Originally published as JCO Early Release 10.1200/JCO.2006.06.1366 on June 26 2006

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Breast-Conserving Treatment With or Without Radiotherapy in Ductal Carcinoma-In-Situ: Ten-Year Results of European Organisation for Research and Treatment of Cancer Randomized Phase III Trial 10853—A Study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group

Nina Bijker, Philip Meijnen, Johannes L. Peterse, Jan Bogaerts, Irène Van Hoorebeeck, Jean-Pierre Julien, Massimiliano Gennaro, Philippe Rouanet, Antoine Avril, Ian S. Fentiman, Harry Bartelink, Emiel J. Th. Rutgers

From the Departments of Radiation Oncology, Surgery, and Pathology, Antoni van Leeuwenhoek Hospital, the Netherlands Cancer Institute, Amsterdam, the Netherlands; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium; Department of Surgery, Centre Henri Becquerel, Rouen; Department of Surgery, CRLC Val D'Aurelle, Montpellier; Department of Surgery, Institut Bergonié, Bordeaux, France; Department of Surgery, Istituto Nazionale dei Tumori, Milan, Italy; and the Department of Academic Oncology, Guy's Hospital, London, United Kingdom

Address reprint requests to Nina Bijker, MD, PhD, Department of Radiation Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands; e-mail: n.bijker{at}nki.nl

PURPOSE: The European Organisation for Research and Treatment of Cancer conducted a randomized trial investigating the role of radiotherapy (RT) after local excision (LE) of ductal carcinoma-in-situ (DCIS) of the breast. We analyzed the efficacy of RT with 10 years follow-up on both the overall risk of local recurrence (LR) and related to clinical, histologic, and treatment factors.

PATIENTS AND METHODS: After complete LE, women with DCIS were randomly assigned to no further treatment or RT (50 Gy). One thousand ten women with mostly (71%) mammographically detected DCIS were included. The median follow-up was 10.5 years.

RESULTS: The 10-year LR-free rate was 74% in the group treated with LE alone compared with 85% in the women treated by LE plus RT (log-rank P < .0001; hazard ratio [HR] = 0.53). The risk of DCIS and invasive LR was reduced by 48% (P = .0011) and 42% (P = .0065) respectively. Both groups had similar low risks of metastases and death. At multivariate analysis, factors significantly associated with an increased LR risk were young age ( 40 years; HR = 1.89), symptomatic detection (HR = 1.55), intermediately or poorly differentiated DCIS (as opposed to well-differentiated DCIS; HR = 1.85 and HR = 1.61 respectively), cribriform or solid growth pattern (as opposed to clinging/micropapillary subtypes; HR = 2.39 and HR = 2.25 respectively), doubtful margins (HR = 1.84), and treatment by LE alone (HR = 1.82). The effect of RT was homogeneous across all assessed risk factors.

CONCLUSION: With long-term follow-up, RT after LE for DCIS continued to reduce the risk of LR, with a 47% reduction at 10 years. All patient subgroups benefited from RT.

Supported by Grants No. 2U10 CA11488-16 through 5U10 CA11488-35 from the National Cancer Institute (National Institutes of Health, Bethesda, MD).

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented at the 28th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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