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    The efficacy of palbociclib and ribociclib in the first-line treatment of metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer in male patients: a Turkish oncology group (TOG) study
    (Springer Japan Kk, 2024) Yildirim, Hasan Cagri; Kutlu, Yasin; Mutlu, Emel; Aykan, Musa Baris; Korkmaz, Mustafa; Yalcin, Selim; Sakalar, Teoman
    IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.MethodsThis study is a multicenter, retrospective study. We included male patients with HR + and HER2-metastatic breast cancer who received palbociclib or ribociclib as first-line treatment. Our primary endpoints were progression-free survival (PFS), overall response rates (ORR), and drug-related adverse effects.ResultsA total of 46 male patients from 27 institutions were enrolled. The median age at initiation of CDK 4/6 inhibitors was 63.64 +/- 13.69 years, with a median follow-up of 21.33 (95% CI 14.92-27.74) months. The ORR were 84% for palbociclib and 76.2% for ribociclib. The mPFS for the entire cohort was 28.06 months (95% CI 18.70-37.42). No significant difference in PFS was observed between palbociclib and ribociclib (mPFS: 24.46 months (95% CI 11.51-37.42) vs 28.33 months (95% CI 14.77-41.88), respectively, p = 0.211). No new adverse events were reported.DiscussionThis study demonstrates that palbociclib and ribociclib are effective and safe options for first-line treatment in male patients with HR + /HER2 - metastatic breast cancer. However, further prospective studies are warranted to establish their efficacy in this population.
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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.