Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial

Purpose In the phase III METEOR trial ( ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here. Patients and Methods Patients completed the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the five-level EuroQol (EQ-5D-5L) questionnaires at baseline and throughout the study. The nine-item FKSI-Disease-Related Symptoms (FKSI-DRS), a subset of FKSI-19, was also investigated. Data were summarized descriptively and by repeated-measures analysis (for which a clinically relevant difference was an effect size ≥ 0.3). Time to deterioration (TTD) was defined as the earlier of date of death, radiographic progressive disease, or ≥ 4-point decrease from baseline in FKSI-DRS. Results The QoL questionnaire completion rates remained ≥ 75% through week 48 in each arm. There was no difference over time for FKSI-19 Total, FKSI-DRS, or EQ-5D data between the cabozantinib and everolimus arms. Among the individual FKSI-19 items, cabozantinib was associated with worse diarrhea and nausea; everolimus was associated with worse shortness of breath. These differences are consistent with the adverse event profile of each drug. Cabozantinib improved TTD overall, with a marked improvement in patients with bone metastases at baseline. Conclusion In patients with advanced renal cell carcinoma, relative to everolimus, cabozantinib generally maintained QoL to a similar extent. Compared with everolimus, cabozantinib extended TTD overall and markedly improved TTD in patients with bone metastases.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Jan 29 [Epub ahead of print]

David Cella, Bernard Escudier, Nizar M Tannir, Thomas Powles, Frede Donskov, Katriina Peltola, Manuela Schmidinger, Daniel Y C Heng, Paul N Mainwaring, Hans J Hammers, Jae Lyun Lee, Bruce J Roth, Florence Marteau, Paul Williams, John Baer, Milan Mangeshkar, Christian Scheffold, Thomas E Hutson, Sumanta Pal, Robert J Motzer, Toni K Choueiri

David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL; Bernard Escudier, Institut Gustave Roussy, Villejuif; Florence Marteau, Ipsen Pharma, Boulogne-Billancourt; Paul Williams, Mapi Group, Lyon, France; Nizar M. Tannir, University of Texas MD Anderson Cancer Center Hospital, Houston; Hans J. Hammers, University of Texas Southwestern Medical Center; Thomas E. Hutson, Texas Oncology-Baylor Sammons Cancer Center, Dallas, TX; Thomas Powles, Queen Mary University of London, London, United Kingdom; Frede Donskov, Aarhus University Hospital, Aarhus, Denmark; Katriina Peltola, Helsinki University Hospital Cancer Center, Helsinki, Finland; Manuela Schmidinger, Medical University of Vienna, Vienna, Austria; Daniel Y.C. Heng, University of Calgary, Calgary, Alberta, Canada; Paul N. Mainwaring, Icon Cancer Care, Brisbane, Queensland, Australia; Jae Lyun Lee, University of Ulsan College of Medicine, Seoul, South Korea; Bruce J. Roth, Washington University in St Louis, St Louis, MO; John Baer, Milan Mangeshkar, and Christian Scheffold, Exelixis, South San Francisco; Sumanta Pal, City of Hope National Medical Center, Duarte, CA; Robert J. Motzer, Memorial Sloan Kettering Cancer Center, New York, NY; and Toni K. Choueiri, Dana-Farber Cancer Institute, Boston, MA.