| Background: In 2016,the Fran?ois Baclesse Center（CFB）in Caen,France,introduced intraoperative radiotherapy（IORT）for the loco-regional treatment of early breast cancers with a favorable prognosis in patients over 65 years.We reported the exhaustive results of our breast cancer population treated using IORT from April 2016 to April 2021.The local recurrence（LR）,overall survival（OS）,complications and side effects,as well as patient satisfaction,were assessed during follow-up（median 25 months,maximum 62 months,interquartile range 12-37）.This study took into consideration the acceptability,harmlessness,and effectiveness of this regimen.Currently,few centers have published their experience based on recruitment criteria as restrictive as those of the CFB.Thus,this very cautious study is an opportunity for more advanced medico-economical recognition and possible changes in practices to apply more extensively this therapy.Methods: This is a single-center retrospective review of all 189 patients with invasive breast carcinomas who underwent IORT of 20 Gy at applicator surface to the surgical cavity using a 50 k V photon applicator（Intrabeam,Zeiss,Oberkochen,Germany）since the onset of the technic,April 2016,up to April 2021.Eligible women were aged > 65 years with a clinical and pathological diagnosis of a unicentric invasive ductal carcinoma of grade I or II with an ultrasound diameter not exceeding20 mm,clinically negative axillary lymph nodes,hormone receptor-positive,HER2 negative,and who were suitable for breast-conserving surgery（BCS）.Supplemental whole-breast irradiation（WBI）was recommended after IORT when the results of the postoperative pathology found risk criteria（tumor > 2 cm,histological grade ≥ grade3,tumor-free margin ≤ 2mm,if there were LVI,EIC,ILC,extensive ductal carcinoma in situ,multifocality/multicentricity lesions,lymph node-positive）.The local recurrence and overall survival were assessed at the maximum follow-up time point of each patient（maximum 62 months）.The variables that may be related to the occurrence of side effects and complications are also analyzed.Results: Among the 189 patients,the median follow-up time was 25 months,the mean age was 76 years,and the mean tumor size was 11.8 mm.For 44 patients a supplemental WBI has been carried out,187 patients were given hormone therapy,and 2 patients were given chemotherapy.The incidence of post-operation complications was 13.2% and delayed and late complications were 62.4%.Fat necrosis was the most frequently observed complication（31.7%）,followed by fibrosis（27.0%）.Regarding potential relation with WBI,a significant difference has been observed between the complication rates in fat necrosis（less in WBI group,p=0.010）and dermatitis（more in WBI group,p=0.002）.No case of local recurrence was observed.One patient developed contralateral new breast cancer one year later.Three deaths were observed,and the overall survival rate was 98.4%.Conclusion: A satisfactory local control rate was achieved by the refined treatment criteria of this center.Moreover,treatments were well-tolerated and this procedure was acclaimed by most of the patients.However,the proportion of supplemental WBI patients is still large and questions the predictability of some criteria.Therefore both inclusion criteria for IORT and criteria for supplementing WBI still need more study populations and longer follow-up to define risk stratification to make more breast cancers patients benefit from IORT. |
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