GEICAM 辅助研究和 El Álamo IV 登记处高危 HR 阳性和 HER2 阴性早期乳腺癌患者的长期结局。
Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Álamo IV registry.
机构信息
Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense, Madrid, Spain.
GEICAM, Spanish Breast Cancer Group, Madrid, Spain.
出版信息
Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.
PURPOSE
The monarchE trial showed that the addition of abemaciclib improves efficacy in patients with high-risk early breast cancer (EBC). We analyzed the long-term outcomes of a population similar to the monarchE trial to put into context the potential benefit of abemaciclib.
METHODS
HR-positive/HER2-negative EBC patients eligible for the monarchE study were selected from 3 adjuvant clinical trials and a breast cancer registry. Patients with ≥ 4 positive axillary lymph nodes (N +) or 1-3 N + with tumor size ≥ 5 cm and/or histologic grade 3 and/or Ki67 ≥ 20%, who had undergone surgery with curative intent and had received anthracyclines ± taxanes and endocrine therapy in the neoadjuvant and /or adjuvant setting were included. We performed analysis of Invasive Disease-Free Survival (iDFS), Distant Disease-Free Survival (dDFS) and Overall Survival (OS) at 5 and 10 years, as well as yearly (up to 10) of Invasive Relapse Rate (IRR), Distant Relapse Rate (DRR) and Death Rate (DR).
RESULTS
A total of 1,617 patients were analyzed from the GEICAM-9906 (312), GEICAM-2003-10 (210), and GEICAM-2006-10 (160) trials plus 935 from El Álamo IV. With a median follow-up of 10.1 years, the 5 and 10 years iDFS rates were 75.2% and 57.0%, respectively. The dDFS and OS rates at 5 years were 77.4% and 88.8% and the respective figures at 10 years were 59.7% and 70.9%.
CONCLUSIONS
This data points out the need for new therapies for those patients. A longer follow-up of the monarchE study to see the real final benefit with abemaciclib is warranted.
TRIAL REGISTRATION
ClinTrials.gov: GEICAM/9906: NCT00129922; GEICAM/ 2003-10: NCT00129935 and GEICAM/ 2006-10: NCT00543127.
目的
monarchE 试验表明，添加 abemaciclib 可提高高危早期乳腺癌（EBC）患者的疗效。我们分析了类似于 monarchE 试验的人群的长期结果，以了解 abemaciclib 的潜在获益。
方法
从 3 项辅助临床试验和乳腺癌登记处中选择符合 monarchE 研究条件的 HR 阳性/HER2 阴性 EBC 患者。入组患者为接受了根治性手术、接受过蒽环类药物±紫杉类药物和内分泌治疗的新辅助和/或辅助治疗、腋窝淋巴结阳性（N+）≥4 个或 1-3 个 N+且肿瘤大小≥5cm 和/或组织学分级 3 级和/或 Ki67≥20%的患者。我们分析了 5 年和 10 年的无侵袭性疾病生存（iDFS）、无远处疾病生存（dDFS）和总生存（OS），以及每年（最长 10 年）的侵袭性复发率（IRR）、远处复发率（DRR）和死亡率（DR）。
结果
共分析了来自 GEICAM-9906（312 例）、GEICAM-2003-10（210 例）和 GEICAM-2006-10（160 例）试验以及 El Álamo IV 登记处的 935 例患者。中位随访 10.1 年后，5 年和 10 年 iDFS 率分别为 75.2%和 57.0%。5 年时的 dDFS 和 OS 率分别为 77.4%和 88.8%，10 年时分别为 59.7%和 70.9%。
结论
这些数据表明需要为这些患者提供新的治疗方法。需要对 monarchE 研究进行更长时间的随访，以了解 abemaciclib 的真实最终获益。
临床试验注册
ClinTrials.gov：GEICAM/9906：NCT00129922；GEICAM/2003-10：NCT00129935 和 GEICAM/2006-10：NCT00543127。
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