Embargoed until March 23, 1999

Contact: Johanna Spangenberg (703) 527-424 [email protected]
Donna Krupa (703) 527-357 [email protected]

NEW RESEARCH STUDIES OFFER NEW HOPE FOR SCREENING AND TREATING HIV-POSITIVE WOMEN WITH GYNECOLOGIC CANCERS

Results of First Clinical Trials for Topical Creams for HIV-Positive Women, Pap smear accuracy, and conization efficacy for HIV-Positive females are all examined at the 30th annual gathering of the Society of Gynecologic Oncologists.

SAN FRANCISCO March 23, 1999 -- Gynecologic oncologists will be presenting four research studies regarding the screening, diagnosis and treatment of HIV-Positive women with gynecologic, or reproductive tract cancers.

The four research studies will be presented before the 30th Annual Meeting of the Society of Gynecologic Oncologists (SGO) being held at the Hyatt Regency in Embarcadero Center, San Francisco, CA, March 20-24, 1999. Summaries of the four research studies follow:

A Phase Three Randomized Trial of Topical Vaginal 5-Fluorouracil (5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High Grade Cervical Dysplasia in HIV-Infected Women: ACTG 200. Mitchell Maiman, MD, Heather Watts, MD, and Janet Andersen, all of the AIDS Clinical Trial Group, joined together to measure the effectiveness of topical vaginal 5-FU (an antineplastic effective in the treatment of some carcinomas) for treating high grade cervical dysplasia in HIV-Positive women.

Methodology: In Phrase three of the test, 101 HIV-Positive women after standard treatment for CIN were scheduled to receive vaginal 5-FU vaginal cream or observation only. The test period was six months. Pap smears and colposcopy were scheduled for both study groups for 18 months after the study period.

Results: Of the entire study group, 38 percent developed recurrence. 14 of 50 (28 percent) of those receiving the cream had recurrence compared to 24 of 51 (47 percent) with observation only. This and the detailed results demonstrate that 5-FU is a safe and therapeutic option to reduce the recurrence of CIN after surgical treatment for CIN in HIV-Positive women.

The False Negative Rate of Conventional Pap Smears in High-Risk HIV Seropositive and Seronegative Women. Many reports contend that a significant false negative rate governs colposcopic evaluation of all HIV-positive women. Annekathryn Goodman, MD from Massachusetts General Hospital and three colleagues from research centers in Cambridge MA and Providence, RI, set out to find if there was a significant difference in the false negative rate as determined by a woman's HIV status.

Methodology: Women attending an STD clinic at Cambridge Hospital and a women's prison in Massachusettes were tested. Blood was drawn from each for HIV testing. An examiner, unaware of each woman's HIV status, then conducted cervical scraping, colposcopy and a Pap smear.

Results: Of the l84 women who volunteered to participate in the study, 82 were HIV-negative, 102 were positive. For the women with a negative status, the false negative rate was 20 percent; the corresponding rate for those with a positive status was 37 percent, indicating a difference between the two groups, and questioning the accuracy of Pap smears administered to HIV-positive women.

The Efficacy of Cervical Conization in the Treatment of Cervical Intra epithelial Neoplasin (CIN) in HIV-Positive Women was examined by Kevin Holcomb MD, and five fellow physicians from the State University of New York Health Science Center, Brooklyn, NY. They set out to determine if conization was an effective means of eradicating cervical Intra epithelial neoplasia (dysplastic changes in the uterine cervix that may precede a squamous cell carcinoma) in HIV-positive women.

Methodology: 158 cone biopsies were conducted on 117 HIV-positive women during the study period. The patients were categorized by surgical cone margins and scrapings within the cervix.

Results: The researchers found that 54 percent of the patients with negative surgical margins and scrapings had a recurrence of CIN. This compares to a 69 percent corresponding rate for patients with positive margins and scrapings. The rates for both indicate that conization is not an effective procedure for eradicating CIN in HIV-Positive women.

The Significance of ASCUS (Atypical Squamous Cells of Unknown Significance) in HIV-Positive Women was another study carried out by Dr. Holcomb and his fellow researchers from SUNY-Brooklyn. Their objective was to assess the incidence and severity of cervical dysplasia associated with a diagnosis of ASCUS in HIV-Positive women.

Methodology: Researchers identified ASCUS in 27% of pap smears performed on 261 HIV-Positive women. The grade and incidence of CIN diagnosed by cervical biopsy, endocervical scraping, or cone biopsy was measured.

Results: Within the study group, the incidence of Human Papilloma Virus (HPV), low grade CIN, and high grade CIN was found to be 40 percent, 17 percent, and 15 percent, respectively. No cases of invasive cancer were found; however, the researchers contend the results show that HIV-Positive women have a high risk for cell abnormalities but the HIV infection in itself does not increase the frequency of CIN associated with ASCUS. They conclude that all HIV-Positive women with an ASCUS pap smear should undergo colposcopic evaluation.

SEE OUR ABSTRACTS ON LINE AT THE SGO Website

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EDITOR'S NOTE: Those desiring a copy of the manuscripts for one or all of the studies, or to interview the research presenter, should contact Johanna Spangenberg at jmsdc@ aol.com or (703) 527-7424 or Donna Krupa at (703) 527.7357.