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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 Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: Results of real-life experience(American Society of Clinical Oncology, 2020) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Artaç, Mehmet; Özhan, Nail; Akar, Emre; Çakar, Burcu; Köstek, Osman; Paksoy, Nail; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Yılmaz, Uğur; Bilgetekin, İrem; Yıldız, Birol; Kılıçkap, Saadettin[Abstract Not Available]Öğe Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: Results of real-life experiences(Elsevier, 2021) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Artaç, Mehmet; Özhan, Nail; Akar, Emre; Çakar, Burcu; Köstek, Osman; Ekenel, Meltem; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Yılmaz, Uğur; Bilgetekin, İrem; Yıldız, Birol; Şendur, Mehmet Ali Nahit; Paksoy, Nail; Dirican, Ahmet; Erdem, Dilek; Selam, Meltem; Tanrıverdi, Özgür; Paydaş, Semra; Urakçı, Zuhat; Atağ, Elif; Güncan, Sabri; Ürün, Yüksel; Alkan, Ali; Kaya, Ali Osman; Tataroğlu Özyükseler, Deniz; Taşkaynatan, Halil; Yıldırım, Mustafa; Sönmez, Müge; Başoğlu, Tuğba; Gündüz, Şeyda; Kılıçkap, SaadettinBackground: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum resistant urothelial carcinoma. Objective: To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. Design, setting, and participants: Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. Outcome measurements and statistical analysis: The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. Results and limitations: Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47-28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25-5.49) and 9.8 mo (95% CI, 6.7-12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3-4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treat-ment response based on clinical notes and local radiographic studies. Conclusions: In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. Patient summary: Atezolizumab is effective and well-tolerated in patients with meta-static urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting.Öğe Comparing the efficacy of regorafenib and 5-fluorouracil-based rechallenge chemotherapy in the third-line treatment of metastatic colorectal cancer(BioMed Central Ltd, 2024) Şenocak Taşçı, Elif; Oyan, Başak; Sönmez, Özlem; Mutlu, Arda Ulaş; Atçı, Muhammed Mustafa; Sakin, Abdullah; Öner, İrem; Yeşil Çınkır, Havva; Karakurt Eryılmaz, Melek; Çağlayan, Dilek; Balçık, Onur Yazdan; Paksoy, Nail; Bozkurt, MustafaBackground: The optimal treatment for metastatic colorectal cancer (mCRC) after the second line is still controversial. Regorafenib has been the standard of care in this setting as it improved overall survival (OS) compared to placebo. In real-world practice chemotherapy rechallenge is also a preferred option even though supporting evidence is not enough. We aim to compare the efficacy of regorafenib and 5-fluorouracil-based (5-FU) rechallenge treatment in the third line setting of mCRC. Methods: In this retrospective multi-institutional trial, mCRC patients from 21 oncology centers who progressed after 2 lines of chemotherapy were analyzed. Patients who were treated with regorafenib or rechallenge therapy in the third-line setting were eligible. Rechallenge chemotherapy was identified as the re-use of the 5-FU based regimen which was administered in one of the previous treatment lines. OS, disease control rate (DCR), progression free survival (PFS) and toxicity were analyzed. Results: Three hundred ninety-four mCRC patients were included in the study. 128 (32.5%) were in the rechallenge, and 266 (67.5%) were in the regorafenib group. Median PFS was 5.82 months in rechallenge and 4 months in regorafenib arms (hazard ratio:1.45,95% CI, p = 0.167). DCR was higher in the rechallenge group than regorafenib (77% vs 49.5%, respectively, p = < 0.001). Median OS after the third-line treatment was 11.99 (95% CI, 9.49–14.49) and 8.08 months (95% CI, 6.88–9.29) for rechallenge and regorafenib groups, respectively (hazard ratio:1.51, 95% CI, p < 0.001). More adverse effects and discontinuation were seen with regorafenib treatment. Conclusion: Our study revealed that higher disease control and OS rates were achieved with rechallenge treatment compared to regorafenib, especially in patients who achieved disease control in one of the first two lines of therapy.