Negative Prognostic Factors and Resulting Clinical Outcome in Patients with Metastatic Renal Cell Carcinoma Included in the Italian Nivolumab-Expanded Access Program

Abstract

Aim: We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program. Patients & methods: Nivolumab was available for patients who relapsed after at least one prior systemic treatment in the advanced or metastatic setting. Results: Of 389 patients, 32 (8%) had brain metastasis, 129 (33%) had liver and 193 (50%) had bone metastasis. These subpopulations achieved a disease control rate of 53, 45 and 47%, respectively. Fifty-one patients had G4 tumor, and they showed 23% objective response rate. The safety profile of the subgroups was in line with the expanded access program population. No new safety signals were reported. Conclusion: Patients with poor prognostic features may derive relevant benefits from nivolumab.

Keywords::

• EAP
• mRCC
• nivolumab
• prognostic factors

Financial & competing interests disclosure

S Bracarda is the Advisory Board Member for Pfizer, Novartis, Bristol-Myers Squib, Exelixis, Ipsen, Roche, Genentech, Eusa Pharma. He is PI for clinical studies with Bristol-Myers Squib, Pfizer, Roche, Exelixis. L Galli is the Advisory Board for Pfizer, Novartis. U De Giorgi is the Advisory Board for Bristol-Myers Squib, Pfizer, Novartis, Ipsen, Astellas, Janssen, Sanofi. G Procopio and C Porta are the Advisory Board for Bristol-Myers Squib, Pfizer, Novartis, Ipsen. E Cortesi is the Advisory Board for Bristol-Myers Squib, Pfizer, Ipsen. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Editorial assistance for the preparation of this manuscript was provided by L Giacomelli; this assistance was supported by internal funds.