Phase II study on the use of intraoperative radiotherapy in early breast cancer

ABSTRACT

To report our early experience using the Intrabeam radiotherapy delivery system for intraoperative radiotherapy [IORT] in early breast cancer. This is a prospective phase 2 study carried out at the Department of Surgery and Radiology, King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia from December 2010 to November 2012. Females eligible for breast-conserving surgery with biopsy-proven invasive duct carcinoma, and with a mass of sentinel lymph node dissection, and surgically positioning of the appropriately sized applicator on the tumor bed, a 20 Gray [Gy] single dose was prescribed using the Intrabeam x-ray generator. External beam radiotherapy [EBRT; 46 Gy/23 fractions/4.5 weeks] was given when the tumor was >3 cm, with lymphovascular invasion, multifocal lesion, extensive intraductal carcinoma, and positive nodes. Early and late toxicity were recorded using the Radiation Therapy Oncology Group [RTOG] criteria. Forty-five patients were included with a median age of 54 [range 27-79 years]. Thirty-six cases [80%] had tumor <3 cm in diameter, and 36 [67%] have pathologically negative axillary lymph node metastases. None of the patients developed delayed wound healing, postoperative infection requiring intravenous antibiotic, or breast seroma requiring aspiration. Sixteen [36%] received EBRT after IORT. Twelve patients developed radiologically proved fat necrosis. The IORT for early stage breast cancer patients using the Intrabeam delivery system was easily implemented in our center with an acceptable toxicity profile and cosmetic outcome: