[Accelerated partial breast irradiation with image-guided intensity-modulated radiotherapy following breast-conserving surgery - preliminary results of a phase II clinical study]. / Gyorsított, részleges külsõ emlõbesugárzás képvezérelt, intenzitásmodulált radioterápiával emlõmegtartó mûtét után - Fázis II klinikai vizsgálat elõzetes eredményei.

The purpose of the study was to implement accelerated partial breast irradiation (APBI) by means of image-guided intensity-modulated radiotherapy (IG-IMRT) following breast-conserving surgery (BCS) for low-risk early invasive breast cancer. Between July 2011 and March 2014, 60 patients with low-risk early invasive (St I-II) breast cancer who underwent BCS were enrolled in our phase II prospective study. Postoperative APBI was given by means of step and shoot IG-IMRT using 4 to 5 fields to a total dose of 36.9 Gy (9×4.1 Gy) using a twice-a-day fractionation. Before each fraction, series of CT images were taken from the region of the target volume using a kV CT on-rail mounted in the treatment room. An image fusion software was used for automatic image registration of the planning and verification CT images. Patient set-up errors were detected in three directions (LAT, LONG, VERT), and inaccuracies were adjusted by automatic movements of the treatment table. Breast cancer related events, acute and late toxicities, and cosmetic results were registered and analysed. At a median follow-up of 24 months (range 12-44) neither locoregional nor distant failure was observed. Grade 1 (G1), G2 erythema, G1 oedema, and G1 and G2 pain occurred in 21 (35%), 2 (3.3%), 23 (38.3%), 6 (10%) and 2 (3.3%) patients, respectively. No G3-4 acute side effects were detected. Among late radiation side effects G1 pigmentation, G1 fibrosis, and G1 fat necrosis occurred in 5 (8.3%), 7 (11.7%), and 2 (3.3%) patients, respectively. No ≥G2 late toxicity was detected. Excellent and good cosmetic outcome was detected in 45 (75%) and 15 (25%) patients. IG-IMRT is a reproducible and feasible technique for the delivery of APBI following conservative surgery for the treatment of low-risk, early-stage invasive breast carcinoma. Preliminary results are promising, early radiation side effects are minimal, and cosmetic results are excellent.