Nivolumab Passes QOL Test in Melanoma

Results from the CheckMate 066 study found that the checkpoint inhibitor nivolumab, which has proven highly efficient in the treatment of melanoma, also performs well in improving the patient’s long-term quality of survival benefit in patients with advanced melanoma.

Immunotherapy, particularly the checkpoint inhibitors that belong to the programmed death 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 or CTLA4, have reformed the treatment landscape in melanoma as well as in lung cancer and created more hope. Although only 20% to 30% of patients respond to these drugs, the extent and duration of response are robust, and results from Checkmate 066 convinced the FDA late last year to grant approval to nivolumab as a single agent in treatment-naïve patients with advanced melanoma who express wild type BRaf.

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ver, concerns with the toxicity of these agents remain, toxicities that can influence a patient’s health-related quality of life (HRQOL). Even if a patient is an ideal candidate to being treated with nivolumab, with high chances of longer survival, is he or she ready to face the accompanying toxicity? This is an important question to consider and finds its place in the various value tools that have been developed. With this in mind, Checkmate 066 was designed to gather data on HRQOL measures, comparing the impact of nivolumab and dacarbazine on patient-reported outcomes.

For the study, researchers evaluated HRQOL at baseline and every 6 weeks on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D). Patients were treated with nivolumab 3 mg/kg every 2 weeks or dacarbazine 1000 mg/m² every 3 weeks. The completion rate for both questionnaires was 65% and 70% for dacarbazine and nivolumab.

The analysis found that the average baseline HRQOL scores were similar for patients in both cohorts, and the baseline HRQOL score levels were maintained with nivolumab over time. However, a difference as observed with the EQ-5D utility index and clinically meaningful EQ-5D improvements from baseline at several time points for patients on nivolumab, the authors write. Nivolumab also did not increase their symptom burden, the patients reported via EORTC QLQ-C30. Patients on dacarbazine, on the other hand, had a high attrition rate after 13 weeks, which prevented meaningful data analyses, although there was no change in the HRQOL information.

Time to deterioration was much greater in the nivolumab-treated cohort, the authors report as measured by the EORTC QLQ-C30 scale, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, and constipation, as well as EQ-5D utility index.

“No deterioration of HRQOL was identified with nivolumab. When added to the survival benefit of nivolumab, the benefit-to-risk ratio favors nivolumab over dacarbazine,” they conclude.

Reference

Ann Oncol

Long GV, Atkinson V, Ascierto PA, et al. Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase 3 Checkmate 066 study [published online July 12, 2016]. . pii: mdw265.