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Canadian agency reports rare, severe skin reactions to cancer drug
A notice about the risk of severe skin reactions associated with the cancer drug capecitabine – including Stevens-Johnson syndrome – has been released by the Canadian health department.
"Very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with" capecitabine, according to a letter to health care professionals, posted on the Health Canada website on Dec. 3. The letter states that treatment with capecitabine should be "immediately discontinued" if a patient develops signs and symptoms of SJS or TEN.
No such notice has been posted by the U.S. Food and Drug Administration. The FDA "constantly monitors and reviews reports from regulatory agencies, especially those concerning products that affect Americans’ health," and is reviewing related scientific information on this issue, an FDA spokesperson said in response to a query on the notice. The agency "will determine what, if any, actions to take," he added.
Capecitabine is a nucleoside metabolic inhibitor, and is marketed as Xeloda in Canada and the United States for treatment of colorectal cancer and breast cancer. In the United States, it was initially approved in 1998 for treating metastatic breast cancer, and is now also approved as a first-line treatment for metastatic colon cancer, as well as for adjuvant colon cancer in patients with Dukes’ C colon cancer. It is marketed by Roche, which the letter says is working with Health Canada to revise the product monograph in Canada. In the United States, a generic formulation is also available.
The U.S. label includes hand-and-foot syndrome (including grade 2 and 3 events), dermatitis, rash, and erythema among the skin and subcutaneous adverse events reported in clinical trials, but there are no reports of SJS or TEN listed.
Serious adverse events associated with capecitabine should be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, at www.fda.gov/Safety/MedWatch/default.htm.
A notice about the risk of severe skin reactions associated with the cancer drug capecitabine – including Stevens-Johnson syndrome – has been released by the Canadian health department.
"Very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with" capecitabine, according to a letter to health care professionals, posted on the Health Canada website on Dec. 3. The letter states that treatment with capecitabine should be "immediately discontinued" if a patient develops signs and symptoms of SJS or TEN.
No such notice has been posted by the U.S. Food and Drug Administration. The FDA "constantly monitors and reviews reports from regulatory agencies, especially those concerning products that affect Americans’ health," and is reviewing related scientific information on this issue, an FDA spokesperson said in response to a query on the notice. The agency "will determine what, if any, actions to take," he added.
Capecitabine is a nucleoside metabolic inhibitor, and is marketed as Xeloda in Canada and the United States for treatment of colorectal cancer and breast cancer. In the United States, it was initially approved in 1998 for treating metastatic breast cancer, and is now also approved as a first-line treatment for metastatic colon cancer, as well as for adjuvant colon cancer in patients with Dukes’ C colon cancer. It is marketed by Roche, which the letter says is working with Health Canada to revise the product monograph in Canada. In the United States, a generic formulation is also available.
The U.S. label includes hand-and-foot syndrome (including grade 2 and 3 events), dermatitis, rash, and erythema among the skin and subcutaneous adverse events reported in clinical trials, but there are no reports of SJS or TEN listed.
Serious adverse events associated with capecitabine should be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, at www.fda.gov/Safety/MedWatch/default.htm.
A notice about the risk of severe skin reactions associated with the cancer drug capecitabine – including Stevens-Johnson syndrome – has been released by the Canadian health department.
"Very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with" capecitabine, according to a letter to health care professionals, posted on the Health Canada website on Dec. 3. The letter states that treatment with capecitabine should be "immediately discontinued" if a patient develops signs and symptoms of SJS or TEN.
No such notice has been posted by the U.S. Food and Drug Administration. The FDA "constantly monitors and reviews reports from regulatory agencies, especially those concerning products that affect Americans’ health," and is reviewing related scientific information on this issue, an FDA spokesperson said in response to a query on the notice. The agency "will determine what, if any, actions to take," he added.
Capecitabine is a nucleoside metabolic inhibitor, and is marketed as Xeloda in Canada and the United States for treatment of colorectal cancer and breast cancer. In the United States, it was initially approved in 1998 for treating metastatic breast cancer, and is now also approved as a first-line treatment for metastatic colon cancer, as well as for adjuvant colon cancer in patients with Dukes’ C colon cancer. It is marketed by Roche, which the letter says is working with Health Canada to revise the product monograph in Canada. In the United States, a generic formulation is also available.
The U.S. label includes hand-and-foot syndrome (including grade 2 and 3 events), dermatitis, rash, and erythema among the skin and subcutaneous adverse events reported in clinical trials, but there are no reports of SJS or TEN listed.
Serious adverse events associated with capecitabine should be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, at www.fda.gov/Safety/MedWatch/default.htm.
Characterization of skin reactions and pain reported by patients receiving radiation therapy for cancer at different sites
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Illness perceptions matter: understanding quality of life and advanced illness behaviors in female patients with late-stage cancer
Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Inspiratory muscle training improved subjective breathlessness in lung cancer
SYDNEY, AUSTRALIA – Inspiratory muscle training using a pressure threshold device improved lung cancer patients’ self-reported measures of breathlessness, but did not affect objective measurements of lung function, a pilot trial found.
The study in 46 patients with mostly advanced but stable lung cancer showed statistically and clinically significant differences in ability to cope with breathlessness (P = .02); satisfaction with breathlessness management (P = .024); fatigue (P = .007); emotional function (P = .006); breathlessness mastery (P = .031); anxiety (P = .027); and depression (P = .048).
In the randomized controlled trial, the difference in modified Borg (mBorg) score between the intervention and control groups at 3 months was 0.80, which was borderline clinically significant but not statistically significant. There were no differences in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) levels between the intervention and control groups, according to data presented at a world conference on lung cancer.
Lead investigator Dr. Alex Molasiotis said management of breathlessness in lung cancer is problematic.
"We have very few pharmacological interventions to offer ... so this is one of the fields where we need new evidence, new information, and new interventions," said Dr. Molasiotis, professor and head of the School of Nursing at Hong Kong Polytechnic University.
Inspiratory muscle training has been shown to be effective in some lung diseases such as chronic obstructive pulmonary disease. While the lack of effect on lung function in this pilot study was disappointing, Dr. Molasiotis said the observed improvements in subjective measures were still important.
"Generally we know that FEV1 and FVC don’t really correspond well with subjective measures, and this is something that is clear in the literature," Dr. Molasiotis said in an interview. "[But] it might be that we gave a sense of control to the patients through these techniques; we helped them cope better."
The pressure threshold device increases resistance on inspiration but not on expiration. Patients were instructed to use the device for 30 minutes per day, 5 days a week, for 12 weeks.
While some patients had to break the 30 minutes down into smaller sessions, Dr. Molasiotis said there was unexpectedly high compliance with use of the device.
