Abstract

563 Background: TARGIT E is a prospective, multicentric single-arm phase II trial (NCT01299987; Neumaier et al. BMC Cancer 2012) that is based on the experimental arm of the protocol of the international randomized TARGIT A study. The trial was designed to investigate the efficiency of a risk-adapted approach consisting of a single dose of intraoperative radiotherapy (IORT) followed by whole breast radiotherapy (WBRT) only when risk factors are present in elderly patients. Methods: Patients with low-risk breast cancer (≥70 years, cT1, cN0, cM0, invasive carcinoma of no special type) were enrolled between February 2011 and September 2014. During breast conserving surgery, a single dose of 20 Gy of low-energy IORT was given (Intrabeam, Carl Zeiss Meditec, Germany). Additional postoperative WBRT (46 – 50 Gy) was applied in case risk factors (larger size, other histology, free margin < 1 cm, lymphatic vessel invasion (L1), positive nodes, multifocality/multicentricity, extensive intraductal component (EIC)) were present. Systemic therapy was applied according to international standards and guidelines. The primary outcome was the local relapse rate. Discontinuation of the trial was judged to be necessary if the local relapse rates exceed 3/4/6% at 2.5/5/7.5 years. Results: A total of 541 patients were screened. Of those 474 patients were enrolled, whereas 347 (73.1%) received IORT only, 99 (10.8%) IORT plus WBRT, 22 (4.6 %) WBRT only and 7 (1.5%) surgery only with no subsequent adjuvant therapies. After a median follow-up of 3.25 years, four ipsilateral in-breast recurrences were observed (after 11, 33, 42 and 43 months) resulting in an actuarial local relapse-free survival of 99.8% after 2.5 years and 98.5% after 5 years. Conclusions: The results of the prospective TARGIT E trial consolidate earlier reports from the randomized TARGIT A trial, supporting the use of accelerated partial breast radiotherapy (APBI) in selected patients. The observed local relapse rates at 2.5 and 5 years are far below the predefined stopping rules. Clinical trial information: NCT01299987.

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