Patients with advanced renal cell carcinoma had an improved time to deterioration (TTD) and similar quality of life (QoL) after treatment with cabozantinib compared with everolimus, according to a study published in the Journal of Clinical Oncology.1
The phase 3 METEOR trial (ClinicalTrials.gov Identifier: NCT01865747) demonstrated that cabozantinib prolonged progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) compared with everolimus, but the impact on QoL was not fully established.
For METEOR, researchers randomly assigned 658 patients with advanced renal cell carcinoma to receive cabozantinib or everolimus. For the QoL analysis, patients were instructed to complete the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) and EuroQol Group’s five-level (EQ-5D-5L) questionnaires at baseline, prior to any assessment at each clinic visit before the first dose, every 4 weeks for 25 weeks, and every 8 weeks thereafter for the first year.
The FKSI-19 evaluates disease-related symptoms (DRS), treatment side effects, and function/well-being. The EQ-5D-5L assesses 5 metrics of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A subset of the FKSI — FKSI-DRS — was also evaluated.
Questionnaire completion rates were greater than 75% through week 48 among all patients. At time of final analysis, no differences in FKSI-19 Total, FKSI-DRS, or EQ-5D-5L were observed between the treatment arms.
Patients in the cabozantinib arm had a median TTD of 5.5 months compared with 3.7 months among patients in the everolimus arm (P < .001), and a marked improvement was observed particularly among patients with bone metastases (median TTD, 5.6 months vs 1.9 months, respectively; P < .001).
The adverse event profiles remained largely consistent with those previously reported: patients in cabozantinib arm reported higher rates of nausea and diarrhea, and patients in the everolimus arm reported more incidences of shortness of breath.
- Cella D, Escudier B, Tannir NM, et al. Quality of life outcomes for cabozantinib versus everolimus in patients with metastatic renal cell carcinoma: METEOR phase III randomized trial. J Clin Oncol. 2018 Jan 29. doi: 10.1200/JCO.2017.75.2170 [Epub ahead of print]