Hematology Times

ALL patient

Photo by Bill Branson

New research suggests that body mass index (BMI) is an inadequate method for estimating changes in body fat and obesity in children with acute lymphoblastic leukemia (ALL).

Investigators found a discrepancy between BMI and body composition in this population, and the cause of this appeared to be increases in body fat with simultaneous loss of lean muscle mass during treatment.

The team reported these findings in Leukemia & Lymphoma.

With previous work, the investigators found that obese children diagnosed with high-risk ALL had a 50% greater risk of their disease recurring compared with children who were not obese.

“In my lab, we’ve seen a direct interaction between fat cells and leukemia cells that may help explain this increased risk of disease relapse,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles in California.

“It appears that the fat cells ‘protect’ leukemia cells, making them less susceptible to chemotherapy and making an accurate measure of body fat essential.”

To determine if BMI accurately reflects body fat in ALL, the investigators analyzed 50 patients. They were predominantly Hispanic, between the ages of 10 to 21, and had newly diagnosed high-risk B-precursor ALL or T-cell ALL.

The team measured the percentage of total body fat and lean muscle mass at the time of diagnosis, at the end of induction, and at the end of delayed intensification. They also calculated BMI Z-score—a measure of how a given child’s BMI deviates from a population of children of the same age and sex—at these time points.

The investigators said sarcopenic obesity—gain in body fat percentage with loss of lean muscle mass—was “surprisingly common” during ALL treatment.

And sarcopenic obesity resulted in poor correlation between changes in BMI Z-score and body fat percentage overall (r=-0.05), within the time points (r=0.02), and within patients (r=-0.09, all not significant). BMI Z-score and body fat percentage changed in opposite directions in more than 50% of interval assessments.

“We found that change in BMI did not reflect changes in body fat or obesity,” said Etan Orgel, MD, of Children’s Hospital Los Angeles.

“In some patients, reaching a ‘healthy’ BMI was due solely to loss of muscle even while body fat continued to rise. Based on these results, we believe that evaluation of obesity in patients with leukemia should include direct measures of body composition.”

ALL patient

Photo by Bill Branson

New research suggests that body mass index (BMI) is an inadequate method for estimating changes in body fat and obesity in children with acute lymphoblastic leukemia (ALL).

Investigators found a discrepancy between BMI and body composition in this population, and the cause of this appeared to be increases in body fat with simultaneous loss of lean muscle mass during treatment.

The team reported these findings in Leukemia & Lymphoma.

With previous work, the investigators found that obese children diagnosed with high-risk ALL had a 50% greater risk of their disease recurring compared with children who were not obese.

“In my lab, we’ve seen a direct interaction between fat cells and leukemia cells that may help explain this increased risk of disease relapse,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles in California.

“It appears that the fat cells ‘protect’ leukemia cells, making them less susceptible to chemotherapy and making an accurate measure of body fat essential.”

To determine if BMI accurately reflects body fat in ALL, the investigators analyzed 50 patients. They were predominantly Hispanic, between the ages of 10 to 21, and had newly diagnosed high-risk B-precursor ALL or T-cell ALL.

The team measured the percentage of total body fat and lean muscle mass at the time of diagnosis, at the end of induction, and at the end of delayed intensification. They also calculated BMI Z-score—a measure of how a given child’s BMI deviates from a population of children of the same age and sex—at these time points.

The investigators said sarcopenic obesity—gain in body fat percentage with loss of lean muscle mass—was “surprisingly common” during ALL treatment.

And sarcopenic obesity resulted in poor correlation between changes in BMI Z-score and body fat percentage overall (r=-0.05), within the time points (r=0.02), and within patients (r=-0.09, all not significant). BMI Z-score and body fat percentage changed in opposite directions in more than 50% of interval assessments.

“We found that change in BMI did not reflect changes in body fat or obesity,” said Etan Orgel, MD, of Children’s Hospital Los Angeles.

“In some patients, reaching a ‘healthy’ BMI was due solely to loss of muscle even while body fat continued to rise. Based on these results, we believe that evaluation of obesity in patients with leukemia should include direct measures of body composition.”

ALL patient

Photo by Bill Branson

New research suggests that body mass index (BMI) is an inadequate method for estimating changes in body fat and obesity in children with acute lymphoblastic leukemia (ALL).

