Patient & Survivor Care

Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.

Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.

Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.

Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.

Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.

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

Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.

Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.

Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.

Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.

Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.

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

Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.

Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.

Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.

Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.

Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.

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

Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.

Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.

Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.

Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.

Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.

Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.

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

Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.

Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.

Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.

Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.

Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.

Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.

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

Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.

Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.

Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.

Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.

Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.

Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.

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

The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.

In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.

Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.

"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.

In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.

Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.

The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.

The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.

Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.

In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.

Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.

"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.

In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.

Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.

The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.

The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.

Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.

In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.

Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.

"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.

In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.

Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.

The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.

The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.

Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – Real-world use of rivaroxaban produced comparatively low rates of cardiovascular and major bleeding events when used for stroke prevention in unselected patients with atrial fibrillation.

The centrally adjudicated annual stroke rate was 1.4% among 1,194 patients given once-daily rivaroxaban (Xarelto) by 230 physicians from private practices and community hospitals across Saxony, Germany, in the prospective Dresden Novel Oral Anticoagulant (NOAC) registry.

This result falls within the annual stroke rate of 1.7% seen in the ROCKET-AF trial, which served as the basis for rivaroxaban’s November 2011 U.S. approval in this setting, Dr. Jan Beyer-Westendorf reported at the annual meeting of the American Society of Hematology.

Nonmajor, clinically relevant bleeding occurred in 21.6% of patients per year in the NOAC registry, while major bleeding was 3.4% per year.

Patrice Wendling/Frontline Medical News

Again, this is within the range of the phase III ROCKET-AF results (3.6% per year) and lower than the rate of up to 8% seen in the daily care of patients on vitamin K antagonists, he said. Gastrointestinal bleeding, a known side effect of rivaroxaban, was the most common major bleed. Intracranial bleeds were rare at three events.

Adherence to the oral direct factor Xa inhibitor was high at 12 months (13.7%), compared with up to 25% of patients who discontinue vitamin K antagonist therapy in the first year.

"In our population, the discontinuation rate was 14%, so basically we don’t have any concern that we put these patients at more risk in a daily care situation by treating them with rivaroxaban," said Dr. Beyer-Westendorf of the University Hospital Carl Gustav Carus, Dresden, Germany.

According to the analysis, 2,345 patients have been prospectively enrolled in the NOAC registry since October 2011; 1,194 with atrial fibrillation have been treated with anticoagulation to prevent venous thromboembolism (VTE) or stroke. No patients have been lost to follow-up, which now stands at 2,313 patient-years.

NOAC patients were slightly older at baseline than were those in ROCKET-AF (74.8 years vs. 73 years), less likely to have had prior vitamin K antagonists (37% vs. 62%), and had lower CHADS2 (Cardiac failure, Hypertension, Age, Diabetes Stroke system) scores (mean, 2.4 vs. 3.48). Higher CHADS₂ scores are associated with worse outcomes, including higher rates of major bleeding.

During follow-up through October 2013, 53 NOAC patients (4.4%) experienced a major vascular event including 22 strokes, transient ischemic attacks (TIA), systemic emboli; 15 acute coronary syndromes; and four VTEs, he said. In all, 56 patients died (4.7%).

Patients on rivaroxaban 20 mg/day vs. 15 mg/day had a significantly lower annual stroke rate (0.9% vs. 2.3%; P = .052), defined as a new stroke, TIA, or systemic embolism.

Compared with those on rivaroxaban 20 mg, patients on the lower dose had higher baseline CHADS₂ scores (mean, 2.8 vs. 2.2), were older (79 years vs. 73 years), more likely to have had a prior stroke (17% vs. 12.5%) or prior vitamin K antagonist therapy (40% vs. 36%), and took more concomitant drugs (mean, 6.4 vs. 5.4).

"It’s no surprise that these patients get a dose reduction because they have more comorbidities; they are at high risk of bleeding, and so it’s not a surprise that they have a slightly higher event rate," said Dr. Beyer-Westendorf, who noted that the lower dose did not reduce the risk of bleeding.

The NOAC registry is supported by scientific grants from Bayer Healthcare, Boehringer Ingelheim, and Pfizer. Dr. Beyer-Westendorf reported research funding from and serving as a speaker for these firms.

Bleeding complications detailed

In a separate presentation at ASH, Dr. Beyer-Westendorf detailed the pattern and management of bleeding complications in NOAC patients treated for stroke prevention in atrial fibrillation or VTE with rivaroxaban, dabigatran (Pradaxa), or apixaban (Eliquis).

These complications are a major concern for practitioners because there isn’t an emergency lab test available or rescue medications.

Of the 1,241 bleeding events that have occurred so far in 879 patients, 742 were minor (60%), 425 were nonmajor clinically relevant (34.2%), and 74 were major (6%).

Major bleeds per year of therapy were reported with rivaroxaban in 3.4% of patients with atrial fibrillation and in 4.4% with VTE. The major bleeding event rate with dabigatran in patients with atrial fibrillation was 2.6/100 patient-years at the 110-mg dose and 2.0/100 patient-years at the 150-mg dose. Short-term follow-up and low numbers of dabigatran and apixaban patients did not allow for sound event-rate calculations, according to Dr. Beyer-Westendorf, who stressed that no direct comparisons should be made between event rates for the different agents since the patients were in different cohorts and not in a randomized trial.

Most bleeds (93.3%) were managed conservatively with watchful waiting, compression, tamponade, or red blood cell transfusion. None of the minor bleeds and 16% (83/499) of the nonmajor clinically relevant and major bleeds required surgical or interventional treatment, he said.

