title: Is IORT ready for roll-out?
abstract: 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.
authors: 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.
authors: Emanuela
authors: E
authors: Esposito
authors: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
authors: Bauke
authors: B
authors: Anninga
authors: Department of Medical Physics Floor 3, Henriette Raphael House, Guy's and St Thomas Hospital, London SE1 9RT, UK.
authors: Ian
authors: I
authors: Honey
authors: Clinical Oncology, Royal Marsden Hospital and Institute of Cancer Research, London SW3 6JJ, UK.
authors: Gillian
authors: G
authors: Ross
authors: Oncoplastic Breast Unit, Royal Hampshire County Hospital, Winchester SO22 5DG, UK.
authors: Dick
authors: D
authors: Rainsbury
authors: Oncoplastic Breast Unit, Royal Hampshire County Hospital, Winchester SO22 5DG, UK.
authors: Siobhan
authors: S
authors: Laws
authors: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
authors: Sygriet
authors: S
authors: Rinsma
authors: Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
authors: Michael
authors: M
authors: Douek
keywords: IORT; breast cancer; intraoperative radiotherapy