Browsing by Author "Dane, Faysal"

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Biosimilar filgrastim vs filgrastim: A multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia
(Dove Medical Press, 2018) Sevinç, Alper; Özkan, Metin; Özet, Ahmet; Dane, Faysal; Öksüzoğlu, Berna; Işıkdoğan, Abdurrahman; Özdemir, Feyyaz; Uncu, Doğan; Gümüş, Mahmut; Yaren, Arzu; Kara, Oğuz; Tekin, Salim Başol; Evrensel, Türkkan; Uludağ Üniversitesi/Tıp Fakültesi/Tıbbi Onkoloji Anabilim Dalı.; 0000-0002-9732-5340; AAJ-1027-2021; 6603942124
Background: 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.
Correlation of high FDG uptake in PET/CT with poor prognosis in metastatic gastric adenocarcinoma.
(Lippincott Williams & Wilkins, 2011-05-20) Korkmaz, Taner; Seber, S.; Bilici, Ahmet; Okutur, Kerem; Toptaş, Tayfun; Başaran, Gül Atalay; Dede, Fuat; Yumuk, Perran Fulden; Dane, Faysal; Kanitez, Metin; Kanat, Oe; Gümüş, Mahmut; Demir, Gökhan; Turhal, Nazım Serdar; Canhoroz, Mustafa; Uludağ Üniversitesi/Tıp Fakültesi/Onkoloji Anabilim Dalı.
Metastatic cutaneous melanoma epidemiological registry in Turkey: A preliminary evaluation of diagnosis and treatment approaches
(Bmc, 2021-03-24) Karaca, Burcak S.; Sezer, Ahmet; Goksu, Sezgin S.; Cicin, Irfan; Erdem, Dilek; Çubukçu, Erdem; Dane, Faysal; Hacibekiroglu, Ilhan; Oksuzoglu, Berna; Alnigenis, Ebru; Ulay, Esat; Celik, Ismail; ÇUBUKÇU, ERDEM; Bursa Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Tıbbi Onkoloji Bilim Dalı.; ETP-1691-2022
Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine plus nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study
(BMC, 2020-03-30) Yalçın, Şuayıb; Dane, Faysal; Öksüzoğlu, Berna; Özdemir, Nuriye Yıldırım; Özkan, Metin; Demirağ, Güzin Gönüllü; Coşkun, Hasan Şenol; Karabulut, Bülent; Ustaoglu, Mehmet Ali; Özdemir, Feyyaz; Turna, Hande; Yavuzşen, Tuğba; Aykan, Faruk; Sevinç, Alper; Akbulut, Hakan; Yüce, Deniz; Hayran, Mutlu; Kılıçkap, Saadettin; Evrensel, Türkkan; Bursa Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları.; 0000-0002-9732-5340; AAJ-1027-2021; 6603942124
BackgroundCombination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown.MethodsA total of 125 patients were randomized to combination therapy (1000mg/m2 gemcitabine +125mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000mg/m2) arms to take treatment weekly for 7 of 8weeks, and following 3 of 4weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.ResultsOverall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p=0.018). These proportions were 27.3 and 36.6% in 6(th) month assessments, respectively (p=0.357). Median overall survivals in combination and single-agent arms were 9.92months and 5.95months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p=0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p=0.008). Median time-to-deterioration were 5.36 vs 3.68months, and objective response rates were 37.1% vs 23.7% (p=0.009), respectively in combination and single-agent arms.ConclusionsCombination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer.Trial registrationThis study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).
Real-world treatment outcomes from nationwide onco-colon turkey registry in ras wild-type patients treated with biologics first-line metastatic colorectal cancer.
