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ASCO plumbs the value of new cancer therapies

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ALEXANDRIA, VA. – The American Society of Clinical Oncology has initiated an ambitious campaign designed to wring order out of the current chaos surrounding the efficacy, toxicities, and costs of emerging therapies for cancer.

ASCO is inviting clinicians and other stakeholders to comment on the initial version of its Value Framework, published June 22, 2015 in the Journal of Clinical Oncology.

Dr. Richard L. Schilsky

“We developed the framework because costs are increasing, and our patients are clearly feeling the impact, and we’ve heard about that directly from patients and their doctors,” said ASCO Chief Medical Officer Richard L. Schilsky at a media briefing announcing publication of the first version of the framework.

The costs of cancer care are growing rapidly, and are expected to increase from approximately $125 billion annually in 2010 to $158 billion by 2020. Cancer drugs are the fastest-growing components of that cost. New cancer drugs on average cost about $10,000 per month, compared with half that amount just 10 years ago, Dr. Schilsky said.

“Some new drugs now exceed $30,000 per month, and as we look to the future of using these new drugs in combination the costs will be even greater,” he said

Out-of-pocket costs for patients are also on the rise. The total out-of-pocket burden is greater for patients with cancer than with other chronic diseases, regardless of the type of insurance the patient has.

“Many cancer patients are facing severe financial strain, even bankruptcy in some cases. In fact, people with cancer are about 2½ times more likely to face bankruptcy than those without cancer,” Dr. Schilsky noted.

He pointed to a 2013 study of financial toxicity among cancer patients, which found that among patients surveyed, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether in order to save on the costs of their care.

How it works

The Value Framework is intended to serve as a standardized system of information on the relative benefits, toxicities, and costs of new therapies as compared with existing therapies in randomized clinical trials.

The framework is specifically built around the comparative trial, with different methodologies to evaluate therapies for advanced/metastatic disease and treatments used with curative intent in the adjuvant setting.

Dr. Lowell E. Schnipper

“This is not meant to be a ranking or a calculator for individual drugs. It’s a way to provide information in a standardized and objective way to both physicians and patients about the value of new treatment options that emerge from clinical trials comparing a standard of care to a new treatment option,” said Dr. Lowell E. Schnipper, chair of ASCO’s Value in Cancer Care Task Force.

“I want to be clear: this is not a way of ranking drugs; this is simply a way of understanding the outcome of a clinical trial,” he said at the briefing.

The frameworks use a scoring system to award or subtract points to a specific therapy based on clinical benefit and toxicity, with the two scores combined to generate a Net Health Benefit score that will then be compared with the direct cost of the treatment.

Clinical benefit

For the adjuvant framework, a score of 1-5 for overall survival (OS) will be assigned based on the hazard ratio when the treatment is compared to the standard of care. If the trial does not report OS data, the hazard ratio for disease-free survival (DFS) will be used instead. The categorical score is multiplied, or weighted, by a factor of 16 for OS and 15 for DFS. In this and in the advanced disease framework, the maximum weight of the benefit on survival will be 80 points (16 x 5).

In the advanced/metastatic framework, clinical benefit will be scored based on fractional improvement in median OS over the standard of a care for a specific clinical scenario. As with the adjuvant framework, OS is considered first, DFS if OS is not available, and if neither is available (for example, in a single-arm trial), response rate will be used. In this framework, OS is weighted by a factor of 16, PFS by 11 “because it is a less clinically meaningful end point and is not always a surrogate for OS,” the framework creators note. Response rate will be weighted by 8, an acknowledgment that clinical responses do not always translate into improvements in OS.

In both frameworks, toxicities will be determined relative to the comparator regimen or drug, with a categorical value ranging from –20 (for substantially less well tolerated) to +20 (substantially better).

 

 

For the advanced/metastatic disease framework, a treatment or regimen can earn “bonus” points if it can be demonstrated to provide a statistically significant improvement in either palliation of symptoms and/or treatment-free intervals, compared with the control treatment in a prospective clinical trial.

Scores and cost

The Net Health Benefit score will be derived from the combination of the clinical benefit and toxicity score, plus points for regimens designed to treat advanced cancer. The maximum achievable scores are 100 for adjuvant therapies and 130 for advanced/metastatic therapies.

Cost estimates included in the valuation process will include both drug acquisition costs and costs to patients.

ASCO is inviting comments via an online survey through August 21, 2015.

