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VIDEO: Integrative oncology expert discusses management
SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.
Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.
He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.
Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.
The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.
One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.
Dr. Abrams reported having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.
Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.
He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.
Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.
The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.
One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.
Dr. Abrams reported having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.
Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.
He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.
Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.
The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.
One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.
Dr. Abrams reported having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Locoregional recurrence of breast cancer less likely after neoadjuvant complete response
Patients with residual disease after neoadjuvant chemotherapy and surgery for breast cancer had a 60%-280% increased risk for locoregional recurrence, compared with patients with a pathologic complete response, an analysis of data from 12 large clinical trials found.
Investigators analyzed data on 11,955 patients with stage I-III breast cancer who underwent neoadjuvant chemotherapy in studies with long-term follow-up and information on complete pathologic response (no residual cancer in the breast and no cancer in the axillary lymph nodes after surgery). They included 5,252 patients in a multivariate analysis of predictors of locoregional recurrence a median of 5 years after treatment.
Overall, the likelihood of locoregional recurrence was low – less than 10%. Locoregional recurrence was seen in 5.5% of patients with a complete pathologic response to neoadjuvant chemotherapy and in 7.1% of patients without a complete response, a significant 60% increase in risk without a complete response, Dr. Eleftherios Mamounas reported in a press briefing held in advance of the breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients with residual cancer in the breast after surgery had a 60% higher risk for locoregional recurrence, and patients with residual cancer in the axillary lymph nodes had a 280% increased risk for locoregional recurrence, compared with patients who had a complete pathologic response, reported Dr. Mamounas, professor of surgery at the University of Central Florida, and medical director of the comprehensive breast program at the University of Florida Health Cancer Center, both in Orlando.
Breast cancer subtypes remained independent predictors of locoregional recurrence, regardless of whether patients had a pathologic complete response or not. The cancer recurred locally or regionally in 4% of patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) grade 1 or 2 cancer, 9% of patients with HR+/HER2– grade 3 cancer, 15% of patients with HR–/HER2+ cancer, 10% of patients with HR+/HER2+ cancer, and 12% of patients with HR–/HER2– cancer (also known as hormone receptor–negative or triple-negative breast cancer).
Those rates would be different today because of more effective treatments for HER2+ breast cancer, he noted.
"For all breast cancer subtypes except for HR+/HER2– grade 1 and 2, there was a progressive increase in the locoregional recurrence rates with decreasing rates of pathologic complete response," he said. In other words, recurrence rates went from highest to lowest in patients "having positive nodes, versus having residual disease in the breast with negative nodes, versus having complete pathologic response," he explained.
Among patients with triple-negative cancer, for example, locoregional recurrence rates went from 6.2% in those with a complete response to 11.9% in patients with residual cancer in the breast but not lymph nodes and 22.1% in those who had positive nodes after treatment.
A pathologic complete response predicted lower locoregional recurrence rates with the various cancer subtypes, regardless of whether the patient underwent lumpectomy or mastectomy, he said.
Based on these results and previously published studies, "we have a lot of evidence that pathologic complete response is predictive of outcome, both in terms of systemic recurrence and also in terms of local recurrence," Dr. Mamounas commented. A previous meta-analysis that reported conflicting results for systemic recurrence "did not quite confirm that an incremental increase in pathologic complete response will improve overall survival, but there are a lot of technical issues if you look at the different studies that were included in the meta-analysis. The bar was very high to prove that concept."
Recurrence is less likely after a pathologic complete response in patients with HER2+ breast cancer, triple-negative cancer, or highly proliferative estrogen receptor–positive breast cancer, he said. That may not be the case for patients with estrogen receptor–positive, HER2– grade 1 disease, who do very well regardless, he added.
"Our findings have clinical implications relative to further tailoring the use of adjuvant radiation therapy after neoadjuvant chemotherapy and support the conduct of ongoing clinical trials attempting to tailor locoregional therapy in this setting," Dr. Mamounas said.
Dr. Mamounas reported financial associations with Genomic Health, GE Healthcare, Celgene, Pfizer, Eisai, and Genentech/Roche. Some of his coinvestigators reported associations with multiple companies.
On Twitter @sherryboschert
This is a group of women who have higher-than-average risk, such that they are being offered up-front chemotherapy to shrink cancers even before they would go for breast surgery.
We’ve known for a long time that this clinical endpoint of complete pathologic response – that is, when you do the breast surgery, there is no evidence of residual cancer – is a powerful predictor of the cancer not recurring somewhere else in the body. These data from Dr. Mamounas show that complete pathologic response also is a predictor for not having the cancer recur within the chest wall or the breast itself. That’s very important information for the clinical team.
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Dr. Mamounas’s data also point to the idea that the breast cancer subtype is very important for predicting the outcomes. In the modern era, so much of what we are thinking about in the way of managing breast cancer is driven by our understanding of these major clinical subtypes, the so-called HER2-positive breast cancers, the so-called triple-negative breast cancers (which lack estrogen receptor, progesterone receptor, and HER2), and finally the spectrum of so-called estrogen receptor–positive, HER2-negative (sometimes called luminal) cancers.
What Dr. Mamounas’s data speak to is a very complicated matrix that helps us understand the risk of local recurrence in a woman who has a greater-than-average risk of breast cancer by factoring in the type of breast cancer, the response that you see with the up-front chemotherapy, and the age of the patient. These multiplex kinds of information set the stage for a variety of trials that are looking at trying to tailor additional therapy for women who are at higher risk and, conversely, sparing women who are at lower risk the need for extra treatment – in this case, possibly the need for radiation therapy.
These are data that really resonate with radiation oncologists, surgeons, and medical oncologists, who are into the nitty-gritty of caring for women with breast cancer and need to determine who is going to need more therapy and who can be spared additional treatment.
Dr. Harold J. Burstein is associate professor of medicine at Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston. He reported having no relevant financial disclosures.
This is a group of women who have higher-than-average risk, such that they are being offered up-front chemotherapy to shrink cancers even before they would go for breast surgery.
We’ve known for a long time that this clinical endpoint of complete pathologic response – that is, when you do the breast surgery, there is no evidence of residual cancer – is a powerful predictor of the cancer not recurring somewhere else in the body. These data from Dr. Mamounas show that complete pathologic response also is a predictor for not having the cancer recur within the chest wall or the breast itself. That’s very important information for the clinical team.
|
|
Dr. Mamounas’s data also point to the idea that the breast cancer subtype is very important for predicting the outcomes. In the modern era, so much of what we are thinking about in the way of managing breast cancer is driven by our understanding of these major clinical subtypes, the so-called HER2-positive breast cancers, the so-called triple-negative breast cancers (which lack estrogen receptor, progesterone receptor, and HER2), and finally the spectrum of so-called estrogen receptor–positive, HER2-negative (sometimes called luminal) cancers.
What Dr. Mamounas’s data speak to is a very complicated matrix that helps us understand the risk of local recurrence in a woman who has a greater-than-average risk of breast cancer by factoring in the type of breast cancer, the response that you see with the up-front chemotherapy, and the age of the patient. These multiplex kinds of information set the stage for a variety of trials that are looking at trying to tailor additional therapy for women who are at higher risk and, conversely, sparing women who are at lower risk the need for extra treatment – in this case, possibly the need for radiation therapy.
These are data that really resonate with radiation oncologists, surgeons, and medical oncologists, who are into the nitty-gritty of caring for women with breast cancer and need to determine who is going to need more therapy and who can be spared additional treatment.
Dr. Harold J. Burstein is associate professor of medicine at Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston. He reported having no relevant financial disclosures.
This is a group of women who have higher-than-average risk, such that they are being offered up-front chemotherapy to shrink cancers even before they would go for breast surgery.
We’ve known for a long time that this clinical endpoint of complete pathologic response – that is, when you do the breast surgery, there is no evidence of residual cancer – is a powerful predictor of the cancer not recurring somewhere else in the body. These data from Dr. Mamounas show that complete pathologic response also is a predictor for not having the cancer recur within the chest wall or the breast itself. That’s very important information for the clinical team.
|
|
Dr. Mamounas’s data also point to the idea that the breast cancer subtype is very important for predicting the outcomes. In the modern era, so much of what we are thinking about in the way of managing breast cancer is driven by our understanding of these major clinical subtypes, the so-called HER2-positive breast cancers, the so-called triple-negative breast cancers (which lack estrogen receptor, progesterone receptor, and HER2), and finally the spectrum of so-called estrogen receptor–positive, HER2-negative (sometimes called luminal) cancers.
What Dr. Mamounas’s data speak to is a very complicated matrix that helps us understand the risk of local recurrence in a woman who has a greater-than-average risk of breast cancer by factoring in the type of breast cancer, the response that you see with the up-front chemotherapy, and the age of the patient. These multiplex kinds of information set the stage for a variety of trials that are looking at trying to tailor additional therapy for women who are at higher risk and, conversely, sparing women who are at lower risk the need for extra treatment – in this case, possibly the need for radiation therapy.
These are data that really resonate with radiation oncologists, surgeons, and medical oncologists, who are into the nitty-gritty of caring for women with breast cancer and need to determine who is going to need more therapy and who can be spared additional treatment.
Dr. Harold J. Burstein is associate professor of medicine at Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston. He reported having no relevant financial disclosures.
Patients with residual disease after neoadjuvant chemotherapy and surgery for breast cancer had a 60%-280% increased risk for locoregional recurrence, compared with patients with a pathologic complete response, an analysis of data from 12 large clinical trials found.
Investigators analyzed data on 11,955 patients with stage I-III breast cancer who underwent neoadjuvant chemotherapy in studies with long-term follow-up and information on complete pathologic response (no residual cancer in the breast and no cancer in the axillary lymph nodes after surgery). They included 5,252 patients in a multivariate analysis of predictors of locoregional recurrence a median of 5 years after treatment.
