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. A critical related question is the interpretation of micrometastases in both the sentinel lymph node and the bone marrow. The clinical significance of these findings on enhanced pathology is a critical treatment issue, which becomes even more important as the use of sentinel node biopsy increases.

COMMENTS ON SENTINEL NODE TRIALS

There are three reasons to do axillary dissection: regional control, staging and to improve survival. For staging, we have enough literature from around the world to tell us the accuracy of sentinel node biopsy. For regional control, surgery results in almost 100% control, as does radiation therapy, so before we abandon something that works very well, we have to be very careful. We don’t have any long-term data on regional control for sentinel node. Regarding survival — there may be a survival advantage in controlling the axilla. The few studies that looked at this were done in an era when we randomized hundreds of patients, not thousands of patients. So the statistical power was not there.

I’ve personally never done a sentinel node procedure in a breast cancer case outside of a clinical trial. I’m not going to say that it shouldn’t be done — this is a judgment call. But in terms of making the claim that sentinel node is as good as axillary dissection, we don’t have the data and we are in an era of evidence-based medicine.

—David Krag, MD

Many surgeons believe that axillary dissection is therapeutic, and they are reluctant not to perform axillary dissection in sentinel node-positive patients. However, a number of randomized studies failed to show that axillary dissection improves survival. In sentinel node-positive women, the sentinel node may be enough because often it’s the only involved node.

Virtually all node-positive women in this country receive adjuvant systemic therapy, and many patients are also receiving opposed tangential field radiation. In studies where patients received lumpectomy with radiation and no axillary dissection, the axillary recurrence rate was extraordinarily low. I think ACOS Z-11 is a very important, very justifiable and ethical trial. For an operation that’s been used for 100 years, it’s time to answer the question about the need for axillary dissection.

—Armando Giuliano, MD

ACCRUAL TO 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, 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

AMERICAN COLLEGE OF SURGEONS Z-10 TRIAL: A PHASE III PROGNOSTIC STUDY OF SENTINEL NODE AND BONE MARROW MICROMETASTASES IN WOMEN WITH STAGE I OR IIA BREAST CANCER PROTOCOL All patients receive whole breast radiotherapy (exclusive of a supraclavicular field) 5 days a week for a maximum of 7 weeks and systemic adjuvant therapy. Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by H & E who choose not to be registered to ACOSOG-Z0011 undergo ALND.     NSABP B-32 TRIAL: PHASE III RANDOMIZED STUDY OF SENTINEL NODE DISSECTION WITH OR WITHOUT CONVENTIONAL AXILLARY DISSECTION IN WOMEN WITH CLINICALLY NODE-NEGATIVE BREAST CANCER OPEN PROTOCOL All patients receive technetium Tc 99m sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector.     AMERICAN COLLEGE OF SURGEONS Z-11 TRIAL: A PHASE III RANDOMIZED STUDY OF AXILLARY LYMPH NODE DISSECTION IN WOMEN WITH STAGE I OR IIA BREAST CANCER WHO HAVE A POSITIVE SENTINEL NODE O PEN PROTOCOL Patients in both arms may receive adjuvant systemic therapy at the discretion of the treating physician.     What technique do you generally utilize for sentinel node biopsy? S U R G E O N S Dye 8% Radioisotope 8% Both 84% Percent of surgeons who feel that sentinel node biopsy is generally a good option for the following women: A 56-year-old woman with a 2 cm breast cancer in the upper outer quadrant and a 1 cm breast cancer in the lower inner quadrant 46% A 42-year-old woman with a 3 cm breast cancer who wants mastectomy with immediate reconstruction using TRAM flap 60% A 55-year-old woman with a 2 cm breast cancer high in the upper outer quadrant in the tail of Spence 78% Percent of surgeons who feel that sentinel lymph node biopsy is a standard of care for patients with clinical T1NO cancer? 70%

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Cox CE et al. Importance of lymphatic mapping in ductal carcinoma in situ (DCIS): Why map DCIS? Am Surg 2001;67(6):513-9;discussion 519-21. Abstract

Grube BJ, Giuliano AE. Observation of the breast cancer patient with a tumor-positive sentinel node: Implications of the ACOSOG Z0011 trial. Semin Surg Oncol 2001;20(3):230-7. Abstract

Harlow SP, Krag DN. Sentinel lymph node — Why study it: Implications of the B-32 study. Sem Surg Oncol 2001;20:224-229. Abstract

Krag DN et al. Radiolabeled sentinel node biopsy: Collaborative trial with the National Cancer Institute. World J Surg 2001;25(6):823-8. Abstract

Lucci A Jr et al. National practice patterns of sentinel lymph node dissection for breast carcinoma. J Am Coll Surg 2001;192(4):453-8. Abstract

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