Öğe Correction: Comparing the efficacy of regorafenib and 5-fluorouracil-based rechallenge chemotherapy in the third-line treatment of metastatic colorectal cancer (BMC Cancer, (2024), 24, 1, (16), 10.1186/s12885-023-11783-5)(BioMed Central Ltd, 2024) Şenocak Taşçı, Elif; Oyan, Başak; Sönmez, Özlem; Mutlu, Arda Ulaş; Atcı, Muhammed Mustafa; Sakin, Abdullah; Öner, İrem; Yeşil Çınkır, Havva; Karakurt Eryılmaz, Melek; Çağlayan, Dilek; Yazdan Balçık, Onur; Paksoy, Nail; Bozkurt, MustafaFollowing publication of the original article [1], the authors reported an error in the affiliations of authors Başak Oyan, Özlem Sönmez, Leyla Özer, Ali Arıcan, Özlem Er and Mustafa Bozkurt. These authors are all affiliated to institution 2.Öğe Crizotinib efficacy and safety in patients with advanced NSCLC harboring MET alterations: A real-life data of Turkish Oncology Group(NLM (Medline), 2022) Gürbüz, Mustafa; Kılıçkap, Saadettin; Bilici, Ahmet; Karadurmuş, Nuri; Sezer, Ahmet; Şendur, Mehmet Ali Nahit; Paydaş, Semra; Artaç, Mehmet; Fulden Yumuk, Perran; Gürsoy, Pınar; Uysal, Mükremin; Şenol Coşkun, Hasan; Tatlı, Ali Murat; Selçukbiricik, Fatih; Dişel, Umut; Köksoy, Elif Berna; Güven, Deniz Can; Uğraklı, Muzaffer; Akkuş, Erman; Yücel, Şebnem; Erol, Cihan; Karakaya, Serdar; Şakalar, Teoman; Khanmammadov, Nijat; Paksoy, Nail; Demirkazık, AhmetCrizotinib is a multikinase inhibitor, effective in non-small cell lung cancer (NSCLC) harboring mesenchymal-epidermal transition (MET) alterations. Although small prospective studies showed efficacy and safety of crizotinib in NSCLC with MET alterations, there is limited real-life data. Aim of this study is to investigate real-life efficacy and safety of crizotinib in patients with advanced NSCLC harboring MET alterations. This was a retrospective, multicenter (17 centers) study of Turkish Oncology Group. Patients' demographic, histological data, treatment, response rates, survival outcomes, and toxicity data were collected. Outcomes were presented for the study population and compared between MET alteration types. Total of 62 patients were included with a median age of 58.5 (range, 26-78). Major histological type was adenocarcinoma, and 3 patients (4.8%) had sarcomatoid component. The most common MET analyzing method was next generation sequencing (90.3%). MET amplification and mutation frequencies were 53.2% (n?=?33) and 46.8% (n?=?29), respectively. Overall response rate and disease control rate were 56.5% and 74.2% in whole study population, respectively. Median progression free survival (PFS) was 7.2 months (95% confidence interval [CI]: 3.8-10.5), and median overall survival (OS) was 18.7 months (95% CI: 13.7-23.7), regardless of treatment line. Median PFS was 6.1 months (95% CI: 5.6-6.4) for patients with MET amplification, whereas 14.3 months (95% CI: 6.7-21.7) for patients with MET mutation (P?=?.217). Median PFS was significantly longer in patients who have never smoked (P?=?.040), have good performance score (P?Öğe Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy(BioMed Central Ltd, 2023) Karacin, Cengiz; Öksüzoğlu, Berna; Demirci, Ayşe; Keskinkılıç, Merve; Baytemür, Naziyet Köse; Yılmaz, Funda; Selvi, Oğuzhan; Erdem, Dilek; Avşar, Esin; Paksoy, Nail; Demir, Necla; Göksu, Sema Sezgin; Türker, Sema; Bayram, Ertuğrul; Çelebi, Abdüssamet; Yılmaz, Hatice; Kuzu, Ömer Faruk; Kahraman, Seda; Gökmen, İvo; Sakin, AbdullahBackground: There is no standard treatment recommended at category 1 level in international guidelines for subsequent therapy after cyclin-dependent kinase 4/6 inhibitor (CDK4/6) based therapy. We aimed to evaluate which subsequent treatment oncologists prefer in patients with disease progression under CDKi. In addition, we aimed to show the effectiveness of systemic treatments after CDKi and whether there is a survival difference between hormonal treatments (monotherapy vs. mTOR-based). Methods: A total of 609 patients from 53 centers were included in the study. Progression-free-survivals (PFS) of subsequent treatments (chemotherapy (CT, n:434) or endocrine therapy (ET, n:175)) after CDKi were calculated. Patients were evaluated in three groups as those who received CDKi in first-line (group A, n:202), second-line (group B, n: 153) and ? 