Overall, the likelihood of locoregional recurrence was low – less than 10%. Locoregional recurrence was seen in 5.5% of patients with a complete pathologic response to neoadjuvant chemotherapy and in 7.1% of patients without a complete response, a significant 60% increase in risk without a complete response, Dr. Eleftherios Mamounas reported in a press briefing held in advance of the breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients with residual cancer in the breast after surgery had a 60% higher risk for locoregional recurrence, and patients with residual cancer in the axillary lymph nodes had a 280% increased risk for locoregional recurrence, compared with patients who had a complete pathologic response, reported Dr. Mamounas, professor of surgery at the University of Central Florida, and medical director of the comprehensive breast program at the University of Florida Health Cancer Center, both in Orlando.
Breast cancer subtypes remained independent predictors of locoregional recurrence, regardless of whether patients had a pathologic complete response or not. The cancer recurred locally or regionally in 4% of patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) grade 1 or 2 cancer, 9% of patients with HR+/HER2– grade 3 cancer, 15% of patients with HR–/HER2+ cancer, 10% of patients with HR+/HER2+ cancer, and 12% of patients with HR–/HER2– cancer (also known as hormone receptor–negative or triple-negative breast cancer).
Those rates would be different today because of more effective treatments for HER2+ breast cancer, he noted.
"For all breast cancer subtypes except for HR+/HER2– grade 1 and 2, there was a progressive increase in the locoregional recurrence rates with decreasing rates of pathologic complete response," he said. In other words, recurrence rates went from highest to lowest in patients "having positive nodes, versus having residual disease in the breast with negative nodes, versus having complete pathologic response," he explained.
Among patients with triple-negative cancer, for example, locoregional recurrence rates went from 6.2% in those with a complete response to 11.9% in patients with residual cancer in the breast but not lymph nodes and 22.1% in those who had positive nodes after treatment.
A pathologic complete response predicted lower locoregional recurrence rates with the various cancer subtypes, regardless of whether the patient underwent lumpectomy or mastectomy, he said.
Based on these results and previously published studies, "we have a lot of evidence that pathologic complete response is predictive of outcome, both in terms of systemic recurrence and also in terms of local recurrence," Dr. Mamounas commented. A previous meta-analysis that reported conflicting results for systemic recurrence "did not quite confirm that an incremental increase in pathologic complete response will improve overall survival, but there are a lot of technical issues if you look at the different studies that were included in the meta-analysis. The bar was very high to prove that concept."
Recurrence is less likely after a pathologic complete response in patients with HER2+ breast cancer, triple-negative cancer, or highly proliferative estrogen receptor–positive breast cancer, he said. That may not be the case for patients with estrogen receptor–positive, HER2– grade 1 disease, who do very well regardless, he added.
"Our findings have clinical implications relative to further tailoring the use of adjuvant radiation therapy after neoadjuvant chemotherapy and support the conduct of ongoing clinical trials attempting to tailor locoregional therapy in this setting," Dr. Mamounas said.
Dr. Mamounas reported financial associations with Genomic Health, GE Healthcare, Celgene, Pfizer, Eisai, and Genentech/Roche. Some of his coinvestigators reported associations with multiple companies.
On Twitter @sherryboschert
Patients with residual disease after neoadjuvant chemotherapy and surgery for breast cancer had a 60%-280% increased risk for locoregional recurrence, compared with patients with a pathologic complete response, an analysis of data from 12 large clinical trials found.
Investigators analyzed data on 11,955 patients with stage I-III breast cancer who underwent neoadjuvant chemotherapy in studies with long-term follow-up and information on complete pathologic response (no residual cancer in the breast and no cancer in the axillary lymph nodes after surgery). They included 5,252 patients in a multivariate analysis of predictors of locoregional recurrence a median of 5 years after treatment.
Overall, the likelihood of locoregional recurrence was low – less than 10%. Locoregional recurrence was seen in 5.5% of patients with a complete pathologic response to neoadjuvant chemotherapy and in 7.1% of patients without a complete response, a significant 60% increase in risk without a complete response, Dr. Eleftherios Mamounas reported in a press briefing held in advance of the breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients with residual cancer in the breast after surgery had a 60% higher risk for locoregional recurrence, and patients with residual cancer in the axillary lymph nodes had a 280% increased risk for locoregional recurrence, compared with patients who had a complete pathologic response, reported Dr. Mamounas, professor of surgery at the University of Central Florida, and medical director of the comprehensive breast program at the University of Florida Health Cancer Center, both in Orlando.
Breast cancer subtypes remained independent predictors of locoregional recurrence, regardless of whether patients had a pathologic complete response or not. The cancer recurred locally or regionally in 4% of patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) grade 1 or 2 cancer, 9% of patients with HR+/HER2– grade 3 cancer, 15% of patients with HR–/HER2+ cancer, 10% of patients with HR+/HER2+ cancer, and 12% of patients with HR–/HER2– cancer (also known as hormone receptor–negative or triple-negative breast cancer).
Those rates would be different today because of more effective treatments for HER2+ breast cancer, he noted.
"For all breast cancer subtypes except for HR+/HER2– grade 1 and 2, there was a progressive increase in the locoregional recurrence rates with decreasing rates of pathologic complete response," he said. In other words, recurrence rates went from highest to lowest in patients "having positive nodes, versus having residual disease in the breast with negative nodes, versus having complete pathologic response," he explained.
Among patients with triple-negative cancer, for example, locoregional recurrence rates went from 6.2% in those with a complete response to 11.9% in patients with residual cancer in the breast but not lymph nodes and 22.1% in those who had positive nodes after treatment.
A pathologic complete response predicted lower locoregional recurrence rates with the various cancer subtypes, regardless of whether the patient underwent lumpectomy or mastectomy, he said.
Based on these results and previously published studies, "we have a lot of evidence that pathologic complete response is predictive of outcome, both in terms of systemic recurrence and also in terms of local recurrence," Dr. Mamounas commented. A previous meta-analysis that reported conflicting results for systemic recurrence "did not quite confirm that an incremental increase in pathologic complete response will improve overall survival, but there are a lot of technical issues if you look at the different studies that were included in the meta-analysis. The bar was very high to prove that concept."
Recurrence is less likely after a pathologic complete response in patients with HER2+ breast cancer, triple-negative cancer, or highly proliferative estrogen receptor–positive breast cancer, he said. That may not be the case for patients with estrogen receptor–positive, HER2– grade 1 disease, who do very well regardless, he added.
"Our findings have clinical implications relative to further tailoring the use of adjuvant radiation therapy after neoadjuvant chemotherapy and support the conduct of ongoing clinical trials attempting to tailor locoregional therapy in this setting," Dr. Mamounas said.
Dr. Mamounas reported financial associations with Genomic Health, GE Healthcare, Celgene, Pfizer, Eisai, and Genentech/Roche. Some of his coinvestigators reported associations with multiple companies.
On Twitter @sherryboschert
FROM THE ASCO BREAST CANCER SYMPOSIUM
Key clinical point: Response to neoadjuvant chemotherapy for breast cancer predicts the locoregional recurrence risk.
Major finding: Risk for locoregional recurrence was 60%-280% higher in patients without a pathologic complete response.
Data source: A pooled analysis of data on 11,955 patients who got neoadjuvant therapy and surgery for stage I-III breast cancer.
Disclosures: Dr. Mamounas reported financial associations with Genomic Health, GE Healthcare, Celgene, Pfizer, Eisai, and Genentech/Roche. Some of his coinvestigators reported associations with multiple companies.
For advanced HER2-negative breast cancer, no best treatment
A new evidence-based practice guideline from the American Society of Clinical Oncology on treating women with advanced breast cancer that is negative for human epidermal growth factor receptor 2 emphasizes that "optimal" chemotherapy regimens may vary considerably between patients.
When choosing treatment for an individual with HER2-negative breast cancer, consider not only the potential efficacy of a therapy but also the potential toxicity, the patient’s performance status and comorbid conditions, history of prior therapy, whether the cancer is indolent or immediately life threatening, and the patient’s preferences and schedule, the guideline states.
That said, the guideline on "Chemotherapy and Targeted Therapy for Women with Human Epidermal Growth Factor Receptor 2-Negative (or unknown) Advanced Breast Cancer" offers some specific recommendations (J. Clin. Oncol. 2014 Sept. 2 [doi:10.1200/JCO.2014.56.7479]).
First-line treatment should be endocrine therapy if the patient has metastatic HER2-negative breast cancer that’s also estrogen receptor positive, unless the disease is immediately life threatening or there is concern about potential resistance to hormone therapy.
Treating with single chemotherapy drugs (in sequential trials, if needed) is preferable to combination chemotherapy for HER2-negative breast cancer in order to limit side effects and help preserve the patient’s quality of life, the guideline states. Although a longer duration of chemotherapy can improve survival, this must be balanced against the treatment’s toxicity.
Use of targeted therapy with bevacizumab, a monoclonal antibody, remains controversial and should only be considered with single-agent chemotherapy for patients with immediately life-threatening disease or severe symptoms, the guideline suggests. Bevacizumab is not approved in the United States to treat breast cancer.
Other targeted therapies have not been shown to improve outcomes in women with advanced HER2-negative breast cancer and should not be used with or instead of chemotherapy in these patients.
Offer palliative care early and throughout the continuum of care, the guideline recommends.
"Although no clear chemotherapy winner emerged, the guideline will help doctors and patients choose the best therapy based on what treatment would be most tolerable and convenient for the patient," Dr. Ann H. Partridge said in an American Society of Clinical Oncology statement. Dr. Partridge cochaired the expert panel that developed the guideline and is director of the Adult Survivorship Program and the Program for Young Women with Breast Cancer at the Dana-Farber Cancer Institute, Boston.
