Dense Breast Progress on Two Fronts: New Trial Results and State Bills Head to Governors
State Insurance Bills
Bills in both Alabama and Wisconsin have advanced to the Governor’s desk. Stay tuned for more details if/when the bills are signed into law.
J-START TRIAL FOLLOW-UP
The J-START, a prospective Japanese randomized trial that compared Mammography plus Ultrasound (US, intervention group) to Mammography alone (control group) in women age 40 to 49 years of age previously showed, as primary endpoints, that the intervention of adding US twice in two years improved detection of early stage (0 or 1) breast cancer and reduced interval cancers, but lowered specificity. In a subset analysis, US improved early breast cancer detection in both nondense and dense breasts.
Longterm follow-up (median exceeding 11 years) is now available, showing significant reduction in advanced stage cancers (stage II or higher: node positive or T2 or both) in the intervention group.
- 234/894 (26%) carcinomas were advanced stage at diagnosis in the intervention group
- 277/843 (33%) carcinomas were advanced in the control group.
- Hazard ratio for advanced stage at diagnosis was 0·83, 95·6% CI 0·70–0·98; p=0·026)
- Divergence between groups emerged around year four, widened until year eight, and remained stable thereafter.
In an accompanying editorial, DBI Medical Advisory Board members Drs Jean Seely and Paula Gordon point out that the magnitude of reduction in advanced cancers due to addition of US in women 40-49 is similar to the magnitude of mortality reduction attributable to screening mammography in that age group across randomized trials. These results are quite compelling for Asian women, though may not generalize to all populations. In many other studies in other patient populations, US has been shown to substantially improve early breast cancer detection when added to annual or biennial 2D mammography in women with dense breasts. The benefits of screening US are very small, however, in women having annual tomosynthesis.