Investigators found a discrepancy between BMI and body composition in this population, and the cause of this appeared to be increases in body fat with simultaneous loss of lean muscle mass during treatment.

The team reported these findings in Leukemia & Lymphoma.

With previous work, the investigators found that obese children diagnosed with high-risk ALL had a 50% greater risk of their disease recurring compared with children who were not obese.

“In my lab, we’ve seen a direct interaction between fat cells and leukemia cells that may help explain this increased risk of disease relapse,” said study author Steven Mittelman, MD, PhD, of Children’s Hospital Los Angeles in California.

“It appears that the fat cells ‘protect’ leukemia cells, making them less susceptible to chemotherapy and making an accurate measure of body fat essential.”

To determine if BMI accurately reflects body fat in ALL, the investigators analyzed 50 patients. They were predominantly Hispanic, between the ages of 10 to 21, and had newly diagnosed high-risk B-precursor ALL or T-cell ALL.

The team measured the percentage of total body fat and lean muscle mass at the time of diagnosis, at the end of induction, and at the end of delayed intensification. They also calculated BMI Z-score—a measure of how a given child’s BMI deviates from a population of children of the same age and sex—at these time points.

The investigators said sarcopenic obesity—gain in body fat percentage with loss of lean muscle mass—was “surprisingly common” during ALL treatment.

And sarcopenic obesity resulted in poor correlation between changes in BMI Z-score and body fat percentage overall (r=-0.05), within the time points (r=0.02), and within patients (r=-0.09, all not significant). BMI Z-score and body fat percentage changed in opposite directions in more than 50% of interval assessments.

“We found that change in BMI did not reflect changes in body fat or obesity,” said Etan Orgel, MD, of Children’s Hospital Los Angeles.

“In some patients, reaching a ‘healthy’ BMI was due solely to loss of muscle even while body fat continued to rise. Based on these results, we believe that evaluation of obesity in patients with leukemia should include direct measures of body composition.”

 

 

Doctor consulting with

a cancer patient

Photo courtesy of NCI/

Mathews Media Group

 

The National Institute for Health and Care Excellence (NICE) has issued a draft guideline for the diagnosis and management of non-Hodgkin lymphoma (NHL).

The guideline, which is open for consultation, covers adults and young people who are referred to secondary care with suspected NHL or who have newly diagnosed or relapsed NHL.

It contains recommendations for the management of 6 different NHL subtypes—diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, MALT lymphoma, Burkitt lymphoma, and peripheral T-cell lymphoma.

The guideline considers which method of biopsy is most appropriate, which diagnostic test most suitable, how the stage of disease is best assessed, and what treatment is likely to be most effective.

It also proposes recommendations for how best to support patients who complete their treatment. These include the provision of end-of-treatment summaries to be discussed with the patient and an increase in education on the possible relapse/late side-effects of their treatment.

“This draft guideline is now open for consultation,” said Mark Baker, director of the Centre of Clinical Practice at NICE.

“We want to hear from patients and all those who provide care for people with non-Hodgkin’s lymphoma in the NHS [National Health Service] so that we can produce a guideline which will support everyone who diagnoses, treats, and has to live with this disease.”

The consultation closes on March 11, 2016, with the final guideline expected in the summer.

 

 

Doctor consulting with

a cancer patient

Photo courtesy of NCI/

Mathews Media Group

 

The National Institute for Health and Care Excellence (NICE) has issued a draft guideline for the diagnosis and management of non-Hodgkin lymphoma (NHL).

The guideline, which is open for consultation, covers adults and young people who are referred to secondary care with suspected NHL or who have newly diagnosed or relapsed NHL.

It contains recommendations for the management of 6 different NHL subtypes—diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, MALT lymphoma, Burkitt lymphoma, and peripheral T-cell lymphoma.

The guideline considers which method of biopsy is most appropriate, which diagnostic test most suitable, how the stage of disease is best assessed, and what treatment is likely to be most effective.

It also proposes recommendations for how best to support patients who complete their treatment. These include the provision of end-of-treatment summaries to be discussed with the patient and an increase in education on the possible relapse/late side-effects of their treatment.

“This draft guideline is now open for consultation,” said Mark Baker, director of the Centre of Clinical Practice at NICE.