Some of the many treatments available for HER2-negative breast cancer are "unnecessarily toxic," expert panel cochair Dr. Ian E. Smith said in the ASCO statement. "Breast cancer can often be controlled with less intensive approaches that offer a better quality of life," said Dr. Smith, a professor of cancer medicine at Royal Marsden Hospital, London.
ASCO’s consensus-driven expert panel reviewed randomized studies in the medical literature from 1993 through May 2013 and used the 2009 systematic review by the National Collaborating Centre for Cancer in England as a starting point for what’s known. The panel considered 79 studies, including 20 systematic reviews or meta-analyses, 30 trials of first-line treatments, and 29 trials of second-line or subsequent treatments.
A majority of patients with advanced breast cancer have HER2-negative disease, for which development of targeted therapies is in the early stages. The current speed of research progress in cancer genomics and potential targets of drug therapy is likely to produce new targeted therapies soon to enhance or replace chemotherapy, the guideline authors predicted.
Even then, collaboration between physician and patient to find the optimal approach will remain key. "Given the heterogeneity of breast cancer, even when restricted to HER2-negative disease, it is also possible that ‘one size will never fit all’ and that there is no best treatment for most patients," they wrote.
Dr. Partridge and Dr. Smith reported having no financial disclosures. Disclosures for several of their coauthors who reported having associations with pharmaceutical companies are available with the article online.
On Twitter @sherryboschert
A new evidence-based practice guideline from the American Society of Clinical Oncology on treating women with advanced breast cancer that is negative for human epidermal growth factor receptor 2 emphasizes that "optimal" chemotherapy regimens may vary considerably between patients.
When choosing treatment for an individual with HER2-negative breast cancer, consider not only the potential efficacy of a therapy but also the potential toxicity, the patient’s performance status and comorbid conditions, history of prior therapy, whether the cancer is indolent or immediately life threatening, and the patient’s preferences and schedule, the guideline states.
That said, the guideline on "Chemotherapy and Targeted Therapy for Women with Human Epidermal Growth Factor Receptor 2-Negative (or unknown) Advanced Breast Cancer" offers some specific recommendations (J. Clin. Oncol. 2014 Sept. 2 [doi:10.1200/JCO.2014.56.7479]).
First-line treatment should be endocrine therapy if the patient has metastatic HER2-negative breast cancer that’s also estrogen receptor positive, unless the disease is immediately life threatening or there is concern about potential resistance to hormone therapy.
Treating with single chemotherapy drugs (in sequential trials, if needed) is preferable to combination chemotherapy for HER2-negative breast cancer in order to limit side effects and help preserve the patient’s quality of life, the guideline states. Although a longer duration of chemotherapy can improve survival, this must be balanced against the treatment’s toxicity.
Use of targeted therapy with bevacizumab, a monoclonal antibody, remains controversial and should only be considered with single-agent chemotherapy for patients with immediately life-threatening disease or severe symptoms, the guideline suggests. Bevacizumab is not approved in the United States to treat breast cancer.
Other targeted therapies have not been shown to improve outcomes in women with advanced HER2-negative breast cancer and should not be used with or instead of chemotherapy in these patients.
Offer palliative care early and throughout the continuum of care, the guideline recommends.
"Although no clear chemotherapy winner emerged, the guideline will help doctors and patients choose the best therapy based on what treatment would be most tolerable and convenient for the patient," Dr. Ann H. Partridge said in an American Society of Clinical Oncology statement. Dr. Partridge cochaired the expert panel that developed the guideline and is director of the Adult Survivorship Program and the Program for Young Women with Breast Cancer at the Dana-Farber Cancer Institute, Boston.
Some of the many treatments available for HER2-negative breast cancer are "unnecessarily toxic," expert panel cochair Dr. Ian E. Smith said in the ASCO statement. "Breast cancer can often be controlled with less intensive approaches that offer a better quality of life," said Dr. Smith, a professor of cancer medicine at Royal Marsden Hospital, London.
ASCO’s consensus-driven expert panel reviewed randomized studies in the medical literature from 1993 through May 2013 and used the 2009 systematic review by the National Collaborating Centre for Cancer in England as a starting point for what’s known. The panel considered 79 studies, including 20 systematic reviews or meta-analyses, 30 trials of first-line treatments, and 29 trials of second-line or subsequent treatments.
A majority of patients with advanced breast cancer have HER2-negative disease, for which development of targeted therapies is in the early stages. The current speed of research progress in cancer genomics and potential targets of drug therapy is likely to produce new targeted therapies soon to enhance or replace chemotherapy, the guideline authors predicted.
Even then, collaboration between physician and patient to find the optimal approach will remain key. "Given the heterogeneity of breast cancer, even when restricted to HER2-negative disease, it is also possible that ‘one size will never fit all’ and that there is no best treatment for most patients," they wrote.
Dr. Partridge and Dr. Smith reported having no financial disclosures. Disclosures for several of their coauthors who reported having associations with pharmaceutical companies are available with the article online.
On Twitter @sherryboschert
A new evidence-based practice guideline from the American Society of Clinical Oncology on treating women with advanced breast cancer that is negative for human epidermal growth factor receptor 2 emphasizes that "optimal" chemotherapy regimens may vary considerably between patients.
When choosing treatment for an individual with HER2-negative breast cancer, consider not only the potential efficacy of a therapy but also the potential toxicity, the patient’s performance status and comorbid conditions, history of prior therapy, whether the cancer is indolent or immediately life threatening, and the patient’s preferences and schedule, the guideline states.
That said, the guideline on "Chemotherapy and Targeted Therapy for Women with Human Epidermal Growth Factor Receptor 2-Negative (or unknown) Advanced Breast Cancer" offers some specific recommendations (J. Clin. Oncol. 2014 Sept. 2 [doi:10.1200/JCO.2014.56.7479]).
First-line treatment should be endocrine therapy if the patient has metastatic HER2-negative breast cancer that’s also estrogen receptor positive, unless the disease is immediately life threatening or there is concern about potential resistance to hormone therapy.
Treating with single chemotherapy drugs (in sequential trials, if needed) is preferable to combination chemotherapy for HER2-negative breast cancer in order to limit side effects and help preserve the patient’s quality of life, the guideline states. Although a longer duration of chemotherapy can improve survival, this must be balanced against the treatment’s toxicity.
Use of targeted therapy with bevacizumab, a monoclonal antibody, remains controversial and should only be considered with single-agent chemotherapy for patients with immediately life-threatening disease or severe symptoms, the guideline suggests. Bevacizumab is not approved in the United States to treat breast cancer.
Other targeted therapies have not been shown to improve outcomes in women with advanced HER2-negative breast cancer and should not be used with or instead of chemotherapy in these patients.
Offer palliative care early and throughout the continuum of care, the guideline recommends.
"Although no clear chemotherapy winner emerged, the guideline will help doctors and patients choose the best therapy based on what treatment would be most tolerable and convenient for the patient," Dr. Ann H. Partridge said in an American Society of Clinical Oncology statement. Dr. Partridge cochaired the expert panel that developed the guideline and is director of the Adult Survivorship Program and the Program for Young Women with Breast Cancer at the Dana-Farber Cancer Institute, Boston.
Some of the many treatments available for HER2-negative breast cancer are "unnecessarily toxic," expert panel cochair Dr. Ian E. Smith said in the ASCO statement. "Breast cancer can often be controlled with less intensive approaches that offer a better quality of life," said Dr. Smith, a professor of cancer medicine at Royal Marsden Hospital, London.
ASCO’s consensus-driven expert panel reviewed randomized studies in the medical literature from 1993 through May 2013 and used the 2009 systematic review by the National Collaborating Centre for Cancer in England as a starting point for what’s known. The panel considered 79 studies, including 20 systematic reviews or meta-analyses, 30 trials of first-line treatments, and 29 trials of second-line or subsequent treatments.
A majority of patients with advanced breast cancer have HER2-negative disease, for which development of targeted therapies is in the early stages. The current speed of research progress in cancer genomics and potential targets of drug therapy is likely to produce new targeted therapies soon to enhance or replace chemotherapy, the guideline authors predicted.
Even then, collaboration between physician and patient to find the optimal approach will remain key. "Given the heterogeneity of breast cancer, even when restricted to HER2-negative disease, it is also possible that ‘one size will never fit all’ and that there is no best treatment for most patients," they wrote.
Dr. Partridge and Dr. Smith reported having no financial disclosures. Disclosures for several of their coauthors who reported having associations with pharmaceutical companies are available with the article online.
On Twitter @sherryboschert
FROM JOURNAL OF CLINICAL ONCOLOGY
Fecal transplant cured severe or complicated C. difficile
Fecal microbiota transplantation successfully treated severe and/or complicated Clostridium difficile infection in a retrospective, multicenter, long-term follow-up study of 17 patients in whom conventional therapy had failed.
The 14 inpatients and 3 outpatients were treated for either severe or complicated C. difficile infection (4 patients) or for both severe and complicated infection (13 patients). They were followed for a mean of 11 months (ranging from 1 to 42 months) after fecal microbiota transplantation.
In 16 patients with diarrhea before transplantation, the diarrhea resolved in 12 patients over an average of 6 days after fecal microbiota transplantation and improved in 4 patients. In 11 patients with abdominal pain before transplantation, the pain resolved in 8 patients over a mean of 10 days and improved in 3 patients, Dr. Olga C. Aroniadis and her associates reported.
Fifteen of 17 patients had no recurrence of C. difficile infection within 90 days of transplantation, for a primary cure rate of 88%. One of the two patients with a recurrence within 90 days was treated successfully with a second fecal microbiota transplantation, for a secondary cure rate of 94%, said Dr. Aroniadis of Montefiore Medical Center, New York.
Patients were considered cured if symptoms of C. difficile infection resolved or improved enough for the patient to be discharged from the hospital, she said in an interview. "In some patients, bowel habits do not return to baseline after successful treatment of C. difficile infection and patients have intermittent diarrhea and soft stools, but these patients no longer have C. difficile. This is what we experienced with some of our patients who we considered to be cured," she said.
