Effectiveness of triennial screening with clinical breast examination: 14‐years follow‐up outcomes of randomized clinical trial in Trivandrum, India. Issue 2 (1st November 2022)

• Record Type: Journal Article
• Authors: Ramadas, Kunnambath; Basu, Partha; Mathew, Beela S.; Muwonge, Richard; Venugopal, Muraleedharan; Prakasan, Aparna M.; Malu, Rafi; Lucas, Eric; Augustine, Paul; Mony, Rari P.; Thara, Somanathan; Sankaranarayanan, Rengaswamy
• Is Part Of: Cancer. Volume 129:Issue 2(2023)
• Page Start: 272
• Page End: 282
• Publication Date: 2022-11-01
• Subjects: breast cancer -- breast cancer mortality -- clinical breast examination -- randomized clinical trial -- screening; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.34526
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract: Background: This study presents the preliminary results of a randomized controlled trial (RCT) initiated in January 2006 in India to evaluate the effectiveness of clinical breast examination (CBE) in reducing breast cancer mortality as compared to a no‐screening control group reported significant downstaging in the intervention group. The present manuscript reports long‐term follow‐up outcomes. Methods: Women 30–69 years old from 133 intervention clusters and 141 control clusters were invited to participate. Women in the intervention arm underwent three rounds of CBE every 3 years. CBE‐positive women were reexamined by a physician, and triple‐assessment was performed on those confirmed to have abnormalities. All participants were followed through home visits and linkage with population‐based cancer registry. Results: Of the 55, 843 eligible women in the intervention arm, 95.7% had CBE at least once and 11.5% were CBE‐positive. Breast cancers were diagnosed in 335 participants in the intervention group and 273 in the control group ( N = 59, 447). Age‐standardized incidence rate of early cancer was 30.4 of 100, 000 in the intervention and 21.9 of 100, 000 in the control group, with a rate ratio (RR) of 1.4 (95% confidence interval [CI], 1.1–1.8). The age‐standardized breast cancer mortality rates were 11.3 and 11.1 per 100, 000 in intervention and control arms, respectively (RR, 1.1; 95% CI, 0.8–1.5) after 15 years. Five‐year breast cancer survival rates were 77.0% in the intervention and 71.2% in the control groups (overall p value = .043). Conclusions: Triennial CBE screening failed to demonstrate any mortality benefit despite achieving a shift toward earlier stage at detection and improved survival in the intervention arm. CBE is a valuable tool for diagnosis of breast cancer in symptomatic women especially in areas where mammography and/or breast cancer screening programs are not widely available. Abstract : The authors demonstrated that an "early diagnosis" approach can be as effective as clinical breast examination screening in reducing breast cancer mortality. These observations have major policy implications.