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Öğe A multicenter, retrospective archive study of radiological and clinical features of ALK-positive non-small cell lung cancer patients and crizotinib efficacy(2024) Kılıçkap, Saadettin; Öztürk, Akın; Karadurmuş, Nuri; Korkmaz, Taner; Yumuk, Perran Fulden; Çiçin, İrfan; Paydaş, Semra; Çılbır, Ebru; Şakalar, Teoman; Uysal, Mükremin; Yeşil Çınkır, Havva; Üskent, Necdet; Demir, Necla; Sakin, Abdullah; Dursun, Oldaç Uras; Aver, Birkan; Turhal, Nazım Serdar; Keskin, Serkan; Tural, Deniz; Eralp, Yeşim; Buğdaycı Başal, Fatma; Yaşar, Hatime Arzu; Şendur, Mehmet Ali Nahit; Demirci, Umut; Çubukçu, Erdem; Karaağaç, Mustafa; Çakar, Burcu; Tatlı, Ali Murat; Yetişyiğit, Tarkan; Urvay, Semiha; Gürsoy, Pınar; Oyan, Başak; Turna, Zeynep Hande; Işıkdoğan, Abdurrahman; Ölmez, Ömer Fatih; Yazıcı, Ozan; Çabuk, Devrim; Şeker, Mehmet Metin; Ünal, Olçun Ümit; Meydan, Nezih; Okutur, Sadi Kerem; Tunalı, Didem; Erman, MustafaTo evaluate radiological and clinical features in metastatic anaplastic lymphoma kinase+ non-small cell lung cancer patients and crizotinib efficacy in different lines. This national, non-interventional, multicenter, retrospective archive screening study evaluated demographic, clinical, and radiological imaging features, and treatment approaches in patients treated between 2013-2017. Totally 367 patients (54.8% males, median age at diagnosis 54 years) were included. Of them, 45.4% were smokers, and 8.7% had a family history of lung cancer. On radiological findings, 55.9% of the tumors were located peripherally, 7.7% of the patients had cavitary lesions, and 42.9% presented with pleural effusion. Pleural effusion was higher in nonsmokers than in smokers (37.3% vs. 25.3%, P = .018). About 47.4% of cases developed distant metastases during treatment, most frequently to the brain (26.2%). Chemotherapy was the first line treatment in 55.0%. Objective response rate was 61.9% (complete response: 7.6%; partial response: 54.2%). The highest complete and partial response rates were observed in patients who received crizotinib as the 2nd line treatment. The median progression-free survival was 14 months (standard error: 1.4, 95% confidence interval: 11.2-16.8 months). Crizotinib treatment lines yielded similar progression-free survival (P = .078). The most frequent treatment-related adverse event was fatigue (14.7%). Adrenal gland metastasis was significantly higher in males and smokers, and pleural involvement and effusion were significantly higher in nonsmokers - a novel finding that has not been reported previously. The radiological and histological characteristics were consistent with the literature data, but several differences in clinical characteristics might be related to population characteristics.Öğe Are pretreatment inflammation-based prognostic scores useful in predicting the outcomes of patients with ALK-positive NSCLC?(Elsevier Science, 2019) Ölmez, Ömer Fatih; Bilici, Ahmet; Gürsoy, Pınar; Çubukçu, Erdem; Yıldız, Özcan; Sakın, Abdullah; Korkmaz, Taner; Çil, İbrahim; Çakar, Beyhan; Menekşe, Serkan; Demir, Tarık; Açıkgöz, Özgen; Hamdard, JamshidBackground: Approximately 5% of all diagnosed non-small cell lung cancer (NSCLC) patients harbor a genetic rearrangement between the ALK and EML4 genes, representing a specific molecular and clinical subgroup (ALK+ NSCLC). To date, upfront treatment with ALK-tyrosine-kinase inhibitors (ALK-TKIs) has