ASCO 2013: Cervical Cancer Screening Using Visual Inspection with Vinegar Reduces Mortality by 31% in Large Study in India
Cervical cancer mortality was reduced by 31% over a period of 15 years among women screened with biennial visual inspection with acetic acid (VIA), or vinegar, delivered by primary health workers in a large randomized study conducted among 150,000 women in India. The researchers estimate this strategy could prevent 22,000 cervical cancer deaths every year in India and close to 73,000 in resource-poor countries worldwide where there is little or no access to Pap screening. Cervical cancer is responsible for more than 250,000 deaths worldwide annually.
“This is the first trial to identify a cervical cancer screening strategy that reduces mortality and is feasible to implement on a broad scale throughout India and in other developing countries. Our trial used primary health-care workers who can easily access women in the community, which is critical in India and other countries that lack sufficient nurses, physicians, and laboratory facilities,” the study’s lead author, Surendra Srinivas Shastri, MD, explained at the 2013 ASCO Annual Meeting (Abstract 2). Dr. Shastri is Professor of Preventive Oncology at Tata Memorial Hospital in Mumbai, India. “We are already working with state and national health authorities in India to make this screening strategy and health education available to women throughout the country,” he added.
VIA a Reasonable Alternative
Previous studies have suggested that the low cost and ease of use of visual screening with acetic acid make it a reasonable alternative to Pap smears or human papillomavirus (HPV) DNA testing in areas where such these tests may not be feasible or available. The test is performed by applying vinegar to the cervix using a cotton swab. After 60 seconds, the cervix is visually examined using a lamp. Precancerous tissue turns white when vinegar is applied, whereas healthy tissue does not change color. (The test is sometimes used in the United States as a visualization technique in evaluating gynecologic patients, but not as cancer screening.) The results are known immediately, a very important advantage in rural areas where women might have to travel for hours for medical care. All trial participants were offered free cervical cancer treatment, if diagnosed.
In accordance with international standards for clinical research that interventions be tested against the local standard of care, women in the study were randomly assigned to biennial screening with VIA (75,360 women) or no screening (76,178 women). The women ranged in age from 35 to 64 years and had no prior history of cancer.
High Level of Community Involvement
VIA was performed by primary health workers, community-based, nonmedical personnel who receive special training and provide basic health-care services in areas where physicians and nurses are unavailable. According to Dr. Shastri, primary health workers are the only health professionals available to deliver VIA screening in remote and rural parts of India. The primary health workers that performed the screenings for this study were local women with at least a 10th grade education and good communication skills. The workers received 4 weeks of intensive training at the beginning of the study, and 1-week refresher courses every year.
“The quality of screening by primary health workers was comparable to that of an expert gynecologist (κ = 0.84),” the researchers reported. As Dr. Shastri explained, “5% of all women who were screened by the primary health workers were also independently screened by an expert. A third person matched the findings from the expert with the community health workers’ findings, and we had an agreement of greater than 95%.”
The screening group received four rounds of VIA screening and cancer education at 24-month intervals between 1998 and 2010. The control group received one round of cancer education at enrollment. On the basis of what they had learned during the initial cancer education sessions, women in the control group were asked to report to the primary health workers any signs/symptoms of cervical cancer that they noticed. The health workers then directed them to the Tata Memorial Hospital, where they received diagnosis and treatment at no cost, or to other nearby facilities of their choice.
Dr. Shastri reported that local communities were involved in helping to set up the screenings. “This ensured a sense of community participation, a sense of community ownership,” he said.
Individual participation was also high. “In the screening group, we achieved 89% participation for screening and 79% for postscreening diagnostic confirmation,” the investigators stated.
Comparable Incidence but Not Mortality
The incidence of invasive cervical cancer was comparable in the two groups (26.7 per 100,000 in the screening group and 27.5 in the control group), suggesting that screening did not lead to overdiagnosis. Cervical cancer–specific death rates, however, were reduced by 31% in the group screening with VIA. The rates were 11.1 per 100,000 in the screening groups vs 16.2 in the control group (mortality rate ratio = 0.69; 95% confidence interval [CI] = 0.54–0.88; P = .003). Cancer was often diagnosed at an earlier stage in the screening group, and there was a 7% reduction in the overall death rate, although the difference was not statistically significant (mortality rate ratio = 0.93; 95% CI = 0.79–1.10; P = .41).
According to the authors, based on the results of their study, 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 aged 35 to 64 years in the state—including women who participated in the study—using the same 24-month interval as the trial. In addition, the authors stated that the Indian government is working to implement VIA screening countrywide and has plans to reach out to other low- to moderate-income countries to inform them of these results and offer training resources.
Lack of Infrastructure
In high-income countries, screening for precancerous and cancerous cells using Pap smears has reduced cervical cancer incidence and deaths by 80%. In India, however, large-scale Pap smear screening or HPV DNA testing is not currently possible due to lack of resources, laboratory infrastructure, and medical professionals.
In 1996, around the time this study was initiated, the Indian Council of Medical Research estimated that, even if the number of existing Pap smear facilities in India were multiplied 12 times, they would only be able to provide a single round of screening to 25% of eligible women in 10 years. In 2006, the Government of India constituted a committee with assistance from the World Health Organization to develop guidelines for population-wide cervical cancer screening in India. This committee again observed that Pap smear–based cervical screening was not feasible in India except at a few centers.
Given that cervical cancer is the leading cause of cancer death in women in India, a strategy implementing early detection and treatment of the disease could have a profound impact.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
