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.

Autor:	Goyal A; Department of Surgery, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK amit.goyal@nhs.net., Mann GB; Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.; Breast Cancer Trials, Newcastle, New South Wales, Australia., Fallowfield L; Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK., Duley L; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Reed M; Brighton and Sussex Medical School, Brighton, UK., Dodwell D; Nuffield Department of Population Health, Oxford University, Oxford, UK., Coleman RE; Department of Oncology and Metabolism, Weston Park Hospital, Sheffield, UK., Fakis A; Research and Development, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK., Newcombe R; Department of Primary Care and Public Health, Cardiff University, Cardiff, UK., Jenkins V; Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK., Whitham D; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Childs M; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Whynes D; School of Economics, University of Nottingham, Nottingham, UK., Keeley V; Lymphoedema Department, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK., Ellis I; School of Medicine, University of Nottingham, Nottingham, UK., Fairbrother P; Patient Advocate, Independent Cancer Patients' Voice, London, UK., Sadiq S; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Monson K; Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK., Montgomery A; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Tan W; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Vale L; Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK., Homer T; Health Economics Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK., Badger H; Breast Cancer Trials, Newcastle, New South Wales, Australia., Haines RH; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Lewis M; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK., Megias D; National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK., Nabi Z; National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK., Singh P; National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK., Caraman A; National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK., Miles E; National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Dec 02; Vol. 11 (12), pp. e054365. Date of Electronic Publication: 2021 Dec 02.
DOI:	10.1136/bmjopen-2021-054365
Abstrakt:	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. Competing Interests: Competing interests: LV was a member of the NIHR Health Technology Assessment Programme, Clinical Trials and Evaluation Panel from 2014 to 2018. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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