Efficacy and safety data in elderly patients with metastatic renal cell carcinoma included in the nivolumab Expanded Access Program (EAP) in Italy

意大利纳武单抗扩展获取计划 (EAP) 中纳入的转移性肾细胞癌老年患者的疗效和安全性数据

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作者: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, Alke

Conclusion

The final results suggest that elderly patients with pretreated metastatic RCC may benefit from therapy with nivolumab.

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.

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