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DANE, FAYSAL

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    PublicationOpen Access
    Role of baseline Ga-68-PSMA PET/CT-derived whole-body volumetric parameters in predicting survival outcomes of metastatic castration-resistant prostate cancer patients receiving first-line treatment
    (2022-08-01) AKIN TELLİ, TUĞBA; ÖZGÜVEN, SALİH; FİLİZOĞLU, NUH; ÖZTÜRK, MEHMET SAADEDDİN; ARIKAN, RUKİYE; DEMİRCAN, NAZIM CAN; BAŞOĞLU TÜYLÜ, TUĞBA; ALSAN ÇETİN, İLKNUR; ÖNEŞ, TUNÇ; DANE, FAYSAL; YUMUK, PERRAN FULDEN; AKIN TELLİ T., ÖZGÜVEN S., Alan O., Filizoglu N., ÖZTÜRK M. S. , Sariyar N., Isik S., Arikan R., DEMİRCAN N. C. , BAŞOĞLU TÜYLÜ T., et al.
    Objective We aimed to evaluate whether baseline Ga-68-PSMA PET/CT-derived whole-body volumetric parameters could be used as predictive biomarkers for survival in metastatic castration-resistant prostate cancer (mCRPC) patients receiving first-line treatment. Materials and methods This retrospective study included 54 mCRPC patients, who underwent baseline Ga-68-PSMA PET/CT imaging within 1 month before starting first-line treatment. Pre-treatment prostate-specific antigen (PSA) levels and treatments were recorded. SUVmax, SUVmean, whole-body PSMA-derived tumor volume (wbPSMA-TV), and whole-body total lesion PSMA (wbTL-PSMA) were calculated for all patients. PSA response was defined as a decline of >= 50% from pre-treatment value at 12 weeks. Overall survival (OS) was measured from the start of the first-line treatment for mCRPC. Results Docetaxel and abiraterone/enzalutamide were administered to 32 and 22 patients in the first-line setting, respectively. wbPSMA-TV (rho = 0.582, p = 0.004) and wbTL-PSMA (rho = 0.564, p = 0.007) showed moderate positive correlations with PSA levels. Older age (p = 0.02), higher wbPSMA-TV (p = 0.007), higher PSA (p = 0.01), higher number of bone metastases (p = 0.02), and lack of PSA response (p = 0.03) were significantly associated with an increased risk of mortality. Multivariate analysis determined wbPSMA-TV (HR: 1.003, 95% CI 1.001-1.004, p = 0.001) and PSA response (HR: 2.241, 95% CI 1.189-4.222, p = 0.01) as independent predictors of OS. Conclusion The wbPSMA-TV may be a useful tool to reflect tumor burden and predict survival outcomes in patients with mCRPC.
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    PublicationOpen Access
    First-line anti-EGFR agents (panitumumab or cetuximab) plus chemotherapy in patients with metastatic colorectal cancer: Onco-colon Turkey study subgroup analysis
    (2022-06-01) DANE, FAYSAL; Isikdogan A., Turk H., Bilir C., Sendur M., Karabulut B., Artac M., Cicin I., Geredeli C., Alacacioglu A., Kefeli U., et al.
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    PublicationOpen Access
    What to expect from HER-2 directed therapies in advanced gastric cancer?
    (MARMARA UNIV, FAC MEDICINE, 2015-04-15) DANE, FAYSAL; Dane, Faysal
    Gastric cancer is the second most common cause of cancer related death worldwide. Over 20% of the advanced gastric cancer are considered to be HER-2 positive. Studies investigating the prognosis of HER-2 positive advanced gastric cancer revealed conflicting results. Trastuzumab, a monoclonal antibody against HER-2, has shown a significant clinical activity in HER-2 positive gastric cancer patients. In this review, I will briefly summarize the clinical studies of anti-HER-2 therapies performed in HER-2 positive gastric carcinoma.