replaced chemotherapy in the first line setting for this subset of patients with excellent results, but reliable prognostic markers are lacking. An increased systemic inflammatory response has been shown to be associated with a poor prognosis, and some of the parameters used to characterize this response can easily be measured in clinical practice in several tumor types, but have not been analyzed extensively in ALK+ lung cancer in the era of crizotinib. Method: We reviewed the medical records of all patients with previously treated advanced ALK-positive NSCLC who received crizotinib between January 2013 and March 2018 outside of a clinical trial. Pre-treatment modified Glasgow prognostic score (mGPS), Prognostic Nutritional Index (PNI) and Systemic immune-inflammation index (SII) were calculated. Multivariable logistic regression and Cox proportional hazards models were used to assess the impact of pretreatment mGPS, PNI and SII on overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). Result: 82 patients were treated. Median age was 52.5 years (range; 20e77 years); 42.7% were female. Eighty-four point two percent of patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1; 17.1% had received 2 prior systemic therapies. The objective response rate was 77.2% (CR+PR). The optimal cutoff levels were 0.09 for mGPS and PNI, 934.7 for SII by ROC curves analysis. Patients in the SII 934.7 grous was significantly correlated with worse PFS and OS by univariate analysis (Figure 1). In multivariate analyses, pretreatment prognostic nutritional index (PNI) 0.09 was independently associated with inferior OS (1 year OS rates, 90.2% vs. 73.7%; HR 2.46, 95% CI 0.88- 4.85; p ¼ 0.035). Additionally, we evaluated the effects of these markers on response prediction. The logistic regression analysis of the predictive factors for the response to crizotinib demonstrated that the mGPS and PNI were associated with inferior ORR (OR: 0.1, 95% CI 0.16-1.04; p ¼ 0.009 and OR: 0.16, 95% CI 0.02-0.55; p ¼ 0.035, respectively). Conclusion: In a cohort of patients with ALK positive NSCLC treated with crizotinib in routine practice, elevated pre-treatment SII was associated with shorter OS and PFS in univariate analysis and PNI was associated with shorter OS in multivariate analyses. Moreover the mGPS and PNI were associated with lower response rates.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 Glass: Global lorlatinib for ALK(+) and ROS1(+) retrospective study: Real world data of 123 NSCLC patients(Elsevier Ireland Ltd, 2020) Peled, Nir; Gillis, Roni; Kılıçkap, Saadettin; Froesch, Patrizia; Orlov, Sergei; Filippova, Elena; Demirci, Umut; Christopoulos, Petros; Çiçin, İrfan; Buğdaycı Basal, Fatma; Yılmaz, Cengiz; Fedor, Moiseenko; Korkmaz, Taner; Paydaş, Semra; Gautschi, Oliver; Zırtıloğlu, Alişan; Eralp, Yeşim; Yeşil Çınkır, Havva; Sezer, Ahmet; Erman, Mustafa; Tural, Deniz; Turna, Hande; Mazieres, Julien; Dudnik, Elizabeth; Reguart, Noemi; Camidge, David Ross; Ng, Terry L.; Çay Şenler, Filiz; Beypınar, İsmail; Yazılıtaş, Doğan; Demirkazık, Ahmet; Karaoğlu, Aziz; Okutur, Kerem; Coşkun, Hasan Şenol; Şendur, Mehmet Ali Nahit; Işıkdoğan, Abdurrahman; Çabuk, Devrim; Yumuk, Perran Fulden; Yıldız, İbrahim; Kaplan, Mehmet Ali; Özyılkan, Özgür; Öztop, İlhan; Ölmez, Ömer Fatih; Aydın, Kübra; Aydıner, Adnan; Meydan, Nezih; Grinberg, Roxana Denisa; Roisman, Laila C.Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1( + ) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib.Methods: 123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria.Results: 106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. The ALK( + ) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 +/- 1.6 months and median overall survival (mOS) was 89.1 +/- 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 +/- 2.5 months and mOS of 90.3 +/- 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters.The most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18 % of patients.Conclusion: Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. The observed mOS of 89 +/- 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 +/- 24 months is unprecedented for ROS1( + ) NSCLC.Öğe Glass: Global lorlatinib for ALK(+) and ROS1(+) retrospective study: Real world data of 123 NSCLC patients(Elsevier Science Inc, 2021) Peled, Nir; Gillis, Roni; Kılıçkap, Saadettin; Froesch, Patrizia; Orlov, Sergei; Filippova, Elena; Demirci, Umut; Christopoulos, Petros; Çiçin, İrfan; Buğdaycı Basal, Fatma; Yılmaz, Cengiz; Fedor, Moiseenko; Korkmaz, Taner; Paydaş, Semra; Gautschi, Oliver; Zırtıloğlu, Alişan; Eralp, Yeşim; Yeşil Çınkır, Havva; Sezer, Ahmet; Erman, Mustafa; Tural, Deniz; Turna, Hande; Mazieres, Julien; Dudnik, Elizabeth; Reguart, Noemi; Camidge, David Ross; Ng, Terry L.; Çay Şenler, Filiz; Beypınar, İsmail; Yazılıtaş, Doğan; Demirkazık, Ahmet; Karaoğlu, Aziz; Okutur, Kerem; Coşkun, Hasan Şenol; Şendur, Mehmet Ali Nahit; Işıkdoğan, Abdurrahman; Çabuk, Devrim; Yumuk, Perran Fulden; Yıldız, İbrahim; Kaplan, Mehmet Ali; Özyılkan, Özgür; Öztop, İlhan; Ölmez, Ömer Fatih; Aydın, Kübra; Aydıner, Adnan; Meydan, Nezih; Grinberg, Roxana Denisa; Roisman, Laila C.Introduction: Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1(+) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib.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 Lorlatinib in ALK- or ROS1-positive non-small cell lung cancer patients: Experience from an early access program in Turkey(Elsevier Science, 2019) Kılıçkap, Saadettin; Demirci, Umut; Buğdaycı, Fatma; Tural, Deniz; Korkmaz, Taner; Paydaş, Semra; Yılmaz, Coşkun; Tuna, Hande; Sezer, Ahmet; Yeşil Çinkir, Havva; Erman, Münire; Eralp, Yeşim; Çabuk, Devrim; Işıkdoğan, Abdurrahman; Demirkazık, Ahmet; Karaoğlu, Aziz; Yazılıtaş, Doğan; Çay Şenler, Filiz; Yumuk, Perran Fulden; Coşkun, Hatice; Yıldız, İbrahim; Öztop, İlhan; Beypınar, İsmail; Aydın, Kübra; Kaplan, M.; Meydan, Nezih; Ölmez, Ömer Fatih; Seber, Samile; Arslan, Çağatay; Şendur, Mehmet Ali Nahit; Çiçin, İrfanBackground: Lorlatinib, a third generation ALK and ROS1 inhibitor, is indicated for the treatment of patients with ALK+ metastatic NSCLC whose disease has progressed on crizotinib and at least one second-generation ALK inhibitor. The aim of this study is to evaluate the efficacy and safety of lorlatinib in an Expanded Access Program (EAP) in Turkey. Method: The EAP was open-label, multicenter, and single-arm. Patients were eligible to receive lorlatinib (100 mg po/day) if they had advanced stage ALK-or ROS1-positive NSCLC and had progressed on crizotinib and/or second generation ALK inhibitors such as ceritinib or alectinib. The primary endpoint was PFS with lorlatinib. Secondary endpoints were objective response rate, overall survival, and safety.