Phase III randomised trial| Volume 90, ISSUE 1, P80-85, January 2009

Download started.


Impact of the boost dose of 10Gy versus 26Gy in patients with early stage breast cancer after a microscopically incomplete lumpectomy: 10-year results of the randomised EORTC boost trial



      To assess the impact of the boost dose in patients with involved surgical margins.

      Patients and methods

      In the EORTC “boost versus no boost” trial, 251 patients with a microscopically incomplete tumour excision were randomised to receive either a low boost dose of 10 Gy (126 patients) or a high boost dose of 26 Gy (125 patients). Overall survival and the cumulative incidence of local recurrence as first event were compared by Logrank and Gray test, respectively (2-sided α = 0.05), with a median follow-up of 11.3 years. The planned sample size was 660 patients, but only 251 were recruited.


      The median age at randomisation was 54 years. Thirty-seven patient initially relapsed locally. At 10 years, the cumulative incidence of local recurrence was 17.5% (95% CI: 10.4–24.6%) versus 10.8% (95% CI: 5.2–16.4%) for the low and high boost dose groups, respectively (HR = 0.83, 95% CI: 0.43–1.57, Gray p > 0.1). Overall, 64 patients have died (25.5%), 47 of them of breast cancer, without a difference in duration of survival between the two groups (HR = 0.97, 95% CI = 0.59–1.5, p > 0.1). Severe fibrosis was palpated in the breast in 1% versus 5% and in the boost area in 3% versus 13% in the low and high boost dose groups, respectively.


      There was no statistically significant difference in local control or survival between the high boost dose of 26 Gy and the low boost dose of 10 Gy in patients with microscopically incomplete excision of early breast cancer. Fibrosis, however, was noted significantly more frequently in cases treated with the high boost dose.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Radiotherapy and Oncology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Fisher B.
        • Anderson S.
        • Bryant J.
        • et al.
        Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.
        N Engl J Med. 2002; 347: 1233-1241
        • Veronesi U.
        • Cascinelli N.
        • Mariani L.
        • et al.
        Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer.
        N Engl J Med. 2002; 347: 1227-1232
        • Voogd A.C.
        • Nielsen M.
        • Peterse J.L.
        • et al.
        Differences in risk factors for local and distant recurrence after breast-conserving therapy or mastectomy for stage I and II breast cancer: pooled results of two large European randomized trials.
        J Clin Oncol. 2001; 19: 1688-1697
      1. Early Breast Cancer Trialists Collaborative Group (EBCTCG). Effects of radiotherapy and differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomized trial. Lancet 2005;366:17–25.

        • Curran D.
        • Van Dongen J.P.
        • Aaronson N.K.
        • et al.
        Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC trial 10801.
        Eur J Cancer. 1998; 34: 307-314
        • Van Dongen J.A.
        • Voogd A.C.
        • Fentiman I.S.
        • et al.
        Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial.
        J Natl Cancer Inst. 2000; 92: 1143-1145
        • Van Limbergen E.
        • Van den Bogaert W.
        • vander Schueren E.
        • Rijnders A.
        Tumor excision and radiotherapy as primary treatment of breast cancer. Analysis of patient and treatment parameters and local control.
        Radiother Oncol. 1987; 8: 1-9
        • Bartelink H.
        • Horiot J.C.
        • Poortmans P.M.
        • et al.
        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.
        J Clin Oncol. 2007; 25: 3259-3265
        • Bartelink H.
        • Borger J.H.
        • van Dongen J.A.
        • Peterse J.L.
        The Impact of tumor size and histology on local control after breast-conserving therapy.
        Radiother Oncol. 1988; 11: 297-303
        • Newman L.A.
        • Kuerer H.M.
        Advances in breast conservation therapy.
        J Clin Oncol. 2005; 23: 1685-1697
        • Van den Broek N.
        • Van der Sangen M.J.
        • Van de Poll-Franse L.V.
        • van Beek M.W.
        • Nieuwenhuijzen G.A.
        • Voogd A.C.
        Margin status and the risk of local recurrence after breast-conserving treatment of lobular breast cancer.
        Breast Cancer Res Treat. 2007; 105: 63-68
      2. TNM – classification of malignant tumours. 4th ed. Fully Revised Edition; 1987. p. 95–6.

      3. International commission of radiation units and measurements: dose specification for reporting external beam therapy with photons and electrons. Report 50. ICRU Publication: Bethesda, MD, USA, 1992.

