The Professional Doctorate: What Are We Waiting for?

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The Professional Doctorate: What Are We Waiting for?
 

The increasingly complex health care system in the United States relies heavily on quality improvement, interprofessional collaboration, patient outcomes, health policy legislation, and advocacy. While important, most of these factors are outside the scope of the traditional master’s-level education program—necessitating the development of methods to help advanced practice providers, including NPs and PAs, obtain additional skills. The solution of choice, for many professions, has been the introduction of the “professional doctorate” as a complementary alternative to the typical research-focused doctoral program, such as the PhD.

Traditional PhD curricula prepare individuals to perform research that is typically specialized and confined to their field of study.1 While this research does produce new knowledge, it usually remains in the realm of academia and often does not address any specific “real-world” problem.2 But to be recognized, compensated, and identified as a full professional in modern society, one must be equipped to address practical problems.

Analysis by Taylor and Maxwell and by Lee, Green, and Brennan has shown that, rather than theory, the workplace demands the application of knowledge geared toward daily professional duties.3,4 They envisioned a doctorate-prepared practitioner who had less skill in pure research but who would be able to apply theory to everyday problems in the workplace.4,5 Rather than devalue the contributions of classical PhD training, this model proposed the creation of a hybrid curriculum that would prepare individuals to use “applied research.”3 As the professional doctorate gained acceptance, it matured from the “first-generation” concept (which was quite similar to the PhD in structure) to “second-generation,” which is more focused on discipline and workplace realities.3,5 In general, these professional doctorates can be earned in less time than a PhD and do not require original research.

Over the past two decades, more than 500 unique professional practice doctorate programs have emerged across the US, in fields ranging from nursing to bioethics. One of the most prominent is the Doctor of Nursing Practice (DNP), designed for RNs seeking a post-professional degree in nursing. In 2004, following three years of research by a task force, the American Association of Colleges of Nursing (AACN) endorsed the DNP, with the goal that it would become the minimum educational standard for advanced practice nurses by 2015.6 According to the AACN, there are 289 DNP programs in the US, with an additional 128 in development.6

The PA profession has lagged behind not only our NP colleagues, but also many other health professions, in the adoption of a discipline-specific, doctoral-level degree. Our counterparts in audiology, physical therapy, occupational therapy, and athletic training have been part of the exponential growth in second-generation health care doctorates.7 While these programs may differ in concept, they share several similarities: They do not require original research; they include a clinical component; and they promote knowledge in the context of the workplace.5-8

In the past five years, PAs have started considering (or debating, depending on your perspective) a professional/clinical doctorate as the next step in our post-professional journey. It’s about time, when you consider that 16.8% of newly certified PAs intend to pursue additional education or clinical training, according to a recent report from the National Commission on Certification of Physician Assistants.9

 

 

 

There are already a few doctoral programs for PAs. Among the earliest clinically focused doctorate programs was the US Army/Air Force-Baylor DScPAS-EM program, designed to educate military PAs at the doctoral level upon completion of an 18-month emergency medicine residency.10 Lincoln Memorial University has a Doctor of Medical Science (DMS) program, comprised of one year of online advanced clinical medicine coursework and one year of online coursework focused on primary care, hospital medicine, emergency medicine, or education.11 And Lynchburg College in Virginia has just launched a post-professional doctoral program for PAs; this DMS program includes a clinical fellowship, as well as coursework in leadership training, health care management and law, organizational behavior, disaster medicine, and global health.12

While not strictly created for PAs, the Doctor of Health Science programs at Nova Southeastern University and A.T. Still University have been educating PAs at the doctoral level for more than 10 years.13,14 Later this year, A.T. Still University plans to introduce a post-professional Doctor of Physician Assistant Studies that will provide a pathway for PAs wishing to become leaders and scholar-practitioners, develop core leadership abilities, and/or enter PA education without the location-specific requirement of a clinical or academic residency.

When the push for professional practice doctorates started, pundits claimed they were just an attempt at a “cash grab” by universities looking to bolster their rosters (and their coffers). But advocates have long argued that these degrees provide practitioners with the knowledge and training required to offer advanced services in increasingly complex social and technologic environments.7 No less than The Institute of Medicine, The Joint Commission, and the Robert Wood Johnson Foundation have called for the reinvention of education programs to equip today’s health professionals with the highest level of scientific knowledge and practice expertise.

Why? First and foremost, to ensure quality patient outcomes. Beyond that, better prepared clinicians can help to address provider shortages. Those with doctorates can also serve as faculty, educating the next generation of health care providers. And practically speaking, for those seeking advanced education, holding a doctorate will create opportunities for increased decision-making and upward mobility in the workplace.

There is no question that our current health care environment is driven by the regulations and costs of the Affordable Care Act, as well as quality management systems and strategies. NPs and PAs are in a unique position to cost-effectively direct the care of, and advocate for, diverse patient populations. NPs and PAs who recognize this opportunity to serve need doctoral-level training tailored to this milieu.

Do you agree? Share your thoughts on professional doctorates with me at [email protected].

References

1. Carnegie Project on the Education Doctorate. Founding literature. www.cpedinitiative.org/?. Accessed May 8, 2017.
2. Costley C, Lester S. Work-based doctorates: professional extension at the highest levels. Studies in Higher Education. 2012;37(3):257-269.
3. Taylor N, Maxwell T. Enhancing the relevance of a professional doctorate: the case of the doctor of education degree at the University of New England. Asia-Pacific J Coop Edu. 2004;5(1):60-69.
4. Lee A, Green B, Brennan M. Organisational knowledge, professional practice and the professional doctorate at work. In: Garrick J, Rhodes C (eds). Research and Knowledge at Work. Perspectives, Case-studies and Innovative Strategies. London: Routledge; 2000.
5. Maxwell T. From first to second generation professional doctorate. Studies in Higher Education. 2003;28(3):279-291.
6. American Association of Colleges of Nursing. DNP fact sheet. www.aacn.nche.edu/media-relations/fact-sheets/dnp. Accessed May 8, 2017.
7. Zusman A. Degrees of change: how new kinds of professional doctorates are changing higher education institutions. Research and Occasional Paper Series. 2013;8(13):1-20.
8. Kumar S, Dawson K. Exploring the impact of a professional practice education doctorate in educational environments. Studies in Continuing Education. 2013;35(2):165-178.
9. National Commission on Certification of Physician Assistants. 2014 statistical profile of recently certified physician assistants: an annual report of the NCCPA. www.nccpa.net/Uploads/docs/RecentlyCertifiedReport2014.pdf. Accessed May 8, 2017.
10. Baylor University. Army-Baylor emergency medicine physician assistant (EMPA) program. www.baylor.edu/graduate/pa/index.php?id=936090. Accessed May 8, 2017.
11. Lincoln Memorial University. Doctor of medical science announcement. www.lmunet.edu/academics/schools/debusk-college-of-osteopathic-medicine/dms. Accessed May 8, 2017.
12. Lynchburg College. Doctor of medical science. www.lynchburg.edu/graduate/physician-assistant-medicine/doctor-of-medical-science/. Accessed May 8, 2017.
13. Nova Southeastern University. Doctor of health science program. http://healthsciences.nova.edu/healthsciences/dhs/. Accessed May 8, 2017.
14. A.T. Still University. About the college of graduate health studies – online. www.atsu.edu/college-of-graduate-health-studies. Accessed May 8, 2017.