"This is a population that’s quite ill, but I think it’s also a population that’s quite desperate to have an improvement, so very few of the patients didn’t follow the regime," Dr. Molasiotis said.
The patients were all off first-line treatment to rule out interference from chemotherapy or radiotherapy, and while initially the study investigators set out to recruit nonsmokers only, recruitment difficulties meant they changed the protocol to recruit smokers as well. There were no differences in response between smokers and nonsmokers.
Dr. Molasiotis said inspiratory muscle training is an option that some clinicians might like to consider, but he stressed that it is not appropriate for patients experiencing an acute episode of breathlessness.
The conference was sponsored by the International Association for the Study of Lung Cancer. There were no relevant financial conflicts of interest declared.
SYDNEY, AUSTRALIA – Inspiratory muscle training using a pressure threshold device improved lung cancer patients’ self-reported measures of breathlessness, but did not affect objective measurements of lung function, a pilot trial found.
The study in 46 patients with mostly advanced but stable lung cancer showed statistically and clinically significant differences in ability to cope with breathlessness (P = .02); satisfaction with breathlessness management (P = .024); fatigue (P = .007); emotional function (P = .006); breathlessness mastery (P = .031); anxiety (P = .027); and depression (P = .048).
In the randomized controlled trial, the difference in modified Borg (mBorg) score between the intervention and control groups at 3 months was 0.80, which was borderline clinically significant but not statistically significant. There were no differences in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) levels between the intervention and control groups, according to data presented at a world conference on lung cancer.
Lead investigator Dr. Alex Molasiotis said management of breathlessness in lung cancer is problematic.
"We have very few pharmacological interventions to offer ... so this is one of the fields where we need new evidence, new information, and new interventions," said Dr. Molasiotis, professor and head of the School of Nursing at Hong Kong Polytechnic University.
Inspiratory muscle training has been shown to be effective in some lung diseases such as chronic obstructive pulmonary disease. While the lack of effect on lung function in this pilot study was disappointing, Dr. Molasiotis said the observed improvements in subjective measures were still important.
"Generally we know that FEV1 and FVC don’t really correspond well with subjective measures, and this is something that is clear in the literature," Dr. Molasiotis said in an interview. "[But] it might be that we gave a sense of control to the patients through these techniques; we helped them cope better."
The pressure threshold device increases resistance on inspiration but not on expiration. Patients were instructed to use the device for 30 minutes per day, 5 days a week, for 12 weeks.
While some patients had to break the 30 minutes down into smaller sessions, Dr. Molasiotis said there was unexpectedly high compliance with use of the device.
"This is a population that’s quite ill, but I think it’s also a population that’s quite desperate to have an improvement, so very few of the patients didn’t follow the regime," Dr. Molasiotis said.
The patients were all off first-line treatment to rule out interference from chemotherapy or radiotherapy, and while initially the study investigators set out to recruit nonsmokers only, recruitment difficulties meant they changed the protocol to recruit smokers as well. There were no differences in response between smokers and nonsmokers.
Dr. Molasiotis said inspiratory muscle training is an option that some clinicians might like to consider, but he stressed that it is not appropriate for patients experiencing an acute episode of breathlessness.
The conference was sponsored by the International Association for the Study of Lung Cancer. There were no relevant financial conflicts of interest declared.
SYDNEY, AUSTRALIA – Inspiratory muscle training using a pressure threshold device improved lung cancer patients’ self-reported measures of breathlessness, but did not affect objective measurements of lung function, a pilot trial found.
The study in 46 patients with mostly advanced but stable lung cancer showed statistically and clinically significant differences in ability to cope with breathlessness (P = .02); satisfaction with breathlessness management (P = .024); fatigue (P = .007); emotional function (P = .006); breathlessness mastery (P = .031); anxiety (P = .027); and depression (P = .048).
In the randomized controlled trial, the difference in modified Borg (mBorg) score between the intervention and control groups at 3 months was 0.80, which was borderline clinically significant but not statistically significant. There were no differences in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) levels between the intervention and control groups, according to data presented at a world conference on lung cancer.
Lead investigator Dr. Alex Molasiotis said management of breathlessness in lung cancer is problematic.
"We have very few pharmacological interventions to offer ... so this is one of the fields where we need new evidence, new information, and new interventions," said Dr. Molasiotis, professor and head of the School of Nursing at Hong Kong Polytechnic University.
Inspiratory muscle training has been shown to be effective in some lung diseases such as chronic obstructive pulmonary disease. While the lack of effect on lung function in this pilot study was disappointing, Dr. Molasiotis said the observed improvements in subjective measures were still important.
"Generally we know that FEV1 and FVC don’t really correspond well with subjective measures, and this is something that is clear in the literature," Dr. Molasiotis said in an interview. "[But] it might be that we gave a sense of control to the patients through these techniques; we helped them cope better."
The pressure threshold device increases resistance on inspiration but not on expiration. Patients were instructed to use the device for 30 minutes per day, 5 days a week, for 12 weeks.
While some patients had to break the 30 minutes down into smaller sessions, Dr. Molasiotis said there was unexpectedly high compliance with use of the device.
"This is a population that’s quite ill, but I think it’s also a population that’s quite desperate to have an improvement, so very few of the patients didn’t follow the regime," Dr. Molasiotis said.
The patients were all off first-line treatment to rule out interference from chemotherapy or radiotherapy, and while initially the study investigators set out to recruit nonsmokers only, recruitment difficulties meant they changed the protocol to recruit smokers as well. There were no differences in response between smokers and nonsmokers.
Dr. Molasiotis said inspiratory muscle training is an option that some clinicians might like to consider, but he stressed that it is not appropriate for patients experiencing an acute episode of breathlessness.
The conference was sponsored by the International Association for the Study of Lung Cancer. There were no relevant financial conflicts of interest declared.
AT THE IASLC WORLD CONFERENCE
Major finding: Inspiratory muscle training with a pressure threshold device improved self-reported patient measures of breathlessness and other symptoms such as anxiety and depression, but it did not improve lung function scores.
Data source: Pilot feasibility randomized controlled trial in 46 patients with advanced, stable lung cancer.
Disclosures: There were no relevant financial conflicts of interest declared.
Five criteria doubled palliative care, cut hospital readmissions
Using five characteristics doubled palliative care consults for patients with solid tumors in a small study at one facility. As a result, hospice utilization rates increased by more than 10% and 30-day readmission rates decreased from 36% to 17%, Dr. Kerin Adelson reported during a press briefing held in advance of the symposium on quality care sponsored by the American Society of Clinical Oncology, where the results of the pilot program will be presented in full.
