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Photo by Esther Dyson

The American Society of Clinical Oncology (ASCO) has issued a policy statement addressing financial barriers to patient participation in cancer clinical trials.

ASCO’s policy statement outlines a series of recommendations designed to address multiple financial barriers that impede access to clinical trials, including patient costs that aren’t covered consistently by health insurance; a lack of information provided to patients about clinical trial costs; and limited available research data on financial hardships related to participation in clinical trials.

“Clinical trials are essential for evaluating the safety and efficacy of new cancer treatments, but cancer researchers have seen consistently low patient participation levels—especially among underserved patient populations—in part, due to the financial burdens facing many patients with cancer,” said ASCO President Monica M. Bertagnolli, MD.

“Addressing financial barriers will help improve the enrollment rate and the efficiency, quality, and applicability of cancer research. By including more—and more diverse—participants in our research studies, we expand our ability to care for all patients.”

The recommendations in ASCO’s policy statement include:

1. Improve payer clinical trial coverage policies. Payment policies should be revised to be made consistent, streamlined, and transparent to all stakeholders.

   1. Payers should have clear definitions of “routine costs.”
   2. Payers should streamline prior authorization processes and facilitate trial enrollment through provider reimbursement of clinical trial-related services.
   3. State Medicaid programs should universally guarantee coverage of routine care costs of clinical trials for their beneficiaries.
   4. The U.S. Centers for Medicare & Medicaid Services (CMS) should revise current policy that requires Medicare Advantage beneficiaries to revert to fee-for-service coverage during clinical trials.
   5. CMS’s Innovation Center should explore the effectiveness of alternative payment models in support of clinical trial accrual.

2. During the clinical trials development and enrollment process, provide patients with clear, transparent information about potential trial-related out-of-pocket costs and include mechanisms to support patient financial/health literacy.

   1. Clinical trial sponsors should perform—and make available to enrolling institutions—comprehensive, prospective coverage analyses.
   2. Research sites should consider offering in-house financial navigation/counseling to patients or consider partnering with organizations that provide such services.
   3. Design clinical trials to minimize incremental costs, consistent with scientific objectives and participant safety.

3. Remove impediments to ethically appropriate financial compensation for trial-related out-of-pocket costs. Provision of such financial support should not be considered undue inducement.

   1. Office for Human Research Protections should develop guidance on targeted financial support.

4. Incentivize research that will better characterize patient costs incurred for participating in cancer clinical trials and support the longer-term development of tools to identify and mitigate the risk of trial-associated financial hardship.

“Continued progress against cancer depends on improving patient access to participation in clinical research,” Dr. Bertagnolli said.

“The recommendations in ASCO’s statement aim to ensure that no patient is denied access to a clinical trial for financial reasons and that patients are not harmed financially because of their contributions to advancing science. Ultimately, this is about strengthening the nation’s cancer research enterprise as a whole.”

Photo by Esther Dyson

The American Society of Clinical Oncology (ASCO) has issued a policy statement addressing financial barriers to patient participation in cancer clinical trials.

ASCO’s policy statement outlines a series of recommendations designed to address multiple financial barriers that impede access to clinical trials, including patient costs that aren’t covered consistently by health insurance; a lack of information provided to patients about clinical trial costs; and limited available research data on financial hardships related to participation in clinical trials.

“Clinical trials are essential for evaluating the safety and efficacy of new cancer treatments, but cancer researchers have seen consistently low patient participation levels—especially among underserved patient populations—in part, due to the financial burdens facing many patients with cancer,” said ASCO President Monica M. Bertagnolli, MD.

“Addressing financial barriers will help improve the enrollment rate and the efficiency, quality, and applicability of cancer research. By including more—and more diverse—participants in our research studies, we expand our ability to care for all patients.”

The recommendations in ASCO’s policy statement include:

1. Improve payer clinical trial coverage policies. Payment policies should be revised to be made consistent, streamlined, and transparent to all stakeholders.

   1. Payers should have clear definitions of “routine costs.”
   2. Payers should streamline prior authorization processes and facilitate trial enrollment through provider reimbursement of clinical trial-related services.
   3. State Medicaid programs should universally guarantee coverage of routine care costs of clinical trials for their beneficiaries.
   4. The U.S. Centers for Medicare & Medicaid Services (CMS) should revise current policy that requires Medicare Advantage beneficiaries to revert to fee-for-service coverage during clinical trials.
   5. CMS’s Innovation Center should explore the effectiveness of alternative payment models in support of clinical trial accrual.

2. During the clinical trials development and enrollment process, provide patients with clear, transparent information about potential trial-related out-of-pocket costs and include mechanisms to support patient financial/health literacy.

   1. Clinical trial sponsors should perform—and make available to enrolling institutions—comprehensive, prospective coverage analyses.
   2. Research sites should consider offering in-house financial navigation/counseling to patients or consider partnering with organizations that provide such services.
   3. Design clinical trials to minimize incremental costs, consistent with scientific objectives and participant safety.

3. Remove impediments to ethically appropriate financial compensation for trial-related out-of-pocket costs. Provision of such financial support should not be considered undue inducement.

   1. Office for Human Research Protections should develop guidance on targeted financial support.

4. Incentivize research that will better characterize patient costs incurred for participating in cancer clinical trials and support the longer-term development of tools to identify and mitigate the risk of trial-associated financial hardship.

“Continued progress against cancer depends on improving patient access to participation in clinical research,” Dr. Bertagnolli said.

“The recommendations in ASCO’s statement aim to ensure that no patient is denied access to a clinical trial for financial reasons and that patients are not harmed financially because of their contributions to advancing science. Ultimately, this is about strengthening the nation’s cancer research enterprise as a whole.”

Photo by Esther Dyson

The American Society of Clinical Oncology (ASCO) has issued a policy statement addressing financial barriers to patient participation in cancer clinical trials.

ASCO’s policy statement outlines a series of recommendations designed to address multiple financial barriers that impede access to clinical trials, including patient costs that aren’t covered consistently by health insurance; a lack of information provided to patients about clinical trial costs; and limited available research data on financial hardships related to participation in clinical trials.

“Clinical trials are essential for evaluating the safety and efficacy of new cancer treatments, but cancer researchers have seen consistently low patient participation levels—especially among underserved patient populations—in part, due to the financial burdens facing many patients with cancer,” said ASCO President Monica M. Bertagnolli, MD.

“Addressing financial barriers will help improve the enrollment rate and the efficiency, quality, and applicability of cancer research. By including more—and more diverse—participants in our research studies, we expand our ability to care for all patients.”

The recommendations in ASCO’s policy statement include:

1. Improve payer clinical trial coverage policies. Payment policies should be revised to be made consistent, streamlined, and transparent to all stakeholders.

   1. Payers should have clear definitions of “routine costs.”
   2. Payers should streamline prior authorization processes and facilitate trial enrollment through provider reimbursement of clinical trial-related services.
   3. State Medicaid programs should universally guarantee coverage of routine care costs of clinical trials for their beneficiaries.
   4. The U.S. Centers for Medicare & Medicaid Services (CMS) should revise current policy that requires Medicare Advantage beneficiaries to revert to fee-for-service coverage during clinical trials.
   5. CMS’s Innovation Center should explore the effectiveness of alternative payment models in support of clinical trial accrual.

2. During the clinical trials development and enrollment process, provide patients with clear, transparent information about potential trial-related out-of-pocket costs and include mechanisms to support patient financial/health literacy.

   1. Clinical trial sponsors should perform—and make available to enrolling institutions—comprehensive, prospective coverage analyses.
   2. Research sites should consider offering in-house financial navigation/counseling to patients or consider partnering with organizations that provide such services.
   3. Design clinical trials to minimize incremental costs, consistent with scientific objectives and participant safety.

3. Remove impediments to ethically appropriate financial compensation for trial-related out-of-pocket costs. Provision of such financial support should not be considered undue inducement.

   1. Office for Human Research Protections should develop guidance on targeted financial support.

4. Incentivize research that will better characterize patient costs incurred for participating in cancer clinical trials and support the longer-term development of tools to identify and mitigate the risk of trial-associated financial hardship.

“Continued progress against cancer depends on improving patient access to participation in clinical research,” Dr. Bertagnolli said.

“The recommendations in ASCO’s statement aim to ensure that no patient is denied access to a clinical trial for financial reasons and that patients are not harmed financially because of their contributions to advancing science. Ultimately, this is about strengthening the nation’s cancer research enterprise as a whole.”

Photo by George Hodan

Physician burnout may jeopardize patient care, according to research published in JAMA Internal Medicine.

A review and meta-analysis suggested that physician burnout was associated with a higher risk of patient safety incidents, reduced patient satisfaction, and low professionalism.

