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 The real-life efficacy and safety of osimertinib in pretreated advanced non-small cell lung cancer patients with T790M mutation: a Turkish Oncology Group Study(2021) Hizal, Mutlu; Bilgin, Burak; Paksoy, Nail; Acikgoz, Ozgur; Sezer, Ahmet; Gurbuz, Mustafa; Ak, Naziye; Yucel, Sebnem; Ayhan, Murat; Erol, Cihan; Demirkiran, Aykut; Mandel, Nil Molinas; Shbair, Abdallah; Gokmen, Ivo; Basoglu, Tugba; Paydas, Semra; Demiray, Atike Gokcen; Iriagac, Yakup; Sakalar, Teoman; Zeynelgil, Esra; Tatli, Ali Murat; Bahceci, Aykut; Guven, Deniz Can; Caner, Burcu; Can, Alper; Gulmez, Ahmet; Karakas, Yusuf; Yalcin, Bulent; Demirkazik, Ahmet; Bilici, Ahmet; Aydiner, Adnan; Yumuk, Perran Fulden; Sendur, Mehmet Ali Nahit; 34331582Introduction Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose disease progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation. Materials and methods This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety. Results Of 163 patients, 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13-month follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion Osimertinib is a highly effective option in second- or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.Item Cardiotoxicity of Trastuzumab Emtansine (T-DM1): A Single-center Experience(2021) Acibuca, Aynur; Sezer, Ahmet; Yilmaz, Mustafa; Sumbul, Ahmet Taner; Demircan, Senol; Muderrisoglu, Ibrahim Haldun; Ozyilkan, Ozgur; 0000-0002-3444-8845; 34898302; ABG-4047-2020Objective New anti-cancer drugs promise to increased survival benefits and reduce adverse events. Trastuzumab emtansine (T-DM1) is a novel anti-human epidermal growth factor receptor 2 agent that has shown minimal cardiotoxicity in clinical trials. However, data on real-life outcomes are required. Methods A retrospective review of our center's medical records was performed, including female patients aged >= 18 years with a diagnosis of metastatic breast cancer who were treated with T-DM1. Descriptive statistics were used to investigate clinical features that could increase the risk of cardiotoxicity. Cardiotoxicity was determined by comparing pre and post-T-DM1 echocardiogram results and was defined as a decrease in the left ventricular ejection fraction (LVEF) >10% to below 55%. Results Data from 41 female patients with a mean age of 52 +/- 11.5 years were evaluated. A significant LVEF decrease (from 59% to 33%) was observed in one patient during T-DM1 treatment. Further investigation showed that this decrease was due to underlying coronary artery disease, and LVEF recovered to the baseline value after coronary revascularization. Conclusion T-DM1 seems to be safe in terms of cardiotoxicity. Real-life data with a larger sample size are still needed to confirm the cardiac safety of T-DM1.Item 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 Low Systemic Inflammation Response Index Predicts Good Prognosis in Locally Advanced Pancreatic Carcinoma Patients Treated with Concurrent Chemoradiotherapy(2020) Topkan, Erkan; Mertsoylu, Huseyin; Kucuk, Ahmet; Besen, Ali Ayberk; Sezer, Ahmet; Sezen, Duygu; Bolukbasi, Yasemin; Selek, Ugur; Pehlivan, Berrin; 0000-0002-7862-0192; 0000-0002-6445-1439; 0000-0002-1932-9784; 0000-0001-8120-7123; AAD-6910-2021; AAD-2667-2020; M-9530-2014; AAG-2213-2021Background. We investigated the prognostic significance of pretreatment systemic inflammation response index (SIRI) in locally advanced pancreatic carcinoma (LAPC) patients treated with concurrent chemoradiotherapy (CRT). Methods. Present retrospective cohort analysis investigated consecutive 154 LAPC patients who received radical CRT. The SIRI was defined as:SIRI=neutrophilxmonocyte/lymphocyte counts. Ideal SIRI cutoff(s) influencing overall survival (OS) and progression-free survival (PFS) results were sought by using receiver operating characteristic (ROC) curve analysis. The primary endpoint was the