Multiple Myeloma

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Results of a multicenter study indicate that a tool cancer patients can use to report adverse events (AEs) is as accurate as other, established patient-reported and clinical measures.

The tool is the National Cancer Institute’s Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Study investigators were able to validate 119 of 124 PRO-CTCAE questions against 2 established measurement tools.

The 5 questions that were not validated could not be evaluated due to underrepresentation in the study population.

This research was published in JAMA Oncology.

“In most cancer clinical trials, information on side effects is collected by providers who have limited time with their patients, and current patient questionnaires are limited in scope and depth,” said study author Amylou Dueck, PhD, of the Mayo Clinic in Scottsdale, Arizona.

“PRO-CTCAE is a library of items for patients to directly report on the level of each of their symptoms, to enhance the reporting of side effects in cancer clinical trials, which is normally based on information from providers. The study itself is unprecedented, as more than 100 distinct questions about symptomatic adverse events were validated simultaneously.”

To assess the PRO-CTCAE, Dr Dueck and her colleagues recruited 975 cancer patients from 9 clinical practices across the US, including 7 cancer centers.

The patients had a range of cancers and were undergoing outpatient chemotherapy and/or radiation therapy. The investigators said these participants reflected the geographic, ethnic, racial, and economic diversity in cancer clinical trials.

The patients were asked to fill out the PRO-CTCAE questionnaire before appointments. The investigators then compared patient reports to clinician-reported Eastern Cooperative Oncology Group (ECOG) performance status and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).

A majority of patients completed items on the PRO-CTCAE questionnaire at their first visit (96.4%, 940/975) and second visit (90.6%, 852/940).

Most patients (99.8%, 938/940) reported having at least 1 symptomatic AE, with 81.7% (768/940) reporting at least 1 AE as frequent, severe, and/or interfering “quite a bit” with daily activities.

To gauge the accuracy of the PRO-CTCAE, the investigators assessed construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.

Construct validity

The investigators explained that construct validity reflects the association between a new measurement tool and an established measure.

Construct validity is often investigated through convergent validity, which determines whether the new tool moves in the same direction as an established instrument, and known-groups validity, which determines whether the tool can distinguish between groups of patients who are thought to be distinct.

When the investigators considered all QLQ-C30 functioning/global scales, they found that all 124 items on the PRO-CTCAE questionnaire were associated in the expected direction with 1 or more scales. One hundred and fourteen of the PRO-CTCAE items demonstrated a meaningful correlation (Pearson r≥0.1), and 111 of them were statistically significant (P<0.05 for all).

Scores for 94 of 124 PRO-CTCAE items were higher among patients with an ECOG performance status of 2 to 4 (17.1% of patients) than among patients with a score of 0 to 1. The difference was significant for 58 of the items (P<0.05 for all).

Test-retest reliability and responsiveness

The investigators said they estimated test-retest reliability using the intraclass correlation coefficient (ICC), based on a 1-way analysis of variance model with an ICC of 0.7 or greater interpreted as high.

Test-retest reliability was 0.7 or greater for 36 of 49 prespecified PRO-CTCAE items. The median ICC was 0.76 [range, 0.53-0.96).

The investigators assessed the responsiveness of PRO-CTCAE items by comparing any change from the first visit to the second visit in 27 items that were selected a priori.

Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were significant for all 27 items (P≤0.006 for all).

“This is a landmark study demonstrating that meaningful information about adverse events can be elicited from patients themselves, which is a major step for advancing the patient-centeredness of clinical trials,” said study author Ethan Basch, MD, of the Lineberger Cancer Center of the University of North Carolina in Chapel Hill.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Results of a multicenter study indicate that a tool cancer patients can use to report adverse events (AEs) is as accurate as other, established patient-reported and clinical measures.

The tool is the National Cancer Institute’s Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Study investigators were able to validate 119 of 124 PRO-CTCAE questions against 2 established measurement tools.

The 5 questions that were not validated could not be evaluated due to underrepresentation in the study population.

This research was published in JAMA Oncology.

“In most cancer clinical trials, information on side effects is collected by providers who have limited time with their patients, and current patient questionnaires are limited in scope and depth,” said study author Amylou Dueck, PhD, of the Mayo Clinic in Scottsdale, Arizona.

“PRO-CTCAE is a library of items for patients to directly report on the level of each of their symptoms, to enhance the reporting of side effects in cancer clinical trials, which is normally based on information from providers. The study itself is unprecedented, as more than 100 distinct questions about symptomatic adverse events were validated simultaneously.”

To assess the PRO-CTCAE, Dr Dueck and her colleagues recruited 975 cancer patients from 9 clinical practices across the US, including 7 cancer centers.

The patients had a range of cancers and were undergoing outpatient chemotherapy and/or radiation therapy. The investigators said these participants reflected the geographic, ethnic, racial, and economic diversity in cancer clinical trials.

The patients were asked to fill out the PRO-CTCAE questionnaire before appointments. The investigators then compared patient reports to clinician-reported Eastern Cooperative Oncology Group (ECOG) performance status and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).

A majority of patients completed items on the PRO-CTCAE questionnaire at their first visit (96.4%, 940/975) and second visit (90.6%, 852/940).

Most patients (99.8%, 938/940) reported having at least 1 symptomatic AE, with 81.7% (768/940) reporting at least 1 AE as frequent, severe, and/or interfering “quite a bit” with daily activities.

To gauge the accuracy of the PRO-CTCAE, the investigators assessed construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.

Construct validity

The investigators explained that construct validity reflects the association between a new measurement tool and an established measure.

Construct validity is often investigated through convergent validity, which determines whether the new tool moves in the same direction as an established instrument, and known-groups validity, which determines whether the tool can distinguish between groups of patients who are thought to be distinct.

When the investigators considered all QLQ-C30 functioning/global scales, they found that all 124 items on the PRO-CTCAE questionnaire were associated in the expected direction with 1 or more scales. One hundred and fourteen of the PRO-CTCAE items demonstrated a meaningful correlation (Pearson r≥0.1), and 111 of them were statistically significant (P<0.05 for all).

Scores for 94 of 124 PRO-CTCAE items were higher among patients with an ECOG performance status of 2 to 4 (17.1% of patients) than among patients with a score of 0 to 1. The difference was significant for 58 of the items (P<0.05 for all).

Test-retest reliability and responsiveness

The investigators said they estimated test-retest reliability using the intraclass correlation coefficient (ICC), based on a 1-way analysis of variance model with an ICC of 0.7 or greater interpreted as high.

Test-retest reliability was 0.7 or greater for 36 of 49 prespecified PRO-CTCAE items. The median ICC was 0.76 [range, 0.53-0.96).

The investigators assessed the responsiveness of PRO-CTCAE items by comparing any change from the first visit to the second visit in 27 items that were selected a priori.

Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were significant for all 27 items (P≤0.006 for all).

“This is a landmark study demonstrating that meaningful information about adverse events can be elicited from patients themselves, which is a major step for advancing the patient-centeredness of clinical trials,” said study author Ethan Basch, MD, of the Lineberger Cancer Center of the University of North Carolina in Chapel Hill.

