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Introduction <p>The poly(ADP-ribose) polymerase inhibitor olaparib was recently approved in China for adjuvant treatment of certain patients with high-risk, human epidermal growth factor (HER2)-negative early breast cancer (eBC) and germline pathogenic/likely pathogenic mutations in <i>BRCA1</i> and <i>BRCA2</i> (gBRCAm). Further evidence on demographics, clinical characteristics, treatment patterns and outcomes is needed to inform local guideline updates and clinical decision-making for patients in China with gBRCAm and eBC who may be eligible for olaparib treatment.</p> Methods <p>This retrospective study analysed deidentified electronic health records at the Fudan University Shanghai Cancer Center. Women ≥ 18&#xa0;years of age diagnosed with eBC between 1 January 2012 and 31 December 2019 who had undergone definitive BC surgery were included. Patients with accessible gBRCA status were included alongside a similar-sized cohort of randomly selected, untested patients. Demographics, clinical characteristics, treatment patterns, pathological complete response (pCR) and invasive disease-free survival (IDFS) were described by tumour subtype and gBRCAm status.</p> Results <p>In total, 949 patients were included (gBRCA tested: <i>n</i> = 466; untested: <i>n</i> = 483). Among 89/466 (19.1%) tested patients with gBRCAm, 29/89 (32.6%) had no family history of breast/ovarian/pancreatic/prostate cancer, and 46/88 (52.3%) with known tumour subtype had hormone receptor-positive tumours. Patients with HER2-negative eBC and gBRCAm had more advanced disease, differing treatment patterns and shorter IDFS versus those with non-gBRCAm. pCR rates among patients who received neoadjuvant therapy were 23.1% in the overall population (<i>n</i> = 91) and 10.9% in patients with HER2-negative eBC (<i>n</i> = 55), 52 (94.5%) of whom received chemotherapy only.</p> Conclusion <p>Characteristics, treatment patterns and outcomes were distinct among patients in China with gBRCAm eBC. Our findings support wider implementation of gBRCA testing for all patients in China with HER2-negative eBC, beyond those with triple-negative tumour subtype and/or family history of cancer, to identify more patients who may benefit from targeted therapy.&#xa0;Infographic available for this article.</p>

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Real-World Epidemiology, Clinical Characteristics and Outcomes of Women with Germline BRCA Mutation and Early Breast Cancer in China

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月26日

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  • Zhen Hu,
  • Qianqian Yu,
  • Liqin Chen,
  • Tingting Su,
  • Luis C. Berrocal-Almanza,
  • Miguel Miranda,
  • Xiaoqing Xu,
  • Meng Ru,
  • Tianyu Zhao,
  • Feng Miao,
  • Mengyu Xie,
  • Zhimin Shao

摘要

Introduction

The poly(ADP-ribose) polymerase inhibitor olaparib was recently approved in China for adjuvant treatment of certain patients with high-risk, human epidermal growth factor (HER2)-negative early breast cancer (eBC) and germline pathogenic/likely pathogenic mutations in BRCA1 and BRCA2 (gBRCAm). Further evidence on demographics, clinical characteristics, treatment patterns and outcomes is needed to inform local guideline updates and clinical decision-making for patients in China with gBRCAm and eBC who may be eligible for olaparib treatment.

Methods

This retrospective study analysed deidentified electronic health records at the Fudan University Shanghai Cancer Center. Women ≥ 18 years of age diagnosed with eBC between 1 January 2012 and 31 December 2019 who had undergone definitive BC surgery were included. Patients with accessible gBRCA status were included alongside a similar-sized cohort of randomly selected, untested patients. Demographics, clinical characteristics, treatment patterns, pathological complete response (pCR) and invasive disease-free survival (IDFS) were described by tumour subtype and gBRCAm status.

Results

In total, 949 patients were included (gBRCA tested: n = 466; untested: n = 483). Among 89/466 (19.1%) tested patients with gBRCAm, 29/89 (32.6%) had no family history of breast/ovarian/pancreatic/prostate cancer, and 46/88 (52.3%) with known tumour subtype had hormone receptor-positive tumours. Patients with HER2-negative eBC and gBRCAm had more advanced disease, differing treatment patterns and shorter IDFS versus those with non-gBRCAm. pCR rates among patients who received neoadjuvant therapy were 23.1% in the overall population (n = 91) and 10.9% in patients with HER2-negative eBC (n = 55), 52 (94.5%) of whom received chemotherapy only.

Conclusion

Characteristics, treatment patterns and outcomes were distinct among patients in China with gBRCAm eBC. Our findings support wider implementation of gBRCA testing for all patients in China with HER2-negative eBC, beyond those with triple-negative tumour subtype and/or family history of cancer, to identify more patients who may benefit from targeted therapy. Infographic available for this article.