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Öğe Biosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia(Dove Medical Press Ltd, 2018) Sevinc, Alper; Ozkan, Metin; Ozet, Ahmet; Dane, Faysal; Oksuzoglu, Berna; Isikdogan, Abdurrahman; Ozdemir, FeyyazBackground: We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. Patients and methods: This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen (R)) or biosimilar filgrastim 30 MIU (Leucostim (R)). Data regarding age, chemotherapeutic agents used, number of chemotherapy courses, previous diagnosis of neutropenia, neutrophil count of patients after treatment, medications used for the treatment of neutropenia, and duration of neutropenia were collected. Time to absolute neutrophil count (ANC) recovery was the primary efficacy measure. Results: Ambulatory and hospitalized patients comprised 11.3% and 45.1% of the enrolled patients, respectively, and a previous diagnosis of neutropenia was reported in 49.3% of the patients, as well. Neutropenia occurred in 13.7% (n=41), 45.5% (n=136), 27.4% (n=82), 11.4% (n=34), and 2.0% (n=6) of the patients during the first, second, third, fourth, and fifth cycles of chemotherapy, respectively. While the mean neutrophil count was 0.53 +/- 0.48 before treatment, a significant increase to 2.44 +/- 0.66 was observed after treatment (p=0.0001). While 90.3% of patients had a neutrophil count,1.49 before treatment, all patients had a neutrophil count >= 1.50 after treatment. Neutropenia resolved within <= 4 days of filgrastim therapy in 60.1%, 56.7%, and 52.6% of the patients receiving biosimilar filgrastim 30 MIU, original filgrastim 30 MIU, and original filgrastim 48 MIU, respectively. However, there was no significant difference between the three arms (p=0.468). Similarly, time to ANC recovery was comparable between the treatment arms (p=0.332). Conclusion: The results indicate that original filgrastim and biosimilar filgrastim have comparable efficacy in treating neutropenia. Biosimilar filgrastim provides a valuable alternative; however, there is need for further studies comparing the two products in different patient subpopulations.Öğe The clinical and pathologic characteristics of 400 gastrointestinal stroinal tumor patients from Turkey: The final results of the Turkish Anatolian Society of Medical Oncology Multicenter Registery(Lippincott Williams & Wilkins, 2014) Sevinc, Alper; Seker, Mesut; Yildiz, Ramazan; Cihan, Sener; Kaplan, Mehmet Ali; Dane, Faysal; Karaca, Halit[Abstract Not Available]Öğe Clinicopathologic characteristics, treatment outcomes, and prognostic factors of primary thoracic soft tissue sarcoma: A multicenter study of the Anatolian Society of Medical Oncology (ASMO)(Wiley, 2015) Unal, Olcun Umit; Oztop, Ilhan; Yasar, Nurgul; Urakci, Zuhat; Ozatli, Tahsin; Bozkurt, Oktay; Sevinc, AlperBackgroundSoft tissue sarcomas (STSs) are rare malignant tumors of embryogenic mesoderm origin. Primary thoracic STSs account for a small percentage of all STSs and limited published information is available. This study aimed to identify the prognostic factors for thoracic STSs and evaluate the disease's clinical outcomes. MethodsThe medical records of 109 patients with thoracic STSs who were treated between 2003 and 2013 were retrospectively reviewed. Patients' survival rates were analyzed and potential prognostic factors evaluated. ResultsThe median follow-up period was 29 months (range: 1-121 months). STSs were most frequently localized on the chest wall (n = 42; 38.5%) and lungs (n = 42; 38.5%). The most common histological types were malignant fibrous histiocytoma (n = 23; 21.1%), liposarcoma (n = 17; 15.6%), and leiomyosarcoma (n = 16; 14.7%). The median survival time of all patients was 40.3 months (95% confidence interval, 14.22-66.37 months), with one and five-year survival rates of 93.4% and 63.5%, respectively. Univariate analysis of all groups revealed that metastatic stage, unresectability, tumor diameter of >10cm, tumor location other than the chest wall, and grade 3 diseases were predictable of poor survival. However, only grade 3 diseases and tumor location other than the chest wall were confirmed by multivariate analysis as poor prognostic factors. ConclusionsPrimary thoracic STSs are rarely seen malignant tumors. Our results indicated that patients with low-grade tumors and those localized on the chest wall often experienced better survival outcomes.