A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study.

Proteus Donna is a randomised controlled trial aimed at prospectively evaluating screening with digital breast tomosynthesis (DBT), including interval cancer detection (ICD) and cancer detection (CD) in the analysis as a cumulative measure over subsequent screening episodes. Consenting women aged 46 to 68 attending the regional Breast Screening Service were randomly assigned to conventional digital mammography (DM, control arm) or DBT in addition to DM (DBT, study arm). At the subsequent round all participants underwent DM. Thirty-six months follow-up allowed for the identification of cancers detected in the subsequent screening and interscreening interval. Relative risk (RR) and 95% confidence interval (95% CI) were computed. Cumulative CD and Nelson-Aalen incidence were analysed over the follow-up period. Between 31 December 2014 and 31 December 2017, 43 022 women were randomised to DM and 30 844 to DBT. At baseline, CD was significantly higher (RR: 1.44, 95% CI: 1.21-1.71) in the study arm. ICD did not differ significantly between the two arms (RR: 0.92, 95% CI: 0.62-1.35). At subsequent screening with DM, the CD was lower (nearly significant) in the study arm (RR: 0.83, 95% CI: 0.65-1.06). Over the follow-up period, the cumulative CD (comprehensive of ICD) was slightly higher in the study arm (RR: 1.15, 95% CI: 1.01-1.31). The Nelson-Aalen cumulative incidence over time remained significantly higher in the study arm for approximately 24 months. Benign lesions detection was higher in the study arm at baseline and lower at subsequent tests. Outcomes are consistent with a lead time gain of DBT compared to DM, with an increase in false positives and moderate overdiagnosis.

Mammographic density: Comparison of visual assessment with fully automatic calculation on a multivendor dataset.

OBJECTIVES: To compare breast density (BD) assessment provided by an automated BD evaluator (ABDE) with that provided by a panel of experienced breast radiologists, on a multivendor dataset. METHODS: Twenty-one radiologists assessed 613 screening/diagnostic digital mammograms from nine centers and six different vendors, using the BI-RADS a, b, c, and d density classification. The same mammograms were also evaluated by an ABDE providing the ratio between fibroglandular and total breast area on a continuous scale and, automatically, the BI-RADS score. A panel majority report (PMR) was used as reference standard. Agreement (κ) and accuracy (proportion of cases correctly classified) were calculated for binary (BI-RADS a-b versus c-d) and 4-class classification. RESULTS: While the agreement of individual radiologists with the PMR ranged from κ = 0.483 to κ = 0.885, the ABDE correctly classified 563/613 mammograms (92 %). A substantial agreement for binary classification was found for individual reader pairs (κ = 0.620, standard deviation [SD] = 0.140), individual versus PMR (κ = 0.736, SD = 0.117), and individual versus ABDE (κ = 0.674, SD = 0.095). Agreement between ABDE and PMR was almost perfect (κ = 0.831). CONCLUSIONS: The ABDE showed an almost perfect agreement with a 21-radiologist panel in binary BD classification on a multivendor dataset, earning a chance as a reproducible alternative to visual evaluation. KEY POINTS: Individual BD assessment differs from PMR with κ as low as 0.483. An ABDE correctly classified 92 % of mammograms with almost perfect agreement (κ = 0.831). An ABDE can be a valid alternative to subjective BD assessment.

Compliance with clinical practice guidelines for breast cancer treatment: a population-based study of quality-of-care indicators in Italy.