“We want to hear from patients and all those who provide care for people with non-Hodgkin’s lymphoma in the NHS [National Health Service] so that we can produce a guideline which will support everyone who diagnoses, treats, and has to live with this disease.”

The consultation closes on March 11, 2016, with the final guideline expected in the summer.

 

 

Doctor consulting with

a cancer patient

Photo courtesy of NCI/

Mathews Media Group

 

The National Institute for Health and Care Excellence (NICE) has issued a draft guideline for the diagnosis and management of non-Hodgkin lymphoma (NHL).

The guideline, which is open for consultation, covers adults and young people who are referred to secondary care with suspected NHL or who have newly diagnosed or relapsed NHL.

It contains recommendations for the management of 6 different NHL subtypes—diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, MALT lymphoma, Burkitt lymphoma, and peripheral T-cell lymphoma.

The guideline considers which method of biopsy is most appropriate, which diagnostic test most suitable, how the stage of disease is best assessed, and what treatment is likely to be most effective.

It also proposes recommendations for how best to support patients who complete their treatment. These include the provision of end-of-treatment summaries to be discussed with the patient and an increase in education on the possible relapse/late side-effects of their treatment.

“This draft guideline is now open for consultation,” said Mark Baker, director of the Centre of Clinical Practice at NICE.

“We want to hear from patients and all those who provide care for people with non-Hodgkin’s lymphoma in the NHS [National Health Service] so that we can produce a guideline which will support everyone who diagnoses, treats, and has to live with this disease.”

The consultation closes on March 11, 2016, with the final guideline expected in the summer.

Elotuzumab (Empliciti)

Photo courtesy of

Bristol-Myers Squibb

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the immunostimulatory antibody elotuzumab (Empliciti).

The CHMP is recommending the drug be approved for use in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission, which usually follows the CHMP’s advice and is expected to deliver its final decision on elotuzumab within 3 months.

The CHMP’s positive opinion of elotuzumab is based on data from the phase 3 ELOQUENT-2 trial, which were presented at ASCO 2015 and published in NEJM.

The trial included 646 MM patients who had received 1 to 3 prior therapies. Baseline patient demographics and disease characteristics were well balanced between treatment arms.

Patients were randomized 1:1 to receive either elotuzumab at 10 mg/kg in combination with lenalidomide and dexamethasone (len-dex) or len-dex alone in 4-week cycles until disease progression or unacceptable toxicity.

The minimum follow-up for all study subjects was 24 months. The co-primary endpoints were progression-free survival (PFS) and overall response rate.

The overall response rate was 78.5% in the elotuzumab arm and 65.5% in the len-dex arm (P=0.0002).

The median PFS was 19.4 months in the elotuzumab arm and 14.9 months in the len-dex arm (P=0.0004). At 1 year, the PFS was 68% in the elotuzumab arm and 57% in the len-dex arm. At 2 years, the PFS was 41% and 27%, respectively.

The most common adverse events in the elotuzumab arm and len-dex arm, respectively, were fatigue (61.6% vs 51.7%), diarrhea (46.9% vs 36.0%), pyrexia (37.4% vs 24.6%), constipation (35.5% vs 27.1%), cough (34.3% vs 18.9%), peripheral neuropathy (26.7% vs 20.8%), nasopharyngitis (24.5% vs 19.2%), upper respiratory tract infection (22.6% vs 17.4%), decreased appetite (20.8% vs 12.6%), and pneumonia (20.1% vs 14.2%).

Serious adverse events occurred in 65.4% of patients in the elotuzumab arm and 56.5% in the len-dex arm. The most frequent events were pneumonia, pyrexia, respiratory tract infection, anemia, pulmonary embolism, and acute renal failure.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab as Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

Elotuzumab (Empliciti)

Photo courtesy of

Bristol-Myers Squibb

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the immunostimulatory antibody elotuzumab (Empliciti).

The CHMP is recommending the drug be approved for use in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission, which usually follows the CHMP’s advice and is expected to deliver its final decision on elotuzumab within 3 months.

The CHMP’s positive opinion of elotuzumab is based on data from the phase 3 ELOQUENT-2 trial, which were presented at ASCO 2015 and published in NEJM.

