Patient Reported Tolerance of 90 Days of Pre-Operative Endocrine Therapy: Results from the POWER Trial.

Background: Prospective randomized data supports radiation omission in women ≥ 65 years who take adjuvant endocrine therapy (AET) following breast-conserving surgery. Many patients who omit radiation stop AET early due to side effects. In the POWER trial, a prospective single-arm study, patients took 90 days of pre-operative endocrine therapy (pre-ET) to assess tolerance before making adjuvant treatment decisions. We hypothesized that patient-reported outcomes (PROs) during pre-ET would be heterogeneous and that 90 days was sufficient time for symptoms to develop.

Patients and methods: PRO data from POWER trial participants was obtained before, during, and after pre-ET, including health-related quality of life (HRQoL), depression, and ET symptoms using the EORTC-QLQ, CESD-R, and BCPT-SCL tools. PRO assessments were further analyzed after stratifying patients by high or low perceived sensitivity to medicine (PSM).

Results: Pre-ET PROs were assessed for 75 participants. The majority (73.3%) reported symptoms during pre-ET. Only 10.7% had symptoms severe enough to stop pre-ET before 90 days. Vasomotor (42.7%) and musculoskeletal (41.3%) symptoms were the most common. HRQoL was preserved for 66.6% participants. Patients with high PSM had more ET side effects.

Conclusion: Patients developed similar side effects during pre-ET as those typically seen with AET. PROs and the impact of pre-ET on HRQoL were patient-dependent. A 90-day course of pre-ET is sufficient for patients to develop symptoms reflective of long-term AET. Future analyses will assess the association of pre-ET PROs with AET initiation and adherence.