User login
ASCO: Cancer Research Must Change Course in 'Molecular Era'
The American Society of Clinical Oncology has issued a report calling for changes to the nation’s cancer research system that could speed delivery of more effective and personalized cancer therapies.
The society’s "blueprint" for transforming clinical and translational research focuses on three priorities: changing the way new cancer therapies are developed to emphasize molecular approaches, designing smarter and faster clinical trials, and harnessing new health information technology tools.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers," American Society of Clinical Oncology (ASCO) president Dr. Michael Link said at a press briefing 40 years after the nation initiated the War on Cancer.
"As we learn more and more about lung cancer, we realize that at a molecular level, lung cancers that look the same under the microscope might have a profile genetically that splits that group of lung cancers into 20 different diseases. And the same is true of colon and breast cancer."
Advances in the understanding of cancer biology have already transformed the treatment of some cancers by targeting specific molecular characteristics, Dr. Link said. This is particularly true for cancers such as chronic myeloid leukemia (CML) that are driven by a single, powerful mutation. For most cancers, however, effective treatment will require targeting a combination of different genes and proteins that cause the cancer to develop and spread.
"What this means for the conduct of clinical trials is that we have to be much smarter about enriching a particular clinical trial with patients that are most likely to benefit based on what we know about the subset of lung cancer they belong to or colon cancer they belong to," he said.
The current approach to developing cancer therapies is ill equipped to capitalize on this growing understanding of cancer’s biological underpinnings, according to Dr. Link, a professor of pediatric hematology and oncology at Stanford (Calif.) University.
Specifically, drug development is hampered by researchers’ limited understanding of which molecular pathways are most important to target, and lacks many of the diagnostic tools needed to identify patients with specific mutations. At the same time, clinical trials lack the flexibility to provide quick answers about the effectiveness of therapies targeted to molecular subgroups, and have been weakened by years of underfunding and a labyrinth of regulatory requirements, he said.
One of the first steps needed to revitalize drug development is to identify and prioritize the molecular targets that have the greatest promise for improving patient survival, said Dr. Neal Meropol, one of three oncologists who served as executive editors of the report "Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research."
Over the next decade, the report envisions that researchers and clinicians will have the tools to quickly conduct a panomic analysis for every cancer patient that will include an examination of their genomic makeup and a complete molecular characterization of their cancer cells. The report also calls for biomarkers and diagnostic assays to be developed and validated simultaneously with cancer treatments, not as separate steps as often occurs today. Also on the agenda is the development of industry standards for biospecimens.
Getting Pharma to Collaborate. Incentives will also need to be developed to encourage industry and the research community to work together in creating new targeted therapies, including combinations of treatments that might involve different sponsors and institutions, said Dr. Meropol, chief of medical oncology at Case Western Reserve University in Cleveland.
"It’s the combination treatments that are really going to be increasingly essential, as we seek to target the multiple defects that we identify within a single patient’s tumor," he said.
When asked by reporters what would motivate pharmaceutical companies to work together to test combination treatments rather than bring their own blockbuster to market, Dr. John Mendelsohn, chair of the Institute of Medicine’s National Cancer Policy Forum, said economics will entice them. Drug companies have learned that response rates with a single targeted agent are "ho-hum," at 5% or 10%, but may be boosted when combined with another agent that targets a different facet of the molecular pathway.
"It’s not happening as much as we’d like, but it’s happening more and more," he said.
ASCO promises to collaborate with partners at the National Cancer Institute and the Institute of Medicine to convene a working group with industry, academia, and other federal agencies to "explore ways to promote a more collaborative approach to developing new prevention and therapeutic strategies," according to the report.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers."
Pharmaceutical companies also stand to profit from a strategy that targets increasingly small subsets of cancer patients. Although there are a little more than 4,000 new cases of Philadelphia chromosome–positive CML each year, the tyrosine kinase inhibitor imatinib (Gleevec) is making a fortune for the company that developed it, Dr. Mendelsohn said.
"It’s expensive, but on the other hand it works, and the five-year survival rate has just rocketed up as a result," he said. "If it’s a good drug and it really will change outcomes, our society is willing to pay for it and it can make a profit."
Dr. Link pointed out that the efficacy of some drugs crosses tumor types, with imatinib also approved for several malignancies including Kit-positive gastrointestinal stromal tumors.
The recently approved anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was also cited as proof that smaller trials in very select patient populations can pay off. Crizotinib pushed response rates to 61% in patients with ALK-positive non–small cell lung cancer (NSCLC), a subset that represents just 1%-7% of NSCLC patients, and may bring Pfizer annual sales of $755 million by 2015, according to analysts surveyed by Bloomberg.
Making Medical Records Do More. Part of ASCO’s vision for the next decade is that advances in health information technology would deliver up-to-the-minute personalized information and save patients from repeating their medical history every time they see a new doctor, Dr. Link said. The data would be linked to national treatment guidelines that would prompt physicians on what national experts view as the appropriate course of treatment.
At the same time, linkage to clinical trial databases would trigger notification of suitable clinical trials based on available data about the patient’s clinical condition and course. On the back end, patient data would be fed into registries that could be analyzed by researchers for clues, not just for clinical trials but for routine care, he said.
The authors did not disclose any conflicts of interest.
The American Society of Clinical Oncology has issued a report calling for changes to the nation’s cancer research system that could speed delivery of more effective and personalized cancer therapies.
The society’s "blueprint" for transforming clinical and translational research focuses on three priorities: changing the way new cancer therapies are developed to emphasize molecular approaches, designing smarter and faster clinical trials, and harnessing new health information technology tools.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers," American Society of Clinical Oncology (ASCO) president Dr. Michael Link said at a press briefing 40 years after the nation initiated the War on Cancer.