The trial included 646 MM patients who had received 1 to 3 prior therapies. Baseline patient demographics and disease characteristics were well balanced between treatment arms.

Patients were randomized 1:1 to receive either elotuzumab at 10 mg/kg in combination with lenalidomide and dexamethasone (len-dex) or len-dex alone in 4-week cycles until disease progression or unacceptable toxicity.

The minimum follow-up for all study subjects was 24 months. The co-primary endpoints were progression-free survival (PFS) and overall response rate.

The overall response rate was 78.5% in the elotuzumab arm and 65.5% in the len-dex arm (P=0.0002).

The median PFS was 19.4 months in the elotuzumab arm and 14.9 months in the len-dex arm (P=0.0004). At 1 year, the PFS was 68% in the elotuzumab arm and 57% in the len-dex arm. At 2 years, the PFS was 41% and 27%, respectively.

The most common adverse events in the elotuzumab arm and len-dex arm, respectively, were fatigue (61.6% vs 51.7%), diarrhea (46.9% vs 36.0%), pyrexia (37.4% vs 24.6%), constipation (35.5% vs 27.1%), cough (34.3% vs 18.9%), peripheral neuropathy (26.7% vs 20.8%), nasopharyngitis (24.5% vs 19.2%), upper respiratory tract infection (22.6% vs 17.4%), decreased appetite (20.8% vs 12.6%), and pneumonia (20.1% vs 14.2%).

Serious adverse events occurred in 65.4% of patients in the elotuzumab arm and 56.5% in the len-dex arm. The most frequent events were pneumonia, pyrexia, respiratory tract infection, anemia, pulmonary embolism, and acute renal failure.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab as Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

Elotuzumab (Empliciti)

Photo courtesy of

Bristol-Myers Squibb

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the immunostimulatory antibody elotuzumab (Empliciti).

The CHMP is recommending the drug be approved for use in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma (MM) who have received at least 1 prior therapy.

The CHMP’s recommendation will be reviewed by the European Commission, which usually follows the CHMP’s advice and is expected to deliver its final decision on elotuzumab within 3 months.

The CHMP’s positive opinion of elotuzumab is based on data from the phase 3 ELOQUENT-2 trial, which were presented at ASCO 2015 and published in NEJM.

The trial included 646 MM patients who had received 1 to 3 prior therapies. Baseline patient demographics and disease characteristics were well balanced between treatment arms.

Patients were randomized 1:1 to receive either elotuzumab at 10 mg/kg in combination with lenalidomide and dexamethasone (len-dex) or len-dex alone in 4-week cycles until disease progression or unacceptable toxicity.

The minimum follow-up for all study subjects was 24 months. The co-primary endpoints were progression-free survival (PFS) and overall response rate.

The overall response rate was 78.5% in the elotuzumab arm and 65.5% in the len-dex arm (P=0.0002).

The median PFS was 19.4 months in the elotuzumab arm and 14.9 months in the len-dex arm (P=0.0004). At 1 year, the PFS was 68% in the elotuzumab arm and 57% in the len-dex arm. At 2 years, the PFS was 41% and 27%, respectively.

The most common adverse events in the elotuzumab arm and len-dex arm, respectively, were fatigue (61.6% vs 51.7%), diarrhea (46.9% vs 36.0%), pyrexia (37.4% vs 24.6%), constipation (35.5% vs 27.1%), cough (34.3% vs 18.9%), peripheral neuropathy (26.7% vs 20.8%), nasopharyngitis (24.5% vs 19.2%), upper respiratory tract infection (22.6% vs 17.4%), decreased appetite (20.8% vs 12.6%), and pneumonia (20.1% vs 14.2%).

Serious adverse events occurred in 65.4% of patients in the elotuzumab arm and 56.5% in the len-dex arm. The most frequent events were pneumonia, pyrexia, respiratory tract infection, anemia, pulmonary embolism, and acute renal failure.

Bristol-Myers Squibb and AbbVie are co-developing elotuzumab as Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

The blood-draw device

Photo courtesy of

Velano Vascular

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new iteration of a needle-free blood-draw device produced by Velano Vascular.

The device was originally cleared by the FDA last year.

It resembles a common syringe and allows peripheral intravenous catheters to be repurposed to draw blood from patients.

