Efficacy and safety data in elderly patients with metastatic renal cell carcinoma included in the nivolumab expanded access program (EAP) in Italy

Maria Giuseppa Vitale, Sarah Scagliarini, Luca Galli, Sandro Pignata, Giovanni Lo Re, Alfredo Berruti, Carlotta Defferrari, Massimiliano Spada, Cristina Masini, Daniele Santini, Libero Ciuffreda, Enzo Maria Ruggeri, Carmelo Bengala, Lorenzo Livi, Daniele Fagnani, Andrea Bonetti, Lucio Giustini, Alketa Hamzaj, Giuseppe Procopio, Claudia CasertaRoberto Sabbatini

Research output: Contribution to journalArticlepeer-review


Background Results from phase III clinical trial CheckMate 025 have established nivolumab as the standard of care for treatment of metastatic renal-cell carcinoma (mRCC) after VEGF inhibitor failure; however, elderly patients are under-represented in the registration trial and little is known about the activity of nivolumab in this subgroup. The purpose of the Expanded Access Program was to provide nivolumab to patients with mRCC who had progressed despite treatment with other agents that were considered standard of care. Methods Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months or until progression or unacceptable toxicity. The current analysis included all patients from the EAP Italian cohort who had received 1 dose of nivolumab. Adverse events (AEs) were monitored using Common Terminology Criteria for Adverse Events v4.0. Results A total of 389 patients with advanced RCC were enrolled in the Italian cohort of the EAP and treated with nivolumab. Of these patients, 125 (32%) were at least 70 years of age and 70 (18%) were at least 75 years of age. Efficacy with nivolumab in the elderly patients was similar to that observed in the overall EAP population and in the CheckMate 025 trial. Safety was comparable between the elderly patients and the overall EAP population, and was consistent with what previously reported. Conclusion The final results suggest that elderly patients with pretreated metastatic RCC may benefit from therapy with nivolumab.

Original languageEnglish
Article numbere0199642
JournalPLoS One
Issue number7
Publication statusPublished - Jul 1 2018

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)


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