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Öğe Crizotinib efficacy in alk-positive advanced stage non-small cell lung cancer patients: A real-world experience from Turkey(Elsevier Science Inc, 2018) Kılıçkap, Sadettin; Öztürk, Akın; Karadurmuş, Nuri; Korkmaz, Taner; Yumuk, Perran Fulden; Çiçin, İrfan; Paydaş, Semra; Çılbır, Ebru; Sakalar, Teoman; Uysal, Mükremin; Üskent, Necdet; Demir, Nurcan; Sakin, Ayşegül; Turhal, Nazım Serdar; Keskin, Serhat; Tural, Deniz; Eralp, Yeşim; Buğdaycı Başal, Fatma; Yaşar, Hatime Arzu; Sendur, Mehmet Ali Nahit; Demirci, Umut; Çubukçu, Erdem; Karaağaç, Mustafa; Karaca, Saziye; Tatlı, Ali Murat; Yetişyiğit, Tarkan; Urvay, Semiha; Gürsoy, Pınar; Oyan Uluç, Başak; Turna, Zeynep Hande; Küçüköner, Mehmet; Ölmez, Ömer Fatih; Çabuk, Devrim; Şeker, Mesut; Ünal, Olçun Umut; Meydan, Nezih; Okutur, Sadi Kerem; Tunalı, DuyguBackground: Increasing evidence leads to a ratiocination that genetic heterogeneity of the lung adenocarcinoma patients with sensitive EGFR mutations may impact clinical responses and outcomes to EGFR-TKIs. Method: We performed targeted NGS with a gene panel covering 416 cancer-related genes to profile genetic characteristics of 69 lung adenocarcinoma patients with activating EGFR mutations and assessed the contribution of targeted NGS to exploration of genetic heterogeneity of such cohort. Result: We detected total 200 actionable genetic alterations (mean 2.9 variations per patient, range: 1-7 variations) in tumor DNA and 140 actionable genetic alterations (mean 2.0 variations per patient, range: 0-5 variations) in matched plasma ctDNA, respectively. The concurrent genes with the highest mutation rate were TP53 (observed in 72.5% patients), other uncommon EGFR mutations (observed in 21.7% patients), EGFR amplification (observed in 20.3% patients), RB1 (observed in 10.1% patients), PIK3CA (observed in 7.2% patients), and MYC (observed in 5.8% patients). NGS provides EGFR mutation detection in plasma with a test sensitivity of 88.2% and specificity of 100.0%.Öğe Does primary tumor localization has prognostic importance in seminoma patients?: Turkish Oncology Group Study(Imprimatur Publications, 2020) Yıldız, Birol; Küçükarda, Ahmet; Gökyer, Ali; Demiray, Atike Gökçen; Paydaş, Semra; Aral, İpek Pınar; Gümüşay, Özge; Bilici, Ahmet; Akdeniz, Nadiye; Bahçeci, Aykut; Demir, Hacer; Esin, Ece; Üyetürk, Ümmügül; Ökten, İlker Nihat; Ertürk, İsmail; Türk, Hacı Mehmet; Topaloğlu, Ulaş Serkan; Başoğlu, Tuğba; Turhal, Nazım Serdar; Yeşil Çınkır, Havva; Menekşe, Serkan; Çakmak, Yağmur; Ürün, Yüksel; Acar, Ramazan; Kut, Engin; Dal, Pınar; Sakalar, Teoman; Aktepe, Oktay Halit; Karadurmuş, NuriPurpose: The purpose of this study was to determine whether primary tumor localization may be a risk factor for relapse and survival in seminomatous germ cell tumors (GCT) patients.Methods: In our study, 612 seminomatous GCT patients diagnosed in 22 centers between 01.01.1989 and 03.02.2019 were retrospectively evaluated. Patient interview information, patient files and electronic system data were used for the study.Results: The primary tumor was localized in the right testis in 305 (49.9%) patients and in 307 (50.1%) in the left testis. Mean age of the patients was 36 years (range 16-85 +/- 10.4).The median follow-up period was 47 months (1-298). Recurrence was observed in 78 (127%) patients and 29 (4.7%) died during the follow-up period. Four-year overall survival (OS) was 95.4% and 4-year progression-free survival (PFS) was 84.5%. The relationship between localization and relapse was significant in 197 patients with stage 2 and stage 3 (p=0.003). In this patient group, 41 (20.8%) relapses were observed. Thirty (73.2%) of the relapses were in the