title: Addressing overtreatment of screen detected DCIS; the LORIS trial.
abstract: Overdiagnosis, and thus overtreatment, are inevitable consequences of most screening programmes; identification of ways of minimising the impact of overdiagnosis demands new prospective research, in particular the need to separate clinically relevant lesions that require active treatment from those that can be safely left alone or monitored and only need treated if they change characteristics. Breast cancer screening has led to a large increase in ductal carcinoma in situ (DCIS) diagnoses. This is a widely heterogeneous disease and most DCIS detected through screening is of high cytonuclear grade and therefore likely to be important clinically. However, the historic practice of surgical treatment for all DCIS is unlikely to be optimal for lower risk patients. A clearer understanding of how to manage DCIS is required. This article describes the background and development of 'The low risk' DCIS trial (LORIS), a phase III trial of surgery versus active monitoring. LORIS will determine if it is appropriate to manage women with screen detected or asymptomatic, low grade and intermediate grade DCIS with low grade features, by active monitoring rather than by surgical treatment.
authors: Department of Breast Surgery, Nuffield House University Hospital Birmingham, Edgbaston, Birmingham, B15 2TH, UK.
authors: Adele
authors: A
authors: Francis
authors: Western General Hospital, Edinburgh, UK.
authors: Jeremy
authors: J
authors: Thomas
authors: Sussex Health Outcomes, Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, BN1 9RX, UK.
authors: Lesley
authors: L
authors: Fallowfield
authors: Cambridge Breast Unit, Addenbrooke's Hospital, Cambridge, CB2 2QQ, UK.
authors: Matthew
authors: M
authors: Wallis
authors: Ontario Institute for Cancer Research, Toronto, Ontario M5G 0A3, Canada.
authors: John M S
authors: JM
authors: Bartlett
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Cassandra
authors: C
authors: Brookes
authors: Health Economics Unit, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Tracy
authors: T
authors: Roberts
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Sarah
authors: S
authors: Pirrie
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Claire
authors: C
authors: Gaunt
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Jennie
authors: J
authors: Young
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Lucinda
authors: L
authors: Billingham
authors: St. James's Hospital, Leeds, UK.
authors: David
authors: D
authors: Dodwell
authors: Department of Histopathology, Academic Unit of Pathology, St James's University Hospital, Leeds, UK.
authors: Andrew
authors: A
authors: Hanby
authors: Division of Cancer Studies, Department of Research Oncology, King's College London, UK.
authors: Sarah E
authors: SE
authors: Pinder
authors: Ninewells Medical School, Dundee, DD1 9SY, UK.
authors: Andrew
authors: A
authors: Evans
authors: University of Sussex, Brighton, BN1 9PX, UK.
authors: Malcolm
authors: M
authors: Reed
authors: Sussex Health Outcomes, Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, BN1 9RX, UK.
authors: Valerie
authors: V
authors: Jenkins
authors: Sussex Health Outcomes, Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, BN1 9RX, UK.
authors: Lucy
authors: L
authors: Matthews
authors: Independent Cancer Patients Voices, London, EC1R 0LL.
authors: Maggie
authors: M
authors: Wilcox
authors: Independent Cancer Patients Voices, London, EC1R 0LL.
authors: Patricia
authors: P
authors: Fairbrother
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Sarah
authors: S
authors: Bowden
authors: Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
authors: Daniel
authors: D
authors: Rea
mesh_terms: D001706:Biopsy; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000191:economics / Q000601:surgery / Q000628:therapy*; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000628:therapy*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008327:Mammography; D008408:Mastectomy / Q000191:economics; D000069342:Medical Overuse / Q000191:economics; D060787:Neoplasm Grading; D018579:Patient Selection; D011237:Predictive Value of Tests; D012107:Research Design; D006113:United Kingdom; D057832:Watchful Waiting / Q000191:economics
keywords: Breast cancer; Breast screening; Clinical trial; DCIS; Low grade DCIS; Over treatment