma, according to a study based on an analysis of patients enrolled in a Phase 3 clinical study evaluating the efficacy of nivolumab.
The life-quality study was conducted by researchers at the Melanoma Institute Australia and Royal North Shore Hospital of The University of Sydney, and funded by Bristol-Myers Squibb, Opdivo’s manufacturer.
One of the main concerns with cancer treatment is the toxicity profile of the drugs used, and how they can diminish health-related quality of life even as they produce meaningful disease outcomes.
In the CheckMate 066 clinical trial, which ran from 2013 to 2014, scientists recruited 418 patients with advanced melanoma and divided them into two groups: those receiving either nivolumab or dacarbazine (Dtic-Dome). The trial’s primary objective was improvement in overall survival, but one of its secondary outcomes was changes from baseline in health-related quality of life.
Participants’ life quality was assessed before the start of the treatments, and again every six weeks for a year while they were taking the drugs, using the EORTC 30-item Quality-of-Life Questionnaire (QLQ–30) (a self-reported measurement of health-related life quality) and the EuroQol Five Dimensions Questionnaire (EQ–5D) (which evaluates mobility, self-care, usual activities, pain and discomfort, and anxiety and depression at three levels: none, some or extreme).
QLQ-30 questionnaire results showed patients on nivolumab therapy first reported a deterioration in global health status on day 253, while those on dacarbazine began reporting a decline much earlier, on day 155.
Similarly, a drop in physical functioning scores occurred later in patients taking nivolumab (after 379 days) compared to patients taking dacarbazine (after 194 days).
“[This confirms] the superior benefit of nivolumab over dacarbazine in terms of not only survival, but also quality of survival from the patients’ perspective,” Professor Georgina V. Long, chair of melanoma medical oncology and translational research at the Melanoma Institute and Royal North Shore Hospital, wrote, according to a news release. “These results suggest that patients receiving nivolumab for melanoma can expect to maintain their quality of life throughout treatment.”
Results of the EQ-5D test revealed that in patients who were taking nivolumab, mobility, self-care, and usual activities improved, while pain, discomfort, anxiety and depression significantly decreased at week 7 compared to the start of the trial. No significant improvements were recorded in patients taking dacarbazine.
The authors concluded that these results “further support the clinical benefit of nivolumab in patients with advanced melanoma and show that nivolumab provides long-term quality of survival benefit in this population.”
According to the researchers, future studies should compare the effectiveness of nivolumab against other therapies to further define its clinical value in advanced melanoma.
Opdivo was approved by the U.S. Food and Drug Administration as a treatment for advanced or metastatic melanoma in December 2014.