Heidi Splete

NATIONAL HARBOR, MARYLAND — Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

NATIONAL HARBOR, MARYLAND — Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

The presence of any aberration in the SMAD4 gene and decreased messenger RNA sequencing expression of SMAD4 were both associated with worse overall survival in patients with resected pancreatic adenocarcinoma.

These were the main findings of a new study of more than 300 individuals.

Previous studies have shown an association between widespread disease and loss of SMAD4 immunolabeling, according to the paper. Biomarkers to predict which pancreatic adenocarcinoma patients may benefit from more aggressive therapy are lacking, wrote Emily J. Anstadt, MD, of the University of Pennsylvania, Philadelphia, and colleagues, in their paper published in Cancer.

The human transcription factor and tumor suppressor, mothers against decapentaplegic homolog 4 (SMAD4), “may be a promising biomarker for predicting the likelihood of experiencing distant failure in patients with pancreatic cancer,” the researchers wrote.

“For patients with pancreatic cancer, improving treatments and overall outcomes remains invaluable,” Dr. Anstadt said in an interview. However, the disparate clinical courses make studies of this patient population challenging.

“As with much of medicine and oncology at this time, we feel the key to better outcomes lies in personalizing treatment strategies and relying on tumor genetics to predict tumor behavior and guide us towards individualized optimal treatments,” she added.
 

Study Methods and Results

The researchers identified 322 patients with resected stage I–III pancreatic adenocarcinoma from The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC). The study population included 165 patients from the TCGA who served as the training set and 157 patients from the ICGC who served as the validation set.

The primary outcomes were overall survival (OS) and distant metastasis-free survival (DMFS).

A total of 50 patients in the TCGA group (30%) had at least one of the three identified SMAD4 genomic aberrations.

Using the TCGA group, the researchers conducted a regression analysis on the survival outcomes as a function of either the presence of an SMAD4 genomic aberration or the expression of messenger RNA sequencing (RNA-seq). They then used the ICGC to validate whether SMAD4 RNA-seq expression improved risk stratification for OS and DMFS in a separate group of patients.

In the TCGA group, 3-year OS for patients with any SMAD4 aberrations vs no SMAD4 aberrations was 18% vs 36% (hazard ratio, 1.55; P = .048). However, the 3-year DMFS for patients with and without SMAD4 aberrations was 14% vs 23%, a nonsignificant difference (HR, 1.33; P = .19).

In a multivariate analysis, SMAD4 aberrations also were associated with increased risk of stage III disease (HR, 1.89; P = .003). The researchers noted that adjuvant radiotherapy and adjuvant chemotherapy were significantly associated with a decreased risk of death in these patients (HR, 0.53 and HR, 0.28, respectively).

In addition, low SMAD4 RNA-seq expression was associated with worse OS and DMFS, (HR, 1.83 and HR, 1.70, respectively) in the TCGA group.

In the ICGC validation group, increased SMAD4 RNA‐seq expression correlated with improved OS (area under the curve .92) and DMFS (AUC, .84).

Dr. Anstadt said she and her colleagues were not surprised by any of their findings, given earlier research’s suggestions of SMAD4 loss having been associated with poor outcomes for pancreatic cancer.

“Prior studies determined SMAD4 status based on immunohistochemistry and different investigators used different scoring systems,” Dr. Anstadt noted, in an interview. “The results of those studies were conflicting, and consequently SMAD4 has not been adopted clinically as part of the work-up or to aid in treatment decisions.”

“It is essential to find robust, reliable, and cost-effective methods for implementing this in the clinic. As such, we were happy to find that expression of SMAD4 by mRNA sequencing may be that method,” she added.

Not Quite Clinic-Ready

“While we are hopeful that this tool will be a reliable method for use in the clinic, it has yet to be validated in a prospective manner,” Dr. Anstadt said in an interview. “In addition, this study showed that [genetic] expression levels are correlated with worse outcomes and can be of prognostic use; however, we have not directly studied whether expression levels can be predictive of treatment response,” she said.

