Originally published as JCO Early Release 10.1200/JCO.2007.11.4991 on June 18 2007

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Impact of a Higher Radiation Dose on Local Control and Survival in Breast-Conserving Therapy of Early Breast Cancer: 10-Year Results of the Randomized Boost Versus No Boost EORTC 22881-10882 Trial

Harry Bartelink, Jean-Claude Horiot, Philip M. Poortmans, Henk Struikmans, Walter Van den Bogaert, Alain Fourquet, Jos J. Jager, Willem J. Hoogenraad, S. Bing Oei, Carla C. Wárlám-Rodenhuis, Marianne Pierart, Laurence Collette

From the Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam; Department of Radiation Oncology, Joint Center for Radiotherapy Arnhem/Nijmegen, St Radboud Hospital, Nijmegen; Department of Radiation Oncology, Radiotherapeutisch Instituut Limburg, Heerlen; Department of Radiation Oncology, Dr Bernard Verbeeten Instituut, Tilburg; Department of Radiation Oncology, University Hospital Leiden, Leiden; Department of Radiation Oncology, University Hospital Utrecht, Utrecht, the Netherlands; European Organisation for Research and Treatment of Cancer, Brussels; Department of Radiation Oncology, University Hospital Gasthuisberg, Leuven, Belgium; Department of Radiation Oncology, Institute Curie, Paris; and the Department of Radiation Oncology, Centre Georges-François Leclerc, Dijon, France

Address reprint requests to Harry Bartelink, MD, PhD, Department of Radiation Oncology, the Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands; e-mail: h.bartelink{at}nki.nl

Purpose To investigate the long-term impact of a boost radiation dose of 16 Gy on local control, fibrosis, and overall survival for patients with stage I and II breast cancer who underwent breast-conserving therapy.

Patients and Methods A total of 5,318 patients with microscopically complete excision followed by whole-breast irradiation of 50 Gy were randomly assigned to receive either a boost dose of 16 Gy (2,661 patients) or no boost dose (2,657 patients), with a median follow-up of 10.8 years.

Results The median age was 55 years. Local recurrence was reported as the first treatment failure in 278 patients with no boost versus 165 patients with boost; at 10 years, the cumulative incidence of local recurrence was 10.2% versus 6.2% for the no boost and the boost group, respectively (P < .0001). The hazard ratio of local recurrence was 0.59 (0.46 to 0.76) in favor of the boost, with no statistically significant interaction per age group. The absolute risk reduction at 10 years per age group was the largest in patients 40 years of age: 23.9% to 13.5% (P = .0014). As a result, the number of salvage mastectomies has been reduced by 41%. Severe fibrosis was statistically significantly increased (P < .0001) in the boost group, with a 10-year rate of 4.4% versus 1.6% in the no boost group (P < .0001). Survival at 10 years was 82% in both arms.

Conclusion After a median follow-up period of 10.8 years, a boost dose of 16 Gy led to improved local control in all age groups, but no difference in survival.

published online ahead of print at www.jco.org on June 18, 2007.

Supported by Grants No. 5R10-CA11488-11 through 2U10-CA11488-36 from the National Cancer Institute (Bethesda, MD).

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

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

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