The criteria used to prompt palliative care consults in patients with sold tumors are as follows:
• Stage IV disease.
• Stage III lung or pancreatic cancer.
• Prior hospitalization within 30-days, excluding routine chemotherapy.
• Hospitalization lasting longer than 7 days.
• Uncontrolled symptoms including pain, nausea/vomiting, dyspnea, delirium, and psychological distress.
"Too many patients receive palliative care too late or go without it altogether. This results in inadequate pain control, emotional distress for patients and caregivers, and overuse of aggressive medical interventions. By increasing access to palliative care services, we hoped to help patients clarify their own treatment goals and, in turn, align our clinical goals with those of our patients," said Dr. Adelson of Mount Sinai Hospital, N.Y.
Over 3 months, 68 patients at the center with solid tumors qualified for the palliative care consultations. The investigators compared outcomes for these patients with rates of palliative care for 51 patients during a 6-week period before the program was implemented.
Before the routine use of the criteria, 41% of the patients received a palliative care consultation. After the program was implemented, this rate doubled to 82% – a significant increase (P less than .0001). Thirty-day readmission rates fell from 36% before use of the criteria to 17% after use of the criteria – also a significant improvement (P = .022). Hospice utilization increased from 14% before to 25% after – a difference that was not statistically significant (P = .146).
The investigators also assessed data from the entire Mount Sinai University Health System Consortium, comparing outcomes during the pilot study to the averages seen within the system during the previous year.
Projecting results from the pilot study onto that data, about 60% of patients admitted with a solid tumor would have been eligible for a consult under the investigational criteria. The intervention would have reduced 30-day readmission rates from 22% to 13% and would have significantly lowered the mortality index – an inpatient death rate that controls for the severity of illness – from 1.39 to 0.59, according to Dr. Adelson.
"This means that fewer patients were dying in acute hospital settings than would be expected for the severity of illness," she said.
Before the five criteria were established, the facility had no guidelines and relied on the treating oncologist’s discretion for identifying patients who needed palliative care consults, said Dr. Adelson, who determined the criteria in collaboration with her Mount Sinai colleagues. Now, patients who meet any of the criteria are offered a palliative care consultation, which could lead to new symptomatic treatments or to hospice care at home or in the hospital.
The facility has now decided to create a palliative care team that will provide consultation for every patient who meets the new criteria, she added.
Dr. Adelson had no financial disclosures related to her presentation.
Using five characteristics doubled palliative care consults for patients with solid tumors in a small study at one facility. As a result, hospice utilization rates increased by more than 10% and 30-day readmission rates decreased from 36% to 17%, Dr. Kerin Adelson reported during a press briefing held in advance of the symposium on quality care sponsored by the American Society of Clinical Oncology, where the results of the pilot program will be presented in full.
The criteria used to prompt palliative care consults in patients with sold tumors are as follows:
• Stage IV disease.
• Stage III lung or pancreatic cancer.
• Prior hospitalization within 30-days, excluding routine chemotherapy.
• Hospitalization lasting longer than 7 days.
• Uncontrolled symptoms including pain, nausea/vomiting, dyspnea, delirium, and psychological distress.
"Too many patients receive palliative care too late or go without it altogether. This results in inadequate pain control, emotional distress for patients and caregivers, and overuse of aggressive medical interventions. By increasing access to palliative care services, we hoped to help patients clarify their own treatment goals and, in turn, align our clinical goals with those of our patients," said Dr. Adelson of Mount Sinai Hospital, N.Y.
Over 3 months, 68 patients at the center with solid tumors qualified for the palliative care consultations. The investigators compared outcomes for these patients with rates of palliative care for 51 patients during a 6-week period before the program was implemented.
Before the routine use of the criteria, 41% of the patients received a palliative care consultation. After the program was implemented, this rate doubled to 82% – a significant increase (P less than .0001). Thirty-day readmission rates fell from 36% before use of the criteria to 17% after use of the criteria – also a significant improvement (P = .022). Hospice utilization increased from 14% before to 25% after – a difference that was not statistically significant (P = .146).
The investigators also assessed data from the entire Mount Sinai University Health System Consortium, comparing outcomes during the pilot study to the averages seen within the system during the previous year.
Projecting results from the pilot study onto that data, about 60% of patients admitted with a solid tumor would have been eligible for a consult under the investigational criteria. The intervention would have reduced 30-day readmission rates from 22% to 13% and would have significantly lowered the mortality index – an inpatient death rate that controls for the severity of illness – from 1.39 to 0.59, according to Dr. Adelson.
"This means that fewer patients were dying in acute hospital settings than would be expected for the severity of illness," she said.
Before the five criteria were established, the facility had no guidelines and relied on the treating oncologist’s discretion for identifying patients who needed palliative care consults, said Dr. Adelson, who determined the criteria in collaboration with her Mount Sinai colleagues. Now, patients who meet any of the criteria are offered a palliative care consultation, which could lead to new symptomatic treatments or to hospice care at home or in the hospital.
The facility has now decided to create a palliative care team that will provide consultation for every patient who meets the new criteria, she added.
Dr. Adelson had no financial disclosures related to her presentation.
Using five characteristics doubled palliative care consults for patients with solid tumors in a small study at one facility. As a result, hospice utilization rates increased by more than 10% and 30-day readmission rates decreased from 36% to 17%, Dr. Kerin Adelson reported during a press briefing held in advance of the symposium on quality care sponsored by the American Society of Clinical Oncology, where the results of the pilot program will be presented in full.
The criteria used to prompt palliative care consults in patients with sold tumors are as follows:
• Stage IV disease.
• Stage III lung or pancreatic cancer.
• Prior hospitalization within 30-days, excluding routine chemotherapy.
• Hospitalization lasting longer than 7 days.
• Uncontrolled symptoms including pain, nausea/vomiting, dyspnea, delirium, and psychological distress.
"Too many patients receive palliative care too late or go without it altogether. This results in inadequate pain control, emotional distress for patients and caregivers, and overuse of aggressive medical interventions. By increasing access to palliative care services, we hoped to help patients clarify their own treatment goals and, in turn, align our clinical goals with those of our patients," said Dr. Adelson of Mount Sinai Hospital, N.Y.
Over 3 months, 68 patients at the center with solid tumors qualified for the palliative care consultations. The investigators compared outcomes for these patients with rates of palliative care for 51 patients during a 6-week period before the program was implemented.
Before the routine use of the criteria, 41% of the patients received a palliative care consultation. After the program was implemented, this rate doubled to 82% – a significant increase (P less than .0001). Thirty-day readmission rates fell from 36% before use of the criteria to 17% after use of the criteria – also a significant improvement (P = .022). Hospice utilization increased from 14% before to 25% after – a difference that was not statistically significant (P = .146).