“Practicing oncologists often have to make difficult decisions in situations where there are no clear answers,” Dr. Anstadt continued. “When considering gray-zone treatment recommendations, we often integrate multiple factors to form an opinion. The reality of cancer medicine is that not all those factors we consider have been validated in prospective studies, but together they produce a picture that is clinically useful. We would submit that SMAD4 status should be one of those factors taken into consideration in forming a comprehensive opinion about suitability for resection or radiotherapy.”

In practice, “if this test is prospectively validated in a future study and will impact clinical decision-making, then this cost will be similar to other genetic tests that have been adopted and have been practice-changing in other oncologic fields,” said Dr. Anstadt. “Being able to individualize treatment can also save overall cost; for instance, predicting which patients would not benefit from local radiation or surgery could decrease use and cost in that population,” she said.

Limitations of the current study included the inability to examine interactions between SMAD4 and radiotherapy because of the sample size and the potential for selection bias, the researchers wrote.
 

Potential Predictive Value

“A major challenge in the management of patients with pancreatic cancer is the difficulty in predicting which patients will develop metastasis early,” said Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, in an interview.

“SMAD4 has previously been evaluated as a prognostic marker in pancreatic cancer, but the association between SMAD4 gene expression, gene mutations, and cancer metastasis has not yet been systematically evaluated in patients, said Dr. Roper, who was not involved in the study.

The new study’s main findings that SMAD4 genomic alterations are associated with worse overall survival, but not distant metastasis-free survival, and that increased SMAD4 expression is associated with improved overall survival and distant metastasis-free survival, suggest that SMAD4 gene expression may be a useful marker in predicting clinical outcomes in pancreatic cancer, Dr. Roper said.

In the future the current study may prompt prospective research to determine a potential association between clinical assessment of SMAD4 gene expression at the time of surgical cancer resection and worse overall survival and distant metastasis-free survival, he said.

The study received no outside funding. Dr. Anstadt and Dr. Roper had no financial conflicts to disclose.

The presence of any aberration in the SMAD4 gene and decreased messenger RNA sequencing expression of SMAD4 were both associated with worse overall survival in patients with resected pancreatic adenocarcinoma.

These were the main findings of a new study of more than 300 individuals.

Previous studies have shown an association between widespread disease and loss of SMAD4 immunolabeling, according to the paper. Biomarkers to predict which pancreatic adenocarcinoma patients may benefit from more aggressive therapy are lacking, wrote Emily J. Anstadt, MD, of the University of Pennsylvania, Philadelphia, and colleagues, in their paper published in Cancer.

The human transcription factor and tumor suppressor, mothers against decapentaplegic homolog 4 (SMAD4), “may be a promising biomarker for predicting the likelihood of experiencing distant failure in patients with pancreatic cancer,” the researchers wrote.

“For patients with pancreatic cancer, improving treatments and overall outcomes remains invaluable,” Dr. Anstadt said in an interview. However, the disparate clinical courses make studies of this patient population challenging.

“As with much of medicine and oncology at this time, we feel the key to better outcomes lies in personalizing treatment strategies and relying on tumor genetics to predict tumor behavior and guide us towards individualized optimal treatments,” she added.
 

Study Methods and Results

The researchers identified 322 patients with resected stage I–III pancreatic adenocarcinoma from The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC). The study population included 165 patients from the TCGA who served as the training set and 157 patients from the ICGC who served as the validation set.

The primary outcomes were overall survival (OS) and distant metastasis-free survival (DMFS).

A total of 50 patients in the TCGA group (30%) had at least one of the three identified SMAD4 genomic aberrations.

Using the TCGA group, the researchers conducted a regression analysis on the survival outcomes as a function of either the presence of an SMAD4 genomic aberration or the expression of messenger RNA sequencing (RNA-seq). They then used the ICGC to validate whether SMAD4 RNA-seq expression improved risk stratification for OS and DMFS in a separate group of patients.