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ALEXANDRIA, VA. – The American Society of Clinical Oncology has initiated an ambitious campaign designed to wring order out of the current chaos surrounding the efficacy, toxicities, and costs of emerging therapies for cancer.

ASCO is inviting clinicians and other stakeholders to comment on the initial version of its Value Framework, published June 22, 2015 in the Journal of Clinical Oncology.

Dr. Richard L. Schilsky

“We developed the framework because costs are increasing, and our patients are clearly feeling the impact, and we’ve heard about that directly from patients and their doctors,” said ASCO Chief Medical Officer Richard L. Schilsky at a media briefing announcing publication of the first version of the framework.

The costs of cancer care are growing rapidly, and are expected to increase from approximately $125 billion annually in 2010 to $158 billion by 2020. Cancer drugs are the fastest-growing components of that cost. New cancer drugs on average cost about $10,000 per month, compared with half that amount just 10 years ago, Dr. Schilsky said.

“Some new drugs now exceed $30,000 per month, and as we look to the future of using these new drugs in combination the costs will be even greater,” he said

Out-of-pocket costs for patients are also on the rise. The total out-of-pocket burden is greater for patients with cancer than with other chronic diseases, regardless of the type of insurance the patient has.

“Many cancer patients are facing severe financial strain, even bankruptcy in some cases. In fact, people with cancer are about 2½ times more likely to face bankruptcy than those without cancer,” Dr. Schilsky noted.

He pointed to a 2013 study of financial toxicity among cancer patients, which found that among patients surveyed, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether in order to save on the costs of their care.

How it works

The Value Framework is intended to serve as a standardized system of information on the relative benefits, toxicities, and costs of new therapies as compared with existing therapies in randomized clinical trials.

The framework is specifically built around the comparative trial, with different methodologies to evaluate therapies for advanced/metastatic disease and treatments used with curative intent in the adjuvant setting.

Dr. Lowell E. Schnipper

“This is not meant to be a ranking or a calculator for individual drugs. It’s a way to provide information in a standardized and objective way to both physicians and patients about the value of new treatment options that emerge from clinical trials comparing a standard of care to a new treatment option,” said Dr. Lowell E. Schnipper, chair of ASCO’s Value in Cancer Care Task Force.

“I want to be clear: this is not a way of ranking drugs; this is simply a way of understanding the outcome of a clinical trial,” he said at the briefing.

The frameworks use a scoring system to award or subtract points to a specific therapy based on clinical benefit and toxicity, with the two scores combined to generate a Net Health Benefit score that will then be compared with the direct cost of the treatment.

Clinical benefit

For the adjuvant framework, a score of 1-5 for overall survival (OS) will be assigned based on the hazard ratio when the treatment is compared to the standard of care. If the trial does not report OS data, the hazard ratio for disease-free survival (DFS) will be used instead. The categorical score is multiplied, or weighted, by a factor of 16 for OS and 15 for DFS. In this and in the advanced disease framework, the maximum weight of the benefit on survival will be 80 points (16 x 5).

In the advanced/metastatic framework, clinical benefit will be scored based on fractional improvement in median OS over the standard of a care for a specific clinical scenario. As with the adjuvant framework, OS is considered first, DFS if OS is not available, and if neither is available (for example, in a single-arm trial), response rate will be used. In this framework, OS is weighted by a factor of 16, PFS by 11 “because it is a less clinically meaningful end point and is not always a surrogate for OS,” the framework creators note. Response rate will be weighted by 8, an acknowledgment that clinical responses do not always translate into improvements in OS.

In both frameworks, toxicities will be determined relative to the comparator regimen or drug, with a categorical value ranging from –20 (for substantially less well tolerated) to +20 (substantially better).

 

 

For the advanced/metastatic disease framework, a treatment or regimen can earn “bonus” points if it can be demonstrated to provide a statistically significant improvement in either palliation of symptoms and/or treatment-free intervals, compared with the control treatment in a prospective clinical trial.

Scores and cost

The Net Health Benefit score will be derived from the combination of the clinical benefit and toxicity score, plus points for regimens designed to treat advanced cancer. The maximum achievable scores are 100 for adjuvant therapies and 130 for advanced/metastatic therapies.

Cost estimates included in the valuation process will include both drug acquisition costs and costs to patients.

ASCO is inviting comments via an online survey through August 21, 2015.

