Tag: breast cancer

Mammography Use Falls after USPSTF 2009 Guideline Change

Posted on by Brian Casey

Mammography use fell after the USPSTF rescinded its recommendation in 2009 of routine breast cancer screening for women in their 40s. The findings, in a new study in JAMA Network Open, confirm the fears of many women’s health advocates following the guideline change.

The women’s health world was shocked in 2009 when the USPSTF pulled its guideline advising women aged 40 to 49 to undergo regular breast screening, instead telling them to consult with their physicians.

  • The group reversed course in 2024, stating that women in their 40s should be screened every two years. Driving the decision were rising cancer rates in younger women, as well as higher mortality rates among Black women.

The new study analyzed data from the Behavioral Risk Factor Surveillance System to find changes in mammography use among 2.6M women, divided into various groups based on age, race, and other demographics.

  • Researchers analyzed self-reported mammography use, focusing on the periods 2000-2008 and 2012 and 2022.

The researchers found that, comparing 2002 to 2022, mammography prevalence fell for…

  • Women aged 40 to 49 (from 70% to 59%).
  • Women aged 50 to 74 (from 81% to 77%).
  • Non-Hispanic Black women in their 40s (from 72% to 65%).

The researchers pointed out that for the above categories, the endpoint comparisons were statistically significant. 

  • But the year-to-year changes in intervening years were not, in particular given a change in BRFSS survey methodology in 2011 that appears to have led to a several-point drop in utilization.

But several subgroups of women saw changes in both endpoint and year-to-year mammography prevalence, with use falling among…

  • Non-Hispanic White women in their 40s (from 71% to 60%).
  • Women in their 40s with insurance (from 74% to 62%) and without (from 47% to 33%).
  • Employed women (from 72% to 61%) as well as in women who classified themselves as homemakers (65% to 55%).

The Takeaway

The new study on falling mammography utilization confirms the fears of many women’s health advocates about the impact of the USPSTF’s 2009 guideline change. While the group righted the ship in 2024, it could take many years to see an effect – as suggested by the new study.

Mammo AI Momentum Builds

Posted on by Brian Casey

Momentum is building toward routine clinical use of AI for breast cancer screening. Several new studies offer even more support for mammography AI, including research published today in Nature Medicine in which AI reduced radiologist workload by over 60% by excluding low-risk studies from human review.

Breast screening has become one of the most promising use cases for AI, with the potential to reduce radiologists’ workload while improving their ability to detect cancer. 

  • For example, the recent MASAI study found that ScreenPoint Medical’s Transpara AI algorithm could replace the second human reader in a double-reading protocol, reducing workload by 44% and improving cancer detection rates by 28%.

The new research in Nature Medicine also used Transpara, as part of the AITIC study in Spain with the goal of seeing if AI could triage low-risk studies so they don’t require review by human radiologists. 

  • AITIC had a prospective design, involving 31k women with screening exams split between 2D mammography (17k) and digital breast tomosynthesis (14k). 

Women in the control arm of the study got conventional double reading by two radiologists – the standard mammography paradigm in Europe.

  • The intervention arm used a partially autonomous AI approach: cases that AI interpreted as low risk were classified as normal and were not reviewed by radiologists, while all other cases were double-read by radiologists using AI support.

In analyzing the results, researchers found…

  • Workload in the AI arm was 64% lower than conventional double reading.
  • AI’s workload reduction was similar between DBT and conventional digital mammography (-66% and -62%, respectively).
  • The AI arm’s cancer detection rate per 1k women was 15% higher (7.3 vs. 6.3 cancers).
  • But the recall rate was also 15% higher.

It’s worth noting that the AITIC study differed from MASAI in its inclusion of DBT screening exams, whereas MASAI only included 2D digital mammography. 

  • While 2D mammography is the norm in Europe, much of the U.S. has switched to DBT for breast screening, so the AITIC results offer good news for U.S. breast imaging practices considering AI adoption.

The Takeaway

The AITIC study’s new results are powerful confirmation of findings from the recent MASAI trial and support broader clinical deployment of mammography AI. Taken together with positive findings from last week’s Nature Cancer articles (see The Wire section in this newsletter), they paint a picture of a technology that’s ready for prime time.