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The increasingly complex health care system in the United States relies heavily on quality improvement, interprofessional collaboration, patient outcomes, health policy legislation, and advocacy. While important, most of these factors are outside the scope of the traditional master’s-level education program—necessitating the development of methods to help advanced practice providers, including NPs and PAs, obtain additional skills. The solution of choice, for many professions, has been the introduction of the “professional doctorate” as a complementary alternative to the typical research-focused doctoral program, such as the PhD.

Traditional PhD curricula prepare individuals to perform research that is typically specialized and confined to their field of study.1 While this research does produce new knowledge, it usually remains in the realm of academia and often does not address any specific “real-world” problem.2 But to be recognized, compensated, and identified as a full professional in modern society, one must be equipped to address practical problems.

Analysis by Taylor and Maxwell and by Lee, Green, and Brennan has shown that, rather than theory, the workplace demands the application of knowledge geared toward daily professional duties.3,4 They envisioned a doctorate-prepared practitioner who had less skill in pure research but who would be able to apply theory to everyday problems in the workplace.4,5 Rather than devalue the contributions of classical PhD training, this model proposed the creation of a hybrid curriculum that would prepare individuals to use “applied research.”3 As the professional doctorate gained acceptance, it matured from the “first-generation” concept (which was quite similar to the PhD in structure) to “second-generation,” which is more focused on discipline and workplace realities.3,5 In general, these professional doctorates can be earned in less time than a PhD and do not require original research.

Over the past two decades, more than 500 unique professional practice doctorate programs have emerged across the US, in fields ranging from nursing to bioethics. One of the most prominent is the Doctor of Nursing Practice (DNP), designed for RNs seeking a post-professional degree in nursing. In 2004, following three years of research by a task force, the American Association of Colleges of Nursing (AACN) endorsed the DNP, with the goal that it would become the minimum educational standard for advanced practice nurses by 2015.6 According to the AACN, there are 289 DNP programs in the US, with an additional 128 in development.6

The PA profession has lagged behind not only our NP colleagues, but also many other health professions, in the adoption of a discipline-specific, doctoral-level degree. Our counterparts in audiology, physical therapy, occupational therapy, and athletic training have been part of the exponential growth in second-generation health care doctorates.7 While these programs may differ in concept, they share several similarities: They do not require original research; they include a clinical component; and they promote knowledge in the context of the workplace.5-8

In the past five years, PAs have started considering (or debating, depending on your perspective) a professional/clinical doctorate as the next step in our post-professional journey. It’s about time, when you consider that 16.8% of newly certified PAs intend to pursue additional education or clinical training, according to a recent report from the National Commission on Certification of Physician Assistants.9

 

 

 

There are already a few doctoral programs for PAs. Among the earliest clinically focused doctorate programs was the US Army/Air Force-Baylor DScPAS-EM program, designed to educate military PAs at the doctoral level upon completion of an 18-month emergency medicine residency.10 Lincoln Memorial University has a Doctor of Medical Science (DMS) program, comprised of one year of online advanced clinical medicine coursework and one year of online coursework focused on primary care, hospital medicine, emergency medicine, or education.11 And Lynchburg College in Virginia has just launched a post-professional doctoral program for PAs; this DMS program includes a clinical fellowship, as well as coursework in leadership training, health care management and law, organizational behavior, disaster medicine, and global health.12

While not strictly created for PAs, the Doctor of Health Science programs at Nova Southeastern University and A.T. Still University have been educating PAs at the doctoral level for more than 10 years.13,14 Later this year, A.T. Still University plans to introduce a post-professional Doctor of Physician Assistant Studies that will provide a pathway for PAs wishing to become leaders and scholar-practitioners, develop core leadership abilities, and/or enter PA education without the location-specific requirement of a clinical or academic residency.

When the push for professional practice doctorates started, pundits claimed they were just an attempt at a “cash grab” by universities looking to bolster their rosters (and their coffers). But advocates have long argued that these degrees provide practitioners with the knowledge and training required to offer advanced services in increasingly complex social and technologic environments.7 No less than The Institute of Medicine, The Joint Commission, and the Robert Wood Johnson Foundation have called for the reinvention of education programs to equip today’s health professionals with the highest level of scientific knowledge and practice expertise.

Why? First and foremost, to ensure quality patient outcomes. Beyond that, better prepared clinicians can help to address provider shortages. Those with doctorates can also serve as faculty, educating the next generation of health care providers. And practically speaking, for those seeking advanced education, holding a doctorate will create opportunities for increased decision-making and upward mobility in the workplace.

There is no question that our current health care environment is driven by the regulations and costs of the Affordable Care Act, as well as quality management systems and strategies. NPs and PAs are in a unique position to cost-effectively direct the care of, and advocate for, diverse patient populations. NPs and PAs who recognize this opportunity to serve need doctoral-level training tailored to this milieu.

Do you agree? Share your thoughts on professional doctorates with me at [email protected].

 

The increasingly complex health care system in the United States relies heavily on quality improvement, interprofessional collaboration, patient outcomes, health policy legislation, and advocacy. While important, most of these factors are outside the scope of the traditional master’s-level education program—necessitating the development of methods to help advanced practice providers, including NPs and PAs, obtain additional skills. The solution of choice, for many professions, has been the introduction of the “professional doctorate” as a complementary alternative to the typical research-focused doctoral program, such as the PhD.