Burnout was defined as “a response to prolonged exposure to occupational stress encompassing feelings of emotional exhaustion, depersonalization, and reduced professional efficacy.”

This research was conducted by Maria Panagioti, PhD, of the University of Manchester in the U.K., and her colleagues.

The researchers analyzed 47 studies on the topics of physician burnout and patient care, which included data from a pooled cohort of 42,473 physicians.

Nearly 45% of studies included physicians in their residency or early career (up to 5 years post-residency), and 55.3% included more experienced physicians. The studies included physicians in a hospital setting (63.8%), primary care setting (27.7%), or a mix of health care settings (8.5%).

The data indicated that physician burnout was significantly associated with:

• An increased risk of patient safety incidents—odds ratio [OR], 1.96 (P<0.001)
• Low professionalism—OR, 2.31 (P<0.001)
• Reduced patient satisfaction—OR, 2.28 (P<0.001).

The researchers noted that the reporting method had an impact on the results. According to physician report, burnout was associated with significantly increased risks of safety incidents (OR, 2.07) and low professionalism (OR, 2.67).

However, according to system reports, there was no significant association between physician burnout and safety incidents (OR, 1.00) or low professionalism (OR, 1.15).

Another factor that impacted results was physician experience. The association between burnout and low professionalism was significantly larger in studies of residents and early career physicians (OR, 3.39) than in studies of middle- and late-career physicians (OR, 1.73).

The researchers noted that this review had its limitations, including variation in outcomes across studies, heterogeneity among studies, potential selection bias by excluding gray literature, and the inability to establish causal links from findings because of the cross-sectional nature of the studies analyzed.

This research was funded by the United Kingdom National Institute for Health Research (NIHR) School for Primary Care Research and the NIHR Greater Manchester Patient Safety Translational Research Centre. Study authors reported no relevant conflicts of interest.

Photo by George Hodan

Physician burnout may jeopardize patient care, according to research published in JAMA Internal Medicine.

A review and meta-analysis suggested that physician burnout was associated with a higher risk of patient safety incidents, reduced patient satisfaction, and low professionalism.

Burnout was defined as “a response to prolonged exposure to occupational stress encompassing feelings of emotional exhaustion, depersonalization, and reduced professional efficacy.”

This research was conducted by Maria Panagioti, PhD, of the University of Manchester in the U.K., and her colleagues.

The researchers analyzed 47 studies on the topics of physician burnout and patient care, which included data from a pooled cohort of 42,473 physicians.

Nearly 45% of studies included physicians in their residency or early career (up to 5 years post-residency), and 55.3% included more experienced physicians. The studies included physicians in a hospital setting (63.8%), primary care setting (27.7%), or a mix of health care settings (8.5%).

The data indicated that physician burnout was significantly associated with:

• An increased risk of patient safety incidents—odds ratio [OR], 1.96 (P<0.001)
• Low professionalism—OR, 2.31 (P<0.001)
• Reduced patient satisfaction—OR, 2.28 (P<0.001).

The researchers noted that the reporting method had an impact on the results. According to physician report, burnout was associated with significantly increased risks of safety incidents (OR, 2.07) and low professionalism (OR, 2.67).

However, according to system reports, there was no significant association between physician burnout and safety incidents (OR, 1.00) or low professionalism (OR, 1.15).

Another factor that impacted results was physician experience. The association between burnout and low professionalism was significantly larger in studies of residents and early career physicians (OR, 3.39) than in studies of middle- and late-career physicians (OR, 1.73).

The researchers noted that this review had its limitations, including variation in outcomes across studies, heterogeneity among studies, potential selection bias by excluding gray literature, and the inability to establish causal links from findings because of the cross-sectional nature of the studies analyzed.

This research was funded by the United Kingdom National Institute for Health Research (NIHR) School for Primary Care Research and the NIHR Greater Manchester Patient Safety Translational Research Centre. Study authors reported no relevant conflicts of interest.

Photo by George Hodan

Physician burnout may jeopardize patient care, according to research published in JAMA Internal Medicine.

A review and meta-analysis suggested that physician burnout was associated with a higher risk of patient safety incidents, reduced patient satisfaction, and low professionalism.

Burnout was defined as “a response to prolonged exposure to occupational stress encompassing feelings of emotional exhaustion, depersonalization, and reduced professional efficacy.”

This research was conducted by Maria Panagioti, PhD, of the University of Manchester in the U.K., and her colleagues.

The researchers analyzed 47 studies on the topics of physician burnout and patient care, which included data from a pooled cohort of 42,473 physicians.

Nearly 45% of studies included physicians in their residency or early career (up to 5 years post-residency), and 55.3% included more experienced physicians. The studies included physicians in a hospital setting (63.8%), primary care setting (27.7%), or a mix of health care settings (8.5%).

The data indicated that physician burnout was significantly associated with:

• An increased risk of patient safety incidents—odds ratio [OR], 1.96 (P<0.001)
• Low professionalism—OR, 2.31 (P<0.001)
• Reduced patient satisfaction—OR, 2.28 (P<0.001).

The researchers noted that the reporting method had an impact on the results. According to physician report, burnout was associated with significantly increased risks of safety incidents (OR, 2.07) and low professionalism (OR, 2.67).

However, according to system reports, there was no significant association between physician burnout and safety incidents (OR, 1.00) or low professionalism (OR, 1.15).

Another factor that impacted results was physician experience. The association between burnout and low professionalism was significantly larger in studies of residents and early career physicians (OR, 3.39) than in studies of middle- and late-career physicians (OR, 1.73).

The researchers noted that this review had its limitations, including variation in outcomes across studies, heterogeneity among studies, potential selection bias by excluding gray literature, and the inability to establish causal links from findings because of the cross-sectional nature of the studies analyzed.

This research was funded by the United Kingdom National Institute for Health Research (NIHR) School for Primary Care Research and the NIHR Greater Manchester Patient Safety Translational Research Centre. Study authors reported no relevant conflicts of interest.

Photo by Rhoda Baer

The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.

The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.

However, the report also notes that cancer continues to pose immense public health challenges in the United States.

The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.

The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.

With this in mind, the AACR is calling on elected officials to:

Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.

Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”

Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.

Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”

Photo by Rhoda Baer

The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.

The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.

However, the report also notes that cancer continues to pose immense public health challenges in the United States.

The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.

The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.

With this in mind, the AACR is calling on elected officials to:

Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.

Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”

Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.

Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”

Photo by Rhoda Baer

The American Association for Cancer Research (AACR) has released its annual Cancer Progress Report, detailing recent advances in the fight against cancer and calling on elected officials to address the challenges that remain.

The AACR Cancer Progress Report 2018 lists the 22 new approvals for cancer treatments that have occurred during the last 12 months, including 12 therapies approved to treat hematologic malignancies.

However, the report also notes that cancer continues to pose immense public health challenges in the United States.

The estimated number of new cancer cases for 2018 is 1,735,350, and the estimated number of cancer deaths is 609,640.

The number of new cancer cases is predicted to increase to 2,387,304 in 2035. This is due, in large part, to the rising number of people age 65 and older, according to the report.

With this in mind, the AACR is calling on elected officials to:

Maintain “robust, sustained, and predictable growth” of the National Institutes of Health (NIH) budget, increasing it at least $2 billion in fiscal year (FY) 2019, for a total funding level of at least $39.1 billion.

Make sure the $711 million in funding provided through the 21st Century Cures Act for targeted initiatives—including the National Cancer Moonshot—“is fully appropriated in FY 2019 and is supplemental to the healthy increase for the NIH’s base budget.”

Raise the Food and Drug Administration’s base budget in FY 2019 to $3.1 billion—a $308 million increase above its FY 2018 level—to secure support for regulatory science and speed the development of medical products that are safe and effective.

Provide the Centers for Disease Control and Prevention’s Cancer Prevention and Control Programs with total funding of at least $517 million. This would include funding for “comprehensive cancer control, cancer registries, and screening and awareness programs for specific cancers.”

Photo by Rhoda Baer

Experts have published updated guidelines on antimicrobial prophylaxis for adults with cancer-related immunosuppression.

The guidelines include antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions, such as hand hygiene, that may reduce infection risk.

The guidelines were developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA) and published in the Journal of Clinical Oncology.

For the most part, the expert panel that created these guidelines endorsed the previous ASCO recommendations, published in 2013.

However, the panel considered six new studies and six new or updated meta-analyses to make modifications and add some new recommendations.

Recommendations

The ASCO/IDSA guidelines say health care providers should systematically assess the risk of febrile neutropenia, taking into account patient-, cancer-, and treatment-related factors.