ALEXANDRIA, VA. – The American Society of Clinical Oncology has initiated an ambitious campaign designed to wring order out of the current chaos surrounding the efficacy, toxicities, and costs of emerging therapies for cancer.

ASCO is inviting clinicians and other stakeholders to comment on the initial version of its Value Framework, published June 22, 2015 in the Journal of Clinical Oncology.

Dr. Richard L. Schilsky

“We developed the framework because costs are increasing, and our patients are clearly feeling the impact, and we’ve heard about that directly from patients and their doctors,” said ASCO Chief Medical Officer Richard L. Schilsky at a media briefing announcing publication of the first version of the framework.

The costs of cancer care are growing rapidly, and are expected to increase from approximately $125 billion annually in 2010 to $158 billion by 2020. Cancer drugs are the fastest-growing components of that cost. New cancer drugs on average cost about $10,000 per month, compared with half that amount just 10 years ago, Dr. Schilsky said.

“Some new drugs now exceed $30,000 per month, and as we look to the future of using these new drugs in combination the costs will be even greater,” he said

Out-of-pocket costs for patients are also on the rise. The total out-of-pocket burden is greater for patients with cancer than with other chronic diseases, regardless of the type of insurance the patient has.

“Many cancer patients are facing severe financial strain, even bankruptcy in some cases. In fact, people with cancer are about 2½ times more likely to face bankruptcy than those without cancer,” Dr. Schilsky noted.

He pointed to a 2013 study of financial toxicity among cancer patients, which found that among patients surveyed, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether in order to save on the costs of their care.

How it works

The Value Framework is intended to serve as a standardized system of information on the relative benefits, toxicities, and costs of new therapies as compared with existing therapies in randomized clinical trials.

The framework is specifically built around the comparative trial, with different methodologies to evaluate therapies for advanced/metastatic disease and treatments used with curative intent in the adjuvant setting.

Dr. Lowell E. Schnipper

“This is not meant to be a ranking or a calculator for individual drugs. It’s a way to provide information in a standardized and objective way to both physicians and patients about the value of new treatment options that emerge from clinical trials comparing a standard of care to a new treatment option,” said Dr. Lowell E. Schnipper, chair of ASCO’s Value in Cancer Care Task Force.

“I want to be clear: this is not a way of ranking drugs; this is simply a way of understanding the outcome of a clinical trial,” he said at the briefing.

The frameworks use a scoring system to award or subtract points to a specific therapy based on clinical benefit and toxicity, with the two scores combined to generate a Net Health Benefit score that will then be compared with the direct cost of the treatment.

Clinical benefit

For the adjuvant framework, a score of 1-5 for overall survival (OS) will be assigned based on the hazard ratio when the treatment is compared to the standard of care. If the trial does not report OS data, the hazard ratio for disease-free survival (DFS) will be used instead. The categorical score is multiplied, or weighted, by a factor of 16 for OS and 15 for DFS. In this and in the advanced disease framework, the maximum weight of the benefit on survival will be 80 points (16 x 5).

In the advanced/metastatic framework, clinical benefit will be scored based on fractional improvement in median OS over the standard of a care for a specific clinical scenario. As with the adjuvant framework, OS is considered first, DFS if OS is not available, and if neither is available (for example, in a single-arm trial), response rate will be used. In this framework, OS is weighted by a factor of 16, PFS by 11 “because it is a less clinically meaningful end point and is not always a surrogate for OS,” the framework creators note. Response rate will be weighted by 8, an acknowledgment that clinical responses do not always translate into improvements in OS.

In both frameworks, toxicities will be determined relative to the comparator regimen or drug, with a categorical value ranging from –20 (for substantially less well tolerated) to +20 (substantially better).

 

 

For the advanced/metastatic disease framework, a treatment or regimen can earn “bonus” points if it can be demonstrated to provide a statistically significant improvement in either palliation of symptoms and/or treatment-free intervals, compared with the control treatment in a prospective clinical trial.

Scores and cost

The Net Health Benefit score will be derived from the combination of the clinical benefit and toxicity score, plus points for regimens designed to treat advanced cancer. The maximum achievable scores are 100 for adjuvant therapies and 130 for advanced/metastatic therapies.

Cost estimates included in the valuation process will include both drug acquisition costs and costs to patients.

ASCO is inviting comments via an online survey through August 21, 2015.

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Obesity, genetic variations found in adult survivors of childhood cancer

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Obesity, genetic variations found in adult survivors of childhood cancer

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

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The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m2. All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m2.