Cancer patient

receiving chemotherapy

Photo by Rhoda Baer

Results of a multicenter study indicate that a tool cancer patients can use to report adverse events (AEs) is as accurate as other, established patient-reported and clinical measures.

The tool is the National Cancer Institute’s Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Study investigators were able to validate 119 of 124 PRO-CTCAE questions against 2 established measurement tools.

The 5 questions that were not validated could not be evaluated due to underrepresentation in the study population.

This research was published in JAMA Oncology.

“In most cancer clinical trials, information on side effects is collected by providers who have limited time with their patients, and current patient questionnaires are limited in scope and depth,” said study author Amylou Dueck, PhD, of the Mayo Clinic in Scottsdale, Arizona.

“PRO-CTCAE is a library of items for patients to directly report on the level of each of their symptoms, to enhance the reporting of side effects in cancer clinical trials, which is normally based on information from providers. The study itself is unprecedented, as more than 100 distinct questions about symptomatic adverse events were validated simultaneously.”

To assess the PRO-CTCAE, Dr Dueck and her colleagues recruited 975 cancer patients from 9 clinical practices across the US, including 7 cancer centers.

The patients had a range of cancers and were undergoing outpatient chemotherapy and/or radiation therapy. The investigators said these participants reflected the geographic, ethnic, racial, and economic diversity in cancer clinical trials.

The patients were asked to fill out the PRO-CTCAE questionnaire before appointments. The investigators then compared patient reports to clinician-reported Eastern Cooperative Oncology Group (ECOG) performance status and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).

A majority of patients completed items on the PRO-CTCAE questionnaire at their first visit (96.4%, 940/975) and second visit (90.6%, 852/940).

Most patients (99.8%, 938/940) reported having at least 1 symptomatic AE, with 81.7% (768/940) reporting at least 1 AE as frequent, severe, and/or interfering “quite a bit” with daily activities.

To gauge the accuracy of the PRO-CTCAE, the investigators assessed construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.

Construct validity

The investigators explained that construct validity reflects the association between a new measurement tool and an established measure.

Construct validity is often investigated through convergent validity, which determines whether the new tool moves in the same direction as an established instrument, and known-groups validity, which determines whether the tool can distinguish between groups of patients who are thought to be distinct.

When the investigators considered all QLQ-C30 functioning/global scales, they found that all 124 items on the PRO-CTCAE questionnaire were associated in the expected direction with 1 or more scales. One hundred and fourteen of the PRO-CTCAE items demonstrated a meaningful correlation (Pearson r≥0.1), and 111 of them were statistically significant (P<0.05 for all).

Scores for 94 of 124 PRO-CTCAE items were higher among patients with an ECOG performance status of 2 to 4 (17.1% of patients) than among patients with a score of 0 to 1. The difference was significant for 58 of the items (P<0.05 for all).

Test-retest reliability and responsiveness

The investigators said they estimated test-retest reliability using the intraclass correlation coefficient (ICC), based on a 1-way analysis of variance model with an ICC of 0.7 or greater interpreted as high.

Test-retest reliability was 0.7 or greater for 36 of 49 prespecified PRO-CTCAE items. The median ICC was 0.76 [range, 0.53-0.96).

The investigators assessed the responsiveness of PRO-CTCAE items by comparing any change from the first visit to the second visit in 27 items that were selected a priori.

Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were significant for all 27 items (P≤0.006 for all).

“This is a landmark study demonstrating that meaningful information about adverse events can be elicited from patients themselves, which is a major step for advancing the patient-centeredness of clinical trials,” said study author Ethan Basch, MD, of the Lineberger Cancer Center of the University of North Carolina in Chapel Hill.

Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have 1 or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

Such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE said it wants to add edoxaban to that list because the drug is a clinically and cost-effective treatment option for these patients.

NICE’s draft guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other newer oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the newer oral anticoagulants.

Nevertheless, the committee recommended edoxaban as a cost-effective treatment for patients with NVAF who have 1 or more risk factors for stroke.

NICE’s draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations.

Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have 1 or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

Such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE said it wants to add edoxaban to that list because the drug is a clinically and cost-effective treatment option for these patients.

NICE’s draft guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other newer oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the newer oral anticoagulants.

Nevertheless, the committee recommended edoxaban as a cost-effective treatment for patients with NVAF who have 1 or more risk factors for stroke.

NICE’s draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations.

Prescription medications

Photo courtesy of the CDC

The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF).

The patients must have 1 or more risk factors for stroke, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischemic attack, and age of 75 years or older.

Such patients are generally treated with warfarin or the newer oral anticoagulants dabigatran, rivaroxaban, and apixaban.

NICE said it wants to add edoxaban to that list because the drug is a clinically and cost-effective treatment option for these patients.

NICE’s draft guidance says the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the patient about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran, and rivaroxaban.

For patients considering switching from warfarin, edoxaban’s potential benefits should be weighed against its potential risks, taking into account the patient’s level of international normalized ratio control.

Clinical effectiveness

NICE’s conclusion that edoxaban is clinically effective was based primarily on results of the ENGAGE AF-TIMI 48 trial. In this trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

Results suggested edoxaban was at least non-inferior to warfarin with regard to efficacy, and edoxaban was associated with a significantly lower rate of major and fatal bleeding.

A committee advising NICE also reviewed a meta-analysis prepared by Daiichi Sankyo Co., Ltd., the company developing edoxaban.

The goal of the meta-analysis was to compare edoxaban with rivaroxaban, apixaban, and dabigatran. The analysis included 4 trials: ENGAGE AF-TIMI 48, ARISTOTLE (apixaban), RE-LY (dabigatran), and ROCKET-AF (rivaroxaban). All 4 trials had a warfarin comparator arm.

The results of the meta-analysis indicated that, for the composite endpoint of stroke and systemic embolism, efficacy was similar for high-dose edoxaban and the other newer oral anticoagulants.

However, edoxaban significantly reduced major bleeding risk by 24% compared to rivaroxaban, 28% compared to dabigatran at 150 mg, and 17% compared to dabigatran at 110 mg. Major bleeding rates were similar for high-dose edoxaban and apixaban.

The committee advising NICE said these results should be interpreted with caution, but edoxaban is unlikely to be different from rivaroxaban, apixaban, and dabigatran in clinical practice.

Cost-effectiveness

Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg), and the daily cost of treatment is £2.10 (excluding value-added tax). However, costs may vary in different settings because of negotiated procurement discounts.

The committee advising NICE analyzed cost information and concluded that edoxaban is cost-effective compared with warfarin, but there is insufficient evidence to distinguish between the clinical and cost-effectiveness of edoxaban and the newer oral anticoagulants.

Nevertheless, the committee recommended edoxaban as a cost-effective treatment for patients with NVAF who have 1 or more risk factors for stroke.

NICE’s draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations.

Woman praying

Photo by Petr Kratochvil

Three meta-analyses shed new light on the role religion and spirituality play in cancer patients’ mental, social, and physical well-being.

The analyses, published in Cancer, indicate that religion and spirituality have significant associations with patients’ health.

