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Nivolumab maintains health-related quality of life for patients with advanced melanoma
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Nivolumab maintained or improved baseline health-related quality of life for patients with advanced melanoma, according to quality-of-life analyses of the CheckMate 066 phase 3 study.
These quality-of-life findings accompany the survival improvement seen with nivolumab (Opdivo, Bristol-Myers Squibb) over dacarbazine for treatment-naive patients with metastatic melanoma in the CheckMate 066 trial.
“A frequent concern with immunotherapies is that their toxicity profile might diminish health-related quality of life, even when meaningful disease outcomes are observed,” Georgina V. Long, PhD, BSc, MBBS, FRACP, chair of melanoma medical oncology and translational research at Melanoma Institute Australia and Royal North Shore Hospital of The University of Sydney in Sydney, Australia, and colleagues wrote. “Given the increasing importance of considering health-related quality of life during treatment decision-making in oncology, the CheckMate 066 study incorporated these measures.”
Georgina V. Long
The study included 418 patients randomly assigned to receive nivolumab (n = 210) or dacarbazine (n = 208) between 2013 and 2014. Long and colleagues used the EORTC 30-item Quality-of-Life Questionnaire (QLQ–30) and the EuroQol Five Dimensions Questionnaire (EQ–5D) to analyze patients’ health-related quality of life at baseline and every 6 weeks while on treatment.
Seventy percent of patients in the nivolumab arm and 65% in the dacarbazine arm completed baseline questionnaires, and these rates remained similar over treatment. Questionnaires were completed over a maximum treatment period of 73 weeks in the nivolumab arm and 61 weeks in the dacarbazine arm, as well as at two follow-up visits after treatment discontinuation.
EORTC QLQ–30 data
The EORTC QLQ–30 is a validated, self-reported generic measure of health-related quality of life that assesses global health status/quality of life, functional quality of life (physical, role, emotional, social and cognitive) and symptoms, such as fatigue, nausea and vomiting, and dyspnea. Researchers converted mean baseline EORTC QLQ–30 global health status/quality-of-life scores into a linear scale ranging from 0 to 100, where higher scores represented better results on the health status and functional scales, but worse results on the symptom scales.
Patients had similar mean baseline EORTC QLQ–30 global health status/quality-of-life scores in the nivolumab and dacarbazine arms (68.9 vs. 66.2). Changes were observed beginning week 7, with a modest improvement in both treatment groups.
Patients in the dacarbazine arm did not experience significant changes in health-related quality of life; however, researchers noted there was a high attrition rate in this arm after week 13.
Further, the functioning subscale and symptom mean scores remained stable overtime in both groups, with few significant or clinically meaningful changes.
“An increased symptom burden was not observed with nivolumab, which was consistent with its adverse event profile,” the researchers wrote.
Patients in the nivolumab group experienced longer median time to first deterioration for EORTC QLQ–30 global health status (253 days vs. 155 days) and physical functioning scores (379 days vs. 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,” Long and colleagues wrote. “These results suggest that patients receiving nivolumab for melanoma can expect to maintain their quality of life throughout treatment.”
EQ–5D results
The EQ–5D utility index evaluates mobility, self-care, usual activities, pain/discomfort and anxiety/depression at three levels: no, some or extreme.
Patients in the nivolumab arm exhibited higher EQ–5D utility index scores at baseline compared with the dacarbazine arm. Further, patients assigned nivolumab had significant improvements from baseline to week 7 (P = .011) and week 49 (P = .034), whereas there were no significant improvements in EQ–5D scores in the dacarbazine arm.
Week 7 was the only point at which patients in the nivolumab arm had a statistically significant improvement in scores compared with patients in the dacarbazine arm (P = .045). Clinically meaningful improvements associated with nivolumab arm occurred at weeks 37, 61 and 67.
Researchers acknowledged that these patient-reported outcomes were not specifically designed for patients with melanoma.
“The health-related quality-of-life results presented for this study 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,” the researchers wrote. “In the future, the health-related quality-of-life analyses performed here should be replicated for nivolumab vs. other standards of care or emerging therapies ... to further delineate the clinical value of nivolumab in advanced melanoma.” – by Nick Andrews
Disclosure: Bristol-Myers Squibb funded this research. HemOnc Today could not confirm the researchers’ relevant financial disclosures at the time of reporting.
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