right testis and 11 (26.8%) in the left testis.Four-year OS was 92.1% in patients with right tumor; and 98.7% in patients with left tumor (p=0.007). When 612 patients were evaluated with a mean follow-up of 4 years, there was a 6.6% survival advantage in patients with left testicular tumor and this difference was significant (p=0.007).Conclusion: Survival rates of patients with primary right testicular localization were worse compared with left testicular localization, and relapse rates were higher in stage 2 and 3 patients with right testicular localization.Öğe Efficacy of regorafenib in the second-and third-line setting for patients with advanced hepatocellular carcinoma: A real life data of multicenter study from Turkey(Imprimatur Publication, 2020) Hacıoğlu, Muhammet Bekir; Köstek, Osman; Karabulut, Senem; Taştekin, Didem; Sezgin Göksu, Sema; Alandağ, Celal; Akagündüz, Baran; Bilgetekin, İrem; Caner, Burcu; Şahin, Ahmet Bilgehan; Yıldız, Birol; Köse, Fatih; Kaplan, Muhammet Ali; Gülmez, Ahmet; Doğan, Ender; Güven, Deniz Can; Gürbüz, Mustafa; Ergun, Yakup; Karaağaç, Mustafa; Demiray, Atike Gökçen; Türker, Sema; Sakalar, Teoman; Özkul, Özlem; Akın Telli, Tuğba; Şahin, Süleyman; Kılıçkap, Saadettin; Bilici, Ahmet; Erdoğan, Bülent; Çiçin, İrfanPurpose: After failure of the first-line sorafenib treatment in advanced or metastatic stage hepatocellular carcinoma (HCC), regorafenib is one of the newly-approved targeted agents. We aimed to evaluate the efficacy of regorafenib in patients with advanced HCC treated in the secondor third-line setting.Methods: In this retrospective and multicenter study, advanced HCC patients not eligible for local therapies, who received a secondor third-line regorafenib therapy after progression on the first-line sorafenib or sequential therapy with chemotherapy (CT) followed by sorafenib, were included.Results: In the first-line setting, 28 (28.9%) patients received CT and 69 (71.1%) patients received sorafenib. There were 24 (24.7%) patients who were intolerant to sorafenib. Disease control rate (DCR) was 53.6% for all patients treated with regorafenib, 62.3% in patients who received regorafenib in the second-line, and 32.1% for those receiving regorafenib in the third-line (p=0.007). Median progression-free survival (PFS) and overall survival (OS) were 5.6 (range; 4.3-6.9) and 8.8 (range, 6.3-11.3) months for all patients treated with regorafenib vs. 7.1 months and 10.3 months for patients who received regorafenib in the second-line vs. 5.1 and 8.7 months for patients who received regorafenib in the third-line, respectively; however, there was no statistically significant difference (p(PFS)=0.22 and p(OS)=0.85).Conclusion: Although receiving CT as a first-line therapy in advanced HCC patients did not affect the survival rates of subsequent regorafenib therapy, it might diminish the DCR of regorafenib.Öğe Is there any prognostic significance in pleural involvement and/or effusion (Ple-I/E) in patients with ALK-positive NSCLC?(Oxford University Press, 2019) Kılıçkap, Saadettin; Buğdaycı Basal, Fatma; Demirkazık, Ahmet; Gürsoy, Pınar; Demirci, Ufuk; Erman, Mustafa; Yumuk, Fulden; Çay Şenler, Filiz; Çakar, Burcu; Çiçin, İrfan; Öztürk, Akın; Coşkun, Hasan Şenol; Çubukçu, Erdem; Işıkdoğan, Abdurrahman; Ölmez, Ömer Fatih; Tatlı, Ali Murat; Karaağaç, Mehmet Onur; Sakalar, Teoman; Eralp, Yeşim; Korkmaz, TanerBackground: ALK mutation occurs in approximately 3-5% of patients with NSCLC. At the baseline, Ple-I/E are more frequent in ALK? patients with NSCLC. In the study, we aimed to evaluate characteristics of ALK?patients who have Ple-I/E. Methods: In this multicenter study, patients with ALK? NSCLC who have Ple-I/E were retrospectively