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Section 2
Management of the axilla

OVERVIEW

A series of classic randomized trials - including NSABP B-04 - formed the basis for level 1 and 2 axillary node dissection becoming a standard of care for invasive breast cancer. The emergence of sentinel node biopsy (SNB) as an initial staging procedure has led to a new generation of trials evaluating the need for axillary dissection in women with both pathologically negative and positive SNB.

In the United States, NSABP B-32 is evaluating the management of patients with negative sentinel node biopsies by randomization to either axillary node dissection or no further axillary surgery. While many investigators are convinced that the anatomic hypothesis of the sentinel node has been demonstrated, one important outcome of the NSABP trial will be to observe the accuracy and reproducibility of this procedure with many surgeons in various clinical settings.

Another key U.S. sentinel node trial is being conducted by the American College of Surgeons. This groundbreaking study will evaluate whether axillary node dissection is necessary in sentinel node-positive patients treated with lumpectomy and breast irradiation. A key factor is whether the additional antitumor effect of adjuvant systemic therapy mitigates the need for axillary dissection in these women.

Fisher B et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Eng J Med 1985; 312:674-681. Abstract

AXILLARY DISSECTION FOR SNB-POSITIVE PATIENTS

For 20 years, we have been hearing that axillary surgery is a staging procedure. However, once you have a positive node, the patient is staged, so does it make sense to subject her to the morbidity of an axillary dissection? I think the answer to that right now is, yes, for several reasons.

First, we know that axillary dissection will maintain local control in the axilla in 98-99 percent of patients - whether they're node-positive or node-negative. That's very important because uncontrolled axillary disease is extremely difficult to treat and extremely morbid. Also, medical oncologists need to accurately estimate the risk of recurrence to educate patients about the risks and benefits of adjuvant therapy. To do that, in general, you need to know the number of positive nodes.

The therapeutic benefit of axillary dissection remains open. NSABP B-04 showed no survival benefit, but the trial was basically a premammography era study so the patients had larger tumors, and no adjuvant therapy was being used at that time. Also, the sample size was not large enough to exclude a small survival difference that today we would think is clinically relevant.

Currently, the standard management of a positive sentinel node is to complete the axillary dissection, although there are individual circumstances where that might not be appropriate. I'm proud to say that our center has the second-highest accrual to the American College of Surgeons trials - basically asking the same question as NSABP B-04 in a modern setting. Without these trials, we will still be asking this question 10 years from now and making random decisions.

-Monica Morrow, MD

ACCRUAL TO SENTINEL NODE TRIALS

In some ways sentinel node mapping is becoming a victim of its own success. As surgeons realize that it is not a terrific technical feat to learn how to do this, and as more patients become aware of it through the Internet and other sources, it will become harder and harder to find both patients and physicians willing to participate in these randomized clinical trials.

-Patrick Borgen, MD

CONTRIBUTION OF SURGEONS TO BREAST CANCER RESEARCH

Although other physicians are being increasingly involved in the primary management of cancer, surgeons remain largely responsible for determining such care and for deciding whether patients enter clinical trials. Surgeons have not only inaugurated the use of systemic adjuvant therapy and continue to be leaders in that effort, they have also redefined the basis for oncologic surgical operation and, in so doing, have contributed to a better understanding of the biology of cancer and, consequently, its treatment.

-Bernard Fisher, MD

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