Fluoroquinolone prophylaxis is recommended for patients at high risk of febrile neutropenia or profound, protracted neutropenia. This includes most patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) and patients undergoing hematopoietic stem cell transplant (HSCT) who are treated with myeloablative conditioning regimens.

Antifungal prophylaxis with an oral triazole or parenteral echinocandin is recommended for patients at risk of profound, protracted neutropenia, which includes HSCT recipients and most patients with AML/MDS.

However, neither antifungal nor antibiotic prophylaxis are routinely recommended for patients with solid tumors.

Prophylaxis with a nucleoside analog, such as acyclovir, is recommended in patients who are herpes simplex virus–seropositive and are undergoing allogeneic HSCT or leukemia induction.

Pneumocystis jirovecii prophylaxis, such as trimethoprim-sulfamethoxazole, is recommended for patients receiving chemotherapy regimens associated with a greater than 3.5% risk for pneumonia from P jirovecii.

Treatment with a nucleoside reverse transcription inhibitor, such as entecavir or tenofovir, is recommended for patients at high risk of hepatitis B virus reactivation.

Yearly influenza vaccination with an inactivated quadrivalent vaccine is recommended for all patients undergoing chemotherapy for malignancy as well as their family members, household contacts, and health care providers.

Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce the risk of pathogen transmission, according to the guidelines.

The guidelines also note that outpatients who develop neutropenia following cancer therapy should avoid prolonged contact with environments that have high concentrations of airborne fungal spores.

The guidelines do not recommend interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks. “Evidence of clinical benefit is lacking” for those interventions, the expert panel said.

Members of the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.

Photo by Rhoda Baer

Experts have published updated guidelines on antimicrobial prophylaxis for adults with cancer-related immunosuppression.

The guidelines include antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions, such as hand hygiene, that may reduce infection risk.

The guidelines were developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA) and published in the Journal of Clinical Oncology.

For the most part, the expert panel that created these guidelines endorsed the previous ASCO recommendations, published in 2013.

However, the panel considered six new studies and six new or updated meta-analyses to make modifications and add some new recommendations.

Recommendations

The ASCO/IDSA guidelines say health care providers should systematically assess the risk of febrile neutropenia, taking into account patient-, cancer-, and treatment-related factors.

Fluoroquinolone prophylaxis is recommended for patients at high risk of febrile neutropenia or profound, protracted neutropenia. This includes most patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) and patients undergoing hematopoietic stem cell transplant (HSCT) who are treated with myeloablative conditioning regimens.

Antifungal prophylaxis with an oral triazole or parenteral echinocandin is recommended for patients at risk of profound, protracted neutropenia, which includes HSCT recipients and most patients with AML/MDS.

However, neither antifungal nor antibiotic prophylaxis are routinely recommended for patients with solid tumors.

Prophylaxis with a nucleoside analog, such as acyclovir, is recommended in patients who are herpes simplex virus–seropositive and are undergoing allogeneic HSCT or leukemia induction.

Pneumocystis jirovecii prophylaxis, such as trimethoprim-sulfamethoxazole, is recommended for patients receiving chemotherapy regimens associated with a greater than 3.5% risk for pneumonia from P jirovecii.

Treatment with a nucleoside reverse transcription inhibitor, such as entecavir or tenofovir, is recommended for patients at high risk of hepatitis B virus reactivation.

Yearly influenza vaccination with an inactivated quadrivalent vaccine is recommended for all patients undergoing chemotherapy for malignancy as well as their family members, household contacts, and health care providers.

Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce the risk of pathogen transmission, according to the guidelines.

The guidelines also note that outpatients who develop neutropenia following cancer therapy should avoid prolonged contact with environments that have high concentrations of airborne fungal spores.

The guidelines do not recommend interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks. “Evidence of clinical benefit is lacking” for those interventions, the expert panel said.

Members of the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.

Photo by Rhoda Baer

Experts have published updated guidelines on antimicrobial prophylaxis for adults with cancer-related immunosuppression.

The guidelines include antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions, such as hand hygiene, that may reduce infection risk.

The guidelines were developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA) and published in the Journal of Clinical Oncology.

For the most part, the expert panel that created these guidelines endorsed the previous ASCO recommendations, published in 2013.

However, the panel considered six new studies and six new or updated meta-analyses to make modifications and add some new recommendations.

Recommendations

The ASCO/IDSA guidelines say health care providers should systematically assess the risk of febrile neutropenia, taking into account patient-, cancer-, and treatment-related factors.

Fluoroquinolone prophylaxis is recommended for patients at high risk of febrile neutropenia or profound, protracted neutropenia. This includes most patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) and patients undergoing hematopoietic stem cell transplant (HSCT) who are treated with myeloablative conditioning regimens.

Antifungal prophylaxis with an oral triazole or parenteral echinocandin is recommended for patients at risk of profound, protracted neutropenia, which includes HSCT recipients and most patients with AML/MDS.

However, neither antifungal nor antibiotic prophylaxis are routinely recommended for patients with solid tumors.

Prophylaxis with a nucleoside analog, such as acyclovir, is recommended in patients who are herpes simplex virus–seropositive and are undergoing allogeneic HSCT or leukemia induction.

Pneumocystis jirovecii prophylaxis, such as trimethoprim-sulfamethoxazole, is recommended for patients receiving chemotherapy regimens associated with a greater than 3.5% risk for pneumonia from P jirovecii.

Treatment with a nucleoside reverse transcription inhibitor, such as entecavir or tenofovir, is recommended for patients at high risk of hepatitis B virus reactivation.

Yearly influenza vaccination with an inactivated quadrivalent vaccine is recommended for all patients undergoing chemotherapy for malignancy as well as their family members, household contacts, and health care providers.

Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce the risk of pathogen transmission, according to the guidelines.

The guidelines also note that outpatients who develop neutropenia following cancer therapy should avoid prolonged contact with environments that have high concentrations of airborne fungal spores.

The guidelines do not recommend interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks. “Evidence of clinical benefit is lacking” for those interventions, the expert panel said.

Members of the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.

HSCs in the bone marrow

Humans may have ten times more hematopoietic stem cells (HSCs) than previously thought, according to research published in Nature.

Researchers developed a new approach for studying HSCs and found evidence suggesting that HSC numbers increase rapidly through childhood, reach a plateau by adolescence, and remain relatively constant throughout adulthood.

“We discovered that healthy adults have between 50,000 and 200,000 blood stem cells, which is about ten times more than previously thought,” said study author Peter Campbell, PhD, of the Wellcome Trust Sanger Institute in Hinxton, UK.

“Whereas previous estimates of blood stem cell numbers were extrapolated from studies in mice, cats, or monkeys, this is the first time stem cell numbers have been directly quantified in humans. This new approach opens up avenues into studying stem cells in other human organs and how they change between health and disease, and as we age.”

For this study, Dr Campbell and his colleagues conducted whole-genome sequencing on hematopoietic stem and progenitor colonies from a healthy 59 year-old man. The team adapted a capture-recapture* method to “tag” stem cells and compare them to the population of blood cells.

Specifically, in the “capture” phase, the researchers isolated individual hematopoietic stem and progenitor cells from a bone marrow aspirate and peripheral blood draw from the male subject. The cells were expanded, and the researchers performed whole-genome sequencing on 198 colonies to identify somatic mutations.

In the “recapture” phase, the researchers isolated bulk populations of mature peripheral blood cells from the subject—granulocytes at three time points and B and T lymphocytes at one time point. The team then performed deep, targeted sequencing on these bulk populations.

“The mutations act like barcodes, each of which uniquely tags a stem cell and its descendants,” said study author Henry Lee-Six, of the Wellcome Trust Sanger Institute.

“We then looked for these mutations in the rest of the blood to see what fraction of blood cells carry the same barcodes, and, from this, we could estimate how many stem cells there were in total.”

The researchers’ results suggested the number of HSCs actively contributing to circulating granulocytes at any one time was in the range of 44,000 to 215,000.

The team also estimated that the time between successive self-renewal HSC divisions is likely in the range of 2 to 20 months.

Finally, the researchers observed signs of “rapid” HSC population expansion during early life, which reaches a relatively stable plateau by late childhood or early adolescence that continues into adulthood.

The team said this stability suggests that symmetric self-renewal divisions (when one HSC divides into two) are balanced by HSC death, senescence, and symmetric divisions into committed progenitors.

*Capture-recapture is commonly used in ecology to estimate a species’ population size. A portion of the population is captured, tagged, and released. Later, another portion is captured, and the number of tagged individuals within the sample is counted. Since the number of marked individuals within the second sample should be proportional to the number of marked individuals in the whole population, an estimate of the total population size can be obtained by dividing the number of marked individuals by the proportion of marked individuals in the second sample.

