ESTRO 37 Abstract book

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ESTRO 37

(n=207). All patients received EORTC QLQ C30 and BR23 questionnaires before surgery (baseline) and at several time points up till 1 year, and were eligible for this analysis if a baseline and at least one of the follow up questionnaires were available. A linear mixed model was used to analyse HRQL across the first year after treatment between groups, with time points baseline, 3, 6 and 12 months. Additionally, EORTC scales were compared cross- sectional postoperative, post-treatment and at 1 year. The post-treatment time point was postoperative for IORT (mean 2 weeks after surgery) and after radiotherapy for EB-APBI patients (mean 7 weeks after surgery). Treatment effect and predictors for global health status (GHS) at 1 year were analysed using multivariable analysis. A p-value of ≤0.01 was deemed significant for repeated measures and multiple testing. For EORTC scales, differences of ≥10 points between groups were considered clinically relevant. Results For this analysis 203 IORT and 154 EB-APBI patients were included. Linear mixed model analyses demonstrated that emotional functioning and future perspective differed significant between groups, but not over time (Figure 1). All other scales showed no difference between groups. Postoperative cross-sectional analysis showed that fatigue and role functioning were significantly worse in IORT patients, but the difference was not clinically relevant (Table 1). Post-treatment cross-sectional analysis showed that role functioning was significantly ánd clinically worse for IORT. Physical functioning, pain and breast symptoms were significantly, but not clinically worse for IORT patients post-treatment. These results suggest a strong influence of surgical recovery. At 1 year none of the functioning or symptom scales were significantly different between the treatment groups. Multivariable analysis of GHS at 1 year identified comorbidity (OR -7.2; -13.2 - -1.2) and systemic treatment (hormonal and chemotherapy) (OR -13.7; -21.7 - -5.9) as significant predictors of GHS.

months, resulting in no clinically relevant differences compared to baseline 1 year after treatment in both groups. Differences in symptom scales after treatment can be contributed to the surgical impact after IORT. At 1 year, systemic therapy and comorbidity have significant impact on GHS. OC-0156 Concordance of patient reported outcomes with clinician and photographic assessments in IMPORT LOW I.S. Bhattacharya 1 , J.S. Haviland 1 , A.M. Kirby 2 , P. Hopwood 1 , J.R. Yarnold 3 , J.M. Bliss 1 , C.E. Coles 4 1 Institute of Cancer Research, Clinical Trials and Statistics Unit, London, United Kingdom 2 Royal Marsden Hospital, Department of Radiotherapy and Imaging, London, United Kingdom 3 Institute of Cancer Research, Department of Radiotherapy and Imaging, London, United Kingdom 4 University of Cambridge, Department of Oncology, Cambridge, United Kingdom Purpose or Objective Normal tissue effects (NTEs) from breast radiotherapy are variously assessed using patient reported outcome measures (PROMs), clinician and/ or photographic assessments. The IMPORT LOW trial found PROMs are capable of differentiating different radiotherapy fractionation regimens. We conducted an analysis to identify the concordance between PROMs and either clinician or photographic assessments within the IMPORT LOW trial with the aim of exploring if PROMs could be used as the primary NTE data ascertainment method in clinical trials. Material and Methods IMPORT LOW (ISRCTN12852634) is a multicentre randomised phase III non inferiority trial comparing the safety and efficacy of standard whole breast radiotherapy with two experimental schedules (reduced dose and partial breast radiotherapy). IMPORT LOW included annual clinician assessments of NTEs in all participants, and PROMs (at 6 months, 1, 2 and 5 years) and photographs (at 2 and 5 years after radiotherapy) in a planned subset of >50% patients. Weighted kappa statistic and Bowker’s test of symmetry were used to test concordance between PROMs, clinician and photographic assessments at 2 and 5 years as detailed in table 1. Analyses were conducted for the overall trial cohort as well as stratified according to baseline patient characteristics including age, treatment group, breast size and surgical deficit assessed on baseline photographs, HADS anxiety and depression subscales, body image scale, whether the patient lives alone, and education level.

Results 2016 patients were recruited to the IMPORT LOW trial. 1265 and 1319 patients consented to the PROMs and photographic sub-studies respectively. PROMs were available at 2 years for 1040 patients of whom 918 had clinician and 736 had photographic assessments. At 5 years PROMs were available for 962 patients of whom 817

Conclusion EB-APBI and IORT were well tolerated. HRQL temporarily decreased after treatment, but recovered within 3