Yuan Yang, Zhang Shaohua, Yan Min, Yin Yongmei, Song Yuhua, Jiang Zefei
Department of Breast Oncology, The Fifth Medical Centre of Chinese PLA General Hospital, Beijing, China.
Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Ann Transl Med. 2021 May;9(10):831. doi: 10.21037/atm-20-8252.
Although endocrine therapy (ET) is the preferred option for hormone receptor-positive HER2-negative metastatic breast cancer (HR+/HER2- MBC), chemotherapy (CT) is still commonly used. The objective of this real-world study was to present the actual choice of first-line treatment for patients with HR+/HER2- MBC and evaluate the consistency with guidelines in China.
Patients with HR+/HER2- MBC between 1996 and September 2018 were identified from of the database of Chinese Society of Clinical Oncology Breast Cancer (CSCO BC). The statistical description was conducted to present the first-line treatment. Factors influencing the prescription of ET or CT were obtained using univariate and multivariate analysis. The consistency of the actual treatment with the guideline of Chinese Society of Clinical Oncology Breast Cancer (CSCO BC guideline) was evaluated.
Of 1,877 patients, 662 (35.3%) received ET, and 1,215 (64.7%) received CT. ET proportion was only 25.4% in 1996-2005 and gradually increased to 44.6% in 2016-2018. Aromatase inhibitors (69% of ET) and taxane-based regimens (66% of CT) were the most commonly used ET and CT, respectively. Univariate and multivariate analysis showed that patients with age ≥60, distant relapse-free interval (DRFI) ≥24 months, ER+/PR+, bone metastasis only, or progression on (neo)adjuvant ET were preferably chosen for ET as first-line treatment. Factors associated with preferring CT were de novo stage IV, liver or lung metastasis. 17.2% of patients (322 cases) who had neither visceral metastasis nor progression on (neo)adjuvant ET wrongly received CT instead of ET, which is inconsistent with CSCO BC guideline. More than half of patients receiving CT discontinued their initial treatment due to adverse events and other non-disease progression reasons.
Although high proportion of HR+/HER2- MBC patients received CT as first-line treatment in China, it is gratifying to see that the proportion of patients receiving ET has gradually increased. Our study revealed that 17.2% of patients were over-treated according to CSCO BC guideline, which may provide data to promote guideline adherence. The clinical application for ET should be appropriately expanded in first-line treatment, especially for patients without visceral disease and proof of endocrine resistance.
尽管内分泌治疗（ET）是激素受体阳性HER2阴性转移性乳腺癌（HR+/HER2-MBC）的首选治疗方案，但化疗（CT）仍被广泛应用。本真实世界研究旨在呈现HR+/HER2-MBC患者一线治疗的实际选择，并评估其与中国指南的一致性。
从中国临床肿瘤学会乳腺癌（CSCO BC）数据库中筛选出1996年至2018年9月期间的HR+/HER2-MBC患者。进行统计描述以展示一线治疗情况。采用单因素和多因素分析来确定影响ET或CT处方的因素。评估实际治疗与中国临床肿瘤学会乳腺癌（CSCO BC）指南的一致性。
1877例患者中，662例（35.3%）接受了ET，1215例（64.7%）接受了CT。1996 - 2005年ET比例仅为25.4%，到2016 - 2018年逐渐增至44.6%。芳香化酶抑制剂（占ET的69%）和紫杉类方案（占CT的66%）分别是最常用的ET和CT方案。单因素和多因素分析显示，年龄≥60岁、远处无复发生存期（DRFI）≥24个月、ER+/PR+、仅骨转移或在（新）辅助ET治疗期间病情进展的患者更倾向于选择ET作为一线治疗。与倾向于选择CT相关的因素包括初诊IV期、肝或肺转移。17.2%的患者（322例）既无内脏转移且在（新）辅助ET治疗期间也无病情进展，但却错误地接受了CT而非ET治疗，这与CSCO BC指南不一致。超过一半接受CT治疗的患者因不良事件及其他非疾病进展原因而中断了初始治疗。
尽管在中国HR+/HER2-MBC患者中很大比例接受CT作为一线治疗，但令人欣慰的是接受ET治疗的患者比例逐渐增加。我们的研究表明，根据CSCO BC指南，17.2%的患者存在过度治疗的情况，这可能为促进指南的遵循提供数据支持。ET在一线治疗中的临床应用应适当扩大，尤其是对于无内脏疾病且无内分泌抵抗证据的患者。
