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Benefits of SLN Biopsy Upheld in Large Trial

Benefits of SLN Biopsy Upheld in Large Trial

NEW ORLEANS—A large study from the United Kingdom has provided some of the
first data from a randomized population in support of sentinel node biopsy (SNB)
in breast cancer patients. Robert E. Mansel, MD, of the University of Wales
College of Medicine, Cardiff, UK, presented the results at the 40th Annual
Meeting of the American Society of Clinical Oncology (abstract 506).

Dr. Mansel noted that axillary clearance surgery is associated with
arm-related morbidity, particularly numbness, pain, impaired mobility, and
lymphedema. "Up to 83% of women actually have at least one symptom in the first
3 months, and some of these symptoms are very persistent," he said. "But the
idea that sentinel node biopsy will have less morbidity is really based on
intuition and not on real data. The studies supporting it are small and

ALMANAC (Axillary Lymphatic Mapping Against Nodal Axillary Clearance)
compared SNB with conventional axillary surgery in clinically node-negative
breast cancer patients. The study used a unique quality-of-life measurement
that was evaluated in 842 patients prior to randomization.

Surgeons Received Training

Surgeons underwent training in SNB technique at their institution, and those
who achieved a set standard in the validation phase—a localization rate of at
least 90% and false-negative rate of 5% or less—performed the procedure in the
randomization phase.

"This is the first randomized multi-center trial to report data," Dr. Mansel
said, "and provides one of the largest detailed datasets of quality of life in
breast cancer."

The researchers randomized 1,031 patients with invasive breast cancer (T1-3,
N0) to undergo SNB (n = 515) or standard axillary clearance or sampling (n =
516). Sentinel node identification was by a combined technique involving blue
dye and radioisotope. Patients with positive sentinel nodes proceeded to
axillary clearance or axillary radiation.


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