AIM: We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program.PATIENTS & METHODS: Nivolumab was available for patients who relapsed after at least one prior systemic treatment in the advanced or metastatic setting.RESULTS: Of 389 patients, 32 (8%) had brain metastasis, 129 (33%) had liver and 193 (50%) had bone metastasis. These subpopulations achieved a disease control rate of 53, 45 and 47%, respectively. Fifty-one patients had G4 tumor, and they showed 23% objective response rate. The safety profile of the subgroups was in line with the expanded access program population. No new safety signals were reported.CONCLUSION: Patients with poor prognostic features may derive relevant benefits from nivolumab.
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal/therapeutic use, Antineoplastic Agents/therapeutic use, Bone Neoplasms/drug therapy, Brain Neoplasms/drug therapy, Carcinoma, Renal Cell/drug therapy, Disease Progression, Disease-Free Survival, Female, Humans, Italy, Kaplan-Meier Estimate, Kidney Neoplasms/drug therapy, Liver Neoplasms/drug therapy, Male, Middle Aged, Neoplasm Recurrence, Local/drug therapy, Nivolumab, Patient Selection, Prognosis, Prospective Studies, Treatment Outcome