The goal of this is to reduce the need for additional needle sticks among patients receiving medications and hydration via intravenous delivery.

The new clearance for the blood-draw device covers a pair of modifications aimed at inpatient blood draws.

The first modification is a clamp for use with syringe draws. And the second is a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral intravenous catheters.

“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” said Eric Stone, co-founder & CEO of Velano Vascular.

Velano Vascular said it is working closely with clinical and non-profit partners, including Brigham and Women’s Hospital, Intermountain Healthcare, Griffin Health, The University of Pennsylvania Health System, The Children’s Hospital of Philadelphia, Children’s National Hospital, and Planetree, to capture patient and practitioner input regarding today’s approaches to inpatient blood draws and how the Velano technology could eventually become a standard of care.

The blood-draw device

Photo courtesy of

Velano Vascular

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new iteration of a needle-free blood-draw device produced by Velano Vascular.

The device was originally cleared by the FDA last year.

It resembles a common syringe and allows peripheral intravenous catheters to be repurposed to draw blood from patients.

The goal of this is to reduce the need for additional needle sticks among patients receiving medications and hydration via intravenous delivery.

The new clearance for the blood-draw device covers a pair of modifications aimed at inpatient blood draws.

The first modification is a clamp for use with syringe draws. And the second is a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral intravenous catheters.

“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” said Eric Stone, co-founder & CEO of Velano Vascular.

Velano Vascular said it is working closely with clinical and non-profit partners, including Brigham and Women’s Hospital, Intermountain Healthcare, Griffin Health, The University of Pennsylvania Health System, The Children’s Hospital of Philadelphia, Children’s National Hospital, and Planetree, to capture patient and practitioner input regarding today’s approaches to inpatient blood draws and how the Velano technology could eventually become a standard of care.

The blood-draw device

Photo courtesy of

Velano Vascular

The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new iteration of a needle-free blood-draw device produced by Velano Vascular.

The device was originally cleared by the FDA last year.

It resembles a common syringe and allows peripheral intravenous catheters to be repurposed to draw blood from patients.

The goal of this is to reduce the need for additional needle sticks among patients receiving medications and hydration via intravenous delivery.

The new clearance for the blood-draw device covers a pair of modifications aimed at inpatient blood draws.

The first modification is a clamp for use with syringe draws. And the second is a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral intravenous catheters.

“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” said Eric Stone, co-founder & CEO of Velano Vascular.

Velano Vascular said it is working closely with clinical and non-profit partners, including Brigham and Women’s Hospital, Intermountain Healthcare, Griffin Health, The University of Pennsylvania Health System, The Children’s Hospital of Philadelphia, Children’s National Hospital, and Planetree, to capture patient and practitioner input regarding today’s approaches to inpatient blood draws and how the Velano technology could eventually become a standard of care.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

New research suggests that people living in the Appalachian region of the US are more likely to develop cancer than people in the rest of the country.

The study showed that Appalachians had a significantly higher incidence of cancer overall and higher rates of many solid tumor malignancies.

However, lymphoma rates were similar between Appalachians and non-Appalachians, and Appalachians had a significantly lower rate of myeloma.

This research was published in Cancer Epidemiology, Biomarkers & Prevention.

“The Appalachian region, which extends from parts of New York to Mississippi, spans 420 counties in 13 US states, and about 25 million people reside in this area,” said study author Reda Wilson, MPH, of the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.

“This region is primarily made up of rural areas, with persistent poverty levels that are at least 20%, which is higher than the national average.”

In 2007, the CDC’s National Program of Cancer Registries (NPCR) published a comprehensive evaluation of cancer incidence rates in Appalachia between 2001 and 2003.

The data showed higher cancer rates in Appalachia than in the rest of the US. However, this publication had some shortcomings, including data that were not available for analysis.

“The current analyses reported here were performed to update the earlier evaluation by expanding the diagnosis years from 2004 to 2011 and including data on 100% of the Appalachian and non-Appalachian populations,” Wilson said.

For this study, Wilson and her colleagues used data from the NPCR and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program. Together, NPCR and SEER cover 100% of the US population.

The researchers analyzed the Appalachian population by region (north, central, and south Appalachia), gender, race (black and white only), and Appalachian Regional Commission-designated economic status (distressed, at-risk, transitional, competitive, and attainment). And the team compared these data with data on the non-Appalachian population.