analyzed. Clinical and demographic characteristics of the disease, response rates, median PFS and OS were evaluated in 362 ALK?patients with NSCLC. Results: Of the patients, 198 (54.7%) were male. The median age at the time of diagnosis was 54 (21-85) years. The median age was higher in male (57 vs 52 years; p¼0.011). The most common histology was adenocarcinoma (100%). At the baseline, 57 (15.7%) patients had Ple-I/E. The median age of patients with Ple-I/E was similar to patients without Ple-I/E (53 vs 55 years; p¼0.541). The rate of smokers was 43.4% (n¼157) in the patients. There was no association between Ple-I/E and gender, lung metastasis and distant LAP metastasis. Pleural involvement was higher in non-smokers than smokers (19.4% vs 13.4%; p¼0.077), but not statistically significant. The frequencies of liver, brain and bone metastasis were a significant higher in ALK?patients with Ple-I/E compared to those with non-metastatasis (respectively 18.2% vs 4.8%, p¼0.008; 19.1% vs 4.8%, p¼0.002; 20.6% vs 8.9%, p¼0.003). The median PFS was longer in ALK? patients who have Ple-I/E 18.7 vs 10.6 months, p¼0.017). The 1-, 2- and 3-year PFS were 59%, 36%, and 24% in patients with Ple-I/E and 47%, 24%, and 8% in patients with non-involvement. Similarly, the median OS was longer in ALK?patients who have pleural involvement/infusion 44.6 vs 22.6 months, p¼0.051). The 1-, 2- and 3- year OS were 78%, 67%, and 57% in patients with Ple-I/E and 66%, 48%, and 34% in patients with non-involvement. Conclusions: Brain, liver and bone metastases are lower in ALK?patients with Ple-I/E. Presentation with Ple-I/E in patients with ALK? NSCLC is associated with longer overall and progression-free survival. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Öğe Merkel cell carcinoma in Turkey: A multicentric study(Wolters Kluwer Medknow Publications, 2021) Yıldız, Fatih; Demirci, Umut; Küçükarda, Ahmet; Büyükşimşek, Mahmut; Sakalar, Teoman; Öztürk Topçu, Türkan; Aslan, Ferit; Tufan, Gülnihal; Aydın, Övgü; Turna, Hande; Akgül Babacan, Nalan; Başoğlu, Tugba; Kurt, Bediz; Yıldız, Birol; Eren, Tülay; Demiray, Atike Gökçen; Gümüşay, Özge; Arslan, Çağatay; Özdemir, Nuriye; Ürün, Yüksel; Baykara, Meltem; Turan, Nedim; Uysal, Mükremin; Bilici, Ahmet; Kavgacı, Halil; Çiçin, İrfan; Kılıçkap, Saadettin; Paydaş, SemraBackground: Merkel cell carcinoma (MCC) is a rare but highly aggressive neuroendocrine carcinoma of the skin. In this study, we aimed to evaluate the clinicopathologic characteristics, treatment outcomes, and survival of MCC cases in Turkey. Materials and methods: The patients diagnosed with MCC between 1999 and 2018 at twenty different centers in Turkey were included in the study. Patient and tumor characteristics and adjuvant and metastatis treatment outcomes were analyzed retrospectively. Results: The median age of totally 89 patients was 70 (26-93). The most common primary location was lower limbs (n = 29, 32.5%). Immunohistochemically, CK20 positivity was present in 59 patients (66.3%). Only two patients had secondary malignancy. The majority of the patients (n = 76, 85.4%) were diagnosed at the localized stage. Surgery was performed for all patients in the early stage, and adjuvant radiotherapy or/and chemotherapy was applied to 52.6% (n = 40) of nonmetastatic patients. The median follow-up was 29 months. Recurrence developed in 21 (27.6%) of the 76 patients who presented with local or regional disease. Two-year disease-free survival (DFS) was 68.1% and 5-year DFS was 62.0% for localized stage. The 5-year DFS was similar for patients receiving adjuvant treatment (chemotherapy, radiotherapy, or sequential chemoradiotherapy) and without adjuvant therapy (P > 0.05). Two-year overall survival in patients who presented with localized disease was 71.3% and 18.5% in metastatic patients (P < 0.001). In the metastatic stage, platinum/etoposide combination was the most preferred combination regimen. Median progression-free survival (PFS) in first-line chemotherapy was 7 months (95% confidence interval: 3.5-10.5 months; standart error: 1.78). Conclusions: Although MCC is rare in Turkey, the incidence is increasing. Gender, CK20 status, tumor size, lymph node involvement, and adjuvant treatment were not associated with recurrence.