In the Journals

Cabozantinib improved time to deterioration, but not quality of life for renal cell carcinoma

Cabozantinib appeared associated with improved time to deterioration compared with chemotherapy among patients with renal cell carcinoma, according to results published in the Journal of Clinical Oncology.

Researchers did not observe a significant difference in quality of life between the two treatments.

“Many patients [with metastatic renal cell carcinoma] present with advanced or unresectable disease at initial diagnosis,” David Cella, PhD, chair of the department of medical social sciences and director of Institute for Public Health and Medicine at Northwestern University Feinberg School of Medicine, and colleagues wrote. “Quality of life in patients with advanced renal cell carcinoma is adversely affected by disease-related symptoms (such as fatigue, weakness, bone pain, hematuria, weight loss and shortness of breath) and treatment-related adverse effects.”

Cella and colleagues assessed quality of life among 658 patients randomly assigned to cabozantinib (Cabometyx/Cometriq, Exelixis) or everolimus. Patients completed the Functional Assessment of Cancer Therapy-Kidney Symptom Index, a disease-related symptom index and the EuroQOL questionnaire at baseline and every 4 weeks through week 25, followed by every 8 weeks through the first year and every 12 weeks thereafter.

Survey completion rates remained above 75% through week 48 of the study.

Researchers observed no difference in quality of life between the treatment arms for any of the surveys used (effect size was < 0.3).

The researchers also assessed time to deterioration, defined as the earlier date of death, radiographic progressive disease or at least a 4-point decrease from baseline in the disease-related symptom index.

Patients randomly assigned cabozantinib had extended time-to-deterioration overall compared with those assigned everolimus (5.5 months vs. 3.7 months; P < .001). Researchers also observed significant improvements in time to deterioration among patients assigned cabozantinib with bone metastases at baseline compared with patients assigned everolimus (5.6 months vs. 1.9 months; P < .001).

“At the time of investigator-determined radiographic progressive disease, quality of life of patients was markedly diminished in both treatment arms,” the researchers wrote. “This finding indicates the negative impact of disease progression on quality of life and is suggestive of the benefit of extending PFS in this patient population. The observed prolongation of time to deterioration in the cabozantinib arm further supports the overall clinical benefit of this agent in addition to improving PFS, overall response rate and OS — albeit without a quality-of-life advantage.” – by Cassie Homer

Disclosures: Exelixis helped fund this study. Cella reports stock or other ownership in FACIT.org; consultant/advisory roles with AbbVie, Astellas Pharma, Bayer, GlaxoSmithKline, Novartis, Pfizer, PledPharma and Puma Biotechnology; institution funding from Bayer, Genentech, Ipsen, Novartis and Pfizer; and travel expenses from Ipsen. Please see the study for a list of all other authors’ relevant financial disclosures.

Cabozantinib appeared associated with improved time to deterioration compared with chemotherapy among patients with renal cell carcinoma, according to results published in the Journal of Clinical Oncology.

Researchers did not observe a significant difference in quality of life between the two treatments.

“Many patients [with metastatic renal cell carcinoma] present with advanced or unresectable disease at initial diagnosis,” David Cella, PhD, chair of the department of medical social sciences and director of Institute for Public Health and Medicine at Northwestern University Feinberg School of Medicine, and colleagues wrote. “Quality of life in patients with advanced renal cell carcinoma is adversely affected by disease-related symptoms (such as fatigue, weakness, bone pain, hematuria, weight loss and shortness of breath) and treatment-related adverse effects.”

Cella and colleagues assessed quality of life among 658 patients randomly assigned to cabozantinib (Cabometyx/Cometriq, Exelixis) or everolimus. Patients completed the Functional Assessment of Cancer Therapy-Kidney Symptom Index, a disease-related symptom index and the EuroQOL questionnaire at baseline and every 4 weeks through week 25, followed by every 8 weeks through the first year and every 12 weeks thereafter.

Survey completion rates remained above 75% through week 48 of the study.

Researchers observed no difference in quality of life between the treatment arms for any of the surveys used (effect size was < 0.3).

The researchers also assessed time to deterioration, defined as the earlier date of death, radiographic progressive disease or at least a 4-point decrease from baseline in the disease-related symptom index.

Patients randomly assigned cabozantinib had extended time-to-deterioration overall compared with those assigned everolimus (5.5 months vs. 3.7 months; P < .001). Researchers also observed significant improvements in time to deterioration among patients assigned cabozantinib with bone metastases at baseline compared with patients assigned everolimus (5.6 months vs. 1.9 months; P < .001).

“At the time of investigator-determined radiographic progressive disease, quality of life of patients was markedly diminished in both treatment arms,” the researchers wrote. “This finding indicates the negative impact of disease progression on quality of life and is suggestive of the benefit of extending PFS in this patient population. The observed prolongation of time to deterioration in the cabozantinib arm further supports the overall clinical benefit of this agent in addition to improving PFS, overall response rate and OS — albeit without a quality-of-life advantage.” – by Cassie Homer

Disclosures: Exelixis helped fund this study. Cella reports stock or other ownership in FACIT.org; consultant/advisory roles with AbbVie, Astellas Pharma, Bayer, GlaxoSmithKline, Novartis, Pfizer, PledPharma and Puma Biotechnology; institution funding from Bayer, Genentech, Ipsen, Novartis and Pfizer; and travel expenses from Ipsen. Please see the study for a list of all other authors’ relevant financial disclosures.

PAGE BREAK