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Adjuvant Endocrine Therapy for Primary Breast Cancer Treatment Associated With Increased Symptom Burden Over 12 Months

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Key Points

  • Compared with no endocrine therapy, patients who received aromatase inhibitors had more severe musculoskeletal symptoms, hot flashes, and cognitive problems, according to the findings of the Mind-Body Study.
  • Compared with no endocrine therapy, patients who received tamoxifen had more severe hot flashes, cognitive problems, and bladder problems.

Patients in the observational Mind-Body Study receiving adjuvant endocrine therapy for primary breast cancer treatment reported a greater symptom burden than did patients not receiving endocrine therapy over 12 months, as reported by Ganz et al in the Journal of Clinical Oncology. No differences in mental health measures were observed.

Study Details

The observational cohort participants provided self-reported data on physical and mental health (Short Form-36 physical component and mental component scales), endocrine therapy–related symptoms (Breast Cancer Prevention Trial symptom scales), depression (Beck Depression Inventory II), fatigue (Multidimensional Fatigue Symptom Inventory), and sleep (Pittsburgh Sleep Quality Index) after primary treatment and prior to initiation of endocrine therapy and at 6 and 12 months. Longitudinal trajectories of outcome measures among 186 patients receiving no endocrine therapy (n = 60), tamoxifen (n = 66), or aromatase inhibitor therapy (n = 60) were compared using linear mixed models.

Patients had a mean age of 52 years. Baseline differences among the three groups were observed for age, education, type of surgery, disease stage, months since last treatment, and prior adjuvant chemotherapy and radiation therapy before initiation of endocrine therapy. A noncollinear set of baseline variables was controlled for in the mixed models.

Increased Symptom Burden

No significant differences were observed in self-reported measures among the groups at baseline or in covariate-adjusted analyses. Physical health scores were below normal levels at baseline but improved in all groups by 12 months; the aromatase inhibitor group had a lower score vs the no endocrine therapy group at 12 months (P = .05). Mental health scores were within normal range and similar among groups at baseline and did not change over time.

The no endocrine therapy group exhibited stable or reduced symptom severity over time, whereas increased severity was frequently observed among patients receiving endocrine therapy. Compared with the no endocrine therapy group, the aromatase inhibitor group reported more severe musculoskeletal symptoms (P = .02), hot flashes (P = .02), and cognitive problems (P = .006) at 6 or 12 months, and the tamoxifen group reported greater severity of hot flashes (P = .002), cognitive problems (P = .016), and bladder problems (P = .02).

At 12 months, no differences between groups were observed for depression symptoms, fatigue, or sleep quality (a significant difference among groups at 6 months was observed for the latter).

The investigators concluded: “Attention should be given to the increased symptom burden associated with [endocrine therapy], and better efforts should be made to address patient-reported outcomes.”

The study was supported by the National Cancer Institute and the Breast Cancer Research Foundation.

Patricia A. Ganz, MD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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