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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 Atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer: A real-life data of the Turkish Oncology Group(Springer, 2022) Gürbüz, Mustafa; Kutlu, Yasin; Akkuş, Erman; Köksoy, Elif Berna; Köse, Naziyet; Öven, Bala Başak; Oyan Uluç, Başak; Demiray, Atike Gökçen; Erdem, Dilek; Demir, Bilgin; Turhal, Nazım Serdar; Üskent, Necdet; Akbaş, Sinem; Selçukbiricik, Fatih; İnal, Ali; Bilici, Ahmet; Ölmez, Ömer Fatih; Çabuk, Devrim; Ünal, Çağlar; Hizal, Mutlu; Şendur, Mehmet Ali Nahit; Korkmaz, Mustafa; Karadurmuş, Nuri; Ertürk, İsmail; Göksu, Sema Sezgin; Tatlı, Ali Murat; Güven, Deniz Can; Kılıçkap, Saadettin; Paksoy, Nail; Aydıner, Adnan; Yeşil Çınkır, Havva; Özkul, Özlem; Öztürk, Akın; Ballı, Sevinç; Kemal, Yasemin; Erdoğan, Atike Pınar; Er, Özlem; Yumuk, Perran Fulden; Demirkazık, AhmetPurpose Atezolizumab has been shown to be effective and safe in randomized trial in the first-line treatment of extensive-stage small cell lung cancer (SCLC). However, there are limited real-life data on atezolizumab. In this study, we aimed to determine the real-life efficacy and safety of atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage SCLC. Methods This trial is a retrospective multicenter study of the Turkish Oncology Group, which included extensive-stage SCLC patients who received atezolizumab combined with chemotherapy in a first-line treatment. The characteristics of the patients, treatment and response rates, and PFS and OS are presented. Factors associated with PFS and OS were analyzed by univariate and multivariate analysis. Results A total of 213 patients at the 30 oncology centers were included. The median number of chemotherapy cycle was 5 (1-8) and atezolizumab cycle was 7 (1-32). After median 11.9 months of follow-up, median PFS and OS was 6.8 months (95%CI 5.7-7.8), and 11.9 months (95%CI 11-12.7), respectively. The ORR was 61.9%. ECOG-PS (p = 0.002) and number of metastatic sites (p = 0.001) were associated with PFS and pack-year of smoking (p = 0.05), while ECOG-PS (p = 0.03) and number of metastatic sites (p = 0.001) were associated with OS. Hematological side effects were common and toxicities were manageable. Conclusion This real-life data confirm the efficacy and safety of atezolizumab in combination with chemotherapy in first-line treatment of extensive-stage SCLC.Öğe Comparison of response and survival of first-line crizotinib therapy according to EML-4 ALK fusion variants in advanced non-small cell lung cancer patients: A Turkish Oncology Group study(Zerbinis Publications, 2021) Tatlı, Ali Murat; Yumuk, Perran Fulden; Öz, Büge; Bilici, Ahmet; Gürsoy, Pınar; Göker, Erdem; Sezer, Ahmet; Özet, Ahmet; Demirci, Umut; Bozkurtlar, Emine; Özbudak, İrem Hicran; Nart, Deniz; Canpolat, Tuğba; Akyürek, Nalan; Kılıçkap, SaadettinPurpose: In the literature there are conflicting data about the treatment efficacy of anaplastic lymphoma kinase (ALK) translocation positive non-small cell lung cancer (NSCLC) patients according to ALK fusion variants. We aimed to study the impact of ALK fusion variants on the survival of first-line crizotinib-treated NSCLC patients. Methods: 101 locally advanced or metastatic ALK positive NSCLC patients treated with first-line crizotinib between January 2013 and December 2019 were retrospectively evaluated. We studied ALK fusion variants in 38 of those patients with adequate tumor tissue with reverse transcription polymerase chain reaction (RT PCR). Patients having ALK fusion variant 1 (v1) and non-variant 1 (non-v1) were compared for survival and response to crizotinib. Results: Median age was 52.5 years (range 35-74), and 22 of 38 patients were male (57.9%). EML-4 ALK v1 was seen in 26 patients (68.4%) and 12 were non-v1 (variant 3a/b in 6, and non-EML-4 ALK variants in 6 patients). Objective response rate was 60.5% in all patients, whereas it was 61.5% in v1 and 58.3% in non-v1 group. Median progression-free survival (PFS) and overall survival (OS) were similar. Median PFS was 13.1 months in v1, and 12.4 months in non-v1 (p=0.232). Median OS was 23.2 months in v1, and 19.4 months non-v1 (p=0.493). Conclusion: ALK v1 and non-v1 patients had the same OS and PFS after first-line crizotinib treatment, however there was a trend for v1 group for better OS.