5-Year Results of a Prospective Phase 2 Trial Evaluating 3-Week Hypofractionated Whole Breast Radiation Therapy Inclusive of a Sequential Boost.
Adult
Aged
Aged, 80 and over
Breast Neoplasms
/ drug therapy
Carcinoma, Intraductal, Noninfiltrating
/ drug therapy
Chemotherapy, Adjuvant
Confidence Intervals
Female
Humans
Linear Models
Lymphatic Irradiation
Middle Aged
Patient Reported Outcome Measures
Prospective Studies
Radiation Dose Hypofractionation
Radiodermatitis
/ etiology
Radiotherapy Planning, Computer-Assisted
Radiotherapy, Conformal
/ adverse effects
Re-Irradiation
Time Factors
Treatment Outcome
Triple Negative Breast Neoplasms
/ drug therapy
Journal
International journal of radiation oncology, biology, physics
ISSN: 1879-355X
Titre abrégé: Int J Radiat Oncol Biol Phys
Pays: United States
ID NLM: 7603616
Informations de publication
Date de publication:
01 10 2019
01 10 2019
Historique:
received:
27
02
2019
revised:
16
05
2019
accepted:
25
05
2019
pubmed:
9
6
2019
medline:
28
1
2020
entrez:
9
6
2019
Statut:
ppublish
Résumé
To report 5-year outcomes of a phase 2 trial of hypofractionated whole breast irradiation (HF-WBI) completed in 3 weeks, inclusive of a sequential boost. Women with stage 0-IIIA breast cancer (ductal carcinoma in situ through T2N2a) were enrolled on a prospective, phase 2 trial of accelerated HF-WBI. We delivered a whole breast dose of 36.63 Gy in 11 fractions of 3.33 Gy, with an equivalent dose to the regional nodes when indicated, followed by a tumor bed boost of 13.32 Gy in 4 fractions of 3.33 Gy over a total of 15 treatment days. The primary endpoint was locoregional control; secondary endpoints included acute/late toxicity and physician-assessed and patient-reported breast cosmesis. Between 2009 and 2017, we enrolled 150 patients, of whom 146 received the protocol treatment. Median age was 54 years (range, 33-82) and median follow-up was 62 months. Patients with higher-risk disease comprised 59% of the cohort, including features such as young age (33% ≤50 years), positive nodes (13%), triple-negative disease (11%), and treatment with regional nodal irradiation (11%) and/or neoadjuvant/adjuvant chemotherapy (36%). Five-year estimated locoregional and distant control were 97.7% (95% confidence interval [CI], 93.0%-99.3%) and 97.9% (95% CI, 93.6%-99.3%), respectively. Five-year breast cancer-specific and overall survival were 99.2% (95% CI, 94.6%-99.9%) and 97.3% (95% CI, 91.9%-99.1%), respectively. Acute/late grade 2 and 3 toxicities were observed in 30%/10% and 1%/3% of patients, respectively. There were no grade 4 or 5 toxicities. Physicians assessed breast cosmesis as good or excellent in 95% of patients; 85% of patients self-reported slight to no difference between the treated and untreated breast. Our phase 2 trial offers one of the shortest courses of HF-WBI; at 5 years of follow-up there continues to be excellent locoregional control and low toxicity with favorable cosmetic outcomes in a heterogeneous cohort of patients.
Identifiants
pubmed: 31175905
pii: S0360-3016(19)30817-X
doi: 10.1016/j.ijrobp.2019.05.063
pmc: PMC9710864
mid: NIHMS1851712
pii:
doi:
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
267-274Subventions
Organisme : NCI NIH HHS
ID : P30 CA072720
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.
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