Abstract
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.
Keywords:
EAP; mRCC; nivolumab; prognostic factors.
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antibodies, Monoclonal / therapeutic use*
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Antineoplastic Agents / therapeutic use*
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Bone Neoplasms / drug therapy
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Bone Neoplasms / mortality
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Bone Neoplasms / secondary
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Brain Neoplasms / drug therapy
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Brain Neoplasms / mortality
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Brain Neoplasms / secondary
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Carcinoma, Renal Cell / drug therapy*
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Carcinoma, Renal Cell / mortality
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Carcinoma, Renal Cell / secondary
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Disease Progression
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Disease-Free Survival
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Female
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Humans
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Italy
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Kaplan-Meier Estimate
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Kidney Neoplasms / drug therapy*
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Kidney Neoplasms / mortality
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Kidney Neoplasms / pathology
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Liver Neoplasms / drug therapy
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Liver Neoplasms / mortality
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Liver Neoplasms / secondary
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Male
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Middle Aged
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Neoplasm Recurrence, Local / drug therapy*
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Neoplasm Recurrence, Local / mortality
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Nivolumab
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Patient Selection
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Prognosis
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Prospective Studies
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Treatment Outcome
Substances
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Antibodies, Monoclonal
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Antineoplastic Agents
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Nivolumab