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    PublicationOpen Access
    Lapatinib plus Capecitabine for HER2-Positive Advanced-Stage Breast Cancer in Elderly Women: Review of the Anatolian Society of Medical Oncology (ASMO) Experience
    (KARGER, 2013) DANE, FAYSAL; Cetin, Bulent; Benekli, Mustafa; Dane, Faysal; Boruban, Cem; Gumus, Mahmut; Oksuzoglu, Berna; Kaplan, Mehmet A.; Tufan, Gulnihal; Sevinc, Alper; Coskun, Ugur; Buyukberber, Suleyman
    Background: The efficacy and safety of the lapatinib and capecitabine combination remain elusive in elderly patients with metastatic breast cancer (MBC), who progress after trastuzumab-based therapy. Patients and Methods: A total of 26 patients with HER2-positive MBC were included in this retrospective multicenter study. Median age was 69 years (range 65-82 years). All patients were treated with the combination of lapatinib (1,250 mg/day, continuously) and capecitabine (2,000 mg/m(2) on days 1-14 of a 21-day cycle). Data on demographics, clinical outcome, and toxicity were collected for descriptive analyses. Results: The median follow-up was 10 months (range 2-31 months). An overall response rate of 33.4% was achieved, including 1 complete response (3.8%), and 8 partial responses (30.8%). Median progression-free survival was 7 months (95% confidence interval (CI) 5-8), and the median overall survival was 15 months (95% CI 11-19). Most common side effects were fatigue (53.8%), diarrhea (46%), vomiting (36.3%), hand-foot syndrome (34.5%), and anorexia (34.6%). Grade 3-4 toxicities were identified as hand-foot syndrome (3.8%), diarrhea (7.6%), and fatigue (11.5%). There were no symptomatic cardiac events. Conclusion: Lapatinib and capecitabine combination therapy was effective and well tolerated in elderly patients with MBC, who had progressive disease after trastuzunnab-based therapy.
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    PublicationOpen Access
    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, 2020-12) DANE, FAYSAL; Yalcin, Suayib; Dane, Faysal; Oksuzoglu, Berna; Ozdemir, Nuriye Yildirim; Isikdogan, Abdurrahman; Ozkan, Metin; Demirag, Guzin Gonullu; Coskun, Hasan Senol; Karabulut, Bulent; Evrensel, Turkkan; Ustaoglu, Mehmet Ali; Ozdemir, Feyyaz; Turna, Hande; Yavuzsen, Tugba; Aykan, Faruk; Sevinc, Alper; Akbulut, Hakan; Yuce, Deniz; Hayran, Mutlu; Kilickap, Saadettin
    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).
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    PublicationOpen Access
    Prognostic Value of Tissue-Resident Memory T Cells and Tumor Microenvironmental Features in Resected Pancreatic Adenocarcinoma
    (2021) ÖZTÜRK, FATİH EMİN; Başoğlu, Tuğba; Akar, Kadriye Ebru; Bağcı, Pelin; Akgül Babacan, Nalan; Öztürk, Mehmet Akif; Öztürk, Fatih Emin; Demircan, Nazım Can; Arikan, Rukiye; Akın Telli, Tuğba; Ercelep, Özlem; Dane, Faysal; Yumuk, Perran Fulden
    BACKGROUND: Pancreatic ductal adenocarcinoma differs from other solid tumors with its unique immunosuppressive microenvironment and non-immunogenic feature. There are not many studies in the literature investigating the effect of these features on prognosis. AIM: To investigate the prognostic value of tissue-resident memory cells, tumor microenvironment features, and tumor-associated immune cells in resected pancreatic ductal adenocarcinomas. STUDY DESIGN: Retrospective cross-sectional study. METHODS: Of 138 patients diagnosed with pancreatic ductal adenocarcinoma between 2011 and 2018, 81 were included in the study. Specimens from operated patients were reassessed separately as peritumoral and intratumoral areas for tissue resident memory and tumor microenvironmental elements (tumor infiltrating lymphocytes, tumor stroma, CD204+ macrophages, PDL1+ immune cells). Disease-free survival and overall survival were defined from the date of operation to the date of recurrence and the date of first diagnosis to the date of death, respectively. If the patient was alive, the last visit date was taken into account. RESULTS: The median age at diagnosis was 63 (range: 40-78). The median follow-up period was 18.9 months (range 1.4-80.4 months). Median overall survival was 23.7 months (1.4-80.4 months) and median disease-free survival was 10.8 months (1.4-74.4 months). Patients with higher intra-tumoral tissue-resident memory cell counts had a longer survival trend than those having lower values (25.6 months vs. 18 months, respectively, P = .84). According to microenvironmental evaluations, lower stromal score (defined as stroma having less desmoplasia and rich in cells) and presence of peritumoral Crohn's-like inflammatory response were associated with higher survival (29.2 months vs. 19.7 months for low vs. high stromal scores, respectively, P = .16 and 30.2 months vs. 18.1 months for the presence of Crohn's-like inflammatory response P = .13). Decreased survival was observed in tumors with increased CD204+ tumor-associated macrophages which were immunosuppressive elements of the microenvironment (12 months vs. 26.3 months for intra-tumoral assessment, P = .29). CONCLUSION: Tissue-resident memory cells and other microenvironmental features may be prognostic in resectable pancreatic ductal adenocarcinomas. Further studies with larger cohorts are needed for validation.