interaction between the SIRI and OS results. Results. The median follow-up, PFS, and OS durations were 14.3 (range: 2.9-74.6), 7.9 [%95 confidence interval (CI): 5.7-10.1), and 14.7 months (%95 CI: 11.4-18.0) for the entire cohort, respectively. ROC curve analyses determined the ideal SIRI cutoff that exhibiting a significant link with OS and PFS outcomes at the rounded 1.6 point (AUC: 74.3%; sensitivity: 73.8%; specificity: 70.1%).The SIRI <1.6 patients (N=58) had significantly superior median PFS (13.8 versus 6.7 months; P<0.001) and OS (28.6 versus 12.6 months; P<0.001) lengths than SIRI >= 1.6 patients (N=96), respectively. Although the N0 (versus N1; P<0.05) and CA 19-9 <= 90 U/mL (versus >90 U/mL) appeared as the other significant associates of better OS and PFS in univariate analyses, yet the results of multivariate analyses confirmed the SIRI <1.6 as the independent indicator of superior OS and PFS (P<0.001 for each). Conclusion. Pretreatment SIRI is a novel independent prognosticator that may further enhance the conventional tumor-node-metastases staging system in a more precise prediction of the OS and PFS outcomes of LAPC patients after radical CRT.Item Comparison of Involved Field Radiotherapy versus Elective Nodal Irradiation in Stage IIIB/C Non-Small-Cell Lung Carcinoma Patients Treated with Concurrent Chemoradiotherapy: A Propensity Score Matching Study(2020) Topkan, Erkan; Ozdemir, Yurday; Guler, Ozan Cem; Kucuk, Ahmet; Besen, Ali Ayberk; Mertsoylu, Huseyin; Sezen, Duygu; Akdemir, Eyub Yasar; Sezer, Ahmet; Bolukbasi, Yasemin; Pehlivan, Berrin; Selek, Ugur; 0000-0002-1932-9784; 0000-0001-6908-3412; 0000-0002-2218-2074; 0000-0002-6445-1439; 0000-0001-8120-7123; 0000-0002-7862-0192; 32952557; M-9530-2014; AAC-5654-2020; AAG-5629-2021; AAD-2667-2020; AAG-2213-2021; AAD-6910-2021Background. We retrospectively compared the incidence of isolated elective nodal failure (IENF) and toxicity rates and survival outcomes after elective nodal irradiation (ENI) versus involved-field RT (IFRT) by employing the propensity score matching (PSM) methodology in stage IIIB/C inoperable non-small-cell lung cancer (NSCLC) patients treated with definitive concurrent chemoradiotherapy (C-CRT).Methods. Our PSM examination included 1048 stage IIIB/C NSCLC patients treated with C-CRT from January 2007 to December 2016: a total dose of 66 Gy (2 Gy/fraction) radiotherapy and 1-3 cycles of platinum-based doublet chemotherapy concurrently. The primary and secondary endpoints were the IENF and toxicity rates and survival outcomes after ENI versus IFRT, respectively. Propensity scores were calculated for each group to adjust for confounding variables and facilitate well-balanced comparability by creating 1 : 1 matched study groups.Results. The median follow-up was 26.4 months for the whole study accomplice. The PSM analysis unveiled 1 : 1 matched 646 patients for the ENI (N = 323) and IFRT (N = 323) cohorts. Intergroup comparisons discovered that the 5-year isolated ENF incidence rates (3.4% versus 4.3%;P=0.52) and median overall survival (25.2 versus 24.6 months;P=0.69), locoregional progression-free survival (15.3 versus 15.1 months;P=0.52), and progression-free survival (11.7 versus 11.2 months;P=0.57) durations were similar between the ENI and IFRT cohorts, separately. However, acute grade 3-4 leukopenia (P=0.0012), grade 3 nausea-vomiting (P=0.006), esophagitis (P=0.003), pneumonitis (P=0.002), late grade 3-4 esophageal toxicity (P=0.038), and the need for hospitalization (P<0.001) were all significantly higher in the ENI than in the IFRT group, respectively.Conclusion. Results of the present large-scale PSM cohort established the absence of meaningful IENF or survival differences between the IFRT and ENI cohorts and, consequently, counseled the IFRT as the elected RT technique for such patients since ENI increased the toxicity rates.
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