Mammo Screening Saves Lives – Even in Late-Stage Cancer

Posted on by Brian Casey

A new study confirms that not only does breast cancer screening save lives, but it also improves survival in women with late-stage disease. Researchers found that women with stage IV breast cancer had a survival rate over three times higher if their disease was detected with screening, thanks largely to its role in driving treatment.

The “Mammography Wars” over breast cancer screening’s effectiveness raged from the 1980s to the 2010s, but eventually were decided in mammography’s favor. 

  • Multiple research studies have demonstrated that the combination of early detection and more effective treatments improve breast cancer survival. The USPSTF’s 2023 shift back to recommending that screening start at 40 settled the issue. 

But pockets of anti-screening resistance remain, with screening skeptics publishing several studies since the USPSTF change questioning the value not only of mammography but also other cancer screening tests.

  • So it’s more important than ever to demonstrate cancer screening’s value.

The new study in the Journal of the National Cancer Institute does just that by analyzing screening’s impact on survival rates in women diagnosed with stage IV disease who had been invited to Denmark’s national breast screening program (not all women completed mammography despite getting invited).

  • In all, 32.8k women with breast cancer were included, of whom 8% presented with stage III or stage IV cancer. 

The researchers found that for women with stage IV breast cancer…

  • Five-year survival was over 2X higher for women with screen-detected cancer versus women who were never screened (75% vs. 32%).
  • Ten-year survival was over 3X higher (62% vs. 17%).
  • Women with later-stage disease detected by screening had survival rates over five years comparable to women with disease one stage lower who were never screened.
  • Survival rates were strongly influenced by treatment type, with surgical treatment showing the longest median survival versus non-surgical treatment and no treatment (6, 2, and 0.1 years, respectively).

The big difference in survival was driven by the fact that women with screen-detected cancers were far more likely to get surgical treatment, and to subsequently have better 10-year survival rates than those treated without surgery (60% vs. 8%).

The Takeaway

The new study once again proves the value of screening mammography, but it goes beyond just showing that screening causes a stage shift to earlier diagnosis. Even in women with late-stage disease, screening is driving more effective treatment that is proving invaluable in saving women’s lives.

More Positive News on Mammo AI from MASAI

Posted on by Brian Casey

The latest results from the landmark MASAI study of AI for mammography screening show a favorable trend toward reducing the rate of interval cancers, or breast cancers that appear between screening rounds. The new findings – published Friday in The Lancet – also confirm mammography AI’s sharp workload reduction and trend toward higher sensitivity. 

MASAI is a large randomized controlled trial conducted in Sweden that examined the impact of ScreenPoint Medical’s Transpara AI algorithm on breast screening.

  • It’s an important issue, because mammography is one of the radiology segments where AI can provide the most help by reducing radiologist workload while improving cancer detection.

Previous MASAI studies demonstrated that AI can reduce radiologist workload by 44% and improve cancer detection rates by 28%.

  • The findings suggest that AI could eliminate the need for double-reading of most mammograms, a practice that’s common in European screening programs.

The new findings focus specifically on interval cancers, cancers that are missed in one screening round, only to be found later. 

  • Like other MASAI studies, the patient population consisted of 106k women screened with mammography and Transpara AI in Sweden’s national program in 2021 and 2022. 

Results indicated that AI-aided mammography…

  • Cut interval cancer rates by 12% per 1k women (1.55 vs. 1.76).
  • Reduced invasive interval cancers by 16% (75 vs. 89) with 27% fewer cancers of aggressive subtypes (43 vs. 59).
  • Detected 9% more cancers at screening (81% vs. 74%) with comparable specificity (99% for both) and recall rates (1.5% vs. 1.4%).

The researchers acknowledged that the study was not powered to show a statistically significant difference in the interval cancer rate. 

  • But its positive trend indicates that AI can be used to replace double-reading without negative consequences for patients – resulting in a sharp workload reduction for radiologists. 

The Takeaway

Results from the MASAI study on mammography AI just keep on getting better. Last week’s findings indicate that there’s really no reason for European breast screening programs to not dive in and replace their second readers with AI for the majority of exams.

