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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Decoding Treatment Failures in Metastatic Renal Cell Carcinoma: Predictors Across Immunotherapy and Targeted Therapies from a Retrospective Real-World Analysis

by
Sorin Saftescu
1,
Vlad-Norin Vornicu
1,
Dorel-Ionel Popovici
1,*,
Radu-Dumitru Dragomir
1,
Dana-Sonia Nagy
1,
Daniela-Lidia Sandu
1,
Ana Dulan
1,
Șerban-Mircea Negru
1 and
Alina-Gabriela Negru
2
1
Department of Oncology, Faculty of Medicine, Victor Babes University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania
2
Department of Cardiology, Faculty of Medicine, Victor Babes University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(15), 5271; https://doi.org/10.3390/jcm14155271
Submission received: 13 June 2025 / Revised: 14 July 2025 / Accepted: 24 July 2025 / Published: 25 July 2025
(This article belongs to the Special Issue Advances and Perspectives in Cancer Diagnostics and Treatment)
Versions Notes

Abstract

Background: Despite recent advances in the management of metastatic renal cell carcinoma (mRCC), real-world outcomes remain heterogeneous, and early treatment failure is common. Predictive biomarkers for time to treatment failure (TTF) outside clinical trials are poorly characterized. Objective: To identify clinical and laboratory predictors associated with early treatment failure in a real-world cohort of mRCC patients treated with immune checkpoint inhibitors (ICIs), tyrosine kinase inhibitors (TKIs), or combination regimens. Methods: We conducted a retrospective, single-center analysis of patients with metastatic non-urothelial RCC treated between 2018 and 2023. Cox proportional hazards regression was used to evaluate the association between baseline biological parameters and TTF for each treatment regimen. Results: Among 137 patients receiving first-line therapy, 50 received Ipilimumab + Nivolumab, 49 Sunitinib, and 17 Avelumab + Axitinib. For Ipilimumab + Nivolumab, elevated AST was significantly associated with shorter TTF. For Avelumab + Axitinib, shorter TTF was associated with lymph node metastases, low lymphocyte count, low creatinine, low BMI, and low hemoglobin. For Cabozantinib in subsequent lines, a higher platelet count, ALT, and presence of liver metastases were associated with shorter TTF. No statistically significant predictors were found for Nivolumab used in the second-line setting. Conclusions: Routine, accessible biomarkers such as AST, hemoglobin, lymphocyte count, and creatinine may serve as predictors of treatment failure in specific therapeutic contexts. These findings support risk-adapted strategies and individualized monitoring in real-world clinical practice, though further validation in larger cohorts is warranted.
Keywords: metastatic renal cell carcinoma; time to treatment failure; real-world evidence; predictors; immunotherapy; targeted therapy metastatic renal cell carcinoma; time to treatment failure; real-world evidence; predictors; immunotherapy; targeted therapy

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MDPI and ACS Style

Saftescu, S.; Vornicu, V.-N.; Popovici, D.-I.; Dragomir, R.-D.; Nagy, D.-S.; Sandu, D.-L.; Dulan, A.; Negru, Ș.-M.; Negru, A.-G. Decoding Treatment Failures in Metastatic Renal Cell Carcinoma: Predictors Across Immunotherapy and Targeted Therapies from a Retrospective Real-World Analysis. J. Clin. Med. 2025, 14, 5271. https://doi.org/10.3390/jcm14155271

AMA Style

Saftescu S, Vornicu V-N, Popovici D-I, Dragomir R-D, Nagy D-S, Sandu D-L, Dulan A, Negru Ș-M, Negru A-G. Decoding Treatment Failures in Metastatic Renal Cell Carcinoma: Predictors Across Immunotherapy and Targeted Therapies from a Retrospective Real-World Analysis. Journal of Clinical Medicine. 2025; 14(15):5271. https://doi.org/10.3390/jcm14155271

Chicago/Turabian Style

Saftescu, Sorin, Vlad-Norin Vornicu, Dorel-Ionel Popovici, Radu-Dumitru Dragomir, Dana-Sonia Nagy, Daniela-Lidia Sandu, Ana Dulan, Șerban-Mircea Negru, and Alina-Gabriela Negru. 2025. "Decoding Treatment Failures in Metastatic Renal Cell Carcinoma: Predictors Across Immunotherapy and Targeted Therapies from a Retrospective Real-World Analysis" Journal of Clinical Medicine 14, no. 15: 5271. https://doi.org/10.3390/jcm14155271

APA Style

Saftescu, S., Vornicu, V.-N., Popovici, D.-I., Dragomir, R.-D., Nagy, D.-S., Sandu, D.-L., Dulan, A., Negru, Ș.-M., & Negru, A.-G. (2025). Decoding Treatment Failures in Metastatic Renal Cell Carcinoma: Predictors Across Immunotherapy and Targeted Therapies from a Retrospective Real-World Analysis. Journal of Clinical Medicine, 14(15), 5271. https://doi.org/10.3390/jcm14155271

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