Fresh frozen plasma and prothrombin complex concentrate were rarely used (seven patients each). No patient received recombinant activated factor VII.

Mortality was 0.4% for all patients with bleeding complications and 6.8% in those with major bleeds.

Death from any cause at 30 days and 90 days post bleeding occurred in 1 of 19 (5.3%) and 3 of 17 (17.6%) patients on dabigatran, respectively; in 5 of 99 (5%) and 6 of 88 (6.8%) on rivaroxaban; and in 1 of 2 (50%) at each time point for the few patients on apixaban.

With vitamin K antagonists, the case-fatality rates of major bleeding reach 14% at 90 days after bleeding leading to hospitalization and 18% within a week of discharge in atrial fibrillation patients, Dr. Beyer-Westendorf observed.

[email protected]

NEW ORLEANS – Real-world use of rivaroxaban produced comparatively low rates of cardiovascular and major bleeding events when used for stroke prevention in unselected patients with atrial fibrillation.

The centrally adjudicated annual stroke rate was 1.4% among 1,194 patients given once-daily rivaroxaban (Xarelto) by 230 physicians from private practices and community hospitals across Saxony, Germany, in the prospective Dresden Novel Oral Anticoagulant (NOAC) registry.

This result falls within the annual stroke rate of 1.7% seen in the ROCKET-AF trial, which served as the basis for rivaroxaban’s November 2011 U.S. approval in this setting, Dr. Jan Beyer-Westendorf reported at the annual meeting of the American Society of Hematology.

Nonmajor, clinically relevant bleeding occurred in 21.6% of patients per year in the NOAC registry, while major bleeding was 3.4% per year.

Patrice Wendling/Frontline Medical News

Again, this is within the range of the phase III ROCKET-AF results (3.6% per year) and lower than the rate of up to 8% seen in the daily care of patients on vitamin K antagonists, he said. Gastrointestinal bleeding, a known side effect of rivaroxaban, was the most common major bleed. Intracranial bleeds were rare at three events.

Adherence to the oral direct factor Xa inhibitor was high at 12 months (13.7%), compared with up to 25% of patients who discontinue vitamin K antagonist therapy in the first year.

"In our population, the discontinuation rate was 14%, so basically we don’t have any concern that we put these patients at more risk in a daily care situation by treating them with rivaroxaban," said Dr. Beyer-Westendorf of the University Hospital Carl Gustav Carus, Dresden, Germany.

According to the analysis, 2,345 patients have been prospectively enrolled in the NOAC registry since October 2011; 1,194 with atrial fibrillation have been treated with anticoagulation to prevent venous thromboembolism (VTE) or stroke. No patients have been lost to follow-up, which now stands at 2,313 patient-years.

NOAC patients were slightly older at baseline than were those in ROCKET-AF (74.8 years vs. 73 years), less likely to have had prior vitamin K antagonists (37% vs. 62%), and had lower CHADS2 (Cardiac failure, Hypertension, Age, Diabetes Stroke system) scores (mean, 2.4 vs. 3.48). Higher CHADS₂ scores are associated with worse outcomes, including higher rates of major bleeding.

During follow-up through October 2013, 53 NOAC patients (4.4%) experienced a major vascular event including 22 strokes, transient ischemic attacks (TIA), systemic emboli; 15 acute coronary syndromes; and four VTEs, he said. In all, 56 patients died (4.7%).

Patients on rivaroxaban 20 mg/day vs. 15 mg/day had a significantly lower annual stroke rate (0.9% vs. 2.3%; P = .052), defined as a new stroke, TIA, or systemic embolism.

Compared with those on rivaroxaban 20 mg, patients on the lower dose had higher baseline CHADS₂ scores (mean, 2.8 vs. 2.2), were older (79 years vs. 73 years), more likely to have had a prior stroke (17% vs. 12.5%) or prior vitamin K antagonist therapy (40% vs. 36%), and took more concomitant drugs (mean, 6.4 vs. 5.4).

"It’s no surprise that these patients get a dose reduction because they have more comorbidities; they are at high risk of bleeding, and so it’s not a surprise that they have a slightly higher event rate," said Dr. Beyer-Westendorf, who noted that the lower dose did not reduce the risk of bleeding.

The NOAC registry is supported by scientific grants from Bayer Healthcare, Boehringer Ingelheim, and Pfizer. Dr. Beyer-Westendorf reported research funding from and serving as a speaker for these firms.

Bleeding complications detailed

In a separate presentation at ASH, Dr. Beyer-Westendorf detailed the pattern and management of bleeding complications in NOAC patients treated for stroke prevention in atrial fibrillation or VTE with rivaroxaban, dabigatran (Pradaxa), or apixaban (Eliquis).

These complications are a major concern for practitioners because there isn’t an emergency lab test available or rescue medications.

Of the 1,241 bleeding events that have occurred so far in 879 patients, 742 were minor (60%), 425 were nonmajor clinically relevant (34.2%), and 74 were major (6%).

Major bleeds per year of therapy were reported with rivaroxaban in 3.4% of patients with atrial fibrillation and in 4.4% with VTE. The major bleeding event rate with dabigatran in patients with atrial fibrillation was 2.6/100 patient-years at the 110-mg dose and 2.0/100 patient-years at the 150-mg dose. Short-term follow-up and low numbers of dabigatran and apixaban patients did not allow for sound event-rate calculations, according to Dr. Beyer-Westendorf, who stressed that no direct comparisons should be made between event rates for the different agents since the patients were in different cohorts and not in a randomized trial.