Öğe Efficacy and safety of oral etoposide maintenance therapy following cisplatin plus etoposide in advanced small cell lung cancers (Study of the Anatolian Society of Medical Oncology)(Lippincott Williams & Wilkins, 2013) Urakci, Zuhat; Kaplan, Muhammet Ali; Unal, Olcun Umit; Kucukoner, Mehmet; Sevinc, Alper; Oztop, Ilhan; Suner, Ali[Abstract Not Available]Öğe Efficacy and Safety of Raltitrexed Combinations with Uracil-Tegafur or Mitomycin C as Salvage Treatment in Advanced Colorectal Cancer Patients: A Multicenter Study of Anatolian Society of Medical Oncology (ASMO)(Asian Pacific Organization Cancer Prevention, 2014) Bozkurt, Oktay; Karaca, Halit; Ciltas, Aydin; Kaplan, M. Ali; Benekli, Mustafa; Sevinc, Alper; Demirci, UmutBackground: There is no standard treatment for patients with colorectal cancer (CRC) progressing after irinotecan and oxaliplatin treatment. Here we aimed to retrospectively evaluate the efficacy and tolerability of raltitrexed in combination with oral 5-fluoropyrimidine (uracil tegafur-UFT) or mitomycin C as salvage therapy in mCRC patients. Materials and Methods: A total of 62 patients who had received raltitrexed combined with UFT or mitomycin C were identified between December 2008 and June 2013. They were given raltitrexed 2.6 mg/m(2) (max 5 mg) i.v. on day 1 in combination with either oral UFT 500 mg/day on days 1-14 every 3 weeks (group A) or mitomycin C 6 mg/m(2) i.v. on day every 3 weeks (group B). Results: Forty-two patients (67.7%) were in group A and 20 (32.2%) in group B. In 15 patients (24%) grade 3/4 toxicity was observed, resulting in dose reduction, and in 13 patients (20.9%) dose delay was necessary. The median progression free survival (PFS) was 3 months (95% CI 2.65-3.34) and median overall survival (OS) was 6 months (95% CI 2.09-9.90) in the whole group. Median PFS was 3 months (95% CI 2.60-3.39) in group A vs 3 months (95% CI 1.64-4.35) in group B (p=0.90). Median OS was 6 months (95% CI 2.47-9.53) in group A vs 12 months (95% CI 2.83-21.1) in group B (p=0.46). Conclusions: The combination of raltitrexed with UFT or mitomycin C seem to be a salvage therapy option due to safety profile and moderate clinical activity in heavily-pretreated mCRC patients.Öğe Efficacy of sorafenib in patients with gastrointestinal stromal tumors in the third- or fourth-line treatment: A retrospective multicenter experience(Spandidos Publ Ltd, 2013) Kefeli, Umut; Benekli, Mustafa; Sevinc, Alper; Yildiz, Ramazan; Kaplan, Muhammed Ali; Ciltas, Aydin; Balakan, OzanSorafenib is a multi-targeted tyrosine kinase receptor inhibitor used to treat patients with advanced gastrointestinal stromal tumors (GISTs). The present study evaluated the efficacy and tolerability of sorafenib therapy for patients with GISTs. Between January 2001 and November 2012, 25 patients, from multiple centers, who had received sorafenib as the third-or fourth-line treatment for GISTs were investigated retrospectively. In total, 17 patients were male and eight were female. The median age was 54.0 years (range, 16-82 years). From the patients, 21 received imatinib for longer than six months and four received it for less than six months. The clinical benefit rate of sorafenib was 40.0%. Treatment-related adverse events were reported in 72% of patients. These adverse events were generally mild to moderate in intensity. The median progression-free survival (PFS) and overall survival (OS) times of the patients who received sorafenib were 7.2 and 15.2 months, respectively. The duration of imatinib usage was an independent prognostic factor for PFS and OS. Sorafenib is an effective treatment in patients with GISTs showing a clinical benefit rate of 40.0% and an acceptable tolerability.