One patient developed a late recurrence (more than 90 days after initial transplantation) in association with taking antibiotics to treat diverticulitis. The recurrent C. difficile infection was treated successfully with repeat fecal microbiota transplantation.
Dr. Aroniadis reported the results at the James W. Freston conference sponsored by the American Gastroenterological Association.
The cure rates are similar to results in previous studies of patients who underwent fecal microbiota transplantation for recurrent C. difficile infection who did not have severe or complicated disease, she said.
The 17 patients in the current study had failed conventional medical therapy with antibiotics such as metronidazole and oral vancomycin prior to fecal microbiota transplantation. Many were hospitalized in the ICU and on vasopressor support, she said.
"It’s truly a rewarding experience to watch these severely ill patients improve after fecal transplantation," Dr. Aroniadis said. "Fecal transplantation even obviated the need for colectomy in one of our patients."
Fecal microbiota transplantation for C. difficile infection can be performed by infusing a donated fecal suspension into the gastrointestinal tract via colonoscopy, upper endoscopy, flexible sigmoidoscopy, or enema. Physicians should "use their clinical judgment when determining the appropriate route of administration in patients with severe or complicated C. difficile infection who may be at increased risk for complications from colonoscopy due to colonic dilation and poor bowel wall integrity," Dr. Aroniadis said.
In the study, C. difficile infection was considered severe if the patient had abdominal tenderness, an albumin level less than 3 g/dL, or a WBC count greater than 15,000 cells/mcL, in accordance with published guidelines, she said. Infection was considered complicated if it necessitated ICU care or if the patient had hypotension with or without the use of vasopressors, a change in mental status, a WBC count greater than 35,000 cells/mcL or less than 2,000 cells/mcL, serum lactate levels of 2.2 mmol/L or greater, end-organ failure, a fever of at least 38.5 °C, or ileus or significant abdominal tenderness.
Patients had a mean age of 66 years (ranging from 38 to 89 years), and 13 of them were women.
Dr. Aroniadis reported having no financial disclosures.
On Twitter @sherryboschert
Fecal microbiota transplantation successfully treated severe and/or complicated Clostridium difficile infection in a retrospective, multicenter, long-term follow-up study of 17 patients in whom conventional therapy had failed.
The 14 inpatients and 3 outpatients were treated for either severe or complicated C. difficile infection (4 patients) or for both severe and complicated infection (13 patients). They were followed for a mean of 11 months (ranging from 1 to 42 months) after fecal microbiota transplantation.
In 16 patients with diarrhea before transplantation, the diarrhea resolved in 12 patients over an average of 6 days after fecal microbiota transplantation and improved in 4 patients. In 11 patients with abdominal pain before transplantation, the pain resolved in 8 patients over a mean of 10 days and improved in 3 patients, Dr. Olga C. Aroniadis and her associates reported.
Fifteen of 17 patients had no recurrence of C. difficile infection within 90 days of transplantation, for a primary cure rate of 88%. One of the two patients with a recurrence within 90 days was treated successfully with a second fecal microbiota transplantation, for a secondary cure rate of 94%, said Dr. Aroniadis of Montefiore Medical Center, New York.
Patients were considered cured if symptoms of C. difficile infection resolved or improved enough for the patient to be discharged from the hospital, she said in an interview. "In some patients, bowel habits do not return to baseline after successful treatment of C. difficile infection and patients have intermittent diarrhea and soft stools, but these patients no longer have C. difficile. This is what we experienced with some of our patients who we considered to be cured," she said.
One patient developed a late recurrence (more than 90 days after initial transplantation) in association with taking antibiotics to treat diverticulitis. The recurrent C. difficile infection was treated successfully with repeat fecal microbiota transplantation.
Dr. Aroniadis reported the results at the James W. Freston conference sponsored by the American Gastroenterological Association.
The cure rates are similar to results in previous studies of patients who underwent fecal microbiota transplantation for recurrent C. difficile infection who did not have severe or complicated disease, she said.
The 17 patients in the current study had failed conventional medical therapy with antibiotics such as metronidazole and oral vancomycin prior to fecal microbiota transplantation. Many were hospitalized in the ICU and on vasopressor support, she said.
"It’s truly a rewarding experience to watch these severely ill patients improve after fecal transplantation," Dr. Aroniadis said. "Fecal transplantation even obviated the need for colectomy in one of our patients."
Fecal microbiota transplantation for C. difficile infection can be performed by infusing a donated fecal suspension into the gastrointestinal tract via colonoscopy, upper endoscopy, flexible sigmoidoscopy, or enema. Physicians should "use their clinical judgment when determining the appropriate route of administration in patients with severe or complicated C. difficile infection who may be at increased risk for complications from colonoscopy due to colonic dilation and poor bowel wall integrity," Dr. Aroniadis said.
In the study, C. difficile infection was considered severe if the patient had abdominal tenderness, an albumin level less than 3 g/dL, or a WBC count greater than 15,000 cells/mcL, in accordance with published guidelines, she said. Infection was considered complicated if it necessitated ICU care or if the patient had hypotension with or without the use of vasopressors, a change in mental status, a WBC count greater than 35,000 cells/mcL or less than 2,000 cells/mcL, serum lactate levels of 2.2 mmol/L or greater, end-organ failure, a fever of at least 38.5 °C, or ileus or significant abdominal tenderness.
Patients had a mean age of 66 years (ranging from 38 to 89 years), and 13 of them were women.
Dr. Aroniadis reported having no financial disclosures.
On Twitter @sherryboschert
Fecal microbiota transplantation successfully treated severe and/or complicated Clostridium difficile infection in a retrospective, multicenter, long-term follow-up study of 17 patients in whom conventional therapy had failed.
The 14 inpatients and 3 outpatients were treated for either severe or complicated C. difficile infection (4 patients) or for both severe and complicated infection (13 patients). They were followed for a mean of 11 months (ranging from 1 to 42 months) after fecal microbiota transplantation.
In 16 patients with diarrhea before transplantation, the diarrhea resolved in 12 patients over an average of 6 days after fecal microbiota transplantation and improved in 4 patients. In 11 patients with abdominal pain before transplantation, the pain resolved in 8 patients over a mean of 10 days and improved in 3 patients, Dr. Olga C. Aroniadis and her associates reported.
Fifteen of 17 patients had no recurrence of C. difficile infection within 90 days of transplantation, for a primary cure rate of 88%. One of the two patients with a recurrence within 90 days was treated successfully with a second fecal microbiota transplantation, for a secondary cure rate of 94%, said Dr. Aroniadis of Montefiore Medical Center, New York.
Patients were considered cured if symptoms of C. difficile infection resolved or improved enough for the patient to be discharged from the hospital, she said in an interview. "In some patients, bowel habits do not return to baseline after successful treatment of C. difficile infection and patients have intermittent diarrhea and soft stools, but these patients no longer have C. difficile. This is what we experienced with some of our patients who we considered to be cured," she said.
One patient developed a late recurrence (more than 90 days after initial transplantation) in association with taking antibiotics to treat diverticulitis. The recurrent C. difficile infection was treated successfully with repeat fecal microbiota transplantation.
Dr. Aroniadis reported the results at the James W. Freston conference sponsored by the American Gastroenterological Association.
The cure rates are similar to results in previous studies of patients who underwent fecal microbiota transplantation for recurrent C. difficile infection who did not have severe or complicated disease, she said.
The 17 patients in the current study had failed conventional medical therapy with antibiotics such as metronidazole and oral vancomycin prior to fecal microbiota transplantation. Many were hospitalized in the ICU and on vasopressor support, she said.
"It’s truly a rewarding experience to watch these severely ill patients improve after fecal transplantation," Dr. Aroniadis said. "Fecal transplantation even obviated the need for colectomy in one of our patients."
Fecal microbiota transplantation for C. difficile infection can be performed by infusing a donated fecal suspension into the gastrointestinal tract via colonoscopy, upper endoscopy, flexible sigmoidoscopy, or enema. Physicians should "use their clinical judgment when determining the appropriate route of administration in patients with severe or complicated C. difficile infection who may be at increased risk for complications from colonoscopy due to colonic dilation and poor bowel wall integrity," Dr. Aroniadis said.
In the study, C. difficile infection was considered severe if the patient had abdominal tenderness, an albumin level less than 3 g/dL, or a WBC count greater than 15,000 cells/mcL, in accordance with published guidelines, she said. Infection was considered complicated if it necessitated ICU care or if the patient had hypotension with or without the use of vasopressors, a change in mental status, a WBC count greater than 35,000 cells/mcL or less than 2,000 cells/mcL, serum lactate levels of 2.2 mmol/L or greater, end-organ failure, a fever of at least 38.5 °C, or ileus or significant abdominal tenderness.
Patients had a mean age of 66 years (ranging from 38 to 89 years), and 13 of them were women.
Dr. Aroniadis reported having no financial disclosures.
On Twitter @sherryboschert
FROM THE 2014 JAMES W. FRESTON CONFERENCE
Key clinical point: Consider fecal microbiota transplantation for severe and/or complicated C. difficile infection.
Major finding: C. difficile infection cleared or improved with no recurrence within 3 months in 88% of patients.
Data source: Retrospective multicenter study of 17 patients followed for a mean of 11 months.
Disclosures: Dr. Aroniadis reported having no financial disclosures.
Islet transplants aided type 1 diabetes patients
SAN FRANCISCO – Half of 48 adults with type 1 diabetes, impaired awareness of hypoglycemia, and a history of severe hypoglycemia were able to stop insulin therapy after experimental transplantation of human pancreatic islet cells in a prospective, phase III trial.
