Authors' objectives:

"The objectives of this study were to assess whether omission of postoperative radiotherapy in women with 'low-risk' axillary node negative breast cancer (T0;2) treated by breast-conserving surgery and endocrine therapy improves quality of life and is more cost-effective."

(from executive summary)

Authors' results and conclusions: The hypothesised improvement overall in quality of life with the omission of radiotherapy was not seen in the EuroQol assessment or in the functionality and symptoms summary domains of the European Organisation for Research in the Treatment of Cancer (EORTC) scales. Some differences were apparent within subscales of the EORTC questionnaires, and insights into the impact of treatment were also provided by the qualitative data obtained by open-ended questions. Differences were most apparent shortly after the time of completion of radiotherapy. Radiotherapy was then associated with increased breast symptoms and with greater fatigue but with less insomnia and endocrine side-effects. Patients had significant concerns about the delivery of radiotherapy services, such as transport, accommodation and travel costs associated with receiving radiotherapy. By the end of follow-up, patients receiving radiotherapy were expressing less anxiety about recurrence than those who had not received radiotherapy. Functionality was not greatly affected by treatment. Within the randomised controlled trial, the Barthel Index demonstrated a small but significant fall in functionality with radiotherapy compared with the no radiotherapy arm of the trial. Results from the non-randomised patients did not confirm this effect, however. Cosmetic results were better in those not receiving radiotherapy but this did not appear to be an important issue to the patients. The use of home-based assessments by a research nurse proved to be an effective way of obtaining high-quality data.

Authors' recommendations: Although there are no differences in overall quality of life scores between the patients treated with and without radiotherapy, there are several dimensions that exhibit significant advantage to the omission of irradiation. Over the first 15 months, radiotherapy for this population is not a cost-effective treatment. However, the early postoperative outcome does not give a complete answer and the eventual cost-effectiveness will only become clear after long-term follow-up. Extrapolations from these data suggest that radiotherapy may not be a cost-effective treatment unless it results in a recurrence rate that is at least 5% lower in absolute terms than those treated without radiotherapy. Implications for healthcare The results of this trial have the following implications for healthcare: The evidence suggests that there are significant differences in some dimensions of quality of life, although there is no significant overall quality-of-life advantage in the omission of adjuvant radiotherapy. Although there is a short-term economic benefit from the omission of radiotherapy in this group of patients, the longer-term benefit has yet to be determined. Comprehensive capture of quality of life and co-morbidity data may be facilitated by nurse-led home assessment. Cosmesis, although impaired by radiotherapy, appears to be of limited importance to the majority of patients within the first 15 months following surgery. More needs to be done to improve access to hospitals for older patients. Older low-risk patients have significant concerns about recurrence of breast cancer, even following radiotherapy.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1069

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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