Patient & Survivor Care

For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.

The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.

The system is manufactured by Nova Biomedical.

[email protected]

For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.

The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.

The system is manufactured by Nova Biomedical.

[email protected]

For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.

The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.

The system is manufactured by Nova Biomedical.

[email protected]

Background Bacteremia is associated with increased risk of complications in patients with febrile neutropenia (FN), although few clinical studies have reported outcomes in apparently stable patients (ASPs) who could be candidates for home treatment.

Objective To assess the risk factors and the impact of bacteremia in ASPs.

Methods We retrospectively analyzed 861 consecutive episodes of FN that were classified according to their presentation into 2 categories: clearly unstable patients and ASPs. We estimated the incidence of bacteremia and severe complications in ASPs. We analyzed predictors for bacteremia and the discriminatory ability of the MASCC score in this setting.

Results We classified 692 episodes as ASPs. Bacteremia occurred in 6%, major complications were noted in 7.3%, and death occurred in 1.3%. Patients with bacteremia had more complications (odds ratio [OR], 8.2), and mortality (OR, 8.2). The integration of the MASCC score and bacteremic status predicted complications with an area under the receiver operating characteristic (ROC) curve of 0.74, sensitivity of 36%, and specificity of 94%. Predictors of bacteremia were temperature ≥ 39°C/102.2°F (OR, 3), rigors (OR, 2.2), ECOG PS ≥ 2 (OR, 2.1), and advanced cancer (OR, 2.5). Two percent of patients who remained afebrile for 48 hours had positive blood cultures afterward.

Limitations A single-center, retrospective analysis, and the absence of a validation set to test the model’s discriminatory ability.

Conclusions Bacteremia is infrequent among ASPs but is associated with a high risk of complications. We identified several variables that could improve the prognostic classification of clinically stable FN.

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

Background Bacteremia is associated with increased risk of complications in patients with febrile neutropenia (FN), although few clinical studies have reported outcomes in apparently stable patients (ASPs) who could be candidates for home treatment.

Objective To assess the risk factors and the impact of bacteremia in ASPs.

Methods We retrospectively analyzed 861 consecutive episodes of FN that were classified according to their presentation into 2 categories: clearly unstable patients and ASPs. We estimated the incidence of bacteremia and severe complications in ASPs. We analyzed predictors for bacteremia and the discriminatory ability of the MASCC score in this setting.

Results We classified 692 episodes as ASPs. Bacteremia occurred in 6%, major complications were noted in 7.3%, and death occurred in 1.3%. Patients with bacteremia had more complications (odds ratio [OR], 8.2), and mortality (OR, 8.2). The integration of the MASCC score and bacteremic status predicted complications with an area under the receiver operating characteristic (ROC) curve of 0.74, sensitivity of 36%, and specificity of 94%. Predictors of bacteremia were temperature ≥ 39°C/102.2°F (OR, 3), rigors (OR, 2.2), ECOG PS ≥ 2 (OR, 2.1), and advanced cancer (OR, 2.5). Two percent of patients who remained afebrile for 48 hours had positive blood cultures afterward.

Limitations A single-center, retrospective analysis, and the absence of a validation set to test the model’s discriminatory ability.

Conclusions Bacteremia is infrequent among ASPs but is associated with a high risk of complications. We identified several variables that could improve the prognostic classification of clinically stable FN.

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

Background Bacteremia is associated with increased risk of complications in patients with febrile neutropenia (FN), although few clinical studies have reported outcomes in apparently stable patients (ASPs) who could be candidates for home treatment.

Objective To assess the risk factors and the impact of bacteremia in ASPs.

Methods We retrospectively analyzed 861 consecutive episodes of FN that were classified according to their presentation into 2 categories: clearly unstable patients and ASPs. We estimated the incidence of bacteremia and severe complications in ASPs. We analyzed predictors for bacteremia and the discriminatory ability of the MASCC score in this setting.

Results We classified 692 episodes as ASPs. Bacteremia occurred in 6%, major complications were noted in 7.3%, and death occurred in 1.3%. Patients with bacteremia had more complications (odds ratio [OR], 8.2), and mortality (OR, 8.2). The integration of the MASCC score and bacteremic status predicted complications with an area under the receiver operating characteristic (ROC) curve of 0.74, sensitivity of 36%, and specificity of 94%. Predictors of bacteremia were temperature ≥ 39°C/102.2°F (OR, 3), rigors (OR, 2.2), ECOG PS ≥ 2 (OR, 2.1), and advanced cancer (OR, 2.5). Two percent of patients who remained afebrile for 48 hours had positive blood cultures afterward.

Limitations A single-center, retrospective analysis, and the absence of a validation set to test the model’s discriminatory ability.

Conclusions Bacteremia is infrequent among ASPs but is associated with a high risk of complications. We identified several variables that could improve the prognostic classification of clinically stable FN.

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

Summer is winding down as we go to press with this month’s issue, and while we might well reflect a little sadly on its departure, we can also look forward to the fall season with its promise of renewal and adventure. As I settled back in to my familiar work routine after the Labor Day weekend, I was reminded of how, despite the remarkable clinical advances in oncology, we are still caregivers, involved in our patients’ everyday lives and that we can never forget our humanity. The advent of high-tech personalized medicine or precision oncology, as I prefer to call it, has given oncologists a remarkable cache of treatment options for their patients and the hope that more – and better – therapies are to come. Next-generation diagnostics are helping us identify the cellular targets we need to take aim at to kill the tumor and globally, research is yielding more and more therapeutics to subdue those targets and hence the tumor.