Traditional PhD curricula prepare individuals to perform research that is typically specialized and confined to their field of study.1 While this research does produce new knowledge, it usually remains in the realm of academia and often does not address any specific “real-world” problem.2 But to be recognized, compensated, and identified as a full professional in modern society, one must be equipped to address practical problems.

Analysis by Taylor and Maxwell and by Lee, Green, and Brennan has shown that, rather than theory, the workplace demands the application of knowledge geared toward daily professional duties.3,4 They envisioned a doctorate-prepared practitioner who had less skill in pure research but who would be able to apply theory to everyday problems in the workplace.4,5 Rather than devalue the contributions of classical PhD training, this model proposed the creation of a hybrid curriculum that would prepare individuals to use “applied research.”3 As the professional doctorate gained acceptance, it matured from the “first-generation” concept (which was quite similar to the PhD in structure) to “second-generation,” which is more focused on discipline and workplace realities.3,5 In general, these professional doctorates can be earned in less time than a PhD and do not require original research.

Over the past two decades, more than 500 unique professional practice doctorate programs have emerged across the US, in fields ranging from nursing to bioethics. One of the most prominent is the Doctor of Nursing Practice (DNP), designed for RNs seeking a post-professional degree in nursing. In 2004, following three years of research by a task force, the American Association of Colleges of Nursing (AACN) endorsed the DNP, with the goal that it would become the minimum educational standard for advanced practice nurses by 2015.6 According to the AACN, there are 289 DNP programs in the US, with an additional 128 in development.6

The PA profession has lagged behind not only our NP colleagues, but also many other health professions, in the adoption of a discipline-specific, doctoral-level degree. Our counterparts in audiology, physical therapy, occupational therapy, and athletic training have been part of the exponential growth in second-generation health care doctorates.7 While these programs may differ in concept, they share several similarities: They do not require original research; they include a clinical component; and they promote knowledge in the context of the workplace.5-8

In the past five years, PAs have started considering (or debating, depending on your perspective) a professional/clinical doctorate as the next step in our post-professional journey. It’s about time, when you consider that 16.8% of newly certified PAs intend to pursue additional education or clinical training, according to a recent report from the National Commission on Certification of Physician Assistants.9

 

 

 

There are already a few doctoral programs for PAs. Among the earliest clinically focused doctorate programs was the US Army/Air Force-Baylor DScPAS-EM program, designed to educate military PAs at the doctoral level upon completion of an 18-month emergency medicine residency.10 Lincoln Memorial University has a Doctor of Medical Science (DMS) program, comprised of one year of online advanced clinical medicine coursework and one year of online coursework focused on primary care, hospital medicine, emergency medicine, or education.11 And Lynchburg College in Virginia has just launched a post-professional doctoral program for PAs; this DMS program includes a clinical fellowship, as well as coursework in leadership training, health care management and law, organizational behavior, disaster medicine, and global health.12

While not strictly created for PAs, the Doctor of Health Science programs at Nova Southeastern University and A.T. Still University have been educating PAs at the doctoral level for more than 10 years.13,14 Later this year, A.T. Still University plans to introduce a post-professional Doctor of Physician Assistant Studies that will provide a pathway for PAs wishing to become leaders and scholar-practitioners, develop core leadership abilities, and/or enter PA education without the location-specific requirement of a clinical or academic residency.

When the push for professional practice doctorates started, pundits claimed they were just an attempt at a “cash grab” by universities looking to bolster their rosters (and their coffers). But advocates have long argued that these degrees provide practitioners with the knowledge and training required to offer advanced services in increasingly complex social and technologic environments.7 No less than The Institute of Medicine, The Joint Commission, and the Robert Wood Johnson Foundation have called for the reinvention of education programs to equip today’s health professionals with the highest level of scientific knowledge and practice expertise.

Why? First and foremost, to ensure quality patient outcomes. Beyond that, better prepared clinicians can help to address provider shortages. Those with doctorates can also serve as faculty, educating the next generation of health care providers. And practically speaking, for those seeking advanced education, holding a doctorate will create opportunities for increased decision-making and upward mobility in the workplace.

There is no question that our current health care environment is driven by the regulations and costs of the Affordable Care Act, as well as quality management systems and strategies. NPs and PAs are in a unique position to cost-effectively direct the care of, and advocate for, diverse patient populations. NPs and PAs who recognize this opportunity to serve need doctoral-level training tailored to this milieu.

Do you agree? Share your thoughts on professional doctorates with me at [email protected].

References

1. Carnegie Project on the Education Doctorate. Founding literature. www.cpedinitiative.org/?. Accessed May 8, 2017.
2. Costley C, Lester S. Work-based doctorates: professional extension at the highest levels. Studies in Higher Education. 2012;37(3):257-269.
3. Taylor N, Maxwell T. Enhancing the relevance of a professional doctorate: the case of the doctor of education degree at the University of New England. Asia-Pacific J Coop Edu. 2004;5(1):60-69.
4. Lee A, Green B, Brennan M. Organisational knowledge, professional practice and the professional doctorate at work. In: Garrick J, Rhodes C (eds). Research and Knowledge at Work. Perspectives, Case-studies and Innovative Strategies. London: Routledge; 2000.
5. Maxwell T. From first to second generation professional doctorate. Studies in Higher Education. 2003;28(3):279-291.
6. American Association of Colleges of Nursing. DNP fact sheet. www.aacn.nche.edu/media-relations/fact-sheets/dnp. Accessed May 8, 2017.
7. Zusman A. Degrees of change: how new kinds of professional doctorates are changing higher education institutions. Research and Occasional Paper Series. 2013;8(13):1-20.
8. Kumar S, Dawson K. Exploring the impact of a professional practice education doctorate in educational environments. Studies in Continuing Education. 2013;35(2):165-178.
9. National Commission on Certification of Physician Assistants. 2014 statistical profile of recently certified physician assistants: an annual report of the NCCPA. www.nccpa.net/Uploads/docs/RecentlyCertifiedReport2014.pdf. Accessed May 8, 2017.
10. Baylor University. Army-Baylor emergency medicine physician assistant (EMPA) program. www.baylor.edu/graduate/pa/index.php?id=936090. Accessed May 8, 2017.
11. Lincoln Memorial University. Doctor of medical science announcement. www.lmunet.edu/academics/schools/debusk-college-of-osteopathic-medicine/dms. Accessed May 8, 2017.
12. Lynchburg College. Doctor of medical science. www.lynchburg.edu/graduate/physician-assistant-medicine/doctor-of-medical-science/. Accessed May 8, 2017.
13. Nova Southeastern University. Doctor of health science program. http://healthsciences.nova.edu/healthsciences/dhs/. Accessed May 8, 2017.
14. A.T. Still University. About the college of graduate health studies – online. www.atsu.edu/college-of-graduate-health-studies. Accessed May 8, 2017.

