AVAHO

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Individuals with type A blood have a 16% higher risk for early onset stroke (EOS) than those with other blood types, new research shows.

Conversely, results from a meta-analysis of nearly 17,000 cases of ischemic stroke in adults younger than 60 years showed that having type O blood reduced the risk for EOS by 12%.

In addition, the associations with risk were significantly stronger in EOS than in those with late-onset stroke (LOS), pointing to a stronger role for prothrombotic factors in younger patients, the researchers noted.

“What this is telling us is that maybe what makes you susceptible to stroke as a young adult is the blood type, which is really giving you a much higher risk of clotting and stroke compared to later onset,” coinvestigator Braxton Mitchell, PhD, professor of medicine and epidemiology and public health at the University of Maryland, Baltimore, said in an interview.

The findings were published online in Neurology.
 

Strong association

The genome-wide association study (GWAS) was done as part of the Genetics of Early Onset Ischemic Stroke Consortium, a collaboration of 48 different studies across North America, Europe, Japan, Pakistan, and Australia. It assessed early onset ischemic stroke in patients aged 18-59 years.

Researchers included data from 16,927 patients with stroke. Of these, 5,825 had a stroke before age 60, defined as early onset. GWAS results were also examined for nearly 600,000 individuals without stroke.

Results showed two genetic variants tied to blood types A and O emerged as highly associated with risk for early stroke.

Researchers found that the protective effects of type O were significantly stronger with EOS vs. LOS (odds ratio [OR], 0.88 vs. 0.96, respectively; P = .001). Likewise, the association between type A and increased EOS risk was significantly stronger than that found in LOS (OR, 1.16 vs. 1.05; P = .005).

Using polygenic risk scores, the investigators also found that the greater genetic risk for venous thromboembolism, another prothrombotic condition, was more strongly associated with EOS compared with LOS (P = .008).

Previous studies have shown a link between stroke risk and variants of the ABO gene, which determines blood type. The new analysis suggests that type A and O gene variants represent nearly all of those genetically linked with early stroke, the researchers noted.

While the findings point to blood type as a risk factor for stroke in younger people, Dr. Mitchell cautions that “at the moment, blood group does not have implications for preventive care.”

“The risk of stroke due to blood type is smaller than other risk factors that we know about, like smoking and hypertension,” he said. “I would be much more worried about these other risk factors, especially because those may be modifiable.”

He noted the next step in the study is to assess how blood type interacts with other known risk factors to raise stroke risk.

“There may be a subset of people where, if you have blood type A and you have some of these other risk factors, it’s possible that you may be at particularly high risk,” Dr. Mitchell said.
 

More research needed on younger patients

In an accompanying editorial, Jennifer Juhl Majersik, MD, associate professor of neurology at the University of Utah, Salt Lake City, and Paul Lacaze, PhD, associate professor and head of the public health genomics program at Monash University, Australia, noted that the study fills a gap in stroke research, which often focuses mostly on older individuals.

“In approximately 40% of people with EOS, the stroke is cryptogenic, and there is scant data from clinical trials to guide the selection of preventative strategies in this population, as people with EOS are often excluded from trials,” Dr. Majersik and Dr. Lacaze wrote.

“This work has deepened our understanding of EOS pathophysiology,” they added.

The editorialists noted that future research can build on the results from this analysis, “with the goal of a more precise understanding of stroke pathophysiology, leading to targeted preventative treatments for EOS and a reduction in disability in patients’ most productive years.”

Dr. Mitchell echoed the call for greater inclusion of young patients with stroke in clinical trials.

“As we’re learning, stroke in older folks isn’t the same as stroke in younger people,” he said. “There are many shared risk factors but there are also some that are different ... so there really is a need to include younger people.”

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

Individuals with type A blood have a 16% higher risk for early onset stroke (EOS) than those with other blood types, new research shows.

Conversely, results from a meta-analysis of nearly 17,000 cases of ischemic stroke in adults younger than 60 years showed that having type O blood reduced the risk for EOS by 12%.

In addition, the associations with risk were significantly stronger in EOS than in those with late-onset stroke (LOS), pointing to a stronger role for prothrombotic factors in younger patients, the researchers noted.

“What this is telling us is that maybe what makes you susceptible to stroke as a young adult is the blood type, which is really giving you a much higher risk of clotting and stroke compared to later onset,” coinvestigator Braxton Mitchell, PhD, professor of medicine and epidemiology and public health at the University of Maryland, Baltimore, said in an interview.