Öğe Pertuzumab, trastuzumab and taxane-based treatment for visceral organ metastatic, trastuzumab-naive breast cancer: Real-life practice outcomes(Springer, 2019) Esin, Ece; Çakmak Öksüzo?lu, Berna; Bilici, Ahmet Erkan; Çiçin, İrfan; Köstek, Osman; Kaplan, Mehmet Ali; Aksoy, Sercan; Aktaş, Burak Yasin; Özdemir, Özlem; Alacacıoğlu, Ahmet; Çabuk, Devrim; Sümbül, Ahmet Taner; Sakin, Abdullah; Paydaş, Semra; Yetişir, Ersin; Er, Özlem; Korkmaz, Taner; Yıldırım, Nilgün; Şakalar, Teoman; Demir, Hacer; Artaç¸, Mehmet; Karaa?aç, Mustafa; Harputluo?lu, Hakan; Bilen, Ebru; Erdur, Erkan; De?irmencio?lu, Serkan; Aliyev, Altay; Çil, Timuçin; Olgun, Polat; Başaran, Gül Atalay; Gümüşay, Özge; Demir, Atakan; Tanrıkulu, Eda; Yumuk, Perran Fulden; İmamoğlu, İnanç; Oyan, Başak; Çetin, Bülent Eren; Haksöyler, Veysel; Karadurmuş, Nuri; Ertürk, İsmail; Evrensel, Türkkan; Yılmaz, Hasan; Beypınar, İsmail; Koçer, Murat; Pilancı, Kezban Nur; Şeker, Mesut Metin; Ürün, Yüksel; Yıldırım, Nuriye O.; Eren, Tülay; Demirci, UmutPurposeIn this study, we aimed to describe the real-life practice outcomes of pertuzumab-trastuzumab-taxane (PTT) combination in visceral organ metastatic, trastuzumab-naive breast cancer (BC) patients.MethodsThis study was conducted by Turkish Oncology Group and included 317 patients' data from 36 centers.ResultsMedian age was 51 (22-82). Median PFS was 28.5months, while median OS was 40.3months. Patients with brain metastases (n: 13, 4.1%) had worse PFS (16.8m vs. 28.5m; p=0.002) and OS (26.7m vs. 40.3m; p=0.009). Patients older than 65years of age (n: 42, 13.2%) had significantly lower OS results (19.8m vs. 40.3m; p=0.01). Two hundred sixty-eight patients (86.7%) received docetaxel while 37 patients (11.7%) received paclitaxel. PFS and OS were similar between taxane groups. In eight patients (2.5%), 5-40% ejection fraction decrement from baseline was detected without any clinical sign of heart failure.ConclusionsOur RLP trial included only visceral metastatic, trastuzumab-naive BC patients including cases with brain involvement who received PTT combination in the first-line treatment. Regardless of negative prognostic characteristics, our results are in parallel with pivotal trial. Further strategies for brain metastasis should be developed to improve outcomes despite encouraging results with PTT treatment. Taxane selection can be personalized and endocrine maintenance may further improve outcomes after taxanes were discontinued. To our knowledge, this is the largest scale real-life clinical practice study of pertuzumab-trastuzumab-taxane therapy to date.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 Systemic inflammatory markers as a predictors of response to crizotinib in patients with ALK-positive non-small-cell lung cancer(Elsevier Science Inc, 2019) Bilici, Ahmet; Ölmez, Ömer Fatih; Gürsoy, Pınar; Çubukçu, Erdem; Yıldız, Özcan; Sakın, Abdullah; Korkmaz, Taner; Çil, İbrahim; Çakar, Beyhan; Menekşe, Serkan; Demir, Tarık; Açıkgöz, Özgen; Hamdard, JamshidThe significance of the presence of a systemic inflammatory response (SIR) in predicting survival has been demonstrated in patients with cancer. Moreover, neutrophil-to-lymphocyte ratio (NLR), lymphocyteratio (NLR), lymphocyte-to-monocyte ratio (LMR) and platelet-to-lymphocyte ratio (PLR) have been also investigated in patients with both early and advanced non-small-cell lung cancer (NSCLC). However, determination of SIR predicting outcomes of patients who are likely to response to crizotinib in ALK-positive NSCLC patients has not been clearly demonstrated.