Öğe Real-life analysis of efficacy and safety of everolimus plus exemestane in hormone receptor-positive, human epidermal growth factor receptor-2-negative metastatic breast cancer patients: A Turkish Oncology Group (TOG) study(Taylor & Francis Inc, 2022) Bilici, Ahmet; Uysal, Mükremin; Menekşe, Serkan; Akın, Semih; Yıldız, Fatih; Turan, Merve; Sezgin Göksu, Sema; Beypınar, İsmail; Sakalar, Teoman; Değirmenci, Mustafa; Erdem, Dilek; Başaran, Gül; Ölmez, Ömer Fatih; Avcı, Nilüfer; Tural, Deniz; Sakin, Abdullah; Türker, Sema; Demir, Atakan; Temiz, Süleyman; Kaplan, Muhammed Ali; Doğan, Mutlu; Tanrıverdi, Özgür; Bilgetekin, İrem; Yeşil Çınkır, Havva; Açıkgöz, Özgür; Paydaş, Semra; Uslu, Rüçhan; Turhal, SerdarPurpose: This study evaluated the efficacy and safety of everolimus (EVE) plus exemestane (EXE) in hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative (HER2?) metastatic breast cancer (MBC) patients in real-life settings. Methods: Overall, 204 HR+, HER2? MBC patients treated with EVE + EXE after progressing following prior endocrine treatment were included. Overall survival (OS) and progression-free survival (PFS) and safety data were analyzed. Results: The objective response rate, median PFS, and median OS were 33.4%, 8.9 months, and 23.4 months, respectively. Multivariate analysis revealed that negative progesterone receptor status was a significant determinant of poor treatment response (p = 0.035) and PFS (p = 0.024). The presence of bone-only metastasis was associated with better treatment response (p = 0.002), PFS (p < 0.001), and OS (p = 0.001). Conclusion: We confirmed the favorable efficacy and safety profile of EVE + EXE for HR+, HER ? MBC patients.Öğe Real-world data on efficacy and safety of first-line alectinib treatment in advanced-stage, ALK-positive non-small-cell lung cancer patients: A Turkish Oncology Group study(Future Medicine Ltd., 2022) Hızal, Mutlu; Bilgin, Burak; Paksoy, Nail; Kılıçkap, Sadettin; Atcı, Muhammed Mustafa; Kahraman, Seda; Keskinkılıç, Merve; Bilgetekin, İrem; Ayhan, Murat; Tural, Deniz; Eren, Önder; Akkoç Mustafayev, Fatma Nihan; Yaman, Şebnem; Tatlı, Ali Murat; Bayram, Ertuğrul; Kutlu, Yasin; Ertürk, İsmail; Özcan, Erkan; Gülmez, Ahmet; Korkmaz, Mustafa; Akagündüz, Baran; Erdem, Dilek; Akın Telli, Tuğba; Aksoy, Asude; Üskent, Necdet; İriağaç, Yakup; Köse Baytemür, Naziyet; Aydın, Dinçer; Sakalar, Teoman; Arak, Haci; Selçukbiricik, Fatih; Ergün, Yakup; Korkmaz, Taner; Ak, Naziye; Ünal, Çağlar; Akdeniz, Nadiye; Özgün, Mehmet Alpaslan; Öksüzoğlu, Berna; Yalçın, Bülent; Öztop, İlhan; Algın, Efnan; Sakin, Abdullah; Aydıner, Adnan; Yumuk, Perran Fulden; Şendur, Mehmet Ali NahitAims: In this multicenter study, the authors aimed to determine the real-life efficacy and safety of first-line alectinib. Materials & methods: This retrospective trial included advanced-stage, ALK-positive non-small-cell lung cancer patients who were treated with first-line alectinib in terms of ALK-tyrosine kinase inhibitors, regardless of previous chemotherapy. The co-primary end points were progression-free survival both for all patients and for the treatment-naive population. The secondary end points were overall response rate, overall survival, rate of CNS progression and safety. Results & conclusion: A total of 274 patients (n = 177 for treatment-naive patients) were enrolled in the study. The median progression-free survival was 26 and 28.8 months for all patients and the treatment-naive group, respectively. The overall response rate, CNS progression rate and 1-year overall survival ratio were 77.9, 12.4 and 77%. Alectinib is a highly effective therapy with a favorable safety profile.