In the TCGA group, 3-year OS for patients with any SMAD4 aberrations vs no SMAD4 aberrations was 18% vs 36% (hazard ratio, 1.55; P = .048). However, the 3-year DMFS for patients with and without SMAD4 aberrations was 14% vs 23%, a nonsignificant difference (HR, 1.33; P = .19).

In a multivariate analysis, SMAD4 aberrations also were associated with increased risk of stage III disease (HR, 1.89; P = .003). The researchers noted that adjuvant radiotherapy and adjuvant chemotherapy were significantly associated with a decreased risk of death in these patients (HR, 0.53 and HR, 0.28, respectively).

In addition, low SMAD4 RNA-seq expression was associated with worse OS and DMFS, (HR, 1.83 and HR, 1.70, respectively) in the TCGA group.

In the ICGC validation group, increased SMAD4 RNA‐seq expression correlated with improved OS (area under the curve .92) and DMFS (AUC, .84).

Dr. Anstadt said she and her colleagues were not surprised by any of their findings, given earlier research’s suggestions of SMAD4 loss having been associated with poor outcomes for pancreatic cancer.

“Prior studies determined SMAD4 status based on immunohistochemistry and different investigators used different scoring systems,” Dr. Anstadt noted, in an interview. “The results of those studies were conflicting, and consequently SMAD4 has not been adopted clinically as part of the work-up or to aid in treatment decisions.”

“It is essential to find robust, reliable, and cost-effective methods for implementing this in the clinic. As such, we were happy to find that expression of SMAD4 by mRNA sequencing may be that method,” she added.

Not Quite Clinic-Ready

“While we are hopeful that this tool will be a reliable method for use in the clinic, it has yet to be validated in a prospective manner,” Dr. Anstadt said in an interview. “In addition, this study showed that [genetic] expression levels are correlated with worse outcomes and can be of prognostic use; however, we have not directly studied whether expression levels can be predictive of treatment response,” she said.

“Practicing oncologists often have to make difficult decisions in situations where there are no clear answers,” Dr. Anstadt continued. “When considering gray-zone treatment recommendations, we often integrate multiple factors to form an opinion. The reality of cancer medicine is that not all those factors we consider have been validated in prospective studies, but together they produce a picture that is clinically useful. We would submit that SMAD4 status should be one of those factors taken into consideration in forming a comprehensive opinion about suitability for resection or radiotherapy.”

In practice, “if this test is prospectively validated in a future study and will impact clinical decision-making, then this cost will be similar to other genetic tests that have been adopted and have been practice-changing in other oncologic fields,” said Dr. Anstadt. “Being able to individualize treatment can also save overall cost; for instance, predicting which patients would not benefit from local radiation or surgery could decrease use and cost in that population,” she said.

Limitations of the current study included the inability to examine interactions between SMAD4 and radiotherapy because of the sample size and the potential for selection bias, the researchers wrote.
 

Potential Predictive Value

“A major challenge in the management of patients with pancreatic cancer is the difficulty in predicting which patients will develop metastasis early,” said Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, in an interview.

“SMAD4 has previously been evaluated as a prognostic marker in pancreatic cancer, but the association between SMAD4 gene expression, gene mutations, and cancer metastasis has not yet been systematically evaluated in patients, said Dr. Roper, who was not involved in the study.

The new study’s main findings that SMAD4 genomic alterations are associated with worse overall survival, but not distant metastasis-free survival, and that increased SMAD4 expression is associated with improved overall survival and distant metastasis-free survival, suggest that SMAD4 gene expression may be a useful marker in predicting clinical outcomes in pancreatic cancer, Dr. Roper said.

In the future the current study may prompt prospective research to determine a potential association between clinical assessment of SMAD4 gene expression at the time of surgical cancer resection and worse overall survival and distant metastasis-free survival, he said.

The study received no outside funding. Dr. Anstadt and Dr. Roper had no financial conflicts to disclose.

