来自日本的真实证据，关于接受CDK4/6抑制剂加内分泌治疗作为激素受体阳性、her2阴性晚期或转移性乳腺癌一线或二线治疗的患者的生存结局和治疗顺序。

IF 2.9

Breast cancer (Tokyo, Japan) Pub Date : 2025-07-01 Epub Date: 2025-05-20 DOI:10.1007/s12282-025-01713-7

Tetsuhiro Yoshinami, Yuko Takano, Yukinori Ozaki, Yukiko Kajiwara, Mitsugu Yamamoto, Ken-Ichi Watanabe, Masami Tsukabe, Fumie Fujisawa, Shigenori E Nagai, Nobuhiro Shibata, Chiya Oshiro, Hiroko Bando, Nobuyuki Tsunoda, Kazuhiko Yamagami, Kei Koizumi, Masahiro Takada, Naoko Toriguchi, Nobuyuki Sekine, Tsutomu Kawaguchi, Shigehira Saji, Yasuaki Sagara, Satoshi Morita, Norikazu Masuda

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引用次数: 0

摘要

背景：细胞周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）加内分泌治疗（ET）是目前激素受体（HR）阳性、her2阴性的晚期/转移性乳腺癌（AMBC）的标准一线/二线治疗方法。我们的目标是提供有关CDK4/6i治疗在这一人群中的真实证据。方法：在这项多中心观察性研究中，使用了2019年1月1日至2021年12月31日期间开始CDK4/6i治疗的患者的数据，作为AMBC的一线/二线治疗；使用Kaplan-Meier方法分析真实世界无进展生存期（rwPFS）、无化疗生存期和总生存期。此外，通过分离患者的无治疗间隔（TFI）来分析数据。结果：分析了745例患者的数据。与palbociclib相比，abemaciclib用于年轻患者和预期预后较差的患者。新发IV期疾病患者的中位rwPFS分别为36.8个月、17.8个月和31.4个月。结论：本研究中接受一线/二线CDK4/6i治疗的患者的真实生存结果与随机3期研究的结果一致。由于初始CDK4/6i + ET后的后续治疗效果仍然不足，需要进一步改善治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Real-world evidence from Japan regarding survival outcomes and treatment sequence in patients receiving CDK4/6 inhibitor plus endocrine therapy as first- or second-line treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

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Background: A cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET) is a current standard first-/second-line treatment for hormone receptor (HR)-positive, HER2-negative advanced/metastatic breast cancer (AMBC). We aimed to provide real-world evidence regarding CDK4/6i therapy in this population.

Methods: In this multicenter observational study, data from patients who had started CDK4/6i therapy between January 1, 2019, and December 31, 2021, as first-/second-line treatment for AMBC were used; real-world progression-free survival (rwPFS), chemotherapy-free survival, and overall survival were analyzed using the Kaplan-Meier method. Additionally, data were analyzed by separating patients with treatment-free interval (TFI) < 12 months (deemed resistant to ET) from the first-line treatment group (hereafter, the exclusive first-line treatment group).

Results: Data from 745 patients were analyzed. Compared with palbociclib, abemaciclib was used in younger patients and those with expected poor prognosis. Median rwPFS was 36.8, 17.8, and 31.4 months in patients with de novo stage IV disease, TFI < 12 months, and TFI ≥ 12 months, respectively, in the first-line treatment group, and 17.4 months in the second-line treatment group. In the exclusive first-line treatment group, median rwPFS of the subsequent treatment after initial CDK4/6i plus ET was < 7 months, regardless of the type of subsequent treatment; prognosis was especially poor in those who were switched to chemotherapy.

Conclusions: The real-world survival outcomes found in this study for patients receiving first-/second-line CDK4/6i therapy were consistent with those of randomized phase 3 studies. As outcomes of subsequent treatment after initial CDK4/6i plus ET remain insufficient, further improvement in treatment is necessary.

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Breast cancer (Tokyo, Japan)

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