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

Summer is winding down as we go to press with this month’s issue, and while we might well reflect a little sadly on its departure, we can also look forward to the fall season with its promise of renewal and adventure. As I settled back in to my familiar work routine after the Labor Day weekend, I was reminded of how, despite the remarkable clinical advances in oncology, we are still caregivers, involved in our patients’ everyday lives and that we can never forget our humanity. The advent of high-tech personalized medicine or precision oncology, as I prefer to call it, has given oncologists a remarkable cache of treatment options for their patients and the hope that more – and better – therapies are to come. Next-generation diagnostics are helping us identify the cellular targets we need to take aim at to kill the tumor and globally, research is yielding more and more therapeutics to subdue those targets and hence the tumor.

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

Summer is winding down as we go to press with this month’s issue, and while we might well reflect a little sadly on its departure, we can also look forward to the fall season with its promise of renewal and adventure. As I settled back in to my familiar work routine after the Labor Day weekend, I was reminded of how, despite the remarkable clinical advances in oncology, we are still caregivers, involved in our patients’ everyday lives and that we can never forget our humanity. The advent of high-tech personalized medicine or precision oncology, as I prefer to call it, has given oncologists a remarkable cache of treatment options for their patients and the hope that more – and better – therapies are to come. Next-generation diagnostics are helping us identify the cellular targets we need to take aim at to kill the tumor and globally, research is yielding more and more therapeutics to subdue those targets and hence the tumor.

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

Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.

“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.

Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.

End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.

“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.

The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.

“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.

The committee made five broad recommendations:

• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.

• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.

• Standardized training and requirements should be developed and implemented.

• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.

• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.

More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.

Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.

He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.

The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”

The IOM report was financed by an anonymous donor, Dr. Fineberg said.

The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.

[email protected]

On Twitter @aliciaault

Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.

“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.

Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.

End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.

“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.

The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.

“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.

The committee made five broad recommendations:

• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.

• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.

• Standardized training and requirements should be developed and implemented.

• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.

• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.

More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.

Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.

He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.

The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”

The IOM report was financed by an anonymous donor, Dr. Fineberg said.

The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.

[email protected]

On Twitter @aliciaault

Physicians should be compensated for counseling patients on end-of-life planning, according to recommendations from the Institute of Medicine, and the health care delivery and payment system should be realigned to encourage and financially reward higher-quality, more comprehensive, more efficient, and more humane care for those with serious illnesses.

“Individuals should have time with their doctors to talk about end-of-life issues, and clinicians should receive the training and financial incentives for such discussions,” said David Walker, the former comptroller general of the United States, who was the cochair of the IOM committee that created the report published Sept. 17.

Dying in America calls on health care providers, payers, policy makers, and the American public to have a more open discourse about death and dying.

End-of-life care was caught up in a political firestorm in 2009 when the Obama administration proposed to pay for advanced care conversations under the Affordable Care Act, Dr. Harvey Fineberg, former IOM president, noted in a video message at a briefing to release the report. Such efforts were construed as “death panels,” and the administration withdrew its proposal within days of it going into effect in 2011, said Dr. Fineberg, who is now at the University of California, San Francisco.

“The controversy on this topic and the political desire to avoid it do not alter the fact that every person will face the end of life one day, and many have had hard experience with the final days of a parent, a spouse, a child, a sibling, another relative, or a dear friend,” Dr. Fineberg said.

The report focuses on three areas: what individuals and their families can do to take more control over their own life and their health care throughout their life; what clinicians and other professionals can do; and what policy makers and payers need to do to try to effectuate change. The 21-member IOM committee spent 2 years developing the consensus report, Mr. Walker said.

“For most people, death does not come suddenly,” said Dr. Philip Pizzo, committee cochair. “Instead, dying is a result of one or more diseases that must be managed carefully and compassionately over weeks, months, or even years, through many ups and downs,” said Dr. Pizzo of Stanford (Calif.) University.

The committee made five broad recommendations:

• Comprehensive care for patients with advanced, serious illness who are nearing the end of life should be covered by public and private payers.

• Evidence-based standards for clinician-patient communication and advanced care planning should be developed by professional societies; such standards should be used as measures for payment, licensing, and credentialing.

• Standardized training and requirements should be developed and implemented.

• Care standards should seek to avoid unnecessary emergency department or acute care services; care should be coordinated across settings and providers by using tools such as interoperable electronic health records and physician orders for life-sustaining treatment programs.

• Fact-based information on end-of-life care planning should be developed and disseminated broadly through public health and other governmental agencies, community-based organizations, and faith-based organizations, as well as through health care providers and payers.

More needs to be done to educate physicians, other health care providers, and patients about the differences between hospice care and palliative care, and the potential they have for improving quality of life and reducing potentially unnecessary – and costly – medical services, according to the committee report.

Dr. Pizzo noted that many physicians, when asked in surveys, have said that they would personally prefer less-aggressive care at the end of life, and if possible, having the patient receive care at home. Yet, when it comes to their patients, they tend to pull out the stops.

He said that was being driven by a lack of understanding of patients’ individual needs and preferences, and by what he and the committee called the “perverse incentives” of the health care system.

The system rewards more care, not less, and acute care more so than palliative or supportive care, Mr. Walker noted. “Our current system is broken. It does not result in the honoring of individual preferences as much as it should.”

The IOM report was financed by an anonymous donor, Dr. Fineberg said.

The donor made money available for the IOM to continue for at least a year, disseminating the findings and encouraging adoption of its recommendations, Mr. Walker said.