Öğe Efficacy of Sunitinib in Turkish Patients with Gastrointestinal Stromal Tumors; Retrospective Multicenter Experience(H G E Update Medical Publishing S A, 2013) Kefeli, Umut; Buyukberber, Suleyman; Akyol, Murat; Yildiz, Ramazan; Kaplan, Muhammed Ali; Ciltas, Aydin; Sevinc, AlperBackground/Aims: Sunitinib is a multi-targeted thyrosine kinase receptor inhibitor used in patients with advanced gastrointestinal stromal tumours (GISTs). We evaluated the efficacy and tolerability of sunitinib therapy in Turkish patients with GISTs. Methodology: Between January 2001 and April 2012, 57 patients who had progressive disease or experienced unacceptable toxicity during imatinib treatment from multiple centers were investigated retrospectively. Results: Thirty-three patients were male and 24 were female. The median age was 55 years (range; 16-84 years). Thirty-eight of the patients received imatinib for longer than 12 months, 13 patients received for 6-12 months, and 6 patients received for less than 6 months. The clinical benefit of sunitinib was 73.7%. Treatment-related adverse events were reported in 78% of the patients. Adverse events were generally mild to moderate in intensity The median progression free survival (PFS) and overall survival (OS) of the patients that received sunitinib were 10.8 months and 23.9 months, respectively. The time of imatinib usage and response to sunitinib were independent prognostic factors for PFS and OS. Also, tumor size was an independent prognostic factor for PFS. Conclusions: Sunitinib is an effective treatment in Turkish patients with GISTs, with a clinical benefit of 73.7% and shows an acceptable tolerabilityÖğe Intrapleural hyperthermic perfusion chemotherapy in subjects with metastatic pleural malignancies(W B Saunders Co Ltd, 2013) Isik, Ahmet Feridun; Sanli, Maruf; Yilmaz, Miray; Meteroglu, Fatih; Dikensoy, Oner; Sevinc, Alper; Camci, CelaletdinObjectives: Malignant pleural effusion (MPE) means poor prognosis in the majority of cases. Intrapleural Hyperthermic perfusion chemotherapy (HIPEC) looks promising approach for these patients. We aimed to investigate whether cytoreductive surgery followed by HIPEC provides any survival benefit in cases with metastatic MPEs. Methods: Between January 2009 and December 2011, 19 patients with metastatic MPEs were treated with HIPEC following surgical interventions such as pleurectomy/decortication and/or lung resection (Group 1). Comparison was done with historical control groups consisted of patients who received either talc pleurodesis or pleurectomy/decortication followed by systemic treatment for the management of metastatic MPEs between June 2007 and June 2008 (group 2 and 3). Statistical analyses including overall survival, disease free interval were done for the group comparisons. Results: Median survival in group 1, 2 and 3 were 15.4, 6, 8 months, respectively. One year survival was 54.7% in group 1 where it was 0.6% and 0.8% in group 2 and 3, respectively. There was no operative mortality. Morbidity was occurred in 1 patient in group 1 (5.3%). Conclusions: HIPEC combined with cytoreductive surgery seems to be a promising treatment option for subjects with metastatic MPEs. Further studies are needed for the optimization of HIPEC method, drug of choice, and the best combination therapy for the multimodal treatment. (C) 2013 Elsevier Ltd. All rights reserved.Öğe Multicentric study on malignant pleural mesothelioma in Turkey: clinicopathologic and survival characteristics of 282 patients(Humana Press Inc, 2012) Elkiran, Emin Tamer; Kaplan, Mehmet Ali; Sevinc, Alper; Aksoy, Sercan; Demirci, Umut; Seker, Mesut; Harputluoglu, HakanMalignant pleural mesothelioma (MPM) is a relatively rare, but aggressive tumor that causes high mortality. The major risk factor involved in the etiology is environmental and occupational exposure to asbestos. The optimal modality of therapy is controversial. The present study retrospectively evaluated the data pertinent to 282 patients who were examined and treated in 11 different medical oncology centers in Turkey. There were 161 males (57.1 %) and 121 females (42.9 %), with a mean age of 56.38 +/- A 12.07 years. Surgery was used in 74 patients, 21 patients (28.4 %) received only chemotherapy and 28 patients (37.8 %) received chemoradiotherapy after surgery. The median survival in patients who were administered adjuvant therapy after surgery was 24 months, while the median survival in patients who had only surgery was 6 months (p = 0.029). 