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    Objective Response Rate is a Surrogate Marker for Long-Term Overall Survival in Metastatic Urothelial Carcinoma Patients Treated With Immune Checkpoint Inhibitors
    (Elsevier Inc., 2024) Tural, Deniz; Arslan, Çağatay; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Erman, Mustafa; Ürün, Yüksel; Erdem, Dilek; Kılıçkap, Saadettin
    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. © 2024 Elsevier Inc.
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    The relationship between pan-immune-inflammation value and survival outcomes in patients with metastatic renal cell carcinoma treated with nivolumab in the second line and beyond: A Turkish oncology group kidney cancer consortium (TKCC) study
    (Springer, 2022) Tural, Deniz; Yekedüz, Emre; Ertürk, İsmail; Karakaya, Serdar; Erol, Cihan; Ercelep, Özlem; Arslan, Çağatay; Sever, Özlem Nuray; Şentürk Öztaş, Nihan; Küçükarda, Ahmet; Can, Orçun; Öksüzoğlu, Berna; Şendur, Mehmet Ali; Karadurmuş, Nuri; Urun, Yüksel; Kılıçkap, Saadettin
    Background Pan-immune-infammation value (PIV) is an easily accessible immune marker based on peripheral blood to estimate prognosis in patients with cancer. This study evaluates the prognostic value of PIV in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab. Methods In this retrospective cohort study, patients with mRCC treated with nivolumab in the second line and beyond were selected from the Turkish Oncology Group Kidney Cancer Consortium (TKCC) database. PIV was calculated using the following formula: neutrophil (103 /mm3 ) x monocyte (103 /mm3 ) x platelet (103 /mm3 )/lymphocyte (103 /mm3 ). Results A total of 152 patients with mRCC were included in this study. According to cut-of value for PIV, 77 (50.7%) and 75 (49.3%) patients fell into PIV-low (? 372) and PIV-high (>372) groups, respectively. In multivariate analysis, PIV-high (HR: 1.64, 95% CI 1.04–2.58, p=0.033 for overall survival (OS); HR: 1.55, 95% CI 1.02–2.38, p=0.042 for progression-free survival (PFS)) was independent risk factor for OS and PFS after adjusting for confounding variables, such as performance score, the International mRCC Database Consortium (IMDC) risk score, and liver metastasis. Conclusion This study established that pre-treatment PIV might be a prognostic biomarker in patients with mRCC treated with nivolumab in the second line and beyond.
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    The relationship between systemic immune inflammation index and survival in patients with metastatic renal cell carcinomatreated withtyrosine kinase inhibitors
    (Nature Research, 2022) Yücel, Kadriye Bir; Yekedüz, Emre; Karakaya, Serdar; Tural, Deniz; Ertürk, İsmail; Erol, Cihan; Ercelep, Özlem; Öztaş Şentürk, Nihan; Arslan, Çağatay; Uçar, Gökhan; Küçükarda, Ahmet; Sever, Özlem Nuray; Kılıçkap, Saadettin; Can, Orçun; Yazgan, Satı Çoskun; Öksüzoğlu, Berna; Karadurmuş, Nuri; Şendur, Mehmet Ali; Ürün, Yüksel
    This study aims to investigate the prognostic value of the systemic immune-inflammation index (SII)and its impact on survival in patients with metastatic renal cell carcinoma (mRCC). A total of 706patients with mRCC treated with tyrosine kinase inhibitors (TKIs)between January 2007 and June 2020 (i.e., sunitinib, pazopanib) were included in this study. SII was calculated in 621 patients with the following formula:[neutrophil (cellsx109/L) x platelet (cellsx109/L)] / lymphocyte (cellsx109/L).All patients were classified into SII-high and SII-low groups based on the cut-off value of SII at 756, which was the median SII level of our study group. The minimal follow-up duration was 10 months in all cohorts. The median age of patients was 60 (interquartile range (IQR):53–67) years. Three out of four patients were male. The majority of patients (85.7%) had clear cell histology, and sarcomatoid differentiation was observed in 16.9% of all patients. There were 311 and 310 patients in the SII-low and SII-high groups, respectively. In general, baseline characteristics were similar in each group. However, the rate of patients treated with sunitinib (63.3% vs. 49.0%, p < 0.001) and those who underwent nephrectomy (83.6% vs. 64.2%, p < 0.001) was higher in the SII-low group than in the SII-high group. On the other hand, patients with the IMDC poorrisk (31.6% vs. 8.0%, p < 0.001), those with bone (51.8% vs. 32.2%, p < 0.001) or central nervous system (12.9% vs. 5.8%, p = 0.026) metastasis, and those with Eastern Cooperative Oncology Group(ECOG) 2–4 performance score (28.1% vs.17.7%, p = 0.002) were more common in the SII-high group than in the SII-low group. The median overall survival (OS) was longer in the SII-low group than in the SII-high group (34.6 months vs. 14.5 months, p < 0.001). Similarly, the median progression-free survival (PFS) was longer in the SII-low group than in the SII-high group (18.0 months vs. 7.7 months, p < 0.001).In multivariableanalysis, SII was an independent prognostic factor for OS (hazard ratio (HR):1.39, 95% confidence interval (CI):1.05–1.85, p = 0.01) and PFS (HR:1.60, 95% CI:1.24–2.05, p < 0.001).Pre-treatment level of high SII might be considered a predictor of poor prognosisin patients with mRCC treated with TKIs.
