Standardisation Of Breast Radiotherapy Trials Research Articles

Evaluation of a Method for Grading Late Photographic Change in Breast Appearance after Radiotherapy for Early Breast Cancer

Aims Serial photographs have been collected prospectively to evaluate the effect of radiotherapy on normal tissues in the breast. The aim of this study was to compare two methods of scoring radiation-induced changes. Materials and methods Five-year photographs of 400 patients randomised to receive either 42.9 or 39 Gy in 13 fractions to the whole breast after tumour excision of early breast cancer were compared with a post-surgery baseline and scored for change in breast appearance on a three-point graded scale. Two alternative methods of scoring using three observers were compared: (a) scores allocated independently, with independent resolution of discrepancies, and (b) scores allocated by consensus. Results Treatment effects estimated from the consensus and independent scores were very similar (odds ratio 1.89, 95% confidence interval 1.21–2.96 vs 2.28, 95% confidence interval 1.50–3.47, respectively). Agreement between the scores obtained from each method was reasonable, and the repeatability of the consensus method was good. Conclusions The consensus method of scoring photographic change in breast appearance seems to be no less sensitive to randomised dose as the independent method of assessment, but is much quicker to administer. The consensus method has been used to score over 3000 sets of photographs in the National Cancer Research Institute Standardisation of Breast Radiotherapy trial.

Age, clinical and psychological associations with fatigue following radiotherapy for early breast cancer – Results from 2208 women in the UK Standardisation of Breast Radiotherapy Trials (START) on behalf of the START Trial Management Group

Purpose: Fatigue is an underevaluated cancer-related and treatment-related symptom. We analyzed fatigue in head and neck cancer patients undergoing radiotherapy (RT).Methods and Materials: A total of 117 patients were enrolled (mean age, 58 years). Radiation therapy (median dose, 66 Gy) was given with either exclusive or postoperative intent in 52 and 65 patients, respectively. Chemotherapy (CT) was added before and/or during RT in 61 patients. The patients completed a 20-item questionnaire (Multidimensional Fatigue Inventory [MFI-20]) before, during (weekly), and after RT. The impact of patient-, tumor-, and treatment-related factors on fatigue was evaluated with unifactorial and multifactorial tests.Results: Fatigue level increased during RT reaching a maximum at Week 6 and then slowly decreased. In multivariate stepwise regression analysis age (inversely related, p < 0.05), psychologic disorders (p < 0.005), and previous head-and-neck surgery (inversely related, p < 0.005) were correlated with higher pre-RT fatigue level. Pre-RT fatigue score (p < 0.0001), induction and/or concomitant CT (p = 0.035), need of cortisone during RT (p = 0.005), and thyroid disorders (p = 0.032) were correlated with higher during-RT fatigue level. Pre-RT fatigue score (p < 0.0001), induction and/or concomitant CT (p < 0.001), and need of cortisone during RT (p < 0.005) were correlated with higher post-RT fatigue level. No impact of gender, performance status, comorbidities other than psychologic and thyroid, tumor stage/site, RT intent, dose, volume, duration, or toxicity was observed.Conclusion: Fatigue affects all patients undergoing RT for head-and-neck cancer, reaches maximum score at the 6th week of RT, and slowly decreases thereafter. Age, thyroid dysfunction, psychologic disorders, pre-RT fatigue score, CT, and cortisone use are correlated with RT-related fatigue levels.

1106 POSTER Prevalence, patterns and predictors of mood disorders in early breast cancer: results from 2208 women in the UK Standardisation of Breast Radiotherapy Trial (START)

1106 POSTER Prevalence, patterns and predictors of mood disorders in early breast cancer: results from 2208 women in the UK Standardisation of Breast Radiotherapy Trial (START)

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)

Quality of life (QOL) assessments of women entering a UK randomised trial of adjuvant radiotherapy (START) were investigated to estimate the independent effects on QOL of age, time since surgery, type of breast surgery, chemotherapy and endocrine therapy. QOL was evaluated using the EORTC general cancer QOL scale (EORTC QLQ-C30), breast cancer module (BR23), the Body Image Scale (BIS) and the Hospital Anxiety and Depression Scale (HADS). Independent effects of age and clinical factors were tested using multiple regression analysis. A total of 2208 (mean age 56.9 years, range 26-87) consented to the QOL study prior to radiotherapy; 17.1% had undergone mastectomy (Mx) and the remainder had undergone a wide local excision (WLE). 33.3% had received adjuvant chemotherapy (CT) and 56.7% were taking endocrine therapy (ET). Age had significant effects on QOL with older and younger subgroups predicting poorer QOL for different domains. CT affected most QOL domains and resulted in worse body image, sexual functioning, breast and arm symptoms (<0.001). Mx was associated with greater body image concerns (p<0.001), and WLE with more arm symptoms (p=0.01). There were no effects of ET on QOL. Women <50 years (proxy pre-menopausal) had worse QOL in respect of anxiety, body image and breast symptoms but age and clinical factors had no effect on depression. Overall, QOL and mental health were favourable for most women about to start RT, but younger age and receiving CT were significant risk factors for poorer QOL, and so patients in these subgroups warrant further monitoring. Surgery had a limited impact and ET had no effect on QOL.

Verification Films: A Study of the Daily and Weekly Reproducibility of Breast Patient Set-up in the START Trial

Verification of patient position in radiotherapy by the use of portal images is a current practice in most radiotherapy departments. All patients within the Standardisation of Breast Radiotherapy Trial (START) were required to have on-treatment verification images. Measurements of maximum lung and breast depth from these were used to provide details for the case-report forms. This study was undertaken to validate these measurements, assess the reproducibility of patients' set-up within the START trial and to compare reproducibility on a day-to-day basis with reproducibility over a longer period. Analysis also included a subjective assessment of image quality. Fifty-three patients from 29 departments were studied. Some centres used electronic portal imaging and others used film. Where film verification was the method of choice, information was collected about the type of film and cassette used. The correlation coefficients for inter- and intra-observer variability of breast and lung depth were 0.99. Comparing maximum breast depth on weekly and daily images, the median per cent standard deviation of breast depth was 4% and 3%, respectively. The mean standard deviation of breast depth for all patients, which gives an indication of the individual patient variability, was 5.5 +/- 2.2 mm for weekly and 3.9 +/- 1.5 mm for daily measurements. For lung depth, mean standard deviation was 6.8 +/- 2.5 mm for weekly and 6.8 +/- 2.8 mm for daily measurements. Images taken using Kodak X-omat V film were inferior to those taken with films in corresponding cassettes. Differences between lung depth measured in simulator and on the treatment unit were evident for many patients. There was little difference in the standard deviations of breast and lung depth for daily and weekly verification films on the treatment machine.