The presence of any aberration in the SMAD4 gene and decreased messenger RNA sequencing expression of SMAD4 were both associated with worse overall survival in patients with resected pancreatic adenocarcinoma.

These were the main findings of a new study of more than 300 individuals.

Previous studies have shown an association between widespread disease and loss of SMAD4 immunolabeling, according to the paper. Biomarkers to predict which pancreatic adenocarcinoma patients may benefit from more aggressive therapy are lacking, wrote Emily J. Anstadt, MD, of the University of Pennsylvania, Philadelphia, and colleagues, in their paper published in Cancer.

The human transcription factor and tumor suppressor, mothers against decapentaplegic homolog 4 (SMAD4), “may be a promising biomarker for predicting the likelihood of experiencing distant failure in patients with pancreatic cancer,” the researchers wrote.

“For patients with pancreatic cancer, improving treatments and overall outcomes remains invaluable,” Dr. Anstadt said in an interview. However, the disparate clinical courses make studies of this patient population challenging.

“As with much of medicine and oncology at this time, we feel the key to better outcomes lies in personalizing treatment strategies and relying on tumor genetics to predict tumor behavior and guide us towards individualized optimal treatments,” she added.
 

Study Methods and Results

The researchers identified 322 patients with resected stage I–III pancreatic adenocarcinoma from The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC). The study population included 165 patients from the TCGA who served as the training set and 157 patients from the ICGC who served as the validation set.

The primary outcomes were overall survival (OS) and distant metastasis-free survival (DMFS).

A total of 50 patients in the TCGA group (30%) had at least one of the three identified SMAD4 genomic aberrations.

Using the TCGA group, the researchers conducted a regression analysis on the survival outcomes as a function of either the presence of an SMAD4 genomic aberration or the expression of messenger RNA sequencing (RNA-seq). They then used the ICGC to validate whether SMAD4 RNA-seq expression improved risk stratification for OS and DMFS in a separate group of patients.

In the TCGA group, 3-year OS for patients with any SMAD4 aberrations vs no SMAD4 aberrations was 18% vs 36% (hazard ratio, 1.55; P = .048). However, the 3-year DMFS for patients with and without SMAD4 aberrations was 14% vs 23%, a nonsignificant difference (HR, 1.33; P = .19).

In a multivariate analysis, SMAD4 aberrations also were associated with increased risk of stage III disease (HR, 1.89; P = .003). The researchers noted that adjuvant radiotherapy and adjuvant chemotherapy were significantly associated with a decreased risk of death in these patients (HR, 0.53 and HR, 0.28, respectively).

In addition, low SMAD4 RNA-seq expression was associated with worse OS and DMFS, (HR, 1.83 and HR, 1.70, respectively) in the TCGA group.

In the ICGC validation group, increased SMAD4 RNA‐seq expression correlated with improved OS (area under the curve .92) and DMFS (AUC, .84).

Dr. Anstadt said she and her colleagues were not surprised by any of their findings, given earlier research’s suggestions of SMAD4 loss having been associated with poor outcomes for pancreatic cancer.

“Prior studies determined SMAD4 status based on immunohistochemistry and different investigators used different scoring systems,” Dr. Anstadt noted, in an interview. “The results of those studies were conflicting, and consequently SMAD4 has not been adopted clinically as part of the work-up or to aid in treatment decisions.”

“It is essential to find robust, reliable, and cost-effective methods for implementing this in the clinic. As such, we were happy to find that expression of SMAD4 by mRNA sequencing may be that method,” she added.

Not Quite Clinic-Ready

“While we are hopeful that this tool will be a reliable method for use in the clinic, it has yet to be validated in a prospective manner,” Dr. Anstadt said in an interview. “In addition, this study showed that [genetic] expression levels are correlated with worse outcomes and can be of prognostic use; however, we have not directly studied whether expression levels can be predictive of treatment response,” she said.

