In a study reported in the Journal of Clinical Oncology, Wagner et al found that patient-reported cognitive impairment was worse at 3 and 6 months in women with early breast cancer receiving adjuvant chemoendocrine therapy vs endocrine therapy alone in the TAILORx trial, with no significant differences between groups being observed with extended follow-up.
“Adjuvant chemoendocrine therapy is associated with significantly greater cancer-related cognitive impairment compared with endocrine therapy alone at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond."— Wagner et al
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Study Details
In the study, patient-reported cognitive impairment was assessed using the 20-item Perceived Cognitive Impairment (FACT-Cog PCI) scale from the Functional Assessment of Cancer Therapy-Cognitive Function questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months. The primary outcome measure was change in FACT-Cog PCI score between baseline and 3 months. Among the subgroup of 552 evaluable patients from the trial, 454 had data from baseline and 3-month assessments, including 218 who had received chemoendocrine therapy and 236 who had received endocrine therapy alone.
Key Findings
FACT-Cog PCI scores were significantly lower (indicating greater impairment) at 3, 6, 12, 24, and 36 months in both groups compared with baseline.
Women receiving chemoendocrine therapy reported significantly greater cognitive impairment from baseline vs those receiving endocrine therapy alone at 3 months (difference in mean PCI score = −3.82, P < .001), the primary endpoint, and at 6 months (difference in mean score = −2.62, P = .02).
No significant differences were found between the chemoendocrine therapy group and the endocrine therapy–alone group at 12 months (mean difference = −1.73, P = .17), 24 months (mean difference = −2.32, P = .09), or 36 months (mean difference = −1.60, P = .25).
In an analysis of clinically meaningful changes in cognitive function, defined as a decrease in PCI score ≥ 6.4 points, the proportions of patients in the chemoendocrine therapy group vs the endocrine therapy–alone group with worsened function were 36.7% vs 26.3% at 3 months, 35.5% vs 30.7% at 6 months, and 37.7% vs 35.3% at 12 months.
Tests for interaction between menopausal status and treatment group for outcomes were not significant.
The authors concluded: “Adjuvant chemoendocrine therapy is associated with significantly greater cancer-related cognitive impairment compared with endocrine therapy alone at 3 and 6 months. These differences abated over time, with no significant differences observed at 12 months and beyond. These findings indicate that chemotherapy produces early, but not sustained, cognitive impairment relative to endocrine therapy, providing reassurance to patients and clinicians in whom adjuvant chemotherapy is indicated to reduce recurrence risk.”
Lynne I. Wagner, PhD, of Wake Forest School of Medicine, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Cancer Institute, Canadian Cancer Society Research Institute, Breast Cancer Research Foundation, Susan G. Komen Foundation, and Genomic Health. For full disclosures of the study authors, visit ascopubs.org.
