Screening With Visual Inspection of Cervix After 4% Acetic Acid Could Reduce Cervical Cancer Mortality by 22,000 per Year in India
Cervical cancer is the leading cause of cancer death in women in India, a nation where large-scale Pap smear screening is not feasible. As reported in the Journal of the National Cancer Institute, Shastri et al have performed a large cluster-randomized study of education and screening of Indian women by primary health workers using visual inspection of the cervix following application of 4% acetic acid. The screening strategy was associated with a significant 31% reduction in cervical cancer mortality.
Study Details
In this community-based study, women aged 35 to 64 years were cluster-randomized from 70 low socioeconomic housing clusters in Mumbai to receive four rounds of cancer education provided by trained medical social workers and visual inspection with acetic acid screening performed by trained primary health workers at 24-month intervals (n = 75,360) or one session of cancer education at time of recruitment (n = 76,178). Both groups were monitored by medical social workers at 24-month intervals for cervical cancer incidence and mortality. The planned study duration is 16 years, including four screening rounds and four monitoring rounds. Poisson regression was used to calculate rate ratios (RRs).
The screening group and the control group were well balanced for age (mean, 45 years in both), mean age at marriage (18 years in both), mean age at first child (21 years in both), educational status (primary school for 56% and 54%), occupation (89% and 92% housewife), religion (78% and 79% Hindu), marital status (83% married in both), and previous consultation for gynecologic complaints (11% and 10%).
The current results are for 12 years of follow-up.
Compliance
In the screening group, 89% of participants were screened at least once, with 71.5%, 61.5%, 58%, and 58% participation in screening rounds 1, 2, 3, and 4. Compliance for diagnosis confirmation was 79% and compliance for treatment completion was 85% for precancers and 86% for invasive disease. Annual attrition was 2.2%, and cumulative attrition was 21.5%. The control group had a 91% participation rate for cancer education, 89% compliance with monitoring, 73% compliance with treatment completion, annual average attrition of 2.3%, and cumulative attrition of 23%.
Incidence
After 12 years of follow-up, there were 328 precancers (219 low-grade squamous intraepithelial lesions, 19 high-grade squamous intraepithelial lesions) and 161 invasive cervical cancers in the screening group and 48 precancers (35 low-grade squamous intraepithelial lesions, 13 high-grade squamous intraepithelial lesions) and 166 invasive cervical cancers in the control group. The incidence of invasive cervical cancer was 26.74 per 100,000 population in the screening group and 27.49/100,000 in the control group. Downstaging was statistically significant after three screening rounds and continued to be significant at 4 years after cessation of screening (P = .002).
Mortality Reduction
Death from cervical cancer occurred in 67 women in the screening group and 98 in the control group (RR = 0.69, P = .003). The total numbers of deaths from all causes were 4,909 vs 5,275 (RR = 0.93, P = .41). A small excess incidence of cancer diagnosis (overdiagnosis) in the screening group did not persist after the seventh year of follow-up.
The investigators concluded, “[Visual inspection with acetic acid] screening by primary health workers statistically significantly reduced cervical cancer mortality. Our study demonstrates the efficacy of an easily implementable strategy that could prevent 22,000 cervical cancer deaths in India and 72,600 deaths in resource-poor countries annually.”
Surendra S. Shastri, MD, of Tata Memorial Centre, Mumbai, is the corresponding author for the Journal of the National Cancer Institute article.
The study was supported by grants from the National Cancer Institute and Tata Memorial Centre. Treatment costs were supported by the Women’s Cancer Initiative, India. The study authors reported no potential conflicts of interest.
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