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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: First results of International Breast Cancer Study Group trial 10-93
Journal of Clinical Oncology, Volume 24, No. 3, Year 2006
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Description
Purpose: Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS). Patients and Methods: Between 1993 and 2002, women ≥ 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years. The primary end point was QL reported by the patient and by physician assessment. Results: A total of 473 patients (234 to Sx + Ax, 239 to Sx) were randomly assigned. The median age was 74 years; 80% had estrogen receptor-positive disease. In both the patients' subjective assessment of their QL and the physicians' perception of the patients' QL, the largest adverse QL effects of Ax were observed from baseline to the first postoperative assessment, but the differences tended to disappear in 6 to 12 months. At a median follow-up of 6.6 years, results for Sx + Ax and Sx yielded similar DFS (6-year DFS, 67% v 66%; hazard ratio [HR] Sx + Ax/Sx, 1.06; 95% CI, 0.79 to 1.42; P = .69) and OS (6-year OS, 75% v 73%; HR Sx + Ax/Sx, 1.05; 95% CI, 0.76 to 1.46; P = .77). Conclusion: Avoiding axillary clearance for women ≥ 60 years old who have clinically node-negative disease and receive Tam for endocrine-responsive disease yields similar efficacy with better early QL. © 2006 by American Society of Clinical Oncology.
Authors & Co-Authors
Rudenstam, Carl Magnus
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Zahrieh, David M.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Forbes, John F.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Crivellari, Diana
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Holmberg, Stig B.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Rey, Piercarlo
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Dent, David M.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Bernhard, Jürg
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Price, Karen N.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Castiglione-Gertsch, Monica
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Goldhirsch, Aaron
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Gelber, Richard D.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Coates, Alan S.
Sweden, Gothenburg
Sahlgrenska Universitetssjukhuset
Statistics
Citations: 305
Authors: 13
Affiliations: 1
Identifiers
Doi:
10.1200/JCO.2005.01.5784
ISSN:
0732183X
Research Areas
Cancer
Disability
Environmental
Health System And Policy
Study Design
Cohort Study
Participants Gender
Female