Compassionate Use Program of Ipilimumab and Nivolumab in Intermediate or Poor Risk Metastatic Renal Cell Carcinoma: A Large Multicenter Italian Study

Author:

Basso UmbertoORCID,Paolieri Federico,Rizzo Mimma,De Giorgi UgoORCID,Bracarda Sergio,Antonuzzo Lorenzo,Atzori FrancescoORCID,Cartenì Giacomo,Procopio Giuseppe,Fratino LuciaORCID,D’Arcangelo ManoloORCID,Fornarini GiuseppeORCID,Zucali Paolo,Cusmai Antonio,Santoni Matteo,Pipitone Stefania,Carella Claudia,Panni Stefano,Deppieri FilippoORCID,Zagonel Vittorina,Tortora Giampaolo

Abstract

This is a retrospective analysis on the safety and activity of compassionate Ipilimumab and Nivolumab (IPI-NIVO) administered to patients with metastatic Renal Cell Carcinoma (mRCC) with intermediate or poor International Metastatic RCC Database Consortium (IMDC) score as a first-line regimen. IPI was infused at 1 mg/kg in combination with Nivolumab 3 mg/kg every three weeks for four doses, followed by maintenance Nivolumab (240 or 480 mg flat dose every two or four weeks, respectively) until disease progression or unacceptable toxicity. A total of 324 patients started IPI-NIVO at 86 Italian centers. Median age was 62 years, 68.2% IMDC intermediate risk. Primary tumor had been removed in 65.1% of patients. Two hundred and twenty patients (67.9%) completed the four IPI-NIVO doses. Investigator-assessed overall response rate was 37.6% (2.8% complete). Twelve-month survival rate was 66.8%, median progression-free survival was 8.3 months. Grade 3 or 4 treatment-related adverse events occurred in 67 patients (26.9%). IMDC intermediate risk, nephrectomy, BMI ≥ 25 kg/m2, and steroid use for toxicities correlated with improved survival, while age < 70 years did not. IPI-NIVO combination is a feasible and effective regimen for the first-line treatment of intermediate-poor IMDC risk mRCC patients in routine clinical practice.

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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