Patient-reported outcomes from the phase 3 randomized IMmotion151 trial: atezolizumab + bevacizumab vs sunitinib in treatment-naive metastatic renal cell carcinoma.

Purpose. Patient-reported outcomes (PROs) were evaluated in the phase 3 IMmotion151 trial (NCT02420821) to inform overall treatment/disease burden of atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (mRCC). Experimental design. Patients were randomized 1:1 to receive atezolizumab 1200 mg IV q3w plus bevacizumab 15 mg/kg IV q3w or sunitinib 50 mg PO QD 4 weeks on/2 weeks off. Patients completed the MD Anderson Symptom Inventory (MDASI), National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), and Brief Fatigue Inventory (BFI) at baseline, q3w during treatment, at end-of-treatment, and during survival follow-up. Longitudinal and time to deterioration (TTD) analyses for core and RCC symptoms and their interference with daily life, treatment side-effect bother, and health-related quality of life (HRQOL) were evaluated. Results. The ITT population included 454 and 461 patients in the atezolizumab plus bevacizumab and sunitinib arms, respectively. Completion rates for each instrument were 83%-86% at baseline and ≥ 70% through week 54. Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL at most visits were reported with atezolizumab plus bevacizumab versus sunitinib. The TTD HR (95% CI) favored atezolizumab plus bevacizumab for core (HR, 0.50 [0.40, 0.62]) and RCC symptoms (HR, 0.45 [0.37, 0.55]); symptom interference (HR, 0.56 [0.46, 0.68]); and HRQOL (HR, 0.68 [0.58, 0.81]). Conclusion. PROs in IMmotion151 suggest lower overall treatment burden with atezolizumab plus bevacizumab compared with sunitinib in patients with treatment-naive mRCC and provide further evidence for clinical benefit of this regimen.