阿贝西利联合依维莫司治疗HR⁺/HER2^-晚期乳腺癌的临床疗效观察

Clinical Efficacy of Abemaciclib Combined with Everolimus in HR⁺/HER2^- Advanced Breast Cancer

摘要

目的 研究阿贝西利联合依维莫司治疗激素受体阳性/人表皮生长因子受体2阴性（hormone receptor-positive/human epidermal growth factor receptor 2-negative，HR⁺/HER2^-）晚期乳腺癌的治疗效果。方法 随机选取2022年1月至2024年1月期间洛阳市妇幼保健院收治的HR⁺/HER2^-晚期乳腺癌患者155例作为研究对象。对照组给予依维莫司联合内分泌治疗，观察组在对照组基础上加用阿贝西利治疗。以21 d为1个周期，2组均治疗8个周期。比较2组治疗8个周期后的疗效，治疗4个周期、8个周期后肿瘤标志物[糖类抗原153（carbohydrate antigen 153，CA153）、癌胚抗原（carcinoembryonic antigen，CEA）、人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2/neu）]、淋巴细胞亚群指标、雌激素指标[雌酮（estrone，E₁）、雌二醇（estradiol，E₂）、雌激素受体（estrogen receptor，ER）]水平及治疗期间不良反应，并随访记录2组生存率。结果 观察组疾病控制率（disease control rate，DCR）显著高于对照组（P< 0.05）；治疗4个周期、8个周期后2组CEA、CA153、HER2/neu、CD8⁺、E₁、E₂及ER水平均较治疗前显著降低（P< 0.05），且观察组均显著低于同期对照组（ P< 0.05）；治疗8个周期后CD3⁺、CD4⁺水平较治疗前显著升高（P< 0.05），且观察组均显著高于同期对照组（ P< 0.05）。2组头痛、胃肠道反应、失眠等总不良反应发生率无明显差异（ P> 0.05）；观察组无进展生存率、总生存率均显著高于对照组（ P< 0.05）。结论 阿贝西利联合依维莫司治疗HR⁺/HER2^-晚期乳腺癌疗效确切，可有效改善患者血清肿瘤标志物水平，且整体安全性良好、不良反应可控，具备较好的临床应用与推广价值。

Abstract

Objective To evaluate the effect of abemaciclib combined with everolimus on hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR⁺/HER2^-) advanced breast cancer. Methods A total of 155 HR⁺/HER2^- advanced breast cancer patients admitted to Luoyang Maternal and Child Health Hospital from January 2022 to January 2024 were enrolled. They were randomly divided into two groups. The control group received a combination of everolimus and endocrine therapy, while the intervention group received abemaciclib in addition to the regimen given to the control group. Both groups were treated for 8 cycles, with 21 days constituting one cycle. The clinical efficacy was assessed after 8 cycles of treatment. The levels of tumor markers [carbohydrate antigen 153 (CA153), carcinoembryonic antigen (CEA), human epidermal growth factor receptor 2 (HER2/neu)], lymphocyte subpopulation indicators, estrogen indicators [estrone (E₁), estradiol (E₂), estrogen receptor (ER)], and adverse reactions were assessed during treatment after 4 and 8 cycles of treatment. Survival rates were documented during follow-up. All data were compared between the two groups.Results The disease control rate (DCR) in the intervention group was higher than that in the control group (P< 0.05). After 4 cycles and 8 cycles of treatment, the levels of CEA, CA153, HER2/neu, CD8 ⁺, E₁, E₂ and ER in both groups were decreased compared with those before treatment, and the levels in the intervention group were lower than those in the control group at the corresponding time points (all P< 0.05). After 8 cycles, the levels of CD3 ⁺ and CD4⁺ were increased compared with baseline, and were higher in the intervention group than those in the control group at the corresponding time points (all P< 0.05). There was no significant difference in the overall incidence of adverse reactions, including headache, gastrointestinal reactions and insomnia between the two groups ( P> 0.05). The progression-free survival rate and overall survival rate in the intervention group were both higher than those in the control group ( P< 0.05). Conclusion Abemaciclib in combination with everolimus demonstrates definite clinical efficacy in the treatment of HR⁺/HER2^- advanced breast cancer. It can effectively improve the serum levels of tumor markers in patients, with a favorable overall safety profile and manageable adverse reactions, thus holding good value for clinical application and promotion.

关键词

阿贝西利 / 依维莫司 / 激素受体阳性/人表皮生长因子受体2阴性 / 乳腺癌 / 癌胚抗原 / 糖类抗原153

Key words

abemaciclib / everolimus / hormone receptor-positive/human epidermal growth factor receptor 2-negative / breast cancer / carcinoembryonic antigen / carbohydrate antigen 153

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