The results showed that cancer incidence rates (IRs) were elevated among Appalachians regardless of how they were categorized. The IRs were per 100,000 people, age-adjusted to the 2000 US standard population.

The IR for all cancers was 565.8 for males in Appalachia and 543.0 for non-Appalachian males (P<0.05). And the cancer IRs for females were 428.7 in Appalachia and 418.2 outside the region (P<0.05).

There was no significant difference between the regions in IRs for lymphomas. The Hodgkin lymphoma IRs were 3.1 in Appalachian males, 3.2 in non-Appalachian males, and 2.5 for females in both regions.

The non-Hodgkin lymphoma IRs were 23.3 in Appalachian males, 23.4 in non-Appalachian males, 16.4 in Appalachian females, and 16.3 in non-Appalachian females.

Myeloma IRs were significantly lower in Appalachia (P<0.05). The myeloma IRs were 7.3 in Appalachian males, 7.5 in non-Appalachian males, 4.7 in Appalachian females, and 4.9 in non-Appalachian females.

There was no significant difference in leukemia IRs among males, but females in Appalachia had a significantly higher leukemia IR (P<0.05). The leukemia IRs were 16.9 in Appalachian males, 16.7 in non-Appalachian males, 10.4 in Appalachian females, and 10.2 in non-Appalachian females.

“Appalachia continues to have higher cancer incidence rates than the rest of the country,” Wilson said. “But a promising finding is that we’re seeing the gap narrow in the incidence rates between Appalachia and non-Appalachia since the 2007 analysis, with the exception of cancers of the oral cavity and pharynx, larynx, lung and bronchus, and thyroid.”

“This study helps identify types of cancer in the Appalachian region that could be reduced through more evidence-based screening and detection. Our study also emphasizes the importance of lifestyle changes needed to prevent and reduce cancer burden.”

The researchers noted that this study did not differentiate urban versus rural areas within each county, and data on screening and risk factors were based on self-reported responses.

Furthermore, cancer IRs were calculated for all ages combined and were not evaluated by age groups. Future analyses will be targeted toward capturing these finer details, Wilson said.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

New research suggests that people living in the Appalachian region of the US are more likely to develop cancer than people in the rest of the country.

The study showed that Appalachians had a significantly higher incidence of cancer overall and higher rates of many solid tumor malignancies.

However, lymphoma rates were similar between Appalachians and non-Appalachians, and Appalachians had a significantly lower rate of myeloma.

This research was published in Cancer Epidemiology, Biomarkers & Prevention.

“The Appalachian region, which extends from parts of New York to Mississippi, spans 420 counties in 13 US states, and about 25 million people reside in this area,” said study author Reda Wilson, MPH, of the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.

“This region is primarily made up of rural areas, with persistent poverty levels that are at least 20%, which is higher than the national average.”

In 2007, the CDC’s National Program of Cancer Registries (NPCR) published a comprehensive evaluation of cancer incidence rates in Appalachia between 2001 and 2003.

The data showed higher cancer rates in Appalachia than in the rest of the US. However, this publication had some shortcomings, including data that were not available for analysis.

“The current analyses reported here were performed to update the earlier evaluation by expanding the diagnosis years from 2004 to 2011 and including data on 100% of the Appalachian and non-Appalachian populations,” Wilson said.

For this study, Wilson and her colleagues used data from the NPCR and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program. Together, NPCR and SEER cover 100% of the US population.

The researchers analyzed the Appalachian population by region (north, central, and south Appalachia), gender, race (black and white only), and Appalachian Regional Commission-designated economic status (distressed, at-risk, transitional, competitive, and attainment). And the team compared these data with data on the non-Appalachian population.

The results showed that cancer incidence rates (IRs) were elevated among Appalachians regardless of how they were categorized. The IRs were per 100,000 people, age-adjusted to the 2000 US standard population.

The IR for all cancers was 565.8 for males in Appalachia and 543.0 for non-Appalachian males (P<0.05). And the cancer IRs for females were 428.7 in Appalachia and 418.2 outside the region (P<0.05).

There was no significant difference between the regions in IRs for lymphomas. The Hodgkin lymphoma IRs were 3.1 in Appalachian males, 3.2 in non-Appalachian males, and 2.5 for females in both regions.

