A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer

Radiation Oncology, Jul 2014

Background Since the results from the randomized TARGIT A trial were published, intraoperative radiotherapy (IORT) is used more often. IORT can be provided as accelerated partial breast irradiation (APBI) or as a boost. The definition of suitable patients for IORT as APBI differs between different national societies (e.g. ESTRO and ASTRO) and different inclusion criteria of trials and so does the eligibility of patients. This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials. Methods Between 01/03 – 12/09, 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim. Complete data sets for age, stage (T, N, and M), histology and hormone receptor status were available in 1108 cases. Parameters to identify eligible patients are as follows: ESTRO: >50 years, invasive ductal carcinoma/other favorable histology (IDC), T1-2 (≤3 cm), N0, any hormone receptor status, M0; ASTRO: ≥60 years, IDC, T1, N0, positive estrogen hormone receptor status, M0; TARGIT E “elderly”, risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology, phase II: ≥70 years, IDC, T1, N0, any hormone receptor status, M0; TARGIT C “consolidation”, risk adapted radiotherapy, phase IV: ≥50 years, IDC, T1, N0, positive hormone receptor status, M0; TARGIT BQR “boost quality registry”: every age, every histology, T1-2 (max. 3.5 cm), any hormone receptor status, N0/+, M0/+. Results Out of the 1108 cases, 379 cases (34.2%) were suitable for IORT as APBI regarding the ESTRO and 175 (15.8%) regarding the ASTRO consensus statements. 82 (7.4%) patients were eligible for the TARGIT E trial, 258 (23.3%) for the TARGIT C trial and 671 (60.6%) for the TARGIT BQR registry. According to the consensus statements of ASTRO (45.1%) and ESTRO (41.4%) about half of the eligible patients were treated with IORT as APBI. From the eligible patients fulfilling the criteria for IORT boost (35%) about one third was eventually treated. Conclusions Patient selection for IORT should be restrictive. For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements.

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A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer

Elena Sperk 1 Daniela Astor 1 Anke Keller 1 Grit Welzel 1 Axel Gerhardt 0 Benjamin Tuschy 0 Marc Stterlin 0 Frederik Wenz 1 0 Department of Obstetrics and Gynecology, University Medical Center Mannheim, University of Heidelberg , Theodor-Kutzer-Ufer 1-3 Mannheim 68167 , Germany 1 Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg , Theodor-Kutzer-Ufer 1-3, Mannheim 68167 , Germany Sperk et al. - A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer Background: Since the results from the randomized TARGIT A trial were published, intraoperative radiotherapy (IORT) is used more often. IORT can be provided as accelerated partial breast irradiation (APBI) or as a boost. The definition of suitable patients for IORT as APBI differs between different national societies (e.g. ESTRO and ASTRO) and different inclusion criteria of trials and so does the eligibility of patients. This analysis identifies eligible patients for IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials. Methods: Between 01/03 12/09, 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim. Complete data sets for age, stage (T, N, and M), histology and hormone receptor status were available in 1108 cases. Parameters to identify eligible patients are as follows: ESTRO: >50 years, invasive ductal carcinoma/other favorable histology (IDC), T1-2 (3 cm), N0, any hormone receptor status, M0; ASTRO: 60 years, IDC, T1, N0, positive estrogen hormone receptor status, M0; TARGIT E elderly, risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology, phase II: 70 years, IDC, T1, N0, any hormone receptor status, M0; TARGIT C consolidation, risk adapted radiotherapy, phase IV: 50 years, IDC, T1, N0, positive hormone receptor status, M0; TARGIT BQR boost quality registry: every age, every histology, T1-2 (max. 3.5 cm), any hormone receptor status, N0/+, M0/+. Results: Out of the 1108 cases, 379 cases (34.2%) were suitable for IORT as APBI regarding the ESTRO and 175 (15.8%) regarding the ASTRO consensus statements. 82 (7.4%) patients were eligible for the TARGIT E trial, 258 (23.3%) for the TARGIT C trial and 671 (60.6%) for the TARGIT BQR registry. According to the consensus statements of ASTRO (45.1%) and ESTRO (41.4%) about half of the eligible patients were treated with IORT as APBI. From the eligible patients fulfilling the criteria for IORT boost (35%) about one third was eventually treated. Conclusions: Patient selection for IORT should be restrictive. For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements. * Correspondence: 1Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, Mannheim 68167, Germany Full list of author information is available at the end of the article 2014 Sperk et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Background Accelerated partial breast irradiation (APBI) has been reported having comparable local control and an excellent cosmetic outcome in comparison to whole breast radiotherapy using different techniques such as balloon brachytherapy [1], multi-catheter technique [2], external beam accelerated partial breast irradiation [3], intraoperative radiotherapy (IORT) with electrons (=IOERT) [4,5] or with low energy x-rays (=LEX-IORT) [6,7]. LEX-IORT with 50 kV x-rays is more often used since the results from the TARGIT A trial showed a noninferiority regarding local control [6,7], less toxicity, especially chronic skin toxicity [8], and an overall survival benefit [7] for patients treated with LEX-IORT in comparison to patients treated with external beam radiotherapy (EBRT). The TARGIT A trial closed recruitment in June 2012. In the meantime the TARGIT E(lderly), TARGIT C(onsolidation) and the TARGIT B(oost)Q (uality)R(egistry) have been conducted or are ongoing. The TARGIT E trial is a phase II, non-randomized single arm trial for elderly patients above the age of 70 years (ClinicalTrials.gov Identifier: NCT01299987) [9]. In this trial all patients receive LEX-IORT without randomization. EBRT to the whole breast is only added after LEX-IORT, if risk factors are present in final his (...truncated)


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Elena Sperk, Daniela Astor, Anke Keller, Grit Welzel, Axel Gerhardt, Benjamin Tuschy, Marc Sütterlin, Frederik Wenz. A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer, Radiation Oncology, 2014, pp. 154, 9, DOI: 10.1186/1748-717X-9-154