Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ – The LORD study

• Published in: European journal of cancer (1990) 2015-08, Vol.51 (12), p.1497-1510
• Main Authors: Elshof, Lotte E, Tryfonidis, Konstantinos, Slaets, Leen, van Leeuwen-Stok, A. Elise, Skinner, Victoria P, Dif, Nicolas, Pijnappel, Ruud M, Bijker, Nina, Rutgers, Emiel J.Th, Wesseling, Jelle
• Format: Article
• Language: English
• Subjects: Active surveillance; Adult; Aged; Breast Neoplasms - diagnosis; Breast Neoplasms - pathology; Breast Neoplasms - therapy; Carcinoma, Intraductal, Noninfiltrating - diagnosis; Carcinoma, Intraductal, Noninfiltrating - pathology; Carcinoma, Intraductal, Noninfiltrating - therapy; Ductal carcinoma in situ; Feasibility Studies; Female; Hematology, Oncology and Palliative Medicine; Hormonal therapy; Humans; Low-grade; Middle Aged; Neoplasm Metastasis - diagnosis; Overdiagnosis; Overtreatment; Prospective Studies; Radiotherapy; Surgery; Watchful Waiting
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2015.05.008

Abstract Background The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ (DCIS) urges the need for prospective studies to address this issue. A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns non- to slow-growing low-grade DCIS. The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS. Design This is a randomised, international multicentre, open-label, phase III non-inferiority trial, led by the Dutch Breast Cancer Research Group (BOOG 2014-04) and the European Organization for Research and Treatment of Cancer (EORTC-BCG 1401). Standard treatment will be compared to active surveillance in 1240 women aged ⩾45 years with asymptomatic, screen-detected, pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only. Both study arms will be monitored with annual digital mammography for a period of 10 years. The primary end-point is 10-year ipsilateral invasive breast cancer free percentage. Secondary end-points include patient reported outcomes, diagnostic biopsy rate during follow-up, ipsilateral mastectomy rate and translational research. Feasibility To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres. A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study. The proposed study design is endorsed by nearly all centres.