Cited by 1,674Breast Cancer Treatment StudiesEstrogen and related hormone effectsEndometrial and Cervical Cancer Treatments

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Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial

Cuzick, Jack, Sestak, Ivana, Baum, Michael, Buzdar, Aman, Howell, Anthony, Dowsett, Mitch, Forbes, John F·2010·The Lancet Oncology

DOI 10.1016/s1470-2045(10)70257-6

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Abstract

Background The Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial was designed to compare the efficacy and safety of anastrozole (1 mg) with tamoxifen (20 mg), both given orally every day for 5 years, as adjuvant treatment for postmenopausal women with early-stage breast cancer. In this analysis, we assess the long-term outcomes after a median follow-up of 120 months.Methods We used a proportional hazards model to assess the primary endpoint of disease-free survival, and the secondary endpoints of time to recurrence, time to distant recurrence, incidence of new contralateral breast cancer, overall survival, and death with or without recurrence in all randomised patients (anastrozole n=3125, tamoxifen n=3116) and hormone-receptor-positive patients (anastrozole n=2618, tamoxifen n=2598). After treatment completion, we continued to collect data on fractures and serious adverse events in a masked fashion (safety population: anastrozole n=3092, tamoxifen n=3094). This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN18233230.Findings Patients were followed up for a median of 120 months (range 0-145); there were 24,522 woman-years of follow-up in the anastrozole group and 23,950 woman-years in the tamoxifen group. In the full study population, there were significant improvements in the anastrozole group compared with the tamoxifen group for disease-free survival (hazard ratio [HR] 0·91, 95% CI 0·83-0·99; p=0·04), time to recurrence (0·84, 0·75-0·93; p=0·001), and time to distant recurrence (0·87, 0·77-0·99; p=0·03). For hormone-receptor-positive patients, the results were also significantly in favour of the anastrozole group for disease-free survival (HR 0·86, 95% CI 0·78-0·95; p=0·003), time to recurrence (0·79, 0·70-0·89; p=0·0002), and time to distant recurrence (0·85, 0·73-0·98; p=0·02). In hormone-receptor-positive patients, absolute differences in time to recurrence between anastrozole and tamoxifen increased over time (2·7% at 5 years and 4·3% at 10 years) and recurrence rates remained significantly lower on anastrozole than tamoxifen after treatment completion (HR 0·81, 95% CI 0·67-0·98; p=0·03), although the carryover benefit was smaller after 8 years. There was weak evidence of fewer deaths after recurrence with anastrozole compared with tamoxifen treatment in the hormone-receptor-positive subgroup (HR 0·87, 95% CI 0·74-1·02; p=0·09), but there was little difference in overall mortality (0·95, 95% CI 0·84-1·06; p=0·4). Fractures were more frequent during active treatment in patients receiving anastrozole than those receiving tamoxifen (451 vs 351; OR 1·33, 95% CI 1·15-1·55; p<0·0001), but were similar in the post-treatment follow-up period (110 vs 112; OR 0·98, 95% CI 0·74-1·30; p=0·9). Treatment-related serious adverse events were less common in the anastrozole group than the tamoxifen group (223 anastrozole vs 369 tamoxifen; OR 0·57, 95% CI 0·48-0·69; p<0·0001), but were similar after treatment completion (66 vs 78; OR 0·84, 95% CI 0·60-1·19; p=0·3). No differences in non-breast cancer causes of death were apparent and the incidence of other cancers was similar between groups (425 vs 431) and continue to be higher with anastrozole for colorectal (66 vs 44) and lung cancer (51 vs 34), and lower for endometrial cancer (six vs 24), melanoma (eight vs 19), and ovarian cancer (17 vs 28). No new safety concerns were reported.Interpretation These data confirm the long-term superior efficacy and safety of anastrozole over tamoxifen as initial adjuvant therapy for postmenopausal women with hormone-sensitive early breast cancer.

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Authors: Cuzick, J., Sestak, I., Baum, M., Buzdar, A., Howell, A., Dowsett, M., & Forbes, J. F.
Affiliations: University of London (GB)
Cancer Research UK (GB)
The University of Texas MD Anderson Cancer Center (US)
Royal Marsden Hospital (GB)
University of Newcastle Australia (AU)
Corresponding author: Cuzick, Jack
ORCID: Cuzick, Jack
Baum, Michael
Buzdar, Aman
Howell, Anthony
Dowsett, Mitch
Forbes, John F
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2010-12
Volume: 11
Issue: 12
Pages: 1135-1141
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(10)70257-6
OpenAlex: W2112780046
Cited by: 1,674
References: 27
Citations by year: 2026: 21 · 2025: 35 · 2024: 50 · 2023: 54 · 2022: 63 · 2021: 64 · 2020: 85 · 2019: 66 · 2018: 85 · 2017: 98 · 2016: 101 · 2015: 116 · 2014: 125 · 2013: 148 · 2012: 121
FWCI: 51.63
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Research Explorer (The University of Manchester) (submittedVersion)
NOVA (University of Newcastle Australia) (submittedVersion)
Funders: AstraZeneca
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Estrogen and related hormone effects
Health Sciences › Medicine › Obstetrics and Gynecology › Endometrial and Cervical Cancer Treatments
Keywords: anastrozole, tamoxifen, adjuvant endocrine therapy, early breast cancer, postmenopausal women, disease-free survival, time to recurrence, distant recurrence, hormone receptor-positive breast cancer, contralateral breast cancer, overall survival, fracture risk, long-term outcomes, ATAC trial, aromatase inhibitors, selective estrogen receptor modulators, breast cancer recurrence
MeSH terms: Anastrozole, Administration, Oral, Breast Neoplasms, Female, Follow-Up Studies, Humans, Neoplasm Staging, Nitriles, Tamoxifen, Triazoles, Treatment Outcome, Chemotherapy, Adjuvant, Postmenopause, Kaplan-Meier Estimate

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Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial

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