The findings were published online in Neurology.
 

Strong association

The genome-wide association study (GWAS) was done as part of the Genetics of Early Onset Ischemic Stroke Consortium, a collaboration of 48 different studies across North America, Europe, Japan, Pakistan, and Australia. It assessed early onset ischemic stroke in patients aged 18-59 years.

Researchers included data from 16,927 patients with stroke. Of these, 5,825 had a stroke before age 60, defined as early onset. GWAS results were also examined for nearly 600,000 individuals without stroke.

Results showed two genetic variants tied to blood types A and O emerged as highly associated with risk for early stroke.

Researchers found that the protective effects of type O were significantly stronger with EOS vs. LOS (odds ratio [OR], 0.88 vs. 0.96, respectively; P = .001). Likewise, the association between type A and increased EOS risk was significantly stronger than that found in LOS (OR, 1.16 vs. 1.05; P = .005).

Using polygenic risk scores, the investigators also found that the greater genetic risk for venous thromboembolism, another prothrombotic condition, was more strongly associated with EOS compared with LOS (P = .008).

Previous studies have shown a link between stroke risk and variants of the ABO gene, which determines blood type. The new analysis suggests that type A and O gene variants represent nearly all of those genetically linked with early stroke, the researchers noted.

While the findings point to blood type as a risk factor for stroke in younger people, Dr. Mitchell cautions that “at the moment, blood group does not have implications for preventive care.”

“The risk of stroke due to blood type is smaller than other risk factors that we know about, like smoking and hypertension,” he said. “I would be much more worried about these other risk factors, especially because those may be modifiable.”

He noted the next step in the study is to assess how blood type interacts with other known risk factors to raise stroke risk.

“There may be a subset of people where, if you have blood type A and you have some of these other risk factors, it’s possible that you may be at particularly high risk,” Dr. Mitchell said.
 

More research needed on younger patients

In an accompanying editorial, Jennifer Juhl Majersik, MD, associate professor of neurology at the University of Utah, Salt Lake City, and Paul Lacaze, PhD, associate professor and head of the public health genomics program at Monash University, Australia, noted that the study fills a gap in stroke research, which often focuses mostly on older individuals.

“In approximately 40% of people with EOS, the stroke is cryptogenic, and there is scant data from clinical trials to guide the selection of preventative strategies in this population, as people with EOS are often excluded from trials,” Dr. Majersik and Dr. Lacaze wrote.

“This work has deepened our understanding of EOS pathophysiology,” they added.

The editorialists noted that future research can build on the results from this analysis, “with the goal of a more precise understanding of stroke pathophysiology, leading to targeted preventative treatments for EOS and a reduction in disability in patients’ most productive years.”

Dr. Mitchell echoed the call for greater inclusion of young patients with stroke in clinical trials.

“As we’re learning, stroke in older folks isn’t the same as stroke in younger people,” he said. “There are many shared risk factors but there are also some that are different ... so there really is a need to include younger people.”

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

Individuals with type A blood have a 16% higher risk for early onset stroke (EOS) than those with other blood types, new research shows.

Conversely, results from a meta-analysis of nearly 17,000 cases of ischemic stroke in adults younger than 60 years showed that having type O blood reduced the risk for EOS by 12%.

In addition, the associations with risk were significantly stronger in EOS than in those with late-onset stroke (LOS), pointing to a stronger role for prothrombotic factors in younger patients, the researchers noted.

“What this is telling us is that maybe what makes you susceptible to stroke as a young adult is the blood type, which is really giving you a much higher risk of clotting and stroke compared to later onset,” coinvestigator Braxton Mitchell, PhD, professor of medicine and epidemiology and public health at the University of Maryland, Baltimore, said in an interview.

The findings were published online in Neurology.
 

Strong association

The genome-wide association study (GWAS) was done as part of the Genetics of Early Onset Ischemic Stroke Consortium, a collaboration of 48 different studies across North America, Europe, Japan, Pakistan, and Australia. It assessed early onset ischemic stroke in patients aged 18-59 years.

Researchers included data from 16,927 patients with stroke. Of these, 5,825 had a stroke before age 60, defined as early onset. GWAS results were also examined for nearly 600,000 individuals without stroke.

Results showed two genetic variants tied to blood types A and O emerged as highly associated with risk for early stroke.

