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Öğe Evaluation of the efficacy and safety of nivolumab in the second- or later-line treatment of patients with locally advanced/metastatic non-small cell lung cancer in Türkiye: a retrospective multicenter non-interventional registry study(Taylor & francis LTD, 2024) Karadurmuş, Nuri; Kaplan, Muhammet Ali; Şendur, Mehmet Ali Nahit; Urun, Yuksel; Demirci, Umut; Karaca, Şaziye Burçak; Aydın, Sabin Göktaş; Aykan, Musa Barış; Bilici, Ahmet; Sezer, Ahmet; Yılmaz, Ülkü; Abalı, Hüseyin; Yumuk, Perran Fulden; Değirmencioğlu, Serkan; Demirkazık, Ahmet; Paydaş, Semra; Mirili, Cem; Turna, Hande; Kargı, Ayşegül; Özdoğan, Mustafa; Güven, Deniz Can; Özgüroğlu, Mustafa; Kılıçkap, SaadettinObjectiveTo evaluate the efficacy and safety of nivolumab in the second-line (2L) or later-line (LL) treatment of patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) in real-life setting in T & uuml;rkiye.MethodsThis study was designed as a national, multi-center, retrospective study. The study population was evaluated in two groups for the line of nivolumab therapy: those receiving nivolumab in the 2L (Group 2L) and third-line (3L) or LL (Group 3L/LL). Efficacy was evaluated based on one-year overall survival (OS) and progression-free survival (PFS). Safety was evaluated based on treatment-related adverse events (AEs) and nivolumab discontinuation rate.ResultsOf 244 patients, 52.9% were in Group 2L and 47.1% were in Group 3L/LL. Demographic and clinical characteristics did not differ between the groups. In Group 2L and Group 3L/LL, one-year OS and PFS rates were 60.8% and 61.4% (p = 0.592) and 31.2% and 21.3% (p = 0.078), respectively. The objective response rate (ORR) was 34.7% in Group 2L and 27.3% in Group 3L/LL (p = 0.262). The percentage of patients reporting at least one AE in Groups 2L and 3L/LL was 34.9% and 43.5%, respectively (p = 0.169). Fatigue was the most common (16.4%) treatment-related AE in each group. The groups were comparable regarding the AE frequency. Nivolumab was discontinued in 61 patients in Group 2L and 53 patients in Group 3L/LL, with the most common reason being disease progression (57.4% and 66.0%, respectively).ConclusionNivolumab is safe and effective in the 2L or 3L/LL treatment of locally advanced/metastatic NSCLC and associated with acceptable AEs in real-life setting. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (around 85% of all lung cancers). Patients with NSCLC are usually diagnosed at advanced or metastatic stages. When cancer cells spread to other areas from where they first formed, it is called metastatic cancer. Surgery may not be a treatment option for such patients. Currently, immunotherapeutic agents are used in the treatment of NSCLC. Nivolumab is one of the approved immunotherapeutic agents in the treatment of patients with metastatic NSCLC, who have failed after receiving chemotherapy. Our study explored the efficacy and safety of nivolumab in real-life setting in T & uuml;rkiye. Nivolumab effectiveness was evaluated by overall survival (OS) and progression-free survival (PFS) rates. OS indicates the proportion of patients who are still alive at a given time after diagnosis or treatment initiation. PFS refers to "the length of time during and after cancer treatment that a person lives with the disease but does not get worse." In the present study, one-year OS for 244 patients who received nivolumab was 61.1% and one-year PFS was 26.4%. Nivolumab safety was evaluated based on the frequency of adverse events observed during nivolumab therapy. Of the patients 38.9% had at least one side effect, with fatigue being the most common (16.4%). Our results support the earlier studies and showed that nivolumab was a safe and effective agent and is associated with acceptable side effects.