References

1. Carnegie Project on the Education Doctorate. Founding literature. www.cpedinitiative.org/?. Accessed May 8, 2017.
2. Costley C, Lester S. Work-based doctorates: professional extension at the highest levels. Studies in Higher Education. 2012;37(3):257-269.
3. Taylor N, Maxwell T. Enhancing the relevance of a professional doctorate: the case of the doctor of education degree at the University of New England. Asia-Pacific J Coop Edu. 2004;5(1):60-69.
4. Lee A, Green B, Brennan M. Organisational knowledge, professional practice and the professional doctorate at work. In: Garrick J, Rhodes C (eds). Research and Knowledge at Work. Perspectives, Case-studies and Innovative Strategies. London: Routledge; 2000.
5. Maxwell T. From first to second generation professional doctorate. Studies in Higher Education. 2003;28(3):279-291.
6. American Association of Colleges of Nursing. DNP fact sheet. www.aacn.nche.edu/media-relations/fact-sheets/dnp. Accessed May 8, 2017.
7. Zusman A. Degrees of change: how new kinds of professional doctorates are changing higher education institutions. Research and Occasional Paper Series. 2013;8(13):1-20.
8. Kumar S, Dawson K. Exploring the impact of a professional practice education doctorate in educational environments. Studies in Continuing Education. 2013;35(2):165-178.
9. National Commission on Certification of Physician Assistants. 2014 statistical profile of recently certified physician assistants: an annual report of the NCCPA. www.nccpa.net/Uploads/docs/RecentlyCertifiedReport2014.pdf. Accessed May 8, 2017.
10. Baylor University. Army-Baylor emergency medicine physician assistant (EMPA) program. www.baylor.edu/graduate/pa/index.php?id=936090. Accessed May 8, 2017.
11. Lincoln Memorial University. Doctor of medical science announcement. www.lmunet.edu/academics/schools/debusk-college-of-osteopathic-medicine/dms. Accessed May 8, 2017.
12. Lynchburg College. Doctor of medical science. www.lynchburg.edu/graduate/physician-assistant-medicine/doctor-of-medical-science/. Accessed May 8, 2017.
13. Nova Southeastern University. Doctor of health science program. http://healthsciences.nova.edu/healthsciences/dhs/. Accessed May 8, 2017.
14. A.T. Still University. About the college of graduate health studies – online. www.atsu.edu/college-of-graduate-health-studies. Accessed May 8, 2017.

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Test goes wide and deep to detect free tumor DNA in blood

Article Type
Changed
Wed, 01/04/2023 - 16:47

– An experimental liquid biopsy method plumbs the depths of the genome to detect a broad array of mutations in blood samples that closely correspond to variants in tumors.

The high-intensity method for detecting circulating free DNA (cfDNA) in plasma detected at least one significant genetic variant in samples from 89% of patients with advanced breast, lung, and prostate cancers.

If validated in further studies, the technique could inform more accurate drug selection in patients with refractory disease and eventually may form the basis for plasma-based assays to detect early-stage cancers, said Pedram Razavi, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York.

Neil Osterweil/Frontline Medical News
Dr. Pedram Razavi


“This novel, high-intensity sequencing assay incorporates an unprecedented combination of depth and breadth of coverage compared to previous assays. High levels of concordance for variants between plasma and tissue provide strong evidence for high rates of tumor DNA detection in plasma,” he said at a press briefing at the annual meeting of the American Society of Clinical Oncology.

The technique also provides important insights into tumor biology, “including first exploration of mutational signatures in the plasma,” he added.

Deep scanning

The high-intensity sequencing method scans for 508 genes in a 2 million base-pair swath of genome, performing 60,000 repeat reads on each genome region to improve the assay’s sensitivity, and deep sequencing allows for detection of rare “needle-in-a-haystack” variants.

Dr. Razavi and his colleagues examined prospectively collected blood and tissues from 161 patients, 124 of whom had samples sufficient for concordance studies.

The samples were collected within 6 weeks of a de novo cancer diagnosis or evidence of disease progression, before the initiation of therapy.

Both cfDNA and genomic data from white blood cells (WBCs) of each patient were sequenced with the aforementioned 508-gene panel covering a broad range of known cancer variants and mutations.

Tumor tissues were sequenced with MSK-IMPACT, a 410 gene assay, with blinding of results in regard to plasma and WBC sequencing. Variants were classified as clonal or subclonal based on tumor sequencing in breast cancer and non–small cell lung cancer (NSCLC).

As noted before, 89% of patients had at least one genetic variant detected in both the tumor and in plasma, including 97% of patients with metastatic breast cancer, 85% of those with NSCLC, and 84% of patients with metastatic prostate cancer.

The investigators identified 864 clonal or subclonal variants in tissue samples from all three of these cancers, and 627 of the variants also were found in plasma.

In addition, 76% of clinically actionable somatic mutations identified in tumors also were found in plasma, which suggests that the high-intensity sequencing technique may be able to identify tumor heterogeneity that is not always evident in single tumor biopsies, Dr. Razavi said.

Neil Osterweil/Frontline Medical News
Dr. John Heymach

‘A clear advance’

“The work by Dr. Razavi and colleagues is a clear advance in the field because it surveys for the first time a much broader panel of genes – 508 genes in this case – and it does it with much deeper sequencing, which means it can detect much rarer alterations,” commented ASCO expert John Heymach, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston.

The study “helps illuminate a path toward a day when we will be using circulating tumor DNA assays for early detection of cancer, and not just for selecting certain therapies,” he added.

“We’re a long way from utilizing liquid biopsy for detecting cancers; already though, we’re seeing some utility of circulating tumor DNA in the domain of identifying novel alterations as a means of segmentation clinical trials,” commented ASCO expert Sumanta Kumar Pal, MD, from City of Hope in Duarte, Calif.

Neil Osterweil/Frontline Medical News
Dr. Sumanta Kumar Pal


Dr. Heymach and Dr. Pal were not involved in the study, but were invited discussants at the briefing.

The study was funded in part by GRAIL. Dr. Razavi reported institutional research funding from the company. Multiple coauthors are employees of the company.