3rd-line (group C, n: 254). PFS was compared according to the use of ET and CT. In addition, ET was compared as monotherapy versus everolimus-based combination therapy. Results: The median duration of CDKi in the ET arms of Group A, B, and C was 17.0, 11.0, and 8.5 months in respectively; it was 9.0, 7.0, and 5.0 months in the CT arm. Median PFS after CDKi was 9.5 (5.0–14.0) months in the ET arm of group A, and 5.3 (3.9–6.8) months in the CT arm (p = 0.073). It was 6.7 (5.8–7.7) months in the ET arm of group B, and 5.7 (4.6–6.7) months in the CT arm (p = 0.311). It was 5.3 (2.5–8.0) months in the ET arm of group C and 4.0 (3.5–4.6) months in the CT arm (p = 0.434). Patients who received ET after CDKi were compared as those who received everolimus-based combination therapy versus those who received monotherapy ET: the median PFS in group A, B, and C was 11.0 vs. 5.9 (p = 0.047), 6.7 vs. 5.0 (p = 0.164), 6.7 vs. 3.9 (p = 0.763) months. Conclusion: Physicians preferred CT rather than ET in patients with early progression under CDKi. It has been shown that subsequent ET after CDKi can be as effective as CT. It was also observed that better PFS could be achieved with the subsequent everolimus-based treatments after first-line CDKi compared to monotherapy ET.Öğe Prognostic factors in patients with metastatic urothelial carcinoma who have treated with atezolizumab(Springer Japan KK, 2021) Tural, Deniz; Ölmez, Ömer Fatih; Sümbül, Ahmet Taner; Özhan, Nail; Çakar, Burcu; Köstek, Osman; Ekenel, Meltem; Erman, Mustafa; Coşkun, Hasan Şenol; Selçukbiricik, Fatih; Keskin, Özge; Paksoy Türköz, Fatma; Oruç, Kerem; Bayram, Selami; Bilgetekin, İrem; Yıldız, Birol; Şendur, Mehmet Ali Nahit; Paksoy, Nail; Dirican, Ahmet; Erdem, Dilek; Selam, Meltem; Tanrıverdi, Özgür; Paydaş, Semra; Urakçı, Zuhat; Atağ, Elif; Güncan, Sabri; Ürün, Yüksel; Alkan, Ali; Kaya, Ali Osman; Tataroğlu Özyükseler, Deniz; Taşkaynatan, Halil; Yıldırım, Mustafa; Sönmez, Müge; Başoğlu, Tuğba; Gündüz, Şeyda; Kılıçkap, Saadettin; Artaç, MehmetBackground Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies of patients with metastatic platinum-resistant urothelial carcinoma. However, the response rate of Atezolizumab was modest. In the current study, we evaluated the pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy in the Expanded-Access Program of Atezolizumab. Patients and methods In this study, we present a retrospective analysis of 113 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. Data of the patients was obtained from patient files and hospital records. Eligible patients included metastatic urothelial carcinoma patients treated with at least one course of ATZ. Univariate analysis was used to identify clinical and laboratory factors that significantly impact OS. Variables were retained for multivariate analysis if they had a statistical relationship with OS (p < 0.1), and then included a final model of p < 0.05. Results The median follow-up duration was 23.5 months. Of the patients, 98 (86.7%) were male and 13.3% were female. The median age was 65 years of age (37-86). In univariate analysis, primary tumor location in the upper tract, increasing absolute neutrophil count (ANC), increasing absolute lymphocyte count, neutrophil-to-lymphocyte ratio (NLR) > 3, liver metastases, baseline creatinine clearance less (GFR) than 60 ml/min, Eastern Cooperative Oncology Group (ECOG) performance status (1 >=), and hemoglobin levels below 10 mg/dl were all the significantly associated with OS. Three of the five adverse prognostic factors according to the Bellmunt criteria were independent of short survival: liver metastases HR 3.105; 95% CI 1.673-5.761; p < (0.001), ECOG PS (1 >=) HR 2.184; 95% CI 1.120-4.256; p = 0.022, and Hemoglobin level below 10 mg/dl HR 2.680; 95% CI 1.558-4.608; p < (0.001). In addition, NLR > 3 hazard ratio [HR] 2.092; 95% CI 1.031-4.243; p = 0.041 and GFR less than 60 ml/min HR 1.829; 95% CI 1.1-3.041; p = 0.02, maintained a significant association with OS in multivariate analysis. Conclusions This model confirms the Bellmunt model with the addition of NLR > 3 and GFR less than 60 ml/min and can be associated with clinical trials that use immunotherapy in patients with bladder cancer.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 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.