The National Institute of Health’s Clinical Islet Transplantation Consortium reported partial, initial results from 365 days of follow-up after islet-cell transplantation in the eight-center study. Speaking for the consortium at the annual scientific sessions of the American Diabetes Association, Dr. Bernhard J. Hering withheld results for the primary outcome measure (the proportion of patients who had a hemoglobin A1c of less than 7% at day 365 and no severe hypoglycemia in days 28 through 365 after the first islet transplant) pending its publication, he said.
Still, results for secondary measures of effectiveness and safety were good enough that "islet transplantation should be considered in this subgroup of patients when other treatment options have failed," said Dr. Hering, a professor of surgery and director of the Islet Cell Transplantation Program at the University of Minnesota, Minneapolis.
The study included patients who had had type 1 diabetes for at least 5 years, with stimulated C-peptide levels below 0.3 ng/mL (considered "absent") and at least one episode of severe hypoglycemia in the prior year with documentation of reduced hypoglycemia awareness and/or marked glycemic lability, if they didn’t meet any of 32 exclusion criteria. All patients underwent immunosuppression as part of the transplantation protocol.
Of the 48 patients, 26 received a second islet cell transplantation, and 1 received a third transplantation. Islet grafts were functioning in more than 90% of patients at day 365 of follow-up, he and his associates reported.
At day 365, roughly 50% of patients were insulin free. Insulin use decreased significantly to a median of 0 unit/kg per day at day 365.
Serum glucose levels and C-peptide secretion during mixed-meal tolerance tests improved over time after transplantation. Clarke scores and Ryan scores to assess patient awareness of hypoglycemia both improved significantly by day 365, as did measures of the glycemic lability index and the mean amplitude of glycemic excursions.
The median percentage of time spent within the desired glucose range increased from about 50% at baseline to nearly 95% at day 365, Dr. Hering reported.
The 19 serious adverse events included 5 that were procedure related (bleeding after percutaneous cannulation of a portal vein), 13 transient events related to immunosuppression (neutropenia, cytokine release, or elevated liver function test results), and 1 episode of hypoglycemia in a patient on insulin. None of these events caused death, disability, or permanent sequelae. Among other adverse events, a small but statistically significant drop in glomerular function test results was associated with the start of immunosuppression, six patients had calculated panel reactive antibodies above zero, and one patient developed acute kidney injury for unclear reasons.
The investigators plan further long-term follow-up.
Registry data suggest that approximately 35% of U.S. patients with type 1 diabetes each year report severe hypoglycemia requiring assistance, Dr. Hering said.
Dr. Hering has been a consultant for Novartis, Janssen, Novo Nordisk, Otsuka, and Sanofi.
On Twitter @sherryboschert
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This is another of the government-funded trials looking at clinical islet-cell transplantation, which are critically important because they have some success in some patients. This does offer promise for people who have hypoglycemia unawareness to the point where they are unable to function in their lives, but we need to find that out from the primary outcome results, which have not been presented. I would not use this treatment at this time.
The indication for islet-cell transplantation was severe hypoglycemia in someone with type 1 diabetes. This identifies a group that may have particular risks with standard therapy, in whom there may be justification for exposing them to the potential side effects of the transplant. That approach changes the risk-benefit ratio – that’s the way I interpret it.
The other exciting piece from this particular study is that it was a multisite project, and they had to do islet isolation at each site under standardized conditions, which is new. If we’re ever going to bring islet transplantation forward as a therapy and have it be approved by the Food and Drug Administration, there must be tremendous standardization in how islets are harvested and prepared for use. The fact that they were able to do that is very exciting.
Dr. Elizabeth R. Seaquist is a professor of medicine and the Pennock Family Chair in Diabetes Research at the University of Minnesota, Minneapolis. She gave these comments in an interview at the meeting. Dr. Seaquist is a colleague of Dr. Hering at the university. She reported financial associations with multiple companies but said none are relevant to this topic.
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This is another of the government-funded trials looking at clinical islet-cell transplantation, which are critically important because they have some success in some patients. This does offer promise for people who have hypoglycemia unawareness to the point where they are unable to function in their lives, but we need to find that out from the primary outcome results, which have not been presented. I would not use this treatment at this time.
The indication for islet-cell transplantation was severe hypoglycemia in someone with type 1 diabetes. This identifies a group that may have particular risks with standard therapy, in whom there may be justification for exposing them to the potential side effects of the transplant. That approach changes the risk-benefit ratio – that’s the way I interpret it.
The other exciting piece from this particular study is that it was a multisite project, and they had to do islet isolation at each site under standardized conditions, which is new. If we’re ever going to bring islet transplantation forward as a therapy and have it be approved by the Food and Drug Administration, there must be tremendous standardization in how islets are harvested and prepared for use. The fact that they were able to do that is very exciting.
Dr. Elizabeth R. Seaquist is a professor of medicine and the Pennock Family Chair in Diabetes Research at the University of Minnesota, Minneapolis. She gave these comments in an interview at the meeting. Dr. Seaquist is a colleague of Dr. Hering at the university. She reported financial associations with multiple companies but said none are relevant to this topic.
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This is another of the government-funded trials looking at clinical islet-cell transplantation, which are critically important because they have some success in some patients. This does offer promise for people who have hypoglycemia unawareness to the point where they are unable to function in their lives, but we need to find that out from the primary outcome results, which have not been presented. I would not use this treatment at this time.
The indication for islet-cell transplantation was severe hypoglycemia in someone with type 1 diabetes. This identifies a group that may have particular risks with standard therapy, in whom there may be justification for exposing them to the potential side effects of the transplant. That approach changes the risk-benefit ratio – that’s the way I interpret it.
The other exciting piece from this particular study is that it was a multisite project, and they had to do islet isolation at each site under standardized conditions, which is new. If we’re ever going to bring islet transplantation forward as a therapy and have it be approved by the Food and Drug Administration, there must be tremendous standardization in how islets are harvested and prepared for use. The fact that they were able to do that is very exciting.
Dr. Elizabeth R. Seaquist is a professor of medicine and the Pennock Family Chair in Diabetes Research at the University of Minnesota, Minneapolis. She gave these comments in an interview at the meeting. Dr. Seaquist is a colleague of Dr. Hering at the university. She reported financial associations with multiple companies but said none are relevant to this topic.
SAN FRANCISCO – Half of 48 adults with type 1 diabetes, impaired awareness of hypoglycemia, and a history of severe hypoglycemia were able to stop insulin therapy after experimental transplantation of human pancreatic islet cells in a prospective, phase III trial.
The National Institute of Health’s Clinical Islet Transplantation Consortium reported partial, initial results from 365 days of follow-up after islet-cell transplantation in the eight-center study. Speaking for the consortium at the annual scientific sessions of the American Diabetes Association, Dr. Bernhard J. Hering withheld results for the primary outcome measure (the proportion of patients who had a hemoglobin A1c of less than 7% at day 365 and no severe hypoglycemia in days 28 through 365 after the first islet transplant) pending its publication, he said.
Still, results for secondary measures of effectiveness and safety were good enough that "islet transplantation should be considered in this subgroup of patients when other treatment options have failed," said Dr. Hering, a professor of surgery and director of the Islet Cell Transplantation Program at the University of Minnesota, Minneapolis.
The study included patients who had had type 1 diabetes for at least 5 years, with stimulated C-peptide levels below 0.3 ng/mL (considered "absent") and at least one episode of severe hypoglycemia in the prior year with documentation of reduced hypoglycemia awareness and/or marked glycemic lability, if they didn’t meet any of 32 exclusion criteria. All patients underwent immunosuppression as part of the transplantation protocol.
Of the 48 patients, 26 received a second islet cell transplantation, and 1 received a third transplantation. Islet grafts were functioning in more than 90% of patients at day 365 of follow-up, he and his associates reported.
At day 365, roughly 50% of patients were insulin free. Insulin use decreased significantly to a median of 0 unit/kg per day at day 365.
Serum glucose levels and C-peptide secretion during mixed-meal tolerance tests improved over time after transplantation. Clarke scores and Ryan scores to assess patient awareness of hypoglycemia both improved significantly by day 365, as did measures of the glycemic lability index and the mean amplitude of glycemic excursions.
The median percentage of time spent within the desired glucose range increased from about 50% at baseline to nearly 95% at day 365, Dr. Hering reported.
The 19 serious adverse events included 5 that were procedure related (bleeding after percutaneous cannulation of a portal vein), 13 transient events related to immunosuppression (neutropenia, cytokine release, or elevated liver function test results), and 1 episode of hypoglycemia in a patient on insulin. None of these events caused death, disability, or permanent sequelae. Among other adverse events, a small but statistically significant drop in glomerular function test results was associated with the start of immunosuppression, six patients had calculated panel reactive antibodies above zero, and one patient developed acute kidney injury for unclear reasons.
The investigators plan further long-term follow-up.
Registry data suggest that approximately 35% of U.S. patients with type 1 diabetes each year report severe hypoglycemia requiring assistance, Dr. Hering said.
Dr. Hering has been a consultant for Novartis, Janssen, Novo Nordisk, Otsuka, and Sanofi.
On Twitter @sherryboschert
SAN FRANCISCO – Half of 48 adults with type 1 diabetes, impaired awareness of hypoglycemia, and a history of severe hypoglycemia were able to stop insulin therapy after experimental transplantation of human pancreatic islet cells in a prospective, phase III trial.
The National Institute of Health’s Clinical Islet Transplantation Consortium reported partial, initial results from 365 days of follow-up after islet-cell transplantation in the eight-center study. Speaking for the consortium at the annual scientific sessions of the American Diabetes Association, Dr. Bernhard J. Hering withheld results for the primary outcome measure (the proportion of patients who had a hemoglobin A1c of less than 7% at day 365 and no severe hypoglycemia in days 28 through 365 after the first islet transplant) pending its publication, he said.
Still, results for secondary measures of effectiveness and safety were good enough that "islet transplantation should be considered in this subgroup of patients when other treatment options have failed," said Dr. Hering, a professor of surgery and director of the Islet Cell Transplantation Program at the University of Minnesota, Minneapolis.