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– An experimental liquid biopsy method plumbs the depths of the genome to detect a broad array of mutations in blood samples that closely correspond to variants in tumors.

The high-intensity method for detecting circulating free DNA (cfDNA) in plasma detected at least one significant genetic variant in samples from 89% of patients with advanced breast, lung, and prostate cancers.

If validated in further studies, the technique could inform more accurate drug selection in patients with refractory disease and eventually may form the basis for plasma-based assays to detect early-stage cancers, said Pedram Razavi, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York.

Neil Osterweil/Frontline Medical News
Dr. Pedram Razavi


“This novel, high-intensity sequencing assay incorporates an unprecedented combination of depth and breadth of coverage compared to previous assays. High levels of concordance for variants between plasma and tissue provide strong evidence for high rates of tumor DNA detection in plasma,” he said at a press briefing at the annual meeting of the American Society of Clinical Oncology.

The technique also provides important insights into tumor biology, “including first exploration of mutational signatures in the plasma,” he added.

Deep scanning

The high-intensity sequencing method scans for 508 genes in a 2 million base-pair swath of genome, performing 60,000 repeat reads on each genome region to improve the assay’s sensitivity, and deep sequencing allows for detection of rare “needle-in-a-haystack” variants.

Dr. Razavi and his colleagues examined prospectively collected blood and tissues from 161 patients, 124 of whom had samples sufficient for concordance studies.

The samples were collected within 6 weeks of a de novo cancer diagnosis or evidence of disease progression, before the initiation of therapy.

Both cfDNA and genomic data from white blood cells (WBCs) of each patient were sequenced with the aforementioned 508-gene panel covering a broad range of known cancer variants and mutations.

Tumor tissues were sequenced with MSK-IMPACT, a 410 gene assay, with blinding of results in regard to plasma and WBC sequencing. Variants were classified as clonal or subclonal based on tumor sequencing in breast cancer and non–small cell lung cancer (NSCLC).

As noted before, 89% of patients had at least one genetic variant detected in both the tumor and in plasma, including 97% of patients with metastatic breast cancer, 85% of those with NSCLC, and 84% of patients with metastatic prostate cancer.

The investigators identified 864 clonal or subclonal variants in tissue samples from all three of these cancers, and 627 of the variants also were found in plasma.

In addition, 76% of clinically actionable somatic mutations identified in tumors also were found in plasma, which suggests that the high-intensity sequencing technique may be able to identify tumor heterogeneity that is not always evident in single tumor biopsies, Dr. Razavi said.

Neil Osterweil/Frontline Medical News
Dr. John Heymach

‘A clear advance’

“The work by Dr. Razavi and colleagues is a clear advance in the field because it surveys for the first time a much broader panel of genes – 508 genes in this case – and it does it with much deeper sequencing, which means it can detect much rarer alterations,” commented ASCO expert John Heymach, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston.

The study “helps illuminate a path toward a day when we will be using circulating tumor DNA assays for early detection of cancer, and not just for selecting certain therapies,” he added.

“We’re a long way from utilizing liquid biopsy for detecting cancers; already though, we’re seeing some utility of circulating tumor DNA in the domain of identifying novel alterations as a means of segmentation clinical trials,” commented ASCO expert Sumanta Kumar Pal, MD, from City of Hope in Duarte, Calif.

Neil Osterweil/Frontline Medical News
Dr. Sumanta Kumar Pal


Dr. Heymach and Dr. Pal were not involved in the study, but were invited discussants at the briefing.

The study was funded in part by GRAIL. Dr. Razavi reported institutional research funding from the company. Multiple coauthors are employees of the company.

– An experimental liquid biopsy method plumbs the depths of the genome to detect a broad array of mutations in blood samples that closely correspond to variants in tumors.

The high-intensity method for detecting circulating free DNA (cfDNA) in plasma detected at least one significant genetic variant in samples from 89% of patients with advanced breast, lung, and prostate cancers.

If validated in further studies, the technique could inform more accurate drug selection in patients with refractory disease and eventually may form the basis for plasma-based assays to detect early-stage cancers, said Pedram Razavi, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York.

Neil Osterweil/Frontline Medical News
Dr. Pedram Razavi


“This novel, high-intensity sequencing assay incorporates an unprecedented combination of depth and breadth of coverage compared to previous assays. High levels of concordance for variants between plasma and tissue provide strong evidence for high rates of tumor DNA detection in plasma,” he said at a press briefing at the annual meeting of the American Society of Clinical Oncology.

The technique also provides important insights into tumor biology, “including first exploration of mutational signatures in the plasma,” he added.

Deep scanning

The high-intensity sequencing method scans for 508 genes in a 2 million base-pair swath of genome, performing 60,000 repeat reads on each genome region to improve the assay’s sensitivity, and deep sequencing allows for detection of rare “needle-in-a-haystack” variants.

Dr. Razavi and his colleagues examined prospectively collected blood and tissues from 161 patients, 124 of whom had samples sufficient for concordance studies.

The samples were collected within 6 weeks of a de novo cancer diagnosis or evidence of disease progression, before the initiation of therapy.

Both cfDNA and genomic data from white blood cells (WBCs) of each patient were sequenced with the aforementioned 508-gene panel covering a broad range of known cancer variants and mutations.

Tumor tissues were sequenced with MSK-IMPACT, a 410 gene assay, with blinding of results in regard to plasma and WBC sequencing. Variants were classified as clonal or subclonal based on tumor sequencing in breast cancer and non–small cell lung cancer (NSCLC).

As noted before, 89% of patients had at least one genetic variant detected in both the tumor and in plasma, including 97% of patients with metastatic breast cancer, 85% of those with NSCLC, and 84% of patients with metastatic prostate cancer.

The investigators identified 864 clonal or subclonal variants in tissue samples from all three of these cancers, and 627 of the variants also were found in plasma.

In addition, 76% of clinically actionable somatic mutations identified in tumors also were found in plasma, which suggests that the high-intensity sequencing technique may be able to identify tumor heterogeneity that is not always evident in single tumor biopsies, Dr. Razavi said.

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Dr. John Heymach

‘A clear advance’

“The work by Dr. Razavi and colleagues is a clear advance in the field because it surveys for the first time a much broader panel of genes – 508 genes in this case – and it does it with much deeper sequencing, which means it can detect much rarer alterations,” commented ASCO expert John Heymach, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston.

The study “helps illuminate a path toward a day when we will be using circulating tumor DNA assays for early detection of cancer, and not just for selecting certain therapies,” he added.

