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

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

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引用次数: 0

Abstract

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.

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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。

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。

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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

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