Browsing by Author "Sendur, MAN"
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Item Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy (vol 23, 136, 2023)Karacin, C; Oksuzoglu, B; Demirci, A; Keskinkiliç, M; Baytemür, NK; Yilmaz, F; Selvi, O; Erdem, D; Avsar, E; Paksoy, N; Demir, N; Göksu, SS; Türker, S; Bayram, E; Çelebi, A; Yilmaz, H; Kuzu, ÖF; Kahraman, S; Gökmen, I; Sakin, A; Alkan, A; Nayir, E; Ugrakli, M; Acar, Ö; Ertürk, I; Demir, H; Aslan, F; Sönmez, Ö; Korkmaz, T; Celayir, ÖM; Karadag, I; Kayikçioglu, E; Sakalar, T; Öktem, IN; Eren, T; Erul, E; Mocan, EE; Kalkan, Z; Yildirim, N; Ergün, Y; Akagündüz, B; Karakaya, S; Kut, E; Teker, F; Demirel, BÇ; Karaboyun, K; Almuradova, E; Ünal, OÜ; Oyman, A; Isik, D; Okutur, K; Öztosun, B; Gülbagci, BB; Kalender, ME; Sahin, E; Seyyar, M; Özdemir, Ö; Selçukbiricik, F; Kanitez, M; Dede, I; Gümüs, M; Gökmen, E; Yaren, A; Menekse, S; Ebinç, S; Aksoy, S; Imamoglu, GI; Altinbas, M; Çetin, B; Uluç, BO; Er, Ö; Karadurmus, N; Erdogan, AP; Artaç, M; Tanriverdi, Ö; Çiçin, I; Sendur, MAN; Oktay, E; Bayoglu, IV; Paydas, S; Aydiner, A; Salim, DK; Geredeli, Ç; Yavuzsen, T; Dogan, M; Hacibekiroglu, IItem Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapyKaracin, C; Oksuzoglu, B; Demirci, A; Keskinkiliç, M; Baytemür, NK; Yilmaz, F; Selvi, O; Erdem, D; Avsar, E; Paksoy, N; Demir, N; Göksu, SS; Türker, S; Bayram, E; Çelebi, A; Yilmaz, H; Kuzu, ÖF; Kahraman, S; Gökmen, I; Sakin, A; Alkan, A; Nayir, E; Ugrakli, M; Acar, Ö; Ertürk, I; Demir, H; Aslan, F; Sönmez, Ö; Korkmaz, T; Celayir, ÖM; Karadag, I; Kayikçioglu, E; Sakalar, T; Öktem, IN; Eren, T; Urul, E; Mocan, EE; Kalkan, Z; Yildirim, N; Ergün, Y; Akagündüz, B; Karakaya, S; Kut, E; Teker, F; Demirel, BÇ; Karaboyun, K; Almuradova, E; Ünal, OÜ; Oyman, A; Isik, D; Okutur, K; Öztosun, B; Gülbagci, BB; Kalender, ME; Sahin, E; Seyyar, M; Özdemir, Ö; Selçukbiricik, F; Kanitez, M; Dede, I; Gümüs, M; Gökmen, E; Yaren, A; Menekse, S; Ebinç, S; Aksoy, S; Imamoglu, GI; Altinbas, M; Çetin, B; Uluç, BO; Er, Ö; Karadurmus, N; Erdogan, AP; Artaç, M; Tanriverdi, Ö; Çiçin, I; Sendur, MAN; Oktay, E; Bayoglu, IV; Paydas, S; Aydiner, A; Salim, DK; Geredeli, Ç; Yavuzsen, T; Dogan, M; Hacibekiroglu, IBackground There is no standard treatment recommended at category 1 level in international guidelines for subsequent therapy after cyclin-dependent kinase 4/6 inhibitor (CDK4/6) based therapy. We aimed to evaluate which subsequent treatment oncologists prefer in patients with disease progression under CDKi. In addition, we aimed to show the effectiveness of systemic treatments after CDKi and whether there is a survival difference between hormonal treatments (monotherapy vs. mTOR-based). Methods A total of 609 patients from 53 centers were included in the study. Progression-free-survivals (PFS) of subsequent treatments (chemotherapy (CT, n:434) or endocrine therapy (ET, n:175)) after CDKi were calculated. Patients were evaluated in three groups as those who received CDKi in first-line (group A, n:202), second-line (group B, n: 153) and >= 3rd-line (group C, n: 254). PFS was compared according to the use of ET and CT. In addition, ET was compared as monotherapy versus everolimus-based combination therapy. Results The median duration of CDKi in the ET arms of Group A, B, and C was 17.0, 11.0, and 8.5 months in respectively; it was 9.0, 7.0, and 5.0 months in the CT arm. Median PFS after CDKi was 9.5 (5.0-14.0) months in the ET arm of group A, and 5.3 (3.9-6.8) months in the CT arm (p = 0.073). It was 6.7 (5.8-7.7) months in the ET arm of group B, and 5.7 (4.6-6.7) months in the CT arm (p = 0.311). It was 5.3 (2.5-8.0) months in the ET arm of group C and 4.0 (3.5-4.6) months in the CT arm (p = 0.434). Patients who received ET after CDKi were compared as those who received everolimus-based combination therapy versus those who received monotherapy ET: the median