Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer

Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial

Ian Smith, Denise Yardley, Howard Burris, Richard De Boer, Dino Amadori, Kristi McIntyre, Bent Ejlertsen, Michael Gnant, Walter Jonat, Kathleen I. Pritchard, Mitch Dowsett, Lowell Hart, Susan Poggio, Lisa Comarella, Herve Salomon, Barbara Wamil, Joyce O'Shaughnessy

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Abstract

Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR)-positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93;95%CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similarDFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (. 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.

Original languageEnglish
Pages (from-to)1041-1048
Number of pages8
JournalJournal of Clinical Oncology
Volume35
Issue number10
DOIs
Publication statusPublished - Apr 1 2017

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letrozole
Clinical Trials
Hormones
Breast Neoplasms
Safety
Disease-Free Survival
anastrozole
Survival Rate

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer : Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial. / Smith, Ian; Yardley, Denise; Burris, Howard; De Boer, Richard; Amadori, Dino; McIntyre, Kristi; Ejlertsen, Bent; Gnant, Michael; Jonat, Walter; Pritchard, Kathleen I.; Dowsett, Mitch; Hart, Lowell; Poggio, Susan; Comarella, Lisa; Salomon, Herve; Wamil, Barbara; O'Shaughnessy, Joyce.

In: Journal of Clinical Oncology, Vol. 35, No. 10, 01.04.2017, p. 1041-1048.

Research output: Contribution to journalArticle

Smith, I, Yardley, D, Burris, H, De Boer, R, Amadori, D, McIntyre, K, Ejlertsen, B, Gnant, M, Jonat, W, Pritchard, KI, Dowsett, M, Hart, L, Poggio, S, Comarella, L, Salomon, H, Wamil, B & O'Shaughnessy, J 2017, 'Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer: Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial', Journal of Clinical Oncology, vol. 35, no. 10, pp. 1041-1048. https://doi.org/10.1200/JCO.2016.69.2871
Smith, Ian ; Yardley, Denise ; Burris, Howard ; De Boer, Richard ; Amadori, Dino ; McIntyre, Kristi ; Ejlertsen, Bent ; Gnant, Michael ; Jonat, Walter ; Pritchard, Kathleen I. ; Dowsett, Mitch ; Hart, Lowell ; Poggio, Susan ; Comarella, Lisa ; Salomon, Herve ; Wamil, Barbara ; O'Shaughnessy, Joyce. / Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer : Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 10. pp. 1041-1048.
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title = "Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer: Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial",
abstract = "Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR)-positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5{\%}]; anastrozole, 368 [17.7{\%}]). The 5-year estimated DFS rate was 84.9{\%} for letrozole versus 82.9{\%} for anastrozole arm (hazard ratio, 0.93;95{\%}CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similarDFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9{\%} for letrozole versus 89.2{\%} for anastrozole arm (hazard ratio, 0.98; 95{\%} CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (. 5{\%} of patients) reported for letrozole versus anastrozole were arthralgia (3.9{\%} v 3.3{\%}, and 48.2{\%} v 47.9{\%} for all adverse events), hypertension (1.2{\%} v 1.0{\%}), hot flushes (0.8{\%} v 0.4{\%}), myalgia (0.8{\%} v 0.7{\%}), dyspnea (0.8{\%} v 0.5{\%}), and depression (0.8{\%} v 0.6{\%}). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.",
author = "Ian Smith and Denise Yardley and Howard Burris and {De Boer}, Richard and Dino Amadori and Kristi McIntyre and Bent Ejlertsen and Michael Gnant and Walter Jonat and Pritchard, {Kathleen I.} and Mitch Dowsett and Lowell Hart and Susan Poggio and Lisa Comarella and Herve Salomon and Barbara Wamil and Joyce O'Shaughnessy",
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TY - JOUR

T1 - Comparative efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor-positive, node-positive early breast cancer

T2 - Final results of the randomized phase III femara versus anastrozole clinical evaluation (FACE) trial

AU - Smith, Ian

AU - Yardley, Denise

AU - Burris, Howard

AU - De Boer, Richard

AU - Amadori, Dino

AU - McIntyre, Kristi

AU - Ejlertsen, Bent

AU - Gnant, Michael

AU - Jonat, Walter

AU - Pritchard, Kathleen I.

AU - Dowsett, Mitch

AU - Hart, Lowell

AU - Poggio, Susan

AU - Comarella, Lisa

AU - Salomon, Herve

AU - Wamil, Barbara

AU - O'Shaughnessy, Joyce

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR)-positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93;95%CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similarDFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (. 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.

AB - Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR)-positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93;95%CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similarDFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (. 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.

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