But investigators observed wide variability among studies with regard to how different dimensions of religion and spirituality relate to different aspects of health.

In the first analysis, the investigators focused on physical health. Patients reporting greater overall religiousness and spirituality reported better physical health, greater ability to perform their usual daily tasks, and fewer physical symptoms of cancer and treatment.

“These relationships were particularly strong in patients who experienced greater emotional aspects of religion and spirituality, including a sense of meaning and purpose in life as well as a connection to a source larger than oneself,” said study author Heather Jim, PhD, of the Moffitt Cancer Center in Tampa, Florida.

Dr Jim noted that patients who reported greater cognitive aspects of religion and spirituality, such as the ability to integrate the cancer into their religious or spiritual beliefs, also reported better physical health. However, physical health was not related to behavioral aspects of religion and spiritualty, such as church attendance, prayer, or meditation.

In the second analysis, the investigators examined patients’ mental health. The team discovered that emotional aspects of religion and spirituality were more strongly associated with positive mental health than behavioral or cognitive aspects of religion and spirituality.

“Spiritual well-being was, unsurprisingly, associated with less anxiety, depression, or distress,” said study author John Salsman, PhD, of Wake Forest School of Medicine in Winston-Salem, North Carolina.

“Also, greater levels of spiritual distress and a sense of disconnectedness with God or a religious community was associated with greater psychological distress or poorer emotional well-being.”

The third analysis pertained to social health, or patients’ capacity to retain social roles and relationships in the face of illness.  Religion and spirituality, as well as each of its dimensions, had modest but reliable links with social health.

“When we took a closer look, we found that patients with stronger spiritual well-being, more benign images of God (such as perceptions of a benevolent God rather than an angry or distant God), or stronger beliefs (such as convictions that a personal God can be called upon for assistance) reported better social health,” said study author Allen Sherman, PhD, of the University of Arkansas for Medical Sciences in Little Rock. “In contrast, those who struggled with their faith fared more poorly.”

The investigators believe future research should focus on how relationships between religious or spiritual involvement and health change over time and whether support services designed to enhance particular aspects of religion and spirituality in interested patients might help improve their well-being.

“In addition, some patients struggle with the religious or spiritual significance of their cancer, which is normal,” Dr Jim said. “How they resolve their struggle may impact their health, but more research is needed to better understand and support these patients.”

Woman praying

Photo by Petr Kratochvil

Three meta-analyses shed new light on the role religion and spirituality play in cancer patients’ mental, social, and physical well-being.

The analyses, published in Cancer, indicate that religion and spirituality have significant associations with patients’ health.

But investigators observed wide variability among studies with regard to how different dimensions of religion and spirituality relate to different aspects of health.

In the first analysis, the investigators focused on physical health. Patients reporting greater overall religiousness and spirituality reported better physical health, greater ability to perform their usual daily tasks, and fewer physical symptoms of cancer and treatment.

“These relationships were particularly strong in patients who experienced greater emotional aspects of religion and spirituality, including a sense of meaning and purpose in life as well as a connection to a source larger than oneself,” said study author Heather Jim, PhD, of the Moffitt Cancer Center in Tampa, Florida.

Dr Jim noted that patients who reported greater cognitive aspects of religion and spirituality, such as the ability to integrate the cancer into their religious or spiritual beliefs, also reported better physical health. However, physical health was not related to behavioral aspects of religion and spiritualty, such as church attendance, prayer, or meditation.

In the second analysis, the investigators examined patients’ mental health. The team discovered that emotional aspects of religion and spirituality were more strongly associated with positive mental health than behavioral or cognitive aspects of religion and spirituality.

“Spiritual well-being was, unsurprisingly, associated with less anxiety, depression, or distress,” said study author John Salsman, PhD, of Wake Forest School of Medicine in Winston-Salem, North Carolina.

“Also, greater levels of spiritual distress and a sense of disconnectedness with God or a religious community was associated with greater psychological distress or poorer emotional well-being.”

The third analysis pertained to social health, or patients’ capacity to retain social roles and relationships in the face of illness.  Religion and spirituality, as well as each of its dimensions, had modest but reliable links with social health.

“When we took a closer look, we found that patients with stronger spiritual well-being, more benign images of God (such as perceptions of a benevolent God rather than an angry or distant God), or stronger beliefs (such as convictions that a personal God can be called upon for assistance) reported better social health,” said study author Allen Sherman, PhD, of the University of Arkansas for Medical Sciences in Little Rock. “In contrast, those who struggled with their faith fared more poorly.”

The investigators believe future research should focus on how relationships between religious or spiritual involvement and health change over time and whether support services designed to enhance particular aspects of religion and spirituality in interested patients might help improve their well-being.

“In addition, some patients struggle with the religious or spiritual significance of their cancer, which is normal,” Dr Jim said. “How they resolve their struggle may impact their health, but more research is needed to better understand and support these patients.”

Woman praying

Photo by Petr Kratochvil

Three meta-analyses shed new light on the role religion and spirituality play in cancer patients’ mental, social, and physical well-being.

The analyses, published in Cancer, indicate that religion and spirituality have significant associations with patients’ health.

But investigators observed wide variability among studies with regard to how different dimensions of religion and spirituality relate to different aspects of health.

In the first analysis, the investigators focused on physical health. Patients reporting greater overall religiousness and spirituality reported better physical health, greater ability to perform their usual daily tasks, and fewer physical symptoms of cancer and treatment.

“These relationships were particularly strong in patients who experienced greater emotional aspects of religion and spirituality, including a sense of meaning and purpose in life as well as a connection to a source larger than oneself,” said study author Heather Jim, PhD, of the Moffitt Cancer Center in Tampa, Florida.

Dr Jim noted that patients who reported greater cognitive aspects of religion and spirituality, such as the ability to integrate the cancer into their religious or spiritual beliefs, also reported better physical health. However, physical health was not related to behavioral aspects of religion and spiritualty, such as church attendance, prayer, or meditation.

In the second analysis, the investigators examined patients’ mental health. The team discovered that emotional aspects of religion and spirituality were more strongly associated with positive mental health than behavioral or cognitive aspects of religion and spirituality.

“Spiritual well-being was, unsurprisingly, associated with less anxiety, depression, or distress,” said study author John Salsman, PhD, of Wake Forest School of Medicine in Winston-Salem, North Carolina.

“Also, greater levels of spiritual distress and a sense of disconnectedness with God or a religious community was associated with greater psychological distress or poorer emotional well-being.”

The third analysis pertained to social health, or patients’ capacity to retain social roles and relationships in the face of illness.  Religion and spirituality, as well as each of its dimensions, had modest but reliable links with social health.

“When we took a closer look, we found that patients with stronger spiritual well-being, more benign images of God (such as perceptions of a benevolent God rather than an angry or distant God), or stronger beliefs (such as convictions that a personal God can be called upon for assistance) reported better social health,” said study author Allen Sherman, PhD, of the University of Arkansas for Medical Sciences in Little Rock. “In contrast, those who struggled with their faith fared more poorly.”

The investigators believe future research should focus on how relationships between religious or spiritual involvement and health change over time and whether support services designed to enhance particular aspects of religion and spirituality in interested patients might help improve their well-being.

