More than 80% of 642 women with low-grade squamous intraepithelial lesions of the uterine cervix tested positive for human papillomaviruses associated with cancer development, indicating limited potential for such testing as a guide to clinical decisions.
These results, reported by Laura Koutsky, Ph.D., University of Washington, Seattle, for the ALTS Group (Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesions Triage Study Group), appear in the March 1 issue of the Journal of the National Cancer Institute.
About 50 million Pap smears are performed in the United States each year, with about 2% of the smears revealing a low-grade squamous intraepithelial lesion (LSIL). The average cost of treatment for women so diagnosed is about $1,000. Because about 70%80% of these low-grade lesions disappear spontaneously, identifying those that are most likely to progress could reduce patient anxiety and inconvenience, minimize invasive testing, and save money.
Many types of human papillomavirus (HPV) play a central role in the development of cervical cancer and its precursor lesions. Therefore, it was thought that HPV DNA testing of women with LSIL might identify those women with cancer-associated HPV who would need immediate referral to colposcopy (microscopic examination of the cervix), while those without HPV could be followed with annual Pap smears.
Women whose Pap smears showed LSIL were enrolled in this study at clinical centers in Birmingham, Oklahoma City, Pittsburgh, and Seattle. Within 6 months of their diagnosis of LSIL, women completed a standardized questionnaire and underwent a pelvic examination at which cervical specimens were collected for HPV DNA testing.
Cells taken from each woman were analyzed for HPV DNA using a commercial assay. In addition, cells from 210 of the women were also tested for HPV DNA by polymerase chain reaction assays. The commercial technique detected HPV DNA in 82.9% of the specimens, while 81.4% of the specimens tested by both methods were positive by both methods.
This high positivity for HPV DNA clearly limits the usefulness of such testing in women with LSIL, the authors conclude. They note, however, that HPV DNA testing may prove beneficial in the management of women with Pap smears showing atypical squamous cells of undetermined significance (ASCUS).
Editorial writers Michele Follen, M.D., M.S., and Rebecca Richards-Kortum, Ph.D., note that, with the relationship of HPV to cervical cancer established, attention has turned to how to use this information to decrease the morbidity and mortality associated with the disease. The expectation in the ALTS Group study was that 50% of LSIL patients would be positive for high-risk HPV types. That 82.9% of the women were positive by the commercial assay makes use of this test ineffective in deciding on treatment options, the editorial writers say. In summary, the ALTS Groups interim analysis suggests that, while the test is biologically plausible and technically feasible, they note that it may not be clinically useful as a primary triage tool in the LSIL population in a developed country like the United States. Meanwhile, cervical cancer screening, detection, and treatment continue to pose different problems in developing versus developed countries. Hopefully, Follen and Richards-Kortum conclude, additional studies will lead to a better understanding of the immunobiologic aspects of HPV infection, tease out the important role of an individuals genetic susceptibility, and rigorously evaluate new and emerging technologies.
Contact: Walter Neary, University of Washington, (206) 543-3620; fax: (206) 685-3333. Editorial, Paula Roberts, University of Texas M. D. Anderson Cancer Center, (713) 745-4780; fax: (713) 792-7586.
Note: This memo to reporters is from the Journal staff and is not an official release of the National Cancer Institute (NCI) or Oxford University Press (OUP) nor does it reflect NCI or OUP policy. In addition, unless otherwise stated, all articles and items published in the Journal reflect the individual views of the authors and not necessarily the official points of view held by NCI, any other component of the U.S. government, OUP, or the organizations with which the authors are affiliated. Neither NCI nor any other component of the U.S. government nor OUP assumes any responsibility for the completeness of the articles or other items or the accuracy of the conclusions reached therein.
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