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.
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.