Breast Cancer ICYMI

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Administration of gonadotropin-releasing hormone analogs (GnRHa) with chemotherapy reduced the risk for premature ovarian insufficiency (POI) in premenopausal women with breast cancer.

Major finding: At 12 months after chemotherapy, POI was reported by 10.3% vs 44.5% of patients in the GnRHa + chemotherapy vs chemotherapy-only group (odds ratio, 0.23; P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 superiority trial including 330 premenopausal women with stages I-III operable breast cancer who were randomly assigned to GnRHa (3.6 mg of goserelin or 3.75 mg of leuprorelin) + chemotherapy or chemotherapy alone.

Disclosures: This study was funded by the Science and Technology Commission, Shanghai, and Zhejiang Medical Association. Dr. Zong reported receiving grants from the Science and Technology Commission of Shanghai Municipality.

Source: Zong X et al. JAMA Oncol. 2021 Dec 30. doi: 10.1001/jamaoncol.2021.6214.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

Key clinical point: Residual cancer burden (RCB) after neoadjuvant chemotherapy was prognostic for event-free survival (EFS) in each hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) subtype of breast cancer.

Major finding: RCB was prognostic for EFS with the hazard ratio associated with each unit increase in RCB being 1.69 (P < .0001) for the overall population and ranging from 1.52 in HR-positive/HER2-negative group to 2.09 in HR-negative/HER2-positive group (P < .0001 for all subtypes).

Study details: Findings are pooled analysis of 4 trials and 8 clinical cohorts, including 5,161 adult patients with primary stage I-III breast cancer treated with neoadjuvant chemotherapy followed by surgery.

Disclosures: This study was funded by the National Cancer Institute, USA. Some of the authors declared serving as a consultant, data and safety monitoring advisor, and/or receiving grants, funding, personal fees, travel support, and honoraria from several sources.

Source: Yau C et al. Lancet Oncol. 2021 Dec 10. doi: 10.1016/S1470-2045(21)00589-1.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

A version of this article first appeared on Medscape.com.

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

A version of this article first appeared on Medscape.com.

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

A version of this article first appeared on Medscape.com.

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D₃ supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D₃ supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D₃, or 80 mcg (3,200 IU) of daily vitamin D₃.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D₃ was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D₃ levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

A version of this article first appeared on Medscape.com.

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

A version of this article first appeared on Medscape.com.

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

A version of this article first appeared on Medscape.com.

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

A version of this article first appeared on Medscape.com.

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

A version of this article first appeared on Medscape.com.

Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.

While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.

“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.

“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.

Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.

For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.

Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.

Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.

The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.

The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.

“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.

Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.

However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.

In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.

“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”

The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.

A version of this article first appeared on Medscape.com.