PMID- 28721885 OWN - NLM STAT- MEDLINE DCOM- 20170814 LR - 20220410 IS - 1879-355X (Electronic) IS - 0360-3016 (Print) IS - 0360-3016 (Linking) VI - 98 IP - 5 DP - 2017 Aug 1 TI - NRG Oncology-Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence. PG - 1028-1035 LID - S0360-3016(17)30702-2 [pii] LID - 10.1016/j.ijrobp.2017.03.016 [doi] AB - PURPOSE: To determine the associated toxicity, tolerance, and safety of partial-breast reirradiation. METHODS AND MATERIALS: Eligibility criteria included in-breast recurrence occurring >1 year after whole-breast irradiation, <3 cm, unifocal, and resected with negative margins. Partial-breast reirradiation was targeted to the surgical cavity plus 1.5 cm; a prescription dose of 45 Gy in 1.5 Gy twice daily for 30 treatments was used. The primary objective was to evaluate the rate of grade >/=3 treatment-related skin, fibrosis, and/or breast pain adverse events (AEs), occurring /=13% for these AEs in a cohort of 55 patients was determined to be unacceptable (86% power, 1-sided alpha = 0.07). RESULTS: Between 2010 and 2013, 65 patients were accrued, and the first 55 eligible and with 1 year follow-up were analyzed. Median age was 68 years. Twenty-two patients had ductal carcinoma in situ, and 33 had invasive disease: 19 1 to 2 cm. All patients were clinically node negative. Systemic therapy was delivered in 51%. All treatment plans underwent quality review for contouring accuracy and dosimetric compliance. All treatment plans scored acceptable for tumor volume contouring and tumor volume dose-volume analysis. Only 4 (7%) scored unacceptable for organs at risk contouring and organs at risk dose-volume analysis. Treatment-related skin, fibrosis, and/or breast pain AEs were recorded as grade 1 in 64% and grade 2 in 7%, with only 1 (<2%) grade >/=3 and identified as grade 3 fibrosis of deep connective tissue. CONCLUSION: Partial-breast reirradiation with 3-dimensional conformal radiation therapy after second lumpectomy for patients experiencing in-breast failures after whole-breast irradiation is safe and feasible, with acceptable treatment quality achieved. Skin, fibrosis, and breast pain toxicity was acceptable, and grade 3 toxicity was rare. CI - Copyright (c) 2017 Elsevier Inc. All rights reserved. FAU - Arthur, Douglas W AU - Arthur DW AD - Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia. Electronic address: douglas.arthur@vcuhealth.org. FAU - Winter, Kathryn A AU - Winter KA AD - NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania. FAU - Kuerer, Henry M AU - Kuerer HM AD - Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Haffty, Bruce G AU - Haffty BG AD - Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey. FAU - Cuttino, Laurie W AU - Cuttino LW AD - Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia. FAU - Todor, Dorin A AU - Todor DA AD - Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia. FAU - Simone, Nicole L AU - Simone NL AD - Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. FAU - Hayes, Shelly B AU - Hayes SB AD - Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. FAU - Woodward, Wendy A AU - Woodward WA AD - Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - McCormick, Beryl AU - McCormick B AD - Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. FAU - Cohen, Randi J AU - Cohen RJ AD - Department of Radiation Oncology, University of Maryland Medical System, Baltimore, Maryland. FAU - Sahijdak, Walter M AU - Sahijdak WM AD - Department of Radiation Oncology, Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan. FAU - Canaday, Daniel J AU - Canaday DJ AD - Cape Cod Hospital, Hyannis, Massachusetts. FAU - Brown, Doris R AU - Brown DR AD - Department of Radiation Oncology, Wake Forest Baptist Health, Winston-Salem, North Carolina. FAU - Currey, Adam D AU - Currey AD AD - Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin. FAU - Fisher, Christine M AU - Fisher CM AD - Department of Radiation Oncology, University of Colorado Denver, Denver, Colorado. FAU - Jagsi, Reshma AU - Jagsi R AD - Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, Michigan. FAU - White, Julia AU - White J AD - Department of Radiation Oncology, Ohio State University, Columbus, Ohio. LA - eng GR - U10 CA180868/CA/NCI NIH HHS/United States GR - UG1 CA189867/CA/NCI NIH HHS/United States GR - U10 CA180834/CA/NCI NIH HHS/United States GR - U10 CA180801/CA/NCI NIH HHS/United States GR - U10 CA037422/CA/NCI NIH HHS/United States GR - U10 CA021661/CA/NCI NIH HHS/United States GR - U10 CA180822/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, N.I.H., Extramural DEP - 20170318 PL - United States TA - Int J Radiat Oncol Biol Phys JT - International journal of radiation oncology, biology, physics JID - 7603616 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Breast/*radiation effects MH - Breast Neoplasms/pathology/*radiotherapy/surgery MH - Carcinoma, Intraductal, Noninfiltrating/pathology/*radiotherapy/surgery MH - Female MH - Fibrosis/pathology MH - Humans MH - *Mastectomy, Segmental MH - Middle Aged MH - Neoplasm Recurrence, Local/pathology/*radiotherapy/surgery MH - Organs at Risk/diagnostic imaging/radiation effects MH - Prospective Studies MH - Radiation Injuries/*pathology MH - Radiation Oncology MH - Radiotherapy, Conformal/*adverse effects/methods MH - Re-Irradiation/*adverse effects MH - Reoperation MH - Skin/pathology/radiation effects PMC - PMC5572128 MID - NIHMS883585 COIS- Conflicts of interest: Dr. Jagsi reports fees from Eviti for serving on a Medical Advisory Board, grants from NIH (R01 and P01), American Cancer Society, National Comprehensive Cancer Network Foundation, Translational Breast Cancer Research Consortium, drug support from Abbvie Pharmaceuticals, outside the submitted work. EDAT- 2017/07/20 06:00 MHDA- 2017/08/15 06:00 PMCR- 2018/08/01 CRDT- 2017/07/20 06:00 PHST- 2016/10/03 00:00 [received] PHST- 2017/03/01 00:00 [revised] PHST- 2017/03/10 00:00 [accepted] PHST- 2017/07/20 06:00 [entrez] PHST- 2017/07/20 06:00 [pubmed] PHST- 2017/08/15 06:00 [medline] PHST- 2018/08/01 00:00 [pmc-release] AID - S0360-3016(17)30702-2 [pii] AID - 10.1016/j.ijrobp.2017.03.016 [doi] PST - ppublish SO - Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):1028-1035. doi: 10.1016/j.ijrobp.2017.03.016. Epub 2017 Mar 18.