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Randomized Controlled Trial
. 2025 Jan 1;117(1):103-111.
doi: 10.1093/jnci/djae219.

Quality-of-life outcomes from NRG Oncology NSABP B-39/RTOG 0413: whole-breast irradiation vs accelerated partial-breast irradiation after breast-conserving surgery

Patricia A Ganz  1 , Reena S Cecchini  2 , Julia R White  3 , Frank A Vicini  4 , Douglas W Arthur  5 , Rachel A Rabinovitch  6 , Robert R Kuske  7 , Thomas B Julian  8 , David S Parda  9 , Michael F Scheier  10 , Kathryn A Winter  11 , Soonmyung Paik  12 , Henry M Kuerer  13 , Laura A Vallow  14 , Lori J Pierce  15 , Eleftherios P Mamounas  16 , Beryl McCormick  17 , Harry D Bear  18 , Isabelle Germain  19 , Gregory S Gustafson  20 , Linda Grossheim  21 , Ivy A Petersen  22 , Richard S Hudes  23 , Walter J Curran Jr  24 , Norman Wolmark  25
Affiliations
Randomized Controlled Trial

Quality-of-life outcomes from NRG Oncology NSABP B-39/RTOG 0413: whole-breast irradiation vs accelerated partial-breast irradiation after breast-conserving surgery

Patricia A Ganz et al. J Natl Cancer Inst. .

Abstract

Background: NRG Oncology NSABP B-39/RTOG 0413 compared whole-breast irradiation (WBI) to accelerated partial-breast irradiation (APBI). APBI was not equivalent to WBI in local tumor control. Secondary outcome was quality of life (QOL).

Methods: The QOL sub-study used validated self-report questionnaires, including the Breast Cancer Treatment Outcome Scale (BCTOS) and the 36-Item Short Form Health Survey (SF-36) vitality scale. Assessments occurred before random assignment, at treatment completion (chemotherapy or radiotherapy), 4 weeks later, at 6, 12, 24, and 36 months. Primary aims: cosmesis change equivalency (baseline to 3 years; a priori margin of equivalence 0.4 standard deviations) and fatigue change superiority (baseline to end of treatment [EOT]) for APBI vs WBI, by patient groups treated with or without chemotherapy when appropriate.

Results: From March 21, 2005 to May 25, 2009, 975 patients enrolled in this sub-study; 950 had follow-up data. APBI had 3-year cosmesis equivalent to WBI (95% CI = -0.0001 to -0.16; equivalence margin -0.22 to -0.22) in all patients. The APBI group without chemotherapy had less EOT fatigue (P = .011; mean score APBI 63 vs WBI 59); the APBI group receiving chemotherapy had worse EOT fatigue (P = .011; APBI 43 vs WBI 49). The APBI group reported less pain (BCTOS) at EOT (WBI 2.29 vs APBI 1.97) but worse pain at 3 years (WBI 1.62 vs APBI 1.71). APBI patients reported greater convenience of care than with WBI and reported less symptom severity at EOT and 4 weeks later.

Conclusion: Cosmetic outcomes were similar for the APBI and WBI groups, with small statistically significant differences in other outcomes that varied over time. Differences in fatigue and other symptoms appeared to resolve by ≥6 months. APBI may be preferred by some patients, for whom extended treatment is burdensome.

Clinicaltrials.gov: NCT00103181.

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Conflict of interest statement

All authors report NCI grants: U10CA180868, U10CA180822, and UG1CA189867, paid to institution.

Patricia A. Ganz, MD—Reports: Royalty for UpToDate Section Editor; and consulting fees for Genentech Roche (for QOL in a clinical trial) and InformedDNA (Scientific Advisory Board).

Rachel A. Rabinovitch, MD—Reports: Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events, unrelated to the content of this article, from Miami Breast Cancer Conference 2023 as an invited speaker and Northwell Health Cancer Institute 2022 as a Grand Rounds Invited Speaker; support for attending meetings and/or travel, unrelated to the content of this article, from Miami Breast Cancer Conference 2023 as an invited speaker, Northwell Health Cancer Institute 2022 as a Grand Rounds Invited Speaker, and NRG Oncology, twice annually, as the Vice-Chair of the Membership Committee; and no stocks/stock options related to this article.

David S. Parda, MD—Reports: Operations support from NRG for study management and oversight duties.

Michael F. Scheier, PhD—Reports: Being a paid consultant for NSABP, royalties or licenses for Pearson Publishing (for Personality Textbook) and Cambridge University Press (for book written); Honorarium (for speaking at retirement of friend); and stock or options with Apple and General Electric.

