Home HOME Neoplasma 2021 Neoplasma Vol.68, No.1, p.208–215, 2021

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Founded: 1954
ISSN 0028-2685
ISSN 1338-4317 (online)

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Neoplasma Vol.68, No.1, p.208–215, 2021

Title: Real-world safety and efficacy of nivolumab for ≥ 2nd line treatment of metastatic renal cell carcinoma: A retrospective cohort study in Croatia, Hungary, and Malta
Author: Eduard Vrdoljak, Claude Magri, Marija Gamulin, Lidija Bošković, Tomislav Omrčen, Žarko Bajić, Tamas Dienes, Lajos Geczi

Abstract: The objective of our study was to assess the real-world safety and efficacy of nivolumab in the second- or later-line treatment of metastatic renal cell carcinoma (mRCC). We conducted a multicenter, retrospective, observational study of real-world data from patients who were treated with nivolumab under a patient expanded access program from 2015 to 2017 in Croatia, Hungary, and Malta. The primary safety endpoint was the discontinuation of therapy because of adverse events. The primary efficacy endpoint was overall survival (OS). We collected data from 87 patients with a median (interquartile range (IQR)) age of 63 (57-68) years, and 21% were women. The median (IQR) follow-up was 11 (5-31) months. Treatment was discontinued because of toxicity in 4 (5%) patients. Four (5%) patients experienced treatment-related adverse events of grade 3 or 4. The OS was 18.0 (95% CI: 11.0 to 28.6) months, and the PFS was 8.5 (95% CI: 4.9 to 12.1) months. Our study indicated a good safety and efficacy profile of nivolumab in the second- or later-line treatment of mRCC patients in a real-world clinical practice environment, which is comparable with the findings of the registrational trial.

Keywords: metastatic renal carcinoma; PD-1 immune checkpoint inhibitor; nivolumab; immunotherapy
Published online: 17-Sep-2020
Year: 2021, Volume: 68, Issue: 1 Page From: 208, Page To: 215

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