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

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Cardiovascular disease in oncology

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In the first quarter of 2015, a number of papers that addressed cardiovascular issues in oncology were published. These included studies of the cardiovascular toxicity of cancer therapy, treatment guidelines from the American Society of Clinical Oncology (ASCO) for venous thromboembolism prophylaxis (VTE), and the prognostic significance of superficial vein thrombosis. 

 

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cardiovascular disease, CVD, cardiovascular toxicity, venous thromboembolism, VTE, superficial vein thrombosis, SVT, prostate cancer, cerebral microbleeds, CMBs, whitematter lesions, WMLs, vascular adverse events, VAEs, nilotinib, ponatinib, bosutinib, dasatinib

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In the first quarter of 2015, a number of papers that addressed cardiovascular issues in oncology were published. These included studies of the cardiovascular toxicity of cancer therapy, treatment guidelines from the American Society of Clinical Oncology (ASCO) for venous thromboembolism prophylaxis (VTE), and the prognostic significance of superficial vein thrombosis. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

In the first quarter of 2015, a number of papers that addressed cardiovascular issues in oncology were published. These included studies of the cardiovascular toxicity of cancer therapy, treatment guidelines from the American Society of Clinical Oncology (ASCO) for venous thromboembolism prophylaxis (VTE), and the prognostic significance of superficial vein thrombosis. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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Cardiovascular disease in oncology
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cardiovascular disease, CVD, cardiovascular toxicity, venous thromboembolism, VTE, superficial vein thrombosis, SVT, prostate cancer, cerebral microbleeds, CMBs, whitematter lesions, WMLs, vascular adverse events, VAEs, nilotinib, ponatinib, bosutinib, dasatinib

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cardiovascular disease, CVD, cardiovascular toxicity, venous thromboembolism, VTE, superficial vein thrombosis, SVT, prostate cancer, cerebral microbleeds, CMBs, whitematter lesions, WMLs, vascular adverse events, VAEs, nilotinib, ponatinib, bosutinib, dasatinib

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Measuring end-of-life care in oncology practices: learning from the care of the dying

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Measuring end-of-life care in oncology practices: learning from the care of the dying

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

 

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Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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Isolated splenic metastasis in a patient with two distinct genitourinary malignancies

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Splenic metastasis is rare, occurring in 2.3%- 7.1% of cases, of which 95% are carcinomas.1 The lung is the most common primary tumor site (21% of cases), followed by the gastrointestinal system, breast, ovaries, and skin. In a retrospective study evaluating the clinical and pathological impact of splenic metastases during a 25-year period in China, it was found that about 5.3% of metastases were isolated splenic metastasis.2  Isolated splenic metastasis from kidney cancer is very rare and is often an incidental finding. Here we report a case with isolated splenic metastasis in a patient with both primary renal cell carcinoma and prostate cancer, which turned out to be metastatic renal cell carcinoma in the spleen.  

 

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Splenic metastasis is rare, occurring in 2.3%- 7.1% of cases, of which 95% are carcinomas.1 The lung is the most common primary tumor site (21% of cases), followed by the gastrointestinal system, breast, ovaries, and skin. In a retrospective study evaluating the clinical and pathological impact of splenic metastases during a 25-year period in China, it was found that about 5.3% of metastases were isolated splenic metastasis.2  Isolated splenic metastasis from kidney cancer is very rare and is often an incidental finding. Here we report a case with isolated splenic metastasis in a patient with both primary renal cell carcinoma and prostate cancer, which turned out to be metastatic renal cell carcinoma in the spleen.  

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Splenic metastasis is rare, occurring in 2.3%- 7.1% of cases, of which 95% are carcinomas.1 The lung is the most common primary tumor site (21% of cases), followed by the gastrointestinal system, breast, ovaries, and skin. In a retrospective study evaluating the clinical and pathological impact of splenic metastases during a 25-year period in China, it was found that about 5.3% of metastases were isolated splenic metastasis.2  Isolated splenic metastasis from kidney cancer is very rare and is often an incidental finding. Here we report a case with isolated splenic metastasis in a patient with both primary renal cell carcinoma and prostate cancer, which turned out to be metastatic renal cell carcinoma in the spleen.  

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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Impact of nurse navigation on timeliness of diagnostic medical services in patients with newly diagnosed lung cancer

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Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

 

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Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

 

Click on the PDF icon at the top of this introduction to read the full article.

Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

 

Click on the PDF icon at the top of this introduction to read the full article.

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Only moderate-quality evidence supports medical cannabinoids

Dearth of high-quality research
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Only moderate-quality evidence supports medical cannabinoids

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.

References

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It is unclear why medical marijuana has averted the usual Food and Drug Administration approval process required of other medications.

Adequately powered, double-blind, randomized, placebo- or treatment-controlled clinical trials are critical to establish cannabinoids’ short- and long-term efficacy and safety. Yet they already qualify by state law for use in conditions as varied as hepatitis C, Crohn’s disease, Parkinson’s disease, psoriasis, sickle cell disease, and posttraumatic stress disorder.

In particular, the risks of repeated exposure to cannabinoids needs further study. Addiction, tolerance, and a distinct withdrawal syndrome have been documented, and there is also a small but definite risk of psychotic disorder.

Dr. Deepak Cyril D’Souza and Dr. Mohini Ranganathan are in the department of psychiatry at Yale University, New Haven; in the psychiatry service at Veterans Affairs Connecticut Healthcare System, West Haven; and at Abraham Ribicoff Research Facilities at the Connecticut Mental Health Center, New Haven. Dr. D’Souza reported receiving grants from AbbVie and Pfizer, and serves on the Connecticut Board of Physicians that advises the Commissioner of Consumer Protection about the Act Concerning the Palliative Use of Marijuana. Dr. Ranganathan reported receiving grants from Insys Therapeutics. Dr. D’Souza and Dr. Ranganathan made these remarks in an editorial accompanying Dr. Whiting’s report (JAMA 2015;313:2431-2).

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It is unclear why medical marijuana has averted the usual Food and Drug Administration approval process required of other medications.

Adequately powered, double-blind, randomized, placebo- or treatment-controlled clinical trials are critical to establish cannabinoids’ short- and long-term efficacy and safety. Yet they already qualify by state law for use in conditions as varied as hepatitis C, Crohn’s disease, Parkinson’s disease, psoriasis, sickle cell disease, and posttraumatic stress disorder.

In particular, the risks of repeated exposure to cannabinoids needs further study. Addiction, tolerance, and a distinct withdrawal syndrome have been documented, and there is also a small but definite risk of psychotic disorder.

Dr. Deepak Cyril D’Souza and Dr. Mohini Ranganathan are in the department of psychiatry at Yale University, New Haven; in the psychiatry service at Veterans Affairs Connecticut Healthcare System, West Haven; and at Abraham Ribicoff Research Facilities at the Connecticut Mental Health Center, New Haven. Dr. D’Souza reported receiving grants from AbbVie and Pfizer, and serves on the Connecticut Board of Physicians that advises the Commissioner of Consumer Protection about the Act Concerning the Palliative Use of Marijuana. Dr. Ranganathan reported receiving grants from Insys Therapeutics. Dr. D’Souza and Dr. Ranganathan made these remarks in an editorial accompanying Dr. Whiting’s report (JAMA 2015;313:2431-2).

Body

It is unclear why medical marijuana has averted the usual Food and Drug Administration approval process required of other medications.

Adequately powered, double-blind, randomized, placebo- or treatment-controlled clinical trials are critical to establish cannabinoids’ short- and long-term efficacy and safety. Yet they already qualify by state law for use in conditions as varied as hepatitis C, Crohn’s disease, Parkinson’s disease, psoriasis, sickle cell disease, and posttraumatic stress disorder.

In particular, the risks of repeated exposure to cannabinoids needs further study. Addiction, tolerance, and a distinct withdrawal syndrome have been documented, and there is also a small but definite risk of psychotic disorder.

Dr. Deepak Cyril D’Souza and Dr. Mohini Ranganathan are in the department of psychiatry at Yale University, New Haven; in the psychiatry service at Veterans Affairs Connecticut Healthcare System, West Haven; and at Abraham Ribicoff Research Facilities at the Connecticut Mental Health Center, New Haven. Dr. D’Souza reported receiving grants from AbbVie and Pfizer, and serves on the Connecticut Board of Physicians that advises the Commissioner of Consumer Protection about the Act Concerning the Palliative Use of Marijuana. Dr. Ranganathan reported receiving grants from Insys Therapeutics. Dr. D’Souza and Dr. Ranganathan made these remarks in an editorial accompanying Dr. Whiting’s report (JAMA 2015;313:2431-2).