Most bleeds (93.3%) were managed conservatively with watchful waiting, compression, tamponade, or red blood cell transfusion. None of the minor bleeds and 16% (83/499) of the nonmajor clinically relevant and major bleeds required surgical or interventional treatment, he said.

Fresh frozen plasma and prothrombin complex concentrate were rarely used (seven patients each). No patient received recombinant activated factor VII.

Mortality was 0.4% for all patients with bleeding complications and 6.8% in those with major bleeds.

Death from any cause at 30 days and 90 days post bleeding occurred in 1 of 19 (5.3%) and 3 of 17 (17.6%) patients on dabigatran, respectively; in 5 of 99 (5%) and 6 of 88 (6.8%) on rivaroxaban; and in 1 of 2 (50%) at each time point for the few patients on apixaban.

With vitamin K antagonists, the case-fatality rates of major bleeding reach 14% at 90 days after bleeding leading to hospitalization and 18% within a week of discharge in atrial fibrillation patients, Dr. Beyer-Westendorf observed.

[email protected]

NEW ORLEANS – Real-world use of rivaroxaban produced comparatively low rates of cardiovascular and major bleeding events when used for stroke prevention in unselected patients with atrial fibrillation.

The centrally adjudicated annual stroke rate was 1.4% among 1,194 patients given once-daily rivaroxaban (Xarelto) by 230 physicians from private practices and community hospitals across Saxony, Germany, in the prospective Dresden Novel Oral Anticoagulant (NOAC) registry.

This result falls within the annual stroke rate of 1.7% seen in the ROCKET-AF trial, which served as the basis for rivaroxaban’s November 2011 U.S. approval in this setting, Dr. Jan Beyer-Westendorf reported at the annual meeting of the American Society of Hematology.

Nonmajor, clinically relevant bleeding occurred in 21.6% of patients per year in the NOAC registry, while major bleeding was 3.4% per year.

Patrice Wendling/Frontline Medical News

Again, this is within the range of the phase III ROCKET-AF results (3.6% per year) and lower than the rate of up to 8% seen in the daily care of patients on vitamin K antagonists, he said. Gastrointestinal bleeding, a known side effect of rivaroxaban, was the most common major bleed. Intracranial bleeds were rare at three events.

Adherence to the oral direct factor Xa inhibitor was high at 12 months (13.7%), compared with up to 25% of patients who discontinue vitamin K antagonist therapy in the first year.

"In our population, the discontinuation rate was 14%, so basically we don’t have any concern that we put these patients at more risk in a daily care situation by treating them with rivaroxaban," said Dr. Beyer-Westendorf of the University Hospital Carl Gustav Carus, Dresden, Germany.

According to the analysis, 2,345 patients have been prospectively enrolled in the NOAC registry since October 2011; 1,194 with atrial fibrillation have been treated with anticoagulation to prevent venous thromboembolism (VTE) or stroke. No patients have been lost to follow-up, which now stands at 2,313 patient-years.

NOAC patients were slightly older at baseline than were those in ROCKET-AF (74.8 years vs. 73 years), less likely to have had prior vitamin K antagonists (37% vs. 62%), and had lower CHADS2 (Cardiac failure, Hypertension, Age, Diabetes Stroke system) scores (mean, 2.4 vs. 3.48). Higher CHADS₂ scores are associated with worse outcomes, including higher rates of major bleeding.

During follow-up through October 2013, 53 NOAC patients (4.4%) experienced a major vascular event including 22 strokes, transient ischemic attacks (TIA), systemic emboli; 15 acute coronary syndromes; and four VTEs, he said. In all, 56 patients died (4.7%).

Patients on rivaroxaban 20 mg/day vs. 15 mg/day had a significantly lower annual stroke rate (0.9% vs. 2.3%; P = .052), defined as a new stroke, TIA, or systemic embolism.

Compared with those on rivaroxaban 20 mg, patients on the lower dose had higher baseline CHADS₂ scores (mean, 2.8 vs. 2.2), were older (79 years vs. 73 years), more likely to have had a prior stroke (17% vs. 12.5%) or prior vitamin K antagonist therapy (40% vs. 36%), and took more concomitant drugs (mean, 6.4 vs. 5.4).

"It’s no surprise that these patients get a dose reduction because they have more comorbidities; they are at high risk of bleeding, and so it’s not a surprise that they have a slightly higher event rate," said Dr. Beyer-Westendorf, who noted that the lower dose did not reduce the risk of bleeding.

The NOAC registry is supported by scientific grants from Bayer Healthcare, Boehringer Ingelheim, and Pfizer. Dr. Beyer-Westendorf reported research funding from and serving as a speaker for these firms.

Bleeding complications detailed

In a separate presentation at ASH, Dr. Beyer-Westendorf detailed the pattern and management of bleeding complications in NOAC patients treated for stroke prevention in atrial fibrillation or VTE with rivaroxaban, dabigatran (Pradaxa), or apixaban (Eliquis).

These complications are a major concern for practitioners because there isn’t an emergency lab test available or rescue medications.

Of the 1,241 bleeding events that have occurred so far in 879 patients, 742 were minor (60%), 425 were nonmajor clinically relevant (34.2%), and 74 were major (6%).