"As we learn more and more about lung cancer, we realize that at a molecular level, lung cancers that look the same under the microscope might have a profile genetically that splits that group of lung cancers into 20 different diseases. And the same is true of colon and breast cancer."
Advances in the understanding of cancer biology have already transformed the treatment of some cancers by targeting specific molecular characteristics, Dr. Link said. This is particularly true for cancers such as chronic myeloid leukemia (CML) that are driven by a single, powerful mutation. For most cancers, however, effective treatment will require targeting a combination of different genes and proteins that cause the cancer to develop and spread.
"What this means for the conduct of clinical trials is that we have to be much smarter about enriching a particular clinical trial with patients that are most likely to benefit based on what we know about the subset of lung cancer they belong to or colon cancer they belong to," he said.
The current approach to developing cancer therapies is ill equipped to capitalize on this growing understanding of cancer’s biological underpinnings, according to Dr. Link, a professor of pediatric hematology and oncology at Stanford (Calif.) University.
Specifically, drug development is hampered by researchers’ limited understanding of which molecular pathways are most important to target, and lacks many of the diagnostic tools needed to identify patients with specific mutations. At the same time, clinical trials lack the flexibility to provide quick answers about the effectiveness of therapies targeted to molecular subgroups, and have been weakened by years of underfunding and a labyrinth of regulatory requirements, he said.
One of the first steps needed to revitalize drug development is to identify and prioritize the molecular targets that have the greatest promise for improving patient survival, said Dr. Neal Meropol, one of three oncologists who served as executive editors of the report "Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research."
Over the next decade, the report envisions that researchers and clinicians will have the tools to quickly conduct a panomic analysis for every cancer patient that will include an examination of their genomic makeup and a complete molecular characterization of their cancer cells. The report also calls for biomarkers and diagnostic assays to be developed and validated simultaneously with cancer treatments, not as separate steps as often occurs today. Also on the agenda is the development of industry standards for biospecimens.
Getting Pharma to Collaborate. Incentives will also need to be developed to encourage industry and the research community to work together in creating new targeted therapies, including combinations of treatments that might involve different sponsors and institutions, said Dr. Meropol, chief of medical oncology at Case Western Reserve University in Cleveland.
"It’s the combination treatments that are really going to be increasingly essential, as we seek to target the multiple defects that we identify within a single patient’s tumor," he said.
When asked by reporters what would motivate pharmaceutical companies to work together to test combination treatments rather than bring their own blockbuster to market, Dr. John Mendelsohn, chair of the Institute of Medicine’s National Cancer Policy Forum, said economics will entice them. Drug companies have learned that response rates with a single targeted agent are "ho-hum," at 5% or 10%, but may be boosted when combined with another agent that targets a different facet of the molecular pathway.
"It’s not happening as much as we’d like, but it’s happening more and more," he said.
ASCO promises to collaborate with partners at the National Cancer Institute and the Institute of Medicine to convene a working group with industry, academia, and other federal agencies to "explore ways to promote a more collaborative approach to developing new prevention and therapeutic strategies," according to the report.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers."
Pharmaceutical companies also stand to profit from a strategy that targets increasingly small subsets of cancer patients. Although there are a little more than 4,000 new cases of Philadelphia chromosome–positive CML each year, the tyrosine kinase inhibitor imatinib (Gleevec) is making a fortune for the company that developed it, Dr. Mendelsohn said.
"It’s expensive, but on the other hand it works, and the five-year survival rate has just rocketed up as a result," he said. "If it’s a good drug and it really will change outcomes, our society is willing to pay for it and it can make a profit."
Dr. Link pointed out that the efficacy of some drugs crosses tumor types, with imatinib also approved for several malignancies including Kit-positive gastrointestinal stromal tumors.
The recently approved anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was also cited as proof that smaller trials in very select patient populations can pay off. Crizotinib pushed response rates to 61% in patients with ALK-positive non–small cell lung cancer (NSCLC), a subset that represents just 1%-7% of NSCLC patients, and may bring Pfizer annual sales of $755 million by 2015, according to analysts surveyed by Bloomberg.
Making Medical Records Do More. Part of ASCO’s vision for the next decade is that advances in health information technology would deliver up-to-the-minute personalized information and save patients from repeating their medical history every time they see a new doctor, Dr. Link said. The data would be linked to national treatment guidelines that would prompt physicians on what national experts view as the appropriate course of treatment.
At the same time, linkage to clinical trial databases would trigger notification of suitable clinical trials based on available data about the patient’s clinical condition and course. On the back end, patient data would be fed into registries that could be analyzed by researchers for clues, not just for clinical trials but for routine care, he said.
The authors did not disclose any conflicts of interest.
The American Society of Clinical Oncology has issued a report calling for changes to the nation’s cancer research system that could speed delivery of more effective and personalized cancer therapies.
The society’s "blueprint" for transforming clinical and translational research focuses on three priorities: changing the way new cancer therapies are developed to emphasize molecular approaches, designing smarter and faster clinical trials, and harnessing new health information technology tools.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers," American Society of Clinical Oncology (ASCO) president Dr. Michael Link said at a press briefing 40 years after the nation initiated the War on Cancer.
"As we learn more and more about lung cancer, we realize that at a molecular level, lung cancers that look the same under the microscope might have a profile genetically that splits that group of lung cancers into 20 different diseases. And the same is true of colon and breast cancer."
Advances in the understanding of cancer biology have already transformed the treatment of some cancers by targeting specific molecular characteristics, Dr. Link said. This is particularly true for cancers such as chronic myeloid leukemia (CML) that are driven by a single, powerful mutation. For most cancers, however, effective treatment will require targeting a combination of different genes and proteins that cause the cancer to develop and spread.
"What this means for the conduct of clinical trials is that we have to be much smarter about enriching a particular clinical trial with patients that are most likely to benefit based on what we know about the subset of lung cancer they belong to or colon cancer they belong to," he said.