Title
Dearth of high-quality research
Dearth of high-quality research

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.

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Key clinical point: Only moderate-quality evidence supports the use of medical cannabinoids, and only for two conditions.

Major finding: Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain and for spasticity due to multiple sclerosis or traumatic paraplegia.

Data source: A comprehensive review of the literature since 1975 and a meta-analysis of 79 clinical trials involving 6,462 participants.

Disclosures: This study was funded by the Swiss Federal Office of Public Health. Dr. Whiting and her associates reported having no relevant financial conflicts of interest.

Comparison of antiemetic efficacy and safety of palonosetron vs ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children

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Comparison of antiemetic efficacy and safety of palonosetron vs ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children

Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.

Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.

Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.

Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.

Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group. 

 

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Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.

Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.

Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.

Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.

Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group. 

 

Click on the PDF icon at the top of this introduction to read the full article.

Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.

Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.

Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.

Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.

Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group. 

 

Click on the PDF icon at the top of this introduction to read the full article.

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Comparison of antiemetic efficacy and safety of palonosetron vs ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children
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It is not your mother/father’s ASCO anymore…

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Well, what just happened in Chicago? Nearly 30,000 of our closest friends and colleagues descended on the windy city to meet in the McCormick Center to catch up on the latest data and updates in oncology at the American Society of Clinical Oncology's annual conference. What a marathon meeting it was. Who remembers when the meeting was held in one hotel (can you believe it), then two hotels, and then eventually shifted to convention centers to accommodate the burgeoning numbers of attendees? The program format is also quite different now than it was at the outset.
 
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Well, what just happened in Chicago? Nearly 30,000 of our closest friends and colleagues descended on the windy city to meet in the McCormick Center to catch up on the latest data and updates in oncology at the American Society of Clinical Oncology's annual conference. What a marathon meeting it was. Who remembers when the meeting was held in one hotel (can you believe it), then two hotels, and then eventually shifted to convention centers to accommodate the burgeoning numbers of attendees? The program format is also quite different now than it was at the outset.
 
Click on the PDF icon at the top of this introduction to read the full article.
 
Well, what just happened in Chicago? Nearly 30,000 of our closest friends and colleagues descended on the windy city to meet in the McCormick Center to catch up on the latest data and updates in oncology at the American Society of Clinical Oncology's annual conference. What a marathon meeting it was. Who remembers when the meeting was held in one hotel (can you believe it), then two hotels, and then eventually shifted to convention centers to accommodate the burgeoning numbers of attendees? The program format is also quite different now than it was at the outset.
 
Click on the PDF icon at the top of this introduction to read the full article.
 
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ICOO: Approach to opioids for cancer pain evolves

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ICOO: Approach to opioids for cancer pain evolves

BOSTON – Opioid abuse might be as much of a problem in patients with cancer pain as in those who need analgesia for another reason, according to palliative care physicians at the Dana Farber Cancer Institute who outlined their safeguards at the International Conference of Opioids.

“Let’s not lose sight of the fact that the very access to these medications, which can do so much good, is in jeopardy,” said Dr. Douglas E. Brandoff, a palliative-care attending physician at the cancer institute. In the current era of “unprecedented regulation and scrutiny,” Dr. Brandoff said, pain practices in cancer care must evolve “to keep up with the times.”

Evidence that opioid abuse among cancer patients rivals that of other patients prescribed those agents is limited but reasonably consistent, according to Dr. Brandoff. He cited several published studies, including a survey of hospices in which substance abuse and diversion were considered a problem in 38% (J. Palliat. Med. 2013;16:237-42) of patients.

“It’s a little disconcerting. This is hospice, right? This doesn’t happen in hospice, but unfortunately, it does,” Dr. Brandoff reported.

At the cancer institute, a multidisciplinary task force convened in 2013 has now produced numerous specific policies designed to protect patients and institutions from abuse of controlled pain medications. Those steps are not much different from those being increasingly employed in clinics for nonmalignant chronic pain, but they are applied uniformly in essentially every patient – not just those singled out for high risk.

One required step is the implementation of a prescription-monitoring program for every patient started on a narcotic drug in controlled substances schedule II or III, a benzodiazepine, or a department of public health scheduled IV or V controlled substance. Another is the use of a medication management agreement designed to educate patients about the benefits and risks of controlled substances and outline expectations. All patients and their clinicians are required to sign the agreement.

