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Öğe Assessing the Clinical Impact of Lutetium-177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) on Metastatic Neuroendocrine Tumors: A Multicenter Real-World Data from Türkiye(2023) Ünal, Çağlar; Seçuk, Nalan Alan; Duymaz, TomrisObjectives: This study aimed to evaluate the clinical outcomes, including progression-free survival (PFS), overall sur-vival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR), in patients received Lutetium-177 (Lu-177) DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) for metastatic neuroendocrine tumors. This study further stratified outcomes based on tumor grade, Ki-67 status, primary tumor localization, number of treatment cycles, and associated adverse effects.Methods: We conducted a multicenter retrospective study analyzing the data of 73 patients with metastatic NETs across 17 different hospitals in various regions of Turkiye. A total of 73 metastatic NET patients underwent Lu-177 DOT-ATATE PRRT between December 2013 and March 2023. Results: Over a median follow-up of 52.7 months, patients showed a median PFS of 13.7 months and OS of 51.2 months. The ORR was 29.6%, and the DCR was 66.2%. Grade 1 and 2 tumor patients had superior outcomes (PFS: 16.9 months, OS: 55.5 months) compared to grade 3 tumor patients (PFS: 8.5 months, OS: 29.5 months). Based on their Ki-67 status, those <= 20% had prolonged PFS (16.9 months) and OS (55.5 months) than those between 21 and 55% (PFS: 5.9 months, OS: 41.3 months). Regarding primary tumor localization, the PFS values were 13.1, 15.3, 13.7, and 8.6 months for pancreatic, GIS, lung, and unknown origin tumors, respectively. The OS across tumor types fluctuated between 41.1 and 54.1 months. Patients who received more than four cycles demonstrated significantly improved median PFS (22.4 months) and OS (90.3 months) compared to those who received <= 4 cycles (median PFS: 9.3 months; median OS: 41.8 months). Grade 3-4 adverse effects were observed in 21.9% of patients.Conclusion: Our findings affirm that PRRT is a potent and well-tolerated treatment for metastatic NETs. Notably, pa-tients who received more than 4 cycles of PRRT experienced a markedly improved median PFS and OS compared to their counterparts who received <= 4 cycles.Öğe Assessment High-Risk Breast Cancer in Older Patients: A Comparative Analysis of PREDICT Scores and TAILORx Risk Categorization(GALENOS PUBL HOUSE, 2023-10) Ünal, Çağlar; Özmen, Tolga; Duymaz, TomrisObjective: This study aimed to evaluate the relationship between PREDICT tool overall survival (OS) scores and high-risk patients according to TAILORx risk categorization in elderly hormone reseptor (HR) positive human epidermal growth factor negative early breast-cancer patients. Materials and Methods: We conducted a retrospective study, extracting data from medical records of 64 patients diagnosed with breast cancer. A retrospective analysis was performed on all patients who had Oncotype Dx Recurrence Scores across five medical centers between 2017 and 2022. PREDICT scores were defined as calculated 10-year OS rates via PREDICT tool. Results: The median age of the patients was 67, with a range between 65-75 years. Low-risk patients had a slightly higher two PREDICT scores compared to high-risk patients (78% vs. 73%), (81% vs. 77%), which were statistically significant. The progesterone receptor (PR) level was significantly lower in the high-risk group (3.5% vs. 80%). A unit decrease in the PREDICT scores was associated with a 11% increase in the odds of being in the high-risk group. However, these effects weren't statistically significant in the multivariate analysis. A unit decrease in the PR level was significantly associated with increased odds (by 5% in the multivariate analysis) of being in the high-risk group. Conclusion: Our study underscores the importance of using a combination of tools, including the PREDICT tool, PR levels, and TAILORx risk categorization, for a comprehensive risk assessment in these patients, especially in the older population. Accurate risk assessment is crucial for tailoring the treatment and optimizing outcomes in this vulnerable population. Future studies are warranted to further validate these findings in larger cohorts and to explore additional biomarkers and genomic signatures that may aid in the risk assessment and management of breast cancer in older patients.Öğe Evaluation of Anti-Mullerian Hormone Levels, Antral Follicle Counts, and Mean Ovarian Volumes in Chemotherapy-Induced Amenorrhea among Breast Cancer Patients: A Prospective Clinical Study(MDPI, 2023-10) Ünal, Çağlar; Özmen, Tolga; Duymaz, TomrisEstradiol (E2), a follicle-stimulating hormone (FSH), AMH, and inhibin B levels, along with AFC and MOV, are used to determine ovarian reserve in pre-menopausal women. Studies have shown that AMH levels are more sensitive than those of E2, FSH, and inhibin B and that AFC and MOV can be used to evaluate ovarian reserve. AMH, AFC, and MOV measurements were performed before and after adjuvant SC in 3-month periods for one year. Patients were classified as experiencing chemotherapy-induced amenorrhea (CIA) if they did not have menstrual cycles for a period of six months or longer following the conclusion of their chemotherapy treatment. We aimed to evaluate the factors affecting chemotherapy-induced amenorrhea in breast cancer patients treated with adjuvant chemotherapy and the performance of baseline measurements of AMH, AFC, and