The objective of this proposal is to develop a minimally invasive accurate technique, which can be readily performed under local anesthesia, of selective lymph node biopsy for staging the regional lymph nodes in breast cancer patients. As has been documented for melanoma (l) and supported by preliminary data for breast cancer (this application), the first lymph node to receive lymphatic drainage from a primary tumor (the sentinel node) should be the first site of lymph node metastasis. In preliminary clinical evaluation of breast cancer patients, the sentinel lymph node was 100% predictive of whether the regional lymph nodes did or did not contain metastases. In operable breast cancer patients, peritumoral injection of radioactive colloid will be performed a variable number of hours prior to surgery in order to radiolabel the sentinel lymph node. Different classes of lymphoscintigraphic agents will be tested for optimal labelling of the sentinel lymph node. Gamma probe-guided resection of the sentinel lymph node will be performed in conjunction with a complete 3-level axillary lymph node resection. Pathologic results will be analyzed for the ability of the sentinel lymph node to predict the status of the regional lymph nodes. The data obtained from this study will be used to design and initiate a multi-institutional prospective randomized clinical trial evaluating sentinel lymph node biopsy v. complete axillary lymph node clearance as a staging criteria. Successful completion of this proposal has the potential to improve accuracy and lessen the stress, morbidity, and cost of staging breast cancer in the majority of breast cancer patients.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01CA065121-01
Application #
2107921
Study Section
Special Emphasis Panel (SRC (76))
Project Start
1994-09-16
Project End
1997-08-31
Budget Start
1994-09-16
Budget End
1995-08-31
Support Year
1
Fiscal Year
1994
Total Cost
Indirect Cost
Name
University of Vermont & St Agric College
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405
Weaver, Donald L; Ashikaga, Takamaru; Krag, David N et al. (2011) Effect of occult metastases on survival in node-negative breast cancer. N Engl J Med 364:412-21
Weaver, Donald L (2010) Pathology evaluation of sentinel lymph nodes in breast cancer: protocol recommendations and rationale. Mod Pathol 23 Suppl 2:S26-32
Weaver, Donald L; Le, Uyen Phuong; Dupuis, Stacey L et al. (2009) Metastasis detection in sentinel lymph nodes: comparison of a limited widely spaced (NSABP protocol B-32) and a comprehensive narrowly spaced paraffin block sectioning strategy. Am J Surg Pathol 33:1583-9
Weaver, Donald L; Krag, David N; Manna, Edward A et al. (2006) Detection of occult sentinel lymph node micrometastases by immunohistochemistry in breast cancer. An NSABP protocol B-32 quality assurance study. Cancer 107:661-7
Weaver, D L (2005) Pathological evaluation of sentinel lymph nodes in breast cancer: a practical academic perspective from America. Histopathology 46:702-6
Weaver, D L; Krag, D N; Ashikaga, T et al. (2000) Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer 88:1099-107
Miner, T J; Shriver, C D; Jaques, D P et al. (1999) Sentinel lymph node biopsy for breast cancer: the role of previous biopsy on patient eligibility. Am Surg 65:493-8;discussion 498-9
Smith, P A; Harlow, S P; Krag, D N et al. (1999) Submission of lymph node tissue for ancillary studies decreases the accuracy of conventional breast cancer axillary node staging. Mod Pathol 12:781-5
Miner, T J; Shriver, C D; Flicek, P R et al. (1999) Guidelines for the safe use of radioactive materials during localization and resection of the sentinel lymph node. Ann Surg Oncol 6:75-82
Krag, D; Harlow, S; Weaver, D et al. (1998) Technique of sentinel node resection in melanoma and breast cancer: probe-guided surgery and lymphatic mapping. Eur J Surg Oncol 24:89-93

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