Risk-Based Mammography Screening Returns

Posted on by Brian Casey

The idea of risk-based mammography screening is back with the publication of a new study in JAMA Network Open claiming that some risk-based strategies averted more breast cancer deaths with fewer false positives than age-based criteria. But like a previous paper on risk-based screening, the new findings raise concerns.

The idea behind risk-based screening is to focus healthcare resources on the people who need them most while sparing low-risk individuals from unnecessary medical interventions.

  • But risk-based breast cancer screening needs more clinical validation before it can be adopted broadly. This was tried with the WISDOM study, but researchers found no statistically significant difference in biopsy rates and only a modest reduction in mammograms performed.

A slightly different tack was taken with the new study, which compared conventional age-based biennial screening to a package of risk-based approaches based on a patient’s five-year breast cancer risk as calculated by widely accepted techniques like the Gail model and BCSC calculator.

  • Out of 50 risk-based strategies, nine averted more deaths than biennial age-based screening for women aged 40-74 (both were compared to no screening), and resulted in fewer false-positive recalls.

One such strategy highlighted by the authors used no screening for younger low-risk women, biennial screening for average-risk women, and annual screening for intermediate- and high-risk women, with the following results…

  • 6% more breast cancer deaths averted per 1k women versus conventional screening (7.2 vs. 6.8).
  • 8% fewer false-positive recalls (1,257 vs. 1,365).
  • While other risk-based strategies saw death reductions as high as 7.5 deaths per 1k women and false-positive reductions of 8-23%.

One key thing to note with the new study is its use of biennial screening as the control group, in line with current USPSTF recommendations for women aged 40-74. 

  • But many clinical organizations like ACR, ACOG, SBI, and NCCN recommend annual screening, and the new study’s findings may have been very different if compared to an annual model.

The Takeaway

This week’s findings are generally more supportive of risk-based screening than those of last year’s WISDOM study. But the new paper’s marginal improvement in cancer deaths averted might disappear when compared with annual age-based mammography. And like WISDOM, its use of clinical models for risk prediction may soon be obsolete given rapid developments in AI-based risk assessment. 

Breast Density’s Impact on Mammography

Posted on by Brian Casey

Breast density has a well-known effect on the accuracy of mammography screening – and it’s not a positive one. But a new study in Academic Radiology sheds light on density’s impact thanks to a massive patient population and its use of digital breast tomosynthesis, the most current breast screening technology.

Breast density is known to reduce the effectiveness of X-ray mammography by obscuring suspicious areas and making cancers harder to find. 

  • Women with dense breast tissue are typically directed to other imaging modalities for screening, such as ultrasound, breast MRI, and contrast-enhanced mammography.

The problem posed by breast density is significant enough that in 2024 the FDA implemented new MQSA rules requiring women getting screening mammograms to be notified of their density status.

  • It’s particularly important because having dense breast tissue is also a risk factor for breast cancer.

In the new study, MGH researchers aimed to quantify exactly how much breast density affects mammography screening through a large patient population screened with DBT, the state of the art in the U.S.

  • Researchers included 111.1k women who got DBT exams from 2013 to 2019 at their institution. 

They then calculated important metrics like sensitivity and specificity, as well as cancer detection and false-negative rates, across the four categories of dense breast tissue, from entirely fatty (A) to extremely dense (D), finding…

  • Sensitivity was lowest in extremely dense tissue compared to entirely fatty (62% vs. 93%).
  • Specificity was also lower for extremely dense and heterogeneously dense categories compared to entirely fatty (93% for both vs. 97%).
  • The false-negative rate for extremely dense tissue was over 8X that of entirely fatty based on adjusted odds ratio (aOR = 8.35).
  • While the abnormal interpretation rate was 57% higher for extremely dense versus entirely fatty tissue.

The Takeaway

The new findings are some of the most definitive yet on the negative effect breast density has on screening mammography’s accuracy and support the FDA’s 2024 notification requirement. They hopefully will spur development of new technologies to mitigate density’s impact. 

Risk-Based Mammo Screening – Ready for Prime Time?

Posted on by Brian Casey

Is mammography screening based on patient risk ready to take over for age-based screening? Results from the WISDOM study presented at last week’s San Antonio Breast Cancer Symposium and published simultaneously in JAMA suggest that while risk-based screening has its merits, more work may need to be done. 

