NRG Oncology/RTOG 1014: Patient Reported Outcomes (PRO) and Cosmesis From a Phase II Study of Repeat Breast Preserving Surgery and 3D Conformal (3D-CRT) Partial Breast Re-Irradiation (PBrI) for In-Breast Recurrence.

Abstract

NRG/RTOG 1014 is a prospective phase II trial of 3D-CRT PBrI following repeat lumpectomy for in-breast recurrence following previous whole breast irradiation (WBI). This analysis focuses on patient reported and cosmetic outcomes. Eligible patients (pts) had in-breast recurrences presenting >1 year following WBI for initial lesion, were confirmed to be <3cm, unifocal and resected with negative margins. Prescription dose of 45 Gy was delivered as 1.5Gy BID for 30 treatments with 3D-CRT. PRO were collected using the Breast Cancer Treatment Outcome Scale (BCTOS) where change compared to the contralateral breast is graded as 1 = none, 2 = slight, 3 = moderate and 4 = large and analyzed in three domains: functional (e.g. shoulder or arm movement, stiffness, pain) , cosmetic (e.g. breast size, texture, shape, scar tissue ) and breast-specific pain (e.g. breast pain, tenderness, sensitivity). MD assessment was done using a four point NRG/RTOG established criteria scale. The BCTOS and MD Cosmetic Score were completed at baseline (prior to the start of PBrI, but after surgery), 12 months (mo), and 36 mo intervals. Of the 58 pts eligible and treated, 46 (79%) consented to the Quality of Life component. BCTOS mean + standard deviation (SD) at baseline, 12 and 36 mo in the table demonstrate that functional status was unchanged over the observation period, breast-specific pain improved and cosmesis worsened slightly at 12 mo and 36 mo.Abstract 84; TableBCTOS Mean + SDFunctionalCosmeticBreast-Specific PainBaseline (n=46)1.27 ± 0.421.95 ± 0.551.92 ± 0.5412-month (n=36)1.28 ± 0.432.05 ± 0.661.70 ± 0.6436-month (n=32)1.29 ± 0.472.12 ± 0.711.76 ± 0.83 Open table in a new tab MD-assessed fibrosis, volume loss, retraction and/or pigment change was scored as effecting cosmesis at baseline (n=44) in 9%, 41%, 28%, 7%, respectively; worsening to 21%, 49%, 36%, 8% at 12 mo (n=39); and, 43%, 57%, 53%, 7% at 36 mo (n=30), respectively. MD assessed cosmesis was excellent/good in 59%, 63% and 52% respectively and Fair/Poor 41%, 37% and 48% respectively at baseline (n=44), 12 mo (n=35) and 36 mo (n=27). When evaluating individual pts with all time points available, improvements and deteriorations in MD scoring were seen. BCTOS cosmetic status mean score correlated to the MD- assessed four point score at the 12 mo interval: BCTOS mean score of 1.67 ± 0.57, 1.88 ± 0.44, 2.19 ± 0.69, and 2.48 ± 1.21 corresponding to the MD assessment of excellent, good, fair, and poor, respectively. Based on PRO, repeat lumpectomy with PBrI had no impact on functional status, breast-specific pain improved over time, and there was a small worsening of cosmesis. MD assessment of cosmesis correlated with this trend. Fibrosis, volume loss, retraction, pigment change were the MD identified factors most commonly affecting cosmesis at 12 and 36 months.