“We’re a long way from utilizing liquid biopsy for detecting cancers; already though, we’re seeing some utility of circulating tumor DNA in the domain of identifying novel alterations as a means of segmentation clinical trials,” commented ASCO expert Sumanta Kumar Pal, MD, from City of Hope in Duarte, Calif.

Neil Osterweil/Frontline Medical News
Dr. Sumanta Kumar Pal


Dr. Heymach and Dr. Pal were not involved in the study, but were invited discussants at the briefing.

The study was funded in part by GRAIL. Dr. Razavi reported institutional research funding from the company. Multiple coauthors are employees of the company.

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Key clinical point: High-intensity sequencing of plasma samples appears capable of detecting actionable tumor mutations in a large proportion of samples.

Major finding: In 89% of patients with advanced cancers, genetic variants were identified in both tumor samples and circulating free DNA testing.

Data source: Prospective study of tissue and plasma samples from 124 patients with non–small cell lung cancer or metastatic breast and prostate cancers.

Disclosures: The study was funded in part by GRAIL. Dr. Razavi reported institutional research funding from the company. Multiple coauthors are employees of the company.

Cost, value of new cancer treatments rarely correlate

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Thu, 03/28/2019 - 14:51

New high-priced cancer treatments rarely demonstrate value, compared with the prices being charged for them.

Researchers examined clinical trial data for new treatments using scoring frameworks developed by both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) that assess the value of cancer therapies by taking into consideration survival gains in relation to toxicity and quality. Findings were simultaneously published online June 2 in The Lancet Oncology (2017 June 2. doi: 10.1016/S1470-2045(17)30415-1) and presented at the annual meeting of the American Society of Clinical Oncology.

crazydiva/Thinkstock


One of the findings from the research quantified the magnitude of how much benefit a new treatment offers patients.

“We were able to compare that across different treatments and we were able to calculate the drug cost per month of treatment with each new cancer treatment,” Christopher Booth, MD, of Queen’s University Cancer Research Institute, Kingston, Ont., and one of the report’s authors, said in an interview.

“We looked to see whether there is a relationship between cost and benefit. In most elements of our economy, if something is of higher value and better quality, we often pay more for it as opposed to something that offers less quality or less value,” he continued. “We found that that relationship does not hold true in the world of cancer drugs. In fact, if anything, we saw an inverse association, meaning that the drugs that are the most expensive actually have the smallest benefit for patients. That is probably the most important finding of the work.”

Dr. Booth suggested that this has to do with the fact that value is never a factor in pricing.

“In very general terms, the way that a new drug is priced is effectively the highest price the market will bear,” he said. “There really isn’t an approach currently to price drugs based on the return that they offer to patients and society. There is a conversation under way within the oncology community about whether we need to be shifting that conversation to something perhaps called value-based pricing where treatments that offer greater benefit to patients are priced higher than treatments that offer negligible benefit.”

He also noted that “there is not a lot of incentive for the research community or pharmaceutical companies to identify drugs that have larger and larger benefits, being that the financial return on their investment does not appear to be related to how much benefit the drug offers. If we shifted that conversation, it would hopefully, at least in some way, drive the research community and push us to find treatments that have large or meaningful benefits to patients instead of some of these treatments that are very expensive with important side effects that really offer very small improvements in patient outcomes.”

Dr. Booth continued: “I think it’s inevitable and I think what these score cards are doing, and even though they are not perfect, are getting the conversation into the mainstream and for the first time allowing oncologists and researchers and policy makers to start some kind of comparative analyses looking at one treatment compared to the other in the same disease setting as offering a greater or lesser benefit to patients,” which is an important conversation as health care systems are faced with stretching their limited resources to help the populations they serve.

The other key finding of the report was the lack of correlation between the scores yielded by the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale.

“We looked at a number of randomized trials of new cancer treatments and we scored them using the European approach and the American approach and found that there is actually fairly little agreement between the two systems,” Dr. Booth said.

The cause, he suggested, was tied to differences in methodology between the two systems, though he noted that both frameworks are evolving and “I suspect there will be convergence over time.”

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New high-priced cancer treatments rarely demonstrate value, compared with the prices being charged for them.

Researchers examined clinical trial data for new treatments using scoring frameworks developed by both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) that assess the value of cancer therapies by taking into consideration survival gains in relation to toxicity and quality. Findings were simultaneously published online June 2 in The Lancet Oncology (2017 June 2. doi: 10.1016/S1470-2045(17)30415-1) and presented at the annual meeting of the American Society of Clinical Oncology.

crazydiva/Thinkstock


One of the findings from the research quantified the magnitude of how much benefit a new treatment offers patients.

“We were able to compare that across different treatments and we were able to calculate the drug cost per month of treatment with each new cancer treatment,” Christopher Booth, MD, of Queen’s University Cancer Research Institute, Kingston, Ont., and one of the report’s authors, said in an interview.

“We looked to see whether there is a relationship between cost and benefit. In most elements of our economy, if something is of higher value and better quality, we often pay more for it as opposed to something that offers less quality or less value,” he continued. “We found that that relationship does not hold true in the world of cancer drugs. In fact, if anything, we saw an inverse association, meaning that the drugs that are the most expensive actually have the smallest benefit for patients. That is probably the most important finding of the work.”

Dr. Booth suggested that this has to do with the fact that value is never a factor in pricing.

“In very general terms, the way that a new drug is priced is effectively the highest price the market will bear,” he said. “There really isn’t an approach currently to price drugs based on the return that they offer to patients and society. There is a conversation under way within the oncology community about whether we need to be shifting that conversation to something perhaps called value-based pricing where treatments that offer greater benefit to patients are priced higher than treatments that offer negligible benefit.”

He also noted that “there is not a lot of incentive for the research community or pharmaceutical companies to identify drugs that have larger and larger benefits, being that the financial return on their investment does not appear to be related to how much benefit the drug offers. If we shifted that conversation, it would hopefully, at least in some way, drive the research community and push us to find treatments that have large or meaningful benefits to patients instead of some of these treatments that are very expensive with important side effects that really offer very small improvements in patient outcomes.”

Dr. Booth continued: “I think it’s inevitable and I think what these score cards are doing, and even though they are not perfect, are getting the conversation into the mainstream and for the first time allowing oncologists and researchers and policy makers to start some kind of comparative analyses looking at one treatment compared to the other in the same disease setting as offering a greater or lesser benefit to patients,” which is an important conversation as health care systems are faced with stretching their limited resources to help the populations they serve.

