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    Efficacy and safety of folfiri plus aflibercept in second-line treatment of metastatic colorectal cancer: Real-life data from Turkish oncology group
    (NLM (Medline), 2022) Erol, Cihan; Şendur, Mehmet Ali Nahit; Bilgetekin, İrem; Bayır Garbioğlu, Duygu; Hamdard, Jamshid; Akbaş, Sinem; Hizal, Mutlu; Arslan, Çağatay; Sevinç, Alper; Küçükarda, Ahmet; Erdem, Dilek; Kahraman, Seda; Çakır, Emre; Demirkıran, Aykut; On, Sercan; Doğan, İzzet; Erdoğan, Atike Pınar; Koca, Sinan; Kubilay, Pınar; Eren, Orhan Önder; Çılbır, Ebru; Çelik, Emir; Araz, Murat; Tataroğlu Özyükseler, Deniz; Yıldırım, Mahmut Emre; Bahçeci, Aykut; Taşkaynatan, Halil; Oyman, Abdilkerim; Deniz, Gülhan İpek; Menekşe, Serkan; Kut, Engin; Gülmez, Ahmet; Sakin, Abdullah; Nayır, Erdinç; Acar, Ramazan; Şen, Erdem; İnal, Ali; Turhal, Serdar; Kaya, Ali Osman; Paydaş, Semra; Taştekin, Didem; Hacıbekiroğlu, İlhan; Çinçin, İrfan; Bilici, Ahmet; Mandel, Nil Molinas; Şener Dede, Didem; Akıncı, Muhammed Bülent; Öksüzoğlu, Berna; Uncu, Doğan; Yalçın, Bülent; Artaç, Mehmet
    Aims: 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.
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    Prognostic significance of tumour tissue NeuGcGM3 ganglioside expression and predictive value of circulating tumour cell count monitoring in patients receiving racotumomab immunotherapy
    (Oxford University Press, 2019) Üskent, Necdet; Ayla, Şule; Mandel, Nil Molinas; Özkan, Metin; Teomete, Mehmet; Baloğlu, Hüseyin; Aydinçer, Cenk; Yergök, H.; Doğan, Erkan; Berk, Barkın; Yazar, Aziz
    [Abstract Not Available]
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    Serum uric acid as a surrogate marker of favorable response to bevacizumab treatment in patients with metastatic colon cancer
    (Springer, 2016) Selçukbiricik, Fatih; Kanbay, Mehmet; Solak, Yalçın; Bilici, Ahmet; Kanıtez, Metin; Balık, Emre; Mandel, Nil Molinas
    Bevacizumab is a monoclonal antibody which is a vascular endothelial growth factor inhibitor. It obscures vascularization of tumor tissue and damages intratumoral microcirculation. The damaged intratumoral microcirculation leads to tissue hypoxia and results in increase of uric acid level. The main aim of our study was to investigate the relationship between uric acid change and response to bevacizumab therapy. This study included a total of 158 patients with metastatic colorectal cancer who had received bevacizumab therapy. The number of male patients was 100 (63.3 %) while female patients number was 58 (37.7 %). The median age was 61 (29-83). There was relationship between increase of uric acid level of third month uric acid level and stable disease (p < 0.001). There was a significant overall survival increased in the group with increased uric acid level (p < 0.001). The decline of CEA level was related to uric acid level (p < 0.022). In conclusion, this study is the first showing significant increases of serum uric acid in patients with metastatic colorectal cancer who favorably responded to chemotherapy with bevacizumab. But further studies are justified to test whether monitoring uric acid levels might predict clinical outcomes of patients with metastatic colorectal cancer.
