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The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial

The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial
The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial
Background: the international standard radiotherapy schedule for early breast cancer delivers 50 Gy in 25 fractions of 2·0 Gy over 5 weeks, but there is a long history of non-standard regimens delivering a lower total dose using fewer, larger fractions (hypofractionation). We aimed to test the benefits of radiotherapy schedules using fraction sizes larger than 2·0 Gy in terms of local-regional tumour control, normal tissue responses, quality of life, and economic consequences in women prescribed post-operative radiotherapy.

Methods: between 1999 and 2001, 2215 women with early breast cancer (pT1-3a pN0-1 M0) at 23 centres in the UK were randomly assigned after primary surgery to receive 50 Gy in 25 fractions of 2·0 Gy over 5 weeks or 40 Gy in 15 fractions of 2·67 Gy over 3 weeks. Women were eligible for the trial if they were aged over 18 years, did not have an immediate reconstruction, and were available for follow-up. Randomisation method was computer generated and was not blinded. The protocol-specified principal endpoints were local-regional tumour relapse, defined as reappearance of cancer at irradiated sites, late normal tissue effects, and quality of life. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59368779.

Findings: 1105 women were assigned to the 50 Gy group and 1110 to the 40 Gy group. After a median follow up of 6·0 years (IQR 5·0–6·2) the rate of local-regional tumour relapse at 5 years was 2·2% (95% CI 1·3–3·1) in the 40 Gy group and 3·3% (95% CI 2·2 to 4·5) in the 50 Gy group, representing an absolute difference of ?0·7% (95% CI ?1·7% to 0·9%)—ie, the absolute difference in local-regional relapse could be up to 1·7% better and at most 1% worse after 40 Gy than after 50 Gy. Photographic and patient self-assessments indicated lower rates of late adverse effects after 40 Gy than after 50 Gy.

Interpretation: a radiation schedule delivering 40 Gy in 15 fractions seems to offer rates of local-regional tumour relapse and late adverse effects at least as favourable as the standard schedule of 50 Gy in 25 fractions
0140-6736
1098-1107
Bentzen, S.M.
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Agrawal, R.K.
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Aird, E.G.A.
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Barrett, J.M.
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Barrett-Lee, P.J.
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Bliss, J.M.
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Brown, J.C.
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Dewar, J.A.
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Dobbs, H.J.
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Haviland, J.S.
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Hoskin, P.J.
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Hopwood, P.
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Lawton, P.A.
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Magee, B.J.
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Mills, J.
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Morgan, D.A.
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Owen, J.R.
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Simmons, S.
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Sumo, G.
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Sydenham, M.A.
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Venables, K.
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Yarnold, J.R.
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Bentzen, S.M.
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Agrawal, R.K.
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Aird, E.G.A.
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Barrett, J.M.
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Barrett-Lee, P.J.
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Bliss, J.M.
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Brown, J.C.
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Dewar, J.A.
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Dobbs, H.J.
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Haviland, J.S.
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Hoskin, P.J.
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Hopwood, P.
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Lawton, P.A.
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Magee, B.J.
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Mills, J.
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Morgan, D.A.
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Owen, J.R.
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Simmons, S.
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Sumo, G.
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Sydenham, M.A.
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Venables, K.
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Yarnold, J.R.
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Bentzen, S.M., Agrawal, R.K., Aird, E.G.A., Barrett, J.M., Barrett-Lee, P.J., Bliss, J.M., Brown, J.C., Dewar, J.A., Dobbs, H.J., Haviland, J.S., Hoskin, P.J., Hopwood, P., Lawton, P.A., Magee, B.J., Mills, J., Morgan, D.A., Owen, J.R., Simmons, S., Sumo, G., Sydenham, M.A., Venables, K. and Yarnold, J.R. (2008) The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. The Lancet, 371 (9618), 1098-1107. (doi:10.1016/S0140-6736(08)60348-7).

Record type: Article

Abstract

Background: the international standard radiotherapy schedule for early breast cancer delivers 50 Gy in 25 fractions of 2·0 Gy over 5 weeks, but there is a long history of non-standard regimens delivering a lower total dose using fewer, larger fractions (hypofractionation). We aimed to test the benefits of radiotherapy schedules using fraction sizes larger than 2·0 Gy in terms of local-regional tumour control, normal tissue responses, quality of life, and economic consequences in women prescribed post-operative radiotherapy.

Methods: between 1999 and 2001, 2215 women with early breast cancer (pT1-3a pN0-1 M0) at 23 centres in the UK were randomly assigned after primary surgery to receive 50 Gy in 25 fractions of 2·0 Gy over 5 weeks or 40 Gy in 15 fractions of 2·67 Gy over 3 weeks. Women were eligible for the trial if they were aged over 18 years, did not have an immediate reconstruction, and were available for follow-up. Randomisation method was computer generated and was not blinded. The protocol-specified principal endpoints were local-regional tumour relapse, defined as reappearance of cancer at irradiated sites, late normal tissue effects, and quality of life. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59368779.

Findings: 1105 women were assigned to the 50 Gy group and 1110 to the 40 Gy group. After a median follow up of 6·0 years (IQR 5·0–6·2) the rate of local-regional tumour relapse at 5 years was 2·2% (95% CI 1·3–3·1) in the 40 Gy group and 3·3% (95% CI 2·2 to 4·5) in the 50 Gy group, representing an absolute difference of ?0·7% (95% CI ?1·7% to 0·9%)—ie, the absolute difference in local-regional relapse could be up to 1·7% better and at most 1% worse after 40 Gy than after 50 Gy. Photographic and patient self-assessments indicated lower rates of late adverse effects after 40 Gy than after 50 Gy.

Interpretation: a radiation schedule delivering 40 Gy in 15 fractions seems to offer rates of local-regional tumour relapse and late adverse effects at least as favourable as the standard schedule of 50 Gy in 25 fractions

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Published date: March 2008
Organisations: Faculty of Medicine

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Local EPrints ID: 354530
URI: https://eprints.soton.ac.uk/id/eprint/354530
ISSN: 0140-6736
PURE UUID: a8b9cb17-10a9-42ed-8691-ef215a5accf4

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Date deposited: 12 Jul 2013 13:06
Last modified: 05 Oct 2018 12:10

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Contributors

Author: S.M. Bentzen
Author: R.K. Agrawal
Author: E.G.A. Aird
Author: J.M. Barrett
Author: P.J. Barrett-Lee
Author: J.M. Bliss
Author: J.C. Brown
Author: J.A. Dewar
Author: H.J. Dobbs
Author: J.S. Haviland
Author: P.J. Hoskin
Author: P. Hopwood
Author: P.A. Lawton
Author: B.J. Magee
Author: J. Mills
Author: D.A. Morgan
Author: J.R. Owen
Author: S. Simmons
Author: G. Sumo
Author: M.A. Sydenham
Author: K. Venables
Author: J.R. Yarnold

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