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.

Autor: Yıldırım HÇ; Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey. hasan-cagri@windowslive.com., Kutlu Y; Department of Medical Oncology, Istanbul Medipol University Medical Faculty, Istanbul, Turkey., Mutlu E; Department of Medical Oncology, Erciyes University Faculty of Medicine, Kayseri, Turkey., Aykan MB; Department of Medical Oncology, Gulhane Training and Research Hospital, Ankara, Turkey., Korkmaz M; Department of Medical Oncology, Tokat State Hospital, Tokat, Turkey., Yalçın S; Department of Medical Oncology, Kırıkkale University Faculty of Medicine, Kırıkkale, Turkey., Şakalar T; Department of Medical Oncology, Kahramanmaras Necip Fazıl City Hospital, Kahramanmaras, Turkey., Celayir ÖM; Department of Medical Oncology, MAA Acıbadem University, Istanbul, Turkey., Kayıkçıoğlu E; Department of Medical Oncology, Süleyman Demirel University, Isparta, Turkey., Aslan F; Department of Medical Oncology, Medicalpark Ankara Batıkent Hospital, Ankara, Turkey., Hafızoğlu E; Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey., Altıntaş YE; Department of Medical Oncology, Koc University Medical Faculty, Istanbul, Turkey., Keskinkılıç M; Department of Medical Oncology, Eylül University Faculty of Medicine, İzmir, Turkey., Chalabiyev E; Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey., Çelebi A; Department of Medical Oncology, Marmara University Faculty of Medicine, Istanbul, Turkey., Dursun B; Department of Medical Oncology, Ankara University Faculty of Medicine, Ankara, Turkey., Kapar C; Department of Medical Oncology, Bakırkoy Dr. Sadi Konuk Educatıon and Research Hospital, Istanbul, Turkey., Özen M; Department of Medical Oncology, Sakarya University Faculty of Medicine, Sakarya, Turkey., Acar Ö; Department of Medical Oncology, Manisa Celal Bayar University Faculty of Medicine, Manisa, Turkey., Dülgar Ö; Department of Medical Oncology, Umraniye Training and Research Hospital, Istanbul, Turkey., Kut E; Department of Medical Oncology, Manisa State Hospital, Manisa, Turkey., Biter S; Department of Medical Oncology, Cukurova University Faculty of Medicine, Adana, Turkey., Kus F; Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey., Almuradova E; Department of Medical Oncology, Tınaztepe Galen Hospital, Izmir, Turkey., Erdoğan AP; Department of Medical Oncology, Manisa Celal Bayar University Faculty of Medicine, Manisa, Turkey., Saray S; Department of Medical Oncology, Balıkesir State Hospital, Balıkesir, Turkey., Güven DC; Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey., Şimşek ET; Department of Medical Oncology, Anadolu Medical Center, Kocaeli, Turkey., Üskent N; Department of Medical Oncology, Anadolu Medical Center, Kocaeli, Turkey., Kemal Y; Department of Medical Oncology, Samsun Medical Park Hospital, Samsun, Turkey., Çakar B; Department of Medical Oncology, Ege University Faculty of Medicine, İzmir, Turkey., Açıkgöz Ö; Department of Medical Oncology, Istanbul Medipol University Medical Faculty, Istanbul, Turkey., Kılıçkap S; Department of Medical Oncology, İstinye University Liv Hospital, Ankara, Turkey., Aksoy S; Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey.
Jazyk: angličtina
Zdroj: International journal of clinical oncology [Int J Clin Oncol] 2024 Mar; Vol. 29 (3), pp. 258-265. Date of Electronic Publication: 2024 Feb 04.
DOI: 10.1007/s10147-023-02460-5
Abstrakt: Introduction: Male 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.
Methods: This 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.
Results: A 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.
Discussion: This 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.
(© 2024. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.)
Databáze: MEDLINE
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