The current approach to developing cancer therapies is ill equipped to capitalize on this growing understanding of cancer’s biological underpinnings, according to Dr. Link, a professor of pediatric hematology and oncology at Stanford (Calif.) University.
Specifically, drug development is hampered by researchers’ limited understanding of which molecular pathways are most important to target, and lacks many of the diagnostic tools needed to identify patients with specific mutations. At the same time, clinical trials lack the flexibility to provide quick answers about the effectiveness of therapies targeted to molecular subgroups, and have been weakened by years of underfunding and a labyrinth of regulatory requirements, he said.
One of the first steps needed to revitalize drug development is to identify and prioritize the molecular targets that have the greatest promise for improving patient survival, said Dr. Neal Meropol, one of three oncologists who served as executive editors of the report "Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research."
Over the next decade, the report envisions that researchers and clinicians will have the tools to quickly conduct a panomic analysis for every cancer patient that will include an examination of their genomic makeup and a complete molecular characterization of their cancer cells. The report also calls for biomarkers and diagnostic assays to be developed and validated simultaneously with cancer treatments, not as separate steps as often occurs today. Also on the agenda is the development of industry standards for biospecimens.
Getting Pharma to Collaborate. Incentives will also need to be developed to encourage industry and the research community to work together in creating new targeted therapies, including combinations of treatments that might involve different sponsors and institutions, said Dr. Meropol, chief of medical oncology at Case Western Reserve University in Cleveland.
"It’s the combination treatments that are really going to be increasingly essential, as we seek to target the multiple defects that we identify within a single patient’s tumor," he said.
When asked by reporters what would motivate pharmaceutical companies to work together to test combination treatments rather than bring their own blockbuster to market, Dr. John Mendelsohn, chair of the Institute of Medicine’s National Cancer Policy Forum, said economics will entice them. Drug companies have learned that response rates with a single targeted agent are "ho-hum," at 5% or 10%, but may be boosted when combined with another agent that targets a different facet of the molecular pathway.
"It’s not happening as much as we’d like, but it’s happening more and more," he said.
ASCO promises to collaborate with partners at the National Cancer Institute and the Institute of Medicine to convene a working group with industry, academia, and other federal agencies to "explore ways to promote a more collaborative approach to developing new prevention and therapeutic strategies," according to the report.
"One of the dominant themes emerging is this notion that all cancers are becoming rare cancers."
Pharmaceutical companies also stand to profit from a strategy that targets increasingly small subsets of cancer patients. Although there are a little more than 4,000 new cases of Philadelphia chromosome–positive CML each year, the tyrosine kinase inhibitor imatinib (Gleevec) is making a fortune for the company that developed it, Dr. Mendelsohn said.
"It’s expensive, but on the other hand it works, and the five-year survival rate has just rocketed up as a result," he said. "If it’s a good drug and it really will change outcomes, our society is willing to pay for it and it can make a profit."
Dr. Link pointed out that the efficacy of some drugs crosses tumor types, with imatinib also approved for several malignancies including Kit-positive gastrointestinal stromal tumors.
The recently approved anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was also cited as proof that smaller trials in very select patient populations can pay off. Crizotinib pushed response rates to 61% in patients with ALK-positive non–small cell lung cancer (NSCLC), a subset that represents just 1%-7% of NSCLC patients, and may bring Pfizer annual sales of $755 million by 2015, according to analysts surveyed by Bloomberg.
Making Medical Records Do More. Part of ASCO’s vision for the next decade is that advances in health information technology would deliver up-to-the-minute personalized information and save patients from repeating their medical history every time they see a new doctor, Dr. Link said. The data would be linked to national treatment guidelines that would prompt physicians on what national experts view as the appropriate course of treatment.
At the same time, linkage to clinical trial databases would trigger notification of suitable clinical trials based on available data about the patient’s clinical condition and course. On the back end, patient data would be fed into registries that could be analyzed by researchers for clues, not just for clinical trials but for routine care, he said.
The authors did not disclose any conflicts of interest.
Documenting the Symptom Experience of Cancer Patients
Volume 9, Issue 6, November-December 2011, Pages 216-223
| doi:10.1016/j.suponc.2011.06.003 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Teresa L. Deshields PhD
Received 11 January 2011; Accepted 9 June 2011. Available online 3 November 2011.
Abstract
Background
Cancer patients experience symptoms associated with their disease, treatment, and comorbidities. Symptom experience is complicated, reflecting symptom prevalence, frequency, and severity. Symptom burden is associated with treatment tolerance as well as patients' quality of life (QOL).
Objectives
The purpose of this study was to document the symptom experience and QOL of patients with commonly diagnosed cancers. The relationship between symptoms and QOL was also explored.
Methods
A convenience sample of patients with the five most common cancers at a comprehensive cancer center completed surveys assessing symptom experience (Memorial Symptom Assessment Survey) and QOL (Functional Assessment of Cancer Therapy). Patients completed surveys at baseline and at 3, 6, 9, and 12 months thereafter. This article describes the study's baseline findings.
Results
Surveys were completed by 558 cancer patients with breast, colorectal, gynecologic, lung, or prostate cancer. Patients reported an average of 9.1 symptoms, with symptom experience varying by cancer type. The mean overall QOL for the total sample was 85.1, with results differing by cancer type. Prostate cancer patients reported the lowest symptom burden and the highest QOL.
Limitations
The sample was limited in terms of racial diversity. Because of the method of recruitment, baseline data were collected 6–8 months after diagnosis, meaning that participants were at various stages of treatment.
Conclusions
The symptom experience of cancer patients varies widely depending on cancer type. Nevertheless, most patients report symptoms, regardless of whether or not they are currently receiving treatment. Patients' QOL is inversely related to their symptom burden.