Öğe Concordance of PD-L1 expression and CD8+ TIL intensity between NSCLC and synchronous brain metastases(2020) Batur, Şebnem; Dülger, Onur; Durak, Şermin; Yumuk, Perran Fulden; Çağlar, Hale Başak; Bozkurtlar, Emine; Bozkurt, Süheyla; Taştekin, Ebru; Çiçin, İrfan; Ahiskalı, Rengin; Çakır, Aslı; Öz, BügeProgrammed death-ligand 1 (PD-L1) is suggested to be a predictive biomarker in non-small-cell lung carcinoma (NSCLC). However, the differential expression of PD-L1 in primary lung tumor vs. synchronous metastases, especially brain metastasis (BM), remains unclear. This study assessed the concordance of PD-L1 expression on tumor cells and tumor-infiltrating lymphocytes (TILs) and CD8+ TIL intensity between primary lung tumors and synchronous BMs from 24 NSCLC patients. PD-L1, CD3, and CD8 positivity was determined by immunohistochemistry (IHC). PD-L1 scoring was based on the proportion of tumor cells with membranous expression of PD-L1 and the cutoff values <1%, 1–49%, and ?50%. CD3 and CD8 positivity in TILs was evaluated semi-quantitatively and the proportion of CD3+/CD8+ TILs was determined. PD-L1 expression on tumor cells and TILs was evaluated in relation to CD3+/CD8+ TIL proportions and the intensity of CD8+ TILs between the paired primary lung and BM tissues. In the primary lung tumors, PD-L1 positivity was observed in 25%, 37.5%, and 37.5% cases for the cutoff values <1%, 1–49%, and ?50%, respectively. PD-L1 expression on tumor cells was strongly correlated between the paired primary lung and BM tissues, in all cutoff groups. However, PD-L1 expression on TILs and the proportion of CD3+/CD8+ TILs were not strongly correlated in all three groups between the paired primary lung tumors and BMs. The intensity of CD8+ TILs was concordant in only 54.16% of the paired primary lung tumors and BMs. This study showed a high concordance of PD-L1 expression in neoplastic cells between primary NSCLC and synchronous BMs.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 Drug-drug interactions among hospitalized cancer patients(Springer, 2018) Umar, Rashida Muhammad; Yumuk, Perran Fulden; Apikoğlu Rabuş, Şule[Abstract Not Available]Öğe Drug-related problems identified in hospitalized cancer patients(Springer, 2018) Umar, Rashida Muhammad; Yumuk, Perran Fulden; Apikoglu Rabus, Şule[Abstract Not Available]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 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 Macroscopic complete resection is not associated with improved survival in patients with malignant pleural mesothelioma(Mosby-Elsevier, 2018) Batırel, Hasan Fevzi; Metintaş, Muzaffer; Çağlar, Hale Başak; Ak, Güntülü; Yumuk, Perran Fulden; Ahıskalı, Rengin; Bozkurtlar, Emine; Bekiroğlu, Nural; Laçin, Tunç; Yıldızeli, Bedrettin; Yüksel, MustafaObjective: Macroscopic complete resection (MCR) is the recommended surgical strategy in malignant pleural mesothelioma. Our objective was to analyze whether MCR influences survival in malignant pleural mesothelioma. Methods: Between 2002 and 2016, 154 patients underwent pleurectomy decortication (n = 90), extrapleural pneumonectomy (n = 42), or exploratory/diagnostic procedures (n = 22) in a single institution. Patient data were recorded in a prospective database. Patients who underwent surgical resection (n = 132) were analyzed according to MCR as a whole group and after propensity score matching based on gender, age, histology, clinical T and N status, adjuvant chemotherapy, and trimodality treatment. Kaplan-Meier survival and univariate and multivariate analyses were performed. Results: Median age was 56 years (range, 26 to 80 years) and 62 were women. One hundred ten had