“Practicing oncologists often have to make difficult decisions in situations where there are no clear answers,” Dr. Anstadt continued. “When considering gray-zone treatment recommendations, we often integrate multiple factors to form an opinion. The reality of cancer medicine is that not all those factors we consider have been validated in prospective studies, but together they produce a picture that is clinically useful. We would submit that SMAD4 status should be one of those factors taken into consideration in forming a comprehensive opinion about suitability for resection or radiotherapy.”

In practice, “if this test is prospectively validated in a future study and will impact clinical decision-making, then this cost will be similar to other genetic tests that have been adopted and have been practice-changing in other oncologic fields,” said Dr. Anstadt. “Being able to individualize treatment can also save overall cost; for instance, predicting which patients would not benefit from local radiation or surgery could decrease use and cost in that population,” she said.

Limitations of the current study included the inability to examine interactions between SMAD4 and radiotherapy because of the sample size and the potential for selection bias, the researchers wrote.
 

Potential Predictive Value

“A major challenge in the management of patients with pancreatic cancer is the difficulty in predicting which patients will develop metastasis early,” said Jatin Roper, MD, a gastroenterologist at Duke University, Durham, North Carolina, in an interview.

“SMAD4 has previously been evaluated as a prognostic marker in pancreatic cancer, but the association between SMAD4 gene expression, gene mutations, and cancer metastasis has not yet been systematically evaluated in patients, said Dr. Roper, who was not involved in the study.

The new study’s main findings that SMAD4 genomic alterations are associated with worse overall survival, but not distant metastasis-free survival, and that increased SMAD4 expression is associated with improved overall survival and distant metastasis-free survival, suggest that SMAD4 gene expression may be a useful marker in predicting clinical outcomes in pancreatic cancer, Dr. Roper said.

In the future the current study may prompt prospective research to determine a potential association between clinical assessment of SMAD4 gene expression at the time of surgical cancer resection and worse overall survival and distant metastasis-free survival, he said.

The study received no outside funding. Dr. Anstadt and Dr. Roper had no financial conflicts to disclose.

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Less than half of the dermatology residents surveyed reported specific training on management of sensitive skin, according to a survey of approximately 200 residents.

Although sensitive skin affects an estimated 40%-70% of the population, knowledge of the pathophysiology of sensitive skin is incomplete, and consensus is lacking as to the best diagnosis and treatment strategies, and the inclusion of sensitive skin education in dermatology curricula has not been examined, according to Erika T. McCormick, BS, and Adam Friedman, MD, of George Washington University, Washington, DC.

For the study, published in the Journal of Drugs in Dermatology, they developed a 26-question survey for dermatology residents that asked about sensitive skin in dermatology residency training. Participants came from the Orlando Dermatology, Aesthetic, and Surgical Conference email list.

Survey respondents included 214 residents at various levels of training at programs across the United States; 67.1% were female, 92.1% were aged 25-34 years, and 85.5% were in academic or university programs.

Overall, 99% of respondents believed that sensitive skin issues should be part of their residency training to some extent, and 84% reported experiences with patients for whom the chief presenting complaint was sensitive skin.

However, fewer than half (48%) of the residents reported specific resident education in sensitive skin, while 51% reported nonspecific education about sensitive skin education in the context of other skin diseases, and 1% reported no education about sensitive skin.

Less than one-quarter of the respondents who received any sensitive skin education reported feeling comfortable in their ability to diagnose, evaluate, and manage sensitive skin, while those with sensitive skin–specific education were significantly more likely to describe themselves as “very knowledgeable.”

As for treatment approaches, residents with specific sensitive skin education were more likely than were those without sensitive skin–specific training to ask patients about allergies and past reactions to skin products, and to counsel them about environmental triggers.

Notably, 96% of the respondents were not familiar with the Sensitive Skin (SS) Scale–10, a validated measure of sensitive skin severity.

The most common challenges in care of patients with sensitive skin were assessing improvement over time, reported by 25% of respondents, recommending products (23%), and prescribing/medical management (22%). The topics residents expressed most interest in learning about were product recommendations (78%), patient counseling (77%), reviewing research on sensitive skin (70%), diagnosing sensitive skin (67%), using the SS-10 (48%), and clinical research updates (40%).