Researchers found that the protective effects of type O were significantly stronger with EOS vs. LOS (odds ratio [OR], 0.88 vs. 0.96, respectively; P = .001). Likewise, the association between type A and increased EOS risk was significantly stronger than that found in LOS (OR, 1.16 vs. 1.05; P = .005).

Using polygenic risk scores, the investigators also found that the greater genetic risk for venous thromboembolism, another prothrombotic condition, was more strongly associated with EOS compared with LOS (P = .008).

Previous studies have shown a link between stroke risk and variants of the ABO gene, which determines blood type. The new analysis suggests that type A and O gene variants represent nearly all of those genetically linked with early stroke, the researchers noted.

While the findings point to blood type as a risk factor for stroke in younger people, Dr. Mitchell cautions that “at the moment, blood group does not have implications for preventive care.”

“The risk of stroke due to blood type is smaller than other risk factors that we know about, like smoking and hypertension,” he said. “I would be much more worried about these other risk factors, especially because those may be modifiable.”

He noted the next step in the study is to assess how blood type interacts with other known risk factors to raise stroke risk.

“There may be a subset of people where, if you have blood type A and you have some of these other risk factors, it’s possible that you may be at particularly high risk,” Dr. Mitchell said.
 

More research needed on younger patients

In an accompanying editorial, Jennifer Juhl Majersik, MD, associate professor of neurology at the University of Utah, Salt Lake City, and Paul Lacaze, PhD, associate professor and head of the public health genomics program at Monash University, Australia, noted that the study fills a gap in stroke research, which often focuses mostly on older individuals.

“In approximately 40% of people with EOS, the stroke is cryptogenic, and there is scant data from clinical trials to guide the selection of preventative strategies in this population, as people with EOS are often excluded from trials,” Dr. Majersik and Dr. Lacaze wrote.

“This work has deepened our understanding of EOS pathophysiology,” they added.

The editorialists noted that future research can build on the results from this analysis, “with the goal of a more precise understanding of stroke pathophysiology, leading to targeted preventative treatments for EOS and a reduction in disability in patients’ most productive years.”

Dr. Mitchell echoed the call for greater inclusion of young patients with stroke in clinical trials.

“As we’re learning, stroke in older folks isn’t the same as stroke in younger people,” he said. “There are many shared risk factors but there are also some that are different ... so there really is a need to include younger people.”

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

BARCELONA – Cardiovascular disease risk factors, as well as established disease, in patients undergoing cancer therapy can be safely managed to minimize cancer therapy–related cardiovascular toxicity (CVR-CVT), conclude the first cardio-oncology guidelines from the European Society of Cardiology.

The guidelines were presented at the annual congress of the European Society of Cardiology and published simultaneously in the European Heart Journal.

Guideline cochair Alexander R. Lyon, MD, PhD, told this news organization that the aim of the guideline was to “personalize the decision-making of a patient with cancer who has cardiovascular disease or is at risk of developing it from their treatment ... because it’s not one size fits all.”

A “very strong theme throughout the guideline is risk assessment, and the fact that that risk is dynamic, it can change ... because how you manage someone who’s at high risk is going to be different” than managing someone who is at moderate or low risk, he said.

“We’re doing a lot of surveillance because one of the big advantages of cardio-oncology is we know when someone is about to get treated,” Dr. Lyon, from the National Heart and Lung Institute, Imperial College London, and Cardio-Oncology Service, Royal Brompton Hospital, London, said.

“You don’t know in nature when someone’s going to have an acute myocardial infarction or acute viral myocarditis, but we do know when they’re coming into an oncology clinic to get an infusion of chemotherapy or tablets,” he noted.

The guidelines offer recommendations so that patients can “have their treatment safely and minimize interruptions.”

“We know these cancer therapies work; we’re here to get the best of both worlds” by minimizing cardiotoxicity, Dr. Lyon said.
 

Steady decline in cancer-related mortality

The guidelines note that since the 1990s there has been a “steady decline in cancer-related mortality, mirrored by a steady increase in cancer survival,” and the result is that “treatment-related side effects have gained more significance.”

Dr. Lyon said that between 2011 and 2021, there was a fivefold increase in the number of new referrals of cancer patients with cardiological consequences to his institution.

He said that one of main drivers is modifiable factors, such as smoking, obesity, and inactivity, which increase the risk for both cancer and cardiovascular disease.