Volume 9, Issue 6, November-December 2011, Pages 216-223
Volume 9, Issue 6, November-December 2011, Pages 216-223
| doi:10.1016/j.suponc.2011.06.003 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Teresa L. Deshields PhD
Received 11 January 2011; Accepted 9 June 2011. Available online 3 November 2011.
Abstract
Background
Cancer patients experience symptoms associated with their disease, treatment, and comorbidities. Symptom experience is complicated, reflecting symptom prevalence, frequency, and severity. Symptom burden is associated with treatment tolerance as well as patients' quality of life (QOL).
Objectives
The purpose of this study was to document the symptom experience and QOL of patients with commonly diagnosed cancers. The relationship between symptoms and QOL was also explored.
Methods
A convenience sample of patients with the five most common cancers at a comprehensive cancer center completed surveys assessing symptom experience (Memorial Symptom Assessment Survey) and QOL (Functional Assessment of Cancer Therapy). Patients completed surveys at baseline and at 3, 6, 9, and 12 months thereafter. This article describes the study's baseline findings.
Results
Surveys were completed by 558 cancer patients with breast, colorectal, gynecologic, lung, or prostate cancer. Patients reported an average of 9.1 symptoms, with symptom experience varying by cancer type. The mean overall QOL for the total sample was 85.1, with results differing by cancer type. Prostate cancer patients reported the lowest symptom burden and the highest QOL.
Limitations
The sample was limited in terms of racial diversity. Because of the method of recruitment, baseline data were collected 6–8 months after diagnosis, meaning that participants were at various stages of treatment.
Conclusions
The symptom experience of cancer patients varies widely depending on cancer type. Nevertheless, most patients report symptoms, regardless of whether or not they are currently receiving treatment. Patients' QOL is inversely related to their symptom burden.
Volume 9, Issue 6, November-December 2011, Pages 216-223
Volume 9, Issue 6, November-December 2011, Pages 216-223
| doi:10.1016/j.suponc.2011.06.003 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Teresa L. Deshields PhD
Received 11 January 2011; Accepted 9 June 2011. Available online 3 November 2011.
Abstract
Background
Cancer patients experience symptoms associated with their disease, treatment, and comorbidities. Symptom experience is complicated, reflecting symptom prevalence, frequency, and severity. Symptom burden is associated with treatment tolerance as well as patients' quality of life (QOL).
Objectives
The purpose of this study was to document the symptom experience and QOL of patients with commonly diagnosed cancers. The relationship between symptoms and QOL was also explored.
Methods
A convenience sample of patients with the five most common cancers at a comprehensive cancer center completed surveys assessing symptom experience (Memorial Symptom Assessment Survey) and QOL (Functional Assessment of Cancer Therapy). Patients completed surveys at baseline and at 3, 6, 9, and 12 months thereafter. This article describes the study's baseline findings.
Results
Surveys were completed by 558 cancer patients with breast, colorectal, gynecologic, lung, or prostate cancer. Patients reported an average of 9.1 symptoms, with symptom experience varying by cancer type. The mean overall QOL for the total sample was 85.1, with results differing by cancer type. Prostate cancer patients reported the lowest symptom burden and the highest QOL.
Limitations
The sample was limited in terms of racial diversity. Because of the method of recruitment, baseline data were collected 6–8 months after diagnosis, meaning that participants were at various stages of treatment.
Conclusions
The symptom experience of cancer patients varies widely depending on cancer type. Nevertheless, most patients report symptoms, regardless of whether or not they are currently receiving treatment. Patients' QOL is inversely related to their symptom burden.
Volume 9, Issue 6, November-December 2011, Pages 216-223
Efficacy and Safety of Fentanyl Pectin Nasal Spray Compared with Immediate-Release Morphine Sulfate Tablets in the Treatment of Breakthrough Cancer Pain: A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy Multiple-Crossover Study
Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Volume 9, Issue 6, November-December 2011, Pages 224-231
| doi:10.1016/j.suponc.2011.07.004 | How to Cite or Link Using DOI |
| Permissions & Reprints |
Original research
Marie Fallon MB, ChB, MD, FRCP
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
Results
Compared with IRMS, FPNS significantly improved mean PID15 scores. 57.5% of FPNS-treated episodes significantly demonstrated onset of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (≥2-point PI decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant nasal effects were reported.
Conclusion
FPNS was efficacious and well tolerated in the treatment of BTCP and provided faster onset of analgesia and attainment of CMPR than IRMS.
The authors acknowledge i3Research, which conducted the study; the technical and editorial support provided by Anita Chadha-Patel at ApotheCom; and the Fentanyl Nasal Spray Study 044 Investigators. This study was sponsored by Archimedes Development, Ltd.
Coordination of Care in Breast Cancer Survivors: An Overview
Volume 9, Issue 6, November-December 2011, Pages 210-215
| doi:10.1016/j.suponc.2011.06.008 | How to Cite or Link Using DOI |
| Permissions & Reprints |
How We Do It
TO READ THE ENTIRE ARTICLE, CLICK ON THE ADJACENT LINK TO THE PDF FILE
Abstract
The number of breast cancer survivors in the United States is increasing. With longer survival, there has been an increase in the complexity and duration of posttreatment care. Multidisciplinary care teams are needed to participate across the broad spectrum of issues that breast cancer survivors face. In this setting, the need for well-established patterns of communication between care providers is increasingly apparent. We have created a multidisciplinary approach to the management of breast cancer survivors to improve communication and education between providers and patients. This approach could be extended to the care and management of survivors of other types of cancer.