“In addition, some patients struggle with the religious or spiritual significance of their cancer, which is normal,” Dr Jim said. “How they resolve their struggle may impact their health, but more research is needed to better understand and support these patients.”

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Blood sample collection

Photo by Juan D. Alfonso

Researchers from the International Myeloma Working Group (IMWG) have proposed revising the International Staging System (ISS) used to stratify patients with newly diagnosed multiple myeloma (MM).

The group’s revised ISS (R-ISS) combines the current ISS with tests for chromosomal abnormalities (CAs) and serum lactate dehydrogenase (LDH) in an attempt to refine the system’s prognostic value.

IMWG researchers assessed the R-ISS in more than 3000 newly diagnosed MM patients and found that patients with R-ISS stage I disease had better overall survival (OS) and progression-free survival (PFS) than patients with stage I disease according to the ISS.

And patients with R-ISS stage III disease had worse survival rates than patients with stage III disease according to the ISS. But PFS and OS numbers for stage II disease were the same with both systems.

The researchers reported these results in the Journal of Clinical Oncology.

They noted that the existing ISS relies on tests for serum β₂-microglobulin and serum albumin to divide patients into 3 risk-factor stages. But the R-ISS adds interphase fluorescence in situ hybridization to check for CAs, along with separate tests for heightened LDH.

The researchers define the 3 R-ISS groups as follows:

• R-ISS I includes patients with ISS stage I disease (serum β₂-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CAs (del[17p] and/or t[4;14] and/or t[14;16]), and normal LDH levels (less than the upper limit of normal range).
• R-ISS III includes patients with ISS stage III disease (serum β₂-microglobulin level > 5.5 mg/L) and high-risk CAs or high LDH levels.
• R-ISS II includes patients with all other possible combinations.

To evaluate the prognostic value of the R-ISS, the researchers analyzed data from 4445 newly diagnosed MM patients who were enrolled in 11 completed trials. ISS, CA, and LDH data were available for 3060 patients.

At a median follow-up of 46 months, the 5-year OS rate was 82% in the R-ISS I group (n=871), 62% in the R-ISS II group (n=1894), and 40% in the R-ISS III group (n=295). The 5-year PFS rates were 55%, 36%, and 24%, respectively.

In comparison, the 5-year OS rate was 77% for patients with ISS stage I disease (n=1615), 62% for ISS stage II (n=1630), and 47% for ISS stage III (n=987). The 5-year PFS rates were 49%, 36%, and 30%, respectively.

Based on this work, the researchers said the R-ISS is a simple but powerful prognostic staging system, and they recommend its use in future studies to stratify newly diagnosed MM patients effectively.

“The revised staging system can be used by doctors to discuss prognostic results very carefully with individual patients,” added Brian G.M. Durie, MD, chairman of the IMWG.

“It’s helpful to know the expectations and consider how treatments can be modified based on the new ISS system.”

Time-lapse images of

apoptosis in cancer cells

Researchers say they have identified a new mechanism by which the tumor suppressor protein p53 triggers apoptosis, and they believe this process could be harnessed to kill cancer cells.

The team discovered how p53 acts in the cytoplasm to trigger cell death by binding to and activating the BAX protein.

The process involves a shape change in one of p53’s amino acids that serves as the “switch” to activate BAX and trigger the apoptotic pathway.

The team also identified the enzyme in the cytoplasm that promotes the change that controls the “switch.”

Richard Kriwacki, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues described these findings in Molecular Cell.

Like up to half of all proteins, p53 includes both structured and disordered regions. A disordered region is a segment that does not adopt a single shape but

remains flexible and constantly switches between different shapes until

it encounters a partner.

Dr Kriwacki and his colleagues showed that both structured and disordered regions of p53 play a role in BAX activation in the cytoplasm.

The process starts when a structured region of p53 known as the DNA-binding domain binds to BAX. That sets the stage for the unstructured region of p53 to form a second bond, which activates BAX and triggers apoptosis.

“There were no previous reports of this disordered region of p53 binding to BAX, so the finding that this region was the key to BAX activation was a total surprise,” Dr Kriwacki said.

The disordered p53 segment included the amino acid proline, which can change between two shapes, particularly in the presence of the enzyme Pin1.

Using NMR spectroscopy, the researchers showed that the proline shape change promotes p53 binding and activation of BAX.

“These results expand our understanding of the different ways p53 modulates cell behavior,” Dr Kriwacki said. “The findings also raise the possibility of killing tumor cells using small molecules to trigger BAX-dependent apoptosis.”

Time-lapse images of

apoptosis in cancer cells

Researchers say they have identified a new mechanism by which the tumor suppressor protein p53 triggers apoptosis, and they believe this process could be harnessed to kill cancer cells.

The team discovered how p53 acts in the cytoplasm to trigger cell death by binding to and activating the BAX protein.

The process involves a shape change in one of p53’s amino acids that serves as the “switch” to activate BAX and trigger the apoptotic pathway.

The team also identified the enzyme in the cytoplasm that promotes the change that controls the “switch.”

Richard Kriwacki, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues described these findings in Molecular Cell.

Like up to half of all proteins, p53 includes both structured and disordered regions. A disordered region is a segment that does not adopt a single shape but

remains flexible and constantly switches between different shapes until

it encounters a partner.

Dr Kriwacki and his colleagues showed that both structured and disordered regions of p53 play a role in BAX activation in the cytoplasm.

The process starts when a structured region of p53 known as the DNA-binding domain binds to BAX. That sets the stage for the unstructured region of p53 to form a second bond, which activates BAX and triggers apoptosis.

“There were no previous reports of this disordered region of p53 binding to BAX, so the finding that this region was the key to BAX activation was a total surprise,” Dr Kriwacki said.

The disordered p53 segment included the amino acid proline, which can change between two shapes, particularly in the presence of the enzyme Pin1.

Using NMR spectroscopy, the researchers showed that the proline shape change promotes p53 binding and activation of BAX.

“These results expand our understanding of the different ways p53 modulates cell behavior,” Dr Kriwacki said. “The findings also raise the possibility of killing tumor cells using small molecules to trigger BAX-dependent apoptosis.”

Time-lapse images of

apoptosis in cancer cells

Researchers say they have identified a new mechanism by which the tumor suppressor protein p53 triggers apoptosis, and they believe this process could be harnessed to kill cancer cells.

The team discovered how p53 acts in the cytoplasm to trigger cell death by binding to and activating the BAX protein.

The process involves a shape change in one of p53’s amino acids that serves as the “switch” to activate BAX and trigger the apoptotic pathway.

The team also identified the enzyme in the cytoplasm that promotes the change that controls the “switch.”

Richard Kriwacki, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues described these findings in Molecular Cell.

Like up to half of all proteins, p53 includes both structured and disordered regions. A disordered region is a segment that does not adopt a single shape but

remains flexible and constantly switches between different shapes until

it encounters a partner.

Dr Kriwacki and his colleagues showed that both structured and disordered regions of p53 play a role in BAX activation in the cytoplasm.