        • Harry Bartelink
        • Jean-Claude Horiot
        • Philip Poortmans
        • et al.
        Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation.
        N Engl J Med. 2001; 345: 1378-1387
        • Poortmans P.M.
        • Ataman F.
        • Davis J.B.
        • et al.
        Quality assurance in the EORTC phase III randomised ‘boost vs. no boost’ trial for breast conserving therapy: comparison of the results of two individual case reviews performed early and late during the accrual period.
        Radiother Oncol. 2005; 76: 278-284
        • Pocock S.J.
        • Simon R.
        Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
        Biometrics. 1975; 31: 103-115
        • Kaplan E.L.
        • Meier P.
        Nonparametric estimation from incomplete observations.
        J Am Stat Assoc. 1958; 53: 457-481
        • Gray R.J.
        A class of K-sample tests for comparing the cumulative incidence of a competing risk.
        Ann Stat. 1988; 16: 1141-1154
        • Schuck A.
        • Ko ¨nemann S.
        • Heinen K.
        • et al.
        Strahlenther Onkol. 2002; 178: 307-313
        • Van Limbergen E.
        • van der Schueren E.
        • Van den Bogaert W.
        • Van Wing J.
        Local control of operable breast cancer with radiotherapy only.
        Eur J Cancer. 1990; 26: 674-679
        • DiBiase S.J.
        • Komarnicky L.T.
        • Schwartz G.F.
        • et al.
        The number of positive margins influences the outcome of women treated with breast preservation for early stage breast carcinoma.
        Cancer. 1998; 82: 2212-2220
        • Park C.C.
        • Mitsumori M.
        • Nixon A.
        • et al.
        Outcome at 8 years after breast-conserving surgery and radiation therapy for invasive breast cancer: influence of margin status and systemic therapy on local recurrence.
        J Clin Oncol. 2000; 18: 1668-1675
        • Solin L.J.
        • Fowble B.L.
        • Schultz D.J.
        • et al.
        The significance of the pathology margins of the tumor excision on the outcome of patients treated with definitive irradiation for early stage breast cancer.
        Int J Radiat Oncol Biol Phys. 1991; 21: 279-287
        • Santiago R.J.
        • Wu L.
        • Harris E.
        • et al.
        Fifteen-year results of breast-conserving surgery and definitive irradiation for stage 1 and II breast carcinoma: The University of Pennsylvania Experience.
        Int J Radiat Oncol Biol Phys. 2004; 58: 233-240
      4. Jones H, Antonini N, Colette L, et al. The impact of boost dose and margins on the local recurrence rate in breast conserving therapy: results from the EORTC Boost–No Boost Trial. Plenary oral presentation, 49th ASTRO-meeting. 28 October 2007–01 November 2007, Los Angeles. Int J Radiat Oncol Biol Phys 2007;69:abstract 2981.

        • Van Limbergen E.
        • Rijnders A.
        • Van der Schueren E.
        • Lerut T.
        • Christiaens R.
        Cosmetic evaluation of breast conserving treatment for mammary cancer. 2. A quantitative analysis of the influence of radiation dose, fractionation schedules and surgical treatment techniques on cosmetic results.
        Radiother Oncol. 1989; 16: 253-267
        • Donovan E.
        • Bleakley N.
        • Denholm E.
        • et al.
        Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy.
        Radiother Oncol. 2007; 82: 254-264
        • Antonini N.
        • Jones H.
        • Horiot J.C.
        • et al.
        Effect of age and radiation dose on local control after breast conserving treatment: EORTC Trial 22881-10882.
        Radiother Oncol. 2007; 82: 265-271
        • Vrieling C.
        • Collette L.
        • Fourquet A.
        • et al.
        Can patient-, treatment- and pathology-related characteristics explain the high local recurrence rate following breast-conserving therapy in young patients?.
        Eur J Cancer. 2003; 39: 932-944
        • Poortmans P.
        • Bartelink H.
        • Horiot J.C.
        • et al.
        The influence of the boost technique on local control in breast conserving treatment in the EORTC “boost versus no boost” randomised trial.
        Radiother Oncol. 2004; 72: 25-33
        • Hurkmans C.W.
        • Meijer G.J.
        • Van Vliet-Vroegindeweij C.
        • Van der Sangen M.J.
        • Cassee J.
        High-dose simultaneously integrated breast boost using intensity-modulated radiotherapy and inverse optimization.
        Int J Radiat Oncol Biol Phys. 2006; 66: 923-930
        • Van der Laan H.P.
        • Dolsma W.V.
        • Maduro J.H.
        • Korevaar E.W.
        • Hollander M.
        • Langendijk J.A.
        Three-dimensional conformal simultaneously integrated boost technique for breast-conserving radiotherapy.
        Int J Radiat Oncol Biol Phys. 2007; 68: 1018-1023