epithelioid histology. MCR was achieved in 75 patients (49%). In-hospital mortality was seen in 7 patients (4.5%). Preoperative chemotherapy was applied in 32 patients. One hundred thirty-three patients underwent adjuvant treatment (45 had chemoradiation). Mean follow-up was 21 +/- 19 months. Overall median survival, 2-year, and 5-year survivals were 18.1 months, 36%, and 16%, respectively. There was no difference in median survival between patients who underwent MCR (21.4 months) and who did not (16.3 months) (P = .6). Following propensity score matching (23 patients in each group), median survivals were similar (13.3 vs 14.2 months; P = .63). Conclusions: MCR was not associated with improved survival in malignant pleural mesothelioma. We need to clearly define MCR and identify subgroups of patients who would benefit from this principle because minimal versus extensive and location of gross residual disease may have different influences on survival.Öğe Pertuzumab, trastuzumab and taxane combination for visceral organ metastatic patients: Real life practice results(Oxford University Press, 2018) Esin, Ece; Çakmak Öksüzoğlu, Ömür Berna; Bilici, Ahmet; Çiçin, İrfan; Aksoy, Sercan; Alacacıoğlu, Ahmet; Kaplan, Mehmet Ali; Çabuk, Devrim; Sümbül, Ahmet Taner; Paydaş, Semra; Sakin, Ayşegül; Korkmaz, Tuba; Özdemir Yıldırım, Nuriye; Artaç, Mehmet; Harputluoğlu, Hakan; Yumuk, Perran Fulden; Atalay Başaran, Gül; Oyan Uluç, Başak; Demirci, Umut[Abstract Not Available]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 Significance of a clinical pharmacist-led comprehensive medication management program for hospitalized oncology patients(Springer, 2020) Umar, Rashida Muhammad; Apikoğlu-Rabuş, Şule; Yumuk, Perran FuldenBackground The use of highly toxic drugs in cancer treatment and supportive care medications exposes patients to an increased number of drug-related problems (DRPs). Clinical pharmacists contribute to the optimal use of medications by intervening in identified drug-related problems. Objective To evaluate the relevance of a comprehensive medication management service in oncology patients. Setting Marmara University Teaching and Research Hospital Medical Oncology Ward, Istanbul, Turkey. Methods This prospective study was carried out between December 2015 and April 2016 with adult patients with confirmed malignancy. Comprehensive medication management was performed by the clinical pharmacist throughout the patient's hospital stay. The medication-related data as well as data regarding demographic and general health status of the patients were reviewed for the presence of drug-related problems. The identified problems, interventions and acceptance rate by physicians were recorded with the help of the Pharmaceutical Care Network Europe V6.0 (PCNE) classification. Main outcome measures Number and causes of drug-related problems, nature and acceptance rate of clinical pharmacist interventions and rate of problems solved. Results The study included 137 patients. The mean (SD) age of the patients was 58 (14.6) years. A total of 481 drug-related problems were recorded. The most frequent drug-related problems were 'adverse drug events [including drug interactions]' (n = 376), 'untreated indications' (n = 59) and 'unnecessary drug treatment' (n = 25). Inappropriate combination of drugs was the cause of 73.2% of the total problems. Interventions were made to stop administration of a suitable drug if the combination with another drug was contraindicated while prescribers were mostly informed about major drug interactions. The prescribers approved 93% of the total intervention proposals. The majority (90.9%) of the identified problems were totally solved. Conclusion Integration of clinical pharmacy services through a comprehensive medication management program in oncology will help to reduce the number of drug-related problems.Öğe 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 NahitIntroduction 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.
