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<p>CDK4/6 inhibitors combined with endocrine therapy (ET) are widely used in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 −) breast cancer (BC). Dermatologic adverse events (AEs) are increasingly recognized, but their overall risk across randomized trials remains unclear. This systematic review and meta-analysis was conducted in accordance with PRISMA 2020 and registered in PROSPERO (CRD42024591531). PubMed, Embase, and CENTRAL were searched from inception to February 8, 2026 for phase II, III randomized controlled trials (RCTs) comparing CDK4/6 inhibitor–based regimens plus ET versus non-CDK4/6 control regimens. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. Twenty reports representing 15 unique RCTs (17,452 patients) were included. Overall, 56.19% (5196/9248) of patients receiving CDK4/6 inhibitor–based regimens experienced at least one all-grade dermatologic AE, compared with 23.46% (1925/8204) in control regimens. CDK4/6 inhibitor–based regimens significantly increased the risk of all-grade dermatologic AEs (RR 2.32, 95% CI 2.13–2.53; <i>I</i><sup><i>2</i></sup> = <i>54%</i>). Grade ≥ 3 dermatologic AEs were rare (0.13% vs 0.08%) and were not significantly increased (RR 1.01, 95% CI 0.40–2.57; <i>I</i><sup><i>2</i></sup> = <i>0%</i>). CDK4/6 inhibitor–based regimens significantly increased the risk of alopecia (RR 2.71, 95% CI 2.12–3.48;<i> I</i><sup><i>2</i></sup> = <i>75%</i>), rash (RR 2.32, 95% CI 1.98–2.71; <i>I</i><sup><i>2</i></sup> = <i>24%</i>), pruritus (RR 2.08, 95% CI 1.83–2.35; <i>I</i><sup><i>2</i></sup> = <i>0%</i>), and dry skin (RR 2.55, 95% CI 2.14–3.01; <i>I</i><sup><i>2</i></sup> = <i>0%</i>). CDK4/6 inhibitor–based regimens are associated with an increased risk of dermatologic AEs in HR + /HER2 − BC, most of which are mild to moderate. Severe dermatologic AEs are uncommon, supporting proactive counseling and early supportive care.</p>

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Cutaneous adverse events with CDK4/6 inhibitors in breast cancer: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年4月17日

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  • Rui Liu,
  • Jiayong Cui,
  • Ze Liu,
  • Zhen Liu,
  • Hengheng Zhang,
  • Jiuda Zhao,
  • Guoshuang Shen

摘要

CDK4/6 inhibitors combined with endocrine therapy (ET) are widely used in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 −) breast cancer (BC). Dermatologic adverse events (AEs) are increasingly recognized, but their overall risk across randomized trials remains unclear. This systematic review and meta-analysis was conducted in accordance with PRISMA 2020 and registered in PROSPERO (CRD42024591531). PubMed, Embase, and CENTRAL were searched from inception to February 8, 2026 for phase II, III randomized controlled trials (RCTs) comparing CDK4/6 inhibitor–based regimens plus ET versus non-CDK4/6 control regimens. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model. Twenty reports representing 15 unique RCTs (17,452 patients) were included. Overall, 56.19% (5196/9248) of patients receiving CDK4/6 inhibitor–based regimens experienced at least one all-grade dermatologic AE, compared with 23.46% (1925/8204) in control regimens. CDK4/6 inhibitor–based regimens significantly increased the risk of all-grade dermatologic AEs (RR 2.32, 95% CI 2.13–2.53; I2 = 54%). Grade ≥ 3 dermatologic AEs were rare (0.13% vs 0.08%) and were not significantly increased (RR 1.01, 95% CI 0.40–2.57; I2 = 0%). CDK4/6 inhibitor–based regimens significantly increased the risk of alopecia (RR 2.71, 95% CI 2.12–3.48; I2 = 75%), rash (RR 2.32, 95% CI 1.98–2.71; I2 = 24%), pruritus (RR 2.08, 95% CI 1.83–2.35; I2 = 0%), and dry skin (RR 2.55, 95% CI 2.14–3.01; I2 = 0%). CDK4/6 inhibitor–based regimens are associated with an increased risk of dermatologic AEs in HR + /HER2 − BC, most of which are mild to moderate. Severe dermatologic AEs are uncommon, supporting proactive counseling and early supportive care.