The study included patients who had had type 1 diabetes for at least 5 years, with stimulated C-peptide levels below 0.3 ng/mL (considered "absent") and at least one episode of severe hypoglycemia in the prior year with documentation of reduced hypoglycemia awareness and/or marked glycemic lability, if they didn’t meet any of 32 exclusion criteria. All patients underwent immunosuppression as part of the transplantation protocol.
Of the 48 patients, 26 received a second islet cell transplantation, and 1 received a third transplantation. Islet grafts were functioning in more than 90% of patients at day 365 of follow-up, he and his associates reported.
At day 365, roughly 50% of patients were insulin free. Insulin use decreased significantly to a median of 0 unit/kg per day at day 365.
Serum glucose levels and C-peptide secretion during mixed-meal tolerance tests improved over time after transplantation. Clarke scores and Ryan scores to assess patient awareness of hypoglycemia both improved significantly by day 365, as did measures of the glycemic lability index and the mean amplitude of glycemic excursions.
The median percentage of time spent within the desired glucose range increased from about 50% at baseline to nearly 95% at day 365, Dr. Hering reported.
The 19 serious adverse events included 5 that were procedure related (bleeding after percutaneous cannulation of a portal vein), 13 transient events related to immunosuppression (neutropenia, cytokine release, or elevated liver function test results), and 1 episode of hypoglycemia in a patient on insulin. None of these events caused death, disability, or permanent sequelae. Among other adverse events, a small but statistically significant drop in glomerular function test results was associated with the start of immunosuppression, six patients had calculated panel reactive antibodies above zero, and one patient developed acute kidney injury for unclear reasons.
The investigators plan further long-term follow-up.
Registry data suggest that approximately 35% of U.S. patients with type 1 diabetes each year report severe hypoglycemia requiring assistance, Dr. Hering said.
Dr. Hering has been a consultant for Novartis, Janssen, Novo Nordisk, Otsuka, and Sanofi.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: You’ll have to wait for the primary results, but secondary outcomes suggest success with islet-cell transplantation in a subset of patients with type 1 diabetes.
Major finding: Half of patients were able to stop insulin within a year of transplantation.
Data source: A prospective, open-label, single-arm study of islet-cell transplantation in 48 adults with type 1 diabetes and a history of severe hypoglycemia and hypoglycemia unawareness.
Disclosures: Dr. Hering has been a consultant for Novartis, Janssen, Novo Nordisk, Otsuka, and Sanofi.
Bundled preventive care reduced surgical site infections
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
The study by Dr. Keenan and several separate recent studies support the idea that surgical site infections after colorectal surgery can be prevented by management based on published evidence, best practice guidelines, and culture change, according to Dr. Ira L. Leeds and Dr. Elizabeth C. Wick.
This involves implementing "processes that span the continuum of care from before surgery through postoperative recovery, and these interventions are far more complex than the Surgical Care Improvement Program measures now held as the gold standard for surgical quality reporting," they wrote (JAMA Surgery 2014 Aug. 27 [doi:10.1001/jamasurg.2014.389]).
The studies also suggest that the subspecialty of colorectal surgery is well situated for developing models of care starting from the patient care level rather than from a typical top-down approach, they added. "The tribelike culture of medicine means that many of the fixes to the health care system will need to come at the unit level rather than [through] institutional, systemic solutions," Dr. Leeds and Dr. Wick wrote.
Their remarks were published in a commentary simultaneously with the publication of Dr. Keenan’s study. Dr. Leeds and Dr. Wick are at the Johns Hopkins University, Baltimore. They reported having no financial disclosures.
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
Implementing a systematic bundle of prevention strategies reduced the absolute rate of superficial surgical site infections after colorectal surgery by 14% at one institution.
The findings came from a retrospective study of data from 2008 through 2012 on 559 patients who underwent major elective colorectal surgery at Duke University, Durham, N.C., either before the implementation of the preventive bundle on July 1, 2011 (62% of patients) or afterward (38%). Among all patients, the rate of superficial surgical site infection was 25% before the bundled care and 6% afterward, Dr. Jeffrey E. Keenan and his associates reported.
To eliminate any significant differences in patient demographics, baseline characteristics, or procedure-specific factors that might affect the surgical site infection rate, they conducted a propensity-matched comparison of 212 patients from each of the pre- and postbundling groups. The surgical site infection rate was 19.3% before implementation of bundled preventive services and 5.7% with bundled care, a significant difference of 13.6%, reported Dr. Keenan of the university.
The results were published online in JAMA Surgery (2014 Aug. 27 [doi:10.1001/jamasurg.2014.346]).
Among secondary outcomes, sepsis rates were significantly higher in the pre–bundled-care period, compared with the bundled-care period, both in the unadjusted cohort (10% vs. 2%, respectively) and in the comparison of matched patients (8% vs. 2%, respectively).
The bundle of care was a multidisciplinary effort involving surgeons, anesthesiologists, clinic nurses, operating room staff, unit nurses, house staff, and hospital midlevel providers led by a colorectal surgeon who met monthly with the various groups to review infection rates and address issues with delivering the bundled strategies.
Designed by colorectal surgeons at the university, the bundle included giving patients educational materials before surgery on preventing surgical site infection. The patients received instructions and materials for a full-body chlorhexidine gluconate shower the night before surgery. The bundled-care team adopted a standardized polyethylene glycol 33350 bowel preparation with oral antibiotics (neomycin sulfate and erythromycin). All patients without allergy received a single 1-g dose of ertapenem sodium for preoperative antibiotic prophylaxis within 1 hour of incision. Patients with an allergy received ciprofloxacin HCl and metronidazole phosphate as an alternative.
Standardized preparation of the surgical field involved use of a 2% chlorhexidine gluconate–70% isopropyl alcohol solution. A wound protector was used during surgery for open incision. Only essential personnel were allowed in and out of the operating room. Anesthesiologists paid close attention to maintaining normothermia and euglycemia. Surgeons and scrub staff changed gowns and gloves at the time of wound closure. A dedicated wound closure tray was used to close the fascia and skin, and a sterile occlusive dressing was placed over the incision following closure. The dressing was removed within 48 hours of surgery, and the wound was washed daily with chlorhexidine. Patients being discharged were given materials and instructions to continue the chlorhexidine washes for 1 week after surgery.
A subgroup analysis of patients who underwent surgery after implementation of the bundled care showed that variable direct costs were 36% higher (after multivariable adjustment) in patients who developed surgical site infection, and patients with infection stayed 72% longer in the hospital, Dr. Keenan reported. Average variable direct costs were $13,253 in patients with superficial surgical site infection and $9,779 in those who did not develop infection. Lengths of stay during the index admission averaged 8 days with infection and 5 days without infection.
It is unlikely that any one part of the preventive bundle was responsible for the reduced infection rate and costs, though it’s impossible to tell, the investigators said. More likely, the framework of bundling preventive strategies supported reliable delivery of multiple preventive measures with high fidelity, they suggested.
Dr. Keenan reported having no relevant financial disclosures.
On Twitter @sherryboschert
FROM JAMA SURGERY
Key clinical point: Bundled preventive care significantly reduced surgical site infection after colorectal surgery.
Major finding: Superficial surgical site infection occurred in about 19% before and about 6% after implementing bundled care.
Data source: A retrospective study of 559 patients undergoing colorectal surgery, 62% before bundled-care implementation.
Disclosures: Dr. Keenan reported having no relevant financial disclosures.
Photodynamic therapy clears thin AKs better than cryotherapy
Thin actinic keratoses on the face or scalp were 14% more likely to clear completely in patients treated with photodynamic therapy, compared with cryotherapy, in a meta-analysis of four studies including 641 patients.
Complete clearance 3 months after treatment was significantly more likely in the 2,170 actinic keratoses treated by photodynamic therapy (PDT), compared with 2,174 actinic keratoses treated by cryotherapy, Dr. Gayatri Patel and her associates reported.
The data came from randomized trials with 10 or more participants in which the PDT used topical aminolevulinic acid hydrochloride or methyl aminolevulinate hydrochloride, the most widely available PDT stabilizers in North America and Europe. Methyl aminolevulinate recently was withdrawn from the U.S. market but remains common in Europe, noted Dr. Patel of the University of California, Davis, and her associates.
The study results were published online in JAMA Dermatology (2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1253]).
The results suggested that PDT works better on thinner actinic keratoses. Grade 1 (thin) actinic keratoses on the face or scalp were 86% more likely to clear by 12 weeks after PDT, compared with cryotherapy, the investigators reported.
Only one of the fours studies found higher efficacy rates for cryotherapy, compared with PDT, and more than 60% of lesions in that study were grade 2 (moderately thick, easily felt) or grade 3 (very thick and/or obvious) actinic keratoses. The other three studies in the meta-analysis excluded thicker lesions or favored thinner ones, the researchers noted.
They excluded from the meta-analysis two other studies that compared PDT with cryotherapy for actinic keratoses because of incompatible follow-up times. They reviewed 13 studies in all, including studies involving treatment of actinic keratosis with imiquimod, fluorouracil, or carbon dioxide laser, but could not meta-analyze data on these other treatments because of different outcome measures and follow-up times or lack of a comparator.
Photosensitivity, pain, erythema, and pruritus were common after PDT. Cryotherapy induced pain and pruritus, but at lower rates than did PDT. Hypopigmentation occurred in 33% of patients after cryotherapy and in 9% after PDT in one study.
Satisfaction ratings by patients and unblinded investigators tended to favor PDT over cryotherapy, perhaps because PDT may produce ancillary cosmetic improvements when treating actinic keratosis, Dr. Patel and her associates speculated.
The findings were limited by the poor quality of the studies, which were lacking double-blind design and description of randomization methods, but no sources of bias were evident, and the large number of patients and relatively similar treatment locations were strengths of the analysis, they said.