The process starts when a structured region of p53 known as the DNA-binding domain binds to BAX. That sets the stage for the unstructured region of p53 to form a second bond, which activates BAX and triggers apoptosis.

“There were no previous reports of this disordered region of p53 binding to BAX, so the finding that this region was the key to BAX activation was a total surprise,” Dr Kriwacki said.

The disordered p53 segment included the amino acid proline, which can change between two shapes, particularly in the presence of the enzyme Pin1.

Using NMR spectroscopy, the researchers showed that the proline shape change promotes p53 binding and activation of BAX.

“These results expand our understanding of the different ways p53 modulates cell behavior,” Dr Kriwacki said. “The findings also raise the possibility of killing tumor cells using small molecules to trigger BAX-dependent apoptosis.”

Doctor and patient

Photo courtesy of NIH

Patients who make 3 or more trips to the general practitioner (GP) before they are referred for cancer tests are more likely to be dissatisfied with subsequent care, according to research published in the European Journal of Cancer Care.

Researchers analyzed survey responses from nearly 60,000 cancer patients and found that about 23% had visited their GP 3 or more times before they were referred for cancer tests.

These patients were more likely than patients with 1 or 2 GP visits to report negative experiences with regard to many different aspects of their care.

“This research shows that first impressions go a long way in determining how cancer patients view their experience of cancer treatment,” said study author Georgios Lyratzopoulos, MD, of University College London in the UK.

“A negative experience of diagnosis can trigger loss of confidence in their care throughout the cancer journey. When they occur, diagnostic delays are largely due to cancer symptoms being extremely hard to distinguish from other diseases, combined with a lack of accurate and easy-to-use tests. New diagnostic tools to help doctors decide which patients need referring are vital to improve the care experience for even more cancer patients.”

Dr Lyratzopoulos and his colleagues initially analyzed survey data from 73,462 cancer patients, but 15,355 of those patients (21%) had not seen a GP prior to their cancer diagnosis.

Of the 58,107 patients who had at least 1 primary care consultation, 44,827 (77%) had seen their GP once or twice before referral for cancer tests, and 13,280 (23%) had seen the GP 3 or more times.

The researchers analyzed patients’ responses to 12 survey questions that assessed satisfaction with various aspects of their cancer care.

And results showed that patients who had seen their GP 3 or more times before referral were significantly more likely than patients with 1 to 2 GP visits to report negative experiences across 10 of the 12 aspects of care.

The 12 aspects of care and patient responses (for 3+ GP visits and 1-2 visits, respectively) were as follows:

1. Dissatisfied with overall care: 16% vs 9% (adjusted* odds ratio [aOR]=1.44, P<0.001)
2. Dissatisfied with the way they were informed of their cancer: 22% vs 14% (aOR=1.38, P<0.001)
3. Dissatisfied with their involvement in decision-making: 32% vs 25% (aOR=1.13, P<0.001)
4. Lack of confidence/trust in their doctors: 19% vs 12% (aOR=1.22, P<0.001)
5. Lack of confidence/trust in their nurses: 36% vs 27% (aOR=1.22, P<0.001)
6. Thought doctors/nurses deliberately withheld information: 16% vs 10% (aOR=1.27, P<0.001)
7. Dissatisfied with staff support: 41% vs 27% (aOR=1.68, P<0.001)
8. Dissatisfied with integration of various caregivers (GP, hospital doctors/nurses, specialist nurses, etc): 45% vs 32% (aOR=1.48, P<0.001)
9. Dissatisfied with the amount of time they had to wait at appointments with their hospital doctor: 31% vs 28% (aOR=1.10, P=0.007)
10. Said their GP did not receive enough information about their condition or hospital treatment: 8% vs 5% (aOR=1.36, P<0.001)
11. Said they did not receive clear written information about what they should or should not do after leaving the hospital: 20% vs 14% (aOR=1.06, P=0.100)
12. Said they did not receive the name of a Clinical Nurse Specialist who would be in charge of their care: 11% vs 9% (aOR=1.00, P=0.894).

“This is the first time we’ve had direct feedback from patients on such a large scale to show how the timeliness of their diagnosis colors their experience of the care they later receive,” said Sara Hiom, of Cancer Research UK, which supported this study.

“It’s another good reason to highlight the importance of diagnosing cancer as quickly as possible, not just to give patients the best chances of survival, but also to improve their experience of the care they receive throughout their cancer journey.”

*The odds ratio was adjusted for patient age, sex, ethnicity, cancer diagnosis, and response tendency (likelihood of giving a positive or negative response to questions).

Doctor and patient

Photo courtesy of NIH

Patients who make 3 or more trips to the general practitioner (GP) before they are referred for cancer tests are more likely to be dissatisfied with subsequent care, according to research published in the European Journal of Cancer Care.

Researchers analyzed survey responses from nearly 60,000 cancer patients and found that about 23% had visited their GP 3 or more times before they were referred for cancer tests.

These patients were more likely than patients with 1 or 2 GP visits to report negative experiences with regard to many different aspects of their care.

“This research shows that first impressions go a long way in determining how cancer patients view their experience of cancer treatment,” said study author Georgios Lyratzopoulos, MD, of University College London in the UK.

“A negative experience of diagnosis can trigger loss of confidence in their care throughout the cancer journey. When they occur, diagnostic delays are largely due to cancer symptoms being extremely hard to distinguish from other diseases, combined with a lack of accurate and easy-to-use tests. New diagnostic tools to help doctors decide which patients need referring are vital to improve the care experience for even more cancer patients.”

Dr Lyratzopoulos and his colleagues initially analyzed survey data from 73,462 cancer patients, but 15,355 of those patients (21%) had not seen a GP prior to their cancer diagnosis.

Of the 58,107 patients who had at least 1 primary care consultation, 44,827 (77%) had seen their GP once or twice before referral for cancer tests, and 13,280 (23%) had seen the GP 3 or more times.

The researchers analyzed patients’ responses to 12 survey questions that assessed satisfaction with various aspects of their cancer care.

And results showed that patients who had seen their GP 3 or more times before referral were significantly more likely than patients with 1 to 2 GP visits to report negative experiences across 10 of the 12 aspects of care.

The 12 aspects of care and patient responses (for 3+ GP visits and 1-2 visits, respectively) were as follows:

1. Dissatisfied with overall care: 16% vs 9% (adjusted* odds ratio [aOR]=1.44, P<0.001)
2. Dissatisfied with the way they were informed of their cancer: 22% vs 14% (aOR=1.38, P<0.001)
3. Dissatisfied with their involvement in decision-making: 32% vs 25% (aOR=1.13, P<0.001)
4. Lack of confidence/trust in their doctors: 19% vs 12% (aOR=1.22, P<0.001)
5. Lack of confidence/trust in their nurses: 36% vs 27% (aOR=1.22, P<0.001)
6. Thought doctors/nurses deliberately withheld information: 16% vs 10% (aOR=1.27, P<0.001)
7. Dissatisfied with staff support: 41% vs 27% (aOR=1.68, P<0.001)
8. Dissatisfied with integration of various caregivers (GP, hospital doctors/nurses, specialist nurses, etc): 45% vs 32% (aOR=1.48, P<0.001)
9. Dissatisfied with the amount of time they had to wait at appointments with their hospital doctor: 31% vs 28% (aOR=1.10, P=0.007)
10. Said their GP did not receive enough information about their condition or hospital treatment: 8% vs 5% (aOR=1.36, P<0.001)
11. Said they did not receive clear written information about what they should or should not do after leaving the hospital: 20% vs 14% (aOR=1.06, P=0.100)
12. Said they did not receive the name of a Clinical Nurse Specialist who would be in charge of their care: 11% vs 9% (aOR=1.00, P=0.894).