Cancer screening exams like mammography have reduced disease-specific mortality, but (with the exception of lung cancer screening) all use exclusively age-based criteria to determine who should get screened.

  • Age isn’t a great tool for determining who’s at higher risk of getting cancer, but it’s the best tool we’ve had – up to now.

New cancer risk prediction tools are now becoming available, prompting debate over whether these techniques could make screening more precise by directing it to those most at risk.

  • Higher-risk people could get more frequent screening, while lower-risk individuals might be directed to longer screening intervals.

The WISDOM study presented at SABCS 2025 investigates this question. WISDOM is a randomized clinical trial that compared risk-based breast screening to age-based annual screening in 28.4k women followed for five years. 

  • Risk categorization was performed with genetic testing, polygenic risk scores, and BCSC scores, which incorporate family history and imaging results. 

Women in the risk-based screening group were directed into one of four screening strategies, from alternating mammography and MRI every six months for high-risk women to no screening until age 50 for low-risk women.

  • The study’s primary outcomes were detection rates for breast cancers rated as stage IIB or higher and effectiveness in reducing biopsy rates – a proxy for screening-caused morbidity.

Across the study population, researchers found…

  • The rate of mammograms per 100k person-years was lower in the risk-based cohort compared to age-based screening (43.1k vs. 46.9k). 
  • The rate of stage IIB or higher cancers per 100k person-years was also lower in the risk-based cohort (30 vs. 48).
  • But there was no statistically significant difference in biopsy rates, with a rate difference of 99 per 100k person-years (p = 0.10).

One problem with the WISDOM trial was that the actual screening exams were performed outside the study, and some patients did not comply with screening recommendations, potentially confounding results. 

The Takeaway

The WISDOM authors concluded that a risk-based screening approach is safe, but the lack of a difference in biopsy rates makes one wonder if veering from established age-based criteria is worth it. In any event, the coming arrival of risk stratification based on AI mammogram analysis could make the genetic testing-based approach used in WISDOM obsolete.

Mammo Screening Deserts Limit Access

Posted on by Brian Casey

It’s no secret that there are sharp regional differences in healthcare access in the U.S. But a new report puts a price on the access problem as it pertains to mammography – nearly 10k additional cases of breast cancer a year due to limited access in “cancer screening deserts” that don’t have mammography equipment. 

Mammography has been a success story among population-based cancer screening tests. 

  • The widespread implementation of breast screening in the 1980s is generally credited – along with improved treatments – with reducing breast cancer mortality by 44% from 1982 to 2022.

But breast cancer is still a lethal disease, killing 42k women a year in the U.S.

  • And screening’s benefits have not been distributed equally, with women in rural areas and those with lower socioeconomic status having lower completion rates.

What would it take to even out the differences? To answer this question, researchers from the Milken Institute analyzed the U.S. mammography installed base at the county level. 

  • They then correlated machine distribution with county population as well as cancer detection rates to find out how efficiently different counties were performing. 

They discovered…

  • High regional variation in mammography machine distribution.
  • The lowest distribution was in the Southwest and southern Midwest while the highest was in major urban areas, particularly on the coasts.
  • 890 counties did not have mammography machines.
  • Counties with the most mammography machines had 7.5% higher breast cancer incidence rates per 100k women compared to counties with no machines (329 vs. 306) – a sign they were detecting more cancers. 
  • There were 155 counties where mammography machine deployment would have the biggest return. 
  • And 9.6k breast cancer cases would be detected if counties with low or no mammography capacity detected breast cancer at the same rate as high-detection counties.

The new results track with another recent study that also revealed the presence of cancer screening deserts in the Southwest.

So what can be done? The Milken researchers proposed that low-resource counties be targeted for investment, but simply installing new machines won’t by itself cure the access problem. 

  • It’s also important to address barriers such as language, transportation, and cost-sharing in order to achieve equal access. 

The Takeaway

The new report shows that mammography access isn’t just an abstract issue – it’s one that is claiming the lives of thousands of U.S. women a year. Fortunately, the Milken researchers have done much of the legwork in identifying the specific areas that deserve attention. 

