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.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT04272801
Funding StatementThis study was funded by the National Institute of Health (NIH) Exploratory Grant: R21CA277311.
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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Institutional Review Board (IRB) of University of Virginia gave ethical approval for this work.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors.
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