Nivolumab Plus Ipilimumab May Improve 2-Year Quality of Life in Advanced Renal Cell Carcinoma
Findings previously demonstrated that nivolumab plus ipilimumab prolongs overall survival and was better tolerated among patients with renal cell carcinoma, but its impact on health-related quality of
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Combination therapy with nivolumab and ipilimumab leads to significant and sustained improvements in health-related quality-of-life (HRQOL) among patients with treatment-naive advanced renal cell carcinoma (aRCC) compared with sunitinib, according to a poster presentation at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.1
The CheckMate-214 study (ClinicalTrials.gov Identifier: NCT02231749) previously demonstrated that nivolumab plus ipilimumab prolongs overall survival (OS) and was better tolerated among patients with intermediate- and poor-risk aRCC, but its impact on HRQOL was not reported.
In this phase 3 study, investigators randomly assigned 847 patients to receive nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks for 4 cycles followed by nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg daily for 3 weeks for 6 cycles. Patients were instructed to complete the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) for RCC-specific symptoms, as well as the Functional Assessment of Cancer Therapy-General (FACT-G). t tests and mixed-model repeated measures (MMRM) were used to analyze results.
Over a 2-year follow-up period, patients in the combination arm had significantly improved outcomes according to FKSI-19 scores from with initial baseline scores compared with patients in the sunitinib arm in all but 2 time points (P < .05).
Nivolumab plus ipilimumab also led to significantly delayed time-to-deterioration according to the FKSI-19 compared with sunitinib (hazard ratio [HR], 0.54; 95% CI, 0.46–0.63; P < 0.0001).2
A pre-planned 6-month assessment of FKSI-19 scores using the MMRM analysis revealed that patients receiving nivolumab plus ipilimumab had a significant improvement of 3.55 (P < .0001) in HRQOL score, showing that patients in this arm had better outcomes in regards to disease-related symptoms, functioning, and treatment toxicity. A MMRM analysis of FACT-G results yielded similar outcomes.
The authors concluded that “in addition to the OS benefit and superior safety profile, descriptive data suggest that nivolumab and ipilimumab offers significant and sustained HRQoL improvement vs sunitinib in [intermediate- and poor-risk patients] with untreated aRCC.”
Read more of Cancer Therapy Advisor's coverage of the American Society of Clinical Oncology (ASCO) 2018 meeting by visiting the conference page.
- Cella D, Grunwald V, Escudier B, et al. Quality of life in patients with advanced renal cell carcinoma in the randomized, open-label CheckMate 214 trial. J Clin Oncol. 2018;38(suppl; abstr 3037).
- Opdivo (nivolumab) Plus Low-Dose (1mg/kg) Yervoy (ipilimumab) Provided Significant and Sustained Health-Related Quality of Life Improvements in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma in CheckMate -214 Study [news release]. Princeton, NJ: Bristol-Myers Squibb; June 1, 2018. https://news.bms.com/press-release/corporatefinancial-news/opdivo-nivolumab-plus-low-dose-1mgkg-yervoy-ipilimumab-provide. Accessed June 6, 2018.