[email protected]

On Twitter @aliciaault

The Journal of Clinical Oncology has recently published its second special edition devoted to Geriatric Oncology. The impetus for the issue was the recognition that the older cancer population is growing rapidly, reflecting the aging of the population. This was recognized by leaders in oncology in 1983 when a symposium was organized to address this issue.

At that time there were a number of issues raised which are still relevant. This includes the recognition of the difference between physiologic and calendar age and the need to examine the factors unique to older cancer patients. These leaders established a research agenda, including analyses of databases, development of prospective clinical trials, longitudinal studies, pharmacokinetics and drug sensitivity of elderly cancer patients, quality of life issues, and physical education. Dr. B.J. Kennedy, as president of the American Society of Clinical Oncology (ASCO) in 1988, and in subsequent writings, emphasized the need to study aging and cancer.

The August 20th special edition of the Journal of Clinical Oncology highlights a number of issues in the field. It brings the readers new information on evidence-based treatment recommendations and discusses areas where data is lacking to stimulate research in these areas. The issue is broadly divided into a number of topics including disease-specific reviews (breast, ovary, lung, colon, prostate, leukemia, and multiple myeloma), clinical trial design methodology, geriatric assessment of the older patient, and survivorship issues (J. Clin. Onc. August 2014 [doi10.1200/JCO.2014.57.4822]).

For the field to advance, physician education is the key factor. Oncologists need to realize that the older patients are now and will continue to be the largest segment of patients they treat. Due to multiple comorbidities, geriatric syndromes, frailty, dependence, and other factors, decision making, whether it is in surgery, radiation, or medical oncology, will be increasingly complex. Physicians need the tools to make these decisions. Studies of geriatric assessment have clearly shown that clinical judgment is not enough.

In addition, the needs, wishes, and goals of the patients and their caregivers need to be central to decision making. Fortunately, Geriatric Oncology has been making inroads into these areas through the work of many individuals and organizations. The International Society of Geriatric Oncology, founded in 2000, has a strong and formalized organizational structure. It has formed a number of task forces which have formulated position papers and treatment recommendations. Its annual meeting is a valuable resource for presentation of data, networking, and stimulation of research concepts. The official journal of the society, the Journal of Geriatric Oncology has been an important avenue for the dissemination of advances in the field.

The Cancer and Aging Research Group has taken a strong leadership role in the field and has been a valuable training ground for young investigators and already has made significant contributions to geriatric assessment and evaluation.

ASCO has long recognized the importance of this issue. The society established a Geriatric Oncology track at the annual meeting with a Clinical Science Symposium, an Educational Committee group, a Special Interest Group, sessions at the ASCO/AACR Vail Clinical Trials Work on Special Populations, a Guidelines group, and the annual B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

The Alliance for Clinical Trials in Oncology (formerly CALGB) has had a Cancer in the Elderly Committee since 1995 and has made a major impact. It is currently doing a series of important database analyses. The Elderly Taskforce of the Gynecologic Oncology Group is conducting a prospective trial in older women with ovarian cancer, evaluating efficacy and the predictive value of a cancer-specific geriatric assessment.

Physicians caring for older cancer patients need to understand basic geriatric principles to be able to adequately assess their patients. The geriatric oncology researchers need to provide easily administered, validated, predictive models to help the practitioners. Patients need to be encouraged to participate in clinical trials, even those not elderly specific, so data can be obtained to help in future decision making. The older cancer patients need to be focus of endeavors. They deserve nothing less.

Dr. Stuart M. Lichtman is professor of medicine, Weill Cornell Medical College, New York, and recipient of the 2014 ASCO B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

The Journal of Clinical Oncology has recently published its second special edition devoted to Geriatric Oncology. The impetus for the issue was the recognition that the older cancer population is growing rapidly, reflecting the aging of the population. This was recognized by leaders in oncology in 1983 when a symposium was organized to address this issue.

At that time there were a number of issues raised which are still relevant. This includes the recognition of the difference between physiologic and calendar age and the need to examine the factors unique to older cancer patients. These leaders established a research agenda, including analyses of databases, development of prospective clinical trials, longitudinal studies, pharmacokinetics and drug sensitivity of elderly cancer patients, quality of life issues, and physical education. Dr. B.J. Kennedy, as president of the American Society of Clinical Oncology (ASCO) in 1988, and in subsequent writings, emphasized the need to study aging and cancer.

The August 20th special edition of the Journal of Clinical Oncology highlights a number of issues in the field. It brings the readers new information on evidence-based treatment recommendations and discusses areas where data is lacking to stimulate research in these areas. The issue is broadly divided into a number of topics including disease-specific reviews (breast, ovary, lung, colon, prostate, leukemia, and multiple myeloma), clinical trial design methodology, geriatric assessment of the older patient, and survivorship issues (J. Clin. Onc. August 2014 [doi10.1200/JCO.2014.57.4822]).

For the field to advance, physician education is the key factor. Oncologists need to realize that the older patients are now and will continue to be the largest segment of patients they treat. Due to multiple comorbidities, geriatric syndromes, frailty, dependence, and other factors, decision making, whether it is in surgery, radiation, or medical oncology, will be increasingly complex. Physicians need the tools to make these decisions. Studies of geriatric assessment have clearly shown that clinical judgment is not enough.