The other key finding of the report was the lack of correlation between the scores yielded by the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale.

“We looked at a number of randomized trials of new cancer treatments and we scored them using the European approach and the American approach and found that there is actually fairly little agreement between the two systems,” Dr. Booth said.

The cause, he suggested, was tied to differences in methodology between the two systems, though he noted that both frameworks are evolving and “I suspect there will be convergence over time.”

New high-priced cancer treatments rarely demonstrate value, compared with the prices being charged for them.

Researchers examined clinical trial data for new treatments using scoring frameworks developed by both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) that assess the value of cancer therapies by taking into consideration survival gains in relation to toxicity and quality. Findings were simultaneously published online June 2 in The Lancet Oncology (2017 June 2. doi: 10.1016/S1470-2045(17)30415-1) and presented at the annual meeting of the American Society of Clinical Oncology.

crazydiva/Thinkstock


One of the findings from the research quantified the magnitude of how much benefit a new treatment offers patients.

“We were able to compare that across different treatments and we were able to calculate the drug cost per month of treatment with each new cancer treatment,” Christopher Booth, MD, of Queen’s University Cancer Research Institute, Kingston, Ont., and one of the report’s authors, said in an interview.

“We looked to see whether there is a relationship between cost and benefit. In most elements of our economy, if something is of higher value and better quality, we often pay more for it as opposed to something that offers less quality or less value,” he continued. “We found that that relationship does not hold true in the world of cancer drugs. In fact, if anything, we saw an inverse association, meaning that the drugs that are the most expensive actually have the smallest benefit for patients. That is probably the most important finding of the work.”

Dr. Booth suggested that this has to do with the fact that value is never a factor in pricing.

“In very general terms, the way that a new drug is priced is effectively the highest price the market will bear,” he said. “There really isn’t an approach currently to price drugs based on the return that they offer to patients and society. There is a conversation under way within the oncology community about whether we need to be shifting that conversation to something perhaps called value-based pricing where treatments that offer greater benefit to patients are priced higher than treatments that offer negligible benefit.”

He also noted that “there is not a lot of incentive for the research community or pharmaceutical companies to identify drugs that have larger and larger benefits, being that the financial return on their investment does not appear to be related to how much benefit the drug offers. If we shifted that conversation, it would hopefully, at least in some way, drive the research community and push us to find treatments that have large or meaningful benefits to patients instead of some of these treatments that are very expensive with important side effects that really offer very small improvements in patient outcomes.”

Dr. Booth continued: “I think it’s inevitable and I think what these score cards are doing, and even though they are not perfect, are getting the conversation into the mainstream and for the first time allowing oncologists and researchers and policy makers to start some kind of comparative analyses looking at one treatment compared to the other in the same disease setting as offering a greater or lesser benefit to patients,” which is an important conversation as health care systems are faced with stretching their limited resources to help the populations they serve.

The other key finding of the report was the lack of correlation between the scores yielded by the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale.

“We looked at a number of randomized trials of new cancer treatments and we scored them using the European approach and the American approach and found that there is actually fairly little agreement between the two systems,” Dr. Booth said.

The cause, he suggested, was tied to differences in methodology between the two systems, though he noted that both frameworks are evolving and “I suspect there will be convergence over time.”

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VIDEO: Olaparib improves outlook in women with BRCA-related HER2-negative MBC

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Wed, 01/04/2023 - 16:47

– Compared with single-agent chemotherapy of the oncologist’s choice, the PARP inhibitor olaparib reduced the risk of progression or death by 42% in women with BRCA-related HER2-negative metastatic breast cancer, the OlympiAD trialists reported in a plenary session at the annual meeting of the American Society of Clinical Oncology.

Lead author Mark E. Robson, MD, of Memorial Sloan Kettering Cancer Center, New York, discussed findings of the randomized phase III trial, as well as strategies for building on the trial’s success and what the future holds for this class of agents in breast cancer.

 



Dr. Robson disclosed that he has a consulting or advisory role with McKesson and AstraZeneca; receives travel, accommodations, and/or expenses from AstraZeneca; receives honoraria from AstraZeneca; and receives research funding (institutional) from AstraZeneca, Abbvie, Myriad Genetics, Biomarin, Medivation, and Tesaro. The trial was funded by AstraZeneca.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Compared with single-agent chemotherapy of the oncologist’s choice, the PARP inhibitor olaparib reduced the risk of progression or death by 42% in women with BRCA-related HER2-negative metastatic breast cancer, the OlympiAD trialists reported in a plenary session at the annual meeting of the American Society of Clinical Oncology.

Lead author Mark E. Robson, MD, of Memorial Sloan Kettering Cancer Center, New York, discussed findings of the randomized phase III trial, as well as strategies for building on the trial’s success and what the future holds for this class of agents in breast cancer.

 



Dr. Robson disclosed that he has a consulting or advisory role with McKesson and AstraZeneca; receives travel, accommodations, and/or expenses from AstraZeneca; receives honoraria from AstraZeneca; and receives research funding (institutional) from AstraZeneca, Abbvie, Myriad Genetics, Biomarin, Medivation, and Tesaro. The trial was funded by AstraZeneca.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– Compared with single-agent chemotherapy of the oncologist’s choice, the PARP inhibitor olaparib reduced the risk of progression or death by 42% in women with BRCA-related HER2-negative metastatic breast cancer, the OlympiAD trialists reported in a plenary session at the annual meeting of the American Society of Clinical Oncology.

Lead author Mark E. Robson, MD, of Memorial Sloan Kettering Cancer Center, New York, discussed findings of the randomized phase III trial, as well as strategies for building on the trial’s success and what the future holds for this class of agents in breast cancer.

 



Dr. Robson disclosed that he has a consulting or advisory role with McKesson and AstraZeneca; receives travel, accommodations, and/or expenses from AstraZeneca; receives honoraria from AstraZeneca; and receives research funding (institutional) from AstraZeneca, Abbvie, Myriad Genetics, Biomarin, Medivation, and Tesaro. The trial was funded by AstraZeneca.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Abiraterone improves survival in high-risk prostate cancer

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– Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.

In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.

Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.

He discussed the findings, including side effects, and ongoing and future studies, in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.

Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.

“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.

Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.

“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”
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– Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.

In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.

Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.

He discussed the findings, including side effects, and ongoing and future studies, in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.

Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.

“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.

Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.

“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”

– Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.

In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.

Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.

