VIA screening by primary health workers statistically significantly reduced cervical cancer mortality. Our study demonstrates the efficacy of an easily implementable strategy that could prevent 22000 cervical cancer deaths in India and 72600 deaths in resource-poor countries annually.

Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries. In May 1998, supported by a grant from the NCI (US), the Tata Memorial Hospital, Mumbai, India, started a clusterrandomized, controlled, screening-trial for cervix and breast cancer using trained primary health workers to provide healtheducation, visual-inspection of cervix (with 4% acetic acid-VIA) and clinical breast examination (CBE) in the screening arm, and only health education in the control arm. Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers. The methodology and interim results after three rounds of screening are presented here. Good randomization was achieved between the screening (n 5 75360) and control arms (n 5 76178). In the screening arm we see: High screening participation rates; Low attrition; Good compliance to diagnostic confirmation; Significant downstaging; Excellent treatment completion rate; Improving case fatality ratios. The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion, language, age, education, occupation, income and health-seeking behavior for gynecological and breast-related complaints. During the same period, in the control arm we see excellent participation rate for health education; Low attrition and a good number of symptomatic referrals for both cervix and breast.Of the estimated 470,000 new cases of cervix cancer diagnosed each year worldwide, 80% occur in developing countries and around 27% occur in India from where 126,000 new cases are diagnosed annually and over 71,000 deaths because of cervix cancer are reported each year.1,2 Nearly 70% of cervix cancer patients in India present at stages III and IV.3 Around 20% of women who develop cervix cancer die within the first year of diagnosis and the 5-year relative survival rate is 50%. 4 Breast cancer is the most common cancer among women worldwide and is also the leading cause of cancer deaths in women. Breast cancer is responsible for an estimated 189,000 and 184,000 deaths in developed and developing countries respectively thus accounting for 16% and 12% of all cancer deaths in women. Although the age-standardized incidence of breast cancer is generally lower in developing countries than in developed countries (23.1 vs. 63.2 per 100,000 women), incidence rates are seen to vary widely between and within countries. Breast cancer is already more common than cervix cancer in a number of developing countries.5 Data from developing countries suggests that age-standardized incidence rates of breast cancer are rising rapidly in low-incidence regions such as Africa and Asia. 6 There are no organized screening programmes for cervix and breast cancers in India. Cervix Cytology and Mammography based screening programmes are difficult to organize in India because of issues related to absence of trained manpower, infrastructu...

Objective To test the efficacy of screening by clinical breast examination in downstaging breast cancer at diagnosis and in reducing mortality from the disease, when compared with no screening. Design Prospective, cluster randomised controlled trial. Setting 20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis). Participants 151 538 women aged 35-64 with no history of breast cancer. Interventions Women in the screening arm (n=75 360) received four screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years, followed by five rounds of active surveillance every two years. Women in the control arm (n=76 178) received one round of cancer awareness followed by eight rounds of active surveillance every two years. Main outcome measures Downstaging of breast cancer at diagnosis and reduction in mortality from breast cancer. Results Breast cancer was detected at an earlier age in the screening group than in the control group (age 55.18 (standard deviation 9.10) v 56.50 (9.10); P=0.01), with a significant reduction in the proportion of women with stage III or IV disease (37% (n=220) v 47% (n=271), P=0.001). A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97) v 24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07). However, a post hoc subset analysis showed nearly 30% relative reduction in breast cancer mortality in women aged 50 and older (24.62 (20.62 to 29.76) v 34.68 (27.54 to 44.37); 0.71 (0.54 to 0.94); P=0.02), but no significant reduction in women younger than 50 (19.53 (17.24 to 22.29) v 21.03 (18.97 to 23.44); 0.93 (0.79 to 1.09); P=0.37). A 5% reduction in all cause mortality was seen in the screening arm versus the control arm, but it was not statistically significant (rate ratio 0.95 (95% confidence interval 0.81 to 1.10); P=0.49). Conclusions These results indicate that clinical breast examination conducted every two years by primary health workers significantly downstaged breast cancer at diagnosis and led to a non-significant 15% reduction in breast cancer mortality overall (but a significant reduction of nearly 30% in mortality in women aged ≥50). No significant reduction in mortality was seen in women younger than 50 years. Clinical breast examination should be considered for breast cancer screening in low and middle income countries. Trial registration Clinical Trials Registry of India CTRI/2010/091/001205; ClinicalTrials.gov NCT00632047 .