The non-Hodgkin lymphoma IRs were 23.3 in Appalachian males, 23.4 in non-Appalachian males, 16.4 in Appalachian females, and 16.3 in non-Appalachian females.

Myeloma IRs were significantly lower in Appalachia (P<0.05). The myeloma IRs were 7.3 in Appalachian males, 7.5 in non-Appalachian males, 4.7 in Appalachian females, and 4.9 in non-Appalachian females.

There was no significant difference in leukemia IRs among males, but females in Appalachia had a significantly higher leukemia IR (P<0.05). The leukemia IRs were 16.9 in Appalachian males, 16.7 in non-Appalachian males, 10.4 in Appalachian females, and 10.2 in non-Appalachian females.

“Appalachia continues to have higher cancer incidence rates than the rest of the country,” Wilson said. “But a promising finding is that we’re seeing the gap narrow in the incidence rates between Appalachia and non-Appalachia since the 2007 analysis, with the exception of cancers of the oral cavity and pharynx, larynx, lung and bronchus, and thyroid.”

“This study helps identify types of cancer in the Appalachian region that could be reduced through more evidence-based screening and detection. Our study also emphasizes the importance of lifestyle changes needed to prevent and reduce cancer burden.”

The researchers noted that this study did not differentiate urban versus rural areas within each county, and data on screening and risk factors were based on self-reported responses.

Furthermore, cancer IRs were calculated for all ages combined and were not evaluated by age groups. Future analyses will be targeted toward capturing these finer details, Wilson said.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

New research suggests that people living in the Appalachian region of the US are more likely to develop cancer than people in the rest of the country.

The study showed that Appalachians had a significantly higher incidence of cancer overall and higher rates of many solid tumor malignancies.

However, lymphoma rates were similar between Appalachians and non-Appalachians, and Appalachians had a significantly lower rate of myeloma.

This research was published in Cancer Epidemiology, Biomarkers & Prevention.

“The Appalachian region, which extends from parts of New York to Mississippi, spans 420 counties in 13 US states, and about 25 million people reside in this area,” said study author Reda Wilson, MPH, of the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.

“This region is primarily made up of rural areas, with persistent poverty levels that are at least 20%, which is higher than the national average.”

In 2007, the CDC’s National Program of Cancer Registries (NPCR) published a comprehensive evaluation of cancer incidence rates in Appalachia between 2001 and 2003.

The data showed higher cancer rates in Appalachia than in the rest of the US. However, this publication had some shortcomings, including data that were not available for analysis.

“The current analyses reported here were performed to update the earlier evaluation by expanding the diagnosis years from 2004 to 2011 and including data on 100% of the Appalachian and non-Appalachian populations,” Wilson said.

For this study, Wilson and her colleagues used data from the NPCR and the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program. Together, NPCR and SEER cover 100% of the US population.

The researchers analyzed the Appalachian population by region (north, central, and south Appalachia), gender, race (black and white only), and Appalachian Regional Commission-designated economic status (distressed, at-risk, transitional, competitive, and attainment). And the team compared these data with data on the non-Appalachian population.

The results showed that cancer incidence rates (IRs) were elevated among Appalachians regardless of how they were categorized. The IRs were per 100,000 people, age-adjusted to the 2000 US standard population.

The IR for all cancers was 565.8 for males in Appalachia and 543.0 for non-Appalachian males (P<0.05). And the cancer IRs for females were 428.7 in Appalachia and 418.2 outside the region (P<0.05).

There was no significant difference between the regions in IRs for lymphomas. The Hodgkin lymphoma IRs were 3.1 in Appalachian males, 3.2 in non-Appalachian males, and 2.5 for females in both regions.

The non-Hodgkin lymphoma IRs were 23.3 in Appalachian males, 23.4 in non-Appalachian males, 16.4 in Appalachian females, and 16.3 in non-Appalachian females.

Myeloma IRs were significantly lower in Appalachia (P<0.05). The myeloma IRs were 7.3 in Appalachian males, 7.5 in non-Appalachian males, 4.7 in Appalachian females, and 4.9 in non-Appalachian females.

