Objective response rate is a surrogate marker for long-term overall survival in metastatic urothelial carcinoma patients treated with immune checkpoint inhibitors
| dc.authorid | 0000-0001-7934-7039 | |
| dc.contributor.author | Tural, Deniz | |
| dc.contributor.author | Arslan, Çağatay | |
| dc.contributor.author | Selçukbiricik, Fatih | |
| dc.contributor.author | Ölmez, Ömer Fatih | |
| dc.contributor.author | Erman, Mustafa | |
| dc.contributor.author | Ürün, Yüksel | |
| dc.contributor.author | Erdem, Dilek | |
| dc.contributor.author | Kılıçkap, Saadettin | |
| dc.date.accessioned | 2024-09-20T11:14:26Z | |
| dc.date.available | 2024-09-20T11:14:26Z | |
| dc.date.issued | 2024 | |
| dc.department | İstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı | |
| dc.description.abstract | Background: 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. | |
| dc.identifier.citation | Tural, D., Arslan, Ç., Selçukbiricik, F., Ölmez, Ö. F., Erman, M., Ürün, Y. ... Kılıçkap, 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). http://dx.doi.org/10.1016/j.clgc.2024.102163 | |
| dc.identifier.doi | 10.1016/j.clgc.2024.102163 | |
| dc.identifier.issn | 1558-7673 | |
| dc.identifier.issn | 1938-0682 | |
| dc.identifier.issue | 5 | |
| dc.identifier.pmid | 39126823 | |
| dc.identifier.scopus | 2-s2.0-85200628717 | |
| dc.identifier.scopusquality | Q1 | |
| dc.identifier.uri | http://dx.doi.org/10.1016/j.clgc.2024.102163 | |
| dc.identifier.uri | https://hdl.handle.net/20.500.12511/12818 | |
| dc.identifier.volume | 22 | |
| dc.identifier.wos | 001293851500001 | en_US |
| dc.identifier.wosquality | Q2 | |
| dc.indekslendigikaynak | Web of Science | |
| dc.indekslendigikaynak | Scopus | |
| dc.indekslendigikaynak | PubMed | |
| dc.institutionauthor | Ölmez, Ömer Fatih | |
| dc.language.iso | en | |
| dc.relation.ispartof | Clinical Genitourinary Cancer | en_US |
| dc.relation.publicationcategory | Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı | |
| dc.rights | info:eu-repo/semantics/openAccess | |
| dc.subject | Bladder Cancer | |
| dc.subject | Immüne Checkpoint Inhibitors | |
| dc.subject | Long-Term Followup | |
| dc.subject | Response Rate | |
| dc.subject | Surrogate Marker | |
| dc.title | Objective response rate is a surrogate marker for long-term overall survival in metastatic urothelial carcinoma patients treated with immune checkpoint inhibitors | |
| dc.type | Article |
