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Poster display session

4778 - Safety and efficacy of Cabozantinib for metastatic renal cell carcinoma (mRCC): real world data from an Italian Expanded Access Program (EAP)


10 Sep 2017


Poster display session


Cytotoxic Therapy;  Renal Cell Cancer


Giuseppe Procopio


Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371


G. Procopio1, M. Prisciandaro1, R. Iacovelli2, M. Mancini3, G. Fornarini4, G. Facchini5, G. Cartenì6, M. Napolitano7, C.N. Sternberg8, C. Caserta9, M. Bregni10, F. Massari11, S. Buti12, E. Biasco13, U. De Giorgi14, F. Zustovich15, R. Ratta1, C. Ortega16, G. Tortora17, E. Verzoni1

Author affiliations

  • 1 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona, Verona/IT
  • 3 Medical Oncology, Policlinico Umberto I, 161 - Roma/IT
  • 4 Medical Oncology, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova/IT
  • 5 Uro-gynecological, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Naples/IT
  • 6 Medical Oncology, Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"-AORN A. Cardarelli, 80131 - Napoli/IT
  • 7 Department Of Oncology, Modena University Hospital, 41124 - Modena/IT
  • 8 Department Of Oncology, San Camillo and Forlanini Hospitals, 156 - Roma/IT
  • 9 Medical Oncology, Azienda Ospedaliera S.ta Maria, 5100 - Terni/IT
  • 10 Medical Oncology, Ospedale di Busto Arsizio, 21052 - Busto Arsizio/IT
  • 11 Medical Oncology, AOU Policlinico Sant'Orsola Malpighi, 40138 - Bologna/IT
  • 12 Medical Oncology, Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 13 Medical Oncology, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 14 Medical Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 15 Oncology Department, Oncology Unit, AULSS 1 Dolomiti, Belluno Hospital, Belluno/IT
  • 16 Medical Oncology, ASLCN2 - Alba-Bra (CN), Alba/IT
  • 17 Medical Oncology, University of Verona, 37134 - Verona/IT


Abstract 4778


Final results from the randomised phase III METEOR trial confirmed a survival benefit of cabozantinib over everolimus in patients (pts) with advanced clear-cell renal cell carcinoma who progressed after at least one previous antiangiogenic inhibitor. The EAP provided the opportunity to treat pts in real world clinical practice.


Data were collected from 91 pts treated with cabozantinib across 23 Italian hospitals. Cabozantinib was available, upon physician request, from September to December 2016. Pts were aged 18 years and older, with mRCC and measurable disease, with Perfomance Status (ECOG) 0 to 2, who had relapsed after one or more prior systemic treatment. 73 pts had 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 53 (58%), lymph nodes 41 (45%), bone 28 (31%), liver 15 (16%) and brain 5 (5%); 42 (46%) pts had two or more sites of disease. Cabozantinib was administered orally at 60 mg once a day in 28 days-cycles. Dose reductions to 40 or 20 mg were allowed if toxicity was encountered. Pts were monitored for adverse events (AEs) 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%) pts, as III line in 18 (19%) pts and as further lines in the remaining 45 (51%) pts. At the time of our analysis, grade 3 and 4 AEs were observed in 21% of pts. Among 91 pts, only 5 (5%) discontinued treatment due to AEs. The best overall response was partial in 28 cases (31%), whereas 23 (25%) pts had stable disease and 23 (25%) had progressive disease; 17 pts (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.


Our data suggest that cabozantinib is safe and active in a large unselected population treated according to everyday clinical practice.

Clinical trial identification

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale dei Tumori of Milan




G. Procopio: Reports receiving fees for serving on advisory boards from Bayer, Bristol-Myers Squibb, Ipsen, Novartis, Pfizer. E. Verzoni: Reports receiving fees for serving on advisory boards from Pfizer and Novartis. All other authors have declared no conflicts of interest.

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