There was no significant difference in leukemia IRs among males, but females in Appalachia had a significantly higher leukemia IR (P<0.05). The leukemia IRs were 16.9 in Appalachian males, 16.7 in non-Appalachian males, 10.4 in Appalachian females, and 10.2 in non-Appalachian females.

“Appalachia continues to have higher cancer incidence rates than the rest of the country,” Wilson said. “But a promising finding is that we’re seeing the gap narrow in the incidence rates between Appalachia and non-Appalachia since the 2007 analysis, with the exception of cancers of the oral cavity and pharynx, larynx, lung and bronchus, and thyroid.”

“This study helps identify types of cancer in the Appalachian region that could be reduced through more evidence-based screening and detection. Our study also emphasizes the importance of lifestyle changes needed to prevent and reduce cancer burden.”

The researchers noted that this study did not differentiate urban versus rural areas within each county, and data on screening and risk factors were based on self-reported responses.

Furthermore, cancer IRs were calculated for all ages combined and were not evaluated by age groups. Future analyses will be targeted toward capturing these finer details, Wilson said.

Panobinostat (Farydak)

Photo courtesy of Novartis

The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending panobinostat (Farydak) be made available on the National Health Service.

In the European Union, panobinostat is approved for use in combination with bortezomib and dexamethasone to treat adults with relapsed and/or refractory multiple myeloma who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent.

NICE’s recommendation of panobinostat is contingent upon the drug being provided with the discount agreed upon in the patient access scheme.

NICE previously issued a guidance in which it did not recommend panobinostat, but the drug’s manufacturer, Novartis, submitted a revised economic analysis that allowed NICE to recommend the drug.

Novartis has agreed to a patient access scheme with the Department of Health. This scheme provides a discount to the list price of panobinostat, with the discount applied at the point of purchase or invoice.

The level of the discount is commercial in confidence, but the Department of Health said this patient access scheme does not constitute an excessive administrative burden on the National Health Service.

Panobinostat costs £776 per 20 mg tablet. The recommended starting dose is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Patients should receive panobinostat for 8 cycles. If they show clinical benefit, they should continue the treatment for 4 additional cycles of 6 weeks each. 

Panobinostat (Farydak)

Photo courtesy of Novartis

The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending panobinostat (Farydak) be made available on the National Health Service.

In the European Union, panobinostat is approved for use in combination with bortezomib and dexamethasone to treat adults with relapsed and/or refractory multiple myeloma who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent.

NICE’s recommendation of panobinostat is contingent upon the drug being provided with the discount agreed upon in the patient access scheme.

NICE previously issued a guidance in which it did not recommend panobinostat, but the drug’s manufacturer, Novartis, submitted a revised economic analysis that allowed NICE to recommend the drug.

Novartis has agreed to a patient access scheme with the Department of Health. This scheme provides a discount to the list price of panobinostat, with the discount applied at the point of purchase or invoice.

The level of the discount is commercial in confidence, but the Department of Health said this patient access scheme does not constitute an excessive administrative burden on the National Health Service.

Panobinostat costs £776 per 20 mg tablet. The recommended starting dose is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Patients should receive panobinostat for 8 cycles. If they show clinical benefit, they should continue the treatment for 4 additional cycles of 6 weeks each. 

Panobinostat (Farydak)

Photo courtesy of Novartis

The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending panobinostat (Farydak) be made available on the National Health Service.

In the European Union, panobinostat is approved for use in combination with bortezomib and dexamethasone to treat adults with relapsed and/or refractory multiple myeloma who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent.

NICE’s recommendation of panobinostat is contingent upon the drug being provided with the discount agreed upon in the patient access scheme.

NICE previously issued a guidance in which it did not recommend panobinostat, but the drug’s manufacturer, Novartis, submitted a revised economic analysis that allowed NICE to recommend the drug.

Novartis has agreed to a patient access scheme with the Department of Health. This scheme provides a discount to the list price of panobinostat, with the discount applied at the point of purchase or invoice.

The level of the discount is commercial in confidence, but the Department of Health said this patient access scheme does not constitute an excessive administrative burden on the National Health Service.

Panobinostat costs £776 per 20 mg tablet. The recommended starting dose is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Patients should receive panobinostat for 8 cycles. If they show clinical benefit, they should continue the treatment for 4 additional cycles of 6 weeks each.