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Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials

Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials
Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials
Abstract: Background Few trials of adjuvant breast radiotherapy have incorporated patient-reported breast symptoms and related areas of quality of life. We assessed these measures in a quality-of-life study that was part of the randomised START (Standardisation of Breast Radiotherapy) trials.

Methods In START trial A, 2236 patients were randomly assigned to receive either 39 Gy or 41.6 Gy delivered in 13 fractions over 5 weeks or a global standard of 50 Gy in 25 fractions. In START trial B, 2215 women were randomly assigned to receive either 40 Gy in 15 fractions over 3 weeks or the same control regimen (50 Gy in 25 fractions) as in trial A. 2739 patients were eligible for the quality-of-life study of whom 2208 (81%) were accrued (1129 patients from trial A and 1079 from trial B). Participants completed the EORTC QLQ-C30 and BR23 questionnaires and protocol-specific radiotherapy items up to 5 years after radiotherapy. We compared results across regimens with generalised. estimating equations and survival analyses. The START trials are registered, ISRCTN59368779.

Findings At 5 years, up to 40% women reported moderate or marked changes to the breast after radiotherapy, and arm and shoulder pain affected up to a third of patients. Breast symptoms and body image concerns reduced over time. Rates of radiotherapy adverse effects were lower for the 39 Gy regimen in trial A and the 40 Gy regimen in trial B, compared with the 50 Gy control regimen; rates of radiotherapy adverse effects were similar between the 41.6 Gy and 50 Gy regimens in trial A. Adverse change in skin appearance was significantly lower for patients who received 39 Gy compared with those who received 50 Gy (HR 0.63, 95% CO 0.47-0.84) and for those who received 40 Gy compared with those who received 50 Gy (0.76, 0.60-0.97); no significant difference was observed between patients who received 41.6 Gy and those who received 50 Gy in trial A (0.83, 0.63-1.08). Patient self-ratings of breast symptoms discriminated a 10% difference in randomised dose intensity. Up to a third of women reported moderate or marked pain in the arm and shoulder over 5 years whilst more than 10% experienced moderate or marked arm and hand swelling, with no significant difference in arm/shoulder subscale scores between the regimens in trial A or trial B; many baseline arm and shoulder symptoms were associated with prior surgery.

Interpretation A substantial proportion of women report moderate or marked breast, arm, and shoulder symptoms over 5 years of follow-up after radiotherapy, but with no detriment to body image. Nonetheless, most patients stand to gain from hypofiractionated radiotherapy regimens with a potential for fewer adverse effects; this strengthens the evidence from the START trials for hypofiractionated regimens for women requiring radiotherapy for early breast cancer.
231-240
Hopwood, Penelope
765b3196-9a42-4dfb-a041-8ecd15b1fe9d
Haviland, Joanne S.
569aa43b-15bd-4e9d-b4a5-e68a84334cfe
Sumo, Georges
25b79d01-4c05-4223-9ffd-9f8294ce0ee1
Mills, Judith
7caf08bf-2475-4403-a130-376e6926ab3b
Bliss, Judith M.
32216b02-f161-4aa5-8a6c-7777c440a458
Yarnold, John R.
c4c07a04-e800-4763-87a6-baa4ce7f56e0
Hopwood, Penelope
765b3196-9a42-4dfb-a041-8ecd15b1fe9d
Haviland, Joanne S.
569aa43b-15bd-4e9d-b4a5-e68a84334cfe
Sumo, Georges
25b79d01-4c05-4223-9ffd-9f8294ce0ee1
Mills, Judith
7caf08bf-2475-4403-a130-376e6926ab3b
Bliss, Judith M.
32216b02-f161-4aa5-8a6c-7777c440a458
Yarnold, John R.
c4c07a04-e800-4763-87a6-baa4ce7f56e0

Hopwood, Penelope, Haviland, Joanne S., Sumo, Georges, Mills, Judith, Bliss, Judith M. and Yarnold, John R. (2010) Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncology, 11 (3), 231-240. (doi:10.1016/S1470-2045(09)70382-1). (PMID:20138809)

Record type: Article

Abstract

Abstract: Background Few trials of adjuvant breast radiotherapy have incorporated patient-reported breast symptoms and related areas of quality of life. We assessed these measures in a quality-of-life study that was part of the randomised START (Standardisation of Breast Radiotherapy) trials.

Methods In START trial A, 2236 patients were randomly assigned to receive either 39 Gy or 41.6 Gy delivered in 13 fractions over 5 weeks or a global standard of 50 Gy in 25 fractions. In START trial B, 2215 women were randomly assigned to receive either 40 Gy in 15 fractions over 3 weeks or the same control regimen (50 Gy in 25 fractions) as in trial A. 2739 patients were eligible for the quality-of-life study of whom 2208 (81%) were accrued (1129 patients from trial A and 1079 from trial B). Participants completed the EORTC QLQ-C30 and BR23 questionnaires and protocol-specific radiotherapy items up to 5 years after radiotherapy. We compared results across regimens with generalised. estimating equations and survival analyses. The START trials are registered, ISRCTN59368779.

Findings At 5 years, up to 40% women reported moderate or marked changes to the breast after radiotherapy, and arm and shoulder pain affected up to a third of patients. Breast symptoms and body image concerns reduced over time. Rates of radiotherapy adverse effects were lower for the 39 Gy regimen in trial A and the 40 Gy regimen in trial B, compared with the 50 Gy control regimen; rates of radiotherapy adverse effects were similar between the 41.6 Gy and 50 Gy regimens in trial A. Adverse change in skin appearance was significantly lower for patients who received 39 Gy compared with those who received 50 Gy (HR 0.63, 95% CO 0.47-0.84) and for those who received 40 Gy compared with those who received 50 Gy (0.76, 0.60-0.97); no significant difference was observed between patients who received 41.6 Gy and those who received 50 Gy in trial A (0.83, 0.63-1.08). Patient self-ratings of breast symptoms discriminated a 10% difference in randomised dose intensity. Up to a third of women reported moderate or marked pain in the arm and shoulder over 5 years whilst more than 10% experienced moderate or marked arm and hand swelling, with no significant difference in arm/shoulder subscale scores between the regimens in trial A or trial B; many baseline arm and shoulder symptoms were associated with prior surgery.

Interpretation A substantial proportion of women report moderate or marked breast, arm, and shoulder symptoms over 5 years of follow-up after radiotherapy, but with no detriment to body image. Nonetheless, most patients stand to gain from hypofiractionated radiotherapy regimens with a potential for fewer adverse effects; this strengthens the evidence from the START trials for hypofiractionated regimens for women requiring radiotherapy for early breast cancer.

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e-pub ahead of print date: 6 February 2010
Published date: March 2010
Organisations: Faculty of Medicine

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Local EPrints ID: 354527
URI: http://eprints.soton.ac.uk/id/eprint/354527
PURE UUID: f8f73e3c-e09c-465c-816b-b394c6ba2e14

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Date deposited: 12 Jul 2013 13:26
Last modified: 22 Jul 2019 16:31

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Contributors

Author: Penelope Hopwood
Author: Joanne S. Haviland
Author: Georges Sumo
Author: Judith Mills
Author: Judith M. Bliss
Author: John R. Yarnold

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