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

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 w...

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Published in:Cancers 2022-05, Vol.14 (9), p.2293
Main Authors: Basso, Umberto, Paolieri, Federico, Rizzo, Mimma, De Giorgi, Ugo, Bracarda, Sergio, Antonuzzo, Lorenzo, Atzori, Francesco, Cartenì, Giacomo, Procopio, Giuseppe, Fratino, Lucia, D'Arcangelo, Manolo, Fornarini, Giuseppe, Zucali, Paolo, Cusmai, Antonio, Santoni, Matteo, Pipitone, Stefania, Carella, Claudia, Panni, Stefano, Deppieri, Filippo Maria, Zagonel, Vittorina, Tortora, Giampaolo
Format: Article
Language:English
Subjects:
Antigens
Autoimmune diseases
Body mass index
Clinical medicine
Drug dosages
FDA approval
Hepatitis C
Histology
Immune system
Kidney cancer
Metastases
Metastasis
Monoclonal antibodies
Nephrectomy
Oncology
Patients
Quality of life
Renal cell carcinoma
Steroids
Surgery
Toxicity
Tumors
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Summary: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.
ISSN:2072-6694
2072-6694
DOI:10.3390/cancers14092293