Clinical Topics & News

Almost half the people who were hospitalized with COVID-19 last spring had been fully vaccinated and received a third dose or booster shot, the Centers for Disease Control and Prevention says.

Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.

The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.

“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”

Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.

The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.

A version of this article first appeared on WebMD.com.

Almost half the people who were hospitalized with COVID-19 last spring had been fully vaccinated and received a third dose or booster shot, the Centers for Disease Control and Prevention says.

Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.

The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.

“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”

Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.

The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.

A version of this article first appeared on WebMD.com.

Almost half the people who were hospitalized with COVID-19 last spring had been fully vaccinated and received a third dose or booster shot, the Centers for Disease Control and Prevention says.

Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.

The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.

“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”

Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.

The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.

A version of this article first appeared on WebMD.com.

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

A version of this article first appeared on Medscape.com.

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

A version of this article first appeared on Medscape.com.

New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.

However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.

“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.

“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.

The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.

The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.

The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.

The median follow-up for both age groups was roughly 7 years.

“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.

When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.

AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).

The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.

The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.

Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.

The authors have no conflicts of interest to report.

A version of this article first appeared on Medscape.com.

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

A version of this article first appeared on Medscape.com.

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

A version of this article first appeared on Medscape.com.

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

A version of this article first appeared on Medscape.com.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Background

Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) are high-risk patients with complex medication regimens, including anti-rejection medications, infection prophylaxis, other post-transplant complication prophylaxis in addition to their chronic medications for co-morbid conditions. At the VA Tennessee Valley Healthcare System (TVHS), there are 3 stages of care once a patient receives an allogeneic transplant: inpatient transplant (through engraftment), outpatient posttransplant (through day +100), and long-term care (LTC) transplant (post-departure from the transplant facility). Currently, TVHS has 2 Clinical Pharmacist Practitioners (CPP) involved in the inpatient and outpatient settings. The purpose of this quality improvement initiative was to evaluate the impact of pharmacist services on continuity of care for longterm HSCT patients, vaccine completion rates, and immunosuppression/chemotherapy monitoring.

Methods

Patients were identified for enrollment based on a referral from a CPP, nurse practitioner (NP), or physician (MD). Patients with a history of allogeneic transplant were automatically referred from the CPP at departure and scheduled for a 2-week and 6-week post-departure visit. During these visits, the pharmacist conducted a medication reconciliation, assessed for medication errors or lapses in therapy, and provided medication counseling deemed necessary by clinical judgement. In addition to these 2 medication reconciliation visits, patients were also automatically scheduled for a vaccine assessment 6-months post-transplant. Pharmacy interventions from these visits were recorded in pre-specified categories. In addition to these predetermined visits, patients with complex medication regimens or undergoing significant changes could also be referred by either the NP or MD.

Results

A total of 18 patients were enrolled in the CPP clinic from October 2021 through May 2022. During this period, 42 visits were completed as each patient was seen multiple times (mean number of visits 1.8). A total of 16 medication errors/lapses were identified and addressed. The most common types of interventions included medication reconciliation (42), adherence counseling (39), general medication interventions (26), and vaccine interventions (20).

Conclusions

This pharmacist-driven telemedicine service incorporated into the long-term care HSCT clinic demonstrated benefit in identifying and addressing medication errors/lapses. Further study including the impact on patient outcomes such as hospital readmissions post-transplant, could strengthen the importance of pharmacy involvement in this setting.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Introduction

Febrile neutropenia (FN) is one of the most concerning complications associated with chemotherapy treatment, often leading to hospitalizations and delays in chemotherapy. The NCCN Guideline recommends primary prophylaxis with G-CSFs for patients receiving chemotherapy regimens that have an intermediate risk for FN if the patients have risk factors. A common intermediate risk for FN regimen is CHOP plus an anti-CD20 monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL). At VASDHCS, an evaluation of the appropriate use of prophylactic GCSFs in this risk group would allow better optimization of patient care.

Objective

To evaluate the incidence of FN in correlation with the appropriate use of G-CSFs in patients who received CHOP plus an anti-CD20 mAb for the treatment of NHL

Methods

This is a retrospective study at VA San Diego of adult veterans with a confirmed diagnosis of NHL who received the first cycle of CHOP plus an anti- CD20 mAb between January 1, 2006, to October 1, 2021. Patients were categorized based on whether they received prophylactic G-CSF during the first cycle. The primary outcome measured was the incidence of FN in veterans with risk factor(s) who received CHOP plus an anti-CD20 mAb. The secondary outcome was the percentage of patients with risk factors who received G-CSF regardless of FN incidence. Primary outcome was analyzed using 2-tailed Fisher exact test.

