转移性激素受体阳性/HER2 阴性乳腺癌患者从 CDK 4/6 抑制剂到二线治疗的历程：对参加 GIM14/BIOMETA 研究的 701 例患者的实际情况分析。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-11-04 DOI:10.1016/j.ejca.2024.115113

Chiara Molinelli , Marco Bruzzone , Eva Blondeaux , Tommaso Ruelle , Chiara Lanzavecchia , Michelino De Laurentiis , Stefania Russo , Ferdinando Riccardi , Valentina Sini , Francesco Cognetti , Grazia Arpino , Alessandra Fabi , Palma Pugliese , Elena Collovà , Andrea Fontana , Fabio Puglisi , Claudia Bighin , Matteo Lambertini , Lucia Del Mastro

{"title":"转移性激素受体阳性/HER2 阴性乳腺癌患者从 CDK 4/6 抑制剂到二线治疗的历程：对参加 GIM14/BIOMETA 研究的 701 例患者的实际情况分析。","authors":"Chiara Molinelli , Marco Bruzzone , Eva Blondeaux , Tommaso Ruelle , Chiara Lanzavecchia , Michelino De Laurentiis , Stefania Russo , Ferdinando Riccardi , Valentina Sini , Francesco Cognetti , Grazia Arpino , Alessandra Fabi , Palma Pugliese , Elena Collovà , Andrea Fontana , Fabio Puglisi , Claudia Bighin , Matteo Lambertini , Lucia Del Mastro","doi":"10.1016/j.ejca.2024.115113","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115113"},"PeriodicalIF":7.6000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Chiara Molinelli , Marco Bruzzone , Eva Blondeaux , Tommaso Ruelle , Chiara Lanzavecchia , Michelino De Laurentiis , Stefania Russo , Ferdinando Riccardi , Valentina Sini , Francesco Cognetti , Grazia Arpino , Alessandra Fabi , Palma Pugliese , Elena Collovà , Andrea Fontana , Fabio Puglisi , Claudia Bighin , Matteo Lambertini , Lucia Del Mastro\",\"doi\":\"10.1016/j.ejca.2024.115113\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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).</div></div><div><h3>Conclusions</h3><div>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.</div></div>\",\"PeriodicalId\":11980,\"journal\":{\"name\":\"European Journal of Cancer\",\"volume\":\"213 \",\"pages\":\"Article 115113\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0959804924017209\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0959804924017209","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

目的：本研究旨在评估CDK 4/6抑制剂（CDK 4-6i）在大型真实世界队列中根据HER2状态（低/零）、内分泌耐药/敏感性以及二线治疗疗效的有效性：GIM14/BIOMETA研究（NCT02284581）是意大利玛梅拉集团（Gruppo Italiano Mammella）的一项回顾性/前瞻性研究，旨在评估转移性乳腺癌（MBC）患者的治疗模式和生存结果。我们检索了接受一线 CDK 4/6i 治疗的激素受体阳性/HER2 阴性 MBC 患者的数据：在参加 GIM14-BIOMETA 研究的 3832 例患者中，有 701 例符合条件。在24.80个月的中位随访中，HER2-0亚组和HER2-低亚组在一线治疗终止时间（TTD）（26.16个月[IQR 12.84-NR] vs. 27.60个月[IQR 12.12-64.44]，p = 0.972）或总生存期（OS）（两组mOS均>60个月，p = 0.398）方面无明显差异。内分泌敏感亚组的中位TTD分别为33.24个月（IQR 16.32-NR），继发性内分泌耐药亚组的中位TTD分别为19.92个月（IQR 8.88-51.24），原发性内分泌耐药亚组的中位TTD分别为17.40个月（IQR 7.44-24.72）（P 结论：内分泌治疗加CDK 4.0的疗效更佳：无论HER2状态如何（低/零），内分泌治疗加CDK 4/6i都是一种有效的治疗方法。二线药物在TTD方面没有明显差异。内分泌耐药癌症对CDK 4/6i的反应较差。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

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

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.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.