Henry M. Kuerer, MD, PhD—Reports: Funding support from American College of Surgeons Oncology Group and Alliance for Clinical Trials in Oncology; support for attending meetings and/or travel: Alliance for Clinical Trials in Oncology; leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid: Chair Publications Committee, American Society of Breast Surgeons, and paid editor, NEJM Group, Inc.

Eleftherios P. Mamounas, MD—Reports: Consulting fees from Genentech, Merck, Exact Sciences, Biotheranostics, Delphi Diagnostics, Novartis, Tersera, and Sanofi-Genzyme; payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Genentech, Merck, and Exact Sciences; support for attending a meeting or travel from Alapharma; and stock or stock options with Moderna.

Harry D. Bear, MD—Reports: Stock with AbbVie and Pfizer, and Viatris, unrelated to this work.

Ivy A. Petersen, MD—Reports: Support for attending meetings and/or travel from NRG Oncology: payments to me as co-chair of the Radiation Oncology Committee.

Walter J. Curran, Jr, MD: Reports: Participation in a Data Monitoring Committee with Bristol Meyers Squibb and Astra Zeneca; stock/stock options with Arterra, Lumonus, and GenesisCare.

Norman Wolmark, MD: Reports: the Breast Cancer Research Foundation (BCRF); the Susan G. Komen Award for Scientific Distinction in Clinical Research; and the American Surgical Association Medallion for Advancement of Surgical Care.

All other authors declare no other potential conflicts of interest.

Figures

Figure 1.
Figure 1.
CONSORT diagram for the NSABP B-39/RTOG 0413 Quality-of-life Sub-study. APBI = accelerated partial-breast irradiation; QOL = quality of life; Tx = treatment; WBI = whole-breast irradiation.
Figure 2.
Figure 2.
Mean symptom scores over time for A) the total score, B) the Radiotherapy-related Breast Skin Changes Subscale Score, and C) the Localized Pain and Breast Symptoms Subscale Score: NSABP B-39/RTOG 0413 Quality-of-life Sub-study. Total symptom scores were calculated as the sum of the 27 symptom-related items (range 0-108). Symptom subscale scores were calculated as the sum of the 5 items related to breast skin changes (range 0-20) and as the sum of the 8 items related to localized pain and breast symptoms (range 0-32). Item responses range from 0 = “not bothered at all” to 4 = “bothered very much.” Thus, a higher score indicates a greater symptom burden. Adjusted least-square means and 95% CI for all time points after baseline were obtained from a mixed model for repeated measures analysis of all post-baseline total or subscale scores. The model included axillary dissection, age group, chemotherapy group, baseline score, treatment, time, and treatment-by-time interaction. The mean at baseline is a raw value. APBI = accelerated partial-breast irradiation; SCL = treatment-related symptom checklist; WBI = whole-breast irradiation.
Figure 3.
Figure 3.
Mean Breast Cancer Treatment Outcomes Scale (BCTOS) Cosmesis Subscale Score over time among A) non-chemotherapy group, B) chemotherapy group, and C) all patients combined regardless of chemotherapy status: NSABP B-39/RTOG 0413 Quality-of-life Sub-study. Scores were calculated as the mean of the items included in the Cosmesis Subscale as suggested by Stanton. Possible scores range from 1 = no difference between the treated and untreated breast to 4 = a large difference between the treated and untreated breast. Thus, a higher score indicates worse cosmesis. Adjusted least-square means and 95% CI for all time points after baseline were obtained from a mixed model for repeated measures analysis of all post-baseline cosmesis scores. The model included axillary dissection, age group, chemotherapy group (Panel C), baseline score, treatment, time, and treatment-by-time interaction. The mean at baseline is a raw value. APBI = accelerated partial-breast irradiation; WBI = whole-breast irradiation.
Figure 4.
Figure 4.
Mean SF-36 vitality score over time among A) non-chemotherapy group, and B) chemotherapy group: NSABP B-39/RTOG 0413 Quality-of-life Sub-study. Scores were calculated as the sum of the 4 vitality items (range 4-20), and then transformed to a 0-100 scale. A higher vitality score indicates more vitality or less fatigue. Adjusted least-square means and 95% CI for all time points after baseline were obtained from a mixed model for repeated measures analysis of all post-baseline vitality scores. The model included axillary dissection, age group, baseline score, treatment, time, and treatment-by-time interaction. The mean at baseline is a raw value. APBI = accelerated partial-breast irradiation; WBI = whole-breast irradiation.
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