Roxanne Nelson

October 23, 2013

VANCOUVER, British Columbia — A Chinese herbal topical ointment, known as AIJP, has shown promise in treating high-grade anal lesions in people infected with HIV.

According to a new study, presented here at the 10th International Conference of the Society for Integrative Oncology (SIO), complete histologic and clinical response was achieved in 18% of the cohort, and some degree of clinical response was achieved in 39%.

That number is encouraging, said lead author Misha R. Cohen, OMD, LAc, a research specialist from integrative medicine at the University of California Institute for Health and Aging in San Francisco. Spontaneous regression rates of high-grade squamous intraepithelial lesion (HSIL) occur in less than 5% of people infected with HIV.

However, she emphasized that the final analysis is not yet complete.

Anal cancer is a growing public health concern, especially for people who are immunocompromised, Dr. Cohen explained. Human papillomavirus (HPV) is a key factor in development of cervical, anal, and vulvar cancers, and people who are HIV-positive are particularly at risk for the development of HPV-associated anal cancer. The development of anal cancer is preceded by a precancerous HSIL, and treatment can prevent progression to anal cancer, just as cervical cancer is prevented with the treatment of high-grade lesions.

However, "there are no treatment algorithms or standards," she said. "There are some treatments, but they are highly invasive."

Adherence and Completion

Dr. Cohen and colleagues conducted a 60-week trial to evaluate the effectiveness of a noninvasive topical therapy for HSIL in preventing the progression to cancer.

The randomized controlled intent-to-treat efficacy trial compared AIJP ointment and a placebo in patients with histologically confirmed anal HSIL.

The cream was to be applied at home twice a day for 48 weeks; the follow-up period was 12 weeks.

Of the 70 patients enrolled in the study, 56 completed it. The cohort ranged in age from 24 to 74 years; 67% of the subjects were 40 to 59 years of age. The majority of the subjects were non-Hispanic white men. HIV and HSIL status and other demographics were similar in the 2 groups. The majority of study participants had multiple anal lesions.

"The patients in this trial were considered to be ineligible for standard treatment or had refused that treatment," Dr. Cohen explained.

The primary outcomes were pathologic response (progression, no change, or regression) and clinical response (complete, partial, or no response). Secondary outcomes were treatment adherence, drop-out rates, and effect size.

An extensive analysis of the data is underway, but currently, 7 patients (25%) in the treatment group and 3 (11%) in the placebo group have achieved a complete histologic response.

Some degree of clinical response was achieved by 39% of the cohort; 61% had no response.

This was a very long study, Dr. Cohen pointed out, and patients had to apply the cream twice daily. "It was very tightly controlled, so we knew exactly what the adherence was," she said.

Conducting this trial was a learning experience, she noted. "Part of what we learned was how to do this kind of work in the future and how people adhere in terms of treatment," Dr. Cohen explained

Awaiting Final Analysis

Completion of a trial and adherence to a treatment regimen are 2 different things, she continued, and these are aspects of the study that are currently being reviewed. Although the analysis of clinical response to rate of adherence is not yet complete, "we are getting very close to that and will be publishing that information," she said.

Because the rate of spontaneous regression in this population is so low, a response rate of 39% is encouraging, Dr. Cohen concluded. "Patients with partial clinical response might be successfully treated with other therapies after the cream. This is a very important point because the patients in this study could not be treated with other therapies."

If the cream can reduce the extent of the lesions, it might be possible for patients to be treated with therapies such as surgery or ablative therapies," she explained. "That was a very important part of what we were looking at."

The final analysis will show the significance of the histologic and clinical response for the treatment and placebo groups.

After the presentation, Susan Bauer-Wu, PhD, RN, associate professor of nursing at Emory University in Atlanta, and president of the SIO, noted that there appears to be dose response, and that there "seems to be a range," depending on adherence.

It will be important to see those data when the final analysis is completed, Dr. Bauer-Wu said.

The authors have disclosed no relevant financial relationships.

10th International Conference of the Society for Integrative Oncology (SIO): Abstract 87. Presented October 20, 2013.

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