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乳腺癌改良根治术与传统根治术的 17 年随访比较:多中心随机对照研究

17-Year Follow-up of Comparing Mastoscopic and Conventional Axillary Dissection in Breast Cancer: A Multicenter, Randomized Controlled Trial.

机构信息

Breast Surgery, Affiliated Beijing Anzhen Hospital, Capital Medical University, No 2, Anzhen Road, Chaoyang District, Beijing, 100029, China.

Breast Surgery, Affiliated Da Lian Hospital, Dalian Medical University, Dalian, China.

出版信息

Adv Ther. 2022 Jun;39(6):2961-2970. doi: 10.1007/s12325-022-02152-y. Epub 2022 Apr 29.

Abstract

INTRODUCTION

Longer follow-up was necessary to determine the exact value of mastoscopic axillary lymph node dissection (MALND).

METHODS

From January 1, 2003, to December 31, 2005, 1027 patients with breast cancer were randomly assigned to two groups: MALND and CALND (conventional axillary lymph node dissection); 996 eligible patients were enrolled.

RESULTS

The final cohort of 996 patients was followed for an average of 198 months. Events other than death differed significantly between the two cohorts (p = 0.0311; 46.3% in MALND and 53.2% in CALND, respectively). The sum of events other than death and deaths from other causes was much higher in the CALND (59.6%) than MALND (53.4%) group (p = 0.0494). The 17-year disease-free survival DFS rates were 36.7% for the MALND and 33.6% for the CALND group, respectively. There was a significant difference between the groups (p = 0.0306). Overall survival (OS) rates were 53.2% after MALND and 46.0% after CALND (p = 0.0119). MALND patients had much less axillary pain (p = 0.0000), numbness or paresthesia (p = 0.0000), arm mobility (p = 0.0000) and arm swelling on the operated side (p = 0.0000). Aesthetic appearance of the axilla was much better in the MALND than CALND group (p = 0.0000) at an average follow-up of 17 years.

CONCLUSIONS

The use of MALND in breast cancer surgery not only decreases the relapse and arm complications but also improves long-term survival of patients. Therefore, MALND should be one of the preferred approaches for breast cancer surgery when ALND is needed.

TRIAL REGISTRATION INFORMATION

The comparison of long-term outcomes of mastoscopic and conventional axillary lymph node dissection in breast cancer: a multicenter randomized control trial. ChiCTR-TRC-11001477, CHiCTR. First registration 08/14/2011.

摘要

简介

为了确定乳腺镜腋窝淋巴结清扫术(MALND)的确切价值,需要进行更长时间的随访。

方法

2003 年 1 月 1 日至 2005 年 12 月 31 日,1027 例乳腺癌患者被随机分为两组:MALND 和 CALND(常规腋窝淋巴结清扫术);共纳入 996 例合格患者。

结果

最终的 996 例患者队列平均随访 198 个月。两组之间除死亡以外的其他事件差异有统计学意义(p=0.0311;MALND 组为 46.3%,CALND 组为 53.2%)。CALND 组(59.6%)除死亡和其他原因死亡以外的事件总和明显高于 MALND 组(53.4%)(p=0.0494)。MALND 组和 CALND 组的 17 年无病生存率(DFS)分别为 36.7%和 33.6%。两组之间存在显著差异(p=0.0306)。MALND 组的总生存率(OS)为 53.2%,CALND 组为 46.0%(p=0.0119)。MALND 患者的腋窝疼痛(p=0.0000)、麻木或感觉异常(p=0.0000)、手臂活动度(p=0.0000)和手术侧手臂肿胀(p=0.0000)明显较少。在平均随访 17 年后,MALND 组的腋窝美容外观明显优于 CALND 组(p=0.0000)。

结论

乳腺癌手术中使用 MALND 不仅降低了复发和手臂并发症的发生率,而且提高了患者的长期生存率。因此,当需要 ALND 时,MALND 应该是乳腺癌手术的首选方法之一。

试验注册信息

乳腺镜与传统腋窝淋巴结清扫术治疗乳腺癌的长期疗效比较:一项多中心随机对照试验。ChiCTR-TRC-11001477,ChiCTR。首次注册 2011 年 8 月 14 日。

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