Abstract：
BACKGROUND: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：男性乳腺癌，约占所有乳腺癌病例的1%，通常导致排除男性患者作为临床试验的标准。虽然细胞周期蛋白依赖性激酶4和6（CDK4/6）抑制剂在女性转移性激素受体阳性（HR）和人表皮生长因子受体2阴性（HER2-）乳腺癌中的疗效已经确定，关于其在男性患者中的有效性的数据有限。我们旨在评估palbociclib或ribociclib在男性乳腺癌患者中的疗效和安全性。
方法：这项研究是一个多中心，回顾性研究。我们纳入了接受palbociclib或ribociclib作为一线治疗的HR+和HER2转移性乳腺癌男性患者。我们的主要终点是无进展生存期（PFS），总反应率（ORR），和药物相关的不良反应。
结果：共纳入来自27个机构的46名男性患者。CDK4/6抑制剂起始的中位年龄为63.64±13.69岁，中位随访时间为21.33个月（95%CI14.92-27.74）。palbociclib的ORR为84%，ribociclib为76.2%。整个队列的mPFS为28.06个月（95％CI18.70-37.42）。palbociclib和ribociclib之间的PFS没有显着差异（mPFS：24.46个月（95％CI11.51-37.42）与28.33个月（95％CI14.77-41.88），分别,p=0.211）。未报告新的不良事件。
结论：本研究表明palbociclib和ribociclib是HR+/HER2转移性乳腺癌男性患者一线治疗的有效和安全的选择。然而,需要进一步的前瞻性研究来确定其在该人群中的疗效.
方法：这项研究是一个多中心，回顾性研究。我们纳入了接受palbociclib或ribociclib作为一线治疗的HR+和HER2转移性乳腺癌男性患者。我们的主要终点是无进展生存期（PFS），总反应率（ORR），和药物相关的不良反应。
结果：共纳入来自27个机构的46名男性患者。CDK4/6抑制剂起始的中位年龄为63.64±13.69岁，中位随访时间为21.33个月（95%CI14.92-27.74）。palbociclib的ORR为84%，ribociclib为76.2%。整个队列的mPFS为28.06个月（95％CI18.70-37.42）。palbociclib和ribociclib之间的PFS没有显着差异（mPFS：24.46个月（95％CI11.51-37.42）与28.33个月（95％CI14.77-41.88），分别,p=0.211）。未报告新的不良事件。
结论：本研究表明palbociclib和ribociclib是HR+/HER2转移性乳腺癌男性患者一线治疗的有效和安全的选择。然而,需要进一步的前瞻性研究来确定其在该人群中的疗效.