PFS in group A, B, and C was 11.0 vs. 5.9 (p = 0.047), 6.7 vs. 5.0 (p = 0.164), 6.7 vs. 3.9 (p = 0.763) months. Conclusion Physicians preferred CT rather than ET in patients with early progression under CDKi. It has been shown that subsequent ET after CDKi can be as effective as CT. It was also observed that better PFS could be achieved with the subsequent everolimus-based treatments after first-line CDKi compared to monotherapy ET.Item The role of the gastrectomy on survival in metastatic gastric cancer patients: A multicenter study of Anatolian Society of Medical Oncology (ASMO)Yazici, O; Ozdemir, N; Duran, AO; Menekse, S; Sendur, MAN; Karaca, H; Goksel, G; Arpaci, E; Eren, T; Hacibekiroglu, I; Bilgetekin, I; Kacan, T; Ozkan, M; Aksoy, S; Aksoy, A; Zengin, NItem Atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer: a real-life data of the Turkish Oncology GroupGürbüz, M; Kutlu, Y; Akkus, E; Köksoy, EB; Köse, N; Öven, BB; Uluç, BO; Demiray, AG; Erdem, D; Demir, B; Turhal, NS; Üskent, N; Akbas, S; Selçukbiricik, F; Inal, A; Bilici, A; Ölmez, ÖF; Çabuk, D; Ünal, Ç; Hizal, M; Sendur, MAN; Korkmaz, M; Karadurmus, N; Ertürk, I; Göksu, SS; Tatli, AM; Güven, DC; Kiliçkap, S; Paksoy, N; Aydiner, A; Çinkir, HY; Özkul, Ö; Öztürk, A; Balli, S; Kemal, Y; Erdogan, AP; Er, Ö; Yumuk, PF; Demirkazik, APurpose Atezolizumab has been shown to be effective and safe in randomized trial in the first-line treatment of extensive-stage small cell lung cancer (SCLC). However, there are limited real-life data on atezolizumab. In this study, we aimed to determine the real-life efficacy and safety of atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage SCLC. Methods This trial is a retrospective multicenter study of the Turkish Oncology Group, which included extensive-stage SCLC patients who received atezolizumab combined with chemotherapy in a first-line treatment. The characteristics of the patients, treatment and response rates, and PFS and OS are presented. Factors associated with PFS and OS were analyzed by univariate and multivariate analysis. Results A total of 213 patients at the 30 oncology centers were included. The median number of chemotherapy cycle was 5 (1-8) and atezolizumab cycle was 7 (1-32). After median 11.9 months of follow-up, median PFS and OS was 6.8 months (95%CI 5.7-7.8), and 11.9 months (95%CI 11-12.7), respectively. The ORR was 61.9%. ECOG-PS (p = 0.002) and number of metastatic sites (p = 0.001) were associated with PFS and pack-year of smoking (p = 0.05), while ECOG-PS (p = 0.03) and number of metastatic sites (p = 0.001) were associated with OS. Hematological side effects were common and toxicities were manageable. Conclusion This real-life data confirm the efficacy and safety of atezolizumab in combination with chemotherapy in first-line treatment of extensive-stage SCLC.Item Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life ExperiencesTural, D; Ölmez, ÖF; Sümbül, AT; Artaç, M; Özhan, N; Akar, E; Çakar, B; Köstek, O; Ekenel, M; Erman, M; Coskun, HS; Selçukbiricik, F; Keskin, Ö; Türköz, FP; Oruç, K; Bayram, S; Yglmaz, U; Bilgetekin, I; Ygldgz, B; Sendur, MAN; Paksoy, N; Dirican, A; Erdem, D; Selam, M; Tanrgverdi, Ö; Paydas, S; Urakçg, Z; Atag, E; Güncan, S; Ürün, Y; Alkan, A; Kaya, AO; Özyükseler, DT; Taskaynatan, H; Ygldgrgm, M; Sönmez, M; Basoglu, T; Gündüz, S; Kglgçkap, SBackground: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum resistant urothelial carcinoma. Objective: To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Design, setting, and participants: Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. Outcome measurements and statistical analysis: The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Results and limitations: Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47-28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25-5.49) and 9.8 mo (95% CI, 