MOV to predict chemotherapy-induced amenorrhea. The effects of different chemotherapy regimens on the AMH level, AFC, and MOV in CIA patients were investigated. Seventy-one patients were eligible for this study, and the median age was 38 years (range: 23–45). The median follow-up was 37 months (range: 20–51), and CIA developed in 62% of the patients. The AMH level and AFC were significantly decreased one year after SC (p < 0.0001), whereas MOV was not (p = 0.507). AMH levels before chemotherapy (median: 1.520 vs. 0.755, p = 0.001) and at the end of the first year (median: 0.073 vs. 0.010, p = 0.030) and pre-treatment AFC (median: 12 vs. 4.50, p = 0.026) were lower in patients with CIA compared to those without CIA. The AMH levels before SC were the most valuable and earliest factor for predicting CIA development. In addition, there was no difference between the chemotherapy regimens (including or not including taxane) in terms of CIA development.Öğe MCM-2 Levels as a Potential Biomarker for Predicting High-Risk Breast Cancer Patients According to TAILORx Classification(DOVE MEDICAL PRESS LTD, 2023-10-14) Ünal, Çağlar; Özmen, Tolga; Dıuymaz, TomrisBackground: The minichromosome maintenance protein-2 (MCM-2) is a more sensitive proliferation marker than Ki-67. This study aimed to evaluate the relationship between MCM-2 and Oncotype DX recurrence score (ODX-RS) and determine an MCM-2 cutoff value in high-risk patients according to TAILORx risk categorization. Methods: Hormone receptor (HR) positive HER-2 negative early-stage breast cancer patients (pT1-2, pN0-N1, M0) who had ODX-RS were included in the study. According to the TAILORx trial, patients were divided into two groups with high (ODX-RS >= 26) and low risk (ODX-RS <26) in terms of ODX-RS. Formalin-fixed-paraffin-embedded tissues of patients were re-evaluated, and 3 mu m sections were prepared for MCM-2 immuno-histochemical staining. The relationship between ODX-RS and the percentage of MCM-2 staining was evaluated in two groups. The ROC curve analysis was performed to determine the MCM-2 cut-off value for the TAILORx high-risk group (ODX-RS >= 26). Results: The mean MCM-2 value was significantly higher in the high-risk group [(60.2 +/- 11.2 vs 34.4 +/- 13.8, p < 0.001)]. In the multivariate analysis, MCM-2 (OR: 1.27, 95% CI: 1.08-1.49, p = 0.003) and progesterone receptor (PR) levels <= 10% (OR: 60.9, 95% CI: 4.1-89.7, p = 0.003) were found to be independent factors indicating a high-risk group. A one-unit increase in MCM-2 level increased the likelihood of being in the high-risk group by 1.27 times. In the ROC curve analysis, the optimal MCM-2 cut-off level was 50 (AUC: 0.921, sensitivity: 86.7%, specificity: 96.0%, p < 0.001). Conclusion: Our study is the first study in the literature to investigate the relationship between ODX-RS and MCM-2 levels in HR-positive HER-2 negative early breast-cancer patients. In this study, MCM-2 was an independent risk factor in identifying high-risk patients according to TAILORx risk classification. MCM 2 cut-off value (50) may help the decision on adjuvant chemotherapy in patients where the Oncotype DX test cannot be performed.Öğe Survival results according to Oncotype Dx recurrence score in patients with hormone receptor positive HER-2 negative early-stage breast cancer: first multicenter Oncotype Dx recurrence score survival data of Turkey(FRONTIERS MEDIA SA, 2023-06-28) Ünal, Çağlar; Duymaz, TomrisBackground: The Oncotype Dx recurrence score (ODx-RS) guides the adjuvant chemotherapy decision-making process for patients with early-stage hormone receptor-positive, HER-2 receptor-negative breast cancer. This study aimed to evaluate survival and its correlation with ODx-RS in pT1-2, N0-N1mic patients treated with adjuvant therapy based on tumor board decisions. Patients and methods: Estrogen-positive HER-2 negative early-stage breast cancer patients (pT1-2 N0, N1mic) with known ODx-RS, operated on between 2010 and 2014, were included in this study. The primary aim was to evaluate 5-year disease-free survival (DFS) rates according to ODX-RS. Results: A total of 203 eligible patients were included in the study, with a median age of 48 (range 26-75) and median follow-up of 84 (range 23-138) months. ROC curve analysis for all patients revealed a recurrence cut-off age of 45 years, prompting evaluation by grouping patients as <= 45 years vs. >45 years. No significant difference in five-year DFS rates was observed between the endocrine-only (ET) and chemo-endocrine (CE) groups. However, among the ET group, DFS was higher in patients over 45 years compared to those aged <= 45 years. When stratifying by ODx-RS as 0-17 and >= 18, DFS was significantly higher in the former group within the ET group. However, such differences were not seen in the CE group. In the ET group, an ODx-RS >= 18 and menopausal status were identified as independent factors affecting survival, with only an ODx-RS >= 18 impacting DFS in patients aged <= 45 years. The ROC curve analysis for this subgroup found the ODx-RS cut-off to be 18. Conclusion: This first multicenter Oncotype Dx survival analysis in Turkey demonstrates the importance of Oncotype Dx recurrence score and age in determining treatment strategies for early-stage breast cancer patients. As a different aproach to the literature, our findings suggest that the addition of chemotherapy to endocrine therapy in young patients (<= 45 years) with Oncotype Dx recurrence scores of >= 18 improves DFS.