In addition, the needs, wishes, and goals of the patients and their caregivers need to be central to decision making. Fortunately, Geriatric Oncology has been making inroads into these areas through the work of many individuals and organizations. The International Society of Geriatric Oncology, founded in 2000, has a strong and formalized organizational structure. It has formed a number of task forces which have formulated position papers and treatment recommendations. Its annual meeting is a valuable resource for presentation of data, networking, and stimulation of research concepts. The official journal of the society, the Journal of Geriatric Oncology has been an important avenue for the dissemination of advances in the field.

The Cancer and Aging Research Group has taken a strong leadership role in the field and has been a valuable training ground for young investigators and already has made significant contributions to geriatric assessment and evaluation.

ASCO has long recognized the importance of this issue. The society established a Geriatric Oncology track at the annual meeting with a Clinical Science Symposium, an Educational Committee group, a Special Interest Group, sessions at the ASCO/AACR Vail Clinical Trials Work on Special Populations, a Guidelines group, and the annual B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

The Alliance for Clinical Trials in Oncology (formerly CALGB) has had a Cancer in the Elderly Committee since 1995 and has made a major impact. It is currently doing a series of important database analyses. The Elderly Taskforce of the Gynecologic Oncology Group is conducting a prospective trial in older women with ovarian cancer, evaluating efficacy and the predictive value of a cancer-specific geriatric assessment.

Physicians caring for older cancer patients need to understand basic geriatric principles to be able to adequately assess their patients. The geriatric oncology researchers need to provide easily administered, validated, predictive models to help the practitioners. Patients need to be encouraged to participate in clinical trials, even those not elderly specific, so data can be obtained to help in future decision making. The older cancer patients need to be focus of endeavors. They deserve nothing less.

Dr. Stuart M. Lichtman is professor of medicine, Weill Cornell Medical College, New York, and recipient of the 2014 ASCO B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

The Journal of Clinical Oncology has recently published its second special edition devoted to Geriatric Oncology. The impetus for the issue was the recognition that the older cancer population is growing rapidly, reflecting the aging of the population. This was recognized by leaders in oncology in 1983 when a symposium was organized to address this issue.

At that time there were a number of issues raised which are still relevant. This includes the recognition of the difference between physiologic and calendar age and the need to examine the factors unique to older cancer patients. These leaders established a research agenda, including analyses of databases, development of prospective clinical trials, longitudinal studies, pharmacokinetics and drug sensitivity of elderly cancer patients, quality of life issues, and physical education. Dr. B.J. Kennedy, as president of the American Society of Clinical Oncology (ASCO) in 1988, and in subsequent writings, emphasized the need to study aging and cancer.

The August 20th special edition of the Journal of Clinical Oncology highlights a number of issues in the field. It brings the readers new information on evidence-based treatment recommendations and discusses areas where data is lacking to stimulate research in these areas. The issue is broadly divided into a number of topics including disease-specific reviews (breast, ovary, lung, colon, prostate, leukemia, and multiple myeloma), clinical trial design methodology, geriatric assessment of the older patient, and survivorship issues (J. Clin. Onc. August 2014 [doi10.1200/JCO.2014.57.4822]).

For the field to advance, physician education is the key factor. Oncologists need to realize that the older patients are now and will continue to be the largest segment of patients they treat. Due to multiple comorbidities, geriatric syndromes, frailty, dependence, and other factors, decision making, whether it is in surgery, radiation, or medical oncology, will be increasingly complex. Physicians need the tools to make these decisions. Studies of geriatric assessment have clearly shown that clinical judgment is not enough.

In addition, the needs, wishes, and goals of the patients and their caregivers need to be central to decision making. Fortunately, Geriatric Oncology has been making inroads into these areas through the work of many individuals and organizations. The International Society of Geriatric Oncology, founded in 2000, has a strong and formalized organizational structure. It has formed a number of task forces which have formulated position papers and treatment recommendations. Its annual meeting is a valuable resource for presentation of data, networking, and stimulation of research concepts. The official journal of the society, the Journal of Geriatric Oncology has been an important avenue for the dissemination of advances in the field.

The Cancer and Aging Research Group has taken a strong leadership role in the field and has been a valuable training ground for young investigators and already has made significant contributions to geriatric assessment and evaluation.

ASCO has long recognized the importance of this issue. The society established a Geriatric Oncology track at the annual meeting with a Clinical Science Symposium, an Educational Committee group, a Special Interest Group, sessions at the ASCO/AACR Vail Clinical Trials Work on Special Populations, a Guidelines group, and the annual B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

The Alliance for Clinical Trials in Oncology (formerly CALGB) has had a Cancer in the Elderly Committee since 1995 and has made a major impact. It is currently doing a series of important database analyses. The Elderly Taskforce of the Gynecologic Oncology Group is conducting a prospective trial in older women with ovarian cancer, evaluating efficacy and the predictive value of a cancer-specific geriatric assessment.

Physicians caring for older cancer patients need to understand basic geriatric principles to be able to adequately assess their patients. The geriatric oncology researchers need to provide easily administered, validated, predictive models to help the practitioners. Patients need to be encouraged to participate in clinical trials, even those not elderly specific, so data can be obtained to help in future decision making. The older cancer patients need to be focus of endeavors. They deserve nothing less.

Dr. Stuart M. Lichtman is professor of medicine, Weill Cornell Medical College, New York, and recipient of the 2014 ASCO B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology.

SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.

Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.

He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.

Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.

The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.

One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.

Dr. Abrams reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.

Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.

He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.

Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.

The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.

One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.

Dr. Abrams reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Integrative oncology gained a solid foothold in mainstream oncology in the past decade, but it still has a long climb ahead before it’s available and accepted everywhere, Dr. Donald I. Abrams says.