106 patients were administered pemetrexed-platinum combination and 35 patients were administered gemcitabine-platinum combination as front-line chemotherapy. Median survival, 1- and 2-year survival rates in patients who received platinum analogues and pemetrexed or gemcitabine combinations were found statistically similar (p = 0.15). The median survival for all patients with MPM in our study was 18 months. The main factors influencing the overall survival were stage of the disease (p = 0.020), performance status (p < 0.001), asbestos exposure (p = 0.030) and mesothelioma histological subtypes (p < 0.001). Results of our study suggest that multi-modality treatment regimens consisting of surgery, radiotherapy and chemotherapy prolong overall survival. Survival rates in patients who received combining platinum analogues with pemetrexed or gemcitabine as front-line chemotherapy were found similar.Öğe Paclitaxel plus Doxorubicin Chemotherapy as Second-Line Therapy in Patients with Advanced Urothelial Carcinoma Pretreated with Platinum plus Gemcitabine Chemotherapy(Karger, 2012) Kaya, Ali O.; Coskun, Ugur; Ozkan, Metin; Sevinc, Alper; Yilmaz, Ahmet U.; Gumus, Mahmut; Unal, Olcun U.Background: We retrospectively evaluated the efficacy and toxicity of paclitaxel plus doxorubicin as a second-line treatment in patients with urothelial carcinoma, who had not responded to a prior platinum plus gemcitabine combination. Patients and Methods: All patients received intravenous infusions of paclitaxel (175 mg/m(2)/h) and doxorubicin (50 mg/m(2)/30 min) on day 1. Chemotherapy courses were repeated every 21 days. Results: The median follow-up duration was 13.5 months (range 2.8-22.4 months). Complete and partial responses were observed in 2 (5.6%) and 10 (27.8%) patients, respectively. Median overall survival was 8.9 months (95% confidence interval (CI): 6.2-11.6). Median time to progression was 3.8 months (95% CI: 2.7-4.8). The most common hematologic toxicities were neutropenia (n = 21, 58.3%), thrombocytopenia (n = 10, 27.8%), and anemia (n = 9, 25%). The most common non-hematologic toxicities consisted of fatigue (n = 15, 41.7%), nausea/vomiting (n = 13, 36.1%), peripheral neuropathy (n = 11, 30.6%), and mucositis (n = 6, 16.7%). Dose reductions by 25-35% were performed in 6 (16.7%) patients because of grade 3/4 toxicity. Anthracycline-related heart failure did not occur. Conclusion: 3-weekly courses of cyclic paclitaxel plus doxorubicin were found to be effective and tolerable in patients with urothelial carcinoma, who had not responded to prior platinum- and gemcitabine-based chemotherapy.Öğe Prognostic Factors in Gastrointestinal Stromal Tumors: Multicenter Experience of 333 Cases from Turkey(H G E Update Medical Publishing S A, 2013) Seker, Mesut; Sevinc, Alper; Yildiz, Ramazan; Cihan, Sener; Kaplan, Mehmet Ali; Gokdurnali, Ayse; Dane, FaysalBackground/Aims: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal neoplasm of the gastrointestinal tract. In an attempt to survey the approximate incidence, clinicopathological characteristics, and immunophenotypic features of GISTs in Turkey, we conducted a clinicopathological and immunohistochemical analysis of GISTs. Methodology: Three hundred and thirty-three patients with GIST from nine institutions in Turkey were retrospectively evaluated. Results: Between January 2001 and March 2011, a total of 333 patients with GISTs were included; of these, 204 (61.2%) were male and 129 (38.8%) were female. The median age was 55 years (range; 22402 years). At the median follow-up of 26 months (range; 4-166 months), the 1-, 3- and 5-year OS rates of the 333 patients were 96.9%, 85.8% and 78.5%, respectively. The 5-year DFS rate was 40%. The 5-year OS rate and median OS time for the patients with R-0 resection were significantly higher than for patients with metastatic diseases (79.7 vs. 75.7% and not reached vs. 115 months, respectively, p=0.04). Conclusion: Although our results should be confirmed by prospective studies, we believe that they contribute to the literature because the study included both resectable and metastatic or unresectable GIST patients and multicenter findings from Turkey.