Pennsylvania Insurance Law, New Study on Risk & SABCS News
New State Insurance Law
A new insurance law in Pennsylvania expands no-cost breast imaging coverage. Please see the Pennsylvania legislative analysis from DenseBreast-info HERE.
New Study
Esserman et al published results from the WISDOM (Women Informed to Screen Depending on Measures of Risk) trial in JAMA. The authors sought to demonstrate that reduced screening based on lower risk was safe. Due to low adherence to recommended screening (with contamination in the annual arm), as indicated in the accompanying editorial, the effectiveness of such an approach remains uncertain. Breast density and other characteristics of women with symptomatic or advanced cancers were not specified. The approach of not screening “low-risk” women in their 40s is particularly problematic for Black, Hispanic, and Asian women who have earlier peak onset of breast cancer and more frequent distant disease at presentation. See also the commentary by the Society of Breast Imaging.
A total of 28,732 women age 40-74 from all 50 states were randomized to risk-based screening or annual mammography.1 Women were followed a median of 5.1 years (up to 10) and cancers, biopsies, and screening were self-reported.
- There was no significant difference in rate of stage IIB or higher breast cancers.2 Similar numbers of stage 0, stage I, and stage IIA cancers were seen in both groups (see eTable 5 in Supplement 1).
- The rate of breast biopsies was not different.3
- Reported adherence to recommended screening was less than 50% even in the first year for all participants and declined each year.
- Women in the annual arm were given risk assessment and told they were at elevated risk if they had BCSC 5-year risk > 5% but were not changed screening assignments.
- While MRI use was more frequent in the risk-based arm (but was lower than expected), a substantial number of MRI examinations were performed in the annual arm.4
Women in the elevated and high-risk groups were counseled on risk-reducing medications, but use remained very low (5.6% at baseline, increasing to 10.3% with intervention, in the highest-risk group and 3.5% increasing to 4% in the elevated risk group).
1 A total of 14212 women were randomized to risk-based screening based on the BCSC Risk Assessment Tool (which includes breast density) and polygenic risk score genetic testing, with 2% (291) “high risk” (≥6% 5-year risk or carrier of known pathogenic variant) and recommended to have alternating 6-month mammography and MRI; 8% (1121) “elevated risk” (top 2.5% of risk by age or extremely dense breasts, or intermediate genetic risk variant) assigned to annual mammography; 63% (8796) “average risk” assigned biennial mammography beginning at age 50; and 27% (3716) “low risk” (women less than 50 with <1.3% 5-year risk). The other 14160 women were randomized to annual mammography screening.
2 There were 41 stage IIB or higher cancers in the risk-based arm (63.1/100,000 person-years) and 43 (68.2/100,000 person-years) in the annual arm (rate ratio 0.92, 95%CI 0.60 to 1.43).
3 There were 1029 biopsies in the risk-based arm (1371/100,000 person-years) and 943 in the annual arm (1272/100,000 person-years, rate ratio 1.08 (95%CI 0.99 to 1.18).
4 Rate of MRI per 100,000 person-years was 1187 in the risk-based arm and 795 in the annual arm (rate ratio 1.49, 95%CI 1.34 to 1.66).
Announced at SABCS
At the San Antonio Breast Cancer Symposium last week, Astrin Biosciences presented encouraging results from an AI-proteomics-based liquid biopsy to detect breast cancer. Specifically:
- High sensitivity and specificity of over 92% each were found in the validation set of 202 cancer cases and 195 controls, with AUC of 0.975.1
- Sensitivity was maintained across all stages2 and subtypes.3
- Patient demographics did not significantly affect results, though further study is warranted.
- They confirmed they were indeed identifying cancer-associated proteins and pathways versus inflammatory markers.
Sources of false positives will be important to understand and mitigate.
1 A training set of 379 cancer cases and 466 controls was used, and all cases were treatment naïve. Training used 5-fold cross validation and showed AUC of 0.961.
2 85% (11/13) for stage 0; 88% (61/69) for stage I; 97% (95/98) for stage II; 88% (14/16) for stage III; and 100% (2/2) for stage IV (no significant differences, but relatively small subsets).
3 100% (20/20) for invasive lobular carcinoma; 94.8% (145/153) for invasive ductal carcinoma; 95.9% (116/121) for hormone receptor +/HER2-; 94% (15/16) for triple negative; 67% (4/6) for triple positive; and 100% (3/3) hormone receptor -/HER2+ (small numbers in most subsets).