A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women

Abstract

Background:Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China. However, its efficacy and cost comparing with mammography has not been evaluated in randomised trials.Methods:At 14 breast centres across China during 2008–2010, 13 339 high-risk women aged 30–65 years were randomised to be screened by mammography alone, ultrasound alone, or by both methods at enrolment and 1-year follow-up.Results:A total of 12 519 and 8692 women underwent the initial and second screenings, respectively. Among the 30 cancers (of which 15 were stage 0/I) detected, 5 (0.72/1000) were in the mammography group, 11 (1.51/1000) in the ultrasound group, and 14 (2.02/1000) in the combined group (P=0.12). In the combined group, ultrasound detected all the 14 cancers, whereas mammography detected 8, making ultrasound more sensitive (100 vs 57.1%, P=0.04) with a better diagnostic accuracy (0.999 vs 0.766, P=0.01). There was no difference between mammography and ultrasound in specificity (100 vs 99.9%, P=0.51) and positive predictive value (72.7 vs 70.0% P=0.87). To detect one cancer, the costs of ultrasound, mammography, and combined modality were $7876, $45 253, and $21 599, respectively.Conclusions:Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women.

Current Status and Future Projections of Breast Cancer in Asia

“…A nationwide randomized trial in China has been undertaken comparing efficacy and cost in high-risk women aged 30-65 years screened by mammography, ultrasound, or both. Although ultrasound was shown to be superior in terms of accuracy and sensitivity [54], there is presently no sound evidence to justify the routine use of ultrasonography as an adjunct screening tool in Asian women at an average population risk for breast cancer [55]. Population-based studies of clinical breast examination combined with diagnostic ultrasound are ongoing in China [56].…”

Breast Ultrasound Past, Present, and Future

“…This includes the Japan Strategic Anti-cancer randomized Trial (J-START), where the sensitivity was significantly higher in the intervention group (mammography plus ultrasound screening) than in the control group but the specificity was significantly lower (87.7% decreased from 91.4%) [53]. Alternatively, in another multiinstitutional trial including 12,519 Chinese women, the authors found comparable PPVs between mammography and ultrasound screening (72.7 vs. 70.0%), which did not reach statistical significance [54]. The lack of decline in the PPV from one modality to the next in this study may be secondary to emphasis on consistency.…”

Early Diagnosis of Breast Cancer – In Respect to Expectations of Participants in Screening Programs and to Contemporary Research in Imaging Methods

“…It is becoming increasingly apparent that its sensitivity is superior in the normal collective, but especially in the clientele with dense breasts. The sensitivity of ultrasound in recent comparative publications is about 20% higher than that of mammography, can be up to 40% in defined collectives [12][13][14][15][16][17][18][19].…”

“…If BIRADS 3 findings are counted as correct negative, there must be no significant difference in the specificity of ultrasound compared to mammography [17,20].…”

“…If ultrasound, as described above, is a screening method suitable for all women [13,17], why breast ultrasound is recommended mainly as a supplementary examination (complementary to mammography)?…”