Real-world Data of Nivolumab for Patients With Advanced Renal Cell Carcinoma in the Netherlands: An Analysis of Toxicity, Efficacy, and Predictive Markers.

Autor: Verhaart SL; Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, United Kingdom., Abu-Ghanem Y; Department of Medical Oncology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands., Mulder SF; Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands., Oosting S; Department of Medical Oncology, University Medical Center Groningen, Groningen, The Netherlands., Van Der Veldt A; Department of Medical Oncology, Erasmus Medical Center-Cancer Institute, Rotterdam, The Netherlands., Osanto S; Department of Medical Oncology, Leids University Medical Center, Leiden, The Netherlands., Aarts MJB; Department of Medical Oncology, Maastricht University Medical Center, Maastricht, The Netherlands., Houtsma D; Department of Medical Oncology, HAGA Hospital, The Hague, The Netherlands., Peters FPJ; Department of Medical Oncology, Zuyderland Hospital, Sittard - Geleen, The Netherlands., Groenewegen G; Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands., Van Herpen CML; Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands., Pronk LM; Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands., Tascilar M; Department of Medical Oncology, Isala Clinics, Zwolle, The Netherlands., Hamberg P; Department of Medical Oncology, Franciscus Gasthuis and Vllietland, Rotterdam, The Netherlands., Los M; Department of Medical Oncology, St. Antonius Hospital, Nieuwegein, The Netherlands., Vreugdenhil G; Department of Medical Oncology, Máxima Medical Center, Eindhoven, The Netherlands., Polee M; Department of Medical Oncology, Medical Center Leeuwarden, Leeuwarden, The Netherlands., Ten Tije AJ; Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands., Haanen JBAG; Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands., Bex A; Department of Medical Oncology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands; Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: axel.bex@nhs.net., van den Eertwegh AJ; Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, London, United Kingdom.
Jazyk: angličtina
Zdroj: Clinical genitourinary cancer [Clin Genitourin Cancer] 2021 Jun; Vol. 19 (3), pp. 274.e1-274.e16. Date of Electronic Publication: 2020 Oct 14.
DOI: 10.1016/j.clgc.2020.10.003
Abstrakt: Background: Nivolumab, a programmed death 1 inhibitor, has been approved as second-line treatment for advanced renal cell carcinoma (RCC) in Europe since 2016. We investigated the toxicity and efficacy of nivolumab as well as potential predictive biomarkers in the Dutch population.
Patients and Methods: This was a retrospective, multicenter study of the Dutch national registry of nivolumab for the treatment of advanced RCC. The main outcome parameters included toxicity, objective response rate (ORR), overall survival (OS), progression-free survival (PFS), time to progression (TTP), and time to treatment failure (TTF). In addition, potential predictive and prognostic biomarkers for outcomes were evaluated.
Results: Data on 264 patients were available, of whom 42% were International Metastatic RCC Database Consortium (IMDC) poor risk at start of nivolumab, 16% had ≥ 3 lines of previous therapy, 7% had non-clear-cell RCC, 11% had brain metastases, and 20% were previously treated with everolimus. Grade 3/4 immune-related adverse events occurred in 15% of patients. The median OS was 18.7 months (95% confidence interval, 13.7-23.7 months). Progression occurred in 170 (64.4%) of 264 patients, with a 6-and 12-months TTP of 49.8% and 31.1%, respectively. The ORR was 18.6% (49 of 264; 95% confidence interval, 14%-23%). Elevated baseline lymphocytes were associated with improved PFS (P = .038) and elevated baseline lactate dehydrogenase with poor OS, PFS, and TTF (P = .000). On-treatment increase in eosinophils by week 8 predicted improved OS (P = .003), PFS (P = .000), and TTF (P = .014), whereas a decrease of neutrophils was associated with significantly better TTF (P = .023).
Conclusions: The toxicity and efficacy of nivolumab for metastatic RCC after previous lines of therapy are comparable with the results in the pivotal phase III trial and other real-world data. On-treatment increase in eosinophil count is a potential biomarker for efficacy and warrants further investigation.
(Copyright © 2020 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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