IOERT versus external beam electrons for boost radiotherapy in stage I/II breast cancer: 10-year results of a phase III randomized study

Breast Cancer Research

Stefano Drago¹  Fabiana Gregucci²  Gerd Fastner³  Felix Sedlmayer³  Ingrid Ziegle³  Antonella Ciabattoni⁴  Maria Alessandra Mirri⁴  Antonio Spera⁵  Silvio Cavuto⁶  Rita Consorti⁷ 

[1] Department of Breast and Reconstructive Surgery, Sando Pertini Hospital;Department of Radiation Oncology, Miulli General Regional Hospital;Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University Hospital Salzburg, Landeskrankenhaus;Department of Radiotherapy, San Filippo Neri Hospital;Department of Radiotherapy, San Giovanni di Dio Hospital, ASP Agrigento;Infrastructure Research and Statistics, Clinical Trials and Statistics Unit, AUSL-IRCCS;Medical Physics Unit, San Filippo Neri Hospital;

关键词: Breast cancer;    Intraoperative radiotherapy;    Electrons;    Tumor bed boost;    Local control;    Toxicity;   

DOI  :  10.1186/s13058-021-01424-9

来源: DOAJ

【 摘 要 】

Abstract Background Intraoperative radiotherapy with electrons (IOERT) boost could be not inferior to external beam radiotherapy (EBRT) boost in terms of local control and tissue tolerance. The aim of the study is to present the long-term follow-up results on local control, esthetic evaluation, and toxicity of a prospective study on early-stage breast cancer patients treated with breast-conserving surgery with an IOERT boost of 10 Gy (experimental group) versus 5 × 2 Gy EBRT boost (standard arm). Both arms received whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose). Methods A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial. Primary endpoints were the evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results. Secondary endpoints were overall survival (OS), disease-free survival (DFS), and patient’s grade of satisfaction with cosmetic outcomes. Results Between 1999 and 2004, 245 patients were randomized: 133 for IOERT and 112 for EBRT. The median follow-up was 12 years (range 10–16 years). The cumulative risk of IBTR at 5–10 years was 0.8% and 4.3% after IOERT, compared to 4.2% and 5.3% after EBRT boost (p = 0.709). The cumulative risk of out-field LR at 5–10 years was 4.7% and 7.9% for IOERT versus 5.2% and 10.3% for EBRT (p = 0.762). All of the IOERT arm recurrences were observed at > 100 months’ follow-up, whereas the mean time to recurrence in the EBRT group was earlier (55.2 months) (p < 0.05). No late complications associated with IOERT were observed. The overall cosmetic results were scored as good or excellent in physician and patient evaluations for both IOERT and EBRT. There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). Conclusion A 10-Gy IOERT boost during breast-conserving surgery provides high local control rates without significant morbidity. Although not significantly superior to external beam boosts, the median time to local recurrences after IOERT is prolonged by more than 4 years.

【 授权许可】

Unknown