Neil Osterweil

ORLANDO – Amish farms appear to be havens of peace and contentment, free from the insults of modern life – including, it appears, inhalant allergies and asthma, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A study comparing asthma and allergic rhinitis prevalence among Amish children in the United States with those of Swiss children living both on and off farms shows that asthma prevalence among the Amish is low and similar to that of children living on Swiss farms, lending further support to the hygiene hypothesis of allergy and asthma, said Dr. Mark Holbreich of Allergy & Asthma Consultants in Indianapolis.

© PeskyMonkey/iStockphoto.com

Only 8 (5%) of 157 in a sample of Amish children had ever received a diagnosis of asthma, and only 1 (0.6%) had ever been diagnosed with hay fever. Swiss farm children had similarly low prevalence levels, with 202 (6.7%) of 3,006 having ever been diagnosed with asthma, and 94 (3.1%) with allergy. In contrast, 1,218 (11.2%) of 10,912 Swiss non–farm dwelling children had been diagnosed with asthma, and 1,259 (11.6%) had a hay fever diagnosis at some point in their lives.

"This study clearly supports the effect of early farm exposures in reducing allergic sensitization," said Dr. Holbreich.

Although the sample of Amish children was too small to determine whether specific factors were protective in farm dwellers both in the United States and Europe, multivariate analyses from other studies suggest that drinking raw, unpasteurized milk, and child and maternal exposure to large animals (especially cows) during pregnancy may confer immune tolerance on the child, Dr. Holbreich said in an interview.

The investigators chose for their comparison group Swiss children aged 6-12 years enrolled in the phase I GABRIEL study, which looked at genetic and environmental causes of asthma in Europe. A stratified sample of these children had undergone serum specific immunoglobulin E (IgE) testing to inhalant allergens, including house dust mites (Dermatophagoides pteronyssinus), cat, birch, mixed trees, and grasses. The GABRIEL investigators defined atopy as any positive IgE level of 0.7 kU/L or greater.

Dr. Holbreich and his colleagues distributed to the families of Amish school children a modified GABRIEL questionnaire, and invited consenting children to a skin test session at the school. The children were tested for skin-prick response to D. pteronyssinus, D. farinae, grass mix, tree mix, ragweed, cat, horse, and Alternaria. They considered a skin prick test positive if it induced a 3-mm or greater wheal after subtraction of the negative control.

Although the testing methods were different between the groups (skin-prick testing for the Amish children, and IgE for the Swiss children), the investigators are confident that the prevalence results are valid, Dr. Holbreich said.

Dust mites were the common offenders in causing atopy among the Amish children (5.8%), with sensitivity to mixed grasses occurring in 2.9%. In contrast, 20.1% of Swiss farm dwelling children, and 39.8% of children who did not live on farms had grass sensitivity, with dust mite sensitivity coming in second (9.3% and 16.4%, respectively), and with birch being the third most common allergen (80% and 19.6%, respectively).

Asked in the question-and-response portion of his presentation whether helminth infections might play a role in allergic desensitization of the Amish children, Dr. Holbreich noted that the Amish people "live a very traditional lifestyle, but they see doctors, they get all their immunizations, and they’re cleanly, and I’m not aware of data [showing] that Amish get helminth infections, so I don’t think that is a factor."

The study was supported by the St. Vincent Foundation, AAAAI, and the European Commission. Dr. Holbreich reported having no conflicts of interest.

ORLANDO – Amish farms appear to be havens of peace and contentment, free from the insults of modern life – including, it appears, inhalant allergies and asthma, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A study comparing asthma and allergic rhinitis prevalence among Amish children in the United States with those of Swiss children living both on and off farms shows that asthma prevalence among the Amish is low and similar to that of children living on Swiss farms, lending further support to the hygiene hypothesis of allergy and asthma, said Dr. Mark Holbreich of Allergy & Asthma Consultants in Indianapolis.

© PeskyMonkey/iStockphoto.com

Only 8 (5%) of 157 in a sample of Amish children had ever received a diagnosis of asthma, and only 1 (0.6%) had ever been diagnosed with hay fever. Swiss farm children had similarly low prevalence levels, with 202 (6.7%) of 3,006 having ever been diagnosed with asthma, and 94 (3.1%) with allergy. In contrast, 1,218 (11.2%) of 10,912 Swiss non–farm dwelling children had been diagnosed with asthma, and 1,259 (11.6%) had a hay fever diagnosis at some point in their lives.

"This study clearly supports the effect of early farm exposures in reducing allergic sensitization," said Dr. Holbreich.

Although the sample of Amish children was too small to determine whether specific factors were protective in farm dwellers both in the United States and Europe, multivariate analyses from other studies suggest that drinking raw, unpasteurized milk, and child and maternal exposure to large animals (especially cows) during pregnancy may confer immune tolerance on the child, Dr. Holbreich said in an interview.

The investigators chose for their comparison group Swiss children aged 6-12 years enrolled in the phase I GABRIEL study, which looked at genetic and environmental causes of asthma in Europe. A stratified sample of these children had undergone serum specific immunoglobulin E (IgE) testing to inhalant allergens, including house dust mites (Dermatophagoides pteronyssinus), cat, birch, mixed trees, and grasses. The GABRIEL investigators defined atopy as any positive IgE level of 0.7 kU/L or greater.

Dr. Holbreich and his colleagues distributed to the families of Amish school children a modified GABRIEL questionnaire, and invited consenting children to a skin test session at the school. The children were tested for skin-prick response to D. pteronyssinus, D. farinae, grass mix, tree mix, ragweed, cat, horse, and Alternaria. They considered a skin prick test positive if it induced a 3-mm or greater wheal after subtraction of the negative control.

Although the testing methods were different between the groups (skin-prick testing for the Amish children, and IgE for the Swiss children), the investigators are confident that the prevalence results are valid, Dr. Holbreich said.

Dust mites were the common offenders in causing atopy among the Amish children (5.8%), with sensitivity to mixed grasses occurring in 2.9%. In contrast, 20.1% of Swiss farm dwelling children, and 39.8% of children who did not live on farms had grass sensitivity, with dust mite sensitivity coming in second (9.3% and 16.4%, respectively), and with birch being the third most common allergen (80% and 19.6%, respectively).

Asked in the question-and-response portion of his presentation whether helminth infections might play a role in allergic desensitization of the Amish children, Dr. Holbreich noted that the Amish people "live a very traditional lifestyle, but they see doctors, they get all their immunizations, and they’re cleanly, and I’m not aware of data [showing] that Amish get helminth infections, so I don’t think that is a factor."

The study was supported by the St. Vincent Foundation, AAAAI, and the European Commission. Dr. Holbreich reported having no conflicts of interest.

ORLANDO – Amish farms appear to be havens of peace and contentment, free from the insults of modern life – including, it appears, inhalant allergies and asthma, researchers reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A study comparing asthma and allergic rhinitis prevalence among Amish children in the United States with those of Swiss children living both on and off farms shows that asthma prevalence among the Amish is low and similar to that of children living on Swiss farms, lending further support to the hygiene hypothesis of allergy and asthma, said Dr. Mark Holbreich of Allergy & Asthma Consultants in Indianapolis.

© PeskyMonkey/iStockphoto.com

Only 8 (5%) of 157 in a sample of Amish children had ever received a diagnosis of asthma, and only 1 (0.6%) had ever been diagnosed with hay fever. Swiss farm children had similarly low prevalence levels, with 202 (6.7%) of 3,006 having ever been diagnosed with asthma, and 94 (3.1%) with allergy. In contrast, 1,218 (11.2%) of 10,912 Swiss non–farm dwelling children had been diagnosed with asthma, and 1,259 (11.6%) had a hay fever diagnosis at some point in their lives.

"This study clearly supports the effect of early farm exposures in reducing allergic sensitization," said Dr. Holbreich.

Although the sample of Amish children was too small to determine whether specific factors were protective in farm dwellers both in the United States and Europe, multivariate analyses from other studies suggest that drinking raw, unpasteurized milk, and child and maternal exposure to large animals (especially cows) during pregnancy may confer immune tolerance on the child, Dr. Holbreich said in an interview.

The investigators chose for their comparison group Swiss children aged 6-12 years enrolled in the phase I GABRIEL study, which looked at genetic and environmental causes of asthma in Europe. A stratified sample of these children had undergone serum specific immunoglobulin E (IgE) testing to inhalant allergens, including house dust mites (Dermatophagoides pteronyssinus), cat, birch, mixed trees, and grasses. The GABRIEL investigators defined atopy as any positive IgE level of 0.7 kU/L or greater.

Dr. Holbreich and his colleagues distributed to the families of Amish school children a modified GABRIEL questionnaire, and invited consenting children to a skin test session at the school. The children were tested for skin-prick response to D. pteronyssinus, D. farinae, grass mix, tree mix, ragweed, cat, horse, and Alternaria. They considered a skin prick test positive if it induced a 3-mm or greater wheal after subtraction of the negative control.

Although the testing methods were different between the groups (skin-prick testing for the Amish children, and IgE for the Swiss children), the investigators are confident that the prevalence results are valid, Dr. Holbreich said.

Dust mites were the common offenders in causing atopy among the Amish children (5.8%), with sensitivity to mixed grasses occurring in 2.9%. In contrast, 20.1% of Swiss farm dwelling children, and 39.8% of children who did not live on farms had grass sensitivity, with dust mite sensitivity coming in second (9.3% and 16.4%, respectively), and with birch being the third most common allergen (80% and 19.6%, respectively).

Asked in the question-and-response portion of his presentation whether helminth infections might play a role in allergic desensitization of the Amish children, Dr. Holbreich noted that the Amish people "live a very traditional lifestyle, but they see doctors, they get all their immunizations, and they’re cleanly, and I’m not aware of data [showing] that Amish get helminth infections, so I don’t think that is a factor."

The study was supported by the St. Vincent Foundation, AAAAI, and the European Commission. Dr. Holbreich reported having no conflicts of interest.

Compelling evidence from a recent randomized trial has prompted the American Society for Clinical Oncology to recommend that palliative care be integrated early on into standard cancer therapies for patients with metastatic cancers or a high burden of cancer symptoms.

