PubMed Açık Erişimli Yayınlar
Permanent URI for this collectionhttps://hdl.handle.net/11727/10763
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Item nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR +, HER2-metastatic breast cancer(2022) Hamilton, Erika; Cortes, Javier; Ozyilkan, Ozgur; Chen, Shin-Cheh; Petrakova, Katarina; Manikhas, Aleksey; Jerusalem, Guy; Hegg, Roberto; Huober, Jens; Zhang, Wei; Chen, Yanyun; Martin, Miguel; 35829935Purpose Resistance to endocrine therapy poses a major clinical challenge for patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). We present the preplanned 24-month final overall survival (OS) results, alongside updated progression-free survival (PFS), and objective response rate (ORR) results. Methods nextMONARCH is an open-label, controlled, randomized, Phase 2 study of abemaciclib alone or in combination with tamoxifen in women with endocrine-refractory HR + , HER2- MBC previously treated with chemotherapy. Patients were randomized 1:1:1 to: abemaciclib 150 mg and tamoxifen 20 mg (A + T), abemaciclib 150 mg (A-150), or abemaciclib 200 mg and prophylactic loperamide (A-200). OS was the main prespecified secondary endpoint. PFS, ORR, and safety at 24 months were compared to previously reported primary analysis results. Results Of the 234 patients enrolled, 12 were receiving study treatment at data cutoff (28Jun2019). Median follow-up was 27.2 months. Median OS was 24.2 months in the A + T arm, 20.8 months in A-150, and 17.0 months in A-200 (A + T versus A-200: HR 0.62; 95%CI [0.40, 0.97], P = 0.03 and A-150 versus A-200: HR 0.96; 95%CI [0.64, 1.44], P = 0.83). PFS and ORR results at 24 months were consistent with the primary analysis. The safety profile corresponded with previous reports. Conclusion The addition of tamoxifen to abemaciclib demonstrated greater OS benefit than monotherapy. This study confirmed the single-agent activity of abemaciclib in heavily pretreated women with endocrine-refractory HR + , HER2- MBC, as well as the previously reported primary PFS and ORR results, with no new safety signals observed.Item Prechemoradiotherapy Systemic Inflammation Response Index Stratifies Stage IIIB/C Non-Small-Cell Lung Cancer Patients into Three Prognostic Groups: A Propensity Score-Matching Analysis(2021) Topkan, Erkan; Selek, Ugur; Kucuk, Ahmet; Haksoyler, Veysel; Ozdemir, Yurday; Sezen, Duygu; Mertsoylu, Huseyin; Besen, Ali Ayberk; Bolukbasi, Yasemin; Ozyilkan, Ozgur; Pehlivan, Berrin; 0000-0001-8120-7123; 0000-0002-2218-2074; 0000-0002-7862-0192; 33552158; AAG-2213-2021; AAG-5629-2021; AAD-6910-2021Purpose. We explored the prognostic influence of the systemic inflammation response index (SIRI) on the survival outcomes of stage IIIB/C non-small-cell lung cancer (NSCLC) patients who underwent concurrent chemoradiotherapy. Methods. Present propensity score-matching (PSM) analysis comprised 876 stage IIIB/C NSCLC patients who received 1-3 cycles of platinum-based doublets concurrent with thoracic radiotherapy from 2007 to 2017. The primary and secondary objectives were the relationships between the SIRI values and overall (OS) and progression-free survival, respectively. Propensity scores were calculated for SIRI groups to adjust for confounders and to facilitate well-balanced comparability between the SIRI groups by creating 1 : 1 matched study groups. Results. The receiver operating characteristic curve analysis identified an optimal SIRI cutoff at 1.9 for OS (AUC: 78.8%; sensitivity: 73.7%; specificity: 70.7%) and PFS (AUC: 80.5%; sensitivity: 75.8%; specificity: 72.9%) and we grouped the patients into two PSM cohorts: SIRI < 1.9 (N = 304) and SIRI >= 1.9 (N = 304), respectively. The SIRI >= 1.9 cohort had significantly worse median OS (P<0.001) and PFS (P<0.001) than their SIRI < 1.9 companions. The further combination of SIRI with disease stage exhibited that the SIRI-1 (IIIB and SIRI < 1.9) and SIRI-3 (IIIC and SIRI >= 1.9) cohorts had the best and worst outcomes, respectively, with SIRI-2 cohort (IIIB and SIRI >= 1.9 or IIIC and SIRI < 1.9) being remained in between (P<0.001 