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Poster display session

3818 - Negative prognostic factors and resulting clinical outcome in patients (pts) with metastatic renal cell carcinoma (mRCC) included in the Italian nivolumab Expanded Access Program (EAP).


10 Sep 2017


Poster display session


Sergio Bracarda


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


S. Bracarda1, L. Galli2, M. Maruzzo3, G. Lo Re4, S. Buti5, A. Favaretto6, F.D. Costanzo7, C. Sacco8, M. Merlano9, C. Mucciarini10, E. Zafarana11, S. Romito12, A. Maestri13, C. Giannitto Giorgio14, M.T. Ionta15, D. Turci16, U. De Giorgi17, G. Procopio18, E. Cortesi19, C. Porta20

Author affiliations

  • 1 Oncology, Ospedale San Donato USLSud-Est, ITT, 52100 - Arezzo/IT
  • 2 Oncology, Azienda Ospedaliero-Universitaria Pisana Istituto Toscano Tumori, Pisa/IT
  • 3 Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 4 Cro Aviano, Oncologia Pordenone-S. Vito,CRO Aviano, 41125 - Pordenone/IT
  • 5 Medical Oncology, Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 6 Specialized Medicine Department, Oncology Unit, AULSS 2, Treviso Hospital, 31100 - Treviso/IT
  • 7 Oncology, AOU Careggi, Firenze/IT
  • 8 Oncology, ASUIUD, 33100 - Udine/IT
  • 9 Clinical Oncology, Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 10 Medical Oncology, Ramazzini Hospital, 41012 - Carpi (Modena)/IT
  • 11 Oncology, Ospedale S Stefano, 59100 - Prato/IT
  • 12 Oncology, Ospedale Riuniti di Foggia, 71100 - Foggia/IT
  • 13 Oncology, Ospedale S.Maria della Scaletta, Imola/IT
  • 14 Oncology, Ospedale Gravina, 90141 - Caltagirone/IT
  • 15 Oncology, Azienda Ospedaliero Universitaria di Cagliari, 9042 - Monserrato/IT
  • 16 Oncology, Ospedale S.Maria delle Croci, 48400 - Ravenna/IT
  • 17 Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 18 Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 19 Oncology, Policlinico Umberto I, 161 - Roma/IT
  • 20 Oncology, IRCCS Policlinico San Matteo, Pavia/IT


Abstract 3818


In recent years, prognostic classifications have been considered an area of growing interest in mRCC. However, independently from the classification used (Memorial Sloan Kettering versus Heng’s) the presence of brain, liver and bone metastases (mets) or sarcomatoid features (G4) resulted in a poorer outcome for pts with mRCC treated with targeted therapies (antiangiogenic agents or mTOR Inhibitors). Regarding this topic, the large Italian EAP represent an important opportunity to analyze the impact of nivolumab in pts treated in a daily clinical practice setting.


Nivolumab was available upon physician request for pts aged ≥18 years who relapsed after at least one prior systemic treatment in the advanced or metastatic setting. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.


Of 389 Italian pts with mRCC enrolled in the EAP, 32 pts (8%) had brain mets, 128 (33%) had liver and 193 (50%) had bone mets. Baseline characteristic are described in the Table. These pts achieved a disease control rate (DCR) of 53%, 45% and 47% respectively. Six and 12 months overall survival rates in the 3 groups of mets were 87.0% and 66.8%, 75.6% and 62.0%, 78.0% and 58.9%, respectively. Histological grading, a matter of high interest, was assigned according to Fuhrman's classification: 51 pts had G4 tumor. The objective response rates in these pts and in the overall population were 23% and 22%, respectively, with a 6 and 12 months OS rate of 61% and 53.6% for the G4 group. The safety profile of the subgroups described above was in line with the general population.


These results suggest that also pts with poor prognostic factors may derive relevant benefits with nivolumab, with safety results consistent with previously reported data.Table:


Age, median (range)Brain MetsLiver MetsBone Mets
65 (43-77)65 (43-81)65 (40-84)
Male %727079
ECOG PS %:0 1 2 NA41 50 6 342 50 7 139 48 10 3
Number of prior Therapies %:1 2 3 > =4 NA13 44 37 6 013 37 24 24 214 36 30 19 1

Clinical trial identification

Expanded Access Program

Legal entity responsible for the study

Italian RCC EAP Group




S. Bracarda: Advisory Board Member for Pfizer, Novartis, Bristol-Myers Squib, Exelixis, Ipsen, Roche, Genentech, Eusa Pharma. PI for clinical studies with Bristol-Myers Squib, Pfizer, Roche, Exelixis. L. Galli: Advisory Board for Pfizer, Novartis. U. De Giorgi: Advisory Board for Bristol-Myers Squib, Pfizer, Novartis, Ipsen, Astellas, Janssen, Sanofi. G. Procopio, C. Porta: Advisory Board for Bristol-Myers Squib, Pfizer, Novartis, Ipsen. E. Cortesi: Advisory Board for Bristol-Myers Squib, Pfizer, Ipsen. All other authors have declared no conflicts of interest.

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