| 张舒洁,褚嘉栋,李晓林,等.阿贝西利联合非甾体芳香化酶抑制剂作为HR+/HER2-晚期乳腺癌的初始治疗：MONARCH 3研究的最终总生存结果解读[J].肿瘤学杂志,2024,30(8):707-714. |
| 阿贝西利联合非甾体芳香化酶抑制剂作为HR+/HER2-晚期乳腺癌的初始治疗：MONARCH 3研究的最终总生存结果解读 |
| Abemaciclib Plus a Nonsteroidal Aromatase Inhibitor as Initial Therapy for HR+/HER2- Advanced Breast Cancer: Interpretation of Final Overall Survival Results of MONARCH 3 |
| 投稿时间：2024-07-21 |
| DOI：10.11735/j.issn.1671-170X.2024.08.B013 |
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| 中文关键词: 总生存期 乳腺肿瘤 阿贝西利 激素受体 人表皮生长因子受体2 CDK4/6抑制剂 一线治疗 |
| 英文关键词:overall survival breast neoplasms Abemaciclib hormone receptor positive human epidermal growth factor receptor 2 negative CDK4/6 inhibitor first-line therapy |
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| 摘要点击次数: 255 |
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| 中文摘要: |
| 摘 要：MONARCH 3研究是一项随机、双盲、安慰剂对照的Ⅲ期研究，入组18岁以上、绝经后、局部晚期不可手术或转移性激素受体（hormone receptor，HR）阳性/人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阴性（HR+/HER2-）乳腺癌，要求晚期阶段未接受过任何系统性治疗。概括地说，MONARCH 3研究入组人群针对的是内分泌敏感HR+/HER2-乳腺癌的晚期一线治疗。入组患者按2∶1比例随机接受阿贝西利联合非甾体芳香化酶抑制剂（non-steroidal aromatase inhibitor，NSAI）或安慰剂联合NSAI治疗，主要终点为研究者评估意向治疗（intention-to-treat，ITT）人群的无进展生存期（progression-free survival，PFS），次要终点为总生存期（overall survival，OS），无化疗生存期（chemotherapy-free survival，CFS）是探索性终点。共有493例女性患者按2∶1的比例随机接受阿贝西利联合NSAI（阿贝西利组，n=328）或安慰剂联合NSAI（安慰剂组，n=165）治疗。中位随访8.1年后，阿贝西利组发生了198例（60.4%）OS事件，安慰剂组发生了116例（70.3%）OS事件，阿贝西利组和安慰剂组的中位OS分别为66.8个月和53.7个月（HR=0.804，95%CI：0.637~1.015，P=0.066 4）。在内脏转移的亚组分析中，阿贝西利组发生了113例（65.3%）OS事件，安慰剂组发生了65例（72.2%）OS事件，中位OS分别为63.7个月和48.8个月（HR=0.758，95%CI：0.558~1.030，P=0.075 7）。在观察期间没有新的安全事件发生。最终OS未获得统计学意义，因此在HR+/HER2-晚期乳腺癌临床研究中实现OS的显著获益或许还面临挑战。 |
| 英文摘要: |
| Abstract： MONARCH 3 is a randomized， double-blind， placebo-controlled phase Ⅲ study that enrolls women aged 18 years or older with postmenopausal， locally advanced， unresectable or metastatic hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer without prior systemic therapy in the advanced setting. In summary， the MONARCH 3 study enrolled population was an advanced first-line treatment for endocrine-sensitive HR+/HER2- breast cancer. The patients were randomized in a 2∶1 ratio to receive Abemaciclib plus non-steroidal aromatase inhibitor (NSAI) or placebo plus NSAI treatment， with the primary endpoint being the investigator-assessed intention-to-treat (ITT) population’s progression-free survival (PFS) and the secondary endpoint being overall survival (OS). Chemotherapy-free survival (CFS) was an exploratory endpoint. A total of 493 women were randomized in a 2∶1 ratio to receive Abemaciclib plus NSAI (Abemaciclib group， n=328) or placebo plus NSAI (placebo group， n=165). After a median follow-up of 8.1 years， there were 198 OS events (60.4%) in the Abemaciclib arm and 116 (70.3%) in the placebo arm (HR=0.804， 95%CI： 0.637～1.015， P=0.066 4). Median OS for Abemaciclib and placebo was 66.8 months and 53.7 months， respectively. In the subgroup with visceral disease， there were 113(65.3%) OS events in the Abemaciclib arm and 65 (72.2%) in the placebo arm (HR=0.758， 95%CI： 0.558～1.030， P=0.075 7). Median OS for Abemaciclib and placebo was 63.7 months and 48.8 months， respectively. No new safety signals were observed. Ultimately， OS did not achieve statistical significance， so achieving significant OS benefit in HR+/HER2- advanced breast cancer clinical trials may still face challenges. |
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