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Aim: To evaluate feasibility, tolerability and cosmetic outcome of intra-operative radiation therapy (IORT) as an exclusive post-surgery treatment of early stage breast cancer., Patients and Methods: From October 2008 to October 2009 30 patients underwent wide breast cancer excision or quadrantectomy followed by IORT on tumor bed with accelerated electrons at the dose of 21Gy. The characteristics of the patients were: ductal breast cancer or invasive lobular cT1, cT2 ≤ 2,5 cm, cN0, G1-2, age over 35 years, M0., Results: The average age was 51.7 (range 38 - 75) with an average follow up of 11.7 months (range 6 - 18). The pathologic stage of the lesions resulted pT1 in 29 cases (96,6%), in particular: one case pT1a (3,3%), 21 cases pT1b (70,0%) and 7 cases pT1c (23,3%). One case (3,3%) was pT2 with a diameter of 2.5 cm. The grading was G2 in 20 cases (66,6%) and G1 in 10 cases (33,3%). The toxicity, evaluated according to the EORTC-RTOG criteria, was G0 (33.3%) in 10 cases, G1 (63,3%) in 19 cases, G2 in one case (3,4%); there was no G3 toxicity. The time needed for a complete healing of the wound was less than 10 days in 96,7% of the cases, with one case of limphocele (3,3%). There were no infections of the surgical wound nor any mastitis, neither in the treated quadrant nor in the other ones. We observed a light fibrosis in 5 cases (16,6%), moderate in 2 cases (6,6%) but never severe. Cosmetics, evaluated in four levels, according to Danoff et al., was excellent in 3 cases (43,3%), good in 15 cases (50%), sufficient in 2 cases (6,7%), never insufficient. As regards local control, there was no local relapse. The global survival was 100%., Conclusions: The IORT in early breast cancer, at the doses used in this study, proved itself as a secure technique, repeatable, with limited complications. The advantages of its use are the possibility of a direct control, by the surgeon and the radiotherapist, of the structures to treat and those to protect; the absence of time needed for cellular repopulation between surgery and radiotherapy; a good cosmetic outcome; and logistic advantages. It is necessary to have a long term follow up to evaluate the efficacy in terms of long term cosmetic and local control.

Thanks to a retrospective analysis of the first 250 cases of sentinel lymph nodes in breast cancer assessed by the authors over the period from October 1998 to December 2000 in the light of a careful review of the literature, it has been possible to establish the importance of careful patient selection, strict compliance with the execution technique and, above all, the need for an adequate learning curve, before the procedure is used in particular protocols and/or in routine clinical practice in the near future. In particular, the training should first of all ensure that all personnel involved, i.e. surgeons, nuclear medicine specialists, and histopathologists, should attend specific courses at qualified Institutions followed by the actual management of a certain number of consecutive cases. In order to perfect the methodology and organisation, a preliminary study in a group of patients at different stages of evolution of the disease is recommended (50 cases in the study population reported). The next phase should include a group of highly selected patients, numbering at least 50-100. The training may be considered complete when in at least 20 cases, an identification rate of at least 90% is achieved with an incidence of false negatives of not more than 5%. In the authors' experience, these results were reached after 100 selected patients, and were later consistently confirmed after a further 50 cases.