Roxanne Nelson

June 03, 2013

CHICAGO — A simple screening technique using an inexpensive agent dramatically reduced deaths related to cervical cancer in a population of Indian women. Visual inspection with acetic acid or vinegar (VIA), conducted by nonmedical personnel trained to deliver basic healthcare, cut the death rate by 31%.

This strategy is effective and can be implemented on a broad scale in low-income countries. "There was almost no overdiagnosis, it doesn't require a laboratory, and it can be widely implemented in the lowest-resource settings, such as India," said lead study author Surendra Srinivas Shastri, MD, professor of preventive oncology at Tata Memorial Hospital in Mumbai, India.

"If implemented nationally in India, it could prevent 22,000 cervical cancer deaths," said Dr. Shastri, who presented the findings of this large randomized trial during a plenary session here at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO®). "If taken globally to the lowest-resource countries, it could prevent around 72,000 deaths in the developing world."

Cervical cancer is the leading cause of cancer-related mortality in women in many developing nations, where access to Pap test screening is very limited or nonexistent. Widespread Pap test screening in high-income countries has significantly reduced the incidence and subsequent death rate from cervical cancer by 80%.

"There is no cervical cancer screening program in India because it is not feasible," explained Dr. Shastri. "There is inadequate infrastructure, a lack of trained human resources, logistic difficulties, and a relatively high cost."

Therefore, the researchers looked at VIA, which is a simple visual test that can be done without laboratory support. "It consists of an application of 4% vinegar to the cervix, and the results are available in 1 minute," Dr. Shastri explained. "Paramedical workers can be trained in 4 weeks."

VIA Validated

What is unique about this study is that it was conducted in the slums of Mumbai in an unscreened population, and participation was high and the size of the sample was large, said Electra D. Paskett PhD, professor of medicine at the Ohio State University Comprehensive Cancer Center in Columbus.

"What is essential here," said Dr. Paskett, who served as a discussant for the study, "is the fact that both diagnostic and treatment services were available to women in both arms without any charge."

She suggested that a follow-up study might compare VIA with low-cost testing for human papillomavirus, which has also been studied in low-resource settings.

Dr. Paskett pointed out that there are several take-home messages from this study; namely, that the VIA method has been validated, has been accepted, is inexpensive, can be use in low-resource areas, and can save lives.

Study Details

In this trial, VIA was performed by community-based nonmedical primary health workers trained to provide basic healthcare services in regions that lack physicians and nurses.

The researchers had to pass through several levels of community barriers, such as community leaders and religious leaders, before being able to speak with the women. "We involved the community, giving them a sense of participation, and we were able to create as sense of community ownership," Dr. Shastri said. "This ensured better participation."

Dr. Shastri and colleagues initiated this cluster randomized controlled trial in 1998 to evaluate the ability of VIA screening to reduce cervical cancer mortality.

The participants were 35 to 64 years of age and had no history of cancer. The study design involved 20 clusters, each with an average of 7500 eligible women. Ten clusters served as the screening group (n = 75,360) and 10 served as the control group (n = 76,178).

In the screening group, 4 rounds of cancer education and VIA screening were conducted by primary health workers at intervals of 24 months. In the control group, cancer education was offered once at recruitment.

Study recruitment was completed in March 31, 2002. Although the researchers had planned for a 16-year study, they analyzed results at 12 years.

Drop in Mortality

Compliance was high, with 89% participation in screening and 79% compliance with postscreening diagnostic confirmation. The researchers note that the quality of screening performed by the primary health workers was comparable to that of an experienced gynecologist (κ = 0.84).

The incidence of invasive cervical cancer was similar in the screening and control groups (26.74 vs 27.49 per 100,000).

For those with invasive cancer, treatment compliance was higher in the screening group than in the control group (86.34% vs. 72.29%). In the screening group, there was a 31% drop in mortality related to cervical cancer, compared with the control group (rate ratio [RR], 0.69; 95% confidence interval, 0.54 - 0.88; P = .003).

In addition to the decrease in deaths related to cervical cancer, there was also a 7% reduction in all-cause mortality (RR, 0.93; P = .41).

On the basis of these results, the Indian health officials in Maharashtra state, where the trial was conducted, are preparing to train primary health care workers to provide VIA screening to all women 35 to 64 years of age at 24-month intervals. In addition, the Indian government is working to implement nationwide VIA screening, and is planning to reach out to other low- to moderate-income countries to share these results and offer assistance with training.

The study was supported by the National Institutes of Health and Women's Cancer Initiative. The authors have disclosed no relevant financial relationships.

2013 Annual Meeting of the American Society of Clinical Oncology: Abstract 2. Presented June 2, 2013.


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