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

• Main Authors: Antonuzzo, L. (Author), Atzori, F. (Author), Basso, U. (Author), Bracarda, S. (Author), Carella, C. (Author), Cartenì, G. (Author), Cusmai, A. (Author), D’arcangelo, M. (Author), De Giorgi, U. (Author), Deppieri, F.M (Author), Fornarini, G. (Author), Fratino, L. (Author), Panni, S. (Author), Paolieri, F. (Author), Pipitone, S. (Author), Procopio, G. (Author), Rizzo, M. (Author), Santoni, M. (Author), Tortora, G. (Author), Zagonel, V. (Author), Zucali, P. (Author)
• Format: Article
• Language: English
• Published: MDPI 2022
• Subjects: immune-related adverse events; ipilimumab; metastatic Renal Cell Carcinoma; nivolumab; progression; retrospective; survival; toxicity
• Online Access: View Fulltext in Publisher
• ISBN: 20726694 (ISSN)
• DOI: 10.3390/cancers14092293

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. © 2022 by the authors. Licensee MDPI, Basel, Switzerland.