The findings were limited by several factors including the reliance on self-reports, the researchers noted. However, the results highlight the lack of consensus in treatment of sensitive skin and the need to address this knowledge gap at the residency level, they said.
 

Improving Tools for Practice

“Many practice patterns and approaches are forged in the fires of training,” corresponding author Dr. Friedman, professor and chair of dermatology and residency program director at George Washington University, said in an interview. “Identifying gaps, especially for heavily prevalent issues, questions, and concerns such as sensitive skin that residents will encounter in practice is important to ensure an educated workforce,” he said.

Education on sensitive skin is lacking because, until recently, research and clinical guidance have been lacking, Dr. Friedman said. The root of the problem is that sensitive skin is mainly considered a symptom, rather than an independent condition, he explained. “Depending on the study, the prevalence of sensitive skin has been reported as high as 70%, with roughly 40% of these patients having no primary skin condition,” he said. This means sensitive skin can be both a symptom and a condition, which causes confusion for clinicians and patients, he added.

“Therefore, in order to overcome this gap, the condition itself at a minimum needs a standard definition and a way to diagnosis, which we fortunately have in the validated research tool known as the SS-10,” said Dr. Friedman.

Almost all residents surveyed in the current study had never heard of the SS-10, but more than half found it to be useful after learning of it through the study survey, he noted.

Looking ahead, greater elucidation of the pathophysiology of sensitive skin is needed to effectively pursue studies of products and treatments for these patients, but the SS-10 can be used to define and monitor the condition to evaluate improvement, he added.

The study was funded by an independent fellowship grant from Galderma. Ms. McCormick is supported by an unrestricted fellowship grant funded by Galderma. Dr. Friedman has served as a consultant for Galderma.

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

Using a new system for classifying established prognostic features of lymph nodes may lead to better staging of oral cavity squamous cell cancer (OSCC) than the TNM staging system, experts say.

The TNM staging system is used by most facilities for cancer reporting, as defined by the National Cancer Institute. This system combines the size and extent of the primary tumor (T), the number of neighboring lymph nodes with cancer and subcategories (N), and whether or not metastasis has occurred (M).

In a new study published in the journal Cancer, the researchers created a novel classification system to better account for extranodal extension (ENE). The study population included 1460 adults with OSCC (696 with no lymph node involvement and 764 with positive lymph nodes), who underwent surgical resections at four centers.

“Our findings build on the growing evidence base that historical factors do not improve staging performance and that their omission results in improved N‐classification [i.e., the nodal status or lymph node involvement in cancer staging] performance,” John R. de Almeida, MD, of the University of Toronto, and colleagues, wrote in their new paper.

For patients with OSCC, this system, known as the 8th edition of American Joint Committee on Cancer/International Union Against Cancer TNM N‐classification (TNM‐8‐N), has several limitations, the researchers explained. These limitations include redundancy in the rare N3a category (i.e., having single or multiple lymph nodes greater than 6 cm or 3-7 lymph nodes without ENE) and the impact of ENE as a new prognostic feature, they said.

“Recent studies have shown that major ENE is associated with a significantly worse outcome than minor ENE, suggesting that these two subgroups should be considered as separate entities,” the authors wrote.
 

Study Methods and Results

The researchers created N-classifications based on adjusted hazard ratios and statistical analysis (recursive partitioning) with a focus on lymph node (LN) size and number and the extent of ENE. They compared their classifications of OSCC cases to those of the TNM-8-N’s classifications of the same cases.

Using the new classification system, lymph node number and size and the extent of ENE were associated with overall survival. The adjusted hazard ratios for LN counts of 1 vs. zero and greater than 1 vs. 0 were 1.92 and 3.21, respectively. The adjusted hazard ratios (aHRs) for LN size of greater than 3 cm vs. 3 cm or less, and for major vs. minor ENE were 1.88 and 1.40, respectively.

