caa a22 4500 445336080 CHVBK 20180317142755.0 cr unu---uuuuu 170323e20110401xx s 000 0 eng 10.1245/s10434-010-1392-6 doi (NATIONALLICENCE)springer-10.1245/s10434-010-1392-6 Local Control Following Single-Dose Intraoperative Radiotherapy Prior to Surgical Excision of Early-Stage Breast Cancer [Elektronische Daten] [Randall Kimple, Nancy Klauber-DeMore, Cherie Kuzmiak, Dag Pavic, Jun Lian, Chad Livasy, WingKeung Chiu, Dominic Moore, Carolyn Sartor, David Ollila] Background: Multiple partial breast radiotherapy techniques are available. We have previously presented the technical details of our procedure of delivering partial breast irradiation with a single fraction of intraoperative radiotherapy (IORT) targeting the tumor in situ prior to partial mastectomy. This study details our completed, single-institution trial. Materials and Methods: An IRB-approved, DSMB-monitored phase II trial was performed with the following inclusion criteria: women age ≥48, ultrasound-visible invasive ductal cancers <3cm, clinically negative axillary nodes. IORT was delivered using mobile electron irradiator, at least a 1.5-cm radial and 1-cm deep margin; patients received 15Gy and immediately underwent partial mastectomy. Ipsilateral breast recurrence was classified as true/marginal, elsewhere in the breast or nodal basin. Kaplan-Meier methods were used to estimate survival functions and exact 95% confidence intervals are reported. Results: Between 2003 and 2007, 71 women underwent IORT (median follow-up: 3.5years). For patients with tumor-involved or close margins, additional therapy was required: 7 patients, total mastectomy; 11, whole breast radiation. Four women experienced invasive ipsilateral breast failures (1 new primary, 3 margin recurrences) for a 3-year local control rate of 49 of 53 (94.8%; 95% confidence interval 92.4% [95% CI] 84.2-98.3%), actuarial three-year in breast recurrence was 8% (95% CI 2-18%), and breast cancer-specific survival was 100%. Conclusions: Intraoperative radiotherapy delivered to an in situ tumor is feasible, but our local control rate at 3.5years is concerning. Possible changes to this technique to improve local control rates include better preoperative imaging (MRI), routine intraoperative ultrasound, and improved IORT delivery (larger cone, increased dose). Society of Surgical Oncology, 2010 Kimple Randall Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Klauber-DeMore Nancy Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Kuzmiak Cherie Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Pavic Dag Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Lian Jun Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Livasy Chad Department of Pathology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Chiu WingKeung Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Moore Dominic Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Sartor Carolyn Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Ollila David Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut Annals of Surgical Oncology Springer-Verlag 18/4(2011-04-01), 939-945 1068-9265 18:4<939 2011 18 10434 https://doi.org/10.1245/s10434-010-1392-6 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1245/s10434-010-1392-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kimple Randall Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Klauber-DeMore Nancy Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Kuzmiak Cherie Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Pavic Dag Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Lian Jun Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Livasy Chad Department of Pathology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Chiu WingKeung Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Moore Dominic Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Sartor Carolyn Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 700 1- Ollila David Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA aut NATIONALLICENCE 773 0- Annals of Surgical Oncology Springer-Verlag 18/4(2011-04-01), 939-945 1068-9265 18:4<939 2011 18 10434 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer