In CheckMate 9ER, patients with renal cell cancer (RCC) treated with nivolumab plus cabozantinib demonstrated both superior clinical outcomes and superior quality of life when compared with patients treated with sunitinib . The CheckMate 9ER trial (NCT03141177) is a phase 3, open-label, randomized controlled trial investigating whether nivolumab combined with cabozantinib is a safe and effective intervention compared with sunitinib in patients with previously untreated advanced or metastatic RCC. Although the study’s estimated completion date is not until May 2024, it reached its primary completion date in February 2021. Researchers included patient-reported outcomes (PROs) as an exploratory endpoint, utilizing 2 instruments: the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the 3-level version of the EuroQol-5 Dimensions scale (EQ-5D-3L). Participants in both arms of the study were invited to complete the questionnaires at baseline (>90% completion rate) and common on-treatment and follow-up visits (≥80% completion rate). Mixed-model repeated measures were employed to express score changes from baseline to week 91. Kaplan-Meier estimates and Cox proportional hazards models were utilized to predict time to confirmed deterioration. Participants receiving nivolumab plus cabozantinib reported a smaller treatment burden than those receiving sunitinib. They had both a decreased risk of confirmed deterioration as well as a delay in deterioration. Patients in the nivolumab plus cabozantinib arm also consistently demonstrated better FKSI-19, disease-related symptoms (DRS), DRS-physical, DRS-emotional, functional well-being, and EQ-5D-3L scores. The nivolumab plus cabozantinib treatment arm has also demonstrated superior clinical outcomes. After the median follow-up period of 18.1 months, participants in this arm achieved longer periods of progression-free survival, higher overall survival rates, and greater objective response rates than those treated with sunitinib. Overall, these results demonstrated that patients with untreated advanced or metastatic RCC can enjoy both favorable clinical outcomes and an improved quality of life when treated with nivolumab plus cabozantinib instead of sunitinib.
- Cella D, et al. Patient-reported outcomes of patients with advanced renal cell carcinoma (aRCC) treated with first-line nivolumab plus cabozantinib versus sunitinib: The CheckMate 9ER trial. ASCO Genitourinary Cancers Symposium, 11–13 February 2021.