ESMO 2017: Safety and efficacy of Cabozantinib for metastatic renal cell carcinoma: Real world data from an Italian Expanded Access Program

Madrid, Spain ( ESMO 2017 in Madrid Spain, Dr. Procopio and colleagues from Italy presented data from the Italian Expanded Access Program (EAP) for using cabozantinib for metastatic renal cell carcinoma (mRCC). The results of the randomized phase III METEOR trial confirmed a survival benefit of cabozantinib over everolimus in patients with advanced clear-cell renal cell carcinoma who progressed after at least one previous antiangiogenic inhibitor [1]. The objective of the current study was to assess results from the Italian EAP for the treatment of mRCC with cabozantinib in real world clinical practice.

For this study, data were collected from 91 patients treated with cabozantinib across 23 Italian hospitals. Cabozantinib was available, upon physician request, from September to December 2016. Patients were 18 years of age and older, with mRCC and measurable disease, with ECOG performance status 0 to 2, who had relapsed after one or more prior systemic therapies. There were 73 patients with clear-cell RCC, while the other 18 had non-clear-cell histologies (type II papillary and chromophobe). The most frequent sites of disease were: lung (n=53, 58%), lymph nodes (n=41, 45%), bone (n=28, 31%), liver (n=15, 16%) and brain (n=5, 5%); 42 (46%) patients had 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 (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. The aim of this analysis was to evaluate the safety and activity of cabozantinib in a large unselected population.

Cabozantinib was administered as second line therapy in 28 (30%) patients, third line in 18 (19%) patients, and as further lines in the remaining 45 (51%) patients. Sixty patients (65%) started treatment at a dosage of 60 mg, while 32 patients (35%) started at 40 mg; 25 patients (27%) reduced dosage due to toxicity. At the time of analysis, grade 3 and 4 adverse events were observed in 21% of patients. Among 91 pts, only 5 (5%) discontinued treatment due to adverse events. The best overall response was partial in 28 cases (31%), whereas 23 (25%) patients had stable disease, and 23 (25%) had progressive disease; 17 patients (18%) have not reached the first response assessment. With a median follow-up of 4 months, the median progression-free survival observed was 3.5 months irrespective of the line of treatment.

The authors concluded that cabozantinib is safe and active in a large unselected population treated according to everyday clinical practice.

Speaker: Giuseppe Procopio, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Co-Authors: M. Prisciandaro (Milan, Italy) R. Iacovelli (Verona, Italy) M. Mancini (Roma, Italy) G. Fornarini (Genova, Italy) G. Facchini (Naples, Italy) G. Cartenì (Napoli, Italy) M. Napolitano (Modena, Italy) C. N. Sternberg (Roma, Italy) C. Caserta (Terni, Italy) M. Bregni (Busto Arsizio, Italy) F. Massari (Bologna, Italy) S. Buti (Parma, Italy) E. Biasco (Pisa, Italy) U. De Giorgi (Meldola, Italy) F. Zustovich (Belluno, Italy) R. Ratta (Milan, Italy) C. Ortega (Alba, Italy) G. Tortora (Verona, Italy) E. Verzoni (Milan, Italy)

Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain


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