Originally published as JCO Early Release 10.1200/JCO.2005.11.181 on September 12 2005

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Assessment of Quality of Life in MA.17: A Randomized, Placebo-Controlled Trial of Letrozole After 5 Years of Tamoxifen in Postmenopausal Women

From McMaster University, Hamilton; the National Cancer Institute of Canada Clinical Trials Group, Kingston; Toronto Sunnybrook Regional Cancer Centre, Toronto, ON, Canada; Harvard Medical School, Boston, MA; Mayo Clinic, Rochester, MN; Inova Fairfax Hospital, Falls Church, VA; John Wayne Cancer Institute, Santa Monica, CA; and University of Vermont, Burlington, VT

Address reprint requests to Timothy J. Whelan, BM, BCh, MSc, Juravinski Cancer Centre, 699 Concession St, Rm 4-204, Hamilton, Ontario L8V 5C2, Canada; e-mail: tim.whelan{at}hrcc.on.ca

PURPOSE: To evaluate the impact of letrozole compared with placebo after adjuvant tamoxifen on quality of life (QOL) in the MA.17 trial.

METHODS: Patients completed the Short Form 36-item Health Survey (SF-36) and the Menopause Specific Quality of Life Questionnaire (MENQOL) at baseline, 6 months, and annually. Mean change scores from baseline were compared between groups for summary measures and domains. A response analysis compared the proportion of patients who demonstrated an important change in QOL.

RESULTS: Of 5,187 randomly assigned women in the trial, 3,612 (69.9%) participated in the QOL substudy: 1,799 were allocated to placebo and 1,813 were allocated to letrozole. No differences were seen between groups in mean change scores from baseline for the SF-36 physical and mental component summary scores at 6, 12, 24, and 36 months. Small (< 0.2 standard deviations) but statistically significant differences in mean change scores from baseline were seen for the SF-36 domains of physical functioning (12 months), bodily pain (6 months) and vitality (6 and 12 months), and the MENQOL vasomotor (6, 12, and 24 months) and sexual domains (12 and 24 months). On the response analysis, a significant difference was seen between groups for the bodily pain domain (percentage of patients reporting a worsening of QOL, 47% placebo v 51% letrozole; P = .009) and the vasomotor domain (22% placebo v 29% letrozole; P = .001).

CONCLUSION: Letrozole did not have an adverse impact on overall QOL. Small effects were seen in some domains consistent with a minority of patients experiencing changes in QOL compatible with a reduction in estrogen synthesis.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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