Objective Response Rate is a Surrogate Marker for Long-Term Overall Survival in Metastatic Urothelial Carcinoma Patients Treated With Immune Checkpoint Inhibitors

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dc.authorscopusidSaadettin Kılıçkap / 8665552100
dc.authorwosidSaadettin Kılıçkap / AAP-3732-2021
dc.contributor.authorTural, Deniz
dc.contributor.authorArslan, Çağatay
dc.contributor.authorSelçukbiricik, Fatih
dc.contributor.authorÖlmez, Ömer Fatih
dc.contributor.authorErman, Mustafa
dc.contributor.authorÜrün, Yüksel
dc.contributor.authorErdem, Dilek
dc.contributor.authorKılıçkap, Saadettin
dc.date.accessioned2025-04-18T10:09:26Z
dc.date.available2025-04-18T10:09:26Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractBackground: This study aimed to evaluate the utility of RECIST criteria-based objective response rate (ORR) as a potential surrogate endpoint for long-term overall survival (OS) in patients with metastatic urothelial carcinoma who were treated with immune checkpoint inhibitors (ICIs). Methods: The primary endpoint was overall ORR and OS, duration of treatment (DoR) with ICIs. ORR was analyzed using Fisher's exact test. Median follow-up and OS were estimated by using the Kaplan–Meier method. Results: The median follow-up was 58 (1.15-71) months. Progression developed in 94 (47%) patients during the first 3 months of ICIs therapy. The treatment response to ICIs included complete response (CR), partial response (PR) and stable disease in 10% (n = 20), 23% (n = 46), and 20% (n = 41) of patients, respectively. The responder and nonresponder groups differed in terms of certain baseline characteristics, such as Bellmunt risk factors, and neutrophil-to-lymphocyte ratio (NLR). The 5-year OS rates for patients with CR and PR were 73% and 23%, respectively. The median DoR for CR, PR, and SD were 51.8 months (44.5-59.1), 20.7 months (16.7-24.6), and 8.8 months (5.5-12.1), respectively. Overall, 16(80%) patients with CR and 14(30%) patients with PR had an ongoing response at the time of the analysis. In the univariate analysis, NLR > 3, liver metastases, ECOG PS ≥ 1, and hemoglobin levels < 10 mg/dl, as well as the PR and CR, were all significantly associated with OS. In multivariate analysis, presence of liver metastases (HR 2.3; 95% CI, 1.3-4.2; P < .004) was found to be an independent determinant of short OS, while PR (HR 0.3; 95% CI, 0.15-0.5; P < .001) and CR (HR 0.06; 95% CI, 0.014-0.27; P < .001) were associated with improved OS. Conclusions: In conclusion, this 5-year analysis of real-world data in the setting of metastatic urothelial cancer indicated a significant correlation between ORR, especially CR, and OS in patients who received ICIs. Therefore, identifying a potential surrogate marker for survival in patients treated with ICIs would represent an important advance in the early identification of patients’ response or resistance to ICIs. © 2024 Elsevier Inc.
dc.identifier.citationTural, D., Arslan, C., Selcukbiricik, F., Olmez, O. F., Erman, M., Ürün, Y., ... & Kilickap, S. (2024). Objective response rate is a surrogate marker for long-term overall survival in metastatic urothelial carcinoma patients treated with immune checkpoint inhibitors. Clinical Genitourinary Cancer, 22(5), 102163.
dc.identifier.doi10.1016/j.clgc.2024.102163
dc.identifier.issn15587673
dc.identifier.issue5
dc.identifier.scopus2-s2.0-85200628717
dc.identifier.scopusqualityQ1
dc.identifier.urihttp://dx.doi.org/10.1016/j.clgc.2024.102163
dc.identifier.urihttps://hdl.handle.net/20.500.12713/6965
dc.identifier.volume22
dc.identifier.wosWOS:001293851500001
dc.identifier.wosqualityQ2
dc.indekslendigikaynakScopus
dc.indekslendigikaynakWeb of Science
dc.institutionauthorKılıçkap, Saadettin
dc.institutionauthoridSaadettin Kılıçkap / 0000-0003-1637-7390
dc.language.isoen
dc.publisherElsevier Inc.
dc.relation.ispartofClinical Genitourinary Cancer
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectBladder Cancer
dc.subjectİmmüne Checkpoint İnhibitors
dc.subjectLong-term Followup
dc.subjectResponse Rate
dc.subjectSurrogate Marker
dc.titleObjective Response Rate is a Surrogate Marker for Long-Term Overall Survival in Metastatic Urothelial Carcinoma Patients Treated With Immune Checkpoint Inhibitors
dc.typeArticle

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