Potentially practice changing, the opinion is based on the best currently available clinical evidence. Palliative care is typically relegated to the final days of life of patients with advanced metastatic cancers, as it is provided only after all other options have failed.

Authors of the opinion, intended to offer guidance to oncologists on this issue, cite a study published in 2010 (N. Engl. J. Med. 2010;363:733-42). The study showed that patients who were randomized to palliative care plus standard therapy for metastatic non–small cell lung cancer (NSCLC) had significantly longer overall survival than did patients randomized to standard care alone, (11.6 vs. 8.9 months, P = .02), even though the palliative care group had less aggressive end-of-life care.

Patients receiving palliative care also had significantly better quality of life scores on a standardized assessment scale, and significantly fewer had depressive symptoms, compared with patients on standard care.

"While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care – when combined with standard cancer care or as the main focus of care – leads to better patient and caregiver outcomes. These include improvement in symptoms, quality of life, and patient satisfaction, with reduced caregiver burden," wrote Dr. Thomas J. Smith and his colleagues in an American Society of Clinical Oncology (ASCO) provisional clinical opinion published online Feb. 6 in the Journal of Clinical Oncology (doi:10.1200/JCO.2011.38.5161).

Palliative care also eases patients and families through the anguish of dashed hopes and has the potential to reduce costs by limiting expensive but often futile intensive hospital-based services, the authors wrote.

"All the data suggest that there’s absolutely no harm from earlier integration of hospice and palliative medicine into patient care. A couple of trials have shown improved survival, and there are very good data from observational studies that people who use hospice actually live longer," Dr. Smith said in an interview. He is director of palliative care for Johns Hopkins University and Hopkins’ Sidney Kimmel Comprehensive Cancer Center in Baltimore.

"I think that ASCO is sending a really strong message to oncologists that we need to do more than we’re currently doing and that comprehensive cancer care needs to included supportive care on top of cancer-directed therapy," said Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston, and lead author of the randomized trial mentioned earlier.

She noted, however, that the study was not powered to detect an overall survival benefit. "All we were hoping for was that early palliative care didn’t lead to a survival detriment ... people could have been concerned that because of the involvement of palliative care, patients would receive less-intensive therapy and have shorter survival," Dr. Temel said. "I’m just very happy that’s not what we saw, but whether the survival benefit we saw was real and will be replicated, we'll have to wait and see."

The primary value of the study, she added, is that it demonstrated distinct benefits of palliative care on patient mood and quality of life.

The Will but Not the Way?

But many oncology practices, particularly those in community settings, may not have the resources to provide a full complement of palliative care services, said an oncologist in community-based practice.

"Those types of palliative care options are not widely available, and they certainly aren’t available in smaller communities," said Dr. Patrick Cobb, managing partner at the Frontier Cancer Center in Billings, Mont.

Services required for effective palliative care, such as patient and family counseling, are not typically reimbursed under current payments systems. In addition, palliative care reimbursement is often an "either/or" proposition: insurers pay for either therapeutic services or hospice care, but not both, said Dr. Cobb, former president of the Community Oncology Alliance.

He added that the so-called Stark law – actually a set of provisions in federal law governing the ability of clinicians to refer patients to clinical or diagnostic facilities in which the clinician has a financial interest – is another barrier to palliative care in the community, particularly in rural areas where the population may not be large enough to support separate palliative care facilities or programs.

Dr. Amy P. Abernethy, medical director of oncology quality, outcomes and patient-centered care in the Duke University Health System, Durham, N.C., and a coauthor of the ASCO provisional clinical opinion, agrees that there are multiple impediments to reimbursement of palliative care.

"The Stark law is one impediment; a second is that the reimbursement mechanisms that are clear in hospice aren’t necessarily as clear in community-based care, and then there are workforce issues. Right now, we have only a finite number of palliative care practitioners, and we only have a finite number of blocks in our graduate training programs, and we're not going to be able, using those slots, to train enough palliative care docs to fill the need that's highlighted in this provisional clinical opinion," she said.

Insurers, Younger Clinicians May Be Open to Change

Insurers seem to be coming around to the idea that palliative care can mean better patient care, however, said Dr Smith.

He points to Aetna, which has a "Compassionate Care" program in which specially trained triage nurses coordinate care, identify resources, and help manage palliative care and hospice benefits for patients with terminal illnesses and their families.

Clinicians in training or new to practice are also more comfortable with the idea of advance directives, palliative care, and hospice than are their more seasoned colleagues who were trained to never give up, Dr. Smith added.

Dr. Abernethy agreed: "What we’re seeing is that young physicians totally get this. Probably because they haven’t grown up in a world where the only thing you focus on is survival, they’ve understood the language of focusing on quality of life from the time they were first exposed to what medicine is," she said.

Randomized Trials Show Benefits, No Harm

In their provisional opinion, the researchers reviewed the study by Dr. Temel and her colleagues, as well as six other randomized controlled trials looking at palliative care in patients with various terminal illnesses; two of the seven total studies evaluated palliative care in cancer patients exclusively, whereas others included diagnoses such as heart failure and advanced chronic obstructive pulmonary disease.

They found that "overall, the addition of palliative care interventions to standard oncology care delivered via different models to patients with cancer provided evidence of benefit. No harm to any patient was observed in any trial, even with discussions of end-of-life planning, such as hospice and advance directives."

There were statistically significant improvements in symptoms with palliative care in 2 of 5 clinical trials that measured such changes, and improvements in quality-of-life measures in 2 of 5 trials. Additionally, in 2 of 3 trials palliative care was associated with improved satisfaction of patients and caregivers, the consensus panel found.

The studies also showed, to varying degrees, improvements in patient mood and a reduction in costs, in one study (J. Am. Geriatr. Soc. 2007;55:993-1000) from $20,222 for usual care to $12,670 for palliative care (P = .03), and in a second study (J. Palliat. Med. 2008;11:180-90) from a total mean of $21,252 for usual care to $14,486 for interdisciplinary palliative care (P less than .001). The latter study also found savings of nearly $5,000 per patient in staffing costs with palliative care.

"Therefore, most trials showed benefits ranging from equal to improved overall survival, reduced depression, improved caregiver and/or patient quality of life, and overall lower resource use and cost because end-of-life hospitalizations were avoided," the opinion authors wrote.

All physicians interviewed for this article reported that they did not have financial conflicts of interest.

Click here to see earlier coverage of this subject and a video of Dr. Temel discussing results of the randomized trial.

Compelling evidence from a recent randomized trial has prompted the American Society for Clinical Oncology to recommend that palliative care be integrated early on into standard cancer therapies for patients with metastatic cancers or a high burden of cancer symptoms.

Potentially practice changing, the opinion is based on the best currently available clinical evidence. Palliative care is typically relegated to the final days of life of patients with advanced metastatic cancers, as it is provided only after all other options have failed.

Authors of the opinion, intended to offer guidance to oncologists on this issue, cite a study published in 2010 (N. Engl. J. Med. 2010;363:733-42). The study showed that patients who were randomized to palliative care plus standard therapy for metastatic non–small cell lung cancer (NSCLC) had significantly longer overall survival than did patients randomized to standard care alone, (11.6 vs. 8.9 months, P = .02), even though the palliative care group had less aggressive end-of-life care.

Patients receiving palliative care also had significantly better quality of life scores on a standardized assessment scale, and significantly fewer had depressive symptoms, compared with patients on standard care.

"While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care – when combined with standard cancer care or as the main focus of care – leads to better patient and caregiver outcomes. These include improvement in symptoms, quality of life, and patient satisfaction, with reduced caregiver burden," wrote Dr. Thomas J. Smith and his colleagues in an American Society of Clinical Oncology (ASCO) provisional clinical opinion published online Feb. 6 in the Journal of Clinical Oncology (doi:10.1200/JCO.2011.38.5161).

Palliative care also eases patients and families through the anguish of dashed hopes and has the potential to reduce costs by limiting expensive but often futile intensive hospital-based services, the authors wrote.

"All the data suggest that there’s absolutely no harm from earlier integration of hospice and palliative medicine into patient care. A couple of trials have shown improved survival, and there are very good data from observational studies that people who use hospice actually live longer," Dr. Smith said in an interview. He is director of palliative care for Johns Hopkins University and Hopkins’ Sidney Kimmel Comprehensive Cancer Center in Baltimore.

"I think that ASCO is sending a really strong message to oncologists that we need to do more than we’re currently doing and that comprehensive cancer care needs to included supportive care on top of cancer-directed therapy," said Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston, and lead author of the randomized trial mentioned earlier.

She noted, however, that the study was not powered to detect an overall survival benefit. "All we were hoping for was that early palliative care didn’t lead to a survival detriment ... people could have been concerned that because of the involvement of palliative care, patients would receive less-intensive therapy and have shorter survival," Dr. Temel said. "I’m just very happy that’s not what we saw, but whether the survival benefit we saw was real and will be replicated, we'll have to wait and see."

The primary value of the study, she added, is that it demonstrated distinct benefits of palliative care on patient mood and quality of life.

The Will but Not the Way?

But many oncology practices, particularly those in community settings, may not have the resources to provide a full complement of palliative care services, said an oncologist in community-based practice.

"Those types of palliative care options are not widely available, and they certainly aren’t available in smaller communities," said Dr. Patrick Cobb, managing partner at the Frontier Cancer Center in Billings, Mont.

Services required for effective palliative care, such as patient and family counseling, are not typically reimbursed under current payments systems. In addition, palliative care reimbursement is often an "either/or" proposition: insurers pay for either therapeutic services or hospice care, but not both, said Dr. Cobb, former president of the Community Oncology Alliance.

He added that the so-called Stark law – actually a set of provisions in federal law governing the ability of clinicians to refer patients to clinical or diagnostic facilities in which the clinician has a financial interest – is another barrier to palliative care in the community, particularly in rural areas where the population may not be large enough to support separate palliative care facilities or programs.

Dr. Amy P. Abernethy, medical director of oncology quality, outcomes and patient-centered care in the Duke University Health System, Durham, N.C., and a coauthor of the ASCO provisional clinical opinion, agrees that there are multiple impediments to reimbursement of palliative care.