The investigators also assessed data from the entire Mount Sinai University Health System Consortium, comparing outcomes during the pilot study to the averages seen within the system during the previous year.
Projecting results from the pilot study onto that data, about 60% of patients admitted with a solid tumor would have been eligible for a consult under the investigational criteria. The intervention would have reduced 30-day readmission rates from 22% to 13% and would have significantly lowered the mortality index – an inpatient death rate that controls for the severity of illness – from 1.39 to 0.59, according to Dr. Adelson.
"This means that fewer patients were dying in acute hospital settings than would be expected for the severity of illness," she said.
Before the five criteria were established, the facility had no guidelines and relied on the treating oncologist’s discretion for identifying patients who needed palliative care consults, said Dr. Adelson, who determined the criteria in collaboration with her Mount Sinai colleagues. Now, patients who meet any of the criteria are offered a palliative care consultation, which could lead to new symptomatic treatments or to hospice care at home or in the hospital.
The facility has now decided to create a palliative care team that will provide consultation for every patient who meets the new criteria, she added.
Dr. Adelson had no financial disclosures related to her presentation.
FROM THE ASCO QUALITY CARE SYMPOSIUM
Major finding: Thirty-day readmission rates fell from 36% before use of the criteria to 17% after use of the criteria – a significant improvement (P = .022).
Data source: A comparison of outcomes in 68 patients treated over 3 months with the criteria in place and in 51 patients treated during a 6-week period before the program was implemented.
Disclosures: The researchers had no relevant financial disclosures.
Family history, genetic testing, and the electronic health record
Family history has always been one of the most powerful and inexpensive tools for assessing a patient’s genetic risks.
In the case of rare single-gene (Mendelian) syndromes , such as Marfan syndrome, cystic fibrosis, or a cancer syndrome, knowledge of the family history can alert the patient and his/her physicians of the potential need for testing, surveillance and/or preventive measures. For common multifactorial disorders, such as diabetes, asthma, or non-Mendelian cancer predisposition, this is even more important, because a single genetic test result is less likely to drastically change an individual’s overall risk assessment.
Obstacles to widespread utilization of family history among primary care physicians have included the time required to gather the data; storage and retrieval of the data; and uncertainty about how to interpret it, especially in the era of evidence-based medicine.
Genetic testing provides another source of data, which shares many of the same obstacles to widespread adoption as family history: choosing and ordering appropriate tests; data storage and retrieval; evidence-based application of these data.
These challenges are not too difficult to solve when dealing with a single mutation or just one or two genes. But we are now in an era of easily accessible genome-wide mapping, with 1 million or more pieces of data in each test result. And clinical-grade sequencing of entire genomes, containing several billion pieces of data, is coming soon.
With specialty training, a human can learn to interpret moderately complicated family histories with a high degree of scientific accuracy. But global assessment of an entire genome, either for identification of the cause of a Mendelian syndrome or for recognition of factors contributing to common disease, is beyond reasonable human capacity.
Realistically, neither family history nor genetic testing is sufficient for robust risk assessment. Combining both sources of genetic information, together with environmental and other personal factors, is the ultimate goal, and is the essence of individualized medicine.
Much work is yet to be done to fully develop the evidence and refine the algorithms that will drive this type of medical care. But for many conditions, there is already sufficient qualitative and quantitative evidence to justify clinical application today. Consider, for example, the inclusion of family history in assessment of coronary artery disease risk or likelihood of carrying a mutation in one of the BRCA genes. So, the third obstacle, evidence-based interpretation, is not really the rate-limiting step today.
The biggest current barriers to integration of family history and genetic (or genomic) data in actual clinical care are data acquisition, storage, and retrieval.
The solution to this problem is obvious: computers.
More specifically, despite all of the grumbling and complaints they generate, electronic health records (EHRs) hold great promise for simplifying our lives while simultaneously improving patient care.
To be maximally useful, a family history should include data on three to four generations: children, siblings, parents/aunts/uncles, and grandparents. Depending upon the specific question at hand, children or grandparents may be more or less relevant to the risk assessment; cousins, nieces, and nephews may sometimes be important, too. For each relative, useful data include age, age of death, cause of death, and the diagnosis and approximate age of onset of each health problem. In many cases, presence or absence of common environmental risk factors is also important (for example, lung cancer without exposure to tobacco, asbestos, or radon suggests a greater likelihood of genetic predisposition). The ancestral origin on each side of the family is also sometimes informative.
Add to that the increasing availability of single-gene and whole-genome testing results, and the task of assembling all of this data becomes overwhelming.
EHRs have the ability to simplify all of this.
Just as is done today when collecting medical information about an individual patient, the family history and genetic testing elements discussed above can be stored as discrete pieces of data for each of that patient’s relatives. Studies have already shown that patients’ recall of their family history is generally pretty reliable. And if they’re encouraged to discuss that history with family members, the quality of the data improves further.
Patient portals, an integral component of meaningful use of EHRs, empower patients to collect and input this information from home, solving the problem of inadequate time during a clinical encounter.
With appropriate informed consent, it is also technically feasible to link EHR data of related individuals to increase the quantity and accuracy of family history data. Genomic sequencing data, from the patient and his/her relatives, can also be electronically linked to the family history.
Once gathered and stored, those discrete elements still need to be displayed in a logical way. People in general and physicians in particular, value flexibility and individuality in how they view data. Some prefer a graphical display of family history in a genogram or pedigree; others prefer tabular representation. Sometimes, it is helpful to see which relatives have a specific condition or group of conditions. Other times, it is useful to view the medical history of each relative individually. One may wish to view the entire family history all at once, but often a filtered view of only certain conditions or relatives of interest is more relevant.
For the most part, EHR vendors have not yet developed the software to support management of family history and genetic data as discussed here. They are not completely to blame. Like any other business, they focus their resources on tools and innovations that their customers need or want. We, the consumers of EHR products, have not yet made this a high enough priority.
Ultimately, detailed and discrete family history, genetic, and environmental data can be fed into evidence-based algorithms, some already in existence, others yet to be developed, to drive clinical decision support that helps physicians at the point of care to deliver safer, more efficient, and more effective medical care. What stands in our way is the ability to gather and organize this data.
EHRs, despite the frustration of implementing and learning to use them, are the key to unlocking this potential.
Please consider asking your EHR vendor to develop the family history and genomic data tools necessary to enable truly individualized medicine.
Dr. Levy is with the division of general internal medicine and the McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University, Baltimore.
Family history has always been one of the most powerful and inexpensive tools for assessing a patient’s genetic risks.
