Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients.

Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme / De Giorgi, U.; Carteni, G.; Giannarelli, D.; Basso, U.; Galli, L.; Cortesi, E.; Caserta, C.; Pignata, S.; Sabbatini, R.; Bearz, A.; Buti, S.; Lo Re, G.; Berruti, A.; Bracarda, S.; Cognetti, F.; Rastelli, F.; Fornarini, G.; Porta, C.; Turci, D.; Sternberg, C. N.; Procopio, G.; Falcone, A.; Roila, F.; Cascinu, S.; Tirelli, U.; Giustini, L.; Sobrero, A.; Cappuzzo, F.; Tassinari, D.; Passalacqua, R.; Pazzola, A.; Surico, G.; Maio, M.; Benedetti, G.; Barone, C.; Adamo, V.; Ricevuto, E.; De Censi, A.; Spada, M.; Tonini, G.; Pinto, C.; Ciuffreda, L.; Ruggeri, E. M.; Bengala, C.; Scotti, V.; Fagnani, D.; Bonetti, A.; Mitterer, M.; Castiglione, F.; Bidoli, P.; Ferrau, F.; Crino, L.; Frassoldati, A.; Marchetti, P.; Mini, E.; Scoppola, A.; Verusio, C.; Favaretto, A.; Di Costanzo, F.; Fasola, G.; Merlano, M.; Artioli, F.; Di Leo, A.; Romito, S.; Maestri, A.; Giannitto Giorgio, C.; Ionta, M. T.; Verderame, F.; Zampa, G.; Numico, G.; Minelli, M.; Tagliaferri, P.; Foa, P.; Palmiotti, G.; De Placido, S.; Mattioli, R.; Iuliano, F.; Defraia, E.; Siena, S.; Clerico, M.; Salvagno, L.; Ceresoli, G. L.; Bernardo, A.; Di Lieto, M.; Moroni, M.; Maisano, M.; Scartozzi, M.; Scagliotti, G.; Soraru, M.; Pepe, S.; Scaltriti, A.; Gebbia, V.; Testa, E.; Lorusso, V.; Bordonaro, R.; De Signoribus, G.; Tedde, N.; Santoro, A.; Francini, G.; Aondio, G.. - In: BJU INTERNATIONAL. - ISSN 1464-4096. - 123:1(2019), pp. 98-105. [10.1111/bju.14461]

Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Buti S.;
2019

Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients.
Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme / De Giorgi, U.; Carteni, G.; Giannarelli, D.; Basso, U.; Galli, L.; Cortesi, E.; Caserta, C.; Pignata, S.; Sabbatini, R.; Bearz, A.; Buti, S.; Lo Re, G.; Berruti, A.; Bracarda, S.; Cognetti, F.; Rastelli, F.; Fornarini, G.; Porta, C.; Turci, D.; Sternberg, C. N.; Procopio, G.; Falcone, A.; Roila, F.; Cascinu, S.; Tirelli, U.; Giustini, L.; Sobrero, A.; Cappuzzo, F.; Tassinari, D.; Passalacqua, R.; Pazzola, A.; Surico, G.; Maio, M.; Benedetti, G.; Barone, C.; Adamo, V.; Ricevuto, E.; De Censi, A.; Spada, M.; Tonini, G.; Pinto, C.; Ciuffreda, L.; Ruggeri, E. M.; Bengala, C.; Scotti, V.; Fagnani, D.; Bonetti, A.; Mitterer, M.; Castiglione, F.; Bidoli, P.; Ferrau, F.; Crino, L.; Frassoldati, A.; Marchetti, P.; Mini, E.; Scoppola, A.; Verusio, C.; Favaretto, A.; Di Costanzo, F.; Fasola, G.; Merlano, M.; Artioli, F.; Di Leo, A.; Romito, S.; Maestri, A.; Giannitto Giorgio, C.; Ionta, M. T.; Verderame, F.; Zampa, G.; Numico, G.; Minelli, M.; Tagliaferri, P.; Foa, P.; Palmiotti, G.; De Placido, S.; Mattioli, R.; Iuliano, F.; Defraia, E.; Siena, S.; Clerico, M.; Salvagno, L.; Ceresoli, G. L.; Bernardo, A.; Di Lieto, M.; Moroni, M.; Maisano, M.; Scartozzi, M.; Scagliotti, G.; Soraru, M.; Pepe, S.; Scaltriti, A.; Gebbia, V.; Testa, E.; Lorusso, V.; Bordonaro, R.; De Signoribus, G.; Tedde, N.; Santoro, A.; Francini, G.; Aondio, G.. - In: BJU INTERNATIONAL. - ISSN 1464-4096. - 123:1(2019), pp. 98-105. [10.1111/bju.14461]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2912877
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