Wos İndeksli Yayınlar Koleksiyonu
Permanent URI for this collectionhttps://hdl.handle.net/11727/4807
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Item Real-life analysis of pathologic complete response with neoadjuvant trastuzumab plus taxane with or without pertuzumab therapy in HER2 positive locally-advanced breast cancer (HER2PATH Study).(2022) Bilici, Ahmet; Olmez, Omer Fatih; Sezer, Ahmet; Oksuzoglu, Berna; Kaplan, Muhammet Ali; Karadurmus, Nuri; Cubukcu, Erdem; Sendur, Mehmet A. N.; Aksoy, Sercan; Erdem, Dilek; Basaran, Gul; Cakar, Burcu; Seker, Mesut; Arslan, Cagatay; Goksu, Sema Sezgin; Cicin, Irfan; Gumus, Mahmut; Selcukbiricik, Fatih; Harputluoglu, Hakan; Helvaci, KaanItem Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial(2021) Sezer, Ahmet; Kilickap, Saadettin; Gumus, Mahmut; Bondarenko, Igor; Ozguroglu, Mustafa; Gogishvili, Miranda; Turk, Haci M.; Cicin, Irfan; Bentsion, Dmitry; Gladkov, Oleg; Clingan, Philip; Sriuranpong, Virote; Rizvi, Naiyer; Gao, Bo; Li, Siyu; Lee, Sue; McGuire, Kristina; Chen, Chieh I; Makharadze, Tamta; Paydas, Semra; Nechaeva, Marina; Seebach, Frank; Weinreich, David M.; Yancopoulos, George D.; Gullo, Giuseppe; Lowy, Israel; Rietschel, Petra; 33581821Background We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%. Methods In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged >= 18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing. Findings Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17.9-not evaluable) with cemiplimab (n=283) versus 14.2 months (11.2-17.5) with chemotherapy (n=280; hazard ratio [HR] 0.57 [0.42-0.77]; p=0.0002). Median progression-free survival was 8.2 months (6.1-8.8) with cemiplimab versus 5.7 months (4.5-6.2) with chemotherapy (HR 0.54 [0.43-0.68]; p<0.0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy. Interpretation Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population. Copyright (C) 2021 Elsevier Ltd. All rights reserved.Item Metastatic Cutaneous Melanoma Epidemiological Registry in Turkey: A Preliminary Evaluation of Diagnosis and Treatment Approaches(2021) Karaca, Burcak S.; Sezer, Ahmet; Goksu, Sezgin S.; Cicin, Irfan; Erdem, Dilek; Cubukcu, Erdem; Dane, Faysal; Hacibekiroglu, Ilhan; Oksuzoglu, Berna; Alnigenis, Ebru; Ulay, Esat; Celik, IsmailItem Prognostic factors for survival in patients with mucosal and ocular melanoma treated with ipilimumab: Turkish Oncology Group study(2020) Yasar, H. Arzu; Turna, Hande; Esin, Ece; Sedef, A. Murat; Alkan, Ali; Oksuzoglu, Berna; Ozdemir, Nuriye; Sendur, M. A. Nahit; Sezer, Ahmet; Kilickap, Saadettin; Utkan, Gungor; Akbulut, Hakan; Celik, Ismail; Abali, Huseyin; Urun, Yuksel; 0000-0002-6445-1439; 30924738; AAD-2667-2020Objective To evaluate prognostic factors associated with the use of ipilimumab in patients with mucosal and uveal melanoma. Methods In this multicenter, retrospective study, 31 patients with uveal and mucosal melanoma diagnosed between 2010 and 2017 were enrolled. Patients' characteristics, metastatic disease sites, treatment before ipilimumab therapy, performance status, hemoglobin, lactate dehydrogenase levels, B-RAF and c-kit mutation status, toxicity, and survival data were assessed for patients with mucosal and uveal melanoma. SPSS version 17 was used for statistical analysis. Kaplan-Meier method was used for survival analysis. The log-rank test was used for univariate analyses. The Cox regression analysis was used to test the association between multivariate variables and survival. The p-value of less than 0.05 was considered statistically significant. Results Twenty patients had uveal and eleven patients had mucosal melanoma. The median overall survival was seven months (95% confidence interval: 1.1-12.7). In univariate analysis, while bone metastasis, anemia, high lactate dehydrogenase level, and more metastatic sites were associated with lower overall survival, better treatment response and administration of ipilimumab in first or second lines were associated with favorable overall survival. In multivariate analysis, only treatment response status and administration of ipilimumab in first or second lines were found to be significant as independent prognostic factors for survival. Conclusion Ipilimumab therapy may be associated with increased survival, but this retrospective small N study makes that hard to definitely conclude.Item GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients(2020) Sezer, Ahmet; Ozyilkan, Ozgur; 0000-0002-6445-1439; 0000-0001-8825-4918; 32799090; AAD-2667-2020; AAD-2817-2021Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1( + ) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib. Methods: 123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria. Results: 106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. The ALK( + ) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 +/- 1.6 months and median overall survival (mOS) was 89.1 +/- 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 +/- 2.5 months and mOS of 90.3 +/- 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters. The most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18 % of patients. Conclusion: Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. The observed mOS of 89 +/- 