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Differences in Patient-Reported Outcomes but Not Global Quality of Life With Exemestane vs Tamoxifen in Early Breast Cancer With Ovarian Suppression

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Key Points

  • There was no difference in global quality of life between treatments.
  • Exemestane was associated with worse vaginal dryness and bone or joint pain and greater decline in sexual interest; tamoxifen was associated with worse hot flushes and sweats.

In a pooled analysis of the TEXT and SOFT trials reported in The Lancet Oncology, Bernhard et al found no difference in global quality of life with exemestane vs tamoxifen in women with early breast cancer undergoing ovarian suppression. The two agents were associated with differences in specific patient-reported outcomes.

Study Details

In the TEXT and SOFT trials, 4,717 premenopausal women with hormone receptor–positive breast cancer were randomly assigned to receive open-label adjuvant exemestane or tamoxifen for 5 years plus ovarian suppression with triptorelin (Trelstar), bilateral oophorectomy, or bilateral ovarian irradiation. Chemotherapy was optional. In a combined efficacy analysis, exemestane treatment was associated with a significant improvement in disease-free survival.

The current study analyzes patient-reported outcomes using an International Breast Cancer Study Group Quality of Life core form including several global and symptom indicators at baseline and 6, 24, and 60 months.

Patient-Reported Outcomes

At the time of analysis, median follow-up was 5.7 years. Changes in global quality-of-life indicators from baseline were small and similar between treatment groups over 5 years.

Patients in the exemestane group had greater exacerbation in vaginal dryness at 6, 24, and 60 months (P < .0001 for each time point) and greater worsening of bone or joint pain at these time points (P < .0001 for each). The exemestane group had a greater decline in sexual interest, with the difference between groups increasing over time (P < .0001 for each), and, among sexually active patients, greater difficulty becoming aroused (P < .01 for each).

Patients in the tamoxifen group had greater worsening of hot flushes (P < .0001 at 6 months), with the difference between groups diminishing over time, and had greater worsening of sweats (P < .0001 at each time point).

The investigators concluded: “Overall, from a [quality-of-life] perspective, there is no strong indication to favour either exemestane plus [ovarian function suppression] or tamoxifen plus [ovarian function suppression]. The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually.”

Jürg Bernhard, PhD, of International Breast Cancer Study Group Coordinating Center, Bern, is the corresponding author for the Lancet Oncology article.

The study was funded by Pfizer, International Breast Cancer Study Group, and National Cancer Institute. For full disclosures of the study authors, visit www.thelancet.com.

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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