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.

中文翻译：

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palbociclib 和 ribociclib 在一线治疗男性患者转移性激素受体阳性、人表皮生长因子受体 2 阴性乳腺癌中的疗效：一项土耳其肿瘤学组 (TOG) 研究

介绍

男性乳腺癌约占所有乳腺癌病例的 1%，通常导致临床试验中排除男性患者作为标准。虽然细胞周期蛋白依赖性激酶 4 和 6 (CDK 4/6) 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 -) 乳腺癌中的疗效已得到证实，但其疗效有限。现有数据表明其对男性患者的有效性。

我们的目的是评估 palbociclib 或 ribociclib 对男性乳腺癌患者的疗效和安全性。

方法

这项研究是一项多中心、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）、总体缓解率（ORR）和药物相关的不良反应。

结果

共有来自 27 个机构的 46 名男性患者入组。开始使用 CDK 4/6 抑制剂时的中位年龄为 63.64 ± 13.69 岁，中位随访时间为 21.33 (95% CI 14.92–27.74) 个月。 palbociclib 的 ORR 为 84%，ribociclib 的 ORR 为 76.2%。整个队列的 mPFS 为 28.06 个月（95% CI 18.70-37.42）。 palbociclib 和 ribociclib 之间的 PFS 没有显着差异（mPFS：分别为 24.46 个月（95% CI 11.51–37.42）与 28.33 个月（95% CI 14.77–41.88），p  = 0.211）。没有报告新的不良事件。

讨论

这项研究表明，palbociclib 和 ribociclib 是 HR + /HER2 - 转移性乳腺癌男性患者一线治疗的有效且安全的选择。然而，需要进一步的前瞻性研究来确定其在该人群中的功效。