In the case of rare single-gene (Mendelian) syndromes , such as Marfan syndrome, cystic fibrosis, or a cancer syndrome, knowledge of the family history can alert the patient and his/her physicians of the potential need for testing, surveillance and/or preventive measures. For common multifactorial disorders, such as diabetes, asthma, or non-Mendelian cancer predisposition, this is even more important, because a single genetic test result is less likely to drastically change an individual’s overall risk assessment.
Obstacles to widespread utilization of family history among primary care physicians have included the time required to gather the data; storage and retrieval of the data; and uncertainty about how to interpret it, especially in the era of evidence-based medicine.
Genetic testing provides another source of data, which shares many of the same obstacles to widespread adoption as family history: choosing and ordering appropriate tests; data storage and retrieval; evidence-based application of these data.
These challenges are not too difficult to solve when dealing with a single mutation or just one or two genes. But we are now in an era of easily accessible genome-wide mapping, with 1 million or more pieces of data in each test result. And clinical-grade sequencing of entire genomes, containing several billion pieces of data, is coming soon.
With specialty training, a human can learn to interpret moderately complicated family histories with a high degree of scientific accuracy. But global assessment of an entire genome, either for identification of the cause of a Mendelian syndrome or for recognition of factors contributing to common disease, is beyond reasonable human capacity.
Realistically, neither family history nor genetic testing is sufficient for robust risk assessment. Combining both sources of genetic information, together with environmental and other personal factors, is the ultimate goal, and is the essence of individualized medicine.
Much work is yet to be done to fully develop the evidence and refine the algorithms that will drive this type of medical care. But for many conditions, there is already sufficient qualitative and quantitative evidence to justify clinical application today. Consider, for example, the inclusion of family history in assessment of coronary artery disease risk or likelihood of carrying a mutation in one of the BRCA genes. So, the third obstacle, evidence-based interpretation, is not really the rate-limiting step today.
The biggest current barriers to integration of family history and genetic (or genomic) data in actual clinical care are data acquisition, storage, and retrieval.
The solution to this problem is obvious: computers.
More specifically, despite all of the grumbling and complaints they generate, electronic health records (EHRs) hold great promise for simplifying our lives while simultaneously improving patient care.
To be maximally useful, a family history should include data on three to four generations: children, siblings, parents/aunts/uncles, and grandparents. Depending upon the specific question at hand, children or grandparents may be more or less relevant to the risk assessment; cousins, nieces, and nephews may sometimes be important, too. For each relative, useful data include age, age of death, cause of death, and the diagnosis and approximate age of onset of each health problem. In many cases, presence or absence of common environmental risk factors is also important (for example, lung cancer without exposure to tobacco, asbestos, or radon suggests a greater likelihood of genetic predisposition). The ancestral origin on each side of the family is also sometimes informative.
Add to that the increasing availability of single-gene and whole-genome testing results, and the task of assembling all of this data becomes overwhelming.
EHRs have the ability to simplify all of this.
Just as is done today when collecting medical information about an individual patient, the family history and genetic testing elements discussed above can be stored as discrete pieces of data for each of that patient’s relatives. Studies have already shown that patients’ recall of their family history is generally pretty reliable. And if they’re encouraged to discuss that history with family members, the quality of the data improves further.
Patient portals, an integral component of meaningful use of EHRs, empower patients to collect and input this information from home, solving the problem of inadequate time during a clinical encounter.
With appropriate informed consent, it is also technically feasible to link EHR data of related individuals to increase the quantity and accuracy of family history data. Genomic sequencing data, from the patient and his/her relatives, can also be electronically linked to the family history.
Once gathered and stored, those discrete elements still need to be displayed in a logical way. People in general and physicians in particular, value flexibility and individuality in how they view data. Some prefer a graphical display of family history in a genogram or pedigree; others prefer tabular representation. Sometimes, it is helpful to see which relatives have a specific condition or group of conditions. Other times, it is useful to view the medical history of each relative individually. One may wish to view the entire family history all at once, but often a filtered view of only certain conditions or relatives of interest is more relevant.
For the most part, EHR vendors have not yet developed the software to support management of family history and genetic data as discussed here. They are not completely to blame. Like any other business, they focus their resources on tools and innovations that their customers need or want. We, the consumers of EHR products, have not yet made this a high enough priority.
Ultimately, detailed and discrete family history, genetic, and environmental data can be fed into evidence-based algorithms, some already in existence, others yet to be developed, to drive clinical decision support that helps physicians at the point of care to deliver safer, more efficient, and more effective medical care. What stands in our way is the ability to gather and organize this data.
EHRs, despite the frustration of implementing and learning to use them, are the key to unlocking this potential.
Please consider asking your EHR vendor to develop the family history and genomic data tools necessary to enable truly individualized medicine.
Dr. Levy is with the division of general internal medicine and the McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University, Baltimore.
Family history has always been one of the most powerful and inexpensive tools for assessing a patient’s genetic risks.
In the case of rare single-gene (Mendelian) syndromes , such as Marfan syndrome, cystic fibrosis, or a cancer syndrome, knowledge of the family history can alert the patient and his/her physicians of the potential need for testing, surveillance and/or preventive measures. For common multifactorial disorders, such as diabetes, asthma, or non-Mendelian cancer predisposition, this is even more important, because a single genetic test result is less likely to drastically change an individual’s overall risk assessment.
Obstacles to widespread utilization of family history among primary care physicians have included the time required to gather the data; storage and retrieval of the data; and uncertainty about how to interpret it, especially in the era of evidence-based medicine.
Genetic testing provides another source of data, which shares many of the same obstacles to widespread adoption as family history: choosing and ordering appropriate tests; data storage and retrieval; evidence-based application of these data.
These challenges are not too difficult to solve when dealing with a single mutation or just one or two genes. But we are now in an era of easily accessible genome-wide mapping, with 1 million or more pieces of data in each test result. And clinical-grade sequencing of entire genomes, containing several billion pieces of data, is coming soon.
With specialty training, a human can learn to interpret moderately complicated family histories with a high degree of scientific accuracy. But global assessment of an entire genome, either for identification of the cause of a Mendelian syndrome or for recognition of factors contributing to common disease, is beyond reasonable human capacity.
Realistically, neither family history nor genetic testing is sufficient for robust risk assessment. Combining both sources of genetic information, together with environmental and other personal factors, is the ultimate goal, and is the essence of individualized medicine.
Much work is yet to be done to fully develop the evidence and refine the algorithms that will drive this type of medical care. But for many conditions, there is already sufficient qualitative and quantitative evidence to justify clinical application today. Consider, for example, the inclusion of family history in assessment of coronary artery disease risk or likelihood of carrying a mutation in one of the BRCA genes. So, the third obstacle, evidence-based interpretation, is not really the rate-limiting step today.