HSCs in the bone marrow

Humans may have ten times more hematopoietic stem cells (HSCs) than previously thought, according to research published in Nature.

Researchers developed a new approach for studying HSCs and found evidence suggesting that HSC numbers increase rapidly through childhood, reach a plateau by adolescence, and remain relatively constant throughout adulthood.

“We discovered that healthy adults have between 50,000 and 200,000 blood stem cells, which is about ten times more than previously thought,” said study author Peter Campbell, PhD, of the Wellcome Trust Sanger Institute in Hinxton, UK.

“Whereas previous estimates of blood stem cell numbers were extrapolated from studies in mice, cats, or monkeys, this is the first time stem cell numbers have been directly quantified in humans. This new approach opens up avenues into studying stem cells in other human organs and how they change between health and disease, and as we age.”

For this study, Dr Campbell and his colleagues conducted whole-genome sequencing on hematopoietic stem and progenitor colonies from a healthy 59 year-old man. The team adapted a capture-recapture* method to “tag” stem cells and compare them to the population of blood cells.

Specifically, in the “capture” phase, the researchers isolated individual hematopoietic stem and progenitor cells from a bone marrow aspirate and peripheral blood draw from the male subject. The cells were expanded, and the researchers performed whole-genome sequencing on 198 colonies to identify somatic mutations.

In the “recapture” phase, the researchers isolated bulk populations of mature peripheral blood cells from the subject—granulocytes at three time points and B and T lymphocytes at one time point. The team then performed deep, targeted sequencing on these bulk populations.

“The mutations act like barcodes, each of which uniquely tags a stem cell and its descendants,” said study author Henry Lee-Six, of the Wellcome Trust Sanger Institute.

“We then looked for these mutations in the rest of the blood to see what fraction of blood cells carry the same barcodes, and, from this, we could estimate how many stem cells there were in total.”

The researchers’ results suggested the number of HSCs actively contributing to circulating granulocytes at any one time was in the range of 44,000 to 215,000.

The team also estimated that the time between successive self-renewal HSC divisions is likely in the range of 2 to 20 months.

Finally, the researchers observed signs of “rapid” HSC population expansion during early life, which reaches a relatively stable plateau by late childhood or early adolescence that continues into adulthood.

The team said this stability suggests that symmetric self-renewal divisions (when one HSC divides into two) are balanced by HSC death, senescence, and symmetric divisions into committed progenitors.

*Capture-recapture is commonly used in ecology to estimate a species’ population size. A portion of the population is captured, tagged, and released. Later, another portion is captured, and the number of tagged individuals within the sample is counted. Since the number of marked individuals within the second sample should be proportional to the number of marked individuals in the whole population, an estimate of the total population size can be obtained by dividing the number of marked individuals by the proportion of marked individuals in the second sample.

HSCs in the bone marrow

Humans may have ten times more hematopoietic stem cells (HSCs) than previously thought, according to research published in Nature.

Researchers developed a new approach for studying HSCs and found evidence suggesting that HSC numbers increase rapidly through childhood, reach a plateau by adolescence, and remain relatively constant throughout adulthood.

“We discovered that healthy adults have between 50,000 and 200,000 blood stem cells, which is about ten times more than previously thought,” said study author Peter Campbell, PhD, of the Wellcome Trust Sanger Institute in Hinxton, UK.

“Whereas previous estimates of blood stem cell numbers were extrapolated from studies in mice, cats, or monkeys, this is the first time stem cell numbers have been directly quantified in humans. This new approach opens up avenues into studying stem cells in other human organs and how they change between health and disease, and as we age.”

For this study, Dr Campbell and his colleagues conducted whole-genome sequencing on hematopoietic stem and progenitor colonies from a healthy 59 year-old man. The team adapted a capture-recapture* method to “tag” stem cells and compare them to the population of blood cells.

Specifically, in the “capture” phase, the researchers isolated individual hematopoietic stem and progenitor cells from a bone marrow aspirate and peripheral blood draw from the male subject. The cells were expanded, and the researchers performed whole-genome sequencing on 198 colonies to identify somatic mutations.

In the “recapture” phase, the researchers isolated bulk populations of mature peripheral blood cells from the subject—granulocytes at three time points and B and T lymphocytes at one time point. The team then performed deep, targeted sequencing on these bulk populations.

“The mutations act like barcodes, each of which uniquely tags a stem cell and its descendants,” said study author Henry Lee-Six, of the Wellcome Trust Sanger Institute.

“We then looked for these mutations in the rest of the blood to see what fraction of blood cells carry the same barcodes, and, from this, we could estimate how many stem cells there were in total.”

The researchers’ results suggested the number of HSCs actively contributing to circulating granulocytes at any one time was in the range of 44,000 to 215,000.

The team also estimated that the time between successive self-renewal HSC divisions is likely in the range of 2 to 20 months.

Finally, the researchers observed signs of “rapid” HSC population expansion during early life, which reaches a relatively stable plateau by late childhood or early adolescence that continues into adulthood.

The team said this stability suggests that symmetric self-renewal divisions (when one HSC divides into two) are balanced by HSC death, senescence, and symmetric divisions into committed progenitors.

*Capture-recapture is commonly used in ecology to estimate a species’ population size. A portion of the population is captured, tagged, and released. Later, another portion is captured, and the number of tagged individuals within the sample is counted. Since the number of marked individuals within the second sample should be proportional to the number of marked individuals in the whole population, an estimate of the total population size can be obtained by dividing the number of marked individuals by the proportion of marked individuals in the second sample.

Photo by Rhoda Baer

New research suggests investigators involved in oncology trials sometimes fail to disclose payments from the pharmaceutical industry.

Researchers looked at clinical trials associated with cancer drugs recently approved in the United States and assessed whether funding was properly disclosed when the trial results were published in scientific journals.

The data showed that roughly a third of investigators failed to completely disclose payments from trial sponsors.

“We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,” said Cole Wayant, a DO/PhD student at Oklahoma State University in Tulsa.

“But what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA [U.S. Food and Drug Administration] approvals and clinical practice guidelines.”

Wayant and his colleagues conducted this research and reported the findings in a letter to JAMA Oncology.

The researchers began by searching the FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications website for oncology drugs approved from Jan. 1, 2016, to Aug. 31, 2017.

The team then identified the published trials supporting these drug approvals and searched the Open Payments website for industry payment data for each U.S.-based oncologist involved in the trials.

Finally, the researchers compared the Open Payments data to the disclosure statements from the publications.

There were 344 authors of clinical trials associated with oncology drugs approved during the period studied. Most authors (76.5%) received at least one industry payment, and the total amount they received exceeded $216 million.

Nearly a third of the authors (32%, n=110) did not fully disclose payments from a trial sponsor.

In all, the authors received about $6.3 million in general payments (e.g., speaking fees), and $1.7 million of that was undisclosed.

They received more than $500,000 in research payments (e.g., fees for study coordination), and more than $200,000 of that was undisclosed.

The authors received close to $210 million in associated research payments (e.g., grants), and about $78 million of that was undisclosed.

Wayant and his colleagues said these results suggest financial relationships between the pharmaceutical industry and oncology trial investigators “may be common, expensive, and frequently undisclosed.” However, the research also suggests Open Payments data could be used to ensure complete disclosure of industry payments.

Photo by Rhoda Baer

New research suggests investigators involved in oncology trials sometimes fail to disclose payments from the pharmaceutical industry.

Researchers looked at clinical trials associated with cancer drugs recently approved in the United States and assessed whether funding was properly disclosed when the trial results were published in scientific journals.

The data showed that roughly a third of investigators failed to completely disclose payments from trial sponsors.

“We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,” said Cole Wayant, a DO/PhD student at Oklahoma State University in Tulsa.

“But what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA [U.S. Food and Drug Administration] approvals and clinical practice guidelines.”

Wayant and his colleagues conducted this research and reported the findings in a letter to JAMA Oncology.

The researchers began by searching the FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications website for oncology drugs approved from Jan. 1, 2016, to Aug. 31, 2017.

The team then identified the published trials supporting these drug approvals and searched the Open Payments website for industry payment data for each U.S.-based oncologist involved in the trials.

Finally, the researchers compared the Open Payments data to the disclosure statements from the publications.

There were 344 authors of clinical trials associated with oncology drugs approved during the period studied. Most authors (76.5%) received at least one industry payment, and the total amount they received exceeded $216 million.

Nearly a third of the authors (32%, n=110) did not fully disclose payments from a trial sponsor.

In all, the authors received about $6.3 million in general payments (e.g., speaking fees), and $1.7 million of that was undisclosed.