Major bleeds per year of therapy were reported with rivaroxaban in 3.4% of patients with atrial fibrillation and in 4.4% with VTE. The major bleeding event rate with dabigatran in patients with atrial fibrillation was 2.6/100 patient-years at the 110-mg dose and 2.0/100 patient-years at the 150-mg dose. Short-term follow-up and low numbers of dabigatran and apixaban patients did not allow for sound event-rate calculations, according to Dr. Beyer-Westendorf, who stressed that no direct comparisons should be made between event rates for the different agents since the patients were in different cohorts and not in a randomized trial.

Most bleeds (93.3%) were managed conservatively with watchful waiting, compression, tamponade, or red blood cell transfusion. None of the minor bleeds and 16% (83/499) of the nonmajor clinically relevant and major bleeds required surgical or interventional treatment, he said.

Fresh frozen plasma and prothrombin complex concentrate were rarely used (seven patients each). No patient received recombinant activated factor VII.

Mortality was 0.4% for all patients with bleeding complications and 6.8% in those with major bleeds.

Death from any cause at 30 days and 90 days post bleeding occurred in 1 of 19 (5.3%) and 3 of 17 (17.6%) patients on dabigatran, respectively; in 5 of 99 (5%) and 6 of 88 (6.8%) on rivaroxaban; and in 1 of 2 (50%) at each time point for the few patients on apixaban.

With vitamin K antagonists, the case-fatality rates of major bleeding reach 14% at 90 days after bleeding leading to hospitalization and 18% within a week of discharge in atrial fibrillation patients, Dr. Beyer-Westendorf observed.

[email protected]

SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.

In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.

Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).

A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm² once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.

None of the patients had to interrupt ECSW therapy due to complications.

The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.

The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.

No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.

Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.

[email protected]

SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.

In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.

Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).

A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm² once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.

None of the patients had to interrupt ECSW therapy due to complications.

The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.

The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.

No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.

Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.

[email protected]

SAN ANTONIO – Extracorporeal shock wave therapy shows early promise for limiting the often-vexing problem of lymphedema arising after axillary lymphadenectomy.

In the first 10 affected patients treated in an ongoing randomized, sham-controlled clinical trial, lymphedema, as measured by median whole-arm water displacement, dropped from 4,200 mL at baseline by 192.5 mL after 10 once-weekly extracorporeal shock wave (ECSW) sessions. Patients who received sham sessions had a 12.5-mL decline from baseline measures, Dr. Sara Imboden reported at the San Antonio Breast Cancer Symposium.

Quantitative CT measures indicated the mean total cross-sectional area of the most swollen part of the arm decreased by 3% in the ECSW group, compared with 1.4% in the control group, added Dr. Imboden of the University of Bern (Switzerland).

A mean of 22 axillary lymph nodes had been removed from the breast cancer patients in the study. The ECSW therapy was performed over the length of the edematous arm at an energy density of 0.25-0.69 mJ/mm² once per week for 10 weeks. The control group followed the same treatment schedule, but the shock waves were contained inside the probe during their sessions.

None of the patients had to interrupt ECSW therapy due to complications.

The researchers plan to expand the randomized trial to include 30 patients, and to augment the results with patient reports of symptoms based on questionnaires assessing body image and with extended follow-up to evaluate functioning and recurrences.

The likely mechanism of benefit in patients with lymphedema involves ECSW-induced stimulation of angiogenesis and lymphatic vessel regeneration. These results have been demonstrated in animal studies.

No medications have been shown effective in treating lymphedema. Conventional therapy entails repeated manual lymph drainage and compression bandages.

Dr. Imboden reported having no financial conflicts of interest with regard to this university-funded study.

[email protected]

Twelve weeks of combined treatment with bupropion and varenicline was more effective than varenicline alone at helping people quit smoking, according to a report published online Jan. 7 in JAMA.

However, 38% of study participants dropped out by 12 weeks, and combined therapy showed no significant advantage over varenicline alone when smoking abstinence was measured 1 year later, said Dr. Jon O. Ebbert of the Nicotine Dependence Center, Mayo Clinic, Rochester, Minn., and his associates (JAMA 2014;311:155-63).

The findings highlight the stubborn public health challenge smoking still presents 50 years after the U.S. Surgeon General’s groundbreaking report on smoking and health debuted in January 1964.

Dr. Ebbert and his colleagues compared the efficacy of the two treatment approaches in a phase III, double-blind clinical trial involving 506 adults treated for 12 weeks at three medical centers during 2009-2013. All the study participants smoked at least 10 cigarettes per day at baseline.

The patients were randomly assigned to receive for 12 weeks either up to 300 mg bupropion SR per day plus up to 2 mg per day of varenicline (249 patients) or varenicline alone (257 patients).

They all attended 11 clinic visits at which they received brief behavioral counseling, were assessed for smoking abstinence using exhaled-air carbon monoxide measurement, and completed assessments of tobacco craving and nicotine withdrawal. The patients also received a follow-up phone call on their target quit date and two more calls during 1 year of follow-up.

The dropout rate was high, at 38%, but did not differ significantly between the two treatment groups. A total of 158 patients (63%) in the combination-therapy group and 157 patients (61%) in the varenicline-only group completed the study.

The study’s primary endpoint was the rate of smoking abstinence at week 12, confirmed by CO testing. The rate was 53% with combination therapy, significantly higher than the 43% rate with varenicline alone. Similarly, the rate of smoking abstinence at week 26 was significantly higher with combination therapy (36.6%) than with varenicline alone (27.6%).