The biggest current barriers to integration of family history and genetic (or genomic) data in actual clinical care are data acquisition, storage, and retrieval.
The solution to this problem is obvious: computers.
More specifically, despite all of the grumbling and complaints they generate, electronic health records (EHRs) hold great promise for simplifying our lives while simultaneously improving patient care.
To be maximally useful, a family history should include data on three to four generations: children, siblings, parents/aunts/uncles, and grandparents. Depending upon the specific question at hand, children or grandparents may be more or less relevant to the risk assessment; cousins, nieces, and nephews may sometimes be important, too. For each relative, useful data include age, age of death, cause of death, and the diagnosis and approximate age of onset of each health problem. In many cases, presence or absence of common environmental risk factors is also important (for example, lung cancer without exposure to tobacco, asbestos, or radon suggests a greater likelihood of genetic predisposition). The ancestral origin on each side of the family is also sometimes informative.
Add to that the increasing availability of single-gene and whole-genome testing results, and the task of assembling all of this data becomes overwhelming.
EHRs have the ability to simplify all of this.
Just as is done today when collecting medical information about an individual patient, the family history and genetic testing elements discussed above can be stored as discrete pieces of data for each of that patient’s relatives. Studies have already shown that patients’ recall of their family history is generally pretty reliable. And if they’re encouraged to discuss that history with family members, the quality of the data improves further.
Patient portals, an integral component of meaningful use of EHRs, empower patients to collect and input this information from home, solving the problem of inadequate time during a clinical encounter.
With appropriate informed consent, it is also technically feasible to link EHR data of related individuals to increase the quantity and accuracy of family history data. Genomic sequencing data, from the patient and his/her relatives, can also be electronically linked to the family history.
Once gathered and stored, those discrete elements still need to be displayed in a logical way. People in general and physicians in particular, value flexibility and individuality in how they view data. Some prefer a graphical display of family history in a genogram or pedigree; others prefer tabular representation. Sometimes, it is helpful to see which relatives have a specific condition or group of conditions. Other times, it is useful to view the medical history of each relative individually. One may wish to view the entire family history all at once, but often a filtered view of only certain conditions or relatives of interest is more relevant.
For the most part, EHR vendors have not yet developed the software to support management of family history and genetic data as discussed here. They are not completely to blame. Like any other business, they focus their resources on tools and innovations that their customers need or want. We, the consumers of EHR products, have not yet made this a high enough priority.
Ultimately, detailed and discrete family history, genetic, and environmental data can be fed into evidence-based algorithms, some already in existence, others yet to be developed, to drive clinical decision support that helps physicians at the point of care to deliver safer, more efficient, and more effective medical care. What stands in our way is the ability to gather and organize this data.
EHRs, despite the frustration of implementing and learning to use them, are the key to unlocking this potential.
Please consider asking your EHR vendor to develop the family history and genomic data tools necessary to enable truly individualized medicine.
Dr. Levy is with the division of general internal medicine and the McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University, Baltimore.
Extended-release hydrocodone approved by FDA
Hydrocodone bitartrate extended-release capsules were approved by the Food and Drug Administration Oct. 25 for severe pain requiring daily long-term treatment and for which other treatment options are inadequate.
The drug, to be marketed as Zohydro ER, is the first FDA-approved extended-release formulation of hydrocodone that is not combined with another analgesic. It is classified as Schedule II under the Controlled Substances Act.
In December, an FDA advisory committee recommended against approval of Zohydro, citing the need for a tamper-proof formulation and a stronger risk mitigation strategy to address the high potential for abuse and misuse of the product.
Experts on the Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2, with 1 abstention, against approval, although they agreed that the manufacturer met the standards for approval for the proposed indication.
However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen – which would make it more attractive as a drug of abuse, particularly for intravenous drug abusers – or a tamper-resistant design, swayed their votes.
In approving the drug, the FDA noted that it carries new labeling and stronger warnings regarding the risks and safety of extended-release and long-acting opioid analgesics. The new labeling requirements were instituted by the agency in September. The drug also will be included in the Risk Evaluation and Mitigation Strategy (REMS) associated with the new labeling requirements.
"These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices," the FDA said in a statement. "Zohydro ER is the first opioid to be labeled in this manner."
Approval was based on safety studies of more than 1,100 chronic pain patients as well as efficacy studies of more than 500 chronic low-back-pain patients. Patients taking Zohydro ER in the efficacy study showed significant improvement in chronic pain, compared with those who took placebo.
FDA will require postmarketing studies of Zohydro ER to study potential abuse/overdose and hyperalgesia when used longer than 12 weeks.
Zohydro ER is manufactured by San Diego–based Zogenix.
Elizabeth Mechcatie contributed to this report.
Hydrocodone bitartrate extended-release capsules were approved by the Food and Drug Administration Oct. 25 for severe pain requiring daily long-term treatment and for which other treatment options are inadequate.
The drug, to be marketed as Zohydro ER, is the first FDA-approved extended-release formulation of hydrocodone that is not combined with another analgesic. It is classified as Schedule II under the Controlled Substances Act.
In December, an FDA advisory committee recommended against approval of Zohydro, citing the need for a tamper-proof formulation and a stronger risk mitigation strategy to address the high potential for abuse and misuse of the product.
Experts on the Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2, with 1 abstention, against approval, although they agreed that the manufacturer met the standards for approval for the proposed indication.
However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen – which would make it more attractive as a drug of abuse, particularly for intravenous drug abusers – or a tamper-resistant design, swayed their votes.
In approving the drug, the FDA noted that it carries new labeling and stronger warnings regarding the risks and safety of extended-release and long-acting opioid analgesics. The new labeling requirements were instituted by the agency in September. The drug also will be included in the Risk Evaluation and Mitigation Strategy (REMS) associated with the new labeling requirements.
"These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices," the FDA said in a statement. "Zohydro ER is the first opioid to be labeled in this manner."
Approval was based on safety studies of more than 1,100 chronic pain patients as well as efficacy studies of more than 500 chronic low-back-pain patients. Patients taking Zohydro ER in the efficacy study showed significant improvement in chronic pain, compared with those who took placebo.
FDA will require postmarketing studies of Zohydro ER to study potential abuse/overdose and hyperalgesia when used longer than 12 weeks.
Zohydro ER is manufactured by San Diego–based Zogenix.
Elizabeth Mechcatie contributed to this report.