"The Stark law is one impediment; a second is that the reimbursement mechanisms that are clear in hospice aren’t necessarily as clear in community-based care, and then there are workforce issues. Right now, we have only a finite number of palliative care practitioners, and we only have a finite number of blocks in our graduate training programs, and we're not going to be able, using those slots, to train enough palliative care docs to fill the need that's highlighted in this provisional clinical opinion," she said.

Insurers, Younger Clinicians May Be Open to Change

Insurers seem to be coming around to the idea that palliative care can mean better patient care, however, said Dr Smith.

He points to Aetna, which has a "Compassionate Care" program in which specially trained triage nurses coordinate care, identify resources, and help manage palliative care and hospice benefits for patients with terminal illnesses and their families.

Clinicians in training or new to practice are also more comfortable with the idea of advance directives, palliative care, and hospice than are their more seasoned colleagues who were trained to never give up, Dr. Smith added.

Dr. Abernethy agreed: "What we’re seeing is that young physicians totally get this. Probably because they haven’t grown up in a world where the only thing you focus on is survival, they’ve understood the language of focusing on quality of life from the time they were first exposed to what medicine is," she said.

Randomized Trials Show Benefits, No Harm

In their provisional opinion, the researchers reviewed the study by Dr. Temel and her colleagues, as well as six other randomized controlled trials looking at palliative care in patients with various terminal illnesses; two of the seven total studies evaluated palliative care in cancer patients exclusively, whereas others included diagnoses such as heart failure and advanced chronic obstructive pulmonary disease.

They found that "overall, the addition of palliative care interventions to standard oncology care delivered via different models to patients with cancer provided evidence of benefit. No harm to any patient was observed in any trial, even with discussions of end-of-life planning, such as hospice and advance directives."

There were statistically significant improvements in symptoms with palliative care in 2 of 5 clinical trials that measured such changes, and improvements in quality-of-life measures in 2 of 5 trials. Additionally, in 2 of 3 trials palliative care was associated with improved satisfaction of patients and caregivers, the consensus panel found.

The studies also showed, to varying degrees, improvements in patient mood and a reduction in costs, in one study (J. Am. Geriatr. Soc. 2007;55:993-1000) from $20,222 for usual care to $12,670 for palliative care (P = .03), and in a second study (J. Palliat. Med. 2008;11:180-90) from a total mean of $21,252 for usual care to $14,486 for interdisciplinary palliative care (P less than .001). The latter study also found savings of nearly $5,000 per patient in staffing costs with palliative care.

"Therefore, most trials showed benefits ranging from equal to improved overall survival, reduced depression, improved caregiver and/or patient quality of life, and overall lower resource use and cost because end-of-life hospitalizations were avoided," the opinion authors wrote.

All physicians interviewed for this article reported that they did not have financial conflicts of interest.

Click here to see earlier coverage of this subject and a video of Dr. Temel discussing results of the randomized trial.

Compelling evidence from a recent randomized trial has prompted the American Society for Clinical Oncology to recommend that palliative care be integrated early on into standard cancer therapies for patients with metastatic cancers or a high burden of cancer symptoms.

Potentially practice changing, the opinion is based on the best currently available clinical evidence. Palliative care is typically relegated to the final days of life of patients with advanced metastatic cancers, as it is provided only after all other options have failed.

Authors of the opinion, intended to offer guidance to oncologists on this issue, cite a study published in 2010 (N. Engl. J. Med. 2010;363:733-42). The study showed that patients who were randomized to palliative care plus standard therapy for metastatic non–small cell lung cancer (NSCLC) had significantly longer overall survival than did patients randomized to standard care alone, (11.6 vs. 8.9 months, P = .02), even though the palliative care group had less aggressive end-of-life care.

Patients receiving palliative care also had significantly better quality of life scores on a standardized assessment scale, and significantly fewer had depressive symptoms, compared with patients on standard care.

"While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care – when combined with standard cancer care or as the main focus of care – leads to better patient and caregiver outcomes. These include improvement in symptoms, quality of life, and patient satisfaction, with reduced caregiver burden," wrote Dr. Thomas J. Smith and his colleagues in an American Society of Clinical Oncology (ASCO) provisional clinical opinion published online Feb. 6 in the Journal of Clinical Oncology (doi:10.1200/JCO.2011.38.5161).

Palliative care also eases patients and families through the anguish of dashed hopes and has the potential to reduce costs by limiting expensive but often futile intensive hospital-based services, the authors wrote.

"All the data suggest that there’s absolutely no harm from earlier integration of hospice and palliative medicine into patient care. A couple of trials have shown improved survival, and there are very good data from observational studies that people who use hospice actually live longer," Dr. Smith said in an interview. He is director of palliative care for Johns Hopkins University and Hopkins’ Sidney Kimmel Comprehensive Cancer Center in Baltimore.

"I think that ASCO is sending a really strong message to oncologists that we need to do more than we’re currently doing and that comprehensive cancer care needs to included supportive care on top of cancer-directed therapy," said Dr. Jennifer S. Temel, clinical director of thoracic oncology at Massachusetts General Hospital in Boston, and lead author of the randomized trial mentioned earlier.

She noted, however, that the study was not powered to detect an overall survival benefit. "All we were hoping for was that early palliative care didn’t lead to a survival detriment ... people could have been concerned that because of the involvement of palliative care, patients would receive less-intensive therapy and have shorter survival," Dr. Temel said. "I’m just very happy that’s not what we saw, but whether the survival benefit we saw was real and will be replicated, we'll have to wait and see."

The primary value of the study, she added, is that it demonstrated distinct benefits of palliative care on patient mood and quality of life.

The Will but Not the Way?

But many oncology practices, particularly those in community settings, may not have the resources to provide a full complement of palliative care services, said an oncologist in community-based practice.

"Those types of palliative care options are not widely available, and they certainly aren’t available in smaller communities," said Dr. Patrick Cobb, managing partner at the Frontier Cancer Center in Billings, Mont.

Services required for effective palliative care, such as patient and family counseling, are not typically reimbursed under current payments systems. In addition, palliative care reimbursement is often an "either/or" proposition: insurers pay for either therapeutic services or hospice care, but not both, said Dr. Cobb, former president of the Community Oncology Alliance.

He added that the so-called Stark law – actually a set of provisions in federal law governing the ability of clinicians to refer patients to clinical or diagnostic facilities in which the clinician has a financial interest – is another barrier to palliative care in the community, particularly in rural areas where the population may not be large enough to support separate palliative care facilities or programs.

Dr. Amy P. Abernethy, medical director of oncology quality, outcomes and patient-centered care in the Duke University Health System, Durham, N.C., and a coauthor of the ASCO provisional clinical opinion, agrees that there are multiple impediments to reimbursement of palliative care.

"The Stark law is one impediment; a second is that the reimbursement mechanisms that are clear in hospice aren’t necessarily as clear in community-based care, and then there are workforce issues. Right now, we have only a finite number of palliative care practitioners, and we only have a finite number of blocks in our graduate training programs, and we're not going to be able, using those slots, to train enough palliative care docs to fill the need that's highlighted in this provisional clinical opinion," she said.

Insurers, Younger Clinicians May Be Open to Change

Insurers seem to be coming around to the idea that palliative care can mean better patient care, however, said Dr Smith.

He points to Aetna, which has a "Compassionate Care" program in which specially trained triage nurses coordinate care, identify resources, and help manage palliative care and hospice benefits for patients with terminal illnesses and their families.

Clinicians in training or new to practice are also more comfortable with the idea of advance directives, palliative care, and hospice than are their more seasoned colleagues who were trained to never give up, Dr. Smith added.

Dr. Abernethy agreed: "What we’re seeing is that young physicians totally get this. Probably because they haven’t grown up in a world where the only thing you focus on is survival, they’ve understood the language of focusing on quality of life from the time they were first exposed to what medicine is," she said.

Randomized Trials Show Benefits, No Harm

In their provisional opinion, the researchers reviewed the study by Dr. Temel and her colleagues, as well as six other randomized controlled trials looking at palliative care in patients with various terminal illnesses; two of the seven total studies evaluated palliative care in cancer patients exclusively, whereas others included diagnoses such as heart failure and advanced chronic obstructive pulmonary disease.

They found that "overall, the addition of palliative care interventions to standard oncology care delivered via different models to patients with cancer provided evidence of benefit. No harm to any patient was observed in any trial, even with discussions of end-of-life planning, such as hospice and advance directives."

There were statistically significant improvements in symptoms with palliative care in 2 of 5 clinical trials that measured such changes, and improvements in quality-of-life measures in 2 of 5 trials. Additionally, in 2 of 3 trials palliative care was associated with improved satisfaction of patients and caregivers, the consensus panel found.

The studies also showed, to varying degrees, improvements in patient mood and a reduction in costs, in one study (J. Am. Geriatr. Soc. 2007;55:993-1000) from $20,222 for usual care to $12,670 for palliative care (P = .03), and in a second study (J. Palliat. Med. 2008;11:180-90) from a total mean of $21,252 for usual care to $14,486 for interdisciplinary palliative care (P less than .001). The latter study also found savings of nearly $5,000 per patient in staffing costs with palliative care.

"Therefore, most trials showed benefits ranging from equal to improved overall survival, reduced depression, improved caregiver and/or patient quality of life, and overall lower resource use and cost because end-of-life hospitalizations were avoided," the opinion authors wrote.

All physicians interviewed for this article reported that they did not have financial conflicts of interest.

Click here to see earlier coverage of this subject and a video of Dr. Temel discussing results of the randomized trial.

SAN DIEGO – High hyperploidy – 50 or more chromosomes – has been recognized since the 1980s as a favorable prognostic feature in children with B-lineage acute lymphoblastic leukemia, but it appears that the best results occur in patients who have 58 or more chromosomes.

Patients with B-lineage acute lymphoblastic leukemia (B-ALL) who had a modal number of chromosomes (MNC) ranging from 58 to 66 had a 6-year event-free survival rate of 99% in a study reported at the annual meeting of the American Society of Hematology.

In comparison, the event-free survival rate was 80% for patients with MNC 51-53 and 89% for patients with MNC 54-57 (P less than .001), said Dr. Nicole Dastugue from the Centre Hospitalier Universitaire – Hôpital Purpan in Toulouse, France, on behalf of colleagues in the EORTC (European Organisation for Research and Treatment of Cancer) CLG 58951 trial.