The smoking abstinence rates were no longer significantly different between the two groups at 1 year: 30.9% with combination therapy, compared with 24.5% with varenicline alone.

Weight gain after smoking cessation was slightly lower with combination therapy (1.1 kg) than with varenicline alone (2.5 kg) at 12 weeks, but that difference disappeared by 26 weeks (3.4 kg vs 3.8 kg). At 1 year, weight gain again was lower after combination therapy (4.9 kg) than after monotherapy (6.1 kg). That finding suggests that combination therapy may be the preferred option for patients who are concerned about weight gain, especially those "for whom weight gain may undermine smoking cessation" attempts, Dr. Ebbert and his associates said.

There were no significant differences between the two study groups at any time point in symptoms of nicotine withdrawal or craving.

The only adverse events deemed to be possibly related to treatment were significant increases in the rate of anxiety (7.2%) and depressive symptoms (3.6%) among patients receiving combination therapy, compared with those receiving monotherapy (3.1% and 0.8%, respectively). However, tobacco withdrawal itself has been linked to symptoms of both anxiety and depression, the investigators noted.

"All patients being treated with pharmacotherapy for tobacco dependence should be monitored for changes in anxiety and mood," which is standard clinical practice, the researchers cautioned.

Exploratory analyses showed that treatment effects did not differ according to patient age or sex. However, combination therapy appeared to be slightly more effective than monotherapy among patients who smoked heavily (20 or more cigarettes per day) and those with higher levels of nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence.

The study is the first to show that a combination approach with varenicline could top monotherapy. "Prior to the current study, no combination therapies with varenicline have been shown to be effective for increasing smoking abstinence rates, compared with varenicline monotherapy," Dr. Ebbert noted in an interview. Other research has indicated that bupropion combined with the nicotine patch may be more beneficial than using the nicotine patch alone, he added.

Alone or in combination, drug therapy must be part of a wider approach to smoking cessation, Dr. Ebbert emphasized. "Behavioral treatment is a critical piece, and it should be a component of all treatment for tobacco use."

The study was supported in part by the National Institutes of Health. Pfizer provided the varenicline used in the study. Dr. Ebbert reported ties to GlaxoSmithKline, JHP Pharmaceuticals, Orexigen, and Pfizer. His associates reported ties to Nabi Biopharmaceuticals and Pfizer.

Twelve weeks of combined treatment with bupropion and varenicline was more effective than varenicline alone at helping people quit smoking, according to a report published online Jan. 7 in JAMA.

However, 38% of study participants dropped out by 12 weeks, and combined therapy showed no significant advantage over varenicline alone when smoking abstinence was measured 1 year later, said Dr. Jon O. Ebbert of the Nicotine Dependence Center, Mayo Clinic, Rochester, Minn., and his associates (JAMA 2014;311:155-63).

The findings highlight the stubborn public health challenge smoking still presents 50 years after the U.S. Surgeon General’s groundbreaking report on smoking and health debuted in January 1964.

Dr. Ebbert and his colleagues compared the efficacy of the two treatment approaches in a phase III, double-blind clinical trial involving 506 adults treated for 12 weeks at three medical centers during 2009-2013. All the study participants smoked at least 10 cigarettes per day at baseline.

The patients were randomly assigned to receive for 12 weeks either up to 300 mg bupropion SR per day plus up to 2 mg per day of varenicline (249 patients) or varenicline alone (257 patients).

They all attended 11 clinic visits at which they received brief behavioral counseling, were assessed for smoking abstinence using exhaled-air carbon monoxide measurement, and completed assessments of tobacco craving and nicotine withdrawal. The patients also received a follow-up phone call on their target quit date and two more calls during 1 year of follow-up.

The dropout rate was high, at 38%, but did not differ significantly between the two treatment groups. A total of 158 patients (63%) in the combination-therapy group and 157 patients (61%) in the varenicline-only group completed the study.

The study’s primary endpoint was the rate of smoking abstinence at week 12, confirmed by CO testing. The rate was 53% with combination therapy, significantly higher than the 43% rate with varenicline alone. Similarly, the rate of smoking abstinence at week 26 was significantly higher with combination therapy (36.6%) than with varenicline alone (27.6%).

The smoking abstinence rates were no longer significantly different between the two groups at 1 year: 30.9% with combination therapy, compared with 24.5% with varenicline alone.

Weight gain after smoking cessation was slightly lower with combination therapy (1.1 kg) than with varenicline alone (2.5 kg) at 12 weeks, but that difference disappeared by 26 weeks (3.4 kg vs 3.8 kg). At 1 year, weight gain again was lower after combination therapy (4.9 kg) than after monotherapy (6.1 kg). That finding suggests that combination therapy may be the preferred option for patients who are concerned about weight gain, especially those "for whom weight gain may undermine smoking cessation" attempts, Dr. Ebbert and his associates said.

There were no significant differences between the two study groups at any time point in symptoms of nicotine withdrawal or craving.

The only adverse events deemed to be possibly related to treatment were significant increases in the rate of anxiety (7.2%) and depressive symptoms (3.6%) among patients receiving combination therapy, compared with those receiving monotherapy (3.1% and 0.8%, respectively). However, tobacco withdrawal itself has been linked to symptoms of both anxiety and depression, the investigators noted.

"All patients being treated with pharmacotherapy for tobacco dependence should be monitored for changes in anxiety and mood," which is standard clinical practice, the researchers cautioned.

