Support HIV & Anal Cancer Screening study

September 8, 2011

Clinical & Translational Research Operations Committee
National Cancer Institute
National Institutes of Health

Dear members of the CTROC:

The undersigned HIV community organizations would like to express their support for AIDS Malignancy Consortium’s proposed HGAIN Outcome Study (HOST). Rates of anal cancer and resulting death and morbidity in HIV-infected men and women are unacceptably high, and will likely continue to increase even further as the population ages. In fact, the Centers for Disease Control and Prevention (CDC) estimates that by 2015 more than half of all people living with HIV in the United States will be over 50, placing a substantial proportion of at risk.

Anal cancer is very similar biologically to cervical cancer. Cervical cancer prevention efforts—including screening for and treatment of high-grade cervical intraepithelial neoplasia (CIN)—have been one of the great public health successes of the last 50 years. Similarly, it is likely that detection and treatment of high-grade anal intraepithelial neoplasia (HGAIN) will reduce the incidence of anal cancer and save thousands of lives. Anal cancer affects all sexually active men and women in the general population. Anal cancer also disproportionately affects vulnerable populations such as those with HIV and other causes of immunosuppression, many of whom come from under-served minority groups.

We are greatly troubled by the fact that the vast majority of at-risk men and women do not have access to these preventive services, because they are not yet considered standard of care. They are not yet standard of care because it has not yet been proven in clinical trials that treatment of HGAIN reduces the incidence of anal cancer. The 2009 USPHS Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents states that “… studies of screening and treatment programs for AIN 2 or 3 should be implemented before definitive recommendations for anal cytology screening can be made”.

The HOST study is critical to obtaining the evidence needed to prove that implementation of screening and treatment services have the potential to save thousands of lives each year—in addition to being highly cost-effective. We have reviewed the proposed study design and find that the study as proposed is both ethical and feasible. We believe that the
study should begin as soon as possible.

This trial also provides a unique opportunity to study the progression of high-grade precancerous HPV lesions to invasive cancer. This would be unethical to do with cervical cancer given that screening and treatment of lesions is the accepted standard of care, and oral HPV often does not form well-defined precancerous lesions that can be followed. The HOST study's observation arm with a cancer endpoint, and an associated biobank, affords researchers an opportunity to study the progression to cancer, develop novel biomarkers that might determine who needs treatment and who doesn’t, and guide the development of novel therapies.

In summary, we urge you to support the host study immediately and fully. As the population of HIV-infected men and women ages, cancer is a growing concern. Screening and treatment of HGAIN offers one of the few opportunities to reduce the incidence of cancer in these groups. The HOST study is essential to making anal cancer screening standard of care, as well as to obtain critical scientific data that will benefit all men and women at risk of HPV-associated cancer. The potential impact of this study on lives saved and science learned will be enormous.

Sincerely,