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Lymphatic mapping and sentinel node biopsy in breast cancer

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SBU Assessment

Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.

Findings by SBU Alert

This is a translation of version 2, published on September 15, 2000. The latest version of this report is not available in English.

Breast cancer surgery always includes an investigation to determine whether cancer has spread to the axillary lymph nodes. In addition to removing the tumor itself, traditional treatment also includes removing several of the axially lymph nodes, for both diagnostic and therapeutic reasons. The intervention carries a substantial risk for complications, eg, edema and limitations in the range of motion. By identifying and investigating the first lymph node (sentinel node) into which the tumor drains, it is possible to avoid unnecessary removal of lymph nodes. The sentinel node is analyzed for the presence of cancer. If this node is cancer free, it is assumed that cancer has not spread to the other lymph nodes, and they can be saved. The method can help reduce suffering in approximately 60 per cent of all breast cancer patients.

A decisive issue concerns the potential for this method to eliminate the possibility that cancer has spread to the other lymph nodes. To date, the method has been tested in several small, and two large, nonrandomized studies. The results from these studies show that the sentinel lymph node could be identified in 87 to 98 per cent of the cases. Approximately 10 per cent of the diagnostic results were false negative (ie, wrongly indicated no tumor).

According to the findings of SBU Alert, moderate* scientific knowledge is available concerning the value of the method as a prognostic instrument. Poor* scientific knowledge is available concerning how the method benefits patients, ie, how the method affects treatment outcomes and quality of life. These aspects, and the cost-effectiveness of the method need further assessment.

Greater knowledge is needed before the method can be accepted as standard medical practice. Results from ongoing studies should first become available, or the method should be addressed within the framework of an assessment study.

*This assessment by SBU Alert uses a 4-point scale to grade the quality and evidence of the scientific documentation. The grades indicate: (1) good, (2) moderate, (3) poor, or (4) no scientific evidence on the subject.

This summary is based on a report prepared at SBU in collaboration with Assoc Prof Jan Frisell, MD PhD, Huddinge University Hospital.

Alert is a joint effort by the Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.

References

  1. Albertini JJ, Lyman GH, Cox C, et al. Lymphatic mapping and sentinel node biopsy in patients with breast cancer. JAMA 1996;276:1818-22.
  2. Frisell J, Bergkvist L, Liljegren G, Thörn M, Damm S et al. Sentinel node in breast cancer - A Swedish pilot study. Submitted 1999.
  3. Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surgery 1994;220:391-401.
  4. Hill A, Tran K, Akhurst T, Yeung H, Yeh S et al. Lessons learned frpm 500 cases of lymphatic mapping for breast cancer. Ann Surg 1999;229:528-535.
  5. Kapteijn BAE. Biopsy of the sentinel node in melanoma, penile carcinoma and breast carcinoma. The case for lymphatic mapping. Thesis, Univcersity of Amsterdam 1997.
  6. Krag DN, Weaver DG, Alex JC, Fairbank JT. Surgical resection and radiolocation of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol 1993;2:335-340.
  7. Krag D, Weaver D, Ashikaga T, Moffat F, Klintberg S, et al. The sentinel node in breast cancer. A multi center validation study. N Eng J Med 1998;339:941-946.
  8. Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast cancer. Ann Surg 1997;226:271-278.
  9. Veronesi U, Paganelli G, Galimberti V, Viale G, et al. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph nodes. Lancet 1997;349:1864-67.
Published: Revised: 8/21/2000
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