Exploratory analyses showed that treatment effects did not differ according to patient age or sex. However, combination therapy appeared to be slightly more effective than monotherapy among patients who smoked heavily (20 or more cigarettes per day) and those with higher levels of nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence.

The study is the first to show that a combination approach with varenicline could top monotherapy. "Prior to the current study, no combination therapies with varenicline have been shown to be effective for increasing smoking abstinence rates, compared with varenicline monotherapy," Dr. Ebbert noted in an interview. Other research has indicated that bupropion combined with the nicotine patch may be more beneficial than using the nicotine patch alone, he added.

Alone or in combination, drug therapy must be part of a wider approach to smoking cessation, Dr. Ebbert emphasized. "Behavioral treatment is a critical piece, and it should be a component of all treatment for tobacco use."

The study was supported in part by the National Institutes of Health. Pfizer provided the varenicline used in the study. Dr. Ebbert reported ties to GlaxoSmithKline, JHP Pharmaceuticals, Orexigen, and Pfizer. His associates reported ties to Nabi Biopharmaceuticals and Pfizer.

Twelve weeks of combined treatment with bupropion and varenicline was more effective than varenicline alone at helping people quit smoking, according to a report published online Jan. 7 in JAMA.

However, 38% of study participants dropped out by 12 weeks, and combined therapy showed no significant advantage over varenicline alone when smoking abstinence was measured 1 year later, said Dr. Jon O. Ebbert of the Nicotine Dependence Center, Mayo Clinic, Rochester, Minn., and his associates (JAMA 2014;311:155-63).

The findings highlight the stubborn public health challenge smoking still presents 50 years after the U.S. Surgeon General’s groundbreaking report on smoking and health debuted in January 1964.

Dr. Ebbert and his colleagues compared the efficacy of the two treatment approaches in a phase III, double-blind clinical trial involving 506 adults treated for 12 weeks at three medical centers during 2009-2013. All the study participants smoked at least 10 cigarettes per day at baseline.

The patients were randomly assigned to receive for 12 weeks either up to 300 mg bupropion SR per day plus up to 2 mg per day of varenicline (249 patients) or varenicline alone (257 patients).

They all attended 11 clinic visits at which they received brief behavioral counseling, were assessed for smoking abstinence using exhaled-air carbon monoxide measurement, and completed assessments of tobacco craving and nicotine withdrawal. The patients also received a follow-up phone call on their target quit date and two more calls during 1 year of follow-up.

The dropout rate was high, at 38%, but did not differ significantly between the two treatment groups. A total of 158 patients (63%) in the combination-therapy group and 157 patients (61%) in the varenicline-only group completed the study.

The study’s primary endpoint was the rate of smoking abstinence at week 12, confirmed by CO testing. The rate was 53% with combination therapy, significantly higher than the 43% rate with varenicline alone. Similarly, the rate of smoking abstinence at week 26 was significantly higher with combination therapy (36.6%) than with varenicline alone (27.6%).

The smoking abstinence rates were no longer significantly different between the two groups at 1 year: 30.9% with combination therapy, compared with 24.5% with varenicline alone.

Weight gain after smoking cessation was slightly lower with combination therapy (1.1 kg) than with varenicline alone (2.5 kg) at 12 weeks, but that difference disappeared by 26 weeks (3.4 kg vs 3.8 kg). At 1 year, weight gain again was lower after combination therapy (4.9 kg) than after monotherapy (6.1 kg). That finding suggests that combination therapy may be the preferred option for patients who are concerned about weight gain, especially those "for whom weight gain may undermine smoking cessation" attempts, Dr. Ebbert and his associates said.

There were no significant differences between the two study groups at any time point in symptoms of nicotine withdrawal or craving.

The only adverse events deemed to be possibly related to treatment were significant increases in the rate of anxiety (7.2%) and depressive symptoms (3.6%) among patients receiving combination therapy, compared with those receiving monotherapy (3.1% and 0.8%, respectively). However, tobacco withdrawal itself has been linked to symptoms of both anxiety and depression, the investigators noted.

"All patients being treated with pharmacotherapy for tobacco dependence should be monitored for changes in anxiety and mood," which is standard clinical practice, the researchers cautioned.

Exploratory analyses showed that treatment effects did not differ according to patient age or sex. However, combination therapy appeared to be slightly more effective than monotherapy among patients who smoked heavily (20 or more cigarettes per day) and those with higher levels of nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence.

The study is the first to show that a combination approach with varenicline could top monotherapy. "Prior to the current study, no combination therapies with varenicline have been shown to be effective for increasing smoking abstinence rates, compared with varenicline monotherapy," Dr. Ebbert noted in an interview. Other research has indicated that bupropion combined with the nicotine patch may be more beneficial than using the nicotine patch alone, he added.

Alone or in combination, drug therapy must be part of a wider approach to smoking cessation, Dr. Ebbert emphasized. "Behavioral treatment is a critical piece, and it should be a component of all treatment for tobacco use."

The study was supported in part by the National Institutes of Health. Pfizer provided the varenicline used in the study. Dr. Ebbert reported ties to GlaxoSmithKline, JHP Pharmaceuticals, Orexigen, and Pfizer. His associates reported ties to Nabi Biopharmaceuticals and Pfizer.

Most general internists are willing to care for adult survivors of childhood cancer, but many are uncomfortable doing so, according to the results of a nationally representative survey.

