Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17

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

Research output: Contribution to journalArticle

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Abstract

Purpose: National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor-positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women. Patients and Methods: In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and ≥ 70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease-free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95% CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. Results: At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age ≥ 70 years. Conclusion: Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole.

Original languageEnglish (US)
Pages (from-to)1956-1964
Number of pages9
JournalJournal of Clinical Oncology
Volume26
Issue number12
DOIs
StatePublished - 2008
Externally publishedYes

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letrozole
Tamoxifen
Placebos
Quality of Life
Breast Neoplasms
Disease-Free Survival
Age Groups
Survival
National Cancer Institute (U.S.)
Menopause
Proportional Hazards Models

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen : NCIC CTG intergroup trial MA.17. / Muss, Hyman B.; Tu, Dongsheng; Ingle, James N.; Martino, Silvana; Robert, Nicholas J.; Pater, Joseph L.; Whelan, Timothy J.; Palmer, Michael J.; Piccart, Martine J.; Shepherd, Lois E.; Pritchard, Kathleen I.; He, Zhi; Goss, Paul E.

In: Journal of Clinical Oncology, Vol. 26, No. 12, 2008, p. 1956-1964.

Research output: Contribution to journalArticle

Muss, HB, Tu, D, Ingle, JN, Martino, S, Robert, NJ, Pater, JL, Whelan, TJ, Palmer, MJ, Piccart, MJ, Shepherd, LE, Pritchard, KI, He, Z & Goss, PE 2008, 'Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17', Journal of Clinical Oncology, vol. 26, no. 12, pp. 1956-1964. https://doi.org/10.1200/JCO.2007.12.6334
Muss, Hyman B. ; Tu, Dongsheng ; Ingle, James N. ; Martino, Silvana ; Robert, Nicholas J. ; Pater, Joseph L. ; Whelan, Timothy J. ; Palmer, Michael J. ; Piccart, Martine J. ; Shepherd, Lois E. ; Pritchard, Kathleen I. ; He, Zhi ; Goss, Paul E. / Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen : NCIC CTG intergroup trial MA.17. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 12. pp. 1956-1964.
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abstract = "Purpose: National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor-positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women. Patients and Methods: In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and ≥ 70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease-free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95{\%} CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. Results: At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age ≥ 70 years. Conclusion: Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole.",
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T1 - Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen

T2 - NCIC CTG intergroup trial MA.17

AU - Muss, Hyman B.

AU - Tu, Dongsheng

AU - Ingle, James N.

AU - Martino, Silvana

AU - Robert, Nicholas J.

AU - Pater, Joseph L.

AU - Whelan, Timothy J.

AU - Palmer, Michael J.

AU - Piccart, Martine J.

AU - Shepherd, Lois E.

AU - Pritchard, Kathleen I.

AU - He, Zhi

AU - Goss, Paul E.

PY - 2008

Y1 - 2008

N2 - Purpose: National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor-positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women. Patients and Methods: In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and ≥ 70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease-free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95% CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. Results: At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age ≥ 70 years. Conclusion: Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole.

AB - Purpose: National Cancer Institute of Canada Clinical Trials Group trial MA.17 randomly assigned 5,187 postmenopausal, hormone-receptor-positive patients with early breast cancer who completed 5 years of tamoxifen to receive either letrozole or placebo. At 30 months median follow-up, letrozole significantly improved disease-free survival (DFS) in all patients and overall survival (OS) in node-positive patients. Breast cancer incidence increases with age and more than 1,300 women age 70 years or older were enrolled onto MA.17, making it ideal to explore the benefits, toxicities, and quality of life (QOL) impact of letrozole on older women. Patients and Methods: In this study, 5,169 randomly assigned patients were divided into three age groups: younger than 60 years (n = 2,152), 60 to 69 years (n = 1,694), and ≥ 70 years (n = 1,323). Log-rank test was used to compare differences in DFS, distant-disease-free survival, and OS between age and treatment groups, and Cox models were used to estimate hazard ratios and associated 95% CIs. QOL was measured using the Medical Outcomes Short Form-36 and the Menopause-Specific Quality-of-Life questionnaire. Results: At 4 years, DFS demonstrated statistically significant differences favoring letrozole only in patients age younger than 60 years (hazard ratio = 0.46; P = .0004); there was no interaction between age and treatment, indicating a similar effect of letrozole among all age groups. There was no difference in toxicity or QOL at 24 months among letrozole- and placebo-treated patients age ≥ 70 years. Conclusion: Healthy patients age 70 years and older completing 5 years of tamoxifen should be considered for extended adjuvant therapy with letrozole.

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