Patients with previously treated advanced renal cell carcinoma receiving nivolumab (Opdivo) in the phase III CheckMate 025 trial had improved health-related quality of life compared with those receiving everolimus (Afinitor), as reported by David Cella, PhD, of Northwestern University, Chicago, et al in The Lancet Oncology.
In the open-label trial, nivolumab was associated with an overall survival benefit compared with everolimus, with the study being stopped early at interim analysis in July 2015. Patients in the everolimus group were permitted to cross over to nivolumab treatment. At the interim analysis, quality of life was assessed using the Functional Assessment of Cancer Therapy–Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and European Quality of Life (EuroQol)-5 Dimensions (EQ-5D) questionnaires. FKSI-DRS scores ranged from 0 (worst) to 36. EQ-5D visual analog scores ranged from 0 (worst) to 100; utility scores ranged from 0 to 1.
Health-Related Quality-of-Life Outcomes
Quality-of-life data were collected at baseline for 362 of 410 patients (88%) in the nivolumab group and 344 of 411 patients (84%) in the everolimus group. Over 84 weeks of follow-up, the mean difference in FKSI-DRS scores between the nivolumab and everolimus groups was 1.6 (P < .0001) on descriptive statistics and 1.7 (P < .0001) using mixed-effects model repeated-measures analysis. A greater proportion of nivolumab patients had an increase of at least 2 points from baseline (defined as clinically meaningful; 55% vs 37%, P < .0001). The nivolumab group also achieved this benefit more quickly than the everolimus group: Median time to quality-of-life improvement was 4.7 months among nivolumab recipients vs not reached in everolimus recipients.
On the EQ-5D visual analog scale, more nivolumab patients had a clinically meaningful improvement (≥ 7 points; 53% vs 39%, P = .0001), and median time to improvement was shorter in this group (6.5 months vs 23.1 months, P = .0054). There was no difference between the groups in proportion of patients with clinically meaningful improvement (≥ 0.08 points; P = .070) or time to improvement (P = .86) using EQ-5D utility scores.
The investigators concluded:
Nivolumab was associated with health-related quality of life improvement compared with everolimus in previously treated patients with advanced renal cell carcinoma.
The study was funded by Bristol-Myers Squibb. ■