Öğe External Validation of a Novel Risk Model in Patients With Favorable Risk Renal Cell Carcinoma Defined by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC): Results From the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database(Elsevier, 2022) Yekedüz, Emre; Karakaya, Serdar; Ertürk, İsmail; Tural, Deniz; Uçar, Gökhan; Öztaş, Nihan Şentürk; Özgüroğlu, Mustafa; Küçükarda, Ahmet; Sever, Özlem Nuray; Kılıçkap, Saadettin; Öksüzoğlu, Berna; Demirci, Umut; Arıkan, NuriyeBackground: A novel prognostic model was recommended for patients with metastatic RCC (mRCC) by the International mRCC Database Consortium (IMDC). In this study, we aimed to externally validate a novel risk model for the IMDC-favorable risk group in patients with mRCC. Methods: The Turkish Oncology Group Kidney Cancer Consortium (TKCC) is a multicenter registry that includes 13 cancer centers in Turkey. As described by Schmidt et al., 3 parameters (ie, time from diagnosis to systemic therapy <3 vs. ?3 years, Karnofsky Performance Status [KPS] 80 vs. >80, and the presence of brain, liver, or bone metastasis) were used to divide the IMDC favorable risk group into 2 new categories: very favorable and favorable risk groups. The primary endpoint was overall survival (OS). Time to treatment failure (TTF) and objective response rate (ORR) in the very favorable and favorable risk groups were the secondary endpoints. Results: A total of 545 patients with mRCC from all IMDC risk groups and 112 patients from the favorable risk group were included in this study. According to the novel classification model, 44 (39.3%) and 68 (60.7%) patients with former favorable risk were categorized into very favorable and favorable risk groups, respectively. The median OS (55.8 months vs. 34.2 months, P = .025) and TTF (25.5 months vs. 15.5 months, P = .010) were longer in the very favorable risk group than in the favorable risk group. The concordance index of the new IMDC model in all patients was 0.65 for OS. Despite the higher ORR in the very favorable risk group than in the favorable risk group, the difference between the groups was not statistically significant (52.4% vs. 44.7, P = .573). Conclusions: This was the first study to externally validate the novel IMDC risk model presented in the American Society of Clinical Oncology Genitourinary Cancers Symposium 2021.Öğe Patient-reported outcomes (PROs) of cemiplimab vs chemotherapy in advanced non-small cell lung cancer (aNSCLC): EMPOWER-lung 1 histology subgroups(ELSEVIER, 2022) Sezer, A.; Kılıçkap, Saadettin; Gümüş, M; Bondarenko, Igor; Özgüroğlu, Mustafa; Gogishvili, Miranda; He, X.; Gullo, Guiseppe; Rietschel, Petra; Quek, RubenPatient-reported outcomes (PROs) of cemiplimab vs chemotherapy in advanced non-small cell lung cancer (aNSCLC): EMPOWER-Lung 1 histology subgroupsÖğe Patient-reported outcomes of cemiplimab versus chemotherapy in advanced NSCLC: PD-L1 level subgroups in EMPOWER-lung 1(Elsevier Science, 2022) Sezer, Ahmet; Gümüş, Mahmut; Bondarenko, Igor N; Özgüroğlu, Mustafa; Gogishvili, Miranda; He, X.; Gullo, Guiseppe; Rietschel, Petra; Quek, Ruben GwPatient-reported outcomes of cemiplimab versus chemotherapy in advanced NSCLC: PD-L1 level subgroups in empower-lung 1Öğe Patient-reported outcomes with cemiplimab versus chemotherapy in advanced non-small cell lung cancer (aNSCLC): geographic region subgroups in EMPOWER-Lung 1(Elsevier, 2022) Ho, Gwo Fuang; Sezer, Ahmet; Kılıçkap, Saadettin; Bondarenko, Igor; Özgüroğlu, Mustafa; Gogishvili, Miranda(Özet Yok / Not Abstract Avaliable)Öğe 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, YükselIntroduction: 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.Öğe 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, YükselThe 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.