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    The effect of the use of complex molecular profiling in advanced solid organ tumours on clinical decision: Turkey Molecular Profiling in Advanced Cancers Trial (TUMPACT)
    (Elsevier, 2020) Ölmez, Ömer Fatih; Bilici, Ahmet; Er, Özgür; Sevinç, Ali İbrahim; Akman, Tülay; Uslu, Rüçhan; Mandel, Nil Molinas; Yalçın, Şule; Teomete, Mehmet; Görümlü, Gürbüz; Demir, Ahmet Muzafer; Namal, Esat; Alıcı, Süleyman; Selçukbiricik, Fatih; Bavbek, Sevil; Paksoy, Fatma; Başaran, Gül; Özer, Leyla; Şener, Nazlı; Harputluoğlu, Hakan
    Background: Molecular genetic profiling (MGP) which has started to take an important part in cancer diagnosis and treatment in recent years, has entered the routineclinical practice much faster than expected. We aimed to evaluate the use of thistechnology in routine practice, the effect of changing the treatment decision.Methods: Two hundred and thirty-four patients who received treatment from 21different centers with OncoDeep MGP platform tests were included, which uses acombination of new generation sequencing (NGS), immunohistochemistry (IHC) andother specific tests (Package Plus).Results: Summary was given in the table. Physician waited for test results in 27%(n¼61) of patients for treatment decision. Prior to MGP analysis patients receivedmedian 2-lines of treatment. The median time between sending the sample abroadfor testing and reaching the result by the physician was 14 days (range:5-71). With thetest results, the physician changed the treatment decision in 51.8% of the patients(n¼118). The most frequent way of drug supply of patients whose treatment decisionwere 64.4% (n ¼ 67) from their own budget. When the treatment responses wereevaluated, the disease control rate was 31.1% and the drug discontinuation wasapplied due to toxicity in 4 patients (3.4%). 63.6% (n ¼ 75) of the patients were foundto be alive with a median follow-up of 18.0 months. (Table).
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    The impact of hybrid capture-based comprehensive genomic profiling on treatment strategies in patients with solid tumors
    (Turkiye Klinikleri, 2022) Dişel, Umut; Köse, Fatih; Bilici, Ahmet; Özgüroğlu, Mustafa; Sağlam, Sezer; Şeker, Mesut; Aksoy, Sercan; Tek, İbrahim; Mandel, Nil Molinas; Demir, Gökhan; Arslan, Çağatay; Demiray, Mutlu; Öztürk, Mehmet Akif; Salepçi, Taflan; Eralp, Yeşim; Selçukbiricik, Fatih; Temizaş, Gökçe; Fidan, Ebru Gül
    Objective: The development of bioinformatics and comprehensive genomic profiling (CGP) has provided insights into the ap-plicability and functionality of the genomic alterations (GA). In this study, we evaluated the impact of CGP on the treatment plan and outcomes in a significant number of patients. Material and Methods: We carried out a retrospective case-control study on 164 adult patients with advanced solid tumors from 15 oncology centers in Türkiye. Results: In all cases, CGP was performed within 23.8 [standard deviation (SD)±32.1] months of initial diagnosis. Non-small cell lung carcinoma, breast cancer, unknown primary carcinoma, colorectal carcinoma, and sarcoma were among the most common tumor types, accounting for 61.5% of all cases. CGP was performed immediately after the diagnosis of advanced cancer in 13 patients (7.9%). In 158 patients (96.4%), at least one GA was found as per the CGP report. Also, in the reports, the average tumor mutational burden (TMB) and GAs were 7.3 (SD±8.7) mut/Mb and 3.5 (SD±2.0), respectively. According to CGP reports, 58 patients had 79 evidence-based drug suggestions for their particular tumor type, whereas 97 patients had 153 evidence-based drug suggestions for another tumor type. After the primary oncologist interpreted the CGP reports, significant changes were made to the treatment of 35 (21.3%) patients. Conclusion: We strongly believe that in the future, high-TMB or other tumor-agnostic biomarkers will become much more afford-able, and CGP will serve as one of the major decision-making tools for the treatment of patients along with pathological, radiological or lab-oratory tests.
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    The real-life efficacy and safety of osimertinib in pretreated advanced non-small cell lung cancer patients with T790M mutation: A Turkish Oncology Group Study
    (Springer, 2022) Hızal, Mutlu; Bilgin, Burak; Paksoy, Nail; Açıkgöz, Özgür; Sezer, Ahmet; Gürbüz, Mustafa; Ak, Naziye; Yücel, Şebnem; Ayhan, Murat; Erol, Cihan; Demirkıran, Aykut; Mandel, Nil Molinas; Shbair, Abdallah; Gökmen, İvo; Başoğlu, Tuğba; Paydaş, Semra; Demiray, Atike Gökçen; İriağaç, Yakup; Şakalar, Teoman; Zeynelgil, Esra; Tatlı, Ali Murat; Bahçeci, Aykut; Güven, Deniz Can; Caner, Burcu; Can, Alper; Gülmez, Ahmet; Karakaş, Yusuf; Yalçın, Bülent; Demirkazık, Ahmet; Bilici, Ahmet; Aydıner, Adnan; Yumuk, Perran Fulden; Şendur, Mehmet Ali Nahit
    Introduction Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose disease progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation. Materials and methods This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety. Results Of 163 patients, 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13-month follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion Osimertinib is a highly effective option in second- or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.