(Lippincott Williams & Wilkins, 2021-05-20) Kefeli, Umut; Arslan, Cagatay; Yildirim, Mahmut Emre; Isikdogan, Abdurrahman; Karadurmus, Nuri; Karabulut, Bulent; Cubukcu, Erdem; Cicin, Irfan; Yalcin, Suayib; Turk, Haci M.; Bilir, Cemil; Karaca, Mustafa; Artac, Mehmet; Sendur, Mehmet Nahit; Alacacioglu, Ahmet; Simsek, Eda Tanrikulu; Dane, Faysal; Bilici, Ahmet; Cevik, Duygu; Gumus, Mahmut; Cubukcu, Erdem; ÇUBUKÇU, ERDEM; Bursa Uludağ Üniversitesi/Tıp Fakültesi.; ETP-1691-2022
Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: The single-arm, open-label regard study
(BMJ Publishing Group, 2020-03) Dane, Faysal; Özgürdal, Kırhan; Yalçın, Şuayib; Benekli, Mustafa; Aykan, Nuri Faruk; Yücel, İdris; Özkan, Metin; Sevinç, Alper; Coşkun, Hasan Şenol; Şanlı, Ulus Ali; Kara, İsmail Oğuz; Yumuk, Perran Fulden; Evrensel, Türkkan; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Tıbbi Onkoloji Anabilim Dalı.; 0000-0002-9732-5340; AAJ-1027-2021; 6603942124
Objectives Regorafenib improved overall survival in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies in two randomised, phase III trials, but has not been evaluated in Turkey. REGARD evaluated the safety and efficacy of regorafenib in Turkish patients with treatment-refractory mCRC. Design Open-label, single-arm, phase IIIb study conducted between July 2013 and April 2015. Setting 11 tertiary centres in Turkey. Participants Eligible patients were adults with mCRC who had disease progression within 3 months after receiving their last dose of approved standard therapies and who had an Eastern Cooperative Oncology Group performance status <= 1. Patients were excluded if they had previously received regorafenib. Of 139 patients screened, 100 were treated and completed the study, and all 100 were analysed. Fifty-eight per cent were male. Interventions Patients received oral regorafenib, 160 mg once daily, for the first 3 weeks of each 4-week cycle until disease progression, death or unacceptable toxicity. Primary and secondary outcome measures The primary endpoint was safety, assessed by incidence of treatment-emergent adverse events (TEAEs). Progression-free survival (PFS) per investigator was the primary efficacy endpoint. There were no secondary endpoints. Results The median treatment duration was 2.5 months (range 0.1 to 20.6). Ninety-six per cent of patients had at least one TEAE and 77% had a grade >= 3 TEAE. The most common grade >= 3 regorafenib-related TEAEs were hypophosphataemia (11%), fatigue (8%), hyperbilirubinaemia (6%), hand-foot skin reaction (5%), hypertension (5%), anorexia (5%) and increased alanine aminotransferase (5%). TEAEs led to dose reduction in 30% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 17% of patients. Median PFS was 3.1 months (95% CI 2.9 to 3.8). Conclusion The regorafenib safety profile and PFS in REGARD were consistent with the results of previous trials of regorafenib in mCRC. Regorafenib is an option for patients in Turkey with treatment-refractory mCRC.
The efficacy and reliability of sequential adjuvant anthracycline-based chemotherapy and weekly paclitaxel regimen in human epidermal growth factor receptor 2 negative breast cancer: A retrospective analysis of a multicentre study
(Imprimatur Publications, 2019-05-01) Kaplan, Muhammet Ali; Oruç, Zeynep; Gümüş, Mahmut; Özaydm, Şükrü; Elkıran, Emin Tamer; Dine, Nur Şener; Sakin, Abdullah; Berk, Veli; Akman, Tülay; Aytekin, Aydin; Yazılıtaş, Doğan; Dane, Faysal; İmamoğlu, Gökşen İnanç; Çubukcu, Erdem; Işıkdoğan, Abdurrahman; ÇUBUKÇU, ERDEM; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Tıbbi Onkoloji Anabilim Dalı.; ERK-4356-2022
Purpose: To analyze the reliability and the effectiveness of chemotherapy and prognostic factors for survival in patients with HER2 (human epidermal growth receptor 2) negative early-stage breast cancer treated with adjuvant sequential anthracycline-based chemotherapy and paclitaxel.Methods: This analysis retrospectively evaluated the medical records of 756 HER2 negative early-stage breast cancel-patients who received adjuvant sequential anthracycline-based chemotherapy and weekly paclitaxel in 15 medical oncology centers in Turkey between 2008-2015. Estrogen receptor (ER), progesterone receptor (PR), HER2, age, tumor size and grade, nodal status, perineural and lymphatic invasion, disease-free survival (DFS) and overall survival (OS) were analyzed.Results: The median patient age was 50 years (22-82). Median follow up period was 46 months (13-82). The rates of recurrence and death detected in this period were 14.8% and 7.4%, respectively.Median OS and PFS were not reached in this period. Five-year DFS and OS rates were 87% and 89%, respectively. Age (OR:0.35, 95%CI 0.12-0.96, p=0.04), PR status (OR:.0.44, 95%CI 0.18-1, p=0.05), lymphatic invasion (OR:.2.6, 95%CI 0.97-7.4, p=0.05) were independent prognostic factors.Most common grade 3-4 toxicides were fatigue (6.7%), neutropenia (1.7%) and nausea (1.3%). Neutropenic fever developed in 1.8% o f the patients and peripheral neuropathy in 16.9%. Dose reduction was necessary for 10%of the patients due to grade 3-4 toxicity, whereas postponement of chemotherapy was neccessary for 7% of the patients.Conclusions: This multicentric retrospective study confirmed that sequential adjuvant therapy with anthracycline-based chemotherapy and paclitaxel for HER2 negative breast cancer is an effective and reliable regimen.