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新辅助化疗后ypN0的cT1-2N1乳腺癌患者术后放疗的影响:一项基于真实世界数据的回顾性研究

The impact of postmastectomy radiotherapy on cT1-2N1 breast cancer patients with ypN0 after neoadjuvant chemotherapy: a retrospective study based on real-world data.

作者信息

Dai Yuran, Ma Shishi, Lan Ailin, Wang Yihua, Wang Yu, Jin Yudi, Ding Nan, Jiang Linshan, Tang Zhenrong, Yin Xuedong, Peng Yang, Liu Shengchun

机构信息

Department of Breast and Thyroid Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Department of Oncology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Discov Oncol. 2023 Jan 7;14(1):2. doi: 10.1007/s12672-022-00609-8.

Abstract

BACKGROUND

The role of postmastectomy radiation therapy (PMRT) in clinical T1-2N1 breast cancer patients who achieve axillary pathological complete response (ypN0) after neoadjuvant chemotherapy (NAC) is controversial.

METHODS

Data from cT1-2N1 breast cancer patients who converted to ypN0 after NAC and subsequent surgery were retrospectively analyzed. Disease-free survival (DFS) and overall survival (OS) were estimated using the Kaplan‒Meier method. Univariate and multivariate Cox regression models were applied to investigate the correlations between clinical or pathological parameters and survival.

RESULTS

From 2012-2019, we identified 116 cases for analysis, including 31 (26.7%) who received PMRT and 85 (73.3%) who did not. At a median follow-up time of 56.4 months, the 5-year DFS and OS rates were 90.2% and 96.7% with PMRT and 93.7% and 97.3% without PMRT, respectively. PMRT did not affect either DFS (p = 0.234) or OS (p = 0.878). On multivariate analyses, no differences in DFS or OS between the two groups were detected, taking into consideration the following factors: age, molecular subtype, Ki67 index, cT stage, and in-breast pathologic complete response (DFS: HR 2.260; 95% CI 0.465-10.982; p = 0.312. OS: HR 1.400; 95% CI 0.138-14.202; p = 0.776). This nonsignificant difference was also consistent in subgroup analyses (all p > 0.05).

CONCLUSIONS

PMRT has limited ability to confer DFS or OS benefits for cT1-2N1 breast cancer patients who achieved axillary pathological complete response after NAC and total mastectomy. It is imperative to conduct prospective studies to investigate the safety and feasibility of omitting PMRT.

TRIAL REGISTRATION

This research was approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University (ID: No. 2021-442).

摘要

背景

对于接受新辅助化疗(NAC)后腋窝病理完全缓解(ypN0)的临床T1-2N1期乳腺癌患者,乳房切除术后放疗(PMRT)的作用存在争议。

方法

回顾性分析cT1-2N1期乳腺癌患者在接受NAC及后续手术后转变为ypN0的数据。采用Kaplan-Meier法估计无病生存期(DFS)和总生存期(OS)。应用单因素和多因素Cox回归模型研究临床或病理参数与生存之间的相关性。

结果

2012年至2019年,共纳入116例患者进行分析,其中31例(26.7%)接受了PMRT,85例(73.3%)未接受PMRT。中位随访时间为56.4个月,接受PMRT的患者5年DFS率和OS率分别为90.2%和96.7%,未接受PMRT的患者分别为93.7%和97.3%。PMRT对DFS(p = 0.234)和OS(p = 0.878)均无影响。多因素分析显示,考虑以下因素时,两组在DFS或OS方面无差异:年龄、分子亚型、Ki67指数、cT分期和乳腺内病理完全缓解(DFS:风险比[HR] 2.260;95%置信区间[CI] 0.465 - 10.982;p = 0.312。OS:HR 1.400;95% CI 0.138 - 14.202;p = 0.776)。亚组分析中这种无显著差异也一致(所有p > 0.05)。

结论

对于接受NAC和全乳切除术后腋窝病理完全缓解的cT1-2N1期乳腺癌患者,PMRT在改善DFS或OS方面作用有限。开展前瞻性研究以探讨省略PMRT的安全性和可行性势在必行。

试验注册

本研究经重庆医科大学附属第一医院伦理委员会批准(编号:2021-442)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b05c/9823173/c0578fc18a83/12672_2022_609_Fig1_HTML.jpg

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