Dr. Patel reported having no financial disclosures.
On Twitter @sherryboschert
Several limitations associated with photodynamic therapy (PDT) make cryotherapy the first-line treatment choice for most practicing dermatologists, Dr. Harvey Lui commented in an article that accompanied Dr. Patel’s report.
Dr. Patel’s meta-analysis found a 14% better chance of complete clearance of actinic keratosis lesions, compared with cryotherapy, but the data are not clear enough to claim better cosmesis or patient acceptance, Dr. Lui said (JAMA Dermatol. 2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1869]).
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PDT costs more in time and equipment than cryotherapy. PDT may seem simple, but achieving optimal results can require longer drug incubation times and/or light-dose fractionation. Local pain is a bigger problem with PDT that requires anticipation and management by clinicians, he said. Cryotherapy, on the other hand, requires relatively brief outpatient visits.
The future of PDT for actinic keratosis may lie in further development of a currently off-label treatment – exposure to ambient outdoor light after application of topical aminolevulinic acid, Dr. Lui suggested: "Perhaps the most tantalizing irony of daylight PDT is the specter of treating a solar-induced neoplasm with sunlight itself."
Dr. Lui is head of the department of dermatology and skin science at the University of British Columbia in Vancouver. He disclosed financial associations with Galderma, LEO Pharma, Janssen, Novartis, Valeant Pharmaceuticals, RepliCel Life Sciences, Lumen Health Technologies, and Verisante Technology.
Several limitations associated with photodynamic therapy (PDT) make cryotherapy the first-line treatment choice for most practicing dermatologists, Dr. Harvey Lui commented in an article that accompanied Dr. Patel’s report.
Dr. Patel’s meta-analysis found a 14% better chance of complete clearance of actinic keratosis lesions, compared with cryotherapy, but the data are not clear enough to claim better cosmesis or patient acceptance, Dr. Lui said (JAMA Dermatol. 2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1869]).
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PDT costs more in time and equipment than cryotherapy. PDT may seem simple, but achieving optimal results can require longer drug incubation times and/or light-dose fractionation. Local pain is a bigger problem with PDT that requires anticipation and management by clinicians, he said. Cryotherapy, on the other hand, requires relatively brief outpatient visits.
The future of PDT for actinic keratosis may lie in further development of a currently off-label treatment – exposure to ambient outdoor light after application of topical aminolevulinic acid, Dr. Lui suggested: "Perhaps the most tantalizing irony of daylight PDT is the specter of treating a solar-induced neoplasm with sunlight itself."
Dr. Lui is head of the department of dermatology and skin science at the University of British Columbia in Vancouver. He disclosed financial associations with Galderma, LEO Pharma, Janssen, Novartis, Valeant Pharmaceuticals, RepliCel Life Sciences, Lumen Health Technologies, and Verisante Technology.
Several limitations associated with photodynamic therapy (PDT) make cryotherapy the first-line treatment choice for most practicing dermatologists, Dr. Harvey Lui commented in an article that accompanied Dr. Patel’s report.
Dr. Patel’s meta-analysis found a 14% better chance of complete clearance of actinic keratosis lesions, compared with cryotherapy, but the data are not clear enough to claim better cosmesis or patient acceptance, Dr. Lui said (JAMA Dermatol. 2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1869]).
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PDT costs more in time and equipment than cryotherapy. PDT may seem simple, but achieving optimal results can require longer drug incubation times and/or light-dose fractionation. Local pain is a bigger problem with PDT that requires anticipation and management by clinicians, he said. Cryotherapy, on the other hand, requires relatively brief outpatient visits.
The future of PDT for actinic keratosis may lie in further development of a currently off-label treatment – exposure to ambient outdoor light after application of topical aminolevulinic acid, Dr. Lui suggested: "Perhaps the most tantalizing irony of daylight PDT is the specter of treating a solar-induced neoplasm with sunlight itself."
Dr. Lui is head of the department of dermatology and skin science at the University of British Columbia in Vancouver. He disclosed financial associations with Galderma, LEO Pharma, Janssen, Novartis, Valeant Pharmaceuticals, RepliCel Life Sciences, Lumen Health Technologies, and Verisante Technology.
Thin actinic keratoses on the face or scalp were 14% more likely to clear completely in patients treated with photodynamic therapy, compared with cryotherapy, in a meta-analysis of four studies including 641 patients.
Complete clearance 3 months after treatment was significantly more likely in the 2,170 actinic keratoses treated by photodynamic therapy (PDT), compared with 2,174 actinic keratoses treated by cryotherapy, Dr. Gayatri Patel and her associates reported.
The data came from randomized trials with 10 or more participants in which the PDT used topical aminolevulinic acid hydrochloride or methyl aminolevulinate hydrochloride, the most widely available PDT stabilizers in North America and Europe. Methyl aminolevulinate recently was withdrawn from the U.S. market but remains common in Europe, noted Dr. Patel of the University of California, Davis, and her associates.
The study results were published online in JAMA Dermatology (2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1253]).
The results suggested that PDT works better on thinner actinic keratoses. Grade 1 (thin) actinic keratoses on the face or scalp were 86% more likely to clear by 12 weeks after PDT, compared with cryotherapy, the investigators reported.
Only one of the fours studies found higher efficacy rates for cryotherapy, compared with PDT, and more than 60% of lesions in that study were grade 2 (moderately thick, easily felt) or grade 3 (very thick and/or obvious) actinic keratoses. The other three studies in the meta-analysis excluded thicker lesions or favored thinner ones, the researchers noted.
They excluded from the meta-analysis two other studies that compared PDT with cryotherapy for actinic keratoses because of incompatible follow-up times. They reviewed 13 studies in all, including studies involving treatment of actinic keratosis with imiquimod, fluorouracil, or carbon dioxide laser, but could not meta-analyze data on these other treatments because of different outcome measures and follow-up times or lack of a comparator.
Photosensitivity, pain, erythema, and pruritus were common after PDT. Cryotherapy induced pain and pruritus, but at lower rates than did PDT. Hypopigmentation occurred in 33% of patients after cryotherapy and in 9% after PDT in one study.
Satisfaction ratings by patients and unblinded investigators tended to favor PDT over cryotherapy, perhaps because PDT may produce ancillary cosmetic improvements when treating actinic keratosis, Dr. Patel and her associates speculated.
The findings were limited by the poor quality of the studies, which were lacking double-blind design and description of randomization methods, but no sources of bias were evident, and the large number of patients and relatively similar treatment locations were strengths of the analysis, they said.
Dr. Patel reported having no financial disclosures.
On Twitter @sherryboschert
Thin actinic keratoses on the face or scalp were 14% more likely to clear completely in patients treated with photodynamic therapy, compared with cryotherapy, in a meta-analysis of four studies including 641 patients.
Complete clearance 3 months after treatment was significantly more likely in the 2,170 actinic keratoses treated by photodynamic therapy (PDT), compared with 2,174 actinic keratoses treated by cryotherapy, Dr. Gayatri Patel and her associates reported.
The data came from randomized trials with 10 or more participants in which the PDT used topical aminolevulinic acid hydrochloride or methyl aminolevulinate hydrochloride, the most widely available PDT stabilizers in North America and Europe. Methyl aminolevulinate recently was withdrawn from the U.S. market but remains common in Europe, noted Dr. Patel of the University of California, Davis, and her associates.
The study results were published online in JAMA Dermatology (2014 Aug. 27 [doi:10.1001/jamadermatol.2014.1253]).
The results suggested that PDT works better on thinner actinic keratoses. Grade 1 (thin) actinic keratoses on the face or scalp were 86% more likely to clear by 12 weeks after PDT, compared with cryotherapy, the investigators reported.
Only one of the fours studies found higher efficacy rates for cryotherapy, compared with PDT, and more than 60% of lesions in that study were grade 2 (moderately thick, easily felt) or grade 3 (very thick and/or obvious) actinic keratoses. The other three studies in the meta-analysis excluded thicker lesions or favored thinner ones, the researchers noted.
They excluded from the meta-analysis two other studies that compared PDT with cryotherapy for actinic keratoses because of incompatible follow-up times. They reviewed 13 studies in all, including studies involving treatment of actinic keratosis with imiquimod, fluorouracil, or carbon dioxide laser, but could not meta-analyze data on these other treatments because of different outcome measures and follow-up times or lack of a comparator.
Photosensitivity, pain, erythema, and pruritus were common after PDT. Cryotherapy induced pain and pruritus, but at lower rates than did PDT. Hypopigmentation occurred in 33% of patients after cryotherapy and in 9% after PDT in one study.
Satisfaction ratings by patients and unblinded investigators tended to favor PDT over cryotherapy, perhaps because PDT may produce ancillary cosmetic improvements when treating actinic keratosis, Dr. Patel and her associates speculated.
The findings were limited by the poor quality of the studies, which were lacking double-blind design and description of randomization methods, but no sources of bias were evident, and the large number of patients and relatively similar treatment locations were strengths of the analysis, they said.
Dr. Patel reported having no financial disclosures.
On Twitter @sherryboschert
FROM JAMA DERMATOLOGY
Key clinical point: Clearance of thin actinic keratosis lesions on the face or head is more likely with photodynamic therapy vs. cryotherapy, but the impact of either treatment on reducing the incidence of squamous cell carcinomas remains unknown.
Major finding: Clearance was 14% more likely at 3 months after PDT, compared with cryotherapy.
Data source: Meta-analysis of four studies including 641 patients with 2,170 actinic keratosis lesions treated by PDT and 2,174 treated by cryotherapy.
Disclosures: Dr. Patel reported having no financial disclosures.