BACKGROUND: It has been documented that variations exist in breast cancer treatment despite wide dissemination of clinical practice guidelines. The aim of this population-based study was to evaluate the impact of regional guidelines (Piedmont guidelines, PGL) for breast cancer diagnosis and treatment on quality-of-care indicators in the Northwestern Italian region of Piedmont. METHODS: We included two samples of women aged 50-69 years with incident breast cancer treated in Piedmont before and after the introduction of PGL: 600 in 2002 (pre-PGL) and 621 in 2004 (post-PGL). Patients were randomly selected among all incident breast cancer cases identified through the hospital discharge records database. We extracted clinical data on breast cancer cases from medical charts and ascertained vital status through linkage with town offices. We assessed compliance with 14 quality-of-care indicators from PGL recommendations, before and after their introduction in clinical practice. RESULTS: Among patients with invasive lesions, 77.1% (N = 368) and 77.5% (N = 383) in the pre-PGL and post-PGL groups, respectively, received breast conservative surgery (BCS) as a first-line treatment. Following BCS, 87.7% received radiotherapy in 2002, compared to 87.9% in 2004. Of all patients at medium-to-high risk of distant metastasis, 65.5% (N = 268) and 63.6% (N = 252) received chemotherapy in 2002 and in 2004, respectively. Among the 117 patients with invasive lesions and negative estrogen receptor status in 2002, hormonal therapy was prescribed in 23 of them (19.6%). The incorrect prescription of hormonal therapy decreased to 10.8% (N = 10) among the 92 estrogen receptor-negative patients in 2004 (p < 0.01).Compliance with PGL recommendations was already high in the pre-PGL group, although some quality-of-care indicators did not reach the standard. In the pre/post analysis, 8 out of 14 quality-of-care indicators showed an improvement from 2002 to 2004, but only 4 out of 14 reached statistical significance. We did not find any change in the risk of mortality in the post-PGL versus the pre-PGL group (adjusted hazard ratio 0.94, 95%CI 0.56-1.56). CONCLUSIONS: These results highlight the need to continue to improve breast cancer care and to measure adherence to PGL.

[Interval cancers as indicators of performance in screening programmes]. / I carcinomi di intervallo quali indicatori di performance di un programma di screening.

GISMa analyses the interval cancer (IS) topic providing guidelines and reference standards in addition to CE recommendations. IC identification is based on Cancer Registries (CR), if existing, or on hospital discharge records, in alternative. The optimal measure of IC frequency (inversely correlated with sensitivity) is the IC proportional incidence (observed IC/carcinomas expected in absence of screening). Other formulas (IC/IC + screen detected cancers; IC rate per 1000 negative screens) look less reliable. IC stage at diagnosis (if available through CR) must be compared with screen detected cancer and cancer detected in non-attenders. Review of mammograms preceding the IC (coded as screening error, minimal signs, or occult) should be done mainly with a blind procedure (IC mixed with negative controls), as this procedure is more representative of the original scenario and more respectful of radiologist's rights.

Does accelerated hypofractionated adjuvant whole-breast radiotherapy increase mammographic density or change mammographic features?

OBJECTIVE: To compare mammographic features before and after accelerated hypofractionated adjuvant whole-breast radiotherapy (AWB-RT) and to evaluate possible appearance of modifications. METHODS: A retrospective review of 177 females before and after an AWB-RT treatment (follow-up ranging from 5 to 9 years) was performed by four radiologists focused in breast imaging who independently evaluated diffuse mammographic density patterns and reported on possible onset of focal alterations; modifications in density and fibrosis with parenchymal distortion were deemed as indicators of AWB-RT treatment impact in breast imaging. RESULTS: Prevalent mammographic density (D) patterns in the 177 females evaluated were according to the American College of Radiology-Breast Imaging Reporting and Data System (ACR-BIRADS): D1, fibroadipose density (score percentage from 55.9% to 43.5%); and D2, scattered fibroglandular density (from 42.9% to 32.7%). No change in diffuse mammographic density and no significant difference in mammographic breast parenchymal structure were observed. "No change" was reported with score percentage from 87% to 79.6%. Appearance of fibrosis with parenchymal distortion was reported by all radiologists in only two cases (1.1%, p = 0.3); dystrophic calcification was identified with percentage score from 2.2% to 3.3% (small type) and from 9.6% to 12.9% (coarse type). CONCLUSION: No statistically significant changes in follow-up mammographies 5-9 years after AWB-RT were detected, justifying large-scale selection of AWB-RT treatment with no risk of altering radiological breast parameters of common use in tumour recurrence detection. ADVANCES IN KNOWLEDGE: The hypofractionated radiotherapy (AWB-RT treatment) is a new proven, safe and effective modality in post-operative patients with early breast cancer with excellent local control and survival. In our study, the absence of changes in mammographic density patterns and in breast imaging before and after AWB-RT treatment (up to 5-9 years after radiotherapy) justifies large-scale use of AWB-RT treatment without hindrance in tumour recurrence diagnosis.