Practice Update: Oncology

ESMO 2017 23

Cabozantinib Is Safe and Effective for Metastatic Renal Cell Carcinoma in Real-World Practice Cabozantinib has been found to be safe and effective in a large unselected population with metastatic renal cell carcinoma treated in everyday clinical practice. T his finding of a study performed in patients in the Italian ExpandedAccess Programwas reported at the European Society for Medical Oncology (ESMO) 2017 Congress, from September 8–12. on physician request from September to December 2016. Patients were age 18 years and older, and harbored measura- ble metastatic renal cell carcinoma.

treatment due to adverse events. The best overall response was partial in 28 cases (31%), whereas 23 (25%) patients achieved stable disease and 23 (25%), pro- gressive disease. A total of 17 patients (18%) have not reached the first assessment of response. After a median follow-up of 4 months, median progression-free survival was 3.5 months irrespective of the line of treatment. Dr. Procopio concluded that cabozantinib was found to be safe and active in this large unselected population of patients with metastatic renal cell carcinoma who were treated in everyday clinical practice. “The results may support physicians in their decision making in everyday clinical practice,” he added. “Our study included special populations, including the elderly, and those with rare histology, brain metas- tasis, and poor prognosis.” “In the future, we hope to evaluate cabo- zantinib early in the first-line setting. We also hope to characterize definitively the role of predictive biomarkers, such as MET.”

They were Eastern Cooperative Oncology Group performance status 0–2. They had relapsed after one or more prior systemic treatments. Of these patients, 73 suffered from clear cell renal cell carcinoma, while the other 18 had non–clear-cell histology (type II papillary and chromophobe). The most frequent sites of disease were lung 58% (n=53), lymph nodes 45% (n=41), bone 31% (n=28), liver 16% (n=15), and brain 5% (n=5). A total of 42 (46%) of patients har- bored two or more sites of disease. Cabozantinib was administered orally at 60 mg once a day in 28 day-cycles. Dose reductions to 40 or 20 mg were allowed if toxicity was encountered. Patients were monitored for adverse events using the National Cancer Institute Common Termi- nology Criteria for Adverse Events v4.0. Cabozantinib was administered second line in 28 (30%) patients, third line in 18 (19%) patients, and as further lines in the remaining 45 (51%). At the time of the analysis, grade 3 and 4 adverse events were observed in 21% of patients. Among 91 patients, only five (5%) discontinued

Giuseppe Procopio, MD, of the Fondazi- one Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy, explained that final results of the randomized phase III Cabo- zantinib vs Everolimus in advanced Renal Cell Carcinoma (METEOR) trial confirmed a survival benefit of cabozantinib over everolimus in patients with advanced clear- cell renal cell carcinoma. “Our goal was to validate clinical data reported for cabozantinib in the phase III trial in an unselected population for the first time,” said Dr. Procopio. Subjects had progressed after receiving at least one previous antiangiogenic inhibi- tor. The Italian Expanded Access Program provided the opportunity to treat patients in real-world clinical practice. Dr. Procopio and colleagues set out to eval- uate the safety and activity of cabozantinib in a large unselected population. Data were collected from 91 patients treated with cabozantinib across 23 Ital- ian hospitals. Cabozantinib was available

PracticeUpdate Editorial Team www.practiceupdate.com/c/58039

© ESMO 2017 Congress

VOL. 1 • NO. 3 • 2017