“This is the first time we’ve had direct feedback from patients on such a large scale to show how the timeliness of their diagnosis colors their experience of the care they later receive,” said Sara Hiom, of Cancer Research UK, which supported this study.

“It’s another good reason to highlight the importance of diagnosing cancer as quickly as possible, not just to give patients the best chances of survival, but also to improve their experience of the care they receive throughout their cancer journey.”

*The odds ratio was adjusted for patient age, sex, ethnicity, cancer diagnosis, and response tendency (likelihood of giving a positive or negative response to questions).

Doctor and patient

Photo courtesy of NIH

Patients who make 3 or more trips to the general practitioner (GP) before they are referred for cancer tests are more likely to be dissatisfied with subsequent care, according to research published in the European Journal of Cancer Care.

Researchers analyzed survey responses from nearly 60,000 cancer patients and found that about 23% had visited their GP 3 or more times before they were referred for cancer tests.

These patients were more likely than patients with 1 or 2 GP visits to report negative experiences with regard to many different aspects of their care.

“This research shows that first impressions go a long way in determining how cancer patients view their experience of cancer treatment,” said study author Georgios Lyratzopoulos, MD, of University College London in the UK.

“A negative experience of diagnosis can trigger loss of confidence in their care throughout the cancer journey. When they occur, diagnostic delays are largely due to cancer symptoms being extremely hard to distinguish from other diseases, combined with a lack of accurate and easy-to-use tests. New diagnostic tools to help doctors decide which patients need referring are vital to improve the care experience for even more cancer patients.”

Dr Lyratzopoulos and his colleagues initially analyzed survey data from 73,462 cancer patients, but 15,355 of those patients (21%) had not seen a GP prior to their cancer diagnosis.

Of the 58,107 patients who had at least 1 primary care consultation, 44,827 (77%) had seen their GP once or twice before referral for cancer tests, and 13,280 (23%) had seen the GP 3 or more times.

The researchers analyzed patients’ responses to 12 survey questions that assessed satisfaction with various aspects of their cancer care.

And results showed that patients who had seen their GP 3 or more times before referral were significantly more likely than patients with 1 to 2 GP visits to report negative experiences across 10 of the 12 aspects of care.

The 12 aspects of care and patient responses (for 3+ GP visits and 1-2 visits, respectively) were as follows:

1. Dissatisfied with overall care: 16% vs 9% (adjusted* odds ratio [aOR]=1.44, P<0.001)
2. Dissatisfied with the way they were informed of their cancer: 22% vs 14% (aOR=1.38, P<0.001)
3. Dissatisfied with their involvement in decision-making: 32% vs 25% (aOR=1.13, P<0.001)
4. Lack of confidence/trust in their doctors: 19% vs 12% (aOR=1.22, P<0.001)
5. Lack of confidence/trust in their nurses: 36% vs 27% (aOR=1.22, P<0.001)
6. Thought doctors/nurses deliberately withheld information: 16% vs 10% (aOR=1.27, P<0.001)
7. Dissatisfied with staff support: 41% vs 27% (aOR=1.68, P<0.001)
8. Dissatisfied with integration of various caregivers (GP, hospital doctors/nurses, specialist nurses, etc): 45% vs 32% (aOR=1.48, P<0.001)
9. Dissatisfied with the amount of time they had to wait at appointments with their hospital doctor: 31% vs 28% (aOR=1.10, P=0.007)
10. Said their GP did not receive enough information about their condition or hospital treatment: 8% vs 5% (aOR=1.36, P<0.001)
11. Said they did not receive clear written information about what they should or should not do after leaving the hospital: 20% vs 14% (aOR=1.06, P=0.100)
12. Said they did not receive the name of a Clinical Nurse Specialist who would be in charge of their care: 11% vs 9% (aOR=1.00, P=0.894).

“This is the first time we’ve had direct feedback from patients on such a large scale to show how the timeliness of their diagnosis colors their experience of the care they later receive,” said Sara Hiom, of Cancer Research UK, which supported this study.

“It’s another good reason to highlight the importance of diagnosing cancer as quickly as possible, not just to give patients the best chances of survival, but also to improve their experience of the care they receive throughout their cancer journey.”

*The odds ratio was adjusted for patient age, sex, ethnicity, cancer diagnosis, and response tendency (likelihood of giving a positive or negative response to questions).

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

Pharmaceutical companies “underinvest” in long-term research to develop new anticancer drugs, according to a study published in American Economic Review.

Investigators used historical data to show that companies are more likely to develop drugs for late-stage cancers than early stage cancers or cancer prevention, and this is likely because late-stage cancer drugs can be brought to market faster.

The team found that late-stage drugs extend patient survival for shorter periods so that clinical trials for these drugs get wrapped up more quickly. This, in turn, gives drug manufacturers more time to control patented drugs in the marketplace.

“There is a pattern where we get more investment in drugs that take a short time to complete and less investment in drugs that take a longer time to complete,” said study author Heidi Williams, PhD, of the Massachusetts Institute of Technology in Cambridge.

To conduct this study, Dr Williams and her colleagues analyzed 4 decades of clinical trial data from a variety of sources, including the National Cancer Institute and the US Food and Drug Administration. The study encompassed more than 200 subcategories of cancers detected at different stages of development.

In analyzing the data, the investigators divided research and development (R&D) into 2 stages: invention (developing the basic idea for a product to the point where it is patentable) and commercialization (bringing an invented product to market).

They defined the “commercialization lag” of an R&D project as the amount of time between invention and commercialization.

The data showed that patient groups with longer commercialization lags (as proxied by longer survival times) tended to have lower levels of R&D investment than groups with shorter commercialization lags (and survival times).

The investigators also found that when surrogate endpoints (endpoints other than survival) were allowed, there were more trials and money poured into research. This supports the idea that companies are more likely to invest in drugs that will have shorter trials and take less time to develop.

Dr Williams and her colleagues used the surrogate endpoint variation to estimate improvements in cancer survival rates that would have been observed if commercialization lags were reduced. The team estimated that, among US cancer patients diagnosed in 2003, longer commercialization lags resulted in around 890,000 lost life-years.

The investigators noted that commercialization lags reduce both public and private R&D investments, but they found the commercialization lag-R&D correlation is significantly more negative for privately financed trials than publicly financed trials.

The team said that, due to either excessive discounting or the fixed patent term, private incentives decline more rapidly than public incentives, which is what gives rise to the distortion.

Based on their findings, Dr Williams and her colleagues devised 3 new policy approaches that could potentially spark the development of more drugs for early stage cancers or cancer prevention.

