Esposito Emanuela, Anninga Bauke, Honey Ian, Ross Gillian, Rainsbury Dick, Laws Siobhan, Rinsma Sygriet, Douek Michael
Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK ; Department of Breast Surgery, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale' - IRCCS, Naples 80131, Italy ; Department of Clinical Medicine and Surgery, Breast Unit, University of Naples Federico II, Naples 80131, Italy.
Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
Ecancermedicalscience. 2015 Mar 12;9:516. doi: 10.3332/ecancer.2015.516. eCollection 2015.
Two large randomised controlled trials of intraoperative radiotherapy (IORT) in breast-conserving surgery (TARGIT-A and ELIOT) have been published 14 years after their launch. Neither the TARGIT-A trial nor the ELIOT trial results have changed the current clinical practice for the use of IORT. The in-breast local recurrence rate (LRR) after IORT met the pre-specified non-inferiority margins in both trials and was 3.3% in TARGIT-A and 4.4% in the ELIOT trial. In both trials, the pre-specified estimates for local recurrence (LR) with external beam radiation therapy (EBRT) significantly overestimated actual LRR. In the TARGIT-A trial, LR with EBRT was estimated at the outset to be 6%, and in the ELIOT trial, it was estimated to be 3%. Surprisingly, LRR in the EBRT groups has been found to be significantly lower, 1.3% in the EBRT arm of the TARGIT-A and 0.4% in the EBRT arm of the ELIOT trial, respectively. Median follow-up was 2.4 years for the TARGIT-A trial and 5.8 years for the ELIOT trial. However, the initial cohort of patients in the TARGIT-A trial (reported in 2010) now have a median follow-up of 3.8 years and data on LR were available at 5 years follow-up on 35% of patients (18% who received IORT). Although further follow-up will increase confidence with the data, it will also further delay clinical implementation. By carefully weighing the risks and benefits of a single-fraction radiation treatment with patients, IORT should be offered within agreed and strict protocols. Patients deemed at low risk of LR or those deemed suitable for partial breast irradiation, according to the GEC-ESTRO and ASTRO recommendations, could be considered as candidates for IORT. These guidelines apply to all partial breast irradiation techniques, and more specific guidelines for IORT would assist clinicians.
两项关于保乳手术中术中放疗（IORT）的大型随机对照试验（TARGIT - A和ELIOT）在启动14年后发表。TARGIT - A试验和ELIOT试验的结果均未改变IORT目前的临床应用实践。两项试验中IORT后的乳腺内局部复发率（LRR）均达到预先设定的非劣效性边界，TARGIT - A试验中为3.3%，ELIOT试验中为4.4%。在两项试验中，预先设定的外照射放疗（EBRT）局部复发（LR）估计值均显著高估了实际LRR。在TARGIT - A试验中，EBRT的LR最初估计为6%，在ELIOT试验中估计为3%。令人惊讶的是，EBRT组的LRR已被发现显著更低，TARGIT - A试验的EBRT组为1.3%，ELIOT试验的EBRT组为0.4%。TARGIT - A试验的中位随访时间为2.4年，ELIOT试验为5.8年。然而，TARGIT - A试验的初始患者队列（2010年报告）现在的中位随访时间为3.8年，并且在5年随访时，35%的患者（18%接受IORT的患者）有LR数据。尽管进一步随访将增加对数据的信心，但也会进一步延迟临床应用。通过与患者仔细权衡单次分割放疗的风险和益处，应在商定且严格的方案内提供IORT。根据GEC - ESTRO和ASTRO的建议，被认为LR风险低或适合部分乳腺照射的患者可被视为IORT的候选者。这些指南适用于所有部分乳腺照射技术，更具体的IORT指南将有助于临床医生。