In fact, on average, the 1,110 survey respondents reported being "somewhat uncomfortable" caring for survivors, and being "somewhat unfamiliar" with available surveillance guidelines for long-term follow-up care of survivors, reported Dr. Eugene Suh of Loyola University Medical Center, Maywood, Ill., and his colleagues.

Only 37%, 27%, and 25% of respondents reported being "somewhat comfortable or "comfortable" caring for survivors of Hodgkin lymphoma, acute lymphoblastic leukemia, and osteosarcoma, respectively. After adjustment for a number of factors, higher levels of comfort in treating childhood cancer survivors were seen in physicians with larger patient volumes, those who had cared for at least 1 survivor during the preceding 5 years, and men.

Furthermore, only 12% of respondents reported being generally familiar with available surveillance guidelines for childhood cancer survivors, and this was borne out in responses to a clinical vignette about a young female survivor of Hodgkin lymphoma. Only 9%, 15%, and 76% of respondents recommend breast cancer surveillance, cardiac surveillance, and thyroid surveillance, respectively, in accordance with guidelines, and only 5% answered all three surveillance questions in accordance with guidelines, the investigators reported. The study was published in the Jan. 7 issue of Annals of Internal Medicine.

The findings are concerning given that more than 80% of adult childhood cancer survivors – a "growing and clinically challenging population" – receive health care from a primary care physician in their community, the researchers noted (Ann. Intern. Med. 2014;160:11-7 [doi:10.7326/M13-1941]).

Chemotherapy and radiation used to treat childhood cancer survivors are associated with significant risk for second malignant neoplasms and a number of other health concerns, including damage to vital organs, which can result in chronic illness and premature death, they added.

The survey was conducted between September 2011 and August 2012 in a random sample of 2,000 U.S. general internists; 62% responded. Questions regarding care preferences and comfort level with caring for adult childhood cancer survivors were answered using a 7-point Likert scale (with responses ranging from very uncomfortable to very comfortable, for example), and adherence to Children’s Oncology Group Long-Term Follow-Up Guidelines was assessed based on responses to clinical vignette. For the purposes of this study, a childhood cancer survivor was defined as a patient diagnosed with cancer at or before age 21 years, at least 5 years from cancer therapy completion, and cancer free.

More than half of the respondents (52%) reported caring for at least one survivor. Only 61 (5.5%) said they preferred to care for childhood cancer survivors independently, while 84% preferred to work in collaboration with a cancer center–based physician or long-term follow-up clinic, and 11% said they would refer survivors to a cancer center–based physician or clinic or to another primary care physician.

Although access to treatment summaries and surveillance guidelines were listed as particularly useful resources, 72% of those respondents said they never received a patient treatment summary.

The findings highlight a critical gap in some physicians’ knowledge of available guidelines as well as the need for improved attention to survivorship care plans (SCPs), which are a cornerstone of recommendations for long-term follow-up care of childhood cancer survivors, the investigators said.

These plans created by the oncology team provide survivors and physicians with a road map for care. Such plans include a cancer treatment summary as well as information about potential late treatment effects, guidelines for surveillance, and contact information for the oncology team.

"Concentrated efforts to improve these gaps should include enhanced education of [primary care physicians] through webinars, education sessions at national meetings, and guidelines linked to internal medicine websites. Focused efforts should also be made to improve comanagement by oncologists and [primary care physicians] throughout the cancer care trajectory," they concluded, noting that electronic medical records, web-based tools, and smartphone/tablet apps could allow for streamlining of SCP creation and dissemination.

The study was funded by the National Cancer Institute. The authors reported no relevant conflicts of interest.

Most general internists are willing to care for adult survivors of childhood cancer, but many are uncomfortable doing so, according to the results of a nationally representative survey.

In fact, on average, the 1,110 survey respondents reported being "somewhat uncomfortable" caring for survivors, and being "somewhat unfamiliar" with available surveillance guidelines for long-term follow-up care of survivors, reported Dr. Eugene Suh of Loyola University Medical Center, Maywood, Ill., and his colleagues.

Only 37%, 27%, and 25% of respondents reported being "somewhat comfortable or "comfortable" caring for survivors of Hodgkin lymphoma, acute lymphoblastic leukemia, and osteosarcoma, respectively. After adjustment for a number of factors, higher levels of comfort in treating childhood cancer survivors were seen in physicians with larger patient volumes, those who had cared for at least 1 survivor during the preceding 5 years, and men.

Furthermore, only 12% of respondents reported being generally familiar with available surveillance guidelines for childhood cancer survivors, and this was borne out in responses to a clinical vignette about a young female survivor of Hodgkin lymphoma. Only 9%, 15%, and 76% of respondents recommend breast cancer surveillance, cardiac surveillance, and thyroid surveillance, respectively, in accordance with guidelines, and only 5% answered all three surveillance questions in accordance with guidelines, the investigators reported. The study was published in the Jan. 7 issue of Annals of Internal Medicine.

The findings are concerning given that more than 80% of adult childhood cancer survivors – a "growing and clinically challenging population" – receive health care from a primary care physician in their community, the researchers noted (Ann. Intern. Med. 2014;160:11-7 [doi:10.7326/M13-1941]).

Chemotherapy and radiation used to treat childhood cancer survivors are associated with significant risk for second malignant neoplasms and a number of other health concerns, including damage to vital organs, which can result in chronic illness and premature death, they added.

