Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient‐reported outcomes substudy

Abstract

BACKGROUND: TAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E). METHODS: Participants completed the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors. RESULTS: Participants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow-up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients. CONCLUSIONS: Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients.

De‐escalation of five‐year adjuvant endocrine therapy in patients with estrogen receptor‐low positive (immunohistochemistry staining 1%‐10%) breast cancer: Propensity‐matched analysis from a prospectively maintained cohort

“…Will the magnitude of endocrine therapy benefit be the same regardless of therapy duration? Unfortunately, currently available data could not provide clear answers to these critical questions 19 . Previous studies mainly focused on the difference in survival outcomes between patients with ER‐low positive and those with ER‐high positive/ER‐negative breast cancer.…”

“…Cancer May 1, 2022 data could not provide clear answers to these critical questions. 19 Previous studies mainly focused on the difference in survival outcomes between patients with ER-low positive and those with ER-high positive/ER-negative breast cancer. Findings on ER-low positive breast cancer mainly came from the subgroup analyses of these studies, and the sample size of the ER-low positive subgroup was usually small.…”

Understanding pain related to adjuvant endocrine therapy after breast cancer: A qualitative report

“…Three months post‐initiation of AET has commonly been selected in prior literature as an early follow‐up timepoint to assess preliminary AET‐related symptoms (Cuzick, Sestak, Cella, & Fallowfield, 2008). Thirty‐six months post‐initiation is commonly used as follow‐up endpoint for studies assessing AET symptoms and aftereffects (Galvano et al, 2019; Garcia et al, 2022; Wagner et al, 2020). As such, we included participants within this timeframe after AET initiation to contextualise experiences of pain of patients compared to existing literature on other experiences in this timeframe.…”

“…Three months post-initiation of AET has commonly been selected in prior literature as an early follow-up timepoint to assess preliminary AET-related symptoms (Cuzick, Sestak, Cella, & Fallowfield, 2008). Thirty-six months post-initiation is commonly used as follow-up endpoint for studies assessing AET symptoms and aftereffects (Galvano et al, 2019;Garcia et al, 2022;Wagner et al, 2020).…”