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    Treatment patterns and attrition in metastatic renal cell carcinoma: real-life experience from the Turkish oncology group kidney cancer consortium (TKCC) database
    (CIG media group, 2024) Bölek, Hatice; Sertesen, Elif; Kuzu, Ömer Faruk; Tural, Deniz; Sim, Saadet; Şendur, Mehmet Ali Nahit; Uçar, Gökhan; Işık, Selver; Hacıoğlu, Bekir; Çiçin, İrfan; Arslan, Çağatay; Göksu, Sema Sezgin; Sever, Özlem Nuray; Karaçin, Cengiz; Karadurmuş, Nuri; Özgüroğlu, Mustafa; Yekedüz, Emre; Ürün, Yüksel
    The inclusion of patients with more favorable prognoses in clinical trials imits generalizability to broader and more diverse patient group. This study examines treatment patterns and attrition rates in Turkish oncology clinics for metastatic renal cell carcinoma. The percentages of patients receiving treatment in the second, third, and fourth lines of therapy were 62.8%, 27.4%, and 8.9%, respectively. Disease progression was the primary cause of attrition, followed by toxicity. Introduction: Despite the rapid evolution in management of metastatic renal cell carcinoma (mRCC) over the past decade, challenges remain in accessing new therapies in some parts of the world. Despite therapeutic advancements, attrition rates remain persistently high. This study aims to assess the treatment patterns and attrition rates of patients with mRCC in oncology clinics across Turkey. Patients and Methods: Patients diagnosed with mRCC between January 1, 2008, and December 31, 2022, with first-line systemic treatment data, were retrospectively evaluated using the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database. Results: The final analysis included a total of 1126 patients. The percentages of patients treated in the 2nd, 3rd, 4th, and 5th lines of therapy were 62.8%, 27.4%, 8.9%, and 2.1%, respectively. The drugs that were most commonly used in the groups were tyrosine kinase inhibitors (TKIs) (52.2%) and interferon (IFN)-alpha (43.3%) for the first line, TKIs (66.3%) and immunotherapy (IO) monotherapy (25.9%) for the second line, TKI (41.4%) and mTOR inhibitors (28.8%) for the third line, TKI (44.4%) and mTOR inhibitors (29%) for the fourth line, and IO monotherapy (37.5%) and TKI (25%) for the fifth line. For the first-line treatment, the primary cause of attrition was disease progression (66.4%), followed by toxicity (16.5%), death (11.2%), and patient preference (5.9%). The primary reason for attrition across all treatment lines was disease progression. Over time, the use of TKIs in first-line treatment increased, while IFN-alpha usage declined. IOs began to be utilized in earlier lines, predominantly in second-line treatment, though use of IO-based combination therapies remains limited. Conclusion: This study underscores that despite significant progress in therapeutic options, the adoption of novel agents remains slow, and attrition rates are still high. These findings indicate a disparity in systemic therapy compared to developed countries.
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    Treatment patterns and attrition in metastatic renal cell carcinoma: real-life experience from the Turkish oncology group kidney cancer consortium (TKCC) database
    (Elsevier inc., 2025) Bölek, Hatice; Sertesen, Elif; Kuzu, Ömer Faruk; Tural, Deniz; Sim, Saadet; Nahit Şendur, Mehmet Ali; Uçar, Gökhan; Işık, Selver; Hacıoğlu, Bekir; Çiçin, İrfan; Arslan, Çağatay; Göksu, Sema Sezgin; Sever, Özlem Nuray; Karaçin, Cengiz; Karadurmuş, Nuri; Özgüroğlu, Mustafa; Yekedüz, Emre; Ürün, Yüksel
    Introduction: Despite the rapid evolution in management of metastatic renal cell carcinoma (mRCC) over the past decade, challenges remain in accessing new therapies in some parts of the world. Despite therapeutic advancements, attrition rates remain persistently high. This study aims to assess the treatment patterns and attrition rates of patients with mRCC in oncology clinics across Turkey. Patients and Methods: Patients diagnosed with mRCC between January 1, 2008, and December 31, 2022, with first-line systemic treatment data, were retrospectively evaluated using the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database. Results: The final analysis included a total of 1126 patients. The percentages of patients treated in the 2nd, 3rd, 4th, and 5th lines of therapy were 62.8%, 27.4%, 8.9%, and 2.1%, respectively. The drugs that were most commonly used in the groups were tyrosine kinase inhibitors (TKIs) (52.2%) and interferon (IFN)-alpha (43.3%) for the first line, TKIs (66.3%) and immunotherapy (IO) monotherapy (25.9%) for the second line, TKI (41.4%) and mTOR inhibitors (28.8%) for the third line, TKI (44.4%) and mTOR inhibitors (29%) for the fourth line, and IO monotherapy (37.5%) and TKI (25%) for the fifth line. For the first-line treatment, the primary cause of attrition was disease progression (66.4%), followed by toxicity (16.5%), death (11.2%), and patient preference (5.9%). The primary reason for attrition across all treatment lines was disease progression. Over time, the use of TKIs in first-line treatment increased, while IFN-alpha usage declined. IOs began to be utilized in earlier lines, predominantly in second-line treatment, though use of IO-based combination therapies remains limited. Conclusion: This study underscores that despite significant progress in therapeutic options, the adoption of novel agents remains slow, and attrition rates are still high. These findings indicate a disparity in systemic therapy compared to developed countries.