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Arthur DW , Winter KA , Kuerer HM , Haffty BG , Cuttino LW , Todor DA , Simone NL , Hayes SB , Woodward WA , McCormick B , Cohen RJ , Sahijdak WM , Canaday DJ , Brown DR , Currey AD , Fisher CM , Jagsi R , White J
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
Int J Radiat Oncol Biol Phys. 2017 Aug 01;98(5) :1028-1035
PMID: 28721885    PMCID: PMC5572128    URL: https://www.ncbi.nlm.nih.gov/pubmed/28721885
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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 </=1 year from re-treatment completion. A rate of >/=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 cm, 13 >1 to </=2 cm, and 1 >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.
1879-355x Arthur, Douglas W Winter, Kathryn A Kuerer, Henry M Haffty, Bruce G Cuttino, Laurie W Todor, Dorin A Simone, Nicole L Hayes, Shelly B Woodward, Wendy A McCormick, Beryl Cohen, Randi J Sahijdak, Walter M Canaday, Daniel J Brown, Doris R Currey, Adam D Fisher, Christine M Jagsi, Reshma White, Julia Journal Article United States 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.