Öğe The efficacy and safety analysis of the treatments of everolimus and exemestane combination in 101 metastatic breast cancer patients: Real-life experience from Turkey(Amer Assoc Cancer Research, 2019) Bilici, Abdullah Yasin; Menekşe, Serkan; Akın, Şeyma Selin; Değirmenci, Mehmet Fatih Kağan; Ölmez, Ömer Fatih; Avcı, Nilüfer; Sakalar, Teoman; Tural, Deniz; Kaplan, Muhammet Ali; Tanrıverdi, Özgür; Bilgetekin, İrem; Uslu, RabiyeBackground: Endocrine treatment and chemotherapy are a treatment options for patients with hormone receptor (HR) positive and HER2-negative metastatic breast cancer (MBC). However, response to first-line hormone treatment could not obtained in all patients, and even patients who havea response will eventually relapse. After disease progression, second-line hormonal treatmentoptions are used sequentially. Everolimus with exemestane has demonstrated promising activity in patients with HR-positive HER2-negative endocrine-resistant MBC with respect to the results of the BOLERO-2 study. In the present study, we aimed to evaluate the efficacy and safety of this combination in the real-life clinical setting for the unselected population in Turkey. Material and Methods: One hundred and one patients with HR-positive HER-2 negative MBC progressing after prior endocrine treatment who were treated with everolimus with exemestane were retrospectively analyzed. The tolerability and efficacy of this combination were evaluated in the unselected Turkish patients. Results: Among 101 patients, 45% of patients had visceral and %50 patients had only bone metastasis. Everolimus with exemestane treatment was administered as a second-line in 21.3% of patients, third-line in 40.4% and forth-line and later in 38.2%. The objective response rate was 24.7% (CR+PR) and stable disease was obtained in 37.7% of patients. At the median follow-up time of 13.5 months, the median progression-free survival (PFS) time and 1-year PFS were 13.8 months and 57.2%, while the median overall survival (OS) interval and 1-year OS were 40 months and 85%. The median treatment duration was 8.3 and 6.5 months for exemestane and everolimus, respectively. The most frequent reason for discontinuation of treatment were disease progression (39%). Moreover, the most common advers events (AE) causing permanent discontinuation were stomatitis (3%) and pneumonitis (3%). A total of 81 % of patients experienced at least one AE of any grade, 25% of patients at least one grade 3 or 4 AE. Due to AEs, everolimus dosage was reduced to 5 mg in 16 (15.8%) of patients. Conclusions: Our findings confirmed that the combination of everolimus with exemestane was the safe and effective treatment options for patients with HR-positive HER-2 negative MBC after second or later lines treatments.Öğe The efficacy and safety of crizotinib in patients with ROS1 positive advanced stage NSCLC: The real-world experience from Turkey(Oxford University Press, 2018) Kılıçkap, Saadettin; Ölmez, Ömer Fatih; Cicin, İrfan; Demirci, Umut; Alan, O.; Çabuk, Devrim; Sakalar, Teoman; Tatlı, Ali Murat; Buğdaycı, F. Başol; Eralp, Yeşim; Uysal, Mükremin; Demirkazik, Ahmet; Bilgin, Burak; Yıldız, Birol; Karaağaç, Mustafa; Okutur, Kerem; Sakin, Ayşegül[Abstract Not Available]