Öğe Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study(Sage Publications Ltd, 2021) Benekli, Mustafa; Gumus, Mahmut; Ozkan, Metin; Dane, Faysal; Elkiran, Emin T.; Cicin, Irfan; Sevinc, AlperObjective Cytokines have been the mainstay of treatment in metastatic renal cell cancer (mRCC) for decades before the introduction of tyrosine kinase inhibitors (TKIs), which dramatically changed the therapeutic landscape in these patients. This observational study was designed to evaluate use of TKIs in the treatment of cytokine-intolerant mRCC patients. Methods A total of 151 cytokine-intolerant mRCC patients who were treated with TKIs (sunitinib, pazopanib and sorafenib) were enrolled in this prospective, non-interventional, multi-center observational study at 16 oncology centers across Turkey. Mean (SD) age was 61.3 (11.1) years and 74.8% were males. Data on duration of TKI treatment was the primary outcome measure. Additionally, overall response rate (ORR), progression free survival (PFS), overall survival (OS) and safety data were recorded. Results Median duration of treatment was 8.2 months at a median follow up of 17.9 months. ORR and disease control rate were 12.5% and 70.8%, respectively. Median PFS and OS were 7.5 months (95%CI: 6.4-10.4) and 27.3 months (95%CI: 17.6-27.3) with no significant difference among three TKI agents in terms of treatment duration, ORR, PFS and OS. The most common adverse events excluding progression-which was the protocol requirement were diarrhea (13.6%), asthenia (13.6%) and hand-foot syndrome (12.6%). Dose modifications were required in 30.5% of the patients and 15% discontinued TKIs because of toxicity. Conclusions Our findings confirm the efficacy and safety profile of TKIs in the first-line treatment of mRCC patients intolerant to cytokine treatment. There was no significant difference among three TKI agents in terms of treatment duration, ORR, PFS and OS.Öğe Weekly Topotecan for Recurrent Small Cell Lung Cancer - a Retrospective Anatolian Medical Oncology Group Study(Asian Pacific Organization Cancer Prevention, 2012) Altinbas, Mustafa; Kalender, Mehmet Emin; Oven, Basak; Sevinc, Alper; Karaca, Halit; Kaplan, M. Ali; Alici, SuleymanAim: To evaluate efficacy and tolerability of topotecan treatment for recurrent small cell lung carcinoma. Patients and Methods: A total of 62 patients were evaluated retrospectively. Statistical analysis was performed using GraphPad Instat (version 3.05). Results: DFifty five of patients (89%) were male and 7 (11%) were female. Median age was 56.7 +/- 9.3 (34-75). Forty eight of patients (80%) were extensive stage (ES) at the time of diagnosis. Fifty of the patients (80.6 Medical Oncology Clinic) were given median 5.36 cycles of cisplatin-etoposide (2-8 cycles). Time to recurrence was 15.6 +/- 6.13 weeks in patients with limited stage (LS) and 6.3 +/- 3.82 weeks in extensive stage (ES) (p<0.0001). Overall survival was 14.0 +/- 6.08 months in ES and 17.9 +/- 6.88 months in LS. The difference between two groups was statistically meaningful (p=0.0447). The overall survival of the patients was 14.8 +/- 6.43 months (4.5-40 months). In terms of survival, there was no difference between males and females (p=0.1171). In 17 (27%) patients who were refractory to topotecan or in whom progression occurred other chemotherapies were used. Conclusion: Small cell lung cancer is chemosensitive, but recurrences occur in short time. Other chemotherapy regimens are used in progression. Topotecan is one of them. Patients who were young and in whom recurrences occur late had given better response to topotecan. Because of the retrospective nature of the study, we couldn't reach the records exactly and consequently, rate and duration of response couldn't be calculated. In recurrent SCLC topotecan is one of the treatment choices. But both hematological and non hematological side effects should be taken into consideration.