Case
Vitae
Dr. Peairs is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Wolff is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Olsenis from the Johns Hopkins School of Nursing, Baltimore, Maryland. |
Dr. Bantugis from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Shockney is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Kantsiper is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Carrino-Tamasi is from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Snyder is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Volume 9, Issue 6, November-December 2011, Pages 210-215
Volume 9, Issue 6, November-December 2011, Pages 210-215
| doi:10.1016/j.suponc.2011.06.008 | How to Cite or Link Using DOI |
| Permissions & Reprints |
How We Do It
TO READ THE ENTIRE ARTICLE, CLICK ON THE ADJACENT LINK TO THE PDF FILE
Abstract
The number of breast cancer survivors in the United States is increasing. With longer survival, there has been an increase in the complexity and duration of posttreatment care. Multidisciplinary care teams are needed to participate across the broad spectrum of issues that breast cancer survivors face. In this setting, the need for well-established patterns of communication between care providers is increasingly apparent. We have created a multidisciplinary approach to the management of breast cancer survivors to improve communication and education between providers and patients. This approach could be extended to the care and management of survivors of other types of cancer.
Case
Vitae
Dr. Peairs is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Wolff is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Olsenis from the Johns Hopkins School of Nursing, Baltimore, Maryland. |
Dr. Bantugis from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Shockney is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Kantsiper is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Carrino-Tamasi is from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Snyder is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Volume 9, Issue 6, November-December 2011, Pages 210-215
Volume 9, Issue 6, November-December 2011, Pages 210-215
| doi:10.1016/j.suponc.2011.06.008 | How to Cite or Link Using DOI |
| Permissions & Reprints |
How We Do It
TO READ THE ENTIRE ARTICLE, CLICK ON THE ADJACENT LINK TO THE PDF FILE
Abstract
The number of breast cancer survivors in the United States is increasing. With longer survival, there has been an increase in the complexity and duration of posttreatment care. Multidisciplinary care teams are needed to participate across the broad spectrum of issues that breast cancer survivors face. In this setting, the need for well-established patterns of communication between care providers is increasingly apparent. We have created a multidisciplinary approach to the management of breast cancer survivors to improve communication and education between providers and patients. This approach could be extended to the care and management of survivors of other types of cancer.
Case
Vitae
Dr. Peairs is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Wolff is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Olsenis from the Johns Hopkins School of Nursing, Baltimore, Maryland. |
Dr. Bantugis from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Shockney is from the Johns Hopkins School of Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Kantsiper is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Dr. Carrino-Tamasi is from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. |
Dr. Snyder is from the Johns Hopkins School of Medicine, Baltimore, Maryland. |
Volume 9, Issue 6, November-December 2011, Pages 210-215
Radiopharmaceuticals: When and How to Use Them to Treat Metastatic Bone Pain
Bone pain due to skeletal metastases constitutes the most common type of cancer-related pain. The management of bone pain remains challenging and is not standardized. In patients with multifocal osteoblastic metastases, systemic radiopharmaceuticals should be the preferred adjunctive therapy for pain palliation. The lack of general knowledge about radiopharmaceuticals, their clinical utility and safety profiles, constitutes the major cause for their underutilization. Our goal is to review the indications, selection criteria, efficacy, and toxicities of two approved radiopharmaceuticals for bone pain palliation: strontium-89 and samarium-153. Finally, a brief review of the data on combination therapy with bisphosphonates or chemotherapy is included.
Vitae
Dr. Paes and Serafini are from the Department of Radiology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Dr. Ernani and Hosein are from the Division of Hematology Oncology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Volume 9, Issue 6, November-December 2011, Pages 197-205
Bone pain due to skeletal metastases constitutes the most common type of cancer-related pain. The management of bone pain remains challenging and is not standardized. In patients with multifocal osteoblastic metastases, systemic radiopharmaceuticals should be the preferred adjunctive therapy for pain palliation. The lack of general knowledge about radiopharmaceuticals, their clinical utility and safety profiles, constitutes the major cause for their underutilization. Our goal is to review the indications, selection criteria, efficacy, and toxicities of two approved radiopharmaceuticals for bone pain palliation: strontium-89 and samarium-153. Finally, a brief review of the data on combination therapy with bisphosphonates or chemotherapy is included.
Vitae
Dr. Paes and Serafini are from the Department of Radiology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Dr. Ernani and Hosein are from the Division of Hematology Oncology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Volume 9, Issue 6, November-December 2011, Pages 197-205
Bone pain due to skeletal metastases constitutes the most common type of cancer-related pain. The management of bone pain remains challenging and is not standardized. In patients with multifocal osteoblastic metastases, systemic radiopharmaceuticals should be the preferred adjunctive therapy for pain palliation. The lack of general knowledge about radiopharmaceuticals, their clinical utility and safety profiles, constitutes the major cause for their underutilization. Our goal is to review the indications, selection criteria, efficacy, and toxicities of two approved radiopharmaceuticals for bone pain palliation: strontium-89 and samarium-153. Finally, a brief review of the data on combination therapy with bisphosphonates or chemotherapy is included.
Vitae
Dr. Paes and Serafini are from the Department of Radiology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Dr. Ernani and Hosein are from the Division of Hematology Oncology, University of Miami/Jackson Memorial Medical Center, Sylvester Comprehensive Cancer Center, Miami, FL. |
Volume 9, Issue 6, November-December 2011, Pages 197-205
Radiopharmaceuticals for Painful Bone Metastases: Perspective from Radiation Oncology
Peer Viewpoint
References [PubMed ID in brackets]
1 V. Damerla, S. Packianathan and P.S. Boerner, et al. Recent developments in nuclear medicine in the management of bone metastases: a review and perspective. Am J Clin Oncol, 28 5 (2005), pp. 513–520.
2 S. Lutz, L. Berk and E. Chang, et al. American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys, 79 4 (2011), pp. 965–976.
3 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
4 Single-fraction compared with multiple-fraction therapy in treating patients with previously irradiated painful bone metastases, ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT00080912.
