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Tiny worms sniff out early-stage pancreatic cancer
Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.
According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.
There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.
Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.
A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.
However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.
In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.
In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034).
According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”
The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.
According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”
The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.
To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.
The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives?
In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.
“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”
The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.
Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.
The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.
A version of this article first appeared on Medscape.com.
Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.
According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.
There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.
Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.
A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.
However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.
In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.
In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034).
According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”
The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.
According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”
The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.
To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.
The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives?
In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.
“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”
The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.
Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.
The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.
A version of this article first appeared on Medscape.com.
Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.
According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.
There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.
Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.
A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.
However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.
In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.
In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034).
According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”
The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.
According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”
The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.
To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.
The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives?
In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.
“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”
The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.
Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.
The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.
A version of this article first appeared on Medscape.com.
Does eating nuts lead to better breast cancer outcomes?
In the first study of its kind, , compared with those who said they had not eaten nuts.
There was also an improvement in overall survival, but this was not statistically significant.
The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis.
The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.
“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.
“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.
However, as with all observational studies, this report shows an association and not causation.
“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.
The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.
Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.
Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.
Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.
She also offered some general advice about eating nuts.
“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.
A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”
The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.
“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
Study authors did an adjusted analysis
The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.
Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.
An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.
Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.
However, the two groups had many differences, as noted by the authors and outside experts.
The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.
So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.
Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).
The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.
The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.
Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.
The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the first study of its kind, , compared with those who said they had not eaten nuts.
There was also an improvement in overall survival, but this was not statistically significant.
The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis.
The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.
“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.
“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.
However, as with all observational studies, this report shows an association and not causation.
“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.
The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.
Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.
Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.
Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.
She also offered some general advice about eating nuts.
“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.
A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”
The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.
“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
Study authors did an adjusted analysis
The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.
Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.
An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.
Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.
However, the two groups had many differences, as noted by the authors and outside experts.
The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.
So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.
Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).
The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.
The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.
Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.
The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the first study of its kind, , compared with those who said they had not eaten nuts.
There was also an improvement in overall survival, but this was not statistically significant.
The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis.
The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.
“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.
“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.
However, as with all observational studies, this report shows an association and not causation.
“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.
The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.
Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.
Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.
Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.
She also offered some general advice about eating nuts.
“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.
A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”
The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.
“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
Study authors did an adjusted analysis
The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.
Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.
An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.
Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.
However, the two groups had many differences, as noted by the authors and outside experts.
The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.
So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.
Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).
The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.
The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.
Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.
The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pfizer offers refund if drug ‘doesn’t work’
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.
Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”
For what it says is the first time in the industry,
“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.
Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.
In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.
Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
Pfizer pledge
Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.
Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.
“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”
This program is only available for patients who reside in the United States.
If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.
“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.
The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.
So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.
“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
Previous scheme ended in court
Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).
Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.
Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.
The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.
Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.
The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.
A version of this article first appeared on Medscape.com.
Could your patient benefit? New trials in lung cancer
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Gut bacteria may fuel prostate cancer treatment resistance
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
No advantages to using ADM in implant-based breast reconstruction
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Childhood vaccination rates up since early pandemic, but few are up to date
The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.
The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.
“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”
While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.
“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”
The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.
Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.
Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.
Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.
“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”
The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.
There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.
The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.
To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.
The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.
However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.
“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.
Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.
“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.
The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.
The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.
“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”
While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.
“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”
The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.
Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.
Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.
Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.
“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”
The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.
There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.
The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.
To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.
The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.
However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.
“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.
Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.
“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.
The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.
The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.
“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”
While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.
“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”
The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.
Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.
Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.
Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.
“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”
The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.
There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.
The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.
To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.
The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.
However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.
“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.
Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.
“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.
FROM JAMA PEDIATRICS
Community mourns nurse knocked over, killed in Times Square
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
Benzene prompts recalls of spray antifungals and sunscreens
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
‘Regionalized’ care tied to better survival in tough cancer
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.