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    PublicationOpen Access
    5-Flourouracil-Induced Encephalopathy in Parkinson's Disease
    (AKAD DOKTORLAR YAYINEVI, 2012-03-31) DANE, FAYSAL; Korkmaz, Taner; Seber, Selcuk; Basaran, Gul; Yumuk, P. Fulden; Dane, Faysal; Kocar, Muharrem; Telli, Ferhat; Turhal, N. Serdar
    A 59 year-old male with Parkinson's disease developed encephalopathy during adjuvant treatment of rectal cancer. Acute neurotoxicity related to high dose 5-Flourouracil infusion is well described, but encephalopathy with low dose bolus 5-Flourouracil is rare. The advanced Parkinson's disease patients may be more prone to hyperammonemia associated encephalopathy caused by 5-Flourouracil. The prompt recognition of the symptoms is key to diagnosis and treatment.
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    PublicationOpen Access
    Real-life experience with maintenance chemotherapy plus biologics after the first-line treatment of RAS wild-type metastatic colon cancer (mCRC): A multicenter Onco-Colon Turkey study
    (2022-06-01) DANE, FAYSAL; Artac M., Cubukcu E., Bozkurt O., Bilici A., Celik S., Ozcelik M., Oven B., Simsek E., Geredeli C., Karaca M., et al.
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    PublicationOpen Access
    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; Dane, Faysal; Ozgurdal, Kirhan; Yalcin, Suayib; Benekli, Mustafa; Aykan, Nuri Faruk; Yucel, Idris; Ozkan, Metin; Evrensel, Turkkan; Sevinc, Alper; Coskun, Hasan Senol; Sanli, Ulus Ali; Kara, Ismail Oguz; Yumuk, Perran Fulden
    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.
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    PublicationOpen Access
    False Positive FDG PET/CT Resulting from Fibrous Dysplasia of the Bone in the Work-Up of a Patient with Bladder Cancer: Case Report and Review of the Literature
    (KOWSAR PUBL, 2012-12-27) DANE, FAYSAL; Aras, Mustafa; Ones, Tunc; Dane, Faysal; Nosheri, Omid; Inanir, Sabahat; Erdil, Tanju Yusuf; Turoglu, Halil Turgut
    Fibrous dysplasia of the bone (FDB) is a common, genetic, developmental disorder with a benign course. FDB can be seen anywhere throughout the skeleton. It is usually asymptomatic and found incidentally on imaging studies that are performed for other purposes. Although whole body 18 F-flourodeoxyglucose PET/CT (FDG PET/CT) is widely used in tumor imaging, infections and benign pathologies like FDB may cause false positive results. Herein we report the case of a 48-year-old FDB patient with transitional cell carcinoma of the urinary bladder. Restaging FDG PET/CT showed multiple mild to moderate hypermetabolic bone lesions which were initially misinterpreted as bone metastases. In this case report, we aimed to guide physicians in evaluating bone lesions in cancer patients with FDB in the light of the literature.