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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.

Hopwood P, Haviland JS, Sumo G et al. Lancet Oncol, 2010, 11, 231-240

The use of radiotherapy in adjuvant treatment of early breast cancer is associated with high incidence of skin toxicity, such as erythema, desquamation and swelling, and also arm and shoulder pain. Radiotherapy is routinely offered to women who opt for lumpectomy, whereas for women who undergo mastectomy, radiotherapy is necessitated by lymph node involvement and tumour-related factors. Although there have been many radiotherapy trials in early breast cancer, very few of these have incorporated any assessment of how radiotherapy impacts on quality of life [1].

The START trials included quality-of-life assessment as part of their protocol and compared the outcomes at baseline and over a 5-year follow-up. Women with early-stage invasive breast cancer needing radiotherapy after primary surgery were eligible for the START trials if they were older than 18 years, did not have breast reconstruction before radiotherapy, and were available for follow-up.

The START trials were run concurrently to compare the international standard dose (50 Gy delivered in 25 fractions over 5 weeks) with alternative schedules based on fewer, larger fractions [2]. In trial A, doses of 39 Gy and 41.6 Gy given in 13 fractions over 5 weeks were compared with the standard international regimen. Trial B was a non-inferiority trial comparing the same standard dose with 40 Gy in 15 fractions over 3 weeks. A questionnaire booklet was given to all women who consented to take part in the quality-of-life study. Subsequent questionnaires were posted to these individuals at 6, 12, 24, 60 months post randomisation. Quality-of-life assessment was made according to the EORTC (European Organisation for Research and Treatment of Cancer) general cancer scale QLQ-C3014 and breast-cancer module (BR23).

A total of 4451 women were enrolled into these trials (2236 from 17 centres in trial A and 2215 from 23 centres in trial B). Of these, 2208 patients were enrolled into the quality-of-life study, with 1129 from 13 centres in trial A and 1079 from 21 centres in trial B. There were fewer adverse events related to radiotherapy in the 39-Gy regimen in trial A and in the 40-Gy regimen in trial B, compared with the 50-Gy control regimen.

The rate of moderate or marked change in skin appearance after radiotherapy in all women (breast-conserving surgery and mastectomy) was significantly lower for the 39- Gy versus 50-Gy regimen in trial A [hazard ratio (HR) 0.63, 95% CI 0.47-0.84] and for the 40-Gy versus 50-Gy regimen in trial B (HR 0.76, 95% CI 0.60-0.97), whereas the 41.6-Gy and 50-Gy regimens in trial A did not differ significantly (HR 0.83, 95% CI 0.63-1.08). Although no further significant differences were found, there was a similar pattern for other post-radiotherapy effects in the breast, with lowest rates of adverse changes in the 39-Gy regimen of trial A and the 40-Gy regimen in trial B, and similar rates in the 41.6-Gy regimen compared with 50 Gy. In trial A, in the 41.6- and 39-Gy regimens, there were fewer arm and shoulder events as compared with 50 Gy, but these were not statistically significant.

We understand through this study that quality of life is a key issue in women who receive radiotherapy in early breast cancer, as not only does this affect them cosmetically, it also has impairs them psychologically. Medical professionals should understand that, despite the toxicity, women do tend to retain a good quality of life after radiotherapy. Women benefit from hypofractionated radiotherapy regimens, with fewer adverse effects, and this is an effective and better mode of therapeutic option in such a setting. Appropriate radiotherapy dosage should be administered to patients, bearing in mind the acute and long-term toxicities.


[1.] Lee TS, Kilbreath TS, Refshauge KM et al. Quality of life of women treated with radiotherapy for breast cancer. Support Care Cancer, 2008, 16, 399-405.

[2.] Hopwood P, Haviland J, Mills J et al. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radiotherapy Trial). Breast, 2007, 16, 241-251.

Correspondence to: Anand Sharma

Department of Medical Oncology

Imperial College Healthcare NHS Trust

1st Floor, E Wing

Charing Cross Hospital

Fulham Palace Road, London W6 8RF, UK

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Author:Sharma, Anand; Jayanth, Akali
Publication:Advances in Breast Cancer
Date:Apr 1, 2010
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