The first is expanded use of surrogate endpoints or more research to determine if wider use of surrogate endpoints is valid.

A second possible policy change is more public funding of R&D for anticancer drugs, since such funding is free of short-term, private-sector shareholder pressure to produce returns.

A third potential new policy would be changing the terms of drug patents, which typically run from the time of patent filing to when the drug hits the market.

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

Pharmaceutical companies “underinvest” in long-term research to develop new anticancer drugs, according to a study published in American Economic Review.

Investigators used historical data to show that companies are more likely to develop drugs for late-stage cancers than early stage cancers or cancer prevention, and this is likely because late-stage cancer drugs can be brought to market faster.

The team found that late-stage drugs extend patient survival for shorter periods so that clinical trials for these drugs get wrapped up more quickly. This, in turn, gives drug manufacturers more time to control patented drugs in the marketplace.

“There is a pattern where we get more investment in drugs that take a short time to complete and less investment in drugs that take a longer time to complete,” said study author Heidi Williams, PhD, of the Massachusetts Institute of Technology in Cambridge.

To conduct this study, Dr Williams and her colleagues analyzed 4 decades of clinical trial data from a variety of sources, including the National Cancer Institute and the US Food and Drug Administration. The study encompassed more than 200 subcategories of cancers detected at different stages of development.

In analyzing the data, the investigators divided research and development (R&D) into 2 stages: invention (developing the basic idea for a product to the point where it is patentable) and commercialization (bringing an invented product to market).

They defined the “commercialization lag” of an R&D project as the amount of time between invention and commercialization.

The data showed that patient groups with longer commercialization lags (as proxied by longer survival times) tended to have lower levels of R&D investment than groups with shorter commercialization lags (and survival times).

The investigators also found that when surrogate endpoints (endpoints other than survival) were allowed, there were more trials and money poured into research. This supports the idea that companies are more likely to invest in drugs that will have shorter trials and take less time to develop.

Dr Williams and her colleagues used the surrogate endpoint variation to estimate improvements in cancer survival rates that would have been observed if commercialization lags were reduced. The team estimated that, among US cancer patients diagnosed in 2003, longer commercialization lags resulted in around 890,000 lost life-years.

The investigators noted that commercialization lags reduce both public and private R&D investments, but they found the commercialization lag-R&D correlation is significantly more negative for privately financed trials than publicly financed trials.

The team said that, due to either excessive discounting or the fixed patent term, private incentives decline more rapidly than public incentives, which is what gives rise to the distortion.

Based on their findings, Dr Williams and her colleagues devised 3 new policy approaches that could potentially spark the development of more drugs for early stage cancers or cancer prevention.

The first is expanded use of surrogate endpoints or more research to determine if wider use of surrogate endpoints is valid.

A second possible policy change is more public funding of R&D for anticancer drugs, since such funding is free of short-term, private-sector shareholder pressure to produce returns.

A third potential new policy would be changing the terms of drug patents, which typically run from the time of patent filing to when the drug hits the market.

Preparing drug capsules

for a clinical trial

Photo by Esther Dyson

Pharmaceutical companies “underinvest” in long-term research to develop new anticancer drugs, according to a study published in American Economic Review.

Investigators used historical data to show that companies are more likely to develop drugs for late-stage cancers than early stage cancers or cancer prevention, and this is likely because late-stage cancer drugs can be brought to market faster.

The team found that late-stage drugs extend patient survival for shorter periods so that clinical trials for these drugs get wrapped up more quickly. This, in turn, gives drug manufacturers more time to control patented drugs in the marketplace.

“There is a pattern where we get more investment in drugs that take a short time to complete and less investment in drugs that take a longer time to complete,” said study author Heidi Williams, PhD, of the Massachusetts Institute of Technology in Cambridge.

To conduct this study, Dr Williams and her colleagues analyzed 4 decades of clinical trial data from a variety of sources, including the National Cancer Institute and the US Food and Drug Administration. The study encompassed more than 200 subcategories of cancers detected at different stages of development.

In analyzing the data, the investigators divided research and development (R&D) into 2 stages: invention (developing the basic idea for a product to the point where it is patentable) and commercialization (bringing an invented product to market).

They defined the “commercialization lag” of an R&D project as the amount of time between invention and commercialization.

The data showed that patient groups with longer commercialization lags (as proxied by longer survival times) tended to have lower levels of R&D investment than groups with shorter commercialization lags (and survival times).

The investigators also found that when surrogate endpoints (endpoints other than survival) were allowed, there were more trials and money poured into research. This supports the idea that companies are more likely to invest in drugs that will have shorter trials and take less time to develop.

Dr Williams and her colleagues used the surrogate endpoint variation to estimate improvements in cancer survival rates that would have been observed if commercialization lags were reduced. The team estimated that, among US cancer patients diagnosed in 2003, longer commercialization lags resulted in around 890,000 lost life-years.

The investigators noted that commercialization lags reduce both public and private R&D investments, but they found the commercialization lag-R&D correlation is significantly more negative for privately financed trials than publicly financed trials.

The team said that, due to either excessive discounting or the fixed patent term, private incentives decline more rapidly than public incentives, which is what gives rise to the distortion.

Based on their findings, Dr Williams and her colleagues devised 3 new policy approaches that could potentially spark the development of more drugs for early stage cancers or cancer prevention.

The first is expanded use of surrogate endpoints or more research to determine if wider use of surrogate endpoints is valid.

A second possible policy change is more public funding of R&D for anticancer drugs, since such funding is free of short-term, private-sector shareholder pressure to produce returns.

A third potential new policy would be changing the terms of drug patents, which typically run from the time of patent filing to when the drug hits the market.

In vitro fertilization

Image courtesy of NHS

Young patients with cancer, particularly females, may be uninformed about their options for preserving fertility, according to a study published in Cancer.

The research showed that males were both more likely to have discussed fertility preservation with their physicians and more likely to have taken steps to preserve fertility.

Other factors such as education and insurance status also appeared to have an impact on fertility preservation.

Margarett Shnorhavorian, MD, of the University of Washington in Seattle, and her colleagues conducted this research.

The team enlisted 459 adolescents and young adults who were diagnosed with cancer in 2007 or 2008, asking them to complete questionnaires on fertility preservation.

Eighty percent of males and 74% of females said they had been told that cancer therapy might affect their fertility. For females, multivariable analysis revealed no significant factors associated with this discussion.

However, multivariable analysis showed that males with an unknown treatment fertility risk were more likely to be uninformed of the potential risk (odds ratio [OR]= 2.73; 95% CI, 1.09-6.86), as were males who did not consult a medical oncologist (OR=2.28; 95% CI, 1.03-5.00).

Twenty-nine percent of males and 56.3% of females said they did not discuss fertility preservation with their doctors before they began cancer treatment. Males raising children younger than 18 were more likely than males without children to miss out on the discussion (OR=2.45; 95% CI, 1.24-4.85).

Males were also more likely to miss the discussion if they had a treatment fertility risk classified as “none/low” rather than “intermediate/high” (OR=3.39; 95% CI, 1.60-7.16) and if they had no insurance or government insurance rather than private insurance (OR=2.91; 95% CI, 1.41-5.97).