“If we have someone who is imminently dying within hours or days, then, no, I would not impose a management agreement expectation on them or myself,” said Dr. Brandoff, but he said that there are essentially no other exceptions.

The agreement, crafted with nonjudgmental language aimed at clarifying the goals of chronic pain relief, is entered into the medical record. It generally has been well accepted, according to Dr. Lida Nabati, also a palliative care attending physician at the cancer institute, Dr. Nabati, who participated with Dr. Brandoff in presenting the cancer institute’s safeguards, noted that patient resistance to the agreement often is a red flag for potential problems with abuse.

The movement to control opioid abuse in cancer patients is relatively new. At the time that the task force began, Dr. Nabati noted that few other institutions had formal policies in place even though others also were beginning to review their approach. As recently as 2014, a directive from the Department of Veterans Affairs for opioid therapy in chronic pain patients specifically excluded those with cancer, Dr. Nabati reported.

Yet, cancer “does not afford some magical protective effect” from the very same risk factors associated with opioid use in noncancer patients, such as anxiety, depression, or history of substance use, according to Dr. Brandoff. Rather, he suggested that the added stress of a cancer diagnosis could exacerbate those factors.

The implementation of strategies aimed at reducing the risk of opioid abuse in patients with chronic cancer pain is needed and timely, according to Dr. Mellar P. Davis, the co-chair of the 2015 ICOO meeting and director of the palliative medicine fellowship program, Taussig Cancer Institute, Cleveland Clinic.

In an interview, Dr. Davis applauded the types of strategies implemented at the cancer institute, which he believes protect the patient, the physician, and the institution. He believes that the patients might be the greatest beneficiaries when appropriate opioid use permits a gain in quality of life through effective but nondebilitating pain control.

Dr. Brandoff and Dr. Nabati reported having no financial disclosures.

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BOSTON – Opioid abuse might be as much of a problem in patients with cancer pain as in those who need analgesia for another reason, according to palliative care physicians at the Dana Farber Cancer Institute who outlined their safeguards at the International Conference of Opioids.

“Let’s not lose sight of the fact that the very access to these medications, which can do so much good, is in jeopardy,” said Dr. Douglas E. Brandoff, a palliative-care attending physician at the cancer institute. In the current era of “unprecedented regulation and scrutiny,” Dr. Brandoff said, pain practices in cancer care must evolve “to keep up with the times.”

Evidence that opioid abuse among cancer patients rivals that of other patients prescribed those agents is limited but reasonably consistent, according to Dr. Brandoff. He cited several published studies, including a survey of hospices in which substance abuse and diversion were considered a problem in 38% (J. Palliat. Med. 2013;16:237-42) of patients.

“It’s a little disconcerting. This is hospice, right? This doesn’t happen in hospice, but unfortunately, it does,” Dr. Brandoff reported.

At the cancer institute, a multidisciplinary task force convened in 2013 has now produced numerous specific policies designed to protect patients and institutions from abuse of controlled pain medications. Those steps are not much different from those being increasingly employed in clinics for nonmalignant chronic pain, but they are applied uniformly in essentially every patient – not just those singled out for high risk.

One required step is the implementation of a prescription-monitoring program for every patient started on a narcotic drug in controlled substances schedule II or III, a benzodiazepine, or a department of public health scheduled IV or V controlled substance. Another is the use of a medication management agreement designed to educate patients about the benefits and risks of controlled substances and outline expectations. All patients and their clinicians are required to sign the agreement.

“If we have someone who is imminently dying within hours or days, then, no, I would not impose a management agreement expectation on them or myself,” said Dr. Brandoff, but he said that there are essentially no other exceptions.

The agreement, crafted with nonjudgmental language aimed at clarifying the goals of chronic pain relief, is entered into the medical record. It generally has been well accepted, according to Dr. Lida Nabati, also a palliative care attending physician at the cancer institute, Dr. Nabati, who participated with Dr. Brandoff in presenting the cancer institute’s safeguards, noted that patient resistance to the agreement often is a red flag for potential problems with abuse.

The movement to control opioid abuse in cancer patients is relatively new. At the time that the task force began, Dr. Nabati noted that few other institutions had formal policies in place even though others also were beginning to review their approach. As recently as 2014, a directive from the Department of Veterans Affairs for opioid therapy in chronic pain patients specifically excluded those with cancer, Dr. Nabati reported.