Dr. Abrams gives an in-depth overview of the strengths and weaknesses of integrative oncology in this video interview, including common misconceptions among conventional oncologists and his own take on controversial topics like antioxidants.

He coedited with Dr. Andrew T. Weil the second edition of the textbook "Integrative Oncology" (2014, Oxford University Press). Dr. Abrams is chief of hematology/oncology at San Francisco General Hospital and director of the Integrative Oncology Research Program at the Osher Center for Integrative Medicine, San Francisco. Dr. Weil is director of the Center for Integrative Medicine at the University of Arizona, Tucson.

Dr. Abrams also gives tips on specific topics in integrative oncology including nutrition, botanical therapies, mushrooms, cannabis, and more.

The number of studies in integrative oncology is increasing, but difficulties in designing trials of these management tools limit their findings, he says.

One of Dr. Abrams’ patients, Manuchehr Shirmohamadi, describes how integrative oncology helped him get through treatment for colon cancer.

Dr. Abrams reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

Approximately 75% of cancer patients with major depression are not receiving treatment for their depression, according to an analysis of data from more than 21,000 patients.

However, a novel integrated treatment program designed specifically for cancer patients was shown in two additional studies to be strikingly more effective than usual care for reducing depressive symptoms and improving quality of life – even in those with a poor prognosis.

The findings were reported online Aug. 28 in the Lancet Psychiatry, the Lancet, and the Lancet Oncology.

Of 21,151 patients (mean age, 64 years) who were attending cancer clinics in Scotland between May 2008 and August 2011, 1,538 had major depression and complete patient-reported treatment data available. Of those, 1,130 (73%) were not receiving appropriate treatment, Jane Walker, Ph.D. of the University of Oxford (England) and her colleagues reported (Lancet Psychiatry 2014 Aug. 28 [doi: 10.1016/S2215-0366(14)70313-X]).

The prevalence of major depression was highest in patients with lung cancer (13.1%), followed by those with gynecological cancer (10.9%), breast cancer (9.3%), colorectal cancer (7.0%), and genitourinary cancer (5.6%). Younger patients, those with lower social deprivation scores, and women with lung or colorectal cancer were at increased risk for major depression.

Younger patients and women were more likely than older patients and men to be receiving treatment, and those with breast cancer were most likely to receive treatment for depression (32%), while those with lung cancer were least likely to receive treatment (19%), the investigators said.

Notably, those who had been living with a cancer diagnosis for more than a year were as likely to have depression as those with a recent diagnosis, and those who had received initial curative treatment were as likely to have depression as those who received palliative treatment, they reported.

The findings suggest that major depression is substantially more common in people with cancer than in the general population, in which the estimated point prevalence is 2% and the estimated 12-month prevalence is 4%-5%.

"Perhaps our most important finding was that most cancer outpatients with depression were not in receipt of potentially effective treatment for their depression," they said, noting that major depression among cancer outpatients merits greater attention, and that systematic approaches to improving depression care for patients with cancer are urgently needed.

One such approach was evaluated by Dr. Walker and her colleagues from the Symptom Management Research Trials (SMaRT) Oncology-2 and Oncology-3 teams.

Of 231 patients with cancer and major depression who were enrolled in the SMaRT Oncology-2 randomized controlled effectiveness trial between May 2008 and May 2011 and assigned to receive integrated collaborative depression care (Depression Care for People with Cancer, or DCPC), 143 (62%) experienced at least a 50% improvement on the Symptom Checklist Depression Scale score at 24 weeks. Of 231 patients assigned to receive usual care, only 40 (17%) achieved a 50% or greater response at 24 weeks (adjusted odds ratio for treatment response, 8.5; number needed to treat, 2.24), Dr. Michael Sharpe of the University of Oxford reported on behalf of the SMaRT Oncology-2 team (Lancet 2014 Aug. 28 [doi: 10/1016/S0140-6736(14)61231-9]).

Additionally, 33% of those in the DCPC group achieved remission of their major depression, compared with 4% of those in the usual care group (odds ratio, 13.1).

Those in the DCPC group had less depression, anxiety, pain, and fatigue, and had better functioning, health, quality of life, and perceived quality of depression care at each of four time points evaluated during the course of the study, the investigators said.

DCPC is a manualized, multicomponent collaborative care treatment, delivered systematically by cancer nurses and psychiatrists, in conjunction with primary care physicians and oncologists, to provide "systematic proactive treatment and follow-up." Usual care was provided by primary care physicians and/or oncologists, who were instructed to treat the patients as they normally would, such as with antidepressants or referral for a mental health assessment.

Patients in SMaRT Oncology-2 were adults with a good prognosis who were attending cancer clinics in Scotland, and who had major depression of at least 4 weeks’ duration.

"The findings of this trial add to the accumulating evidence for the effectiveness of collaborative care approaches to the treatment of depression comorbid with medical conditions. They also provide new evidence that large and sustained treatment effects can be achieved if depression treatment is integrated with medical care, intensive, and systematically delivered by a well-trained and supervised team," the investigators concluded. The cost of DCPC as delivered in this trial was "quite modest, especially in the context of cancer treatment," they noted.

In a related trial (SMaRT Oncology-3), the investigators found that even patients with a poor prognosis respond well to DCPC. Patients in SMaRT Oncology-3 were adults with major depression attending cancer clinics in Scotland between January 2009 and September 2011. All had a diagnosis of primary lung cancer, and a predicted survival of at least 3 months.

