A Highly Successful Approach on Memphis Medical News

A Highly Successful Approach

By: LYNNE JETER

Left to right: Todd Tillmanns, MD; Linda Smiley, MD; Mark Reed, MD; Joseph Santoso, MD.

Memphis OB/GYN Identifies Better Examination Method to Screen for Anal Precancerous Lesions

Joseph T. Santoso, MD, a gynecologic oncologist with The West Clinic and a professor at the University of Tennessee Health Sciences Center, recognized that human papilloma- virus (HPV) is common in women and men, and infects the genital areas. Yet no one had studied the anal area except a few pioneer investigators evaluating men who have sex with men. (See related article below.)

Santoso’s concerns about heterosexual women being at risk of HPV infection in the anal area led to an important research study and subsequent lead article that appeared in the September edition of Obstetrics & Gynecology, the official journal of the American College of OB/GYN, identifying a better examination method to screen for anal precancerous lesions with 100 percent sensitivity.

“HPV is very common in American women, who have an 80 percent lifetime risk,” said Santoso, lead author of the study. “Persistent HPV causes genital cancers, and a Pap smear has been very effective in preventing cervical cancer, but this study shows that a Pap smear is ineffective in detecting precursors of anal cancer. Surprisingly, there’s a high rate—32 percent—of anal sex in Mid-South women, as found by our research, which is a possible risk factor for anal cancer. This newer method of anoscopy is better than an anal Pap smear.”

After Santoso explained the research methods to the University Hospital’s institutional review board, approval was granted to initiate the study. From June 2006 to December 2009, the team studied 205 consecutive patients with genital intraepithelial neoplasia referred to the University of Tennessee—West Clinic gynecologic oncology division.

“Patients were included in the study if they had a confirmed diagnosis of genital intraepithelial neoplasia, any anogenital cancer, or absence of a rectum,” explained Santoso. “All patients were evaluated as part of our clinical practice with anal cytology and anoscopy by one gynecologic oncologist, who was trained in high-resolution anoscopy.”

Medical history and demographic data were collected from the chart; unique identifiers were deleted to protect patient privacy, and anonymous data were reviewed in detail.

By asking study participants questions with a professional and non-judgmental approach, Santoso was able to overcome challenges often involved with gaining insight into sexual habits.

“Most patients are pretty open about the regular sexual history—vaginal intercourse, number of partners—when it’s done professionally and discreetly,” he explained. “However, there were a few who seemed embarrassed about having anal sex. I wouldn’t be surprised to learn the rate of anal sex is actually higher than reported, since some may decline to answer truthfully.”

Caucasian women represented the majority of the heterosexual study population practicing anal sex (58 percent), followed by African Americans (41 percent) and Hispanics (2 percent). Participants who underwent anal cytology and anoscopy ranged in age from 14 to 83 years; the average age was 39.6.

“Perhaps we’ve become more liberal and experimental with our sexual life,” Santoso said, speculating about the trend of women practicing anal sex. “When you talked to teenagers, some are having anal intercourse to protect their vaginal virginity.”

Most of the females were single (43 percent); 36 percent were divorced and 2 percent were widowed. Nearly four in 10 women (37 percent) were married. They reported the time span of a male sex partner averaged 6.4 years; 5 percent were HIV-positive, based on medical history. Perhaps more surprisingly, 36 percent of participants were not sexually active at the time of the study.

Two aspects of the study process most interested Santoso. “First, there’s a significant number of women at risk for anal dysplasia when they have an abnormal Pap smear or other genital dysplasia,” he said. “Second, that there’s a high rate of anal intercourse in the Bible belt areas.”

Results showed that the two common screening methods for anal cancer—anoscopy and anal cytology—are statistically different.

“Because a better screening method is the test with higher sensitivity, anoscopy (100 percent sensitivity) is a better screening test for anal intraepithelial neoplasia than anal cytology (8 percent sensitivity),” Santoso said.

Santoso plans to soon launch a follow up study by “looking into enlarging the study,” he said, “and evaluating what specific life risk factors contribute to anal dysplasia.”

Related article

In a Nutshell

The objective of the research study, “Anal Intraepithelial Neoplasia in Women with Genital Intraepithelial Neoplasia,” was to estimate the prevalence of anal intraepithelial neoplasia (AIN) in heterosexual women with genital intraepithelial neoplasia, and to compare anal cytology with colposcopy for its effectiveness in anal intraepithelial neoplasia screening.

Led by Joseph T. Santoso, MD, a gynecologic oncologist with The West Clinic and a professor at the University of Tennessee Health Sciences Center, and assisted by Mary Long, MD, Mary Crigger, RN, OCN, Jim Y. Wan, PhD, and Hope K. Haefner, MD, the study focused on women with confirmed intraepithelial neoplasia on the cervix, vagina, or vulva who were referred for gynecologic oncology care. All patients underwent anal cytology and high-resolution anoscopy, with any lesion that was detected on anoscopy biopsied. McNemar’s test compared the two screening methods.

“There are no clear data on how to screen for anal intraepithelial neoplasia,” said Santoso. “Although formal guidelines recommending anal Pap test screening haven’t been adopted by the U.S. Public Health Service, some specialists recommend anal cytologic screening for HIV-infected men and women. Some investigators recommended anal cytology as the screening method for anal intraepithelial neoplasia with high-resolution anoscopy to follow for abnormal anal cytology. This recommendation, however, hasn’t been tested in a research setting nor accepted completely by others. Other studies suggest anoscopy as a better method to diagnose AIN than anal cytology. Additionally, there’s no formal consensus on how to treat it. Many healthcare providers treat AIN as they do cervical intraepithelial neoplasia, with ablation therapy—infrared coagulation, tricholoroacetic acid—or surgical excision.”

Of the 205 patients with genital intraepithelial neoplasia, 25 patients had biopsy-proven AIN, while 12 patients had abnormal anal cytology. There were 78 patients with abnormal anoscopy findings that resulted in 25 biopsy-proven anal intraepithelial neoplasias. In diagnosing AIN, anoscopy has 100 percent sensitivity and 71 percent specificity, while anal cytology has 8 percent sensitivity and 94 percent specificity.

“The prevalence of anal intraepithelial neoplasia is unknown,” Santoso discussed. “The prevalence of anal intraepithelial neoplasia in women in the general population with genital intraepithelial neoplasia and the methods for screening for anal intraepithelial neoplasia hasn’t been studied extensively. We found a significant rate of anal intraepithelial neoplasia in women with intraepithelial neoplasia of the cervix, vulva, or vagina. It was expected that anal intraepithelial neoplasia would be present in these women, considering that human papillomavirus (HPV) infects all of these locations. However, we didn’t expect that greater than 10 percent of women with genital intraepithelial neoplasia also suffer from anal intraepithelial neoplasia.

These findings suggest that women with cervical, vulvar, or vaginal intraepithelial neoplasia should be screened with high-resolution anoscopy for anal intraepithelial neoplasia. This is an important finding because the care of women with lower genital tract intraepithelial neoplasia has traditionally been followed by healthcare providers who haven’t been trained in high-resolution anoscopy. Collaboration between specialties that provide care for women is needed to optimize anal intraepithelial neoplasia screening.”

Santoso and his team concluded that patients with cervical, vulvar, and vaginal intraepithelial neoplasia have 12 percent prevalence of AIN and should be screened with high-resolution anoscopy. In AIN screening, anoscopy is more sensitive, yet less specific than anal cytology.