BMJ Open (Dec 2021)
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
- Wei Tan,
- Luke Vale,
- Alastair Thompson,
- Alan Montgomery,
- Sarah Craig,
- Vaughan Keeley,
- Laura Ternent,
- Nisha Sharma,
- Eleanor Mitchell,
- Lelia Duley,
- Ian Ellis,
- Alistair Ring,
- Nicole Francis,
- Hannah Price,
- Ian White,
- David Dodwell,
- Elizabeth Miles,
- Rebecca Haydock,
- Margaret Childs,
- Mara Ozolins,
- Diane Whitham,
- Apostolos Fakis,
- David Whynes,
- Patricia Fairbrother,
- Robert Newcombe,
- Malcolm Reed,
- Daniel Davis,
- Tara Homer,
- Kathryn Monson,
- Ramsey Cutress,
- Valerie Jenkins,
- Lesley Fallowfield,
- Clare Brittain,
- Daniel Rea,
- Judith Bliss,
- Amit Goyal,
- G Bruce Mann,
- Robert E Coleman,
- Shabina Sadiq,
- Heath Badger,
- Rachel Helen Haines,
- Mickey Lewis,
- Daniel Megias,
- Zohal Nabi,
- Preetinder Singh,
- Andrei Caraman,
- Romaana Mir,
- Teresa Grieve,
- Clare Upton,
- Aisha Shafayat,
- Charlotte Gidman,
- Flonda Probert,
- Lisa Paksec,
- Rose Lucas,
- Annette Dempsey,
- Rochelle Thornton,
- Roeum Butt,
- Peter Barrett Lee,
- Julie Wolfarth,
- Peter Dubsky
Affiliations
- Wei Tan
- Institute of Brain Science and Advanced Technology, Wuhan University of Science and Technology, Wuhan, Hubei, China
- Luke Vale
- Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, UK
- Alastair Thompson
- professor
- Alan Montgomery
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Sarah Craig
- Vaughan Keeley
- 4 Lymphedema Clinic, Derby Hospitals NHS Foundation Trust, Derby, UK
- Laura Ternent
- Health Economics Group, Newcastle University, Newcastle upon Tyne, UK
- Nisha Sharma
- Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Eleanor Mitchell
- 1 Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK
- Lelia Duley
- professor of clinical trials research
- Ian Ellis
- School of Medicine, University of Nottingham, Nottingham, UK
- Alistair Ring
- Nicole Francis
- Hannah Price
- 1 Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA
- Ian White
- 4 MRC Clinical Trials Unit at UCL, University College London, London, UK
- David Dodwell
- Nuffield Department of Population Health, University of Oxford, Oxford, UK
- Elizabeth Miles
- 4 National Radiotherapy Trials Quality Assurance Group, Mount Vernon Hospital, Northwood, UK
- Rebecca Haydock
- 1Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Margaret Childs
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Mara Ozolins
- Diane Whitham
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Apostolos Fakis
- Derby Clinical Trials Support Unit, Royal Derby Hospital, Derby, UK
- David Whynes
- School of Economics, University of Nottingham, Nottingham, UK
- Patricia Fairbrother
- Independent Cancer Patients Voice, London, UK
- Robert Newcombe
- Department of Primary Care and Public Health, Cardiff University, Cardiff, UK
- Malcolm Reed
- Brighton and Sussex Medical School, Brighton, UK
- Daniel Davis
- Tara Homer
- 1 Health Economics Group, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, UK
- Kathryn Monson
- 4 Sussex Health Outcomes, Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, Brighton, UK
- Ramsey Cutress
- Cancer Sciences Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK
- Valerie Jenkins
- 4 Sussex Health Outcomes, Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, Brighton, UK
- Lesley Fallowfield
- 4 Sussex Health Outcomes, Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, Brighton, UK
- Clare Brittain
- Daniel Rea
- Judith Bliss
- 1 Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK
- Amit Goyal
- Department of Surgery, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
- G Bruce Mann
- Department of Surgery, The University of Melbourne - Parkville Campus, Melbourne, Victoria, Australia
- Robert E Coleman
- Department of Oncology and Metabolism, Weston Park Hospital, Sheffield, UK
- Shabina Sadiq
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Heath Badger
- Breast Cancer Trials, Newcastle, New South Wales, Australia
- Rachel Helen Haines
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Mickey Lewis
- Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Daniel Megias
- National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK
- Zohal Nabi
- National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK
- Preetinder Singh
- National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK
- Andrei Caraman
- National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Northwood, UK
- Romaana Mir
- Teresa Grieve
- Clare Upton
- Aisha Shafayat
- Charlotte Gidman
- Flonda Probert
- Lisa Paksec
- Rose Lucas
- Annette Dempsey
- Rochelle Thornton
- Roeum Butt
- Peter Barrett Lee
- Julie Wolfarth
- Peter Dubsky
- 9 Hirslanden Klinik St Anna, Lucerne, Switzerland
- DOI
- https://doi.org/10.1136/bmjopen-2021-054365
- Journal volume & issue
-
Vol. 11,
no. 12
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