Abstract
BackgroundIn an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normal-tissue effects (NTE) need to be balanced against risk of relapse. NTE are assessed using patient-reported outcome measures (PROMs), clinician-reported outcomes (CRO) and photographs. This analysis investigates whether PROMs can be used as primary NTE endpoints in breast radiotherapy trials. MethodsAnalyses were conducted within IMPORT LOW (ISRCTN12852634) at 2 and 5 years. NTE were recorded by CRO, photographs and PROMs. Measures of agreement tested concordance, risk ratios for radiotherapy groups were compared, and influence of baseline characteristics on concordance investigated. ResultsIn 1095 patients who consented to PROMS and photographs, PROMs were available at 2 and/or 5 years for 976 patients, of whom 909 had CRO and 844 had photographs. Few patients had moderate/marked NTE, irrespective of method used (eg. 19% patients and 9% clinicians reported breast shrinkage at year-5). Patients reported more NTE than assessed from CRO or photographs (p < 0.001 for most NTE). Concordance between assessments was poor on an individual patient level; eg. for year-5 breast shrinkage, % agreement = 48% and weighted kappa = 0.17. Risk ratios comparing radiotherapy schedules were consistent between PROMs and CRO or photographs. ConclusionsFew patients had moderate/marked NTE irrespective of method used. Patients reported more NTE than CRO and photographs, therefore NTE may be underestimated if PROMs are not used. Despite poor concordance between methods, effect sizes from PROMs were consistent with CRO and photographs, suggesting PROMs can be used as primary NTE endpoints in breast radiotherapy trials.
Highlights
In an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normaltissue effects (NTE) need to be balanced against risk of relapse
Despite poor concordance between methods, effect sizes from patient-reported outcome measures (PROMs) were consistent with clinician-reported outcomes (CRO) and photographs, suggesting PROMs can be used as primary NTE endpoints in breast radiotherapy trials
In the 41 centres participating in the PROMs sub-study, 1265/1333 (95%) patients consented to PROMs, and 1318/1466 (90%) patients consented to the photographic sub-study from 37 participating centres. 1095 patients consented to both sub-studies (Fig. 1a)
Summary
In an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normaltissue effects (NTE) need to be balanced against risk of relapse. NTE are assessed using patient-reported outcome measures (PROMs), clinician-reported outcomes (CRO) and photographs. This analysis investigates whether PROMs can be used as primary NTE endpoints in breast radiotherapy trials. NTE were recorded by CRO, photographs and PROMs. Measures of agreement tested concordance, risk ratios for radiotherapy groups were compared, and influence of baseline characteristics on concordance investigated. Few patients had moderate/ marked NTE, irrespective of method used 19% patients and 9% clinicians reported breast shrinkage at year-5). Conclusions: Few patients had moderate/marked NTE irrespective of method used. Despite poor concordance between methods, effect sizes from PROMs were consistent with CRO and photographs, suggesting PROMs can be used as primary NTE endpoints in breast radiotherapy trials.
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