Quality of life of therapies for hormone receptor positive advanced/metastatic breast cancer: Regulatory aspects and clinical impact in Europe

Moscetti, L.; Sperdutia, I.; Frassoldati, A.; Musolino, A.; Nasso, C.; Toss, A.; Omarini, C.; Dominici, M.; Piacentini, F.

doi:10.1016/j.breast.2021.07.008

In recent years, thenumber of trials incorporatinghealth-relatedqualityof life (HRQoL) data has increased. The impact of HRQoL on regulatory decision making in the European context and on clinical practiceisnotwellestablished.Weconductedananalysisof theroleofQoLdataextractedfromthe clinical trialsof thedrugsapprovedforhormonereceptorpositive/HER2-negativeadvanced/metastatic breastcancer(mBC).TheresultsfromtheHRQoLwerecollectedandameta-analysiswasperformedto evaluatetheimpactofexperimentaldrugscomparedtostandardtreatments.Theresultsshowedanondetrimental effect inHRQoL fromthenewtreatments.As regards theapprovalprocess, fromanexaminationoftheEuropeanMedicineAgency(EMA)documents,HRQoLwasreportednonextensivelyand containedanddiscussedintheEuropeanassessmentreports(EPARs) foreleventrials intheapproval processandcitedinthreecasesintheEPARsandsummaryofmedicinalproductcharacteristics(SmPC). AneffortshouldbemadebyallthestakeholderstoincreasethevisibilityoftheHRQoLresultsinorderto allowincreasedconsiderationintheapprovalprocesstomakeQoLdatamoreeasilyandvisiblyavailable for the clinician and the patients.TheevaluationshouldbereflectedintheSmPCinordertoincreasethe amountof informationprovidedtothephysician.

Moscetti, L., Sperdutia, I., Frassoldati, A., Musolino, A., Nasso, C., Toss, A., et al. (2021). Quality of life of therapies for hormone receptor positive advanced/metastatic breast cancer: Regulatory aspects and clinical impact in Europe. THE BREAST, 59, 232-238 [10.1016/j.breast.2021.07.008].