for OS and PFS, separately). In multivariate analysis, the two- and three-laddered stratifications per the 1.9 cutoffs and SIRI groups retained their independent significance, individually. Conclusions. The SIRI >= 1.9 independently prognosticated significantly worse OS and PFS results and plated the stage IIIB/C patients into three fundamentally distinct prognostic groups.Item Characteristics of Newly Diagnosed Hepatocellular Carcinoma Patients Across Turkey: Prospective Multicenter Observational 3K Registry Study(2021) Ozyilkan, Ozgur; 34876392Aims: To evaluate patient profile for epidemiological and clinicopathological characteristics and potential risk/prognostic factors in newly diagnosed hepatocellular carcinoma (HCC) patients across Turkey. Methods: A total of 547 patients (mean (SD) age 62.6 (10.3) years, 81.9% were males) were included in this registry study. Data on patient characteristics, etiologies of HCC, laboratory values, and tumor characteristics and stages were recorded at study enrollment. Results: HBV infection (68.2%) was the leading etiology, followed by HCV infection (17.2%), HDV infection (5.5%), alcohol (6.4%), and NAFLD (3.5%), as the major etiologies. Considering that 51.6% of the patients had >5 cm HCC, 44% were Child-Pugh B/C and 57% were BCLC B-D, it appears that a significant group of HCC patients were diagnosed at advanced stages. Of 540 patients, 271 (50.2%) were referred or applied with the diagnosis of HCC. Patients with HCC at presentation had larger tumor size (median (min-max) 6.6 (0-30) vs. 4.8 (0-90) cm, P<.001) and more advanced BCLC stage (Stage C-D in 40.8% vs. 26.4%, respectively, P=.005), compared to patients who were diagnosed during follow-up. Conclusions: Our findings revealed that HBV infection was the leading etiology and a moderate-to-advanced disease was evident in more than half of patients at the time of diagnosis. HCC patients diagnosed at follow-up had smaller tumor size and earlier BCLC stage.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 Usefulness Of Advanced Lung Cancer Inflammation Index In Locally-Advanced Pancreatic Carcinoma Patients Treated With Radical Chemoradiotherapy(2019) Topkan, Erkan; Mertsoylu, Huseyin; Ozdemir, Yurday; Sezer, Ahmed; Kucuk, Ahmet; Besen, Ali Ayberk; Ozyilkan, Ozgur; Selek, Ugur; 0000-0002-6445-1439; 31632140Background/Aims: Previously advanced lung cancer inflammation index (ALI) has been demonstrated to have prognostic utility in the stratification of patients into distinctive survival groups, but the prognostic value of ALI has never been explored in the setting of locally advanced pancreatic carcinomas (LAPC) treated with concurrent chemoradiotherapy (CCRT). Hence, we aimed to investigate the prognostic value of pre-treatment ALI in LAPC patients who underwent radical CCRT. Methods: Present retrospective cohort analysis incorporated 141 LAPC patients who received radical CCRT. Accessibility of baseline ALI cutoff(s) impacting survival outcomes was sought by receiver operating characteristic (ROC) curve analysis. Interaction between the ALI and overall- (OS) and progression-free survival (PFS) comprised our primary and secondary endpoints, respectively. Results: At a median follow-up of 14.4 months (range: 3.2-74.2), the median PFS and OS were 7.5 (%95 CI: 5.9-9.1) and 14.6 months (%95 CI: 11.6-17.6), respectively. ROC curve analyses set the ideal ALI cutoff value at 25.3 (AUC: 75.6%; sensitivity: 72.7%; specificity: 70.3%) that exhibited significant associations with both the OS and PFS results. Patient stratification into two groups per ALI [<= 25.3 (N=75) versus>25.3 (N=66)] showed that the ALI>25.3 group had significantly superior median OS (25.8 versus 11.4 months; P<0.001) and PFS (15.9 versus 6.0 months; P<0.001) durations than its ALI <= 25.3 counterpart. Other factors exhibiting significantly better OS and PFS rates were N-0 stage (versus N1; P<0.05 for each endpoint) and CA 19-9 <= 90 U/mL (versus >90 U/mL; P<0.05 for each endpoint), respectively. These three factors were additionally asserted to be independent indicators of longer