SS 12 - Breast 1 - Toxicity
84 - 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.
Monday, October 22
10:55 AM - 11:05 AM
Location: Room 214 C/D
Douglas Arthur, MD, FASTRO
Virginia Commonwealth University
Virginia Commonwealth University: Professor and Chairman: Employee
Advanced Radiation Therapy, inc: Advisory Board
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.
D. W. Arthur1, J. Moughan2, H. M. Kuerer3, B. G. Haffty Jr4, L. W. Cuttino1, W. A. Woodward5, D. A. Todor6, N. L. Simone7, P. R. Anderson8, E. A. Strom9, B. McCormick10, R. J. Cohen11, W. M. Sahijdak12, U. Matunlonis13, D. R. Brown14, A. D. Currey15, C. M. Fisher16, R. Jagsi17, K. Winter18, and J. R. White19; 1Virginia Commonwealth University Health System, Richmond, VA, 2NRG, Philadelphia, PA, 3University of Texas-MD Anderson Cancer Center, Houston, TX, 4Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, 5The University of Texas MD Anderson Cancer Center, Department of Radiation Oncology, Houston, TX, 6Virginia Commonwealth University, Richmond, VA, 7Sidney Kimmel Medical College at Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, PA, 8Fox Chase Cancer Center, Philadelphia, PA, 9MD Anderson Cancer Center, Houston, TX, 10Memorial Sloan Kettering Cancer Center, New York, NY, 11University of Maryland School of Medicine, Baltimore, MD, 12Michigan Cancer Research Consortium CCOP, Ann Arbor, MI, 13Dana Farber/Partners CanerCare LAPS, Boston, MA, 14Wake Forest Baptist Health accruals for Arizona Oncology Services Foundation, Winston-Salem, NC, 15Medical College of Wisconsin, Milwaukee, WI, 16Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, CO, 17University of Michigan, Ann Arbor, MI, 18NRG Oncology Statistics and Data Management Center-ACR, Philadelphia, PA, 19The Ohio State University Wexner Medical Center, Department of Radiation Oncology, Columbus, OH
Purpose/Objective(s): 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.
Materials/Methods: 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.
Results: 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.
|BCTOS Mean + SD ||Functional ||Cosmetic ||Breast-Specific Pain |
|Baseline (n=46) ||1.27 ± 0.42 ||1.95 ± 0.55 ||1.92 ± 0.54 |
|12-month (n=36) ||1.28 ± 0.43 ||2.05 ± 0.66 ||1.70 ± 0.64 |
|36-month (n=32) ||1.29 ± 0.47 ||2.12 ± 0.71 ||1.76 ± 0.83 |
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.
Conclusion: 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.
Author Disclosure: D.W. Arthur: Advisory Board; Advanced Radiation Therapy, inc. J. Moughan: None. H. Kuerer: Independent Contractor; McGraw-Hill Professional, Lightpoint Medical, Inc. Research Grant; Genomic Health, Inc. Speaker's Bureau; Physicain Education Resource. Asscoiate Editor; NEJM. Member; NRG Oncology, American Society of Breast Surgeons. B.G. Haffty: Research Grant; Breast Cancer Research Foundation. Board of Directors-Science Liaison; RSNA. L.W. Cuttino: None. W.A. Woodward: None. N.L. Simone: Radiation Oncology Leader; Thomas Jefferson University. B. McCormick: Stock; Varian. A.D. Currey: Honoraria; Wisconsin Oncology Network. C.M. Fisher: None. R. Jagsi: Research Grant; American Cancer Society, NCCN, Breast Cancer Research Foundation, Abbott and Abbvie Pharmaceuticals. Advisory Board; Eviti. Research Committee Chair; Radiation Oncology Institute. Board of Directors; ASCO. K. Winter: None. J.R. White: Honoraria; Qfix. reserach funding; Intra op. Co-chair, Breast Cancer Committee; NRG. Member; NCI Breast Cancer Steering Group.