They received more than $500,000 in research payments (e.g., fees for study coordination), and more than $200,000 of that was undisclosed.

The authors received close to $210 million in associated research payments (e.g., grants), and about $78 million of that was undisclosed.

Wayant and his colleagues said these results suggest financial relationships between the pharmaceutical industry and oncology trial investigators “may be common, expensive, and frequently undisclosed.” However, the research also suggests Open Payments data could be used to ensure complete disclosure of industry payments.

Photo by Rhoda Baer

New research suggests investigators involved in oncology trials sometimes fail to disclose payments from the pharmaceutical industry.

Researchers looked at clinical trials associated with cancer drugs recently approved in the United States and assessed whether funding was properly disclosed when the trial results were published in scientific journals.

The data showed that roughly a third of investigators failed to completely disclose payments from trial sponsors.

“We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,” said Cole Wayant, a DO/PhD student at Oklahoma State University in Tulsa.

“But what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA [U.S. Food and Drug Administration] approvals and clinical practice guidelines.”

Wayant and his colleagues conducted this research and reported the findings in a letter to JAMA Oncology.

The researchers began by searching the FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications website for oncology drugs approved from Jan. 1, 2016, to Aug. 31, 2017.

The team then identified the published trials supporting these drug approvals and searched the Open Payments website for industry payment data for each U.S.-based oncologist involved in the trials.

Finally, the researchers compared the Open Payments data to the disclosure statements from the publications.

There were 344 authors of clinical trials associated with oncology drugs approved during the period studied. Most authors (76.5%) received at least one industry payment, and the total amount they received exceeded $216 million.

Nearly a third of the authors (32%, n=110) did not fully disclose payments from a trial sponsor.

In all, the authors received about $6.3 million in general payments (e.g., speaking fees), and $1.7 million of that was undisclosed.

They received more than $500,000 in research payments (e.g., fees for study coordination), and more than $200,000 of that was undisclosed.

The authors received close to $210 million in associated research payments (e.g., grants), and about $78 million of that was undisclosed.

Wayant and his colleagues said these results suggest financial relationships between the pharmaceutical industry and oncology trial investigators “may be common, expensive, and frequently undisclosed.” However, the research also suggests Open Payments data could be used to ensure complete disclosure of industry payments.

Photo by Rhoda Baer

New research suggests cancer survivors are just as likely as people without a history of cancer to have complete mental health (CMH), which is defined as “optimal functioning” and the “absence of psychopathology.”

In a study of nearly 11,000 Canadians, 77.5% of cancer survivors and 76.8% of people with no cancer history had CMH.

As for patients who were battling cancer at the time of the study, 66.1% had CMH.

Esme Fuller-Thomson, PhD, and Keri West, both of the University of Toronto in Canada, conducted this research and reported the findings in Aging & Mental Health.

“Cancer patients were doing much better than we had expected,” Dr. Fuller-Thomson said. “Two-thirds met our very stringent criteria for complete mental health . . . . The news for cancer survivors was even better, with three-quarters living in complete mental health, which is a prevalence comparable to that of individuals with no cancer history.”

This study included a nationally representative sample of Canadian community dwellers age 50 and older. Subjects had current cancer (n=438), previous cancer (n=1174), or no cancer history (n=9279).

Data were obtained from Statistics Canada’s 2012 Canadian Community Health Survey-Mental Health.

To meet criteria for CMH, subjects had to have all of the following:

• Absence of mental illness, addictions, and suicidal thoughts in the past year
• Almost daily happiness or life satisfaction in the past month
• Psychosocial well-being.

The prevalence of CMH was 77.5% in cancer survivors and 76.8% in subjects who had never had cancer. Both were significantly higher than the 66.1% prevalence of CMH in current cancer patients (P<0.001).

In a multivariable model adjusted for demographics, current cancer patients had 45% lower odds of CMH compared to subjects with no cancer history (odds ratio [OR]=0.55). The odds of CMH were comparable for cancer survivors and those without a history of cancer (OR=0.98).

The researchers also conducted a multivariable analysis in which they adjusted for “all relevant factors,” which included demographics as well as adverse childhood events, socioeconomic status, health variables, lifetime mental illness, etc.

In this analysis, current cancer patients had 37% lower odds of CMH than subjects with no cancer history (OR=0.63). And cancer survivors had comparable odds of CMH as those with no cancer history (OR=1.06).

The researchers identified several factors that were associated with CMH in the population affected by cancer.

“Among those with former or current cancer, the odds of complete mental health were higher for women, white, married, and older respondents, as well as those with higher income and those who did not have disabling pain nor functional limitations,” West said.

“We found that earlier difficulties cast a long shadow. Those who had been physically abused during their childhood and those who had ever had depression or anxiety disorders were less likely to be in complete mental health.”

West and Dr Fuller-Thomson emphasized that these results are only correlational, and it is impossible to determine causality due to the cross-sectional and observational nature of the study.

The pair also said future longitudinal research is needed to improve understanding of what pathways improve resilience and recovery among cancer patients.

Photo by Rhoda Baer

New research suggests cancer survivors are just as likely as people without a history of cancer to have complete mental health (CMH), which is defined as “optimal functioning” and the “absence of psychopathology.”

In a study of nearly 11,000 Canadians, 77.5% of cancer survivors and 76.8% of people with no cancer history had CMH.

As for patients who were battling cancer at the time of the study, 66.1% had CMH.

Esme Fuller-Thomson, PhD, and Keri West, both of the University of Toronto in Canada, conducted this research and reported the findings in Aging & Mental Health.

“Cancer patients were doing much better than we had expected,” Dr. Fuller-Thomson said. “Two-thirds met our very stringent criteria for complete mental health . . . . The news for cancer survivors was even better, with three-quarters living in complete mental health, which is a prevalence comparable to that of individuals with no cancer history.”

This study included a nationally representative sample of Canadian community dwellers age 50 and older. Subjects had current cancer (n=438), previous cancer (n=1174), or no cancer history (n=9279).

Data were obtained from Statistics Canada’s 2012 Canadian Community Health Survey-Mental Health.

To meet criteria for CMH, subjects had to have all of the following:

• Absence of mental illness, addictions, and suicidal thoughts in the past year
• Almost daily happiness or life satisfaction in the past month
• Psychosocial well-being.

The prevalence of CMH was 77.5% in cancer survivors and 76.8% in subjects who had never had cancer. Both were significantly higher than the 66.1% prevalence of CMH in current cancer patients (P<0.001).

In a multivariable model adjusted for demographics, current cancer patients had 45% lower odds of CMH compared to subjects with no cancer history (odds ratio [OR]=0.55). The odds of CMH were comparable for cancer survivors and those without a history of cancer (OR=0.98).

The researchers also conducted a multivariable analysis in which they adjusted for “all relevant factors,” which included demographics as well as adverse childhood events, socioeconomic status, health variables, lifetime mental illness, etc.

In this analysis, current cancer patients had 37% lower odds of CMH than subjects with no cancer history (OR=0.63). And cancer survivors had comparable odds of CMH as those with no cancer history (OR=1.06).

The researchers identified several factors that were associated with CMH in the population affected by cancer.

“Among those with former or current cancer, the odds of complete mental health were higher for women, white, married, and older respondents, as well as those with higher income and those who did not have disabling pain nor functional limitations,” West said.

“We found that earlier difficulties cast a long shadow. Those who had been physically abused during their childhood and those who had ever had depression or anxiety disorders were less likely to be in complete mental health.”

West and Dr Fuller-Thomson emphasized that these results are only correlational, and it is impossible to determine causality due to the cross-sectional and observational nature of the study.

The pair also said future longitudinal research is needed to improve understanding of what pathways improve resilience and recovery among cancer patients.

Photo by Rhoda Baer

New research suggests cancer survivors are just as likely as people without a history of cancer to have complete mental health (CMH), which is defined as “optimal functioning” and the “absence of psychopathology.”

In a study of nearly 11,000 Canadians, 77.5% of cancer survivors and 76.8% of people with no cancer history had CMH.

As for patients who were battling cancer at the time of the study, 66.1% had CMH.

Esme Fuller-Thomson, PhD, and Keri West, both of the University of Toronto in Canada, conducted this research and reported the findings in Aging & Mental Health.

“Cancer patients were doing much better than we had expected,” Dr. Fuller-Thomson said. “Two-thirds met our very stringent criteria for complete mental health . . . . The news for cancer survivors was even better, with three-quarters living in complete mental health, which is a prevalence comparable to that of individuals with no cancer history.”

This study included a nationally representative sample of Canadian community dwellers age 50 and older. Subjects had current cancer (n=438), previous cancer (n=1174), or no cancer history (n=9279).