Hydrocodone bitartrate extended-release capsules were approved by the Food and Drug Administration Oct. 25 for severe pain requiring daily long-term treatment and for which other treatment options are inadequate.
The drug, to be marketed as Zohydro ER, is the first FDA-approved extended-release formulation of hydrocodone that is not combined with another analgesic. It is classified as Schedule II under the Controlled Substances Act.
In December, an FDA advisory committee recommended against approval of Zohydro, citing the need for a tamper-proof formulation and a stronger risk mitigation strategy to address the high potential for abuse and misuse of the product.
Experts on the Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2, with 1 abstention, against approval, although they agreed that the manufacturer met the standards for approval for the proposed indication.
However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen – which would make it more attractive as a drug of abuse, particularly for intravenous drug abusers – or a tamper-resistant design, swayed their votes.
In approving the drug, the FDA noted that it carries new labeling and stronger warnings regarding the risks and safety of extended-release and long-acting opioid analgesics. The new labeling requirements were instituted by the agency in September. The drug also will be included in the Risk Evaluation and Mitigation Strategy (REMS) associated with the new labeling requirements.
"These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices," the FDA said in a statement. "Zohydro ER is the first opioid to be labeled in this manner."
Approval was based on safety studies of more than 1,100 chronic pain patients as well as efficacy studies of more than 500 chronic low-back-pain patients. Patients taking Zohydro ER in the efficacy study showed significant improvement in chronic pain, compared with those who took placebo.
FDA will require postmarketing studies of Zohydro ER to study potential abuse/overdose and hyperalgesia when used longer than 12 weeks.
Zohydro ER is manufactured by San Diego–based Zogenix.
Elizabeth Mechcatie contributed to this report.
Self-administration of romiplostim in patients with chronic immune thrombocytopenia
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Sulfasalazine may make radiation-induced diarrhea worse
ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.
Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.
But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)
The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.
"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.
Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.
The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.
The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.
Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.
In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.
Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.
The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.
ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.
Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.
But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)
The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.
"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.
Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.
The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.
The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.
Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.
In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.
Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.
The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.
ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.
Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.
But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)
The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.
"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.
The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.
Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.
The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.
The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.
Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.
In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.
Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.
The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.
AT THE ASTRO ANNUAL MEETING
Major finding: In all, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with 11% of patients who received placebo (P = .037)
Data source: Randomized, controlled, phase III investigational study.
Disclosures: The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.
Low-grade toxicities take a toll on older cancer patients
AMSTERDAM – Low-grade toxicity resulted in modification of chemotherapy regimens for nearly one in five older cancer patients and discontinuation of treatment in one in ten, judging from findings from a recent study.
"This is a quite clinically meaningful finding in a large, but understudied patient group," Dr. Tania Kalsi said at the multidisciplinary European cancer congresses.
More than half of cancer diagnoses occur in patients older than 65 years, and this heterogeneous group is growing in size with the aging world population.
Dr. Kalsi reported on a subsample of 108 patients treated with chemotherapy who were part of a prospective, cohort of 516 patients, aged 65 years and older, receiving any cancer treatment at the chemotherapy day unit in a tertiary referral hospital in London. All patients completed the Comprehensive Geriatric Assessment screening questionnaire to evaluate their comorbidities, functional status, and quality of life.
Their mean age was 72 years (range 65-86), 51% were male, and 59.3% were receiving chemotherapy with a palliative intent. Cancers were colorectal in 33, gynecologic in 18, upper gastrointestinal in 16, lung in 15, and other in 26. On average, 4.2 cycles of chemotherapy were delivered.
Of the 108 patients studied, 66 (55.5%) required modification of their chemotherapy regimen due to toxicity, and 21 of them (19.4%) had toxicity of grade 2 or lower, said Dr. Kalsi, a geriatric oncology research fellow at Guy’s and St. Thomas’ NHS Foundation Trust, London.
The mean number of grade 2 toxicities resulting in treatment modification was 2.19; seven patients who needed treatment modification had only one grade 2 toxicity.
Dose modifications were most commonly triggered by fatigue and hematologic toxicity (eight patients each), gastrointestinal (six patients), and infections (five patients), she said.
In univariate analysis, no significant association was seen between low- vs. high-grade toxicity treatment modifications and performance status (P = .730), treatment intent (P = .978), and patient age (less than 75 years vs. at least 75 years; P = .47).
"This is really one of the first studies to look at the impact of low-grade toxicity in older people"
Low-grade toxicity, however, triggered treatment modifications significantly more often in patients with multiple comorbidities (four or more) vs. fewer comorbidities (24.4% vs. 58%; P = .011), Dr. Kalsi said.
Although the series involved few patients, this finding is particularly interesting, said Dr. Riccardo Audisio of the University of Liverpool, U.K., who featured the study (Ab. 1555) in a highlights session at the meeting.
Overall, 23 patients (21.2%) stopped chemotherapy early due to toxicity, and nine (8.3%) of these patients had no toxicity above grade 2.
An average of 1.78 grade 2 toxicities prompted treatment discontinuation and 3 patients had only one grade 2 toxicity. The same culprits of fatigue (5 patients) and hematological toxicity (4 patients) caused early discontinuation, Dr. Kalsi said.
Univariate analysis found no significant association between low- vs. high-grade toxicity treatment discontinuation and performance status (P = 1.00), treatment intent (P = .657), patient age (P = .417), or comorbidities (P = .657), although the small sample size may have influenced the analyses, she said.
"This is really one of the first studies to look at the impact of low-grade toxicity in older people" and "highlights some key questions around clinical decision making" Dr. Kalsi said. Future research will need to tease out whether low-grade toxicity truly has a greater clinical impact on older people or whether there are differences in the clinical interaction between doctors and older patients. For example, is there a lower threshold for modifying/discontinuing treatment in older people; do older people report their symptoms differently than younger patients; and would additional support from a geriatrician liaison improve treatment tolerance; she asked.
Dr. Kalsi reported no relevant conflicts of interest.
AMSTERDAM – Low-grade toxicity resulted in modification of chemotherapy regimens for nearly one in five older cancer patients and discontinuation of treatment in one in ten, judging from findings from a recent study.
"This is a quite clinically meaningful finding in a large, but understudied patient group," Dr. Tania Kalsi said at the multidisciplinary European cancer congresses.
More than half of cancer diagnoses occur in patients older than 65 years, and this heterogeneous group is growing in size with the aging world population.
Dr. Kalsi reported on a subsample of 108 patients treated with chemotherapy who were part of a prospective, cohort of 516 patients, aged 65 years and older, receiving any cancer treatment at the chemotherapy day unit in a tertiary referral hospital in London. All patients completed the Comprehensive Geriatric Assessment screening questionnaire to evaluate their comorbidities, functional status, and quality of life.