Open surgery for 34% of inpatient breast biopsies
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
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The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
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The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
The methodology of the study makes it impossible to know the overall national rates of breast biopsy techniques because the National Inpatient Sample data that the investigators analyzed capture only inpatient procedures, while most breast biopsies are done in outpatient settings, Dr. Taylor S. Riall said in an interview.
|
|
The study may underestimate the national rate of minimally invasive breast biopsy because of that. Regardless, the true rate is likely below national goals of 90% of breast biopsies being done using minimally invasive methods, she said.
Because the National Inpatient Sample data represent single hospital stays that cannot be linked to show multiple admissions for individuals, it’s possible that some of the 34% of patients who had open breast biopsies previously underwent failed minimally invasive breast biopsies. "If minimally invasive breast biopsy was done first, then open biopsy, this is appropriate" in cases with failed (nondiagnostic) minimally invasive biopsies, she said.
The study looked at patient and hospital factors associated with biopsy rates but not at physician factors. "While there is geographic variation in the use of minimally invasive breast biopsy, there also is significant variation across physicians and facilities. Based on data we recently reviewed, I feel that physician practice and referral patterns are a major contributor to underuse of minimally invasive breast biopsy," Dr. Riall said.
"These practice patterns may be tied to reimbursement, lack of knowledge of the guidelines, access to minimally invasive breast biopsy facilities, or referral networks. Many surgeons may work in settings where mammography and biopsy are done before they even see a patient, whereas other surgeons may see patients before diagnosis and be responsible for this decision. Targeting interventions at the hospital and physician factors that are associated with low rates of minimally invasive breast biopsy can definitely improve outcomes," she added.
Organizational networks that are associated with low rates of minimally invasive breast biopsy should be assessed to find ways to increase those rates, Dr. Riall suggested. "Who do these patients see first? Do groups of physicians who refer to each other have practice patterns that violate the current recommendations?"
More in-depth analysis of racial disparities also is in order, she said. "Are these patients choosing open biopsy? If so, why? Or, alternatively, are they seeing physicians that exclusively or mostly do open biopsy? The answers to these questions will guide interventions to improve minimally invasive breast biopsy rates."
Dr. Taylor S. Riall is a professor of surgery and the John Sealy Distinguished Chair in Clinical Research at the University of Texas, Galveston. She reported having no financial disclosures.
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
Open breast biopsy accounted for 34% of breast biopsies in 25,965 U.S. inpatients between 2008 and 2010, a retrospective study found.
The finding suggests that minimally invasive breast biopsy techniques are underutilized, with a national rate that’s far off the widely acknowledge goal of having at least 90% of biopsies for suspicious breast lesions be minimally invasive, Dr. Linda Adepoju reported.
Most breast biopsies are performed in outpatient settings. Although the study analyzed a national data sample for hospitalized patients, the rate of open breast biopsy is consistent with previous studies of outpatient databases for individual institutions or states that have reported rates of open breast biopsy from 24% to 36%, noted Dr. Adepoju of the University of Toledo (Ohio).
She and her associates analyzed data from 46 states in the Healthcare Cost and Utilization Project National Inpatient Sample for 2008-2010, excluding 222 cases in which an open breast biopsy and minimally invasive breast biopsy were performed during the same hospital stay.
Open breast biopsy rates were significantly higher in women aged 49 years or younger (47%), compared with older women (29%), and in Asian women (40%) or Hispanic women (41%), compared with white women (34%) or black women (31%). Open breast biopsy also was significantly more likely in women who had private insurance than in women covered by Medicaid or Medicare – 41% vs. 31% (Am. J. Surg. 2014;208:382-90).
The type and location of hospital also was associated with open biopsy rates, with higher rates in small, private, rural, and/or nonteaching hospitals.
"Interventions targeting small, rural, and nonteaching hospitals could significantly decrease hospital costs and improve the overall quality of breast care," Dr. Adepoju and her associates commented, but "we must be sensitive" to the needs and limitations of various health care delivery settings, they added.
"A critical access hospital in rural Ohio may not be able to afford a mammographer and stereotactic equipment" for minimally invasive breast biopsy. Previous data "are clear that patients preferably seek their care in and near their community. Given workforce shortages and the current economic climate, this may mean accepting higher open breast biopsy rates in rural America," the investigators concluded.
Patients who had open breast biopsies in the current study were more likely to need more than one biopsy for diagnosis (1.2%), compared with women who had minimally invasive breast biopsies (0.5%). Hematoma drainage was needed in 1.4% of patients after open breast biopsy and 0.6% after minimally invasive biopsy. Open breast biopsy also was more expensive, based on analysis of data from the University of Toledo, averaging $1,700 in Medicare reimbursement, compared with $300-$1,100 for minimally invasive breast biopsy, depending on the specific procedure, Dr. Adepoju reported.
Previous data have shown that minimally invasive breast biopsies are less expensive, less scarring, require less recovery time, cause fewer complications, reduce the time between diagnosis and definitive treatment, produce fewer positive margins, and facilitate preoperative multidisciplinary treatment planning, compared with open breast biopsies.
The report from the third international consensus conference on image-detected breast cancer in 2009 called minimally invasive breast biopsy a best practice that should be the gold standard for initial diagnosis and proposed a goal of limiting open breast biopsy to 5%-10% of cases (J. Am. Coll. Surg. 2009;209:504-20).
Dr. Adepoju reported having no financial disclosures.
On Twitter @sherryboschert
FROM THE AMERICAN JOURNAL OF SURGERY
Key clinical point: Inpatient breast biopsies may underemploy minimally invasive techniques.
Major finding: Open breast biopsies comprised 34% of breast biopsies.
Data source: Retrospective analysis of National Inpatient Sample data on 25,965 women who underwent breast biopsy in 2008-2010.
Disclosures: Dr. Adepoju reported having no financial disclosures.
Critical Care Recommendations for Disasters
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
 |
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The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
|
|
The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
|
|
The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
FROM CHEST
Crises inform updated critical care recommendations for disasters
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
|
|
The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
|
|
The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
The consensus statement moves forward planning for critical care during pandemics and disasters in unprecedented ways, Dr. Christian Sandrock said in an editorial.
|
|
The principles behind recommendations for conservation of personnel and supplies (particularly scarce medications and oxygen therapy), substitutions where necessary, and triage "are very relevant today where the resource limitations in West Africa are hindering both patient care and management outbreak," wrote Dr. Sandrock.
Emphases on technology and telemedicine, baseline education plus just-in-time training, and mental health support during disasters should help support health care workers on the front lines to deliver the best care possible, he added.
A goal of "a 20% increase in surge within the health-system resources to a 200% surge with regional and national resource support sets an international benchmark for health-system preparedness," Dr. Sandrock wrote.
Recommendations for coordinating patient flow and resources at a regional level have "not been described elsewhere," and the task force’s vision of incorporating critical care expertise in large, central coordination of patient flow, resources, and care "sets a high but necessary benchmark for public health and government officials," he wrote.
Perhaps the greatest contribution of the document is its attention to potential health care inequities during disasters and the need for ethical and equal care, Dr. Sandrock suggested. The consensus statement provides "a foundation of disaster response for the critically ill that provides justice to the most adversely affected patients," which is an unparalleled accomplishment, he wrote.
Dr. Sandrock is in the division of pulmonary and critical care medicine at the University of California, Davis.
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
Care of critically ill or injured patients during Hurricane Sandy, the 2010 earthquake in Haiti, and the H1N1 influenza pandemic in Mexico City played a role in shaping new recommendations from the American College of Chest Physicians.
The 14-part consensus statement from the College’s Task Force for Mass Critical Care updates and expands on the task force’s previous recommendations from 2008, which did not address pediatrics, trauma, subspecialty critical care, or critical care during disasters in the developing world, among other topics.
Although there is some overlap with the 2008 recommendations, "by and large the specific suggestions are all new or have been updated since the 2008 guidelines, based upon lessons learned from pandemics and disasters that have occurred in the interval," Dr. Jeffrey R. Dichter said in an interview.
If history is any guide, clinicians will want to incorporate the 2014 recommendations as a matter of routine instead of placing them on a shelf only to be retrieved in times of crisis, said Dr. Dichter, a member of the task force. He is medical director for intensive care at Unity Hospital, Fridley, Minn., and a past president of the Society of Hospital Medicine.
The task force heard from colleagues that the 2008 document helped them plan to scale up ICU capacity and manage ventilated patients during the 2009 Mexican influenza epidemic – plans that they did not need to implement but that gave them reassurance nonetheless.
Triage guidelines in the 2008 document helped Bellevue Hospital in New York plan for allocating scarce resources such as electricity from backup generators during 2012’s Hurricane Sandy, a hospital physician reported at the College’s 2013 annual meeting. "Simply knowing they had an approach in place to make those decisions if required allowed the staff to focus on dealing with the situation at hand effectively rather than being distracted by the uncertainty of what would happen if the generators failed," Dr. Dichter said.
The 2014 document’s attention to evacuation of critically ill and injured patients should be of particular interest. "We have seen the challenge related to evacuating ICUs, particularly during the New York hurricane," he said.
Another highlight is a focus on developing the capacity to increase health care personnel and supplies when needed (also known as "surge response") to meet disasters of various sizes – small, medium, or large. The previous recommendations covered only the largest, "crisis" care.
The document provides advice for everyone from individual doctors to hospital administrators, regional health systems, and national governments. "While it is important for all health care workers to have a broad understanding of the issues of emergency preparedness, readers can focus on the areas more relevant to them by consulting the tables in each document" that identify the people for whom those recommendations are most relevant, he said.
The recommendations are based on expert consensus because there is no research to support evidence-based guidelines, the task force stated. That should change by the time the recommendations are updated again in the future, Dr. Dichter said. Groups such as the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium are starting to conduct research during pandemics and disasters.
And, of course, more crises will occur, providing experience that will help improve planning for the next inevitable disaster.
Dr. Dichter reported having no financial disclosures.
On Twitter @sherryboschert
FROM CHEST