Mean depression severity – a summary measure of each participant’s depression severity scores averaged over the course of the study (up to 32 weeks) was significantly lower in 68 patients with lung cancer who were assigned to receive DCPC than in 74 patients assigned to receive usual care (mean Symptom Checklist Depression Scale scores of 1.24 vs. 1.61; standardized mean difference, –0.62), Dr. Walker reported on behalf of the SMaRT Oncology-3 team.

In addition, significantly more patients receiving DCPC achieved at least a 50% reduction in depression severity scale scores (51% vs. 15%).

"We also recorded significant differences between the treatment groups in self-rated depression improvement, anxiety, quality of life, role functioning, and perceived quality of care, all in favor of the depression care for the people with lung cancer group," they said.

"Our findings suggest that, despite the rapid deterioration of this patient group, successful clinical trials in patients with poor-prognosis cancer and comorbid major depression are possible, through adaptation of both trial design and treatment delivery. Our results also suggest that it is possible to effectively treat major depression in this patient group. ... Large trials are now needed to estimate the effectiveness and cost-effectiveness of depression care for people with lung cancer in this population, and further adaptation of the treatment is needed to address the unmet needs of patients with major depression and a shorter life expectancy," they concluded.

The authors reported having no conflicts of interest. The Lancet Psychiatry and Lancet studies were jointly sponsored by the University of Edinburgh and NHS Lothian, and were funded by Cancer Research UK (CRUK), with additional funding from the Chief Scientist Office (CSO) of the Scottish Government and NHS Research Scotland. The Lancet Psychiatry article was also funded by CRUK and the CSO of the Scottish Government. Dr. Walker is supported by Sir Michael Sobell House Hospice, Oxford; and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at the Oxford Health NHS Foundation Trust.

Approximately 75% of cancer patients with major depression are not receiving treatment for their depression, according to an analysis of data from more than 21,000 patients.

However, a novel integrated treatment program designed specifically for cancer patients was shown in two additional studies to be strikingly more effective than usual care for reducing depressive symptoms and improving quality of life – even in those with a poor prognosis.

The findings were reported online Aug. 28 in the Lancet Psychiatry, the Lancet, and the Lancet Oncology.

Of 21,151 patients (mean age, 64 years) who were attending cancer clinics in Scotland between May 2008 and August 2011, 1,538 had major depression and complete patient-reported treatment data available. Of those, 1,130 (73%) were not receiving appropriate treatment, Jane Walker, Ph.D. of the University of Oxford (England) and her colleagues reported (Lancet Psychiatry 2014 Aug. 28 [doi: 10.1016/S2215-0366(14)70313-X]).

The prevalence of major depression was highest in patients with lung cancer (13.1%), followed by those with gynecological cancer (10.9%), breast cancer (9.3%), colorectal cancer (7.0%), and genitourinary cancer (5.6%). Younger patients, those with lower social deprivation scores, and women with lung or colorectal cancer were at increased risk for major depression.

Younger patients and women were more likely than older patients and men to be receiving treatment, and those with breast cancer were most likely to receive treatment for depression (32%), while those with lung cancer were least likely to receive treatment (19%), the investigators said.

Notably, those who had been living with a cancer diagnosis for more than a year were as likely to have depression as those with a recent diagnosis, and those who had received initial curative treatment were as likely to have depression as those who received palliative treatment, they reported.

The findings suggest that major depression is substantially more common in people with cancer than in the general population, in which the estimated point prevalence is 2% and the estimated 12-month prevalence is 4%-5%.

"Perhaps our most important finding was that most cancer outpatients with depression were not in receipt of potentially effective treatment for their depression," they said, noting that major depression among cancer outpatients merits greater attention, and that systematic approaches to improving depression care for patients with cancer are urgently needed.

One such approach was evaluated by Dr. Walker and her colleagues from the Symptom Management Research Trials (SMaRT) Oncology-2 and Oncology-3 teams.

Of 231 patients with cancer and major depression who were enrolled in the SMaRT Oncology-2 randomized controlled effectiveness trial between May 2008 and May 2011 and assigned to receive integrated collaborative depression care (Depression Care for People with Cancer, or DCPC), 143 (62%) experienced at least a 50% improvement on the Symptom Checklist Depression Scale score at 24 weeks. Of 231 patients assigned to receive usual care, only 40 (17%) achieved a 50% or greater response at 24 weeks (adjusted odds ratio for treatment response, 8.5; number needed to treat, 2.24), Dr. Michael Sharpe of the University of Oxford reported on behalf of the SMaRT Oncology-2 team (Lancet 2014 Aug. 28 [doi: 10/1016/S0140-6736(14)61231-9]).

Additionally, 33% of those in the DCPC group achieved remission of their major depression, compared with 4% of those in the usual care group (odds ratio, 13.1).

Those in the DCPC group had less depression, anxiety, pain, and fatigue, and had better functioning, health, quality of life, and perceived quality of depression care at each of four time points evaluated during the course of the study, the investigators said.

DCPC is a manualized, multicomponent collaborative care treatment, delivered systematically by cancer nurses and psychiatrists, in conjunction with primary care physicians and oncologists, to provide "systematic proactive treatment and follow-up." Usual care was provided by primary care physicians and/or oncologists, who were instructed to treat the patients as they normally would, such as with antidepressants or referral for a mental health assessment.

Patients in SMaRT Oncology-2 were adults with a good prognosis who were attending cancer clinics in Scotland, and who had major depression of at least 4 weeks’ duration.

