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Hospital Diagnostic Errors May Affect 7% of Patients
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Diagnostic errors are common in hospitals and are largely preventable, according to a new observational study led by Anuj K. Dalal, MD, from the Division of General Internal Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, published in BMJ Quality & Safety.
Dalal and his colleagues found that 1 in 14 general medicine patients (7%) suffer harm due to diagnostic errors, and up to 85% of these cases could be prevented.
Few Studies on Diagnostic Errors
The study found that adverse event surveillance in hospital underestimated the prevalence of harmful diagnostic errors.
“It is difficult to quantify and characterize diagnostic errors, which have been studied less than medication errors,” Micaela La Regina, MD, an internist and head of the Clinical Governance and Risk Management Unit at ASL 5 in La Spezia, Italy, told Univadis Italy. “Generally, it is estimated that around 50% of diagnostic errors are preventable, but the authors of this study went beyond simply observing the hospital admission period and followed their sample for 90 days after discharge. Their findings will need to be verified in other studies, but they seem convincing.”
The researchers in Boston selected a random sample of 675 hospital patients from a total of 9147 eligible cases who received general medical care between July 2019 and September 2021, excluding the peak of the COVID-19 pandemic (April-December 2020). They retrospectively reviewed the patients’ electronic health records using a structured method to evaluate the diagnostic process for potential errors and then estimated the impact and severity of any harm.
Cases sampled were those featuring transfer to intensive care more than 24 hours after admission (100% of 130 cases), death within 90 days of hospital admission or after discharge (38.5% of 141 cases), complex clinical problems without transfer to intensive care or death within 90 days of admission (7% of 298 cases), and 2.4% of 106 cases without high-risk criteria.
Each case was reviewed by two experts trained in the use of diagnostic error evaluation and research taxonomy, modified for acute care. Harm was classified as mild, moderate, severe, or fatal. The review assessed whether diagnostic error contributed to the harm and whether it was preventable. Cases with discrepancies or uncertainties regarding the diagnostic error or its impact were further examined by an expert panel.
Most Frequent Situations
Among all the cases examined, diagnostic errors were identified in 160 instances in 154 patients. The most frequent situations with diagnostic errors involved transfer to intensive care (54 cases), death within 90 days (34 cases), and complex clinical problems (52 cases). Diagnostic errors causing harm were found in 84 cases (82 patients), of which 37 (28.5%) occurred in those transferred to intensive care; 18 (13%) among patients who died within 90 days; 23 (8%) among patients with complex clinical issues; and 6 (6%) in low-risk cases.
The severity of harm was categorized as minor in 5 cases (6%), moderate in 36 (43%), major in 25 (30%), and fatal in 18 cases (21.5%). Overall, the researchers estimated that the proportion of harmful, preventable diagnostic errors with serious harm in general medicine patients was slightly more than 7%, 6%, and 1%, respectively.
Most Frequent Diagnoses
The most common diagnoses associated with diagnostic errors in the study included heart failure, acute kidney injury, sepsis, pneumonia, respiratory failure, altered mental state, abdominal pain, and hypoxemia. Dalal and colleagues emphasize the need for more attention to diagnostic error analysis, including the adoption of artificial intelligence–based tools for medical record screening.
“The technological approach, with alert-based systems, can certainly be helpful, but more attention must also be paid to continuous training and the well-being of healthcare workers. It is also crucial to encourage greater listening to caregivers and patients,” said La Regina. She noted that in the past, a focus on error prevention has often led to an increased workload and administrative burden on healthcare workers. However, the well-being of healthcare workers is key to ensuring patient safety.
“Countermeasures to reduce diagnostic errors require a multimodal approach, targeting professionals, the healthcare system, and organizational aspects, because even waiting lists are a critical factor,” she said. As a clinical risk expert, she recently proposed an adaptation of the value-based medicine formula in the International Journal for Quality in Health Care to include healthcare professionals’ care experience as one of the elements that contribute to determining high-value healthcare interventions. “Experiments are already underway to reimburse healthcare costs based on this formula, which also allows the assessment of the value of skills and expertise acquired by healthcare workers,” concluded La Regina.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Lawsuit Targets Publishers: Is Peer Review Flawed?
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.
The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.
The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
Flawed Reviews
A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.
As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”
Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.
Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
Lack of Awareness
A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.
While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”
Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.
A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.
The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
Fanelli’s Perspective
Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.
“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
De-escalation still beneficial after 10 years for some HER2+ breast cancers
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Lowering the intensity of chemotherapy also reduces the adverse events that are associated with it.