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 +/- 24 months is unprecedented for ROS1( + ) NSCLC.Item Concurrent versus sandwich treatment in adjuvant treatment in high risk operated gastric cancer: A single center experience(2020) Sezer, Ahmet; Akkus, Berna; Guler, Ozan Cem; Onal, Huseyin Cem; Sumbul, Ahmet Taner; 0000-0001-6908-3412; 0000-0002-2742-9021; 33277854; AAC-5654-2020; D-5195-2014Purpose: In this study we compared postoperative early vs sandwich chemoradiotherapy in operated stage IIA-IIIC gastric cancer patients in terms of effectiveness and outcome. Methods: The data of 201 gastric cancer patients treated in the same center between December 2006 and June 2017 were retrospectively evaluated. One hundred forty nine patients who were eligible for the study criteria were divided into two groups according to the postoperative treatment modality. The first group included 85 patients who were given chemoradiotherapy simultaneously (ETG) and the second group icluded 64 patients who received sandwich (chemotherapychemoradiotherapy-chemotherapy) (STG) treatment. Overall survival (OS) and disease-free survival (DFS) were evaluated as primary endpoints. Results: The median follow-up time for all patient groups was 26.7 months (1.3-136.5 months). Adjuvant chemotherapy and radiotherapy were initiated concurrently in patients receiving concomitant therapy. Half of the planned chemotherapy, then chemoradiotherapy and then the remaining chemotherapy treatments were given to the sandwich treatment group. A total of 50.4 Gy radiotherapy was given to the concurrent chemoradiotherapy group and a total of 45 Gy radiotherapy to the group receiving the sandwich treatment. OS was 30.6 months (23.7-37.5) in all groups, 30.4 months (23.7-35.0) in concurrent therapy (ETG) and 35.6 months (26.3-45) in sandwich therapy (STG) (p=0.73). DFS was 26.6 months (21.3-32.0) in all groups and 24.5 months (18.1-31.0) in the group receiving ETG, 32.5 months (22.242.8) in STG. (p=0.46). The most common grade 3 and above toxicities were; acute upper gastrointestinal toxicity (19.1% in ETG vs. 9.0% in STG, p=0.01) and hematological toxicity (31.8% in ETG vs. 13.9% in STG; p=0.002). Early cessation of treatment was similar in both groups. In multivariate analysis, female gender (p=0.01), stage III disease, grade III disease were seen as negative predictive factors for overall survival. In DFS multivariate analysis, there was no difference between the groups in terms of gender, T stage, N stage, and AJCC stage. Conclusion: In this study, superiority of sandwich treatment over concurrent treatment was observed in patients with operated stage IIB-IIIC gastric cancer, but the difference was not statistically significant. If this study is performed in larger patient series, the difference of sandwich treatment may become meaningful.Item Prognostic factors for survival in patients with metastatic malign melanoma treated with ipilimumab: Turkish Oncology Group study(2019) Urun, Yuksel; Yasar, H. Arzu; Turna, Hande; Esin, Ece; Sedef, A. Murat; Alkan, Ali; Oksuzoglu, Berna; Ozdemir, Nuriye; Sendur, M. A. Nahit; Sezer, Ahmet; Kilickap, Saadettin; Utkan, Gungor; Akman, Tulay; Akbulut, Hakan; Celik, Ismail; Abali, Huseyin; 30400750Purpose Studies in the last decade show survival improvement with checkpoint blocker therapy in patients with metastatic malign melanoma. Our purpose was to define the efficacy of ipilimumab according to the patient's baseline characteristics including absolute lymphocytes count. Methods We collected the data of 97 patients with advanced malign melanoma treated with ipilimumab (3 mg/kg, q3w) retrospectively. Log-rank test was used to analyze the univariate effects of patient's characteristics (age, gender, metastatic sites, ECOG PS, type of melanoma, lactic dehydrogenase levels, anemia, lymphocytes (L), neutrophils (N), N/L ratio), c-kit and BRAF status. Survival analyses were estimated with Kaplan-Meier method. Cox regression analysis was used to assess the possible factors identified with log-rank test. Results The median age was 58, and 58% were male and 90% of patients had at least one prior systemic therapy. The median survival was 9.7 months for all patients; and the 12- and 24-month survival rates were 43% and 19%, respectively. Absolute lymphocytes count, lactic dehydrogenase level, bone metastasis, the number of metastatic sites, and RECIST response were significantly related to survival. After Cox regression analysis, RECIST response (complete or partial response), absolute lymphocytes count (more than 1500/mm(3)) and the number of metastatic sites (less than three sites) remained as significant independent prognostic factors for longer survival. Conclusion Ipilimumab improved survival of patients with metastatic malign melanoma. However, patients with fewer metastatic sites and higher absolute lymphocytes count have a significantly better benefit. To determine if these markers could be used to direct patient therapy, further validation analysis is needed.Item Re: Combination of radiotherapy and immunotherapy? Do timing and dose matter?(2019) Urun, Yuksel; Yasar, H. Arzu; Turna, Hande; Kilickap, Saadettin; Sezer, Ahmet; Oksuzoglu, Berna; Ozdemir, Nuriye; Sendur, M. A. Nahit; Abali, Huseyin; 31226917