Posted on February 22, 2001 at 12:45 p.m.
BIRMINGHAM, AL — Testing for the human papillomavirus (HPV) may help doctors and patients decide what to do about the mildly abnormal and very common Pap test result known as ASCUS, according to a national multi-center study in which UAB (University of Alabama at Birmingham) played a major role.
The initial findings from the major study are being published Feb. 21 in the Journal of the National Cancer Institute (NCI). They indicate that HPV testing is highly sensitive in identifying which Pap-detected abnormalities require immediate attention, according to Dr. Edward Partridge, who headed the UAB arm of the study. Partridge heads the division of gynecology-oncology at UAB, which was one of four centers nationwide involved in the study.
More than 5,000 women — including 1,500 at UAB — participated in the randomized study. Other centers were at the University of Oklahoma, University of Washington, and the University of Pittsburgh Medical Center. About two-thirds had ASCUS (atypical squamous cells of undetermined significance) and one-third had the more definite abnormality called LSIL (low-grade squamous intraepithelial lesion).
The ASCUS and LSIL Triage Study (ALTS) was a three-year effort sponsored by the NCI. What to do about mildly abnormal Pap test results has been a major issue in cervical cancer screening. Most of the ASCUS results go away without treatment, but physicians and patients have had no way to tell which few cases represent more serious conditions — precancer or cancer — that need to be treated.
“These results are based on data from the first of the three years of the study and indicate that HPV testing is an excellent option for women and their doctors to consider when making decisions about these results,” Partridge said. “This phase of testing showed that HPV testing identified virtually all (96 percent) of the ASCUS abnormalities that needed treatment. A negative HPV test in these cases provides women with strong peace of mind that precancer or cancer is not present.”
Partridge noted that two other approaches to ASCUS remain options to consider — a procedure called colposcopy in which a physician examines the cervix through a magnifying instrument and biopsies any abnormal areas, or follow-up by repeat Pap tests every six months. Cost and patient preferences may be taken into account by patients and physicians when regarding follow-up appointments. Long-term analysis of the data will include information on the cost effectiveness of the various options.
“Now we know HPV testing is effective, but it is an added cost. Because cervical cancer is such a slow-growing disease, taking 10 years to develop, it may be that repeating the Pap smear in six months is just as effective and perhaps cheaper,” Partridge says. “The psychological aspect of asking a woman to wait six months for definitive answers must also be factored into the equation.”
The study will be able to answer these questions through analysis of data from the entire ALTS trial, he says. He expects official recommendations from the analysis to be published in about a year.
Drs. Larry Kilgore (OB/GYN) and Isam Eltoum (Pathology) were co-principal investigators on the trial. Shirley Hester was the study manager and Carole Shaw was data manager. Pap tests were performed under the direction of Janie Roberson, and HPV tests were performed under the direction of Gina Coshatt.