6.7-12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3-4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treat-ment response based on clinical notes and local radiographic studies. Conclusions: In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Patient summary: Atezolizumab is effective and well-tolerated in patients with meta-static urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.Item Efficacy and safety of folfiri plus aflibercept in second-line treatment of metastatic colorectal cancer: Real-life data from Turkish oncology groupErol, C; Sendur, MAN; Bilgetekin, I; Garbioglu, DB; Hamdard, J; Akbas, S; Hizal, M; Arslan, C; Sevinc, A; Kucukarda, A; Erdem, D; Kahraman, S; Cakir, E; Demirkiran, A; On, S; Dogan, I; Erdogan, AP; Koca, S; Kubilay, P; Eren, OO; Cilbir, E; Celik, E; Araz, M; Ozyukseler, DT; Yildirim, ME; Bahceci, A; Taskaynatan, H; Oyman, A; Deniz, GI; Menekse, S; Kut, E; Gulmez, A; Sakin, A; Nayir, E; Acar, R; Sen, E; Inal, A; Turhal, S; Kaya, AO; Paydas, S; Tastekin, D; Hacibekiroglu, I; Cincin, I; Bilici, A; Mandel, NM; Dede, DS; Akinci, MB; Oksuzoglu, B; Uncu, D; Yalcin, B; Artac, MAims: The addition of aflibercept to the fluorouracil and irinotecan (FOLFIRI) regimen significantly improved clinical outcomes in patients with metastatic colorectal cancer (CRC) previously treated with oxaliplatin. We aimed to investigate the efficacy and safety of second-line FOLFIRI and aflibercept combination in patients with metastatic CRC in real-life experience. Materials and Methods: Four hundred and thirty-three patients who treated with FOLFIRI and aflibercept in the second-line were included in the study. The clinical and pathological features of the patients were recorded retrospectively. Survival (overall and progression-free survival [PFS]), response rates, and safety data were analyzed. Results: The median age was 61. Majority of patients (87.5%) received first-line bevacizumab and 10.1% of patients received anti-epidermal growth factor receptor agents. About 80% of patients had KRAS, 18.6% of patients had NRAS, and 6.4% of patients had BRAF mutations. The median OS was 11.6 months (95% confidence interval [CI], 10.6-12.6) and the median PFS was 6 months (95% CI, 5.5-6.5). About 4.6% of patients had complete response and 30.6% of patients had partial response as best tumor response. Grade 1-2 toxicities were seen in 33.4% of patients, while grade 3-4 toxicities were recorded in 27% of patients. Eight patients (2%) died due to treatment toxicity. Conclusions: Overall and PFS were similar in routine clinical practice compared to phase III pivotal VELOUR trial. However, response rates were found to be higher. It was observed that there were fewer adverse events compared to the VELOUR trial.Item Prognostic factors in patients with metastatic urothelial carcinoma who have treated with AtezolizumabTural, D; Ölmez, ÖF; Sümbül, AT; Özhan, N; Çakar, B; Köstek, O; Ekenel, M; Erman, M; Coskun, HS; Selçukbiricik, F; Keskin, Ö; Türköz, FP; Oruç, K; Bayram, S; Bilgetekin, I; Yildiz, B; Sendur, MAN; Paksoy, N; Dirican, A; Erdem, D; Selam, M; Tanriverdi, Ö; Paydas, S; Urakçi, Z; Atag, E; Güncan, S; Ürün, Y; Alkan, A; Kaya, AO; Özyükseler, DT; Taskaynatan, H; Yildirim, M; Sönmez, M; Basoglu, T; Gündüz, S; Kiliçkap, S; Artaç, MBackground Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies of patients with metastatic platinum-resistant urothelial carcinoma. However, the response rate of Atezolizumab was modest. In the current study, we evaluated the pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy in the Expanded-Access Program of Atezolizumab. Patients and methods In this study, we present a retrospective analysis of 113 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. Data of the patients was obtained from patient files and hospital records. Eligible patients included metastatic urothelial carcinoma patients