前哨淋巴结阳性的乳腺癌患者行乳房切除术后完成腋窝治疗的价值：一项荷兰随机对照多中心试验（BOOG 2013 - 07）

The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch randomized controlled multicentre trial (BOOG 2013-07).

作者信息

van Roozendaal L M, de Wilt J H W, van Dalen T, van der Hage J A, Strobbe L J A, Boersma L J, Linn S C, Lobbes M B I, Poortmans P M P, Tjan-Heijnen V C G, Van de Vijver K K B T, de Vries J, Westenberg A H, Kessels A G H, Smidt M L

机构信息

Division of Surgical Oncology, Maastricht University Medical Centre, Maastricht, The Netherlands.

GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.

出版信息

BMC Cancer. 2015 Sep 3;15:610. doi: 10.1186/s12885-015-1613-2.

DOI:10.1186/s12885-015-1613-2

PMID:26335105

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4559064/

Abstract

BACKGROUND

Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013-07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy.

DESIGN

This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up.

DISCUSSION

We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival.

TRIAL REGISTRATION

The BOOG 2013-07 study is registered in the register of ClinicalTrials.gov since April 10, 2014, Identifier: NCT02112682 .

摘要

背景

在接受保乳治疗的乳腺癌患者中，若前哨淋巴结转移有限，试验未能证明完成腋窝淋巴结清扫具有额外价值。有人提出，这些试验中较低的区域复发率可能部分归因于全乳放疗意外照射了部分腋窝，这使得无法将结果外推至接受乳房切除术的患者。因此，随机对照的BOOG 2013 - 07试验的目的是研究在接受乳房切除术的前哨淋巴结阳性乳腺癌患者中，是否可以安全地省略完成腋窝治疗。

设计

本研究设计为非劣效性随机对照多中心试验。年龄在18岁及以上、诊断为单侧临床T1 - 2 N0浸润性乳腺癌且接受乳房切除术、腋窝前哨淋巴结最多有三个包含微转移和/或宏转移的女性，将被随机分为完成腋窝治疗组和不进行完成腋窝治疗组。完成腋窝治疗可包括完成腋窝淋巴结清扫或腋窝放疗。主要终点是5年时的区域复发率。基于对照组5年区域无复发生存率为98%，研究对象为96%，每组样本量为439例（包括10%失访者），以便能够以0.8的概率拒绝研究对象和对照对象的复发率至少低5%的零假设。随访5年和10年后将报告结果。