Results

57 patients were included in the final analysis. In patients with at least one risk factor for FN, 26 (60%) received prophylactic G-CSF and 17 (40%) did not. There is 1 case of FN in the group that received G-CSF and 2 cases of FN in the group without G-CSF (RR, 0.33; P = .55; 95% CI, 0.03-3.33).

Conculsions

In patients receiving treatment for NHL with CHOP plus an anti-CD20 mAb, most of the patients with at least 1 risk factor for FN were initiated on G-CSF. Based on the results of the study, our veteran population does not appear to have an increased risk for FN without G-CSF. A larger study is warranted to further evaluate the significance of FN in correlation with prophylactic G-CSF.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Purpose

Ensuring that patients/families are engaged as partners in their health care is an effective way to measure the quality of patient care. Self-reported patient data, such as symptom burden, provides an accurate and effective way to measure patient-reported outcomes. Our team reviewed 20 patient charts, randomly, to assess for documentation of at least 3 or more domains of toxicities of immune checkpoint inhibitors. The baseline comprehensive documentation rate was 50%. Our goal is to improve the documentation rate to 80% for our first process improvement cycle.

Aim Statement

Increase documentation of 3 or more toxicities immune checkpoint inhibitors to a goal rate of 80%.

Methods

A free online patient monitoring checklist tool was printed and provided to patients receiving immune checkpoint inhibitors (on their infusion day) during the check-in process. The patients were instructed to complete the tool prior to the provider clinic visit, while in the waiting area. The completed tool was given to the provider on the day of their visit. Prior to the start of this Plan-Do-Study-Act (PDSA) cycle, all providers were “reminded”/ instructed to ensure documentation of 3 or more toxicities immune checkpoint inhibitors. The cycle lasted for 3 weeks. At the end of the 3 weeks, our team reviewed the charts of those patients.

Results

Documentation rate of 3 or more toxicities increased from 50% to 90%.

Conclusions

When completed patient monitoring tools were provided to the providers during the clinic visit, the providers increased their documentation rate of the toxicities. There is literature supporting improving patient satisfaction using self-reported symptoms monitoring tools. Also, given the burden of documentation and shorter visit times, providers found this to be an easy way to address patient symptoms. While electronic patient-reported outcome (e-PRO) tools are ideal for ongoing symptom monitoring, this is a simple way to address the same in low-resourced communities. For our next cycle, we plan on using patient feedback to improve the documentation form incorporating larger fonts for patients with low vision.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.

Background/Purpose

Tumor lysis syndrome (TLS) is caused by the release of intracellular products into the blood following rapid lysis of malignant cells resulting in hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia. Complications of TLS include acute renal failure, cardiac arrhythmias, seizure, and sudden death. Allopurinol is commonly initiated as prophylaxis for patients at risk for TLS to prevent buildup of uric acid and decrease the incidence of obstructive uropathy caused by uric acid precipitation. Allopurinol takes several days to reduce uric acid levels, therefore it is recommended to initiate allopurinol 1 to 2 days prior to the start of chemotherapy and continue until the risk of TLS has ceased, usually within 7 days of chemotherapy initiation. Unnecessarily continuing allopurinol beyond 10 days increases the risk of adverse events, including allergic skin rashes and myelosuppression. A report of allopurinol orders for TLS from March 1, 2020, to March 31, 2021 was generated. Of these orders, there were 44 unique patients and 56 total allopurinol courses. The median duration of allopurinol for TLS was 39 days, with a duration of allopurinol of 10 days or less in 10 (18.2%) cases.

Methods

On September 16, 2021, inpatient prescribing of new allopurinol orders was restricted to an inpatient order menu with quick orders designating an indication of gout or TLS in the comment section. The TLS quick order was defaulted to a dose of 300 mg for 10 days. Education was also provided to the medical staff. Descriptive statistics were used.

Results

Since implementation of the allopurinol order menu, 17 patients with cancer have initiated allopurinol for TLS. The menu was used in 14 (82.4%) patients. The median duration of allopurinol was 8 days and 11 (64.7%) allopurinol courses were 10 days or less. The main reasons for not using the allopurinol menu were due to dose reduction of allopurinol due to renal dysfunction or the primary hematologist/oncologist ordering outpatient allopurinol prior to admission for chemotherapy.

Implications

The introduction of an inpatient allopurinol order menu has decreased excessive allopurinol therapy when utilized for TLS. This has resulted in decreased pill burden, adverse events, and cost.