Data were obtained from Statistics Canada’s 2012 Canadian Community Health Survey-Mental Health.

To meet criteria for CMH, subjects had to have all of the following:

• Absence of mental illness, addictions, and suicidal thoughts in the past year
• Almost daily happiness or life satisfaction in the past month
• Psychosocial well-being.

The prevalence of CMH was 77.5% in cancer survivors and 76.8% in subjects who had never had cancer. Both were significantly higher than the 66.1% prevalence of CMH in current cancer patients (P<0.001).

In a multivariable model adjusted for demographics, current cancer patients had 45% lower odds of CMH compared to subjects with no cancer history (odds ratio [OR]=0.55). The odds of CMH were comparable for cancer survivors and those without a history of cancer (OR=0.98).

The researchers also conducted a multivariable analysis in which they adjusted for “all relevant factors,” which included demographics as well as adverse childhood events, socioeconomic status, health variables, lifetime mental illness, etc.

In this analysis, current cancer patients had 37% lower odds of CMH than subjects with no cancer history (OR=0.63). And cancer survivors had comparable odds of CMH as those with no cancer history (OR=1.06).

The researchers identified several factors that were associated with CMH in the population affected by cancer.

“Among those with former or current cancer, the odds of complete mental health were higher for women, white, married, and older respondents, as well as those with higher income and those who did not have disabling pain nor functional limitations,” West said.

“We found that earlier difficulties cast a long shadow. Those who had been physically abused during their childhood and those who had ever had depression or anxiety disorders were less likely to be in complete mental health.”

West and Dr Fuller-Thomson emphasized that these results are only correlational, and it is impossible to determine causality due to the cross-sectional and observational nature of the study.

The pair also said future longitudinal research is needed to improve understanding of what pathways improve resilience and recovery among cancer patients.

Photo by Rhoda Baer

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the US and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” said study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

Using US Department of Agriculture population classifications known as Rural-Urban Continuum Codes, the researchers categorized the patients as either rural or urban and analyzed their outcomes.

A minority of patients (19.4%, n=7184) were from rural locations. They were significantly more likely than urban patients to be 65 or older (P<0.001) and significantly less likely to be black (vs all other races; P<0.001).

However, there was no significant between-group difference in sex (P=0.53), and all major US geographic regions (West, Midwest, South, and Northeast) were represented.

Results

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-negative, progesterone receptor-negative breast cancer. Rural patients with this cancer didn’t live as long as their urban counterparts. The hazard ratio (HR) was 1.27 (95% CI, 1.06-1.51; P=0.008) for OS and 1.26 (95% CI, 1.04-1.52; P=0.02) for cancer-specific survival.

The researchers believe this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML but slightly worse OS if they had MM or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.91 (95% CI, 0.64-1.29; P=0.60)
• AML—HR=0.94 (95% CI, 0.83-1.06; P=0.29)
• MM—HR=1.05 (95% CI, 0.93-1.18, P=0.46)
• Advanced aggressive NHL—HR=1.05 (95% CI, 0.87-1.27; P=0.60).

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.98 (95% CI, 0.66-1.45; P=0.90)
• AML—HR=1.01 (95% CI, 0.86-1.20; P=0.87)
• MM—HR=1.04 (95% CI, 0.90-1.20; P=0.60)
• Advanced aggressive NHL—HR=1.08 (95% CI, 0.87-1.34; P=0.50).

The researchers said these findings suggest it is access to care, and not other characteristics, that drive the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr Unger said.

This research was supported by the National Cancer Institute and the HOPE Foundation. The researchers reported financial relationships with various pharmaceutical companies.

Photo by Rhoda Baer

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the US and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” said study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

Using US Department of Agriculture population classifications known as Rural-Urban Continuum Codes, the researchers categorized the patients as either rural or urban and analyzed their outcomes.

A minority of patients (19.4%, n=7184) were from rural locations. They were significantly more likely than urban patients to be 65 or older (P<0.001) and significantly less likely to be black (vs all other races; P<0.001).

However, there was no significant between-group difference in sex (P=0.53), and all major US geographic regions (West, Midwest, South, and Northeast) were represented.

Results

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-negative, progesterone receptor-negative breast cancer. Rural patients with this cancer didn’t live as long as their urban counterparts. The hazard ratio (HR) was 1.27 (95% CI, 1.06-1.51; P=0.008) for OS and 1.26 (95% CI, 1.04-1.52; P=0.02) for cancer-specific survival.

The researchers believe this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML but slightly worse OS if they had MM or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.91 (95% CI, 0.64-1.29; P=0.60)
• AML—HR=0.94 (95% CI, 0.83-1.06; P=0.29)
• MM—HR=1.05 (95% CI, 0.93-1.18, P=0.46)
• Advanced aggressive NHL—HR=1.05 (95% CI, 0.87-1.27; P=0.60).

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.98 (95% CI, 0.66-1.45; P=0.90)
• AML—HR=1.01 (95% CI, 0.86-1.20; P=0.87)
• MM—HR=1.04 (95% CI, 0.90-1.20; P=0.60)
• Advanced aggressive NHL—HR=1.08 (95% CI, 0.87-1.34; P=0.50).

The researchers said these findings suggest it is access to care, and not other characteristics, that drive the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr Unger said.

This research was supported by the National Cancer Institute and the HOPE Foundation. The researchers reported financial relationships with various pharmaceutical companies.

Photo by Rhoda Baer

New research suggests that better access to quality care may reduce disparities in survival between cancer patients living in rural areas of the US and those living in urban areas.

The study showed that urban and rural cancer patients had similar survival outcomes when they were enrolled in clinical trials.

These results, published in JAMA Network Open, cast new light on decades of research showing that cancer patients living in rural areas don’t live as long as urban cancer patients.

“These findings were a surprise, since we thought we might find the same disparities others had found,” said study author Joseph Unger, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“But clinical trials are a key difference here. In trials, patients are uniformly assessed, treated, and followed under a strict, guideline-driven protocol. This suggests that giving people with cancer access to uniform treatment strategies could help resolve the disparities in outcomes that we see between rural and urban patients.”

Dr Unger and his colleagues studied data on 36,995 patients who were enrolled in 44 phase 3 or phase 2/3 SWOG trials from 1986 through 2012. All 50 states were represented.

Patients had 17 different cancer types, including acute myeloid leukemia (AML), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM).

Using US Department of Agriculture population classifications known as Rural-Urban Continuum Codes, the researchers categorized the patients as either rural or urban and analyzed their outcomes.

A minority of patients (19.4%, n=7184) were from rural locations. They were significantly more likely than urban patients to be 65 or older (P<0.001) and significantly less likely to be black (vs all other races; P<0.001).

However, there was no significant between-group difference in sex (P=0.53), and all major US geographic regions (West, Midwest, South, and Northeast) were represented.

Results

The researchers limited their analysis of survival to the first 5 years after trial enrollment to emphasize outcomes related to cancer and its treatment. They looked at overall survival (OS) as well as cancer-specific survival.

The team found no meaningful difference in OS or cancer-specific survival between rural and urban patients for 16 of the 17 cancer types.

The exception was estrogen receptor-negative, progesterone receptor-negative breast cancer. Rural patients with this cancer didn’t live as long as their urban counterparts. The hazard ratio (HR) was 1.27 (95% CI, 1.06-1.51; P=0.008) for OS and 1.26 (95% CI, 1.04-1.52; P=0.02) for cancer-specific survival.

The researchers believe this finding could be attributed to a few factors, including timely access to follow-up chemotherapy after patients’ first round of cancer treatment.

Although there were no significant survival differences for patients with hematologic malignancies, rural patients had slightly better OS if they had advanced indolent NHL or AML but slightly worse OS if they had MM or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.91 (95% CI, 0.64-1.29; P=0.60)
• AML—HR=0.94 (95% CI, 0.83-1.06; P=0.29)
• MM—HR=1.05 (95% CI, 0.93-1.18, P=0.46)
• Advanced aggressive NHL—HR=1.05 (95% CI, 0.87-1.27; P=0.60).

Rural patients had slightly better cancer-specific survival if they had advanced indolent NHL but slightly worse cancer-specific survival if they had AML, MM, or advanced aggressive NHL. The HRs were as follows:

• Advanced indolent NHL—HR=0.98 (95% CI, 0.66-1.45; P=0.90)
• AML—HR=1.01 (95% CI, 0.86-1.20; P=0.87)
• MM—HR=1.04 (95% CI, 0.90-1.20; P=0.60)
• Advanced aggressive NHL—HR=1.08 (95% CI, 0.87-1.34; P=0.50).

