NRG Oncology RTOG 1014: 1 Year Toxicity Report From a Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (3D-CRT PBrI) for In-Breast Recurrence

Publication date: Available online 18 March 2017
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Douglas W. Arthur, Kathryn A. Winter, Henry M. Kuerer, Bruce G. Haffty, Laurie W. Cuttino, Dorin A. Todor, Nicole L. Simone, Shelly B. Hayes, Wendy A. Woodward, Beryl McCormick, Randi J. Cohen, Walter M. Sahijdak, Daniel J. Canaday, Doris R. Brown, Adam D. Currey, Christine M. Fisher, Reshma Jagsi, Julia White
PurposeTrial**** is a prospective phase II trial of 3D-CRT PBrI following repeat lumpectomy for in-breast recurrence following previous whole breast irradiation (WBI). The primary goal of the trial was to determine the associated toxicity, tolerance and safety of PBrI.Materials and MethodsEligibility criteria included in-breast recurrence occurring >1 year following WBI, <3cm, unifocal and resected with negative margins. PBrI was targeted to surgical cavity + 1.5 cm; prescription dose of 45 Gy in 1.5Gy BID 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 α=0.07.ResultsBetween 2010 and 2013, 65 patients were accrued and the first 55 eligible and with 1 year follow-up were analyzed. Median age is 68 years. 22 patients had DCIS and 33 invasive disease; 19 ≤1cm, 13 >1 to ≤2cm and 1 >2cm. 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 (TV) contouring and TV dose volume analysis (DVA). Only 4 (7%) scored unacceptable for organs at risk (OAR) contouring and OAR DVA. Treatment-related skin, fibrosis, and/or breast pain AEs were recorded as grade 1 in 64%, grade 2 in 7% with only 1 (<2%) grade ≥3 and identified as grade 3 fibrosis of deep connective tissue.ConclusionPBrI with 3D-CRT following second lumpectomy for patients experiencing in-breast failures after WBI is safe and feasible with acceptable treatment quality achieved. Skin, fibrosis and breast pain toxicity was acceptable and grade 3 toxicity was rare.

Teaser

Trial**** is a phase II trial investigating partial breast re-irradiation (PBrI) with 3D-CRT following second lumpectomy for patients experiencing in-breast failures after whole breast irradiation (WBI). At the 1 year follow up interval, PBrI delivered with 3D-CRT technique is found to be well tolerated, safe and feasible with acceptable treatment quality achieved.


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