Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 505
© 2004 American Society of Clinical Oncology

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Abstract

A randomized trial comparing axillary clearance versus no axillary clearance in older patients ( 60 years) with breast cancer: First results of International Breast Cancer Study Group Trial 10–93

International Breast Cancer Study Group (IBCSG), Bern, Switzerland

505

Background: Axillary clearance is associated with undesirable side-effects. We therefore investigated if avoiding axillary surgery in older women would result in improved quality of life (QL) and similar disease-free survival (DFS) and overall survival (OS). Methods: Between 1993 and 2002, women 60 years old with clinically N₀ operable breast cancer were randomized to primary surgery plus axillary clearance (Sx+Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam. The primary endpoint was QL reported by the patient (using linear analogue self-assessment [LASA] scales) and by physician assessment at sequential time points. Results: 473 patients (234 to Sx+Ax, 239 to Sx) were randomized to meet the target accrual of 472 patients. The median age was 74 years in both arms. Other characteristics were also balanced: 80% ER-positive; 45% mastectomies; 33% breast-conserving surgery with radiotherapy (RT); 22% breast-conserving surgery without RT. The table below gives the results of 2 of the LASAs and 2 of the physician-reported side-effects. In all of these assessments the largest differences were observed from baseline to post-operative, with patients randomized to Sx+Ax having worse QL and more side effects, but the differences tended to approach baseline values in 6 to 12 months. At a median follow-up of 6 years, results for Sx+Ax vs. Sx were similar for DFS (total events: 84 vs. 77; 5-year DFS: 71% vs. 70%; relative risk (RR) [Sx+Ax/Sx]: 1.12; 95% CI: 0.82–1.53; p=0.46) and OS (total deaths: 65 vs. 62; 5-year OS: 78% vs. 80%; RR [Sx+Ax/Sx]: 1.10; 95% CI: 0.77–1.55; p=0.61). Conclusions: Avoiding axillary clearance for women 60 years old who have clinically N₀ disease and receive Tam results in similar efficacy with improved QL.

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Abstract presentation from the 2004 ASCO Annual Meeting