treated with at least one course of ATZ. Univariate analysis was used to identify clinical and laboratory factors that significantly impact OS. Variables were retained for multivariate analysis if they had a statistical relationship with OS (p < 0.1), and then included a final model of p < 0.05. Results The median follow-up duration was 23.5 months. Of the patients, 98 (86.7%) were male and 13.3% were female. The median age was 65 years of age (37-86). In univariate analysis, primary tumor location in the upper tract, increasing absolute neutrophil count (ANC), increasing absolute lymphocyte count, neutrophil-to-lymphocyte ratio (NLR) > 3, liver metastases, baseline creatinine clearance less (GFR) than 60 ml/min, Eastern Cooperative Oncology Group (ECOG) performance status (1 >=), and hemoglobin levels below 10 mg/dl were all the significantly associated with OS. Three of the five adverse prognostic factors according to the Bellmunt criteria were independent of short survival: liver metastases HR 3.105; 95% CI 1.673-5.761; p < (0.001), ECOG PS (1 >=) HR 2.184; 95% CI 1.120-4.256; p = 0.022, and Hemoglobin level below 10 mg/dl HR 2.680; 95% CI 1.558-4.608; p < (0.001). In addition, NLR > 3 hazard ratio [HR] 2.092; 95% CI 1.031-4.243; p = 0.041 and GFR less than 60 ml/min HR 1.829; 95% CI 1.1-3.041; p = 0.02, maintained a significant association with OS in multivariate analysis. Conclusions This model confirms the Bellmunt model with the addition of NLR > 3 and GFR less than 60 ml/min and can be associated with clinical trials that use immunotherapy in patients with bladder cancer.Item Activity of CDK4/6 inhibitors and parameters affecting survival in elderly patients in age-subgroups: Turkish Oncology Group (TOG) retrospective studyKahraman, S; Hizal, M; Demirel, BC; Guven, DC; Gumusay, O; Uluc, BO; Bayram, E; Gulbagci, B; Yasar, A; Davarci, SE; Mocan, EE; Acar, O; Isik, D; Aydin, E; Karakas, Y; Ozcelik, M; Keser, M; Okutur, SK; Eren, O; Menekse, S; Aydin, D; Yilmaz, F; Dogan, O; Ozkanli, G; Yucel, H; Sunar, V; Aykan, MB; Ozdemir, O; Duman, BB; Keskinkilic, M; Sakalar, T; Inal, A; Karaoglanoglu, M; Aksoy, A; Er, MM; Turhal, NS; Kalkan, NO; Sendur, MANHighly selective inhibitors of cyclin-dependent kinase 4 and 6 (CDK4/6is) have emerged as a standart of care for first- and second-line therapies in combination with endocrine therapy (ET) for HR+/HER2- metastatic breast cancer (MBC) patients. It has been reported that combination therapy is more effective than ET alone and is safe in elderly patients as well as young patients. Nevertheless, elderly and very old patients with HR+/HER2-MBC treated with CDK4/6 inhibitor (CDK4/6i) combinations are relatively underrepresented in randomized controlled trials. To contribute to the literature, we investigated the real-world efficacy, factors associated with survival and the rates of adverse events (AEs) of the treatment with palbociclib or ribociclib plus ET in the HR+/HER2- MBC patient cohort over the age of 65 for age subgroups. In this retrospective study, 348 patients were divided into subgroups: 65-69 years old, 70-79 years old and 80 years and older. Median PFS (mPFS) for whole group was 18.3 (95% CI,14.3-22.3) months. There was no significant difference in mPFS between age groups (p = 0.75). The estimated median OS (mOS) was 39.5 (95% CI, 24.9-54.1) months and there was no significant difference between age groups (p = 0.15). There was a meaningfull numerical difference that did not reach statistical significance in patients who received CDK4/6i treatment as the first line for MBC. Grade 3-4 AEs were reported in 42.7% for the entire group, and neutropenia was the most common (37.3%). It can be concluded that combination therapy with palbociclib or ribociclib with an ET partner has similar efficacy and is safe among subgroups of older patients diagnosed with HR+/HER2-MBC.