He discussed the findings, including side effects, and ongoing and future studies, in a video interview.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.

Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.

“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.

Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.

“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”
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Interventions ease cancer-related stress, depression

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– Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.

As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.

For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).

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Dr. Viviane Hess


“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.

Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.

STREAM

Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.

The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.

The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.

For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.

In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.

Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).

At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.

Neil Osterweil/Frontline Medical News
Dr. Don S. Dizon


“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.

“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.

Recurrence fears assuaged

In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.

“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.

Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).

Neil Osterweil/Frontline Medical News
Dr. Jane McNeil Beith


Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.

The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.

They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.

The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.

Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.

“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.

The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.

 

 

CALM

In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.

Neil Osterweil/Frontline Medical News
Dr. Gary Rodin


Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.

In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.

The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.

In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.

“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.

The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.

The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.

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– Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.

As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.

For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).

Neil Osterweil/Frontline Medical News
Dr. Viviane Hess


“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.

Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.

STREAM

Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.

The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.

The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.

For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.

In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.

Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).

At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.

Neil Osterweil/Frontline Medical News
Dr. Don S. Dizon


“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.

“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.

Recurrence fears assuaged

In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.

“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.

Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).

Neil Osterweil/Frontline Medical News
Dr. Jane McNeil Beith


Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.

The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.

They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.

The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.

Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.

“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.

The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.

 

 

CALM

In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.

Neil Osterweil/Frontline Medical News
Dr. Gary Rodin


Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.

In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.

The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.

In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.

“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.

The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.

The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.

– Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.

As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.

For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).

Neil Osterweil/Frontline Medical News
Dr. Viviane Hess


“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.

Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.

STREAM

Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.

The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.

The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.

For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.

In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.

Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).

At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.

Neil Osterweil/Frontline Medical News
Dr. Don S. Dizon


“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.

“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.

Recurrence fears assuaged

In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.

“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.

Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).

Neil Osterweil/Frontline Medical News
Dr. Jane McNeil Beith


Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.

The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.

They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.

The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.

Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.

“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.

The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.

 

 

CALM

In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.

Neil Osterweil/Frontline Medical News
Dr. Gary Rodin


Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.

In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.

The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.

In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.

“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.

The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.

The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.

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Key clinical point: Oncologists and patients may focus on only the clinical aspects of care while overlooking cancer-associated distress, anxiety, or fear.

Major finding: Each of three psychological interventions was effective at reducing mental health symptoms in patients with cancer.

Data source: Randomized trials of interventions aimed at relieving mental health symptoms associated with a new cancer diagnoses, fear of cancer recurrence, and advanced or metastatic disease.

Disclosures: The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.

VIDEO: TRK inhibitor shows 76% ORR across diverse cancers harboring TRK fusions

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– An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.

Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.

Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.

Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.

Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

– An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.

Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.

Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Severe health conditions decrease among childhood cancer survivors

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Severe health conditions decrease among childhood cancer survivors

Photo © ASCO/Danny Morton 2017
Lobby of McCormick Place during ASCO 2017

CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).

Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.

Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.

Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.

Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.

The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).

The investigators found significant decreases in severe health conditions in 6 diagnostic groups:

  • Wilms tumor, decreased from 13% to 5% (P<0.0001)
  • HL, decreased from 18% to 11% (P<0.0001)
  • Astrocytoma, decreased from 15% to 9% (P=0.004)
  • NHL, decreased from 10% to 6% (P=0.04)
  • ALL, decreased from 9% to 7% (P=0.002)
  • Ewings sarcoma, decreased from 19% to 10% (P=0.01)

They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.

The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.

They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.

The National Institutes of Health funded the study.

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Photo © ASCO/Danny Morton 2017
Lobby of McCormick Place during ASCO 2017

CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).

Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.

Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.

Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.

Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.

The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).

The investigators found significant decreases in severe health conditions in 6 diagnostic groups:

  • Wilms tumor, decreased from 13% to 5% (P<0.0001)
  • HL, decreased from 18% to 11% (P<0.0001)
  • Astrocytoma, decreased from 15% to 9% (P=0.004)
  • NHL, decreased from 10% to 6% (P=0.04)
  • ALL, decreased from 9% to 7% (P=0.002)
  • Ewings sarcoma, decreased from 19% to 10% (P=0.01)

They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.

The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.

They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.

The National Institutes of Health funded the study.

Photo © ASCO/Danny Morton 2017
Lobby of McCormick Place during ASCO 2017

CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).

Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.

Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.

Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.

Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.

The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).

The investigators found significant decreases in severe health conditions in 6 diagnostic groups:

  • Wilms tumor, decreased from 13% to 5% (P<0.0001)
  • HL, decreased from 18% to 11% (P<0.0001)
  • Astrocytoma, decreased from 15% to 9% (P=0.004)
  • NHL, decreased from 10% to 6% (P=0.04)
  • ALL, decreased from 9% to 7% (P=0.002)
  • Ewings sarcoma, decreased from 19% to 10% (P=0.01)

They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.

The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.

They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.

The National Institutes of Health funded the study.

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Severe health conditions decrease among childhood cancer survivors
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Single-dose RT suffices for treatment of spinal cord compression due to mets

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– A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.

“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”

The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.

Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.

Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.

“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.

“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”

Findings in context

The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.

Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”

“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.

“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”

Study details

SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.

At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).

At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.

The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.

Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.

Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).

 

 

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– A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.

“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”

The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.

Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.

Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.

“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.

“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”

Findings in context

The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.

Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”

“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.

“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”

Study details

SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.

At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).

At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.

The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.

Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.

Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).

 

 

– A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.

“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”

The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.

Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.

Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.

“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.

“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”

Findings in context

The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.

Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”

“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.

“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”

Study details

SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.

At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).

At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.

The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.

Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.

Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).

 

 

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Key clinical point: A single dose of radiation therapy works essentially as well as multiple doses for treating spinal cord compression due to cancer metastases.

Major finding: At 8 weeks, the proportion of patients able to walk was 69.5% with 8 Gy given in a single dose and 73.3% with 20 Gy given in five doses.

Data source: A randomized phase III noninferiority trial among 688 patients with spinal cord compression due to metastatic cancer (SCORAD III trial).

Disclosures: Dr. Hoskin disclosed that he receives research funding (institutional) from Varian Medical Systems. The trial was funded by Cancer Research UK.

U.S. malaria cases dipped slightly in 2014

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The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.

The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.

Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.

Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).

“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.

Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.

“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.

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The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.

The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.

Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.

Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).

“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.

Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.

“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.

The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.

The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.

Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.

Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).

“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.

Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.

“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.

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