"In our study, the best indicator of excellent outcome was ploidy assessed with karyotype," she said, adding that patients with a DNA index of 1.24 or greater also had good outcomes, with a 94% event-free survival rate at 6 years (P = .03).

The investigators recommended assessing ploidy with both karyotyping and DNA index methods, a combination that can better detect hyperploidy greater than 50 chromosomes, and exclude near-triploidy or duplication of hypoploidy of 30-40 chromosomes, which indicate poor prognosis.

Previous studies have suggested that factors predicting better outcomes in childhood B-ALL included a DNA greater than 1.16, 56 or more chromosomes, triple trisomies (+4,+10,+17), double trisomies (+4,+10), and trisomy 18, Dr. Dastugue said.

She and her colleagues tested the above factors in 541 patients with hyperploidy greater than 50 who were enrolled in the trial, which studied combination chemotherapy plus steroids in children with ALL and lymphoblastic non-Hodgkin’s lymphoma.

Hyperploidy was identified by cytogenetics (karyotype and fluorescent in situ hybridization [FISH]) and/or DNA index via flow cytometry.

Patients were stratified by risk group (very low risk, average risk 1 or 2, and very high risk) according to DNA index, MNC, white blood count, central nervous system and/or gonadal involvement, or presence of very high risk features. Of the 541 patients, MNC could be evaluated in 446 (82%) and DNA index in 490 (91%).

In all, 87 patients were found to have 51-53 chromosomes, 258 had 54-57 chromosomes, and 101 had 58 or more chromosomes. Significant prognostic factors for event-free survival included MNC, DNA index, triple and double trisomies, and minimal residual disease, Dr. Dastugue said.

Among the patients with 58 or more chromosomes, all had a good response to prophase therapy, only three had minimal residual disease after induction chemotherapy, and only one patient experienced a relapse. The investigators could not identify specific patterns of chromosome gains associated with prognosis because all chromosomes except chromosome 1 were found to contribute to trisomies or tetrasomies.

Higher DNA index also was significantly associated with better outcomes, with patients who had a DNA index of 1.24 or greater having a 95% 6-year event-free survival, compared with 83% for DNA index below 1.16 and 90% for DNA index from 1.16 through 1.23 (P = .01), she reported.

Triple trisomies were associated with a 96% 6-year event-free survival rate vs. 86% for no triple trisomies (P = .005). The 6-year event-free survival rate for double trisomies was 94%, compared with 84% for no double trisomies (P = .003).

When the investigators ranked variables based on the presence of 58 or more chromosomes and trisomies, they found that the 6-year event-free survival rate for 58+ chromosomes was 99%, compared with 93% for triple trisomies with lower chromosome numbers and 84% for double trisomies with lower chromosome numbers (P = .04).

This finding implies that the favorable outcomes seen in patients with triple and double trisomies were at least partly due to their frequent association with high MNC, Dr. Dastugue said.

Noting that the investigators had consistently found triple trisomies of chromosomes 4, 10, and 17, session comoderator Dr. Christine J. Harrison of the Northern Institute for Cancer Research at Newcastle University in Newcastle upon Tyne, England, asked whether they had found any other trisomies associated with a favorable prognosis.

Dr. Dastugue said that no trisomies tested were significant predictors of outcome.

The trial was sponsored by the European Organisation for Research and Treatment of Cancer. The authors reported no relevant conflicts of interest. Dr. Harrison reported no relevant conflicts.

SAN DIEGO – High hyperploidy – 50 or more chromosomes – has been recognized since the 1980s as a favorable prognostic feature in children with B-lineage acute lymphoblastic leukemia, but it appears that the best results occur in patients who have 58 or more chromosomes.

Patients with B-lineage acute lymphoblastic leukemia (B-ALL) who had a modal number of chromosomes (MNC) ranging from 58 to 66 had a 6-year event-free survival rate of 99% in a study reported at the annual meeting of the American Society of Hematology.

In comparison, the event-free survival rate was 80% for patients with MNC 51-53 and 89% for patients with MNC 54-57 (P less than .001), said Dr. Nicole Dastugue from the Centre Hospitalier Universitaire – Hôpital Purpan in Toulouse, France, on behalf of colleagues in the EORTC (European Organisation for Research and Treatment of Cancer) CLG 58951 trial.

"In our study, the best indicator of excellent outcome was ploidy assessed with karyotype," she said, adding that patients with a DNA index of 1.24 or greater also had good outcomes, with a 94% event-free survival rate at 6 years (P = .03).

The investigators recommended assessing ploidy with both karyotyping and DNA index methods, a combination that can better detect hyperploidy greater than 50 chromosomes, and exclude near-triploidy or duplication of hypoploidy of 30-40 chromosomes, which indicate poor prognosis.

Previous studies have suggested that factors predicting better outcomes in childhood B-ALL included a DNA greater than 1.16, 56 or more chromosomes, triple trisomies (+4,+10,+17), double trisomies (+4,+10), and trisomy 18, Dr. Dastugue said.

She and her colleagues tested the above factors in 541 patients with hyperploidy greater than 50 who were enrolled in the trial, which studied combination chemotherapy plus steroids in children with ALL and lymphoblastic non-Hodgkin’s lymphoma.

Hyperploidy was identified by cytogenetics (karyotype and fluorescent in situ hybridization [FISH]) and/or DNA index via flow cytometry.

Patients were stratified by risk group (very low risk, average risk 1 or 2, and very high risk) according to DNA index, MNC, white blood count, central nervous system and/or gonadal involvement, or presence of very high risk features. Of the 541 patients, MNC could be evaluated in 446 (82%) and DNA index in 490 (91%).

In all, 87 patients were found to have 51-53 chromosomes, 258 had 54-57 chromosomes, and 101 had 58 or more chromosomes. Significant prognostic factors for event-free survival included MNC, DNA index, triple and double trisomies, and minimal residual disease, Dr. Dastugue said.

Among the patients with 58 or more chromosomes, all had a good response to prophase therapy, only three had minimal residual disease after induction chemotherapy, and only one patient experienced a relapse. The investigators could not identify specific patterns of chromosome gains associated with prognosis because all chromosomes except chromosome 1 were found to contribute to trisomies or tetrasomies.

Higher DNA index also was significantly associated with better outcomes, with patients who had a DNA index of 1.24 or greater having a 95% 6-year event-free survival, compared with 83% for DNA index below 1.16 and 90% for DNA index from 1.16 through 1.23 (P = .01), she reported.

Triple trisomies were associated with a 96% 6-year event-free survival rate vs. 86% for no triple trisomies (P = .005). The 6-year event-free survival rate for double trisomies was 94%, compared with 84% for no double trisomies (P = .003).

When the investigators ranked variables based on the presence of 58 or more chromosomes and trisomies, they found that the 6-year event-free survival rate for 58+ chromosomes was 99%, compared with 93% for triple trisomies with lower chromosome numbers and 84% for double trisomies with lower chromosome numbers (P = .04).

This finding implies that the favorable outcomes seen in patients with triple and double trisomies were at least partly due to their frequent association with high MNC, Dr. Dastugue said.

Noting that the investigators had consistently found triple trisomies of chromosomes 4, 10, and 17, session comoderator Dr. Christine J. Harrison of the Northern Institute for Cancer Research at Newcastle University in Newcastle upon Tyne, England, asked whether they had found any other trisomies associated with a favorable prognosis.

Dr. Dastugue said that no trisomies tested were significant predictors of outcome.

The trial was sponsored by the European Organisation for Research and Treatment of Cancer. The authors reported no relevant conflicts of interest. Dr. Harrison reported no relevant conflicts.

SAN DIEGO – High hyperploidy – 50 or more chromosomes – has been recognized since the 1980s as a favorable prognostic feature in children with B-lineage acute lymphoblastic leukemia, but it appears that the best results occur in patients who have 58 or more chromosomes.

Patients with B-lineage acute lymphoblastic leukemia (B-ALL) who had a modal number of chromosomes (MNC) ranging from 58 to 66 had a 6-year event-free survival rate of 99% in a study reported at the annual meeting of the American Society of Hematology.

In comparison, the event-free survival rate was 80% for patients with MNC 51-53 and 89% for patients with MNC 54-57 (P less than .001), said Dr. Nicole Dastugue from the Centre Hospitalier Universitaire – Hôpital Purpan in Toulouse, France, on behalf of colleagues in the EORTC (European Organisation for Research and Treatment of Cancer) CLG 58951 trial.

"In our study, the best indicator of excellent outcome was ploidy assessed with karyotype," she said, adding that patients with a DNA index of 1.24 or greater also had good outcomes, with a 94% event-free survival rate at 6 years (P = .03).

The investigators recommended assessing ploidy with both karyotyping and DNA index methods, a combination that can better detect hyperploidy greater than 50 chromosomes, and exclude near-triploidy or duplication of hypoploidy of 30-40 chromosomes, which indicate poor prognosis.

Previous studies have suggested that factors predicting better outcomes in childhood B-ALL included a DNA greater than 1.16, 56 or more chromosomes, triple trisomies (+4,+10,+17), double trisomies (+4,+10), and trisomy 18, Dr. Dastugue said.

She and her colleagues tested the above factors in 541 patients with hyperploidy greater than 50 who were enrolled in the trial, which studied combination chemotherapy plus steroids in children with ALL and lymphoblastic non-Hodgkin’s lymphoma.

Hyperploidy was identified by cytogenetics (karyotype and fluorescent in situ hybridization [FISH]) and/or DNA index via flow cytometry.

Patients were stratified by risk group (very low risk, average risk 1 or 2, and very high risk) according to DNA index, MNC, white blood count, central nervous system and/or gonadal involvement, or presence of very high risk features. Of the 541 patients, MNC could be evaluated in 446 (82%) and DNA index in 490 (91%).

In all, 87 patients were found to have 51-53 chromosomes, 258 had 54-57 chromosomes, and 101 had 58 or more chromosomes. Significant prognostic factors for event-free survival included MNC, DNA index, triple and double trisomies, and minimal residual disease, Dr. Dastugue said.