The survey was conducted between September 2011 and August 2012 in a random sample of 2,000 U.S. general internists; 62% responded. Questions regarding care preferences and comfort level with caring for adult childhood cancer survivors were answered using a 7-point Likert scale (with responses ranging from very uncomfortable to very comfortable, for example), and adherence to Children’s Oncology Group Long-Term Follow-Up Guidelines was assessed based on responses to clinical vignette. For the purposes of this study, a childhood cancer survivor was defined as a patient diagnosed with cancer at or before age 21 years, at least 5 years from cancer therapy completion, and cancer free.

More than half of the respondents (52%) reported caring for at least one survivor. Only 61 (5.5%) said they preferred to care for childhood cancer survivors independently, while 84% preferred to work in collaboration with a cancer center–based physician or long-term follow-up clinic, and 11% said they would refer survivors to a cancer center–based physician or clinic or to another primary care physician.

Although access to treatment summaries and surveillance guidelines were listed as particularly useful resources, 72% of those respondents said they never received a patient treatment summary.

The findings highlight a critical gap in some physicians’ knowledge of available guidelines as well as the need for improved attention to survivorship care plans (SCPs), which are a cornerstone of recommendations for long-term follow-up care of childhood cancer survivors, the investigators said.

These plans created by the oncology team provide survivors and physicians with a road map for care. Such plans include a cancer treatment summary as well as information about potential late treatment effects, guidelines for surveillance, and contact information for the oncology team.

"Concentrated efforts to improve these gaps should include enhanced education of [primary care physicians] through webinars, education sessions at national meetings, and guidelines linked to internal medicine websites. Focused efforts should also be made to improve comanagement by oncologists and [primary care physicians] throughout the cancer care trajectory," they concluded, noting that electronic medical records, web-based tools, and smartphone/tablet apps could allow for streamlining of SCP creation and dissemination.

The study was funded by the National Cancer Institute. The authors reported no relevant conflicts of interest.

Most general internists are willing to care for adult survivors of childhood cancer, but many are uncomfortable doing so, according to the results of a nationally representative survey.

In fact, on average, the 1,110 survey respondents reported being "somewhat uncomfortable" caring for survivors, and being "somewhat unfamiliar" with available surveillance guidelines for long-term follow-up care of survivors, reported Dr. Eugene Suh of Loyola University Medical Center, Maywood, Ill., and his colleagues.

Only 37%, 27%, and 25% of respondents reported being "somewhat comfortable or "comfortable" caring for survivors of Hodgkin lymphoma, acute lymphoblastic leukemia, and osteosarcoma, respectively. After adjustment for a number of factors, higher levels of comfort in treating childhood cancer survivors were seen in physicians with larger patient volumes, those who had cared for at least 1 survivor during the preceding 5 years, and men.

Furthermore, only 12% of respondents reported being generally familiar with available surveillance guidelines for childhood cancer survivors, and this was borne out in responses to a clinical vignette about a young female survivor of Hodgkin lymphoma. Only 9%, 15%, and 76% of respondents recommend breast cancer surveillance, cardiac surveillance, and thyroid surveillance, respectively, in accordance with guidelines, and only 5% answered all three surveillance questions in accordance with guidelines, the investigators reported. The study was published in the Jan. 7 issue of Annals of Internal Medicine.

The findings are concerning given that more than 80% of adult childhood cancer survivors – a "growing and clinically challenging population" – receive health care from a primary care physician in their community, the researchers noted (Ann. Intern. Med. 2014;160:11-7 [doi:10.7326/M13-1941]).

Chemotherapy and radiation used to treat childhood cancer survivors are associated with significant risk for second malignant neoplasms and a number of other health concerns, including damage to vital organs, which can result in chronic illness and premature death, they added.

The survey was conducted between September 2011 and August 2012 in a random sample of 2,000 U.S. general internists; 62% responded. Questions regarding care preferences and comfort level with caring for adult childhood cancer survivors were answered using a 7-point Likert scale (with responses ranging from very uncomfortable to very comfortable, for example), and adherence to Children’s Oncology Group Long-Term Follow-Up Guidelines was assessed based on responses to clinical vignette. For the purposes of this study, a childhood cancer survivor was defined as a patient diagnosed with cancer at or before age 21 years, at least 5 years from cancer therapy completion, and cancer free.

More than half of the respondents (52%) reported caring for at least one survivor. Only 61 (5.5%) said they preferred to care for childhood cancer survivors independently, while 84% preferred to work in collaboration with a cancer center–based physician or long-term follow-up clinic, and 11% said they would refer survivors to a cancer center–based physician or clinic or to another primary care physician.

Although access to treatment summaries and surveillance guidelines were listed as particularly useful resources, 72% of those respondents said they never received a patient treatment summary.

The findings highlight a critical gap in some physicians’ knowledge of available guidelines as well as the need for improved attention to survivorship care plans (SCPs), which are a cornerstone of recommendations for long-term follow-up care of childhood cancer survivors, the investigators said.

These plans created by the oncology team provide survivors and physicians with a road map for care. Such plans include a cancer treatment summary as well as information about potential late treatment effects, guidelines for surveillance, and contact information for the oncology team.

"Concentrated efforts to improve these gaps should include enhanced education of [primary care physicians] through webinars, education sessions at national meetings, and guidelines linked to internal medicine websites. Focused efforts should also be made to improve comanagement by oncologists and [primary care physicians] throughout the cancer care trajectory," they concluded, noting that electronic medical records, web-based tools, and smartphone/tablet apps could allow for streamlining of SCP creation and dissemination.

The study was funded by the National Cancer Institute. The authors reported no relevant conflicts of interest.