TY - JOUR
T1 - Efficacy and safety data in elderly patients with metastatic renal cell carcinoma included in the nivolumab expanded access program (EAP) in Italy
AU - Vitale, Maria Giuseppa
AU - Scagliarini, Sarah
AU - Galli, Luca
AU - Pignata, Sandro
AU - Re, Giovanni Lo
AU - Berruti, Alfredo
AU - Defferrari, Carlotta
AU - Spada, Massimiliano
AU - Masini, Cristina
AU - Santini, Daniele
AU - Ciuffreda, Libero
AU - Ruggeri, Enzo Maria
AU - Bengala, Carmelo
AU - Livi, Lorenzo
AU - Fagnani, Daniele
AU - Bonetti, Andrea
AU - Giustini, Lucio
AU - Hamzaj, Alketa
AU - Procopio, Giuseppe
AU - Caserta, Claudia
AU - Sabbatini, Roberto
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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.
AB - 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.
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U2 - 10.1371/journal.pone.0199642
DO - 10.1371/journal.pone.0199642
M3 - Article
AN - SCOPUS:85049581579
VL - 13
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 7
M1 - e0199642
ER -