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OFS 联合 AI 或 SERM 与单独使用 SERM 治疗激素受体阳性乳腺癌的绝经前妇女:一项使用真实世界数据库的前瞻性队列研究。

OFS plus AI or SERM vs. SERM alone in premenopausal women with hormone receptor-positive breast cancer: a prospective cohort study using the real-world database.

机构信息

Laboratory of Molecular Diagnosis of Cancer, Clinical Research Center for Breast, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, Sichuan, People's Republic of China.

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, 171 77, Stockholm, Sweden.

出版信息

Breast Cancer. 2019 May;26(3):339-348. doi: 10.1007/s12282-018-0929-6. Epub 2018 Oct 26.

DOI:10.1007/s12282-018-0929-6
PMID:30367358
Abstract

BACKGROUND

Ovarian function suppression (OFS) plus other endocrine treatment was recommended to hormone receptor (HR)-positive breast cancer by some guidelines recently. We performed this study to validate the survival benefits of OFS plus aromatase inhibitors (AI) or selective estrogen receptor modulators (SERM) in the real world.

METHODS

All premenopausal, HR-positive breast cancer patients diagnosed between 1996 and 2017 were identified. Eligible patients were classified into three groups according to their adjuvant endocrine treatment, including OFS plus AI, OFS plus SERM and SERM alone. The primary outcome is invasive disease-free survival (iDFS), whereas the secondary outcome is overall survival (OS). Cox proportional hazards models and propensity score adjusted models were used to compare the survival benefits in three groups.

RESULTS

We included 2838 patients, of which 246 received OFS plus AI, 175 received OFS plus SERM, and 2417 received SERM alone. Compared with SERM alone, OFS plus AI was associated with an improved iDFS (HR 0.59, 95% CI 0.36-0.96) and OS (HR 0.26, 95% CI 0.08-0.85). OFS plus SERM, however, was not significantly associated with extended iDFS or OS. Among patients older than 40 years old, OFS plus AI was more effective than OFS plus SERM (HR 0.38, 95% CI 0.17-0.88) or SERM alone (HR 0.44, 95% CI 0.23-0.84) in terms of iDFS.

CONCLUSIONS

Our findings suggest that OFS plus AI treatment may extend both iDFS and OS among premenopausal patients with hormone receptor-positive breast cancer in the real world.

摘要

背景

最近,一些指南建议对激素受体(HR)阳性乳腺癌患者进行卵巢功能抑制(OFS)加其他内分泌治疗。我们进行这项研究是为了验证 OFS 联合芳香化酶抑制剂(AI)或选择性雌激素受体调节剂(SERM)在真实世界中的生存获益。

方法

所有诊断为 1996 年至 2017 年期间的绝经前 HR 阳性乳腺癌患者均被纳入研究。根据辅助内分泌治疗将合格患者分为三组,包括 OFS 联合 AI、OFS 联合 SERM 和 SERM 单药治疗。主要结局是无侵袭性疾病生存(iDFS),次要结局是总生存(OS)。采用 Cox 比例风险模型和倾向评分调整模型比较三组的生存获益。

结果

我们纳入了 2838 例患者,其中 246 例接受 OFS 联合 AI,175 例接受 OFS 联合 SERM,2417 例接受 SERM 单药治疗。与 SERM 单药治疗相比,OFS 联合 AI 可改善 iDFS(HR 0.59,95%CI 0.36-0.96)和 OS(HR 0.26,95%CI 0.08-0.85)。然而,OFS 联合 SERM 与延长 iDFS 或 OS 无关。在年龄大于 40 岁的患者中,OFS 联合 AI 比 OFS 联合 SERM(HR 0.38,95%CI 0.17-0.88)或 SERM 单药治疗(HR 0.44,95%CI 0.23-0.84)更能有效延长 iDFS。

结论

我们的研究结果表明,在真实世界中,OFS 联合 AI 治疗可能延长绝经前 HR 阳性乳腺癌患者的 iDFS 和 OS。

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