The use of an aHR improved cancer staging compared to the TNM-8-N by eliminating the N2c and 6-cm threshold, stratifying the extent of ENE, and stratifying N2b by 3-cm threshold, the researchers wrote.

The researchers compared their new system to the TNM-8 and also two other classification systems and their own recursive partitioning analysis (another statistical model).

The aHR-based system ranked first out of five in terms of correctly staging cancer, while the TNM-8 was fifth in the discovery cohort and fifth in the validation cohorts.

Outcome predictions (percentage variance explained) were 19.81 with the aHR vs. 18.95 in theTNM-8 in the discovery cohort, and similarly were 11.72 vs. 10.13, respectively, in the validation cohort.

“Overall, 25 patients staged as IVa in TNM‐8 were upstaged to IVb in the aHR proposal, and one patient staged as IVb was downstaged to IVa. Otherwise, overall stage between TNM‐8 and aHR remained the same,” the authors wrote.

“Our proposed N-classification based on aHR challenges previous tenets such as the importance of the 6-cm threshold and the importance of contralateral nodes,” the researchers wrote in their discussion.

The results from the new classification system were limited by the relatively small sample sizes and may not generalize to nonsquamous oral cancers, the researchers noted.

Further validation is needed before this system may be routinely applied in practice, but the results support evidence in favor of eliminating historical factors from staging, they said.
 

Experts Tout Advantages of Proposed Classification System

Cancer staging must be as accurate as possible and reviewed frequently, Shawn Li, MD, an otolaryngologist at University Hospitals, Cleveland, said in an interview. “This study aims to optimize nodal staging in oral cavity cancer. The current staging system doesn’t reflect updated data, and may not be specific enough to oral cavity cancers.”

This study notes the importance of stratifying extranodal extension (ENE) by micro (less than 2 mm) and macro (greater than 2 mm),” he said. It also points out that metastatic disease greater than 6 cm without ENE is infrequent enough not to require its own subcategory, he said.

Finally, in the new classification, proposed in this paper, “N2c was removed, because, statistically, it doesn’t seem to be a worse prognosis in cancers of the oral cavity,” he said.

“The data [described in this new paper] suggests that certain traditional criteria used in nodal staging for oral cavity cancer, such as [involving] very large lymph nodes greater than 6 cm in size and contralateral nodal involvement, may be less important than criteria that have not as of yet been incorporated into head and neck staging,” Wesley Talcott, MD, said in an interview. “The current study provides evidence that in oral cavity cancer, the prognostic accuracy of staging may improve by dropping these older criteria and incorporating degree of extranodal extension.”

This evidence is apparent in the ranking of the new aHR classification as first of the five strategies compared in the study, said Dr. Talcott, who was not involved in the study.

Highlighting the importance of microscopic vs. macroscopic extension may lead to doctors improving their identification of patients at highest risk for recurrence and refining treatment strategies, suggested Dr. Talcott, MD, a radiation oncologist at Northwell Health, New York, NY. However, a larger dataset is needed to validate the diagnostic accuracy of the authors’ proposed staging system, he said.

The TNM‐8‐N was updated in 2017, Dr. Li noted. “Since this system is widely referenced, it will likely need to be updated again before the changes in this study are widely adopted,” he said.

The study was supported by the National Institutes of Health and the National Cancer Institute. The researchers, Dr. Li, and Dr. Talcott had no financial conflicts to disclose.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.

METHODOLOGY:

• The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
• Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
• Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).

TAKEAWAY: 

• Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
• E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
• Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.

IN PRACTICE:

“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote. 

SOURCE:

The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research. 

LIMITATIONS:

The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments. 

DISCLOSURES:

The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

TOPLINE:

Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
• The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
• The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study. 

TAKEAWAY:

• The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
• Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
• Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.

IN PRACTICE:

“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine. 

LIMITATIONS:

A lack of data on smoking status and other residual confounding factors limited the study findings. 

DISCLOSURES:

The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.

A version of this article appeared on Medscape.com.

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.