Among the patients with 58 or more chromosomes, all had a good response to prophase therapy, only three had minimal residual disease after induction chemotherapy, and only one patient experienced a relapse. The investigators could not identify specific patterns of chromosome gains associated with prognosis because all chromosomes except chromosome 1 were found to contribute to trisomies or tetrasomies.

Higher DNA index also was significantly associated with better outcomes, with patients who had a DNA index of 1.24 or greater having a 95% 6-year event-free survival, compared with 83% for DNA index below 1.16 and 90% for DNA index from 1.16 through 1.23 (P = .01), she reported.

Triple trisomies were associated with a 96% 6-year event-free survival rate vs. 86% for no triple trisomies (P = .005). The 6-year event-free survival rate for double trisomies was 94%, compared with 84% for no double trisomies (P = .003).

When the investigators ranked variables based on the presence of 58 or more chromosomes and trisomies, they found that the 6-year event-free survival rate for 58+ chromosomes was 99%, compared with 93% for triple trisomies with lower chromosome numbers and 84% for double trisomies with lower chromosome numbers (P = .04).

This finding implies that the favorable outcomes seen in patients with triple and double trisomies were at least partly due to their frequent association with high MNC, Dr. Dastugue said.

Noting that the investigators had consistently found triple trisomies of chromosomes 4, 10, and 17, session comoderator Dr. Christine J. Harrison of the Northern Institute for Cancer Research at Newcastle University in Newcastle upon Tyne, England, asked whether they had found any other trisomies associated with a favorable prognosis.

Dr. Dastugue said that no trisomies tested were significant predictors of outcome.

The trial was sponsored by the European Organisation for Research and Treatment of Cancer. The authors reported no relevant conflicts of interest. Dr. Harrison reported no relevant conflicts.

SAN DIEGO – Women diagnosed with lymphoma during pregnancy stand a good chance of carrying a healthy child to term even when they opt for treatment during the second or third trimester, according to a retrospective multicenter analysis.

Among 82 women diagnosed with either Hodgkin’s or non-Hodgkin’s lymphoma during pregnancy, 48 opted to start therapy during pregnancy rather than defer it until after delivery, investigators reported at the annual meeting of the American Society of Hematology.

All but one woman had a normal birth, the exception being a severe malformation: microcephaly in the fetus of a woman who had received four cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for diffuse large B-cell lymphoma (DLBCL).

The timing of therapy did not appear to affect overall survival, with the 3-year progression-free survival (PFS) rate being 76% among women who underwent treatment during pregnancy, compared with 79% for those who deferred it, said Dr. Andrew M. Evens of the University of Massachusetts in Worcester.

Respective overall survival rates were 92% and 83%, he reported. For the six women who elected to terminate their pregnancies, the 3-year PFS rate and overall survival rate were each 100%.

Among 39 women with Hodgkin’s lymphoma (HL), the 3-year PFS rate was 90%, and overall survival was 95%. Among 33 patients with B-cell non-Hodgkin’s lymphomas (NHL), 73% were progression free at 3 years; the overall survival rate was 82%. For 10 women with NHL of T-cell histology, the respective figures were 50% and 90%.

"We conclude that standard chemotherapy – non-antimetabolite chemotherapy – and radiation in select cases, in particular localized disease likely above the diaphragm during the second and third trimester, were associated with expected maternal complications and fetal detriment," Dr. Evens said.

Women with low-risk disease, such as indolent NHL, or a diagnosis late in gestation may be able to defer therapy until after delivery, he added.

Cancers in Pregnancy Uncommon. Cancer diagnoses during pregnancy are uncommon, occurring in about 3,500 women annually in the United States. The estimated prevalence is 1 in 1,000 gestations. Hematologic malignancies, primarily lymphomas, account for about 20% of all cancers diagnosed in pregnancy, Dr. Evens said.

He and his colleagues at nine academic medical centers conducted a descriptive retrospective analysis looking at histology, disease characteristics, therapy received, and maternal and fetal complications among pregnant women diagnosed with lymphomas from 1998 through 2011.

Of the 82 women identified for whom follow-up data were available, 43 (52%) were diagnosed with NHL (83% B-cell and 17% T-cell histologies) and 39 (48%) with HL. The median time of diagnosis was at 24 weeks gestation (range 5-40 weeks).

Six patients (4 with NHL and 2 with HL) decided to terminate the pregnancies to have immediate chemotherapy. Five of these patients were diagnosed in the first trimester and required systemic therapy.

The remaining patient was diagnosed early in the second trimester with lymphoma involving the central nervous system and requiring high-dose methotrexate, an antimetabolite in FDA pregnancy category X (positive evidence of fetal harm from animal or human studies and/or clinical experience; contraindicated). Other antimetabolites are classified in category D (positive evidence of fetal risk, but the benefits may warrant use in pregnant women).

A total of 28 patients (34%) chose to defer therapy, including 15 with HL, 5 with follicular lymphoma, 4 with DLBCL, 3 with T-cell lymphoma, and 1 with Burkitt’s lymphoma. The median gestation time at diagnosis in these patients was 34 weeks (range 6-38).

Of the 48 patients who chose to start therapy during pregnancy, 27 patients with NHL received therapy with CHOP, CHOP plus rituximab (Rituxan), modified hyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone), or similar regimens.

All but 2 patients with HL received the ABVD regimen (doxorubicin, bleomycin, vinblastine, and dacarbazine), and 4 of these patients also received partial-dose radiation therapy with shielding of the fetus. One patient received AVD (no bleomycin), and 1 received ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone). Treatments ranged from the 13th to the 33rd week of gestation.

Among the 48 treated patients, gestation reached full term in 73% with delivery at a median of 37 weeks (range 31-40); most of the deliveries occurred at or after 35 weeks. Among the 28 patients who deferred therapy, delivery was at a median of 38 weeks (range 26-40), and 86% of these women were able to carry their pregnancies to term.

"The goal in every patient, whether they received therapy or not, was to try and deliver as close to term as possible," Dr. Evens said.

Among all patients, 72% had vaginal delivery, and 28% had cesarean sections.

Labor Induced in Nearly Half of Patients. The most common preterm complication was the need for induction of labor in 45%. Preeclampsia occurred in 8%, 5% had spontaneous rupture of membranes, and 4% had gestational diabetes. There were no reported cases of endometritis or chorioamnionitis. There were no significant differences in preterm events between patients who were treated or deferred therapy.

There was one stillbirth, occurring in a 34-year-old woman with double-hit (two-mutation) NHL at 19 weeks after one cycle of R-CHOP.

One woman died before giving birth. She had very-high-risk DLBCL with significant metastases to the liver. She had been diagnosed at week 29 and died at week 32 from encephalopathy, but delivered a healthy infant before her death.

Outcomes for the fetuses of the 76 women who opted to continue their pregnancies included the aforementioned stillbirth and 1 case of microcephaly in a woman who had received four cycles of CHOP for DLBCL.

The median birth weight of neonates was 2,427 g (range 1,005-5,262 g), and there were no differences between the children of women who underwent antepartum chemotherapy or deferred therapy.

Dr. Evens noted that the investigators looked only at acute fetal outcomes, and have not evaluated long-term developmental measures.

The study was funded by the participating centers. The authors reported no relevant conflicts of interest.

SAN DIEGO – Women diagnosed with lymphoma during pregnancy stand a good chance of carrying a healthy child to term even when they opt for treatment during the second or third trimester, according to a retrospective multicenter analysis.

Among 82 women diagnosed with either Hodgkin’s or non-Hodgkin’s lymphoma during pregnancy, 48 opted to start therapy during pregnancy rather than defer it until after delivery, investigators reported at the annual meeting of the American Society of Hematology.

All but one woman had a normal birth, the exception being a severe malformation: microcephaly in the fetus of a woman who had received four cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for diffuse large B-cell lymphoma (DLBCL).

The timing of therapy did not appear to affect overall survival, with the 3-year progression-free survival (PFS) rate being 76% among women who underwent treatment during pregnancy, compared with 79% for those who deferred it, said Dr. Andrew M. Evens of the University of Massachusetts in Worcester.

Respective overall survival rates were 92% and 83%, he reported. For the six women who elected to terminate their pregnancies, the 3-year PFS rate and overall survival rate were each 100%.

Among 39 women with Hodgkin’s lymphoma (HL), the 3-year PFS rate was 90%, and overall survival was 95%. Among 33 patients with B-cell non-Hodgkin’s lymphomas (NHL), 73% were progression free at 3 years; the overall survival rate was 82%. For 10 women with NHL of T-cell histology, the respective figures were 50% and 90%.

"We conclude that standard chemotherapy – non-antimetabolite chemotherapy – and radiation in select cases, in particular localized disease likely above the diaphragm during the second and third trimester, were associated with expected maternal complications and fetal detriment," Dr. Evens said.

Women with low-risk disease, such as indolent NHL, or a diagnosis late in gestation may be able to defer therapy until after delivery, he added.

Cancers in Pregnancy Uncommon. Cancer diagnoses during pregnancy are uncommon, occurring in about 3,500 women annually in the United States. The estimated prevalence is 1 in 1,000 gestations. Hematologic malignancies, primarily lymphomas, account for about 20% of all cancers diagnosed in pregnancy, Dr. Evens said.

He and his colleagues at nine academic medical centers conducted a descriptive retrospective analysis looking at histology, disease characteristics, therapy received, and maternal and fetal complications among pregnant women diagnosed with lymphomas from 1998 through 2011.

Of the 82 women identified for whom follow-up data were available, 43 (52%) were diagnosed with NHL (83% B-cell and 17% T-cell histologies) and 39 (48%) with HL. The median time of diagnosis was at 24 weeks gestation (range 5-40 weeks).

Six patients (4 with NHL and 2 with HL) decided to terminate the pregnancies to have immediate chemotherapy. Five of these patients were diagnosed in the first trimester and required systemic therapy.

The remaining patient was diagnosed early in the second trimester with lymphoma involving the central nervous system and requiring high-dose methotrexate, an antimetabolite in FDA pregnancy category X (positive evidence of fetal harm from animal or human studies and/or clinical experience; contraindicated). Other antimetabolites are classified in category D (positive evidence of fetal risk, but the benefits may warrant use in pregnant women).

