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

Authors :
Umberto Basso
Federico Paolieri
Mimma Rizzo
Ugo De Giorgi
Sergio Bracarda
Lorenzo Antonuzzo
Francesco Atzori
Giacomo Cartenì
Giuseppe Procopio
Lucia Fratino
Manolo D’Arcangelo
Giuseppe Fornarini
Paolo Zucali
Antonio Cusmai
Matteo Santoni
Stefania Pipitone
Claudia Carella
Stefano Panni
Filippo Maria Deppieri
Vittorina Zagonel
Giampaolo Tortora
Source :
Cancers, Vol 14, Iss 9, p 2293 (2022)
Publication Year :
2022
Publisher :
MDPI AG, 2022.

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.

Details

Language :
English
ISSN :
20726694
Volume :
14
Issue :
9
Database :
Directory of Open Access Journals
Journal :
Cancers
Publication Type :
Academic Journal
Accession number :
edsdoj.6fa7ef73d3be40e0b39d769255424bab
Document Type :
article
Full Text :
https://doi.org/10.3390/cancers14092293