Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense, Madrid, Spain.
GEICAM, Spanish Breast Cancer Group, Madrid, Spain.
Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.
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.
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).
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%.
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.
ClinTrials.gov: GEICAM/9906: NCT00129922; GEICAM/ 2003-10: NCT00129935 and GEICAM/ 2006-10: NCT00543127.
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。
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）。
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%。
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。
ClinTrials.gov：GEICAM/9906：NCT00129922；GEICAM/2003-10：NCT00129935 和 GEICAM/2006-10：NCT00543127。