A total of 28 patients (34%) chose to defer therapy, including 15 with HL, 5 with follicular lymphoma, 4 with DLBCL, 3 with T-cell lymphoma, and 1 with Burkitt’s lymphoma. The median gestation time at diagnosis in these patients was 34 weeks (range 6-38).

Of the 48 patients who chose to start therapy during pregnancy, 27 patients with NHL received therapy with CHOP, CHOP plus rituximab (Rituxan), modified hyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone), or similar regimens.

All but 2 patients with HL received the ABVD regimen (doxorubicin, bleomycin, vinblastine, and dacarbazine), and 4 of these patients also received partial-dose radiation therapy with shielding of the fetus. One patient received AVD (no bleomycin), and 1 received ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone). Treatments ranged from the 13th to the 33rd week of gestation.

Among the 48 treated patients, gestation reached full term in 73% with delivery at a median of 37 weeks (range 31-40); most of the deliveries occurred at or after 35 weeks. Among the 28 patients who deferred therapy, delivery was at a median of 38 weeks (range 26-40), and 86% of these women were able to carry their pregnancies to term.

"The goal in every patient, whether they received therapy or not, was to try and deliver as close to term as possible," Dr. Evens said.

Among all patients, 72% had vaginal delivery, and 28% had cesarean sections.

Labor Induced in Nearly Half of Patients. The most common preterm complication was the need for induction of labor in 45%. Preeclampsia occurred in 8%, 5% had spontaneous rupture of membranes, and 4% had gestational diabetes. There were no reported cases of endometritis or chorioamnionitis. There were no significant differences in preterm events between patients who were treated or deferred therapy.

There was one stillbirth, occurring in a 34-year-old woman with double-hit (two-mutation) NHL at 19 weeks after one cycle of R-CHOP.

One woman died before giving birth. She had very-high-risk DLBCL with significant metastases to the liver. She had been diagnosed at week 29 and died at week 32 from encephalopathy, but delivered a healthy infant before her death.

Outcomes for the fetuses of the 76 women who opted to continue their pregnancies included the aforementioned stillbirth and 1 case of microcephaly in a woman who had received four cycles of CHOP for DLBCL.

The median birth weight of neonates was 2,427 g (range 1,005-5,262 g), and there were no differences between the children of women who underwent antepartum chemotherapy or deferred therapy.

Dr. Evens noted that the investigators looked only at acute fetal outcomes, and have not evaluated long-term developmental measures.

The study was funded by the participating centers. The authors reported no relevant conflicts of interest.

SAN DIEGO – Women diagnosed with lymphoma during pregnancy stand a good chance of carrying a healthy child to term even when they opt for treatment during the second or third trimester, according to a retrospective multicenter analysis.

Among 82 women diagnosed with either Hodgkin’s or non-Hodgkin’s lymphoma during pregnancy, 48 opted to start therapy during pregnancy rather than defer it until after delivery, investigators reported at the annual meeting of the American Society of Hematology.

All but one woman had a normal birth, the exception being a severe malformation: microcephaly in the fetus of a woman who had received four cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for diffuse large B-cell lymphoma (DLBCL).

The timing of therapy did not appear to affect overall survival, with the 3-year progression-free survival (PFS) rate being 76% among women who underwent treatment during pregnancy, compared with 79% for those who deferred it, said Dr. Andrew M. Evens of the University of Massachusetts in Worcester.

Respective overall survival rates were 92% and 83%, he reported. For the six women who elected to terminate their pregnancies, the 3-year PFS rate and overall survival rate were each 100%.

Among 39 women with Hodgkin’s lymphoma (HL), the 3-year PFS rate was 90%, and overall survival was 95%. Among 33 patients with B-cell non-Hodgkin’s lymphomas (NHL), 73% were progression free at 3 years; the overall survival rate was 82%. For 10 women with NHL of T-cell histology, the respective figures were 50% and 90%.

"We conclude that standard chemotherapy – non-antimetabolite chemotherapy – and radiation in select cases, in particular localized disease likely above the diaphragm during the second and third trimester, were associated with expected maternal complications and fetal detriment," Dr. Evens said.

Women with low-risk disease, such as indolent NHL, or a diagnosis late in gestation may be able to defer therapy until after delivery, he added.

Cancers in Pregnancy Uncommon. Cancer diagnoses during pregnancy are uncommon, occurring in about 3,500 women annually in the United States. The estimated prevalence is 1 in 1,000 gestations. Hematologic malignancies, primarily lymphomas, account for about 20% of all cancers diagnosed in pregnancy, Dr. Evens said.

He and his colleagues at nine academic medical centers conducted a descriptive retrospective analysis looking at histology, disease characteristics, therapy received, and maternal and fetal complications among pregnant women diagnosed with lymphomas from 1998 through 2011.

Of the 82 women identified for whom follow-up data were available, 43 (52%) were diagnosed with NHL (83% B-cell and 17% T-cell histologies) and 39 (48%) with HL. The median time of diagnosis was at 24 weeks gestation (range 5-40 weeks).

Six patients (4 with NHL and 2 with HL) decided to terminate the pregnancies to have immediate chemotherapy. Five of these patients were diagnosed in the first trimester and required systemic therapy.

The remaining patient was diagnosed early in the second trimester with lymphoma involving the central nervous system and requiring high-dose methotrexate, an antimetabolite in FDA pregnancy category X (positive evidence of fetal harm from animal or human studies and/or clinical experience; contraindicated). Other antimetabolites are classified in category D (positive evidence of fetal risk, but the benefits may warrant use in pregnant women).

A total of 28 patients (34%) chose to defer therapy, including 15 with HL, 5 with follicular lymphoma, 4 with DLBCL, 3 with T-cell lymphoma, and 1 with Burkitt’s lymphoma. The median gestation time at diagnosis in these patients was 34 weeks (range 6-38).

Of the 48 patients who chose to start therapy during pregnancy, 27 patients with NHL received therapy with CHOP, CHOP plus rituximab (Rituxan), modified hyperCVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone), or similar regimens.

All but 2 patients with HL received the ABVD regimen (doxorubicin, bleomycin, vinblastine, and dacarbazine), and 4 of these patients also received partial-dose radiation therapy with shielding of the fetus. One patient received AVD (no bleomycin), and 1 received ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone). Treatments ranged from the 13th to the 33rd week of gestation.

Among the 48 treated patients, gestation reached full term in 73% with delivery at a median of 37 weeks (range 31-40); most of the deliveries occurred at or after 35 weeks. Among the 28 patients who deferred therapy, delivery was at a median of 38 weeks (range 26-40), and 86% of these women were able to carry their pregnancies to term.

"The goal in every patient, whether they received therapy or not, was to try and deliver as close to term as possible," Dr. Evens said.

Among all patients, 72% had vaginal delivery, and 28% had cesarean sections.

Labor Induced in Nearly Half of Patients. The most common preterm complication was the need for induction of labor in 45%. Preeclampsia occurred in 8%, 5% had spontaneous rupture of membranes, and 4% had gestational diabetes. There were no reported cases of endometritis or chorioamnionitis. There were no significant differences in preterm events between patients who were treated or deferred therapy.

There was one stillbirth, occurring in a 34-year-old woman with double-hit (two-mutation) NHL at 19 weeks after one cycle of R-CHOP.

One woman died before giving birth. She had very-high-risk DLBCL with significant metastases to the liver. She had been diagnosed at week 29 and died at week 32 from encephalopathy, but delivered a healthy infant before her death.

Outcomes for the fetuses of the 76 women who opted to continue their pregnancies included the aforementioned stillbirth and 1 case of microcephaly in a woman who had received four cycles of CHOP for DLBCL.

The median birth weight of neonates was 2,427 g (range 1,005-5,262 g), and there were no differences between the children of women who underwent antepartum chemotherapy or deferred therapy.

Dr. Evens noted that the investigators looked only at acute fetal outcomes, and have not evaluated long-term developmental measures.

The study was funded by the participating centers. The authors reported no relevant conflicts of interest.

SAN DIEGO – In patients with spontaneous, isolated superficial vein thrombosis, a 45-day course of fondaparinux significantly reduced the rate of systemic thromboembolic complications compared with placebo, including events linked to thrombi with extensions more than 3 cm from the saphenofemoral junction, according to results of a post hoc analysis from the CALISTO trial.

Among patients with extension of a superficial vein thrombosis (SVT) either to 3 cm or less or more than 3 cm from the saphenofemoral junction, fondaparinux reduced the rate of symptomatic venous thromboembolic events (VTEs) by 79%, Dr. Alain Leizorovicz of the University of Lyon (France) reported at the annual meeting of the American Society of Hematology.

The results of the post hoc analysis were similar to those seen in the original analysis of the CALISTO (Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis With Placebo) trial. The results of the original analysis were first presented at the 2009 annual meeting of the American Society of Hematology, and published in the New England Journal of Medicine (N. Engl. J. Med. 2010;363:1222-32).

At that time, investigators showed that 2.5 mg fondaparinux injected subcutaneously once daily for 45 days reduced by 82% the rate of the primary end point, a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of SVT at day 47.

Principal investigator Dr. Hervé Décousus explained in an interview that the trial was designed with a pragmatic end point, looking at the effect of fondaparinux, a factor Xa inhibitor, on the incidence of symptomatic SVT with heads that extended no more than 3 cm from the saphenofemoral junction.

"These are considered by the vast majority of clinicians to be a proximal DVT [deep vein thrombosis]. Everybody accepted the idea that extension to the saphenofemoral junction was a very clinically pertinent end point," said Dr. Décousus from the Hôpital Nord in Saint-Étienne, France.

The CALISTO trial was a randomized, double-blind study comparing fondaparinux to placebo in 3,002 adults with symptomatic lower-limb SVT at least 5 cm long on compression ultrasonography. A total of 1,502 patients were assigned to receive fondaparinux and 1,500, to placebo. Patients were followed for 77 days from the initiation of therapy.

Because symptomatic extensions of index SVT to more than 3 cm from the saphenofemoral junction were not included in the primary end point, the authors created a secondary, post hoc end point considering more distal SVT.