Vitae
Dr. Barnes is from the Department of Radiation Oncology, Odette Cancer Centre, Toronto, Canada. |
| The Journal of Supportive Oncology Volume 9, Issue 6, November-December 2011, Pages 208-209 |
Peer Viewpoint
References [PubMed ID in brackets]
1 V. Damerla, S. Packianathan and P.S. Boerner, et al. Recent developments in nuclear medicine in the management of bone metastases: a review and perspective. Am J Clin Oncol, 28 5 (2005), pp. 513–520.
2 S. Lutz, L. Berk and E. Chang, et al. American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys, 79 4 (2011), pp. 965–976.
3 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
4 Single-fraction compared with multiple-fraction therapy in treating patients with previously irradiated painful bone metastases, ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT00080912.
Vitae
Dr. Barnes is from the Department of Radiation Oncology, Odette Cancer Centre, Toronto, Canada. |
| The Journal of Supportive Oncology Volume 9, Issue 6, November-December 2011, Pages 208-209 |
Peer Viewpoint
References [PubMed ID in brackets]
1 V. Damerla, S. Packianathan and P.S. Boerner, et al. Recent developments in nuclear medicine in the management of bone metastases: a review and perspective. Am J Clin Oncol, 28 5 (2005), pp. 513–520.
2 S. Lutz, L. Berk and E. Chang, et al. American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys, 79 4 (2011), pp. 965–976.
3 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
4 Single-fraction compared with multiple-fraction therapy in treating patients with previously irradiated painful bone metastases, ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT00080912.
Vitae
Dr. Barnes is from the Department of Radiation Oncology, Odette Cancer Centre, Toronto, Canada. |
| The Journal of Supportive Oncology Volume 9, Issue 6, November-December 2011, Pages 208-209 |
Radiopharmaceuticals: Present and Future
Peer Viewpoint
Radiopharmaceuticals: Present and Future
References 22 [PubMed ID in brackets]
1 M.G. Lam, J.M. de Klerk and P.P. van Rijk, et al. Bone seeking radiopharmaceuticals for palliation of pain in cancer patients with osseous metastases. Anticancer Agents Med Chem, 7 4 (2007), pp. 381–397.
2 M.H. van den Beuken-van Everdingen, J.M. de Rijke and A.G. Kessels, et al. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol, 18 9 (2007), pp. 1437–1449.
3 R.L. Theriault, J.S. Biermann and E. Brown, et al. NCCN Task Force Report, . J Natl Compr Canc Netw, 4 suppl 2 (2006), pp. S1–S20 quiz S21–S2.
4 N. Pandit-Taskar, M. Batraki and C.R. Divgi, Radiopharmaceutical therapy for palliation of bone pain from osseous metastases. J Nucl Med, 45 8 (2004), pp. 1358–1365.
5 F.M. Paes and A.N. Serafini, Systemic metabolic radiopharmaceutical therapy in the treatment of metastatic bone pain. Semin Nucl Med, 40 2 (2010), pp. 89–104.
6 S.M. Tu, S.H. Lin and D.A. Podoloff, et al. Multimodality therapy: bone-targeted radioisotope therapy of prostate cancer. Clin Adv Hematol Oncol, 8 5 (2010), pp. 341–351.
7 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
8 R.J. Amato, J. Hernandez-McClain and H. Henary, Bone-targeted therapy: phase II study of strontium-89 in combination with alternating weekly chemohormonal therapies for patients with advanced androgen-independent prostate cancer. Am J Clin Oncol, 31 6 (2008), pp. 532–538.
9 K. Fizazi, P. Beuzeboc and J. Lumbroso, et al. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol, 27 15 (2009), pp. 2429–2435.
Vitae
Drs. Atkinson and Tu are from the Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. |
Volume 9, Issue 6, November-December 2011, Pages 206-207
Peer Viewpoint
Radiopharmaceuticals: Present and Future
References 22 [PubMed ID in brackets]
1 M.G. Lam, J.M. de Klerk and P.P. van Rijk, et al. Bone seeking radiopharmaceuticals for palliation of pain in cancer patients with osseous metastases. Anticancer Agents Med Chem, 7 4 (2007), pp. 381–397.
2 M.H. van den Beuken-van Everdingen, J.M. de Rijke and A.G. Kessels, et al. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol, 18 9 (2007), pp. 1437–1449.
3 R.L. Theriault, J.S. Biermann and E. Brown, et al. NCCN Task Force Report, . J Natl Compr Canc Netw, 4 suppl 2 (2006), pp. S1–S20 quiz S21–S2.
4 N. Pandit-Taskar, M. Batraki and C.R. Divgi, Radiopharmaceutical therapy for palliation of bone pain from osseous metastases. J Nucl Med, 45 8 (2004), pp. 1358–1365.
5 F.M. Paes and A.N. Serafini, Systemic metabolic radiopharmaceutical therapy in the treatment of metastatic bone pain. Semin Nucl Med, 40 2 (2010), pp. 89–104.
6 S.M. Tu, S.H. Lin and D.A. Podoloff, et al. Multimodality therapy: bone-targeted radioisotope therapy of prostate cancer. Clin Adv Hematol Oncol, 8 5 (2010), pp. 341–351.
7 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
8 R.J. Amato, J. Hernandez-McClain and H. Henary, Bone-targeted therapy: phase II study of strontium-89 in combination with alternating weekly chemohormonal therapies for patients with advanced androgen-independent prostate cancer. Am J Clin Oncol, 31 6 (2008), pp. 532–538.
9 K. Fizazi, P. Beuzeboc and J. Lumbroso, et al. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol, 27 15 (2009), pp. 2429–2435.
