


Sentinel-Node Biopsy Gains Ground in Breast Cancer |
by David W. Sharp |
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WHAT'S HOT IN MEDICINE...
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S. Hulley, et al., "Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women," JAMA-J. Amer. Med. Assoc., 280(7):605-13, 19 August 1998. [U. Calif., San Francisco; Johns Hopkins U., Baltimore, MD; Wake Forest U.
Sch. Med., Winston-Salem, NC; Wyeth-Ayerst Res., Radnor, PA] *110ME |
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J.G. McHutchinson, et al., "Interferon alpha-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C," New Engl. J. Med., 339(21):1485-92, 19 November 1998. [8 U.S. institutions] *139VT |
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B. Fisher, et al., "Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 study," J. Natl. Cancer Inst., 90(18):1371-88, 16 September 1998. [10 U.S. and Canadian institutions] *120NT |
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G.L. Davis, et al., "Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis c," New Engl. J. Med., 339(21):1493-9, 19 November 1998. [10 institutions worldwide] *139VT |
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T. Poynard, et al., "Randomised trial of interferon
a2b ribavirin for 48 weeks or for 24 weeks versus interferon
a2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus," The Lancet, 352(9138):1426-32, 31 October 1998. [11 institutions worldwide] *134AJ |
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C.-L. Lai, et al., "A one-year trial of lamivudine for chronic hepatitis B," New Engl. J. Med., 339(2):61-8, 9 July 1999. [12 institutions worldwide] *ZY828 |
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D.M. Eisenberg, et al., "Trends in alternative medicine use in the United States, 1990-1997: Results of a follow-up national survey," JAMA-J. Amer. Med. Assoc., 280(18):1569-75, 11 November 1998. [Beth Israel Deaconess Med. Ctr., Boston, MA; Harvard Med.
Sch., Boston] *136GX |
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D. Krag, et al., "The sentinel node in breast cancer: a multicenter validation study," New Engl. J. Med., 339(14):941-6, 1 October 1998. [9 U.S. institutions] *124MW |
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M.D. Pegram, et al., "Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotheraphy treatment," J. Clin. Oncol., 16(8):2659-71, August 1998. [7 U.S. institutions] *107NT |
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H.B. Rubins, et al., "Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol," New Engl. J. Med., 341(6):410-8, 5 August 1999. [11U.S. institutions] *223UN |
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reast cancer is predominantly, but not exclusively, a disease of women. Historically it has attracted far more public (including political) attention and research activity than the exclusively male disease cancer of the prostate. That balance is beginning to change, but Science Watch readers should not be disappointed to see that the disease focused on in the previous issue (that paper is now at #3) is once more the subject of attention. Surgeons who operate on the breast for malignant disease need to know how far the cancer has spread, and since this process is the transport of malignant cells via the lymphatic system, lymph nodes in the axillary region are explored for this purpose. Removing all these lymph nodes as part of the treatment program or for diagnostic staging of the disease may have serious consequences for the patient. Can such radical removal be avoided? For the past 20 years or so, many clinicians have been looking at an alternative. If lymph nodes closest to the primary site—and therefore at the beginning of the drainage system—could be tested, the surgical investigation could be simplified.
These so-called sentinel nodes first have to be identified, and the methods used have included dyes, radiographic contrast media, and nuclear-medicine techniques. The 11-center study reported in paper #8 by Dr. David Krag, University of Vermont, Burlington, and colleagues, used the radioactive trace technetium-99m sulfur colloid. All the 443 patients were scheduled to undergo complete axillary clearance so findings in the sentinel node could be compared with the examination of all nodes.
In the past year (up to September 16, 2000) there have been 148 publications on this investigative technique, including observational studies and review articles—but no randomized trials. Breast cancer apart, applications include melanoma, cervical cancer, and gastrointestinal tumors. In a recent review from the breast unit at the Royal Marsden Hospital, London, U.K., Dr. Andrew J. Spillane and Dr. Nigel P. M. Sacks (see Austral. & NZ J. Surg., 70[7]:515-24, 2000) conclude that the absence of randomized-trial evidence means that sentinel-node biopsy "has no proven superiority over axillary dissection," but they concede that the method will be used increasingly because of "encouraging results from major centres responsible for its development, and patient demand."
Krag himself remains cautious. In April of this year he wrote: "Until the impact of this very promising technology is confirmed to provide the same staging and prognosis, regional control, and survival as conventional surgery, it is considered an experimental approach."(see Cancer J., 6:S121-4,
Suppl. 2, 2000). There are two U.S. trials and one British one in progress. The cited study (#8) found "hot spots" (sentinels) by a gamma probe in 93% of patients, and when the dissected tissue was examined the sentinel biopsy was found to have high specificity and sensitivity—these measures being reflections of the unwanted false positives and false negatives, respectively. However, the study illustrates a regular problem with surgical trials that non-surgical trials do not usually face. The performance of this biopsy technique varied from center to
center.
Mr. David W.
Sharp, MA (Cambridge) is Deputy Editor of The Lancet, London, U.K.
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