At day 77, symptomatic SVTs within 3 cm of the SVT were seen in 59 (2% of all patients) and extensions to greater than 3 cm were seen in 68 (2.3%). The rate of the secondary thromboembolic outcome used in the post hoc analysis (a composite of symptomatic pulmonary emboli, DVT, extension of the index SVT, and symptomatic recurrence of the index SVT) among patients on placebo was 9.4%, compared with 1.9% for patients on fondaparinux (relative risk, 0.21; P less than .001).

Among patients on placebo, 9.3% of those with a symptomatic SVT within 3 cm and 8.9% of those with an extension beyond 3 cm had a symptomatic pulmonary embolic or DVT event during the trial. In contrast, no patients on fondaparinux experienced either event.

Patients on fondaparinux also used fewer analgesics, antiplatelet agents, and anticoagulants and had fewer ultrasound exams, surgeries to treat SVT, and hospitalizations after a thromboembolic event, compared with patients on placebo, the authors noted.

CALISTO was funded by GlaxoSmithKline. Dr. Leizorovicz disclosed receiving research funding, honoraria, and/or consulting fees from GSK, Bristol-Myers Squibb, Sanofi-Aventis, Bayer, and Boehringer Ingelheim. He also disclosed off-label use of fondaparinux for the treatment of SVT. Dr. Décousus disclosed serving on the board of directors or advisory committees for, and/or receiving research funding from, GSK, Bristol-Meyers Squibb, Boehringer Ingleheim, and Daiichi Sankyo. Coauthor Dr. Paolo Prandoni disclosed membership on a board or advisory committee for GSK.

SAN DIEGO – In patients with spontaneous, isolated superficial vein thrombosis, a 45-day course of fondaparinux significantly reduced the rate of systemic thromboembolic complications compared with placebo, including events linked to thrombi with extensions more than 3 cm from the saphenofemoral junction, according to results of a post hoc analysis from the CALISTO trial.

Among patients with extension of a superficial vein thrombosis (SVT) either to 3 cm or less or more than 3 cm from the saphenofemoral junction, fondaparinux reduced the rate of symptomatic venous thromboembolic events (VTEs) by 79%, Dr. Alain Leizorovicz of the University of Lyon (France) reported at the annual meeting of the American Society of Hematology.

The results of the post hoc analysis were similar to those seen in the original analysis of the CALISTO (Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis With Placebo) trial. The results of the original analysis were first presented at the 2009 annual meeting of the American Society of Hematology, and published in the New England Journal of Medicine (N. Engl. J. Med. 2010;363:1222-32).

At that time, investigators showed that 2.5 mg fondaparinux injected subcutaneously once daily for 45 days reduced by 82% the rate of the primary end point, a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of SVT at day 47.

Principal investigator Dr. Hervé Décousus explained in an interview that the trial was designed with a pragmatic end point, looking at the effect of fondaparinux, a factor Xa inhibitor, on the incidence of symptomatic SVT with heads that extended no more than 3 cm from the saphenofemoral junction.

"These are considered by the vast majority of clinicians to be a proximal DVT [deep vein thrombosis]. Everybody accepted the idea that extension to the saphenofemoral junction was a very clinically pertinent end point," said Dr. Décousus from the Hôpital Nord in Saint-Étienne, France.

The CALISTO trial was a randomized, double-blind study comparing fondaparinux to placebo in 3,002 adults with symptomatic lower-limb SVT at least 5 cm long on compression ultrasonography. A total of 1,502 patients were assigned to receive fondaparinux and 1,500, to placebo. Patients were followed for 77 days from the initiation of therapy.

Because symptomatic extensions of index SVT to more than 3 cm from the saphenofemoral junction were not included in the primary end point, the authors created a secondary, post hoc end point considering more distal SVT.

At day 77, symptomatic SVTs within 3 cm of the SVT were seen in 59 (2% of all patients) and extensions to greater than 3 cm were seen in 68 (2.3%). The rate of the secondary thromboembolic outcome used in the post hoc analysis (a composite of symptomatic pulmonary emboli, DVT, extension of the index SVT, and symptomatic recurrence of the index SVT) among patients on placebo was 9.4%, compared with 1.9% for patients on fondaparinux (relative risk, 0.21; P less than .001).

Among patients on placebo, 9.3% of those with a symptomatic SVT within 3 cm and 8.9% of those with an extension beyond 3 cm had a symptomatic pulmonary embolic or DVT event during the trial. In contrast, no patients on fondaparinux experienced either event.

Patients on fondaparinux also used fewer analgesics, antiplatelet agents, and anticoagulants and had fewer ultrasound exams, surgeries to treat SVT, and hospitalizations after a thromboembolic event, compared with patients on placebo, the authors noted.

CALISTO was funded by GlaxoSmithKline. Dr. Leizorovicz disclosed receiving research funding, honoraria, and/or consulting fees from GSK, Bristol-Myers Squibb, Sanofi-Aventis, Bayer, and Boehringer Ingelheim. He also disclosed off-label use of fondaparinux for the treatment of SVT. Dr. Décousus disclosed serving on the board of directors or advisory committees for, and/or receiving research funding from, GSK, Bristol-Meyers Squibb, Boehringer Ingleheim, and Daiichi Sankyo. Coauthor Dr. Paolo Prandoni disclosed membership on a board or advisory committee for GSK.

SAN DIEGO – In patients with spontaneous, isolated superficial vein thrombosis, a 45-day course of fondaparinux significantly reduced the rate of systemic thromboembolic complications compared with placebo, including events linked to thrombi with extensions more than 3 cm from the saphenofemoral junction, according to results of a post hoc analysis from the CALISTO trial.

Among patients with extension of a superficial vein thrombosis (SVT) either to 3 cm or less or more than 3 cm from the saphenofemoral junction, fondaparinux reduced the rate of symptomatic venous thromboembolic events (VTEs) by 79%, Dr. Alain Leizorovicz of the University of Lyon (France) reported at the annual meeting of the American Society of Hematology.

The results of the post hoc analysis were similar to those seen in the original analysis of the CALISTO (Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis With Placebo) trial. The results of the original analysis were first presented at the 2009 annual meeting of the American Society of Hematology, and published in the New England Journal of Medicine (N. Engl. J. Med. 2010;363:1222-32).

At that time, investigators showed that 2.5 mg fondaparinux injected subcutaneously once daily for 45 days reduced by 82% the rate of the primary end point, a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of SVT at day 47.

Principal investigator Dr. Hervé Décousus explained in an interview that the trial was designed with a pragmatic end point, looking at the effect of fondaparinux, a factor Xa inhibitor, on the incidence of symptomatic SVT with heads that extended no more than 3 cm from the saphenofemoral junction.

"These are considered by the vast majority of clinicians to be a proximal DVT [deep vein thrombosis]. Everybody accepted the idea that extension to the saphenofemoral junction was a very clinically pertinent end point," said Dr. Décousus from the Hôpital Nord in Saint-Étienne, France.

The CALISTO trial was a randomized, double-blind study comparing fondaparinux to placebo in 3,002 adults with symptomatic lower-limb SVT at least 5 cm long on compression ultrasonography. A total of 1,502 patients were assigned to receive fondaparinux and 1,500, to placebo. Patients were followed for 77 days from the initiation of therapy.

Because symptomatic extensions of index SVT to more than 3 cm from the saphenofemoral junction were not included in the primary end point, the authors created a secondary, post hoc end point considering more distal SVT.

At day 77, symptomatic SVTs within 3 cm of the SVT were seen in 59 (2% of all patients) and extensions to greater than 3 cm were seen in 68 (2.3%). The rate of the secondary thromboembolic outcome used in the post hoc analysis (a composite of symptomatic pulmonary emboli, DVT, extension of the index SVT, and symptomatic recurrence of the index SVT) among patients on placebo was 9.4%, compared with 1.9% for patients on fondaparinux (relative risk, 0.21; P less than .001).

Among patients on placebo, 9.3% of those with a symptomatic SVT within 3 cm and 8.9% of those with an extension beyond 3 cm had a symptomatic pulmonary embolic or DVT event during the trial. In contrast, no patients on fondaparinux experienced either event.

Patients on fondaparinux also used fewer analgesics, antiplatelet agents, and anticoagulants and had fewer ultrasound exams, surgeries to treat SVT, and hospitalizations after a thromboembolic event, compared with patients on placebo, the authors noted.

CALISTO was funded by GlaxoSmithKline. Dr. Leizorovicz disclosed receiving research funding, honoraria, and/or consulting fees from GSK, Bristol-Myers Squibb, Sanofi-Aventis, Bayer, and Boehringer Ingelheim. He also disclosed off-label use of fondaparinux for the treatment of SVT. Dr. Décousus disclosed serving on the board of directors or advisory committees for, and/or receiving research funding from, GSK, Bristol-Meyers Squibb, Boehringer Ingleheim, and Daiichi Sankyo. Coauthor Dr. Paolo Prandoni disclosed membership on a board or advisory committee for GSK.

BOSTON – A person with mental illness who insists on defending himself in court should not be allowed to sink or swim on his own, said a forensic psychiatrist at the annual meeting of the American Academy of Psychiatry and the Law.

A survey of forensic evaluators suggests that a minimum standard for determining pro se competency should include the defendant’s willingness to accept standby counsel, appraise legal defenses, plan legal strategy, and question and challenge witnesses.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman from the State University of New York Upstate Medical Center in Syracuse.

"To represent yourself, there are several things you have to do: You have to be able to organize your defense, make motions, argue points, participate in jury selection, question witnesses, read legal documents, address the court – a very complex skill set," he said.

Dr. Kaufman noted that the case of Indiana v. Edwards, decided by the U.S. Supreme Court in 2008, established that the state standard for determining competence required for self-defense may be higher than that for determining whether a defendant is competent to stand trial, with the trial judge having the final burden of making the determination.

In the Edwards case, a man who had fired at a security guard and wounded a bystander while attempting to steal a pair of shoes was twice found incompetent to stand trial by a judge and appealed for the right to represent himself.

The minority held that, in the words of Justice Antonin Scalia, "the dignity at issue is the supreme dignity of being master of one’s own fate rather than a ward of the state – the dignity of individual choice."

But Justice Stephen Breyer, writing for the majority, said that "a self-representation right at trial will not ‘affirm the dignity’ of a defendant who lacks the mental capacity to conduct his defense without assistance of counsel." To allow a defendant to act as his own lawyer in such a case "may undercut the most basic of the Constitution’s criminal law objectives: providing a fair trial," the opinion stated.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman.