Vitae
Drs. Atkinson and Tu are from the Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. |
Volume 9, Issue 6, November-December 2011, Pages 206-207
Peer Viewpoint
Radiopharmaceuticals: Present and Future
References 22 [PubMed ID in brackets]
1 M.G. Lam, J.M. de Klerk and P.P. van Rijk, et al. Bone seeking radiopharmaceuticals for palliation of pain in cancer patients with osseous metastases. Anticancer Agents Med Chem, 7 4 (2007), pp. 381–397.
2 M.H. van den Beuken-van Everdingen, J.M. de Rijke and A.G. Kessels, et al. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol, 18 9 (2007), pp. 1437–1449.
3 R.L. Theriault, J.S. Biermann and E. Brown, et al. NCCN Task Force Report, . J Natl Compr Canc Netw, 4 suppl 2 (2006), pp. S1–S20 quiz S21–S2.
4 N. Pandit-Taskar, M. Batraki and C.R. Divgi, Radiopharmaceutical therapy for palliation of bone pain from osseous metastases. J Nucl Med, 45 8 (2004), pp. 1358–1365.
5 F.M. Paes and A.N. Serafini, Systemic metabolic radiopharmaceutical therapy in the treatment of metastatic bone pain. Semin Nucl Med, 40 2 (2010), pp. 89–104.
6 S.M. Tu, S.H. Lin and D.A. Podoloff, et al. Multimodality therapy: bone-targeted radioisotope therapy of prostate cancer. Clin Adv Hematol Oncol, 8 5 (2010), pp. 341–351.
7 S.M. Tu, R.E. Millikan and B. Mengistu, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet, 357 9253 (2001), pp. 336–341.
8 R.J. Amato, J. Hernandez-McClain and H. Henary, Bone-targeted therapy: phase II study of strontium-89 in combination with alternating weekly chemohormonal therapies for patients with advanced androgen-independent prostate cancer. Am J Clin Oncol, 31 6 (2008), pp. 532–538.
9 K. Fizazi, P. Beuzeboc and J. Lumbroso, et al. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol, 27 15 (2009), pp. 2429–2435.
Vitae
Drs. Atkinson and Tu are from the Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. |
Volume 9, Issue 6, November-December 2011, Pages 206-207
Screening cancer patients for distress: guidelines for routine implementation
The psychological and social consequences of cancer treatment were largely neglected until the latter part of the 20th century, despite the awareness that cancer patients often struggled with anxiety, depression, and emotional upheaval so severe as to jeopardize adherence to treatment. These psychological and emotional states were attributed to patients’ subjective responses to their condition, which were deemed unmeasurable and therefore not easily assessed in routine cancer care. Nevertheless, a study in the early 1980s1 showed that if newly diagnosed patients were screened for distress, those identified as being distressed could be helped to cope better.
To improve the recognition and treatment of distress in cancer patients, the National Comprehensive Cancer Network (NCCN) created a panel of experts in 1997 to formulate clinical practice guidelines for distress management.2 The guidelines, which were based on the evidence and consensus of an expert panel, were the first in the United States designed for clinicians. The term “distress” was chosen because it suggests a normal response, which can vary from an expected level to a severe one (eg, anxiety, depression).3 The term also reduces the stigma attached to words such as “psychiatric.”
The NCCN Distress Management Guidelines, which are updated annually, recommend that each new patient be rapidly assessed for distress in the office or clinic waiting room using a brief screening tool.3,4 Based on the lessons learned from the success of pain management, the panel suggested using the Distress Thermometer (DT), a self-report measure with a 0–10 scale in which 0 indicates “no distress” and 10, “extreme distress.” Patients who score 4 or more are identified as having clinically significant distress, based on validity studies showing sensitivity and specificity.5 They are then asked to check off the domains they identify as causing the distress in a separate Problem List. Depending on the nature of the problem elicited by the nurse or oncologist, patients can be referred to a professional, such as a social worker, nurse, psychologist, chaplain, or psychiatrist.6,7 The screen should be repeated at points of transition during clinical treatment.7
* For a PDF of the full article, click in the link to the left of this introduction.
The psychological and social consequences of cancer treatment were largely neglected until the latter part of the 20th century, despite the awareness that cancer patients often struggled with anxiety, depression, and emotional upheaval so severe as to jeopardize adherence to treatment. These psychological and emotional states were attributed to patients’ subjective responses to their condition, which were deemed unmeasurable and therefore not easily assessed in routine cancer care. Nevertheless, a study in the early 1980s1 showed that if newly diagnosed patients were screened for distress, those identified as being distressed could be helped to cope better.
To improve the recognition and treatment of distress in cancer patients, the National Comprehensive Cancer Network (NCCN) created a panel of experts in 1997 to formulate clinical practice guidelines for distress management.2 The guidelines, which were based on the evidence and consensus of an expert panel, were the first in the United States designed for clinicians. The term “distress” was chosen because it suggests a normal response, which can vary from an expected level to a severe one (eg, anxiety, depression).3 The term also reduces the stigma attached to words such as “psychiatric.”
The NCCN Distress Management Guidelines, which are updated annually, recommend that each new patient be rapidly assessed for distress in the office or clinic waiting room using a brief screening tool.3,4 Based on the lessons learned from the success of pain management, the panel suggested using the Distress Thermometer (DT), a self-report measure with a 0–10 scale in which 0 indicates “no distress” and 10, “extreme distress.” Patients who score 4 or more are identified as having clinically significant distress, based on validity studies showing sensitivity and specificity.5 They are then asked to check off the domains they identify as causing the distress in a separate Problem List. Depending on the nature of the problem elicited by the nurse or oncologist, patients can be referred to a professional, such as a social worker, nurse, psychologist, chaplain, or psychiatrist.6,7 The screen should be repeated at points of transition during clinical treatment.7
* For a PDF of the full article, click in the link to the left of this introduction.
