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    The percentage of ALK-positive cells and the efficacy of first-line alectinib in advanced non-small cell lung cancer: is it a novel factor for stratification? (Turkish Oncology Group Study)
    (Springer, 2022) Kılıçkap, Saadettin; Paksoy, Nil; Bilgin, Burak; Sakin, Abdullah; Özcan, Erkan; Tatlı, Ali Murat; Hızal, Mutlu; Paksoy, Nail; Kahraman, Sedat
    Introduction: Alectinib is an effective second-generation ALK tyrosine kinase inhibitor (TKI) used in the first-line treatment of patients with advanced ALK-positive NSCLC. Recent studies demonstrated that the percentage of ALK-positive tumor cells in patient groups receiving crizotinib might affect outcomes. This study aimed to investigate whether the percentage of ALK-positive cells had a predictive effect in patients with advanced NSCLC who received first-line Alectinib as ALK-TKI. Materials and methods: This retrospective study included patients with advanced-stage NSCLC who received alectinib as a first-line ALK-TKI and whose percentage of ALK-positive cells was determined by FISH at 27 different centers. Patients who received any ALK-TKI before alectinib were not included in the study. Patients were separated into two groups according to the median (40%) value of the percentage of ALK-positive cells (high-positive group ? 40% and low-positive group < 40%). The primary endpoint was PFS, and the secondary endpoints were OS, ORR, and PFS of the subgroups based on different threshold values for the percentage of ALK-positive cells. Results: 211 patients were enrolled (48.3% female, 51.7% male) to study. 37% (n = 78) of the patients had received chemotherapy previously. After a median of 19.4 months of follow-up, the median PFS was not reached in the high-positive group (n = 113), but it was 10.8 months in the low-positive group (n = 98) (HR 0.39; 95% CI 0.25-0.60, p < 0.001). The median OS in the high-positive group was not reached, whereas it was 22.8 months in the low-positive group (HR 0.37; 95% CI 0.22-0.63, p < 0.001). ORR was significantly higher in the high-positive group (87.2 vs. 68.5%; p = 0.002). According to the cut-off values of < 20%, 20-39%, 40-59%, and ? 60%, the median PFS was 4.5, 17.1, and 26 months, respectively, and could not be reached in the ? 60% group. Conclusion: Our study demonstrated that the efficacy of alectinib varies significantly across patient subgroups with different percentages of ALK-positive cells. If these findings are prospectively validated, the percentage of ALK-positive cells may be used as a stratification factor in randomized trials comparing different ALK-TKIs.
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    Real-life comparison of afatinib and erlotinib in non-small cell lung cancer with rare EGFR exon 18 and exon 20 mutations: a Turkish Oncology Group (TOG) study
    (Springer, 2022) Tatlı , Ali Murat; Erdem, Dilek; Göker, Erdem; Çelik, Emir; Demirci, Nebi Serkan; Sakin, Abdullah; Atçı , Muhammed Mustafa; Bayram, Ertuğrul; Akın Telli, Tuğba; Bilgin, Burak; Bilici, Ahmet; Akangündüz , Baran; Ballı, Sevinç; Demirkazık, Ahmet; Selçukbiricik, Fatih; Menekşe, Serkan; Çavdar, Eyyüp; Öztürk, Akın; Türkmen Bekmez, Esma; Turhal, Serdal; Kılıçkap, Sadettin; Yıldırım, Hasan Çağrı; Oyan, Başak; Aksoy, Asude; Paksoy Türköz, Fatma; Kut, Engin; Katgı, Nuran; Sakalar, Teoman; Akyol, Murat; Ellez, Halil İbrahim; Topçu, Atakan; Erdoğan, Atike Pınar; Pılancı, Kezban Nur; Hedem, Engin; Arak, Hacı; Akdeniz, Nadiye; Alan, Özkan; Yapar, Burcu; Nart, Deniz; Yumuk, Perran Fulden
    Objectives To compare the survival of frst- and second-generation tyrosine kinase inhibitors (TKIs) in patients with rare EGFR exon 18 and exon 20 mutation-positive non-small cell lung cancer (NSCLC). Materials and methods We retrospectively evaluated survival characteristics of 125 patients with EGFR exon 18 and exon 20 mutated NSCLC who received erlotinib or afatinib as frst line treatment between 2012 and 2021 from 34 oncology centres. Since exon 20 insertion is associated with TKI resistance, these 18 patients were excluded from the study. Results EGFR exon 18 mutations were seen in 60%, exon 20 mutations in 16%, and complex mutations in 24% of the patients with NSCLC who were evaluated for the study. There were 75 patients in erlotinib treated arm and 50 patients in afatinib arm. Patients treated with erlotinib had progression-free survival time (PFS) of 8.0 months and PFS was 7.0 months in the afatinib arm (p=0.869), while overall survival time (OS) was 20.0 vs 24.8 months, respectively (p=0.190). PFS of exon 18 mutated arm was 7.0 months, exon 20 mutated arm was 4.3 months, and complex mutation positive group was 17.3 months, and this was statistically signifcant (p=0.036). The longest OS was 32.5 months, seen in the complex mutations group, which was not statistically diferent than exon 18 and in exon 20 mutated groups (21.0 and 21.2 months, respectively) (p=0.323). Conclusion In this patient group, especially patients with complex mutations are as sensitive to EGFR TKI treatment similar to classical mutations, and in patients with rare exon 18 and exon 20 EGFR mutation both frst- and second-generation EGFR-TKIs should be considered, especially as frst- and second-line options.
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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, 2021) Hizal, Mutlu; Bilgin, Burak; Paksoy, Nail; Açıkgöz, Özgür; Sezer, Ahmet; Can, Alper
    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 frst-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efcacy 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 diferent 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 efective option in second- or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profle.
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    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
    (Atypon, 2022) Hızal, Mutlu; Bilgin, Burak; Paksoy, Nail; Kılıçkap, Saadettin; Atcı, Muhammed Mustafa; Kahraman, Seda; Ayhan, Murat; Tural, Deniz; Yaman, Şebnem; Kutlu, Yasin; Korkmaz, Mustafa; Aksoy, Asude; Arak, Hacı; Korkmaz, Taner; Ak, Naziye; Akdeniz, Nadiye; Sakin, Abdullah; Fulden Yumuk, Perran
    Aims: 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.