The Supreme Court failed, however, to provide much guidance for trial court judges who are charged with determining whether someone found competent to stand trial is also competent to conduct his own legal defense, Dr. Kaufman said.

He and his colleagues initially sent an open-ended survey to 400 New York trial court judges, and received 18 responses. The respondents said that they would consider cognitive disorders (mental retardation, dementia) and that psychosis as conditions that would limit pro se competence.

The judges expressed eagerness for expert assistance in determining competence, and said that the domains that should be assessed in individual cases include the defendant intellectual and analytic abilities, legal knowledge and experience, language ability, and issues of severe mental illness and behavioral control.

The investigators then used the pilot data from that survey to create a new survey of forensic mental health experts, asking whether scores on individual items of the Competency Assessment Instrument (CAI), established by A. Louis McGarry and widely used to assess competence to stand trial, would need to be the same, somewhat higher, or much higher to determine pro se competence. They also asked about suitable levels of cognitive abilities, whether standby counsel should be mandatory, and whether the presence of standby counsel would change the level of competence require for self-defense.

Of the 300 contacted, 68 (23%) responded. In all, 58 of the 68 respondents were forensic psychiatrists with a mean 16.6 years if experience, and a mean number of competence-to-stand-trial evaluations of 263.

The respondents said the ability to take advantage of and plan legal strategies, to question or challenge witnesses, to understand court procedures, and to appraise likely outcomes needed to be higher or much higher than those for a standard competence determination. Other domains, such as self-serving motivation, the ability to appreciate change, appropriate behavior, role of court personnel, and ability to testify relevantly could be the same.

Nearly two-thirds of the respondents (60.3%) said that standby counsel should be mandatory, 22.1% disagreed, and 17.6% expressed no opinion. Additionally, 76% said the defendant needed at least average intelligence, 69% said at least average literacy, and 71% said at least average verbal communication abilities to be judged competent for self defense.

"As in other criminal competencies, there should be a presumption of competence, and since pro se competency in our opinion should be a higher standard – the court said ‘may be’ a higher standard, we believe it should be – the defendant must of course meet competency to stand trial criteria," Dr. Kaufman said.

To be declared incompetent, there must be a mental disease or defect and not simply poor judgment as the cause for incompetence, he added.

The study was internally funded. Dr. Kaufman reported that he had no financial disclosures.

BOSTON – A person with mental illness who insists on defending himself in court should not be allowed to sink or swim on his own, said a forensic psychiatrist at the annual meeting of the American Academy of Psychiatry and the Law.

A survey of forensic evaluators suggests that a minimum standard for determining pro se competency should include the defendant’s willingness to accept standby counsel, appraise legal defenses, plan legal strategy, and question and challenge witnesses.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman from the State University of New York Upstate Medical Center in Syracuse.

"To represent yourself, there are several things you have to do: You have to be able to organize your defense, make motions, argue points, participate in jury selection, question witnesses, read legal documents, address the court – a very complex skill set," he said.

Dr. Kaufman noted that the case of Indiana v. Edwards, decided by the U.S. Supreme Court in 2008, established that the state standard for determining competence required for self-defense may be higher than that for determining whether a defendant is competent to stand trial, with the trial judge having the final burden of making the determination.

In the Edwards case, a man who had fired at a security guard and wounded a bystander while attempting to steal a pair of shoes was twice found incompetent to stand trial by a judge and appealed for the right to represent himself.

The minority held that, in the words of Justice Antonin Scalia, "the dignity at issue is the supreme dignity of being master of one’s own fate rather than a ward of the state – the dignity of individual choice."

But Justice Stephen Breyer, writing for the majority, said that "a self-representation right at trial will not ‘affirm the dignity’ of a defendant who lacks the mental capacity to conduct his defense without assistance of counsel." To allow a defendant to act as his own lawyer in such a case "may undercut the most basic of the Constitution’s criminal law objectives: providing a fair trial," the opinion stated.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman.

The Supreme Court failed, however, to provide much guidance for trial court judges who are charged with determining whether someone found competent to stand trial is also competent to conduct his own legal defense, Dr. Kaufman said.

He and his colleagues initially sent an open-ended survey to 400 New York trial court judges, and received 18 responses. The respondents said that they would consider cognitive disorders (mental retardation, dementia) and that psychosis as conditions that would limit pro se competence.

The judges expressed eagerness for expert assistance in determining competence, and said that the domains that should be assessed in individual cases include the defendant intellectual and analytic abilities, legal knowledge and experience, language ability, and issues of severe mental illness and behavioral control.

The investigators then used the pilot data from that survey to create a new survey of forensic mental health experts, asking whether scores on individual items of the Competency Assessment Instrument (CAI), established by A. Louis McGarry and widely used to assess competence to stand trial, would need to be the same, somewhat higher, or much higher to determine pro se competence. They also asked about suitable levels of cognitive abilities, whether standby counsel should be mandatory, and whether the presence of standby counsel would change the level of competence require for self-defense.

Of the 300 contacted, 68 (23%) responded. In all, 58 of the 68 respondents were forensic psychiatrists with a mean 16.6 years if experience, and a mean number of competence-to-stand-trial evaluations of 263.

The respondents said the ability to take advantage of and plan legal strategies, to question or challenge witnesses, to understand court procedures, and to appraise likely outcomes needed to be higher or much higher than those for a standard competence determination. Other domains, such as self-serving motivation, the ability to appreciate change, appropriate behavior, role of court personnel, and ability to testify relevantly could be the same.

Nearly two-thirds of the respondents (60.3%) said that standby counsel should be mandatory, 22.1% disagreed, and 17.6% expressed no opinion. Additionally, 76% said the defendant needed at least average intelligence, 69% said at least average literacy, and 71% said at least average verbal communication abilities to be judged competent for self defense.

"As in other criminal competencies, there should be a presumption of competence, and since pro se competency in our opinion should be a higher standard – the court said ‘may be’ a higher standard, we believe it should be – the defendant must of course meet competency to stand trial criteria," Dr. Kaufman said.

To be declared incompetent, there must be a mental disease or defect and not simply poor judgment as the cause for incompetence, he added.

The study was internally funded. Dr. Kaufman reported that he had no financial disclosures.

BOSTON – A person with mental illness who insists on defending himself in court should not be allowed to sink or swim on his own, said a forensic psychiatrist at the annual meeting of the American Academy of Psychiatry and the Law.

A survey of forensic evaluators suggests that a minimum standard for determining pro se competency should include the defendant’s willingness to accept standby counsel, appraise legal defenses, plan legal strategy, and question and challenge witnesses.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman from the State University of New York Upstate Medical Center in Syracuse.

"To represent yourself, there are several things you have to do: You have to be able to organize your defense, make motions, argue points, participate in jury selection, question witnesses, read legal documents, address the court – a very complex skill set," he said.

Dr. Kaufman noted that the case of Indiana v. Edwards, decided by the U.S. Supreme Court in 2008, established that the state standard for determining competence required for self-defense may be higher than that for determining whether a defendant is competent to stand trial, with the trial judge having the final burden of making the determination.

In the Edwards case, a man who had fired at a security guard and wounded a bystander while attempting to steal a pair of shoes was twice found incompetent to stand trial by a judge and appealed for the right to represent himself.

The minority held that, in the words of Justice Antonin Scalia, "the dignity at issue is the supreme dignity of being master of one’s own fate rather than a ward of the state – the dignity of individual choice."

But Justice Stephen Breyer, writing for the majority, said that "a self-representation right at trial will not ‘affirm the dignity’ of a defendant who lacks the mental capacity to conduct his defense without assistance of counsel." To allow a defendant to act as his own lawyer in such a case "may undercut the most basic of the Constitution’s criminal law objectives: providing a fair trial," the opinion stated.

The defendant also should have at least average cognitive abilities, including intelligence, literacy, and verbal ability, said Dr. Andrew R. Kaufman.

The Supreme Court failed, however, to provide much guidance for trial court judges who are charged with determining whether someone found competent to stand trial is also competent to conduct his own legal defense, Dr. Kaufman said.

He and his colleagues initially sent an open-ended survey to 400 New York trial court judges, and received 18 responses. The respondents said that they would consider cognitive disorders (mental retardation, dementia) and that psychosis as conditions that would limit pro se competence.

The judges expressed eagerness for expert assistance in determining competence, and said that the domains that should be assessed in individual cases include the defendant intellectual and analytic abilities, legal knowledge and experience, language ability, and issues of severe mental illness and behavioral control.

The investigators then used the pilot data from that survey to create a new survey of forensic mental health experts, asking whether scores on individual items of the Competency Assessment Instrument (CAI), established by A. Louis McGarry and widely used to assess competence to stand trial, would need to be the same, somewhat higher, or much higher to determine pro se competence. They also asked about suitable levels of cognitive abilities, whether standby counsel should be mandatory, and whether the presence of standby counsel would change the level of competence require for self-defense.

Of the 300 contacted, 68 (23%) responded. In all, 58 of the 68 respondents were forensic psychiatrists with a mean 16.6 years if experience, and a mean number of competence-to-stand-trial evaluations of 263.

The respondents said the ability to take advantage of and plan legal strategies, to question or challenge witnesses, to understand court procedures, and to appraise likely outcomes needed to be higher or much higher than those for a standard competence determination. Other domains, such as self-serving motivation, the ability to appreciate change, appropriate behavior, role of court personnel, and ability to testify relevantly could be the same.

Nearly two-thirds of the respondents (60.3%) said that standby counsel should be mandatory, 22.1% disagreed, and 17.6% expressed no opinion. Additionally, 76% said the defendant needed at least average intelligence, 69% said at least average literacy, and 71% said at least average verbal communication abilities to be judged competent for self defense.

"As in other criminal competencies, there should be a presumption of competence, and since pro se competency in our opinion should be a higher standard – the court said ‘may be’ a higher standard, we believe it should be – the defendant must of course meet competency to stand trial criteria," Dr. Kaufman said.

To be declared incompetent, there must be a mental disease or defect and not simply poor judgment as the cause for incompetence, he added.

The study was internally funded. Dr. Kaufman reported that he had no financial disclosures.