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Background: Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results., Methods: Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033., Findings: Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17.2 years (IQR 13.0-19.0). 20-year overall survival was 59.7% (99% CI 56.3-63.0) in the boost group versus 61.1% (57.6-64.3) in the no boost group, hazard ratio (HR) 1.05 (99% CI 0.92-1.19, p=0.323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0.65 (99% CI 0.52-0.81, p<0.0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16.4% (99% CI 14.1-18.8) in the no boost group versus 12.0% (9.8-14.4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1.8% (99% CI 1.1-2.5) in the no boost group versus 5.2% (99% CI 3.9-6.4) in the boost group (p<0.0001)., Interpretation: A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years., Funding: Fonds Cancer, Belgium., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Availability and quality of expensive treatment modalities such as botulinum toxin (BTX) largely depend on organizational aspects such as costs, reimbursement by insurance companies, expertise and facilities for expert training, and the propagation of research. To investigate which determinants influence the organization of BTX' use throughout nine Central European countries (Austria, Croatia, Czech Republic, Germany, Hungary, Italy, Slovakia, Slovenia and Switzerland) we sent out questionnaires to leading BTX experts and consulted data banks of manufacturers and bulletins of international organizations. In Western European countries, there is a tendency for users to organize themselves in formal groups and to concentrate on research whereas the way how BTX is provided is diverse regarding qualifications of specialists and institutions. In the post-communist Eastern European countries, we found a tendency towards a centralized system of reimbursement and BTX treatment seems to be more in the hands of neurologists than any other specialists. Strong correlations were observed between the number of BTX centres, degree of organization of user groups and number of scientific publications, on the one hand, and parameters of healthcare performance and socioeconomic determinants, on the other. Our study suggests that in the nine countries surveyed, organizational aspects of BTX use vary considerably, whilst similarities are based mainly on socioeconomic rather than socio-demographic determinants.