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

• Published in: Breast cancer research : BCR 2021-04, Vol.23 (1), p.46-11, Article 46
• Main Authors: Ciabattoni, Antonella, Gregucci, Fabiana, Fastner, Gerd, Cavuto, Silvio, Spera, Antonio, Drago, Stefano, Ziegler, Ingrid, Mirri, Maria Alessandra, Consorti, Rita, Sedlmayer, Felix
• Format: Article
• Language: English
• Subjects: Adult; Aged; Analysis; Biopsy; Breast cancer; Breast Neoplasms - pathology; Breast Neoplasms - radiotherapy; Breast Neoplasms - surgery; Cancer; Cancer therapies; Care and treatment; Chemotherapy; Dosimetry; Electrons; Electrons - therapeutic use; Female; Follow-Up Studies; Histology; Humans; Intraoperative Period; Intraoperative radiotherapy; Local control; Lumpectomy; Mammography; Mastectomy, Segmental; Metastasis; Middle Aged; Morbidity; Neoplasm Recurrence, Local; Neoplasm Staging; Oncology, Experimental; Patients; Prospective Studies; Radiation therapy; Radiotherapy; Radiotherapy Dosage; Radiotherapy, Adjuvant; Surgery; Survival; Survival Analysis; Toxicity; Treatment Outcome; Tumor bed boost; Ultrasonic imaging
• ISSN: 1465-542X; 1465-5411; 1465-542X
• DOI: 10.1186/s13058-021-01424-9

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). 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. 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