The CheckMate 9ER trial, which began in 2017, showed that nivolumab plus cabozantinib improved or maintained the health-related quality of life (HRQoL) of patients with previously untreated advanced renal cell carcinoma (aRCC) compared with sunitinib.
Researchers conducted an exploratory follow-up analysis (minimum follow-up, 36.5 months) of HRQoL in International mRCC Database Consortium (IMDC) risk-based subgroups treated with nivolumab plus cabozantinib versus sunitinib. The results of the analysis will be presented at the American Society of Clinical Oncology 2023 Annual Meeting.
The risk-based subgroups were stratified by the IMDC categories of favorable (F) risk (score=0) or intermediate/poor (I/P) risk (score=1-6) at randomization. HRQoL was measured using the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19). Changes from baseline through week 151 were analyzed using mixed model repeated measures.
Negative reactions due to treatment side effects (FKSI-19 item GP5) were analyzed using a model comprising generalized estimating equations (responses were categorized as minimal [“not at all” or “a little bit”] vs notable [“somewhat,” “quite a bit,” or “very much”]). Cox proportional hazards modeling was used to evaluate time to confirmed deterioration (TTCD).
Any differences in least square means for FKSI-19 scores through week 151 pointed to HRQoL benefit in the nivolumab plus cabozantinib arm compared with the sunitinib arm for I/P-risk patients (n=505) but not for F-risk patients (n=146). In the I/P-risk subgroup, a longitudinal analysis of total FKSI-19 scores indicated that HRQoL had improved through week 151 in the nivolumab plus cabozantinib arm yet decreased from baseline measurements in the sunitinib arm. HRQoL declined from baseline measurements through week 151 in F-risk patients in both the nivolumab plus cabozantinib and sunitinib arms.
Patients in the cabozantinib plus nivolumab arm were less likely to be burdened by negative side effects compared with the sunitinib arm, regardless of risk (I/P-risk odds ratio [OR], 0.50; 95% CI, 0.34-0.75; F-risk OR, 0.51; 95% CI, 0.28-0.91). TTCD analysis of FKSI-19 scores of the I/P-risk subgroup indicated that the nivolumab and cabozantinib arm had a lower deterioration risk than the sunitinib arm. For the F-risk subgroup, risk based on FKSI-19 total scores was similar in both treatment arms.
Nivolumab plus cabozantinib resulted in an improved or maintained HRQoL in I/P-risk patients when compared with sunitinib and had less side effect burden among all subgroups. No significant differences were found between treatment arms for F-risk patients.