Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Oct 1;38(28):3261-3272.
doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.

Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer

Adrian Murray Brunt  1 , Joanne S Haviland  2 , Mark Sydenham  2 , Rajiv K Agrawal  3 , Hafiz Algurafi  4 , Abdulla Alhasso  5 , Peter Barrett-Lee  6 , Peter Bliss  7 , David Bloomfield  8 , Joanna Bowen  9 , Ellen Donovan  10 , Andy Goodman  11 , Adrian Harnett  12 , Martin Hogg  13 , Sri Kumar  14 , Helen Passant  6 , Mary Quigley  15 , Liz Sherwin  16 , Alan Stewart  17 , Isabel Syndikus  18 , Jean Tremlett  8 , Yat Tsang  19 , Karen Venables  19 , Duncan Wheatley  20 , Judith M Bliss  2 , John R Yarnold  21
Affiliations
Clinical Trial

Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer

Adrian Murray Brunt et al. J Clin Oncol. .

Abstract

Purpose: Previous studies of hypofractionated adjuvant whole-breast radiotherapy for early breast cancer established a 15- or 16-fraction (fr) regimen as standard. The FAST Trial (CRUKE/04/015) evaluated normal tissue effects (NTE) and disease outcomes after 5-fr regimens. Ten-year results are presented.

Methods: Women ≥ 50 years of age with low-risk invasive breast carcinoma (pT1-2 pN0) were randomly assigned to 50 Gy/25 fr (5 weeks) or 30 or 28.5 Gy in 5 once-weekly fr of 6.0 or 5.7 Gy. The primary end point was change in photographic breast appearance at 2 and 5 years; secondary end points were physician assessments of NTE and local tumor control. Odds ratios (ORs) from longitudinal analyses compared regimens.

Results: A total of 915 women were recruited from 18 UK centers (2004-2007). Five-year photographs were available for 615/862 (71%) eligible patients. ORs for change in photographic breast appearance were 1.64 (95% CI, 1.08 to 2.49; P = .019) for 30 Gy and 1.10 (95% CI, 0.70 to 1.71; P = .686) for 28.5 Gy versus 50 Gy. α/β estimate for photographic end point was 2.7 Gy (95% CI, 1.5 to 3.9 Gy), giving a 5-fr schedule of 28 Gy (95% CI, 26 to 30 Gy) estimated to be isoeffective with 50 Gy/25 fr. ORs for any moderate/marked physician-assessed breast NTE (shrinkage, induration, telangiectasia, edema) were 2.12 (95% CI, 1.55 to 2.89; P < .001) for 30 Gy and 1.22 (95% CI, 0.87 to 1.72; P = .248) for 28.5 Gy versus 50 Gy. With 9.9 years median follow-up, 11 ipsilateral breast cancer events (50 Gy: 3; 30 Gy: 4; 28.5 Gy: 4) and 96 deaths (50 Gy: 30; 30 Gy: 33; 28.5 Gy: 33) have occurred.

Conclusion: At 10 years, there was no significant difference in NTE rates after 28.5 Gy/5 fr compared with 50 Gy/25 fr, but NTE were higher after 30 Gy/5 fr. Results confirm the published 3-year findings that a once-weekly 5-fr schedule of whole-breast radiotherapy can be identified that appears to be radiobiologically comparable for NTE to a conventionally fractionated regimen.

Trial registration: ClinicalTrials.gov NCT00107497.

PubMed Disclaimer

Conflict of interest statement

Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Adrian Murray Brunt

Consulting or Advisory Role: Roche, Genomic Health

Speakers' Bureau: Roche, BMS, Novartis, Genomic health

Research Funding: Roche (Inst), Novartis (Inst)

Peter Barrett-Lee

Expert Testimony: Roche/Genentech

Andy Goodman

Honoraria: Genomic Health, Bristol Myers Squibb

Adrian Harnett

Honoraria: Genomic Health

Consulting or Advisory Role: General Medical Council, UK

Travel, Accommodations, Expenses: James Paget University Hospital

Martin Hogg

Honoraria: Clovis, Pfizer

Isabel Syndikus

Travel, Accommodations, Expenses: Bayer

Duncan Wheatley

Honoraria: AstraZeneca, Roche, Pfizer, Lilly

Consulting or Advisory Role: Roche, Pfizer, AstraZeneca, Novartis, Daiichi Sankyo

Travel, Accommodations, Expenses: Roche, Lilly

Judith M. Bliss

Research Funding: AstraZeneca (Inst), Merck Sharp & Dohme (Inst), Medivation (Inst), Puma Biotechnology (Inst), Clovis Oncology (Inst), Pfizer (Inst), Janssen-Cilag (Inst), Roche (Inst), Novartis (previously GSK) (Inst)

Travel, Accommodations, Expenses: Pfizer

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Physician assessments of late normal tissue effects. (A) Breast shrinkage to 10 years; (B) time to first reported moderate/marked breast shrinkage; (C) breast induration to 10 years; (D) time to first reported moderate/marked breast induration; (E) breast edema to 10 years; (F) time to first reported moderate/marked breast edema; (G) telangiectasia to 10 years; and (H) time to first reported moderate/marked telangiectasia.
FIG 1.
FIG 1.
Physician assessments of late normal tissue effects. (A) Breast shrinkage to 10 years; (B) time to first reported moderate/marked breast shrinkage; (C) breast induration to 10 years; (D) time to first reported moderate/marked breast induration; (E) breast edema to 10 years; (F) time to first reported moderate/marked breast edema; (G) telangiectasia to 10 years; and (H) time to first reported moderate/marked telangiectasia.
FIG A1.
FIG A1.
Examples of no change and marked change in photographic breast appearance.
FIG A2.
FIG A2.
FAST Trial profile. FU, follow-up; fr, fraction; RT, radiotherapy; trt, treatment. (*) Only major treatment deviations are listed. Minor deviations due to public holidays, machine service days, and machine breakdowns not included.
See this image and copyright information in PMC

Comment in

References

    1. Yarnold J, Ashton A, Bliss J, et al. Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: Long-term results of a randomised trial Radiother Oncol 759–172005 - PubMed
    1. Owen JR, Ashton A, Bliss JM, et al. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: Long-term results of a randomised trial Lancet Oncol 7467–4712006 - PubMed
    1. Whelan TJ, Pignol J-P, Levine MN, et al. Long-term results of hypofractionated radiation therapy for breast cancer N Engl J Med 362513–5202010 - PubMed
    1. Haviland JS, Owen JR, Dewar JA, et al. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials Lancet Oncol 141086–10942013 - PubMed
    1. National Institute for Health and Clinical Excellence: NICE clinical guideline 101: Early and locally advanced breast cancer: Diagnosis and management. http://www.nice.org.uk/guidance/ng101. - PubMed

Publication types

Associated data