SummaryBackground Standard curative schedules of radiotherapy to the breast deliver 25 fractions of 2·0 Gy over 5 weeks. In a randomised trial, we tested whether fewer, larger fractions were at least as safe and as eff ective as standard regimens. In this analysis, we assessed the long-term results of tumour control in the same population.

Background and purpose: Unlike squamous carcinomas, breast adenocarcinoma may be as sensitive to fraction size as late dose-limiting normal tissues. If so, fewer larger fractions would be as safe and effective as regimens based on 2.0 Gy fractions. The first step is to test the effects of radiotherapy fractions O2.0 Gy on late normal tissue responses in the breast after tumour excision and radiotherapy for early breast cancer.Patients and methods: One thousand four-hundred and ten women with T1-3 N0-1 M0 invasive breast cancer were randomised between 1986-98 into one of three radiotherapy regimens after local tumour excision of early stage breast cancer; 50 Gy in 25 fractions (F) vs two dose levels of a test schedule giving 39 or 42.9 Gy in 13 F over 5 weeks. Fraction sizes were 2.0, 3.0 and 3.3 Gy, respectively. The primary endpoint was late change in breast appearance compared to post-surgical appearance scored from annual photographs blinded to treatment allocation. Secondary endpoints included palpable breast induration (fibrosis) and ipsilateral tumour recurrence.Results: After a minimum 5-year follow up, the risk of scoring any change in breast appearance after 50 Gy/25 F, 39 Gy/13 F and 42.9 Gy/13 F was 39.6, 30.3 and 45.7%, from which an a/b value of 3.6 Gy (95% CI 1.8-5.4) is estimated. The a/b value for palpable breast induration was 3.1 Gy (95% CI 1.8-4.4).Conclusions: An a/b value of around 3 Gy for late normal tissue changes in the breast is derived from the estimated equivalence of 41.6 Gy in 13 fractions and 50 Gy in 25 fractions over 5 weeks, in line with trial predictions. q 2005 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 75 (2005) 9-17.

The possibility that psychological response within a few weeks of a breast cancer diagnosis can influence the outcome of the disease is a contentious issue. Psychological response, including helplessness/hopelessness, fighting spirit and depression was assessed in early-stage breast cancer patients between 1 and 3 months post-diagnosis, in order to ascertain effect on cancer prognosis. Patients were followed up for a period of 10 years in order to clarify the effect of psychological response on disease outcome. After 10 years, there is a continuing effect of helplessness/hopelessness on disease-free survival (adjusted hazard ratio (HR) 1.53, 95% confidence interval (CI) 1.11-2.11) but not of depression (adjusted HR for overall survival for ÔcasesÕ 2.43, 95% CI 0.97-6.10). Longer follow-up also indicates that a high fighting spirit confers no survival advantage. The results showed that, in patients who were disease-free at 5 years, their baseline helpless/hopeless response still exerted a significant effect on disease-free survival beyond 5 (and up to 10) years. The effect is therefore maintained for up to 10 years of follow-up. Clinicians may wish to screen for helplessness around the time of diagnosis in order to target psychological care resources. Further large studies, with similarly prolonged follow-up, are needed to replicate this effect and clarify its mechanism of action.

The original MAC Scale remains a satisfactory measure of psychological outcome. Two-higher order factors representing global adjustment are now available to provide an overall summary measure alongside the original specific sub-scales.

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