An open-label study of about 400 participants indicated that 12 weeks of treatment with paclitaxel (Abraxane) and trastuzumab (Herceptin), followed by 9 months of trastuzumab monotherapy, was associated with very good long-term outcomes for patients with certain HER2-positive breast cancers. Few distant recurrences were observed, and tolerability was good.
The study was conducted by a team that included researchers from the European Institute of Oncology in Milan, one of the main oncology institutes in Italy.
“HER2-positive breast cancers harbor a particularly poor prognosis, compared with HER2-negative tumors, if left untreated. However, the blockade of HER2 with trastuzumab, when added to adjuvant multiagent chemotherapy, has been shown to improve outcomes for this population,” wrote the researchers, led by Sara M. Tolaney, MD, chief of breast oncology at Dana-Farber Cancer Institute in Boston. “To our knowledge, this is the first study to report the long-term outcomes of patients with small, node-negative, HER2-positive breast cancers prospectively treated with a de-escalated adjuvant regimen.”
The study was published in the March issue of The Lancet Oncology.
Avoiding side effects
HER2-positive breast cancers, which are characterized by amplification of the HER2 gene and overexpression of the HER2 protein, account for 15% of new cases of localized breast cancer. They are more aggressive and resistant to some anticancer treatments but show sensitivity to stronger chemotherapy.
“We presented the 10-year analysis, which shows that survival for breast cancer among the 406 patients recruited in the study was 98.8% after 10 years, with only 6 recurrences,” study author Paolo Tarantino, MD, researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, Boston, said in a statement. “Our data support the use of the de-escalated adjuvant paclitaxel trastuzumab regimen as an adequate standard for small HER2-positive breast cancers, which avoids the side effects of polychemotherapy.”
The researchers also focused on patient selection and identified a significant relationship between the value of HER2DX, a new diagnostic tool capable of describing multiple characteristics of HER2-positive breast cancer, and the prognosis. If future research validates these preliminary results, the biomarker may help to further customize cancer treatments in the future, according to Dr. Tarantino.
‘A valuable alternative’
“This is the 10-year update of the APT study, which is not randomized and has no control arm,” Alessandra Gennari, MD, PhD, associate professor of oncology at the University of Eastern Piedmont and head of oncology at Maggiore University Hospital in Novara, Italy, said in an interview. Dr. Gennari, who was not involved in the study, was lead author of the European Society for Medical Oncology’s 2021 guidelines on metastatic breast cancer. “This study shows, nevertheless, that in a subpopulation of HER2-positive patients with low to moderate risk of recurrence, the de-escalation of chemotherapy together with trastuzumab is a valuable alternative to more complex regimens with chemotherapy agents and is very well tolerated.”
Dr. Gennari’s comment echoes those of an editorial that accompanied the Lancet Oncology study. “This work represents a milestone in the history of breast cancer: We have definitively shown that for early HER2-positive tumors, you can do less by getting more,” coauthor Giuseppe Curigliano, MD, PhD, full professor of medical oncology at University of Milan and head of early drug development at the European Institute of Oncology, told this news organization. “It completes a pathway started by my group at the European Institute of Oncology in 2009, when we showed that HER2-positive tumors have a very good prognosis if diagnosed at a very early stage, and therefore can be treated with less aggressive and less toxic chemotherapies.” Candiolo Cancer Institute oncologists Elena Geuna, MD, and Filippo Montemurro, MD, coauthored the editorial with Dr. Curigliano.
Research on de-escalation increased after that study, and data showed that a lighter chemotherapy regimen is safe and effective and allows patients to live longer and with fewer side effects. “This finding immediately changed clinical practice, and the newly published work now adds an important piece: De-escalation maintains its benefit over the long term, beyond 10 years,” said Dr. Curigliano. “It also shows that in the future, we could identify the patients that will benefit from doing more, but also those that will benefit from doing even less, thanks to the new marker HER2DX.”
The study was funded by Genentech. Dr. Tolaney has received consulting or advisory board fees from Genentech, AstraZeneca, Eli Lilly, Merck, Novartis, Pfizer, Gilead, BMS, Eisai, Sanofi, and other pharmaceutical companies. Dr. Tarantino has received consulting or advisory board fees from AstraZeneca, Daiichi Sankyo, and Lilly, and has received payment or honoraria for educational events from AstraZeneca and Daiichi Sankyo. Dr. Curigliano and Dr. Gennari reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM LANCET ONCOLOGY