Males diagnosed in 2008 were less likely than those diagnosed in 2007 to miss out on the discussion (OR=0.43; 95% CI, 0.20-0.80).

Females raising children under 18 were more likely than females without children to say they did not discuss fertility preservation with their doctors (OR=3.38; 95% CI, 1.43-8.02). Females without private insurance were more likely to miss the discussion as well (OR=5.46; 95% CI, 1.59-18.72).

Females diagnosed in 2008 were less likely to miss the discussion than those diagnosed in 2007 (OR=0.36; 95% CI, 0.15-0.85).

Sixty-nine percent of males and 93.2% of females said they did not make fertility preservation arrangements. Men were more likely to lack arrangements if they were raising children younger than 18 years (OR=3.53; 95% CI, 1.63-7.65) or had less than a college degree (OR, 1.98; 95% CI, 1.00-3.97).

The researchers did not conduct a multivariable analysis for women because so few women made arrangements for fertility preservation.

“The access and health-related reasons for not making arrangements for fertility preservation reported by participants in this study further highlight the need for decreased cost, improved insurance coverage, and partnerships between cancer healthcare providers and fertility experts to develop strategies that increase awareness of fertility preservation options and decrease delays in cancer therapy as fertility preservation for adolescent and young adult cancer patients improves,” Dr Shnorhavorian concluded.

In vitro fertilization

Image courtesy of NHS

Young patients with cancer, particularly females, may be uninformed about their options for preserving fertility, according to a study published in Cancer.

The research showed that males were both more likely to have discussed fertility preservation with their physicians and more likely to have taken steps to preserve fertility.

Other factors such as education and insurance status also appeared to have an impact on fertility preservation.

Margarett Shnorhavorian, MD, of the University of Washington in Seattle, and her colleagues conducted this research.

The team enlisted 459 adolescents and young adults who were diagnosed with cancer in 2007 or 2008, asking them to complete questionnaires on fertility preservation.

Eighty percent of males and 74% of females said they had been told that cancer therapy might affect their fertility. For females, multivariable analysis revealed no significant factors associated with this discussion.

However, multivariable analysis showed that males with an unknown treatment fertility risk were more likely to be uninformed of the potential risk (odds ratio [OR]= 2.73; 95% CI, 1.09-6.86), as were males who did not consult a medical oncologist (OR=2.28; 95% CI, 1.03-5.00).

Twenty-nine percent of males and 56.3% of females said they did not discuss fertility preservation with their doctors before they began cancer treatment. Males raising children younger than 18 were more likely than males without children to miss out on the discussion (OR=2.45; 95% CI, 1.24-4.85).

Males were also more likely to miss the discussion if they had a treatment fertility risk classified as “none/low” rather than “intermediate/high” (OR=3.39; 95% CI, 1.60-7.16) and if they had no insurance or government insurance rather than private insurance (OR=2.91; 95% CI, 1.41-5.97).

Males diagnosed in 2008 were less likely than those diagnosed in 2007 to miss out on the discussion (OR=0.43; 95% CI, 0.20-0.80).

Females raising children under 18 were more likely than females without children to say they did not discuss fertility preservation with their doctors (OR=3.38; 95% CI, 1.43-8.02). Females without private insurance were more likely to miss the discussion as well (OR=5.46; 95% CI, 1.59-18.72).

Females diagnosed in 2008 were less likely to miss the discussion than those diagnosed in 2007 (OR=0.36; 95% CI, 0.15-0.85).

Sixty-nine percent of males and 93.2% of females said they did not make fertility preservation arrangements. Men were more likely to lack arrangements if they were raising children younger than 18 years (OR=3.53; 95% CI, 1.63-7.65) or had less than a college degree (OR, 1.98; 95% CI, 1.00-3.97).

The researchers did not conduct a multivariable analysis for women because so few women made arrangements for fertility preservation.

“The access and health-related reasons for not making arrangements for fertility preservation reported by participants in this study further highlight the need for decreased cost, improved insurance coverage, and partnerships between cancer healthcare providers and fertility experts to develop strategies that increase awareness of fertility preservation options and decrease delays in cancer therapy as fertility preservation for adolescent and young adult cancer patients improves,” Dr Shnorhavorian concluded.

In vitro fertilization

Image courtesy of NHS

Young patients with cancer, particularly females, may be uninformed about their options for preserving fertility, according to a study published in Cancer.

The research showed that males were both more likely to have discussed fertility preservation with their physicians and more likely to have taken steps to preserve fertility.

Other factors such as education and insurance status also appeared to have an impact on fertility preservation.

Margarett Shnorhavorian, MD, of the University of Washington in Seattle, and her colleagues conducted this research.

The team enlisted 459 adolescents and young adults who were diagnosed with cancer in 2007 or 2008, asking them to complete questionnaires on fertility preservation.

Eighty percent of males and 74% of females said they had been told that cancer therapy might affect their fertility. For females, multivariable analysis revealed no significant factors associated with this discussion.

However, multivariable analysis showed that males with an unknown treatment fertility risk were more likely to be uninformed of the potential risk (odds ratio [OR]= 2.73; 95% CI, 1.09-6.86), as were males who did not consult a medical oncologist (OR=2.28; 95% CI, 1.03-5.00).

Twenty-nine percent of males and 56.3% of females said they did not discuss fertility preservation with their doctors before they began cancer treatment. Males raising children younger than 18 were more likely than males without children to miss out on the discussion (OR=2.45; 95% CI, 1.24-4.85).

Males were also more likely to miss the discussion if they had a treatment fertility risk classified as “none/low” rather than “intermediate/high” (OR=3.39; 95% CI, 1.60-7.16) and if they had no insurance or government insurance rather than private insurance (OR=2.91; 95% CI, 1.41-5.97).

Males diagnosed in 2008 were less likely than those diagnosed in 2007 to miss out on the discussion (OR=0.43; 95% CI, 0.20-0.80).

Females raising children under 18 were more likely than females without children to say they did not discuss fertility preservation with their doctors (OR=3.38; 95% CI, 1.43-8.02). Females without private insurance were more likely to miss the discussion as well (OR=5.46; 95% CI, 1.59-18.72).

Females diagnosed in 2008 were less likely to miss the discussion than those diagnosed in 2007 (OR=0.36; 95% CI, 0.15-0.85).

Sixty-nine percent of males and 93.2% of females said they did not make fertility preservation arrangements. Men were more likely to lack arrangements if they were raising children younger than 18 years (OR=3.53; 95% CI, 1.63-7.65) or had less than a college degree (OR, 1.98; 95% CI, 1.00-3.97).

The researchers did not conduct a multivariable analysis for women because so few women made arrangements for fertility preservation.

“The access and health-related reasons for not making arrangements for fertility preservation reported by participants in this study further highlight the need for decreased cost, improved insurance coverage, and partnerships between cancer healthcare providers and fertility experts to develop strategies that increase awareness of fertility preservation options and decrease delays in cancer therapy as fertility preservation for adolescent and young adult cancer patients improves,” Dr Shnorhavorian concluded.