OS (P<0.05 for each) and PFS (P<0.05 for each) in multivariate analyses. Conclusion: Results of this hypothesis-generating research proposed the pre-CCRT ALI as a novel robust associate of OS and PFS outcomes for LAPC patients undergoing CCRT.Item Targeted treatment with pazopanib in metastatic soft tissue sarcoma: Nearly complete response in two cases(2015) Sedef, Ali Murat; Kose, Fatih; Dogan, Ozlem; Ergun, Tarkan; Sezer, Ahmet; Mertsoylu, Hoseyin; Muallaoglu, Sadik; Besen, Ayberk; Ozyilkan, Ozgur; 25798275Soft tissue sarcomas (STS) are a group of rare mesenchymal cancers that include approximately 50 histological types and account for 1% of all adult cancers. The standard curative treatment option for localized disease is surgical resection and, if a surgically removed tumor exhibits high-risk characteristics, adjuvant chemotherapy and radiotherapy may be administered. Sarcoma presenting at an advanced stage has a dismal prognosis and survival has not markedly improved over the last 20 years. The standard first-line treatment for advanced STS, other than gastrointestinal stromal tumors, is cytotoxic chemotherapy. Therapies targeting pro-angiogenic factors have been a focus of drug development for STS over the last few years. Pazopanib, a multitargeted tyrosine kinase inhibitor, is a novel treatment option for patients with metastatic STS in the second-line setting. This is a presentation of 2 case reports of patients with metastatic STS who responded well to treatment with pazopanib.Item Concurrent Chemoradiotherapy with Vinorelbine plus Split-Dose Cisplatin may be an Option in Inoperable Stage III Non-Small Cell Lung Cancer: A Single-Center Experience(2015) Mertsoylu, Huseyin; Kose, Fatih; Sumbul, Ahmet Taner; Sedef, Ali Murat; Dogan, Ozlem; Besen, Ali Ayberk; Parlak, Cem; Findikcioglu, Alper; Muallaoglu, Sadik; Sezer, Ahmet; Sakalli, Hakan; Ozyilkan, Ozgur; 25731741Background: Concurrent chemoradiotherapy is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC). In this study we aimed to investigate the efficacy and toxicity of CCRT with split dose of cisplatin (30 mg/m(2)) and vinorelbine (20 mg/m(2)) in patients with inoperable stage III NSCLC followed in our oncology clinic. Material/Methods: Medical records of 97 patients with inoperable stage III NSCLC treated with concurrent chemoradiotherapy with cisplatin-vinorelbine were retrospectively analyzed. Cisplatin (30 mg/m(2)) and vinorelbine (20 mg/m(2)) were administered on days 1, 8, 22, and 29 during radiotherapy. Two cycles of consolidation chemotherapy were given. All patient data, including pathological, clinical, radiological, biochemical, and hematological data, were assessed retrospectively using our database system. Results: Our study included 97 unresectable stage III NSCLC patients who were treated with CCRT. Median age was 58 years old (range 39-75) and 87 (89.7%) of the patients were men. ECOG performance score was 0-1 in 93 patients (95.9%). Squamous histology, the most common histology, was diagnosed in 46 patients (47.4%). Median follow-up time was 23.8 months. Median progression-free survival (PFS) and median overall survival time (OS) were 10.3 months and 17.8 months, respectively. Objective response rate and clinical benefit rate were 75.3% and 83.5%, respectively. Distant and local relapse rate were 57.1% and 42.9%, respectively. Hematological and non-hematological grade 3-4 toxicities were seen in 13 (13.4%) and 16 (16.5%) patients, respectively. Six (6.1%) patients died due to toxicity. Conclusions: The results of this study suggest that split-dose cisplatin may offer fewer grade III-IV toxicities without sacrificing efficacy and could be an option in patients with inoperable stage III NSCLC during CCRT. Similar to past studies, despite high response rate during CCRT, distant relapse is the major parameter that influences patient survival in long-term in NSCLC.Item An old enemy not to be forgotten during PET CT scanning of cancer patients: tuberculosis(2016) Sumbul, Ahmet Taner; Sezer, Ahmet; Abali, Huseyin; Gultepe, Bilge; Kocer, Emrah; Reyhan, Mehmet; Tonyali, Onder; Ozyilkan, Ozgur; 