The researchers said these findings suggest it is access to care, and not other characteristics, that drive the survival disparities typically observed between urban and rural cancer patients.

“If people diagnosed with cancer, regardless of where they live, receive similar care and have similar outcomes, then a reasonable inference is that the best way to improve outcomes for rural patients is to improve their access to quality care,” Dr Unger said.

This research was supported by the National Cancer Institute and the HOPE Foundation. The researchers reported financial relationships with various pharmaceutical companies.

Photo by Rhoda Baer

Better communication between cancer patients and healthcare providers may provide tangible benefits, according to research published in JNCCN.

Cancer survivors who reported greater satisfaction in communicating with healthcare providers had better general health and mental health, fewer doctor visits, and reduced healthcare spending, when compared to patients who were less satisfied with communication.

“Our study suggests that when cancer care providers are more effective communicators, their patients are more likely to follow medical advice and medication protocols,” said study author Ashish Rai, PhD, of the American Cancer Society in Framingham, Massachusetts.

For this study, Dr Rai and his colleagues analyzed data from the Medical Expenditure Panel Survey (MEPS) from 2008 through 2014.

The researchers evaluated 4588 cancer survivors, dividing them into non-elderly and elderly groups. The non-elderly patients (n=2257) had a median age of 54 (range, 18-64), and the elderly patients (n=2331) had a median age of 75.

Communication satisfaction was measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS), in conjunction with the MEPS data.

Patients used a 4-point scale ranging from “never” to “always” to track whether their providers did the following:

• Listened carefully
• Explained things in a way that was easy to understand
• Showed respect for what the respondent had to say
• Spent enough time with the respondent.

A global satisfaction rating scale (0 to 10) was factored into a composite score and tracked across 12 months.

The researchers then assessed various patient outcomes.

Satisfaction and outcomes

Overall, patients who were the most satisfied with communication had the best outcomes with regard to general, physical, and mental health; fewer emergency department, hospital, and office visits; and reduced drug, out-of-pocket, and total healthcare expenditures.

However, the associations between communication satisfaction and outcomes were not always significant.

In an adjusted analysis, the elderly patients who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for general health, mental health, and total healthcare expenditures.

For the non-elderly patients, those who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for physician office visits and mental health.

Baseline health and satisfaction

In both age groups, patients with better baseline health reported higher satisfaction with communication. Conversely, the more comorbidities patients had, the lower their satisfaction rating.

The researchers said this suggests that more complex circumstances negatively impacted patients’ perception of their communication, and the finding highlights the importance of coordinating care across a team of providers.

“The results of this study present an interesting challenge: those survivors most in need of good communication about complex medical issues may not be receiving the information they seek in a manner that they find helpful. That, in turn, results in higher healthcare utilization and expenditure,” said Crystal Denlinger, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, who was not involved in this study.

“This could be due to many factors, including time constraints, competing priorities, and increasingly complex cancer therapies. This study highlights the need for additional research into how to tailor the healthcare experience both during and after cancer treatment in order to communicate more effectively.”

Conclusions

“Communication needs vary from patient to patient,” Dr Rai noted. “While time constraints do pose a challenge, the amount of time spent is only one of the attributes of effective communication. By tailoring their communication strategy to a patient’s specific needs, providers may be able to communicate more effectively in the same amount of time.”

Dr Rai also pointed out the importance of delegating both clinical and communication duties as needed. Dr Rai and his colleagues also cited earlier research demonstrating better outcomes for patients who had the option of communicating with their provider electronically.^1,2

Ultimately, the researchers concluded that effective provider communication can improve outcomes by streamlining care, alleviating anxiety, boosting mutual trust, and increasing treatment adherence.

1. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 2017;318:197–198.

2. Smith AB, Basch E. Role of patient-reported outcomes in postsurgical monitoring in oncology. J Oncol Pract 2017;13:535–538.

Photo by Rhoda Baer

Better communication between cancer patients and healthcare providers may provide tangible benefits, according to research published in JNCCN.

Cancer survivors who reported greater satisfaction in communicating with healthcare providers had better general health and mental health, fewer doctor visits, and reduced healthcare spending, when compared to patients who were less satisfied with communication.

“Our study suggests that when cancer care providers are more effective communicators, their patients are more likely to follow medical advice and medication protocols,” said study author Ashish Rai, PhD, of the American Cancer Society in Framingham, Massachusetts.

For this study, Dr Rai and his colleagues analyzed data from the Medical Expenditure Panel Survey (MEPS) from 2008 through 2014.

The researchers evaluated 4588 cancer survivors, dividing them into non-elderly and elderly groups. The non-elderly patients (n=2257) had a median age of 54 (range, 18-64), and the elderly patients (n=2331) had a median age of 75.

Communication satisfaction was measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS), in conjunction with the MEPS data.

Patients used a 4-point scale ranging from “never” to “always” to track whether their providers did the following:

• Listened carefully
• Explained things in a way that was easy to understand
• Showed respect for what the respondent had to say
• Spent enough time with the respondent.

A global satisfaction rating scale (0 to 10) was factored into a composite score and tracked across 12 months.

The researchers then assessed various patient outcomes.

Satisfaction and outcomes

Overall, patients who were the most satisfied with communication had the best outcomes with regard to general, physical, and mental health; fewer emergency department, hospital, and office visits; and reduced drug, out-of-pocket, and total healthcare expenditures.

However, the associations between communication satisfaction and outcomes were not always significant.

In an adjusted analysis, the elderly patients who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for general health, mental health, and total healthcare expenditures.

For the non-elderly patients, those who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for physician office visits and mental health.

Baseline health and satisfaction

In both age groups, patients with better baseline health reported higher satisfaction with communication. Conversely, the more comorbidities patients had, the lower their satisfaction rating.

The researchers said this suggests that more complex circumstances negatively impacted patients’ perception of their communication, and the finding highlights the importance of coordinating care across a team of providers.

“The results of this study present an interesting challenge: those survivors most in need of good communication about complex medical issues may not be receiving the information they seek in a manner that they find helpful. That, in turn, results in higher healthcare utilization and expenditure,” said Crystal Denlinger, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, who was not involved in this study.

“This could be due to many factors, including time constraints, competing priorities, and increasingly complex cancer therapies. This study highlights the need for additional research into how to tailor the healthcare experience both during and after cancer treatment in order to communicate more effectively.”

Conclusions

“Communication needs vary from patient to patient,” Dr Rai noted. “While time constraints do pose a challenge, the amount of time spent is only one of the attributes of effective communication. By tailoring their communication strategy to a patient’s specific needs, providers may be able to communicate more effectively in the same amount of time.”

Dr Rai also pointed out the importance of delegating both clinical and communication duties as needed. Dr Rai and his colleagues also cited earlier research demonstrating better outcomes for patients who had the option of communicating with their provider electronically.^1,2

Ultimately, the researchers concluded that effective provider communication can improve outcomes by streamlining care, alleviating anxiety, boosting mutual trust, and increasing treatment adherence.

1. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 2017;318:197–198.

2. Smith AB, Basch E. Role of patient-reported outcomes in postsurgical monitoring in oncology. J Oncol Pract 2017;13:535–538.

Photo by Rhoda Baer

Better communication between cancer patients and healthcare providers may provide tangible benefits, according to research published in JNCCN.

Cancer survivors who reported greater satisfaction in communicating with healthcare providers had better general health and mental health, fewer doctor visits, and reduced healthcare spending, when compared to patients who were less satisfied with communication.

“Our study suggests that when cancer care providers are more effective communicators, their patients are more likely to follow medical advice and medication protocols,” said study author Ashish Rai, PhD, of the American Cancer Society in Framingham, Massachusetts.

For this study, Dr Rai and his colleagues analyzed data from the Medical Expenditure Panel Survey (MEPS) from 2008 through 2014.

The researchers evaluated 4588 cancer survivors, dividing them into non-elderly and elderly groups. The non-elderly patients (n=2257) had a median age of 54 (range, 18-64), and the elderly patients (n=2331) had a median age of 75.

Communication satisfaction was measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS), in conjunction with the MEPS data.

Patients used a 4-point scale ranging from “never” to “always” to track whether their providers did the following:

• Listened carefully
• Explained things in a way that was easy to understand
• Showed respect for what the respondent had to say
• Spent enough time with the respondent.

A global satisfaction rating scale (0 to 10) was factored into a composite score and tracked across 12 months.

The researchers then assessed various patient outcomes.

Satisfaction and outcomes

Overall, patients who were the most satisfied with communication had the best outcomes with regard to general, physical, and mental health; fewer emergency department, hospital, and office visits; and reduced drug, out-of-pocket, and total healthcare expenditures.

