转移性激素受体阳性/HER2 阴性乳腺癌患者从 CDK4/6 抑制剂到二线治疗的历程：GIM14/BIOMETA 研究中 701 例患者的真实世界分析。
The journey of patients affected by metastatic hormone receptor-positive/HER2-negative breast cancer from CDK 4/6 inhibitors to second-line treatment: A real-world analysis of 701 patients enrolled in the GIM14/BIOMETA study.
机构信息
Department of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy; Department of Medical Oncology, UOC Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova, Italy. Electronic address: https://twitter.com/@ChiaraMolinelli.
U. O. Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
出版信息
Eur J Cancer. 2024 Dec;213:115113. doi: 10.1016/j.ejca.2024.115113. Epub 2024 Nov 4.
PURPOSE
The aim of this study was to evaluate the effectiveness of CDK 4/6 inhibitors (CDK 4-6i) according to HER2 status (low/zero), and endocrine resistance/sensitivity, as well as the efficacy of second-line treatments, in a large real-world cohort.
METHODS
The GIM14/BIOMETA study (NCT02284581) is a retrospective/prospective study of the Gruppo Italiano Mammella evaluating treatment patterns and survival outcomes in patients with metastatic breast cancer (MBC). We retrieved data on patients with hormone receptor-positive/HER2-negative MBC receiving first-line CDK 4/6i.
RESULTS
Among 3832 patients enrolled in the GIM14-BIOMETA study, 701 were eligible. At a median follow-up of 24.80 months, no significant differences were found between HER2-zero and HER2-low subgroups in terms of first-line time to treatment discontinuation (TTD) (26.16 months [IQR 12.84-NR] vs. 27.60 months [IQR 12.12-64.44], p = 0.972) or overall survival (OS) (mOS>60 months for both groups, p = 0.398). Median TTD was 33.24 months (IQR 16.32-NR) for the endocrine sensitive subgroup, 19.92 months (IQR 8.88-51.24) for the secondary endocrine resistant subgroup and 17.40 months (IQR 7.44-24.72) for the primary endocrine resistant subset, respectively (p < 0.001). Among 239 patients receiving second-line treatment, no significant difference (p = 0.188) was found in terms of second-line TTD between those treated with capecitabine (6.11 months, IQR 2.96-11.47), taxane-based chemotherapy (5.06 months, IQR 2.99-9.99), everolimus plus exemestane (5.39 months, IQR 2.53-9.03) or fulvestrant (6.44 months, IQR 3.38-NR).
CONCLUSIONS
Endocrine therapy plus CDK 4/6i represents an effective treatment, regardless of HER2 status (low/zero). Second-line agents did not differ significantly in terms of TTD. Endocrine resistant cancers exhibit poor response to CDK 4/6i.
目的
本研究旨在评估 CDK4/6 抑制剂（CDK4-6i）在不同 HER2 状态（低/零）、内分泌抵抗/敏感性以及二线治疗疗效方面的有效性，该研究基于一个大型真实世界队列。
方法
GIM14/BIOMETA 研究（NCT02284581）是意大利乳腺肿瘤组对转移性乳腺癌（MBC）患者治疗模式和生存结局的回顾性/前瞻性研究。我们检索了接受一线 CDK4/6i 治疗的激素受体阳性/HER2 阴性 MBC 患者的数据。
结果
在 GIM14-BIOMETA 研究中，共纳入 3832 例患者，其中 701 例符合条件。中位随访 24.80 个月时，HER2 阴性和 HER2 低表达亚组在一线治疗停药时间（TTD）（26.16 个月[IQR 12.84-NR] vs. 27.60 个月[IQR 12.12-64.44]，p=0.972）或总生存（OS）方面无显著差异（两组 mOS>60 个月，p=0.398）。内分泌敏感亚组的中位 TTD 为 33.24 个月（IQR 16.32-NR），继发性内分泌耐药亚组为 19.92 个月（IQR 8.88-51.24），原发性内分泌耐药亚组为 17.40 个月（IQR 7.44-24.72）（p<0.001）。在接受二线治疗的 239 例患者中，接受卡培他滨（6.11 个月，IQR 2.96-11.47）、基于紫杉烷的化疗（5.06 个月，IQR 2.99-9.99）、依维莫司联合依西美坦（5.39 个月，IQR 2.53-9.03）或氟维司群（6.44 个月，IQR 3.38-NR）治疗的患者之间的二线 TTD 无显著差异（p=0.188）。
结论
内分泌治疗联合 CDK4/6i 是一种有效的治疗方法，与 HER2 状态（低/零）无关。二线药物在 TTD 方面无显著差异。内分泌耐药性癌症对 CDK4/6i 反应较差。
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