POSNOC-POsitive Sentinel NOde：辅助治疗单独与辅助治疗加清除或腋窝放疗的对比：一项在早期乳腺癌且一个或两个前哨淋巴结有转移的女性中进行的腋窝治疗的随机对照试验。

POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes.

机构信息

Department of Surgery, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK

Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.

出版信息

BMJ Open. 2021 Dec 2;11(12):e054365. doi: 10.1136/bmjopen-2021-054365.

DOI:10.1136/bmjopen-2021-054365

PMID:34857578

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8640630/

Abstract

INTRODUCTION

ACOSOG-Z0011(Z11) trial showed that axillary node clearance (ANC) may be omitted in women with ≤2 positive nodes undergoing breast conserving surgery (BCS) and whole breast radiotherapy (RT). A confirmatory study is needed to clarify the role of axillary treatment in women with ≤2 macrometastases undergoing BCS and groups that were not included in Z11 for example, mastectomy and those with microscopic extranodal invasion. The primary objective of POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC) is to evaluate whether for women with breast cancer and 1 or 2 macrometastases, adjuvant therapy alone is non-inferior to adjuvant therapy plus axillary treatment, in terms of 5-year axillary recurrence.

METHODS AND ANALYSIS

POSNOC is a pragmatic, multicentre, non-inferiority, international trial with participants randomised in a 1:1 ratio. Women are eligible if they have T1/T2, unifocal or multifocal invasive breast cancer, and 1 or 2 macrometastases at sentinel node biopsy, with or without extranodal extension. In the intervention group women receive adjuvant therapy alone, in the standard care group they receive ANC or axillary RT. In both groups women receive adjuvant therapy, according to local guidelines. This includes systemic therapy and, if indicated, RT to breast or chest wall. The UK Radiotherapy Trials Quality Assurance Group manages the in-built radiotherapy quality assurance programme. Primary endpoint is 5-year axillary recurrence. Secondary outcomes are arm morbidity assessed by Lymphoedema and Breast Cancer Questionnaire and QuickDASH questionnaires; quality of life and anxiety as assessed with FACT B+4 and State/Trait Anxiety Inventory questionnaires, respectively; other oncological outcomes; economic evaluation using EQ-5D-5L. Target sample size is 1900. Primary analysis is per protocol. Recruitment started on 1 August 2014 and as of 9 June 2021, 1866 participants have been randomised.

ETHICS AND DISSEMINATION

Protocol was approved by the National Research Ethics Service Committee East Midlands-Nottingham 2 (REC reference: 13/EM/0459). Results will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ISRCTN54765244; NCT0240168Cite Now.

摘要

介绍

ACOSOG-Z0011(Z11)试验表明，对于接受保乳手术(BCS)和全乳放疗(RT)的≤2 个阳性淋巴结的女性，腋窝淋巴结清扫(ANC)可能被省略。需要一项确证性研究来阐明在接受 BCS 和 Z11 未纳入的女性中的腋窝治疗作用，例如，乳房切除术和那些有镜下淋巴结外侵犯的女性。POsitive Sentinel NOde：单独辅助治疗与辅助治疗加清除或腋窝放疗(POSNOC)的主要目的是评估对于 1 或 2 个宏转移的乳腺癌女性，单独辅助治疗是否在 5 年腋窝复发方面不劣于辅助治疗加腋窝治疗。

方法和分析

POSNOC 是一项实用的、多中心、非劣效性、国际试验，参与者按 1:1 的比例随机分组。如果女性有 T1/T2、单灶或多灶性浸润性乳腺癌，以及前哨淋巴结活检中有 1 或 2 个宏转移，伴或不伴淋巴结外延伸，则有资格参加。在干预组中，女性接受单独辅助治疗，在标准治疗组中，女性接受 ANC 或腋窝 RT。两组女性均根据当地指南接受辅助治疗。这包括全身治疗，如果有指征，还包括乳房或胸壁 RT。英国放射治疗试验质量保证小组管理内置放疗质量保证计划。主要终点是 5 年腋窝复发。次要结果是通过淋巴水肿和乳腺癌问卷和快速 DASH 问卷评估手臂发病率；使用 FACT B+4 和状态/特质焦虑量表分别评估生活质量和焦虑；其他肿瘤学结果；使用 EQ-5D-5L 进行经济评估。目标样本量为 1900 例。主要分析是基于方案。招募于 2014 年 8 月 1 日开始，截至 2021 年 6 月 9 日，已有 1866 名参与者被随机分组。