细胞周期蛋白依赖型激酶CDK4/6抑制剂哌柏西利可阻断乳腺癌细胞有丝分裂周期由DNA合成前期进入DNA合成期，三项随机对照研究PALOMA-1、2、3已经证实哌柏西利＋内分泌治疗可显著改善激素受体阳性HER2阴性晚期乳腺癌患者的无进展生存。不过，哌柏西利＋内分泌治疗对于中国晚期乳腺癌的实际疗效尚不明确。
2020年11月30日，美国《医学科学监测》在线发表复旦大学附属肿瘤医院刘畅、李婷、陶中华、曹君、王磊苹、张剑、王碧芸、胡夕春等学者的真实世界研究报告，调查了中国激素受体阳性HER2阴性晚期乳腺癌患者哌柏西利＋内分泌治疗的临床结局。
该单中心回顾研究利用电子病历系统，对2016年9月～2019年8月复旦大学附属肿瘤医院130例激素受体阳性HER2阴性晚期乳腺癌患者哌柏西利＋内分泌治疗的临床特征和疗效数据进行回顾分析。
结果，其中哌柏西利初始剂量为每天125毫克的患者占87.0%，剂量减少的患者占8.5%，由于毒性停止治疗的患者占2.3%。
总体而言，病变控制（完全缓解＋部分缓解＋病变稳定）患者占77.4%，临床获益（完全缓解＋部分缓解）患者占63.4%。
中位随访10.6个月的中位无进展生存为9.2个月。一线、至少二线、至少四线治疗的中位无进展生存分别为14.7、7.4、4.4个月。
哌柏西利对于至少四线内分泌治疗患者的疗效有限，除非哌柏西利联合已经获得耐药的内分泌治疗。哌柏西利治疗失败后，进一步化疗与内分泌治疗结局相似（P=0.571）。
因此，该单中心小样本回顾研究结果表明，对于激素受体阳性HER2阴性晚期乳腺癌患者，即使内分泌治疗耐药，哌柏西利＋内分泌治疗的有效性和耐受性良好，进一步化疗与内分泌治疗结局相似。
Med Sci Monit. 2020 Nov 30;26:e927187.
Clinical Outcomes of 130 Patients with Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer Treated with Palbociclib plus Endocrine Therapy and Subsequent Therapy: A Real-World Single-Center Retrospective Study in China.
Liu C, Li T, Tao Z, Cao J, Wang L, Zhang J, Wang B, Hu X.
Fudan University Shanghai Cancer Center, Shanghai, China; Shanghai Medical College, Fudan University, Shanghai, China.
BACKGROUND: This retrospective single-center study conducted in China aimed to investigate the clinical outcomes of patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) treated with palbociclib plus endocrine therapy (ET) and subsequent therapy.
MATERIAL AND METHODS: Eligible patients were women with HR+ and HER2- MBC who initiated palbociclib plus ET between September 2016 and August 2019 at Fudan University Shanghai Cancer Center. Clinical characteristics and efficacy data were retrospectively recorded from the electronic medical record system.
RESULTS: In total, 130 patients were included in the study, of whom 87.0% of patients started palbociclib on 125 mg/day, 8.5% of patients had dose reduction, and 2.3% of patients discontinued the treatment because of toxicity. Overall, the disease control rate was 77.4% and clinical benefit rate was 63.4%. After a median follow-up period of 10.6 months, the median progression-free survival was 9.2 months. There was limited efficacy in patients who received palbociclib as no less than a fourth line of ET, except for patients who added palbociclib to the ET, which they had acquired resistance to. After disease progression on palbociclib, further treatment with chemotherapy and ET had similar efficacy (P=0.571).
CONCLUSIONS: The findings from this real-world single-center study in China showed that treatment with palbociclib plus ET exhibited favorable efficacy and good tolerance in patients with HR+ and HER2- MBC, even in patients who were initially resistant to endocrine therapy, and there was no difference in outcomes between subsequent treatment with chemotherapy and ET.
PMID: 33250509
DOI: 10.12659/MSM.927187
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