However, the associations between communication satisfaction and outcomes were not always significant.

In an adjusted analysis, the elderly patients who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for general health, mental health, and total healthcare expenditures.

For the non-elderly patients, those who were more satisfied with communication in year 1 had significantly better outcomes in year 2 for physician office visits and mental health.

Baseline health and satisfaction

In both age groups, patients with better baseline health reported higher satisfaction with communication. Conversely, the more comorbidities patients had, the lower their satisfaction rating.

The researchers said this suggests that more complex circumstances negatively impacted patients’ perception of their communication, and the finding highlights the importance of coordinating care across a team of providers.

“The results of this study present an interesting challenge: those survivors most in need of good communication about complex medical issues may not be receiving the information they seek in a manner that they find helpful. That, in turn, results in higher healthcare utilization and expenditure,” said Crystal Denlinger, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, who was not involved in this study.

“This could be due to many factors, including time constraints, competing priorities, and increasingly complex cancer therapies. This study highlights the need for additional research into how to tailor the healthcare experience both during and after cancer treatment in order to communicate more effectively.”

Conclusions

“Communication needs vary from patient to patient,” Dr Rai noted. “While time constraints do pose a challenge, the amount of time spent is only one of the attributes of effective communication. By tailoring their communication strategy to a patient’s specific needs, providers may be able to communicate more effectively in the same amount of time.”

Dr Rai also pointed out the importance of delegating both clinical and communication duties as needed. Dr Rai and his colleagues also cited earlier research demonstrating better outcomes for patients who had the option of communicating with their provider electronically.^1,2

Ultimately, the researchers concluded that effective provider communication can improve outcomes by streamlining care, alleviating anxiety, boosting mutual trust, and increasing treatment adherence.

1. Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 2017;318:197–198.

2. Smith AB, Basch E. Role of patient-reported outcomes in postsurgical monitoring in oncology. J Oncol Pract 2017;13:535–538.

Photo by Graham Colm

New technology has enabled researchers to create a “genomic atlas of the human plasma proteome,” according to an article published in Nature.

The researchers identified nearly 2000 genetic associations with close to 1500 proteins, and they believe these discoveries will improve our understanding of diseases and aid drug development.

“Compared to genes, proteins have been relatively understudied in human blood, even though they are the ‘effectors’ of human biology, are disrupted in many diseases, and are the targets of most medicines,” said study author Adam Butterworth, PhD, of the University of Cambridge in the UK.

“Novel technologies are now allowing us to start addressing this gap in our knowledge.”

Dr Butterworth and his colleagues used an assay called SOMAscan (developed by the company SomaLogic) to measure 3622 proteins in the blood of 3301 people. The team then analyzed the DNA of these individuals to see which regions of their genomes were associated with protein levels.

In this way, the researchers found 1927 significant associations between 1478 proteins and 764 genomic regions. These findings are publicly available via the University of Cambridge website.

The researchers said one way to use this information is to identify biological pathways that cause diseases.

“Thanks to the genomics revolution over the past decade, we’ve been good at finding statistical associations between the genome and disease, but the difficulty has been then identifying the disease-causing genes and pathways,” said study author James Peters, PhD, of the University of Cambridge.

“Now, by combining our database with what we know about associations between genetic variants and disease, we are able to say a lot more about the biology of disease.”

In some cases, the researchers identified multiple genetic variants influencing levels of a protein. By combining these variants into a “score” for that protein, they were able to identify new associations between proteins and disease.

The team also said the proteomic genetic data can be used to aid drug development. In addition to highlighting potential side effects of drugs, the findings can provide insights on protein targets of new and existing drugs.

By linking drugs, proteins, genetic variation, and diseases, the researchers have already suggested existing drugs that could potentially be used to treat different diseases and increased confidence that certain drugs currently in development might be successful in clinical trials.

“Our database is really just a starting point,” said study author Benjamin Sun, an MB/PhD student at the University of Cambridge.

“We’ve given some examples in this study of how it might be used, but now it’s over to the research community to begin using it and finding new applications.”

The research was funded by MSD, National Institute for Health Research, NHS Blood and Transplant, British Heart Foundation, Medical Research Council, UK Research and Innovation, and SomaLogic.

Photo by Graham Colm

New technology has enabled researchers to create a “genomic atlas of the human plasma proteome,” according to an article published in Nature.

The researchers identified nearly 2000 genetic associations with close to 1500 proteins, and they believe these discoveries will improve our understanding of diseases and aid drug development.

“Compared to genes, proteins have been relatively understudied in human blood, even though they are the ‘effectors’ of human biology, are disrupted in many diseases, and are the targets of most medicines,” said study author Adam Butterworth, PhD, of the University of Cambridge in the UK.

“Novel technologies are now allowing us to start addressing this gap in our knowledge.”

Dr Butterworth and his colleagues used an assay called SOMAscan (developed by the company SomaLogic) to measure 3622 proteins in the blood of 3301 people. The team then analyzed the DNA of these individuals to see which regions of their genomes were associated with protein levels.

In this way, the researchers found 1927 significant associations between 1478 proteins and 764 genomic regions. These findings are publicly available via the University of Cambridge website.

The researchers said one way to use this information is to identify biological pathways that cause diseases.

“Thanks to the genomics revolution over the past decade, we’ve been good at finding statistical associations between the genome and disease, but the difficulty has been then identifying the disease-causing genes and pathways,” said study author James Peters, PhD, of the University of Cambridge.

“Now, by combining our database with what we know about associations between genetic variants and disease, we are able to say a lot more about the biology of disease.”

In some cases, the researchers identified multiple genetic variants influencing levels of a protein. By combining these variants into a “score” for that protein, they were able to identify new associations between proteins and disease.

The team also said the proteomic genetic data can be used to aid drug development. In addition to highlighting potential side effects of drugs, the findings can provide insights on protein targets of new and existing drugs.

By linking drugs, proteins, genetic variation, and diseases, the researchers have already suggested existing drugs that could potentially be used to treat different diseases and increased confidence that certain drugs currently in development might be successful in clinical trials.

“Our database is really just a starting point,” said study author Benjamin Sun, an MB/PhD student at the University of Cambridge.

“We’ve given some examples in this study of how it might be used, but now it’s over to the research community to begin using it and finding new applications.”

The research was funded by MSD, National Institute for Health Research, NHS Blood and Transplant, British Heart Foundation, Medical Research Council, UK Research and Innovation, and SomaLogic.

Photo by Graham Colm

New technology has enabled researchers to create a “genomic atlas of the human plasma proteome,” according to an article published in Nature.

The researchers identified nearly 2000 genetic associations with close to 1500 proteins, and they believe these discoveries will improve our understanding of diseases and aid drug development.

“Compared to genes, proteins have been relatively understudied in human blood, even though they are the ‘effectors’ of human biology, are disrupted in many diseases, and are the targets of most medicines,” said study author Adam Butterworth, PhD, of the University of Cambridge in the UK.

“Novel technologies are now allowing us to start addressing this gap in our knowledge.”

Dr Butterworth and his colleagues used an assay called SOMAscan (developed by the company SomaLogic) to measure 3622 proteins in the blood of 3301 people. The team then analyzed the DNA of these individuals to see which regions of their genomes were associated with protein levels.

In this way, the researchers found 1927 significant associations between 1478 proteins and 764 genomic regions. These findings are publicly available via the University of Cambridge website.

The researchers said one way to use this information is to identify biological pathways that cause diseases.

“Thanks to the genomics revolution over the past decade, we’ve been good at finding statistical associations between the genome and disease, but the difficulty has been then identifying the disease-causing genes and pathways,” said study author James Peters, PhD, of the University of Cambridge.

“Now, by combining our database with what we know about associations between genetic variants and disease, we are able to say a lot more about the biology of disease.”

In some cases, the researchers identified multiple genetic variants influencing levels of a protein. By combining these variants into a “score” for that protein, they were able to identify new associations between proteins and disease.

The team also said the proteomic genetic data can be used to aid drug development. In addition to highlighting potential side effects of drugs, the findings can provide insights on protein targets of new and existing drugs.

By linking drugs, proteins, genetic variation, and diseases, the researchers have already suggested existing drugs that could potentially be used to treat different diseases and increased confidence that certain drugs currently in development might be successful in clinical trials.

“Our database is really just a starting point,” said study author Benjamin Sun, an MB/PhD student at the University of Cambridge.

“We’ve given some examples in this study of how it might be used, but now it’s over to the research community to begin using it and finding new applications.”

The research was funded by MSD, National Institute for Health Research, NHS Blood and Transplant, British Heart Foundation, Medical Research Council, UK Research and Innovation, and SomaLogic.