Assessment of quality of life in MA. 17

A randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women

Timothy J. Whelan, Paul E. Goss, James N. Ingle, Joseph L. Pater, Dongsheng Tu, Kathleen Pritchard, Shifang Liu, Lois E. Shepherd, Michael Palmer, Nicholas J. Robert, Silvana Martino, Hyman B. Muss

Research output: Contribution to journalArticle

192 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)6931-6940
Number of pages10
JournalJournal of Clinical Oncology
Volume23
Issue number28
DOIs
StatePublished - 2005

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letrozole
Tamoxifen
Randomized Controlled Trials
Placebos
Quality of Life
Menopause
Pain
Health Surveys

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Whelan, Timothy J.; Goss, Paul E.; Ingle, James N.; Pater, Joseph L.; Tu, Dongsheng; Pritchard, Kathleen; Liu, Shifang; Shepherd, Lois E.; Palmer, Michael; Robert, Nicholas J.; Martino, Silvana; Muss, Hyman B.

In: Journal of Clinical Oncology, Vol. 23, No. 28, 2005, p. 6931-6940.

Research output: Contribution to journalArticle

Whelan, TJ, Goss, PE, Ingle, JN, Pater, JL, Tu, D, Pritchard, K, Liu, S, Shepherd, LE, Palmer, M, Robert, NJ, Martino, S & Muss, HB 2005, 'Assessment of quality of life in MA. 17: A randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women', Journal of Clinical Oncology, vol. 23, no. 28, pp. 6931-6940. https://doi.org/10.1200/JCO.2005.11.181
Whelan, Timothy J. ; Goss, Paul E. ; Ingle, James N. ; Pater, Joseph L. ; Tu, Dongsheng ; Pritchard, Kathleen ; Liu, Shifang ; Shepherd, Lois E. ; Palmer, Michael ; Robert, Nicholas J. ; Martino, Silvana ; Muss, Hyman B. / Assessment of quality of life in MA. 17 : A randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 28. pp. 6931-6940.
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abstract = "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.",
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T2 - A randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women

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AU - Goss, Paul E.

AU - Ingle, James N.

AU - Pater, Joseph L.

AU - Tu, Dongsheng

AU - Pritchard, Kathleen

AU - Liu, Shifang

AU - Shepherd, Lois E.

AU - Palmer, Michael

AU - Robert, Nicholas J.

AU - Martino, Silvana

AU - Muss, Hyman B.

PY - 2005

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N2 - 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.

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