LAUSR

Abstract Background Hormonal therapy (HT) is generally proposed to all patients with endocrine receptor positive breast cancer to reduce the risk of recurrence and death. However, HT is associated with side effects. The aim of the present study was to determine the preferences of women treated with adjuvant HT for breast cancer. Methods Preferences have been elicited with a self-completed, validated questionnaire administered at study entry in eligible patients. The questionnaires, showing hypothetical scenarios based on potential survival times (5 or 15 years) and rates (60% or 80% at 5 years) without HT, were used to determine the lowest gains women judged necessary to make the treatment. The analyses were conducted into three different groups of early breast cancer patients to evaluate the expected survival benefit before starting HT (A), after a few months from the beginning (B) and after several years of HT (C). Patients also completed psychological questionnaires and the patient reported symptoms form. Results A total of 452 patients were included in the study: 149 in group A, 150 in group B and 153 in group C. In group C, 65% of patients were receiving HT with aromatase inhibitors (with or without a LHRH analogue). 12%, 24% and 35% of patients received adjuvant chemotherapy in group A, B and C, respectively. Overall, 355 women (79%) had children. The responses were quite similar between the three groups. A mean gain of 13 years was judged necessary to make adjuvant endocrine therapy worthwhile based on the hypothetical scenario of untreated mean survival time of 15 years. A mean gain of 22% more women surviving was judged necessary to make adjuvant HT worthwhile based on an untreated 5-year survival rate expectation of 60%. Cognitive dysfunction was considered the side effect least compatible with the continuation of treatment in all three groups. The willingness to continue therapy was unrelated to age, marriage and presence of children. Conclusions This is a large study of patient preferences on HT. Preferences have been elicited also in premenopausal patients treated with aromatase inhibitors. Compared with other studies with similar design, the patients included in the present study required larger benefits to make adjuvant therapy worthwhile. Clinical trial identification NCT 03939156 Release date 05.03.2019. Legal entity responsible for the study The authors. Funding Women cancer center. Disclosure E. Montagna: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili; Advisory / Consultancy: Novartis. M.A. Colleoni: Honoraria (self): Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Pfizer; Advisory / Consultancy: OBI Pharma; Advisory / Consultancy: Puma Biotechnology; Advisory / Consultancy: Celldex; Advisory / Consultancy: AstraZeneca. G. Cancello: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili. E. Munzone: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Genomic Health. S. Dellapasqua: Travel / Accommodation / Expenses: Roche. M. Mazza: Advisory / Consultancy: Novartis; Advisory / Consultancy: Gentili; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.