Their mean age was 72 years (range 65-86), 51% were male, and 59.3% were receiving chemotherapy with a palliative intent. Cancers were colorectal in 33, gynecologic in 18, upper gastrointestinal in 16, lung in 15, and other in 26. On average, 4.2 cycles of chemotherapy were delivered.
Of the 108 patients studied, 66 (55.5%) required modification of their chemotherapy regimen due to toxicity, and 21 of them (19.4%) had toxicity of grade 2 or lower, said Dr. Kalsi, a geriatric oncology research fellow at Guy’s and St. Thomas’ NHS Foundation Trust, London.
The mean number of grade 2 toxicities resulting in treatment modification was 2.19; seven patients who needed treatment modification had only one grade 2 toxicity.
Dose modifications were most commonly triggered by fatigue and hematologic toxicity (eight patients each), gastrointestinal (six patients), and infections (five patients), she said.
In univariate analysis, no significant association was seen between low- vs. high-grade toxicity treatment modifications and performance status (P = .730), treatment intent (P = .978), and patient age (less than 75 years vs. at least 75 years; P = .47).
"This is really one of the first studies to look at the impact of low-grade toxicity in older people"
Low-grade toxicity, however, triggered treatment modifications significantly more often in patients with multiple comorbidities (four or more) vs. fewer comorbidities (24.4% vs. 58%; P = .011), Dr. Kalsi said.
Although the series involved few patients, this finding is particularly interesting, said Dr. Riccardo Audisio of the University of Liverpool, U.K., who featured the study (Ab. 1555) in a highlights session at the meeting.
Overall, 23 patients (21.2%) stopped chemotherapy early due to toxicity, and nine (8.3%) of these patients had no toxicity above grade 2.
An average of 1.78 grade 2 toxicities prompted treatment discontinuation and 3 patients had only one grade 2 toxicity. The same culprits of fatigue (5 patients) and hematological toxicity (4 patients) caused early discontinuation, Dr. Kalsi said.
Univariate analysis found no significant association between low- vs. high-grade toxicity treatment discontinuation and performance status (P = 1.00), treatment intent (P = .657), patient age (P = .417), or comorbidities (P = .657), although the small sample size may have influenced the analyses, she said.
"This is really one of the first studies to look at the impact of low-grade toxicity in older people" and "highlights some key questions around clinical decision making" Dr. Kalsi said. Future research will need to tease out whether low-grade toxicity truly has a greater clinical impact on older people or whether there are differences in the clinical interaction between doctors and older patients. For example, is there a lower threshold for modifying/discontinuing treatment in older people; do older people report their symptoms differently than younger patients; and would additional support from a geriatrician liaison improve treatment tolerance; she asked.
Dr. Kalsi reported no relevant conflicts of interest.
AMSTERDAM – Low-grade toxicity resulted in modification of chemotherapy regimens for nearly one in five older cancer patients and discontinuation of treatment in one in ten, judging from findings from a recent study.
"This is a quite clinically meaningful finding in a large, but understudied patient group," Dr. Tania Kalsi said at the multidisciplinary European cancer congresses.
More than half of cancer diagnoses occur in patients older than 65 years, and this heterogeneous group is growing in size with the aging world population.
Dr. Kalsi reported on a subsample of 108 patients treated with chemotherapy who were part of a prospective, cohort of 516 patients, aged 65 years and older, receiving any cancer treatment at the chemotherapy day unit in a tertiary referral hospital in London. All patients completed the Comprehensive Geriatric Assessment screening questionnaire to evaluate their comorbidities, functional status, and quality of life.
Their mean age was 72 years (range 65-86), 51% were male, and 59.3% were receiving chemotherapy with a palliative intent. Cancers were colorectal in 33, gynecologic in 18, upper gastrointestinal in 16, lung in 15, and other in 26. On average, 4.2 cycles of chemotherapy were delivered.
Of the 108 patients studied, 66 (55.5%) required modification of their chemotherapy regimen due to toxicity, and 21 of them (19.4%) had toxicity of grade 2 or lower, said Dr. Kalsi, a geriatric oncology research fellow at Guy’s and St. Thomas’ NHS Foundation Trust, London.
The mean number of grade 2 toxicities resulting in treatment modification was 2.19; seven patients who needed treatment modification had only one grade 2 toxicity.
Dose modifications were most commonly triggered by fatigue and hematologic toxicity (eight patients each), gastrointestinal (six patients), and infections (five patients), she said.
In univariate analysis, no significant association was seen between low- vs. high-grade toxicity treatment modifications and performance status (P = .730), treatment intent (P = .978), and patient age (less than 75 years vs. at least 75 years; P = .47).
"This is really one of the first studies to look at the impact of low-grade toxicity in older people"
Low-grade toxicity, however, triggered treatment modifications significantly more often in patients with multiple comorbidities (four or more) vs. fewer comorbidities (24.4% vs. 58%; P = .011), Dr. Kalsi said.
Although the series involved few patients, this finding is particularly interesting, said Dr. Riccardo Audisio of the University of Liverpool, U.K., who featured the study (Ab. 1555) in a highlights session at the meeting.
Overall, 23 patients (21.2%) stopped chemotherapy early due to toxicity, and nine (8.3%) of these patients had no toxicity above grade 2.
An average of 1.78 grade 2 toxicities prompted treatment discontinuation and 3 patients had only one grade 2 toxicity. The same culprits of fatigue (5 patients) and hematological toxicity (4 patients) caused early discontinuation, Dr. Kalsi said.
Univariate analysis found no significant association between low- vs. high-grade toxicity treatment discontinuation and performance status (P = 1.00), treatment intent (P = .657), patient age (P = .417), or comorbidities (P = .657), although the small sample size may have influenced the analyses, she said.
"This is really one of the first studies to look at the impact of low-grade toxicity in older people" and "highlights some key questions around clinical decision making" Dr. Kalsi said. Future research will need to tease out whether low-grade toxicity truly has a greater clinical impact on older people or whether there are differences in the clinical interaction between doctors and older patients. For example, is there a lower threshold for modifying/discontinuing treatment in older people; do older people report their symptoms differently than younger patients; and would additional support from a geriatrician liaison improve treatment tolerance; she asked.
Dr. Kalsi reported no relevant conflicts of interest.
AT THE EUROPEAN CANCER CONGRESS 2013
Major finding: Low-grade toxicity resulted in chemotherapy modifications in 19.4% and treatment discontinuation in 8.3% of older cancer patients.
Data source: A subsample of 108 cancer patients, aged 65 years and older.
Disclosures: Dr. Kalsi reported no relevant conflicts of interest.