The psychological and social consequences of cancer treatment were largely neglected until the latter part of the 20th century, despite the awareness that cancer patients often struggled with anxiety, depression, and emotional upheaval so severe as to jeopardize adherence to treatment. These psychological and emotional states were attributed to patients’ subjective responses to their condition, which were deemed unmeasurable and therefore not easily assessed in routine cancer care. Nevertheless, a study in the early 1980s1 showed that if newly diagnosed patients were screened for distress, those identified as being distressed could be helped to cope better.
To improve the recognition and treatment of distress in cancer patients, the National Comprehensive Cancer Network (NCCN) created a panel of experts in 1997 to formulate clinical practice guidelines for distress management.2 The guidelines, which were based on the evidence and consensus of an expert panel, were the first in the United States designed for clinicians. The term “distress” was chosen because it suggests a normal response, which can vary from an expected level to a severe one (eg, anxiety, depression).3 The term also reduces the stigma attached to words such as “psychiatric.”
The NCCN Distress Management Guidelines, which are updated annually, recommend that each new patient be rapidly assessed for distress in the office or clinic waiting room using a brief screening tool.3,4 Based on the lessons learned from the success of pain management, the panel suggested using the Distress Thermometer (DT), a self-report measure with a 0–10 scale in which 0 indicates “no distress” and 10, “extreme distress.” Patients who score 4 or more are identified as having clinically significant distress, based on validity studies showing sensitivity and specificity.5 They are then asked to check off the domains they identify as causing the distress in a separate Problem List. Depending on the nature of the problem elicited by the nurse or oncologist, patients can be referred to a professional, such as a social worker, nurse, psychologist, chaplain, or psychiatrist.6,7 The screen should be repeated at points of transition during clinical treatment.7
* For a PDF of the full article, click in the link to the left of this introduction.
Patient-centered care and distress screening: tracking the sixth vital sign
We often make note in these pages of the remarkable advances occurring in the realm of new oncologic therapeutics based on the burgeoning understanding of cancer biology. Although no one would argue about the importance of treating the cancer, we should always remember that the goal of treatment is to take care of the patient as a whole, working also to heal the emotional, psychological, and social upheaval that can follow a cancer diagnosis.
Indeed, that focus on the patient’s overall needs is now termed patient-centered care, and it is a fundamental attribute in approaching any therapeutic maneuver. No group of patients requires a more comprehensive approach to patient-centered care than do cancer patients. Faced with an existential crisis, huge costs of care, physical and psychological symptoms, and frequent and progressive loss of independence and function, it is no surprise that these patients— and their families—routinely suffer great psychosocial distress while battling the disease.
The Institute of Medicine’s 2007 report Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs was an attempt to categorize the challenges faced by cancer patients and the scope of available services for addressing those challenges at the local, regional, and national levels. I was privileged to serve on the committee that reviewed the evidence and formulated solutions to the problem. A number of recommendations arose from that report.
* For a PDF of the full article, click in the link to the left of this introduction.
We often make note in these pages of the remarkable advances occurring in the realm of new oncologic therapeutics based on the burgeoning understanding of cancer biology. Although no one would argue about the importance of treating the cancer, we should always remember that the goal of treatment is to take care of the patient as a whole, working also to heal the emotional, psychological, and social upheaval that can follow a cancer diagnosis.
Indeed, that focus on the patient’s overall needs is now termed patient-centered care, and it is a fundamental attribute in approaching any therapeutic maneuver. No group of patients requires a more comprehensive approach to patient-centered care than do cancer patients. Faced with an existential crisis, huge costs of care, physical and psychological symptoms, and frequent and progressive loss of independence and function, it is no surprise that these patients— and their families—routinely suffer great psychosocial distress while battling the disease.
The Institute of Medicine’s 2007 report Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs was an attempt to categorize the challenges faced by cancer patients and the scope of available services for addressing those challenges at the local, regional, and national levels. I was privileged to serve on the committee that reviewed the evidence and formulated solutions to the problem. A number of recommendations arose from that report.
* For a PDF of the full article, click in the link to the left of this introduction.
We often make note in these pages of the remarkable advances occurring in the realm of new oncologic therapeutics based on the burgeoning understanding of cancer biology. Although no one would argue about the importance of treating the cancer, we should always remember that the goal of treatment is to take care of the patient as a whole, working also to heal the emotional, psychological, and social upheaval that can follow a cancer diagnosis.
Indeed, that focus on the patient’s overall needs is now termed patient-centered care, and it is a fundamental attribute in approaching any therapeutic maneuver. No group of patients requires a more comprehensive approach to patient-centered care than do cancer patients. Faced with an existential crisis, huge costs of care, physical and psychological symptoms, and frequent and progressive loss of independence and function, it is no surprise that these patients— and their families—routinely suffer great psychosocial distress while battling the disease.
The Institute of Medicine’s 2007 report Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs was an attempt to categorize the challenges faced by cancer patients and the scope of available services for addressing those challenges at the local, regional, and national levels. I was privileged to serve on the committee that reviewed the evidence and formulated solutions to the problem. A number of recommendations arose from that report.
* For a PDF of the full article, click in the link to the left of this introduction.
Most Cancer Patients Want to Discuss Prognosis
Physicians should start end-of-life conversations early. They can start prognosis discussions by asking broad open-ended questions. Dr. Susan Block shares her practice wisdom at the Chicago Supportive Oncology Conference.
Physicians should start end-of-life conversations early. They can start prognosis discussions by asking broad open-ended questions. Dr. Susan Block shares her practice wisdom at the Chicago Supportive Oncology Conference.
Physicians should start end-of-life conversations early. They can start prognosis discussions by asking broad open-ended questions. Dr. Susan Block shares her practice wisdom at the Chicago Supportive Oncology Conference.