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Randomized Controlled Trial Multicenter Study
Impact of the boost dose of 10 Gy versus 26 Gy in patients with early stage breast cancer after a microscopically incomplete lumpectomy: 10-year results of the randomised EORTC boost trial.
- Philip M Poortmans, Laurence Collette, Jean-Claude Horiot, Walter F Van den Bogaert, Alain Fourquet, Abraham Kuten, Evert M Noordijk, Willem Hoogenraad, René-Olivier Mirimanoff, Marianne Pierart, Erik Van Limbergen, Harry Bartelink, and EORTC Radiation Oncology and Breast Cancer Groups.
- Department of Radiation Oncology, Dr. Bernard Verbeeten Instituut, Tilburg, The Netherlands. poortmans.ph@bvi.nl
- Radiother Oncol. 2009 Jan 1; 90 (1): 80-5.
PurposeTo assess the impact of the boost dose in patients with involved surgical margins.Patients And MethodsIn 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 alpha=0.05), with a median follow-up of 11.3 years. The planned sample size was 660 patients, but only 251 were recruited.ResultsThe 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.ConclusionsThere 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.
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