607 Background: IORT for breast cancer using either electrons or low-energy x-rays is of increasing interest over the last few years. In our institution, IORT is delivered by a mobile x-ray source (Intrabeam™) producing isotropic 50 kV x-ray fields. Because this treatment method includes single high doses to the normal breast tissue, careful and long-term evaluation of early and late toxicity is mandatory. To date there are still fewdata on long-term follow-up of patients treated with low-energy x-rays. Methods: Between 2/02 and 12/06 204 breast cancer patients received IORT either as a tumour-bed boost (133) followed by 46 Gy external beam radiotherapy (EBRT) or as partial breast irradiation (PBI) only (71). Median age was 66.4 years (35–95), median tumour size was 9 mm (1–45). Spherical applicators (median 4. 0 cm) were inserted into the tumour-cavity and a single dose of 20 Gy was given. Follow-up (f/u) included physical examination and ultrasound 1 week, 2 months, then every 6 months after therapy and mammography at yearly intervals. Radiobiological modelling of the expected spatial distribution of late reactions was done for typical cases using the linear-quadratic model with special consideration of relative biological effectiveness, spatial dose distribution and dose rate. Results: Median f/u was 28 months (1–56). Minor postoperative side effects included erythema (5%), delayed wound healing (4%), mastitis (1%) and hematoseroma (4%). A fibrotic induration of the tumour bed was observed in 9, 18, 24, 23, 26% and 24% of the patients at 2, 6 12, 24, 36 and 48 month f/u. These fibrosis rates were distributed equally in both groups. Reoperation was required in 2 patients after 10 (fibrosis) and 12 months (fat necrosis). Conclusions: Although two thirds of the patients were treated with a combination of IORT and EBRT, acute reactions in all patients were mild. A fibrotic induration confined to the tumourbed was observed in up to 25% of all patients after 2 years. The low level of clinically observed late reactions so far is in agreement with predictions from radiobiological modelling. No significant financial relationships to disclose.