"The findings of this trial add to the accumulating evidence for the effectiveness of collaborative care approaches to the treatment of depression comorbid with medical conditions. They also provide new evidence that large and sustained treatment effects can be achieved if depression treatment is integrated with medical care, intensive, and systematically delivered by a well-trained and supervised team," the investigators concluded. The cost of DCPC as delivered in this trial was "quite modest, especially in the context of cancer treatment," they noted.

In a related trial (SMaRT Oncology-3), the investigators found that even patients with a poor prognosis respond well to DCPC. Patients in SMaRT Oncology-3 were adults with major depression attending cancer clinics in Scotland between January 2009 and September 2011. All had a diagnosis of primary lung cancer, and a predicted survival of at least 3 months.

Mean depression severity – a summary measure of each participant’s depression severity scores averaged over the course of the study (up to 32 weeks) was significantly lower in 68 patients with lung cancer who were assigned to receive DCPC than in 74 patients assigned to receive usual care (mean Symptom Checklist Depression Scale scores of 1.24 vs. 1.61; standardized mean difference, –0.62), Dr. Walker reported on behalf of the SMaRT Oncology-3 team.

In addition, significantly more patients receiving DCPC achieved at least a 50% reduction in depression severity scale scores (51% vs. 15%).

"We also recorded significant differences between the treatment groups in self-rated depression improvement, anxiety, quality of life, role functioning, and perceived quality of care, all in favor of the depression care for the people with lung cancer group," they said.

"Our findings suggest that, despite the rapid deterioration of this patient group, successful clinical trials in patients with poor-prognosis cancer and comorbid major depression are possible, through adaptation of both trial design and treatment delivery. Our results also suggest that it is possible to effectively treat major depression in this patient group. ... Large trials are now needed to estimate the effectiveness and cost-effectiveness of depression care for people with lung cancer in this population, and further adaptation of the treatment is needed to address the unmet needs of patients with major depression and a shorter life expectancy," they concluded.

The authors reported having no conflicts of interest. The Lancet Psychiatry and Lancet studies were jointly sponsored by the University of Edinburgh and NHS Lothian, and were funded by Cancer Research UK (CRUK), with additional funding from the Chief Scientist Office (CSO) of the Scottish Government and NHS Research Scotland. The Lancet Psychiatry article was also funded by CRUK and the CSO of the Scottish Government. Dr. Walker is supported by Sir Michael Sobell House Hospice, Oxford; and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at the Oxford Health NHS Foundation Trust.

Approximately 75% of cancer patients with major depression are not receiving treatment for their depression, according to an analysis of data from more than 21,000 patients.

However, a novel integrated treatment program designed specifically for cancer patients was shown in two additional studies to be strikingly more effective than usual care for reducing depressive symptoms and improving quality of life – even in those with a poor prognosis.

The findings were reported online Aug. 28 in the Lancet Psychiatry, the Lancet, and the Lancet Oncology.

Of 21,151 patients (mean age, 64 years) who were attending cancer clinics in Scotland between May 2008 and August 2011, 1,538 had major depression and complete patient-reported treatment data available. Of those, 1,130 (73%) were not receiving appropriate treatment, Jane Walker, Ph.D. of the University of Oxford (England) and her colleagues reported (Lancet Psychiatry 2014 Aug. 28 [doi: 10.1016/S2215-0366(14)70313-X]).

The prevalence of major depression was highest in patients with lung cancer (13.1%), followed by those with gynecological cancer (10.9%), breast cancer (9.3%), colorectal cancer (7.0%), and genitourinary cancer (5.6%). Younger patients, those with lower social deprivation scores, and women with lung or colorectal cancer were at increased risk for major depression.

Younger patients and women were more likely than older patients and men to be receiving treatment, and those with breast cancer were most likely to receive treatment for depression (32%), while those with lung cancer were least likely to receive treatment (19%), the investigators said.

Notably, those who had been living with a cancer diagnosis for more than a year were as likely to have depression as those with a recent diagnosis, and those who had received initial curative treatment were as likely to have depression as those who received palliative treatment, they reported.

The findings suggest that major depression is substantially more common in people with cancer than in the general population, in which the estimated point prevalence is 2% and the estimated 12-month prevalence is 4%-5%.

"Perhaps our most important finding was that most cancer outpatients with depression were not in receipt of potentially effective treatment for their depression," they said, noting that major depression among cancer outpatients merits greater attention, and that systematic approaches to improving depression care for patients with cancer are urgently needed.

One such approach was evaluated by Dr. Walker and her colleagues from the Symptom Management Research Trials (SMaRT) Oncology-2 and Oncology-3 teams.

Of 231 patients with cancer and major depression who were enrolled in the SMaRT Oncology-2 randomized controlled effectiveness trial between May 2008 and May 2011 and assigned to receive integrated collaborative depression care (Depression Care for People with Cancer, or DCPC), 143 (62%) experienced at least a 50% improvement on the Symptom Checklist Depression Scale score at 24 weeks. Of 231 patients assigned to receive usual care, only 40 (17%) achieved a 50% or greater response at 24 weeks (adjusted odds ratio for treatment response, 8.5; number needed to treat, 2.24), Dr. Michael Sharpe of the University of Oxford reported on behalf of the SMaRT Oncology-2 team (Lancet 2014 Aug. 28 [doi: 10/1016/S0140-6736(14)61231-9]).

Additionally, 33% of those in the DCPC group achieved remission of their major depression, compared with 4% of those in the usual care group (odds ratio, 13.1).

Those in the DCPC group had less depression, anxiety, pain, and fatigue, and had better functioning, health, quality of life, and perceived quality of depression care at each of four time points evaluated during the course of the study, the investigators said.

DCPC is a manualized, multicomponent collaborative care treatment, delivered systematically by cancer nurses and psychiatrists, in conjunction with primary care physicians and oncologists, to provide "systematic proactive treatment and follow-up." Usual care was provided by primary care physicians and/or oncologists, who were instructed to treat the patients as they normally would, such as with antidepressants or referral for a mental health assessment.

Patients in SMaRT Oncology-2 were adults with a good prognosis who were attending cancer clinics in Scotland, and who had major depression of at least 4 weeks’ duration.

"The findings of this trial add to the accumulating evidence for the effectiveness of collaborative care approaches to the treatment of depression comorbid with medical conditions. They also provide new evidence that large and sustained treatment effects can be achieved if depression treatment is integrated with medical care, intensive, and systematically delivered by a well-trained and supervised team," the investigators concluded. The cost of DCPC as delivered in this trial was "quite modest, especially in the context of cancer treatment," they noted.

In a related trial (SMaRT Oncology-3), the investigators found that even patients with a poor prognosis respond well to DCPC. Patients in SMaRT Oncology-3 were adults with major depression attending cancer clinics in Scotland between January 2009 and September 2011. All had a diagnosis of primary lung cancer, and a predicted survival of at least 3 months.

Mean depression severity – a summary measure of each participant’s depression severity scores averaged over the course of the study (up to 32 weeks) was significantly lower in 68 patients with lung cancer who were assigned to receive DCPC than in 74 patients assigned to receive usual care (mean Symptom Checklist Depression Scale scores of 1.24 vs. 1.61; standardized mean difference, –0.62), Dr. Walker reported on behalf of the SMaRT Oncology-3 team.

In addition, significantly more patients receiving DCPC achieved at least a 50% reduction in depression severity scale scores (51% vs. 15%).

"We also recorded significant differences between the treatment groups in self-rated depression improvement, anxiety, quality of life, role functioning, and perceived quality of care, all in favor of the depression care for the people with lung cancer group," they said.

"Our findings suggest that, despite the rapid deterioration of this patient group, successful clinical trials in patients with poor-prognosis cancer and comorbid major depression are possible, through adaptation of both trial design and treatment delivery. Our results also suggest that it is possible to effectively treat major depression in this patient group. ... Large trials are now needed to estimate the effectiveness and cost-effectiveness of depression care for people with lung cancer in this population, and further adaptation of the treatment is needed to address the unmet needs of patients with major depression and a shorter life expectancy," they concluded.

The authors reported having no conflicts of interest. The Lancet Psychiatry and Lancet studies were jointly sponsored by the University of Edinburgh and NHS Lothian, and were funded by Cancer Research UK (CRUK), with additional funding from the Chief Scientist Office (CSO) of the Scottish Government and NHS Research Scotland. The Lancet Psychiatry article was also funded by CRUK and the CSO of the Scottish Government. Dr. Walker is supported by Sir Michael Sobell House Hospice, Oxford; and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at the Oxford Health NHS Foundation Trust.

In oncology clinical trials, overall survival (OS) remains the gold standard for clinical benefit. However, because there are so many available treatment options for most types of cancer, survival analysis in clinical trials is often confounded by subsequent therapies. Progression-free survival (PFS) is an endpoint not so confounded, and one that requires fewer patients and less time to arrive at a conclusion about a new therapy. As a result, an ever-increasing number of oncology clinical trials are launched in which PFS is used as the primary endpoint. Several years ago, Pazdur¹ emphasized that the time-to-progression endpoint must use the same evaluation techniques and schedules for all treatment arms and he recommended blinding of trials or at minimum, the use of an external blinded radiographic review committee. He also noted that improvement in disease-related symptoms qualifies as clinical benefit and may therefore be an appropriate endpoint for drug approval.

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

In oncology clinical trials, overall survival (OS) remains the gold standard for clinical benefit. However, because there are so many available treatment options for most types of cancer, survival analysis in clinical trials is often confounded by subsequent therapies. Progression-free survival (PFS) is an endpoint not so confounded, and one that requires fewer patients and less time to arrive at a conclusion about a new therapy. As a result, an ever-increasing number of oncology clinical trials are launched in which PFS is used as the primary endpoint. Several years ago, Pazdur¹ emphasized that the time-to-progression endpoint must use the same evaluation techniques and schedules for all treatment arms and he recommended blinding of trials or at minimum, the use of an external blinded radiographic review committee. He also noted that improvement in disease-related symptoms qualifies as clinical benefit and may therefore be an appropriate endpoint for drug approval.

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

In oncology clinical trials, overall survival (OS) remains the gold standard for clinical benefit. However, because there are so many available treatment options for most types of cancer, survival analysis in clinical trials is often confounded by subsequent therapies. Progression-free survival (PFS) is an endpoint not so confounded, and one that requires fewer patients and less time to arrive at a conclusion about a new therapy. As a result, an ever-increasing number of oncology clinical trials are launched in which PFS is used as the primary endpoint. Several years ago, Pazdur¹ emphasized that the time-to-progression endpoint must use the same evaluation techniques and schedules for all treatment arms and he recommended blinding of trials or at minimum, the use of an external blinded radiographic review committee. He also noted that improvement in disease-related symptoms qualifies as clinical benefit and may therefore be an appropriate endpoint for drug approval.

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