Yet, cancer “does not afford some magical protective effect” from the very same risk factors associated with opioid use in noncancer patients, such as anxiety, depression, or history of substance use, according to Dr. Brandoff. Rather, he suggested that the added stress of a cancer diagnosis could exacerbate those factors.

The implementation of strategies aimed at reducing the risk of opioid abuse in patients with chronic cancer pain is needed and timely, according to Dr. Mellar P. Davis, the co-chair of the 2015 ICOO meeting and director of the palliative medicine fellowship program, Taussig Cancer Institute, Cleveland Clinic.

In an interview, Dr. Davis applauded the types of strategies implemented at the cancer institute, which he believes protect the patient, the physician, and the institution. He believes that the patients might be the greatest beneficiaries when appropriate opioid use permits a gain in quality of life through effective but nondebilitating pain control.

Dr. Brandoff and Dr. Nabati reported having no financial disclosures.

BOSTON – Opioid abuse might be as much of a problem in patients with cancer pain as in those who need analgesia for another reason, according to palliative care physicians at the Dana Farber Cancer Institute who outlined their safeguards at the International Conference of Opioids.

“Let’s not lose sight of the fact that the very access to these medications, which can do so much good, is in jeopardy,” said Dr. Douglas E. Brandoff, a palliative-care attending physician at the cancer institute. In the current era of “unprecedented regulation and scrutiny,” Dr. Brandoff said, pain practices in cancer care must evolve “to keep up with the times.”

Evidence that opioid abuse among cancer patients rivals that of other patients prescribed those agents is limited but reasonably consistent, according to Dr. Brandoff. He cited several published studies, including a survey of hospices in which substance abuse and diversion were considered a problem in 38% (J. Palliat. Med. 2013;16:237-42) of patients.

“It’s a little disconcerting. This is hospice, right? This doesn’t happen in hospice, but unfortunately, it does,” Dr. Brandoff reported.

At the cancer institute, a multidisciplinary task force convened in 2013 has now produced numerous specific policies designed to protect patients and institutions from abuse of controlled pain medications. Those steps are not much different from those being increasingly employed in clinics for nonmalignant chronic pain, but they are applied uniformly in essentially every patient – not just those singled out for high risk.

One required step is the implementation of a prescription-monitoring program for every patient started on a narcotic drug in controlled substances schedule II or III, a benzodiazepine, or a department of public health scheduled IV or V controlled substance. Another is the use of a medication management agreement designed to educate patients about the benefits and risks of controlled substances and outline expectations. All patients and their clinicians are required to sign the agreement.

“If we have someone who is imminently dying within hours or days, then, no, I would not impose a management agreement expectation on them or myself,” said Dr. Brandoff, but he said that there are essentially no other exceptions.

The agreement, crafted with nonjudgmental language aimed at clarifying the goals of chronic pain relief, is entered into the medical record. It generally has been well accepted, according to Dr. Lida Nabati, also a palliative care attending physician at the cancer institute, Dr. Nabati, who participated with Dr. Brandoff in presenting the cancer institute’s safeguards, noted that patient resistance to the agreement often is a red flag for potential problems with abuse.

The movement to control opioid abuse in cancer patients is relatively new. At the time that the task force began, Dr. Nabati noted that few other institutions had formal policies in place even though others also were beginning to review their approach. As recently as 2014, a directive from the Department of Veterans Affairs for opioid therapy in chronic pain patients specifically excluded those with cancer, Dr. Nabati reported.

Yet, cancer “does not afford some magical protective effect” from the very same risk factors associated with opioid use in noncancer patients, such as anxiety, depression, or history of substance use, according to Dr. Brandoff. Rather, he suggested that the added stress of a cancer diagnosis could exacerbate those factors.

The implementation of strategies aimed at reducing the risk of opioid abuse in patients with chronic cancer pain is needed and timely, according to Dr. Mellar P. Davis, the co-chair of the 2015 ICOO meeting and director of the palliative medicine fellowship program, Taussig Cancer Institute, Cleveland Clinic.

In an interview, Dr. Davis applauded the types of strategies implemented at the cancer institute, which he believes protect the patient, the physician, and the institution. He believes that the patients might be the greatest beneficiaries when appropriate opioid use permits a gain in quality of life through effective but nondebilitating pain control.

Dr. Brandoff and Dr. Nabati reported having no financial disclosures.

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EXPERT ANALYSIS AT THE INTERNATIONAL CONFERENCE ON OPIOIDS

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