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. - STAMPA. - 123:(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
Mini E.;Di Costanzo F.;
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.
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