27358601Aim of the study: Positron emission tomography-computed tomography (PET CT) scan is commonly used in current medical oncology practice as an imaging method. In this study we present data from cancer patients who were followed at our clinic and suspected of having tuberculosis during PET CT scanning. After the biopsy, they were diagnosed with concomitant tuberculosis. Material and methods: In this study, 14 patients who applied to our clinic and followed up due to cancer, and had PET CT scanning for the preliminary staging or further evaluation, were included. The patients were diagnosed with metastatic or recurrent disease, and their biopsy results revealed tuberculosis. Results: The mean age was 57.8 years with SD (standard deviation) 13.1 years and gender distribution of 78.6% (n = 11) females and 21.4% (n = 3) males. None of the patients had tuberculosis in their personal history (0%). Among the patients, 5 (35.7%) were diagnosed with tuberculosis during the preliminary staging, whereas 9 (64.3%) were diagnosed during the follow-up after the treatment. The median time to tuberculosis diagnosis was 11 months (min-max: 3-24 months) after the treatment. The most commonly involved lymph nodes during PET CT scanning were mediastinal in 8 (64.3%), axillary in 3 (21.4%) and para-aortic in 3 (21.4%) patients. The mean SUVmax (maximum standardised uptake value) of lymph node involved by PET CT scanning was defined as 8.5 (SD 2.6). Conclusions: Despite all improvements in modern medicine, tuberculosis is still a serious public health problem. It should always be considered in differential diagnosis while evaluating PET CT scanning results of cancer patients, because it may cause false positive results.Item A national, multicenter, non-interventional, observational study on treatment patterns in patients with metastatic renal cell carcinoma in Turkey - NOTES study(2018) Ozyilkan, Ozgur; Yalcin, Suayib; Yildiz, Ramazan; Dane, Faysal; Karaoglu, Aziz; Oksuzoglu, Berna; Sevinc, Alper; Ozdemir, Feyyaz; Turna, Hande; Uslu, Ruchan; Ulay, Esat; 0000-0001-8825-4918; 29551901; AAD-2817-2021Introduction: The introduction of targeted therapies in renal cell carcinoma has significantly improved its prognosis and treatment outcomes in recent years. Such treatment options are targeted therapies of the vascular endothelial growth factor (VEGF) pathway and the mammalian target of the rapamycin pathway. With the use of tyrosine kinase inhibitors (TKIs) and mammalian target of the rapamycin inhibitors, overall survival has increased up to 2 years. In Turkey, due to applicable reimbursement conditions for patients with metastatic renal cell carcinoma (mRCC), interferon use is mandated as a first-line treatment, thus providing information on the use of everolimus only after initial interferon and second-line VEGF-targeted treatments such as VEGF-TKI. Patients and methods: To provide a first real-life data set in Turkey, we conducted a prospective, non-interventional, observational study and assessed the efficacy and safety of everolimus after two lines of treatment including interferon. A total of 100 patients with histologically confirmed mRCC were enrolled in the study from 11 centers between June 2012 and March 2014 (70 males and 30 females). Efficacy was assessed on the basis of progression-free survival and overall survival; safety of everolimus was assessed on the basis of adverse event occurrence. Results: The study results showed that the median progression-free survival with everolimus treatment was 8.1 months (95% CI: 5.1-11.1) and the median overall survival was 17.6 months (95% CI: 10.1-25.1), thus indicating a better overall response based on survival durations than those from the randomized Phase III REnal Cell cancer treatment with Oral RAD001 given Daily study results (4.9 and 14.8 months, respectively). Conclusion: The study showed that everolimus treatment is a safe and effective treatment option in the treatment of mRCC after VEGF-TKI, with an acceptable safety and tolerability profile in real-life settings.