Hologic to Go Private in $18.3B Buyout

Posted on by Brian Casey

Women’s imaging vendor Hologic will go private in an $18.3B buyout led by two private equity firms, Blackstone and TPG. The move is easily the largest acquisition in radiology this year – the question is how it will impact one of the biggest corporate success stories in women’s health. 

Hologic has a long history in medical imaging and was founded in 1985 to develop and market bone densitometry systems. It soon expanded into mammography, molecular diagnostics, and women’s health treatments.

  • The company went public in 1990, and has maintained its independence even as radiology underwent a period of consolidation in the 1990s and 2000s that saw most mid-cap firms get acquired by multinational OEMs.

Much of Hologic’s momentum was driven by the conversion of U.S. mammography facilities from standard 2D mammography to 3D digital breast tomosynthesis. 

  • This shift was led by Hologic’s Selenia Dimensions system, which in 2011 was the first DBT system to get FDA approval. Hologic rode its momentum to a U.S. mammography installed base market share approaching 70%. (Signify Research estimates Hologic currently has a 34% market share of the global mammography market.)

But as often happens to many market leaders, Hologic’s position began slipping in recent years. 

  • The multinational OEMs have improved their positions in women’s imaging, releasing DBT systems that are more competitive with Hologic’s offerings while also benefiting from multiyear purchasing agreements with large health systems in which mammography systems can be bundled with CT, MRI, and other equipment. 

Perhaps as a result, Hologic’s Breast Health segment has become a drag on revenue growth due to lower equipment sales. Breast Health revenues for the most recent Q3 period fell 5.8%, following a 6.9% drop in Q2 and a 2.1% decline in Q1. 

  • Indeed, reports began surfacing in May 2025 that Blackstone and TPG were targeting Hologic for acquisition, with Hologic reportedly rejecting a $16.7B offer. 

The bid was apparently sweetened, with an acquisition price of $79 a share, a 46% premium from before the acquisition rumors started, for a total value of $18.3B. The buyout should close in the first half of calendar 2026.

The Takeaway

Hologic built itself into a radiology success story through a combination of technological innovation and an obsessive focus on a single market segment – women’s health. The question is whether that focus will continue under its new PE-led ownership.

Perils of Missed Mammography

Posted on by Brian Casey

Yet another study is illustrating the perils of missing mammography screening. New research in JAMA Network Open found that women diagnosed with breast cancer who missed their previous screening exam had signs of delayed diagnosis and worse clinical outcomes. 

Mammography screening is generally credited – along with improved treatments – with a steady decline in breast cancer death rates since the start of population-based breast screening.

  • But most studies on mammography’s effectiveness tend to compare women who participated regularly in screening with those who never did. 

That’s not really a realistic comparison these days, as mammography’s relatively high compliance rate means that most women are getting screened at least some of the time.

  • But what happens if women miss a screening exam? In a BMJ study published last month, researchers found that women who missed their first screening exam had a 40% higher risk of breast cancer death.

In the current study, researchers took a slightly different tack, looking at 8.6k women in Sweden whose breast cancer was detected on screening exams starting in 2015. 

  • In all, 17% of women missed the screening exam immediately before their cancer diagnosis. 

Compared to women who attended all screening rounds, those who missed their previous exam had higher adjusted odds ratio for…

  • Larger tumors ≥ 20 mm (AOR = 1.55).
  • Lymph node involvement (AOR = 1.28).
  • Distant metastasis (AOR = 4.64).
  • Worse breast cancer-specific survival (AOR = 1.33).
  • Lower 20-year breast cancer-specific survival (86% vs. 89%). 

What’s more, the program’s cancer detection rate per 1k screenings was sharply higher in the second screening round for women who missed the first round (7.35 vs. 5.59). 

  • This is most likely a sign that cancers that could have been detected in the first round instead were detected in the second round – another sign of delayed diagnosis.

Women who had missed their previous screening tended to be younger, unemployed, unmarried, and born outside of Sweden, and also had lower income. 

  • Women with these characteristics could be targeted for more intensive outreach, such as shorter invitation intervals or outreach after a missed appointment. 

The Takeaway

The new study once again highlights the importance of regular mammography screening in detecting breast cancer. Even one missed exam can have serious clinical consequences – highlighting the importance of identifying and contacting women who might be more prone to missed appointments.

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