“Allied to that, there’s been an improvement in treating cardiovascular diseases in people in their 40s, 50s, and 60s, so they’re surviving their heart failure, myocardial infarction, atrial fibrillation to develop cancers in later life.”

Combined with the aging population, the result is that “not only are many more people being diagnosed with cancer, because they’re living longer, but they have all these pre-existing heart risk factors, whether as confirmed disease or just the risk factors associated with that,” he said.

Another aspect is that many of the newer, targeted cancer therapies confer a cardiovascular risk.

Dr. Lyon said that the “most famous one” is trastuzumab, a monoclonal antibody that is used to treat HER2-positive breast cancer but that also causes left ventricular impairment “in about 15%-20% of the women taking it and can cause severe heart failure if it is missed.”

That, he continued, was the “forerunner of designer, targeted therapies,” and the subsequent “explosion” in the availability of modern cancer therapies has included many that confer cardiac issues.

The final reason for the greater interest in cardio-oncology, Dr. Lyon added, is the increasing awareness in oncology and hematology teams of the potential for cardiac problems among their patients.

“We have been reaching out to our oncology and hematology colleagues over the last 5-10 years to explain we’re here to help. We’re not here to stop their treatments, we’re here to support them.”

Presenting the guidelines, cochair Teresa López-Fernández, MD, cardiology department, La Paz University Hospital, IdiPAZ Research Institute, Madrid, said that the “spectrum of CVR-CVT presentations” includes arterial hypertension, cardiac arrhythmias, coronary artery disease, heart failure, and myocarditis.

She explained that cytotoxic cancer therapies are associated with an increased risk for cardiac toxicity that is most acute during the treatment phase but is not entirely diminished once it is over, then typically accumulates during long-term follow-up.

Crucially, the impact of cancer therapy on cardiovascular risk is dependent on several factors, such as patient age, cancer history, pre-existing cardiovascular risk factors or cardiovascular disease, and previous cardiotoxic cancer therapy.

There are nevertheless a number of potential strategies to reduce the risk for cardiac toxicity, including primary and secondary prevention prior to the start of cancer therapy and early CVR-CVT management during treatment, as well as cardiovascular risk assessment in the first year after treatment completion and cancer-survivorship programs.

To those ends, Dr. López-Fernández said the guidelines incorporate 272 new recommendations that cover the entire cardio-oncology care pathway, beginning with cardiovascular risk stratification before anticancer therapy.

They offer a risk-assessment checklist and make a series of recommendations for patients to be treated with potentially cardiotoxic drugs, such as anthracyclines, as well as recommendations on cardiac imaging.

The guidelines provide a range of recommendations for primary and secondary cancer therapy–related cardiovascular toxicity prevention, including minimization of the use of cardiotoxic drugs and the use of angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, beta blockers, and statins for primary prevention.

They establish CVR-CVT monitoring protocols across the gamut of cancer therapies, from HER-targeted therapies, through immune checkpoint inhibitors, Bruton tyrosine kinase, CDK4/6, EGFR, VEGF, and ALK inhibitors, and androgen-deprivation and endocrine therapies, to the more novel CAR-T-cell therapies.

A section on radiotherapy-induced cardiovascular toxicity has its own protocol for the establishment of an individual’s mean heart dose of radiation or the amount of radiation exposure to the heart during treatment.

Next, Dr. Lyon looked at recommendations for the management of cardiovascular disease and cancer therapy–related cardiovascular toxicity in patients receiving anticancer treatment.

He underlined that treatment decisions should consider the cancer and cardiovascular symptom burden, the cancer prognosis, the requirements for cancer treatment, including alternative options, drug-drug interactions, and patient preferences.

Dr. Lyon highlighted the algorithms designed to aid the management of cardiac dysfunction related to anthracycline chemotherapy, HER2-targeted therapy, and immune checkpoint inhibitors, as well as QTc-prolonging anticancer drugs.

In the first 12 months after the completions of therapy, there are a number of risk factors for future cardiovascular disease, he continued.

These include high and very high baseline cardiovascular toxicity risk, anticancer treatments known to have a high risk for long-term cardiovascular complications, such as doxorubicin and radiotherapy, and moderate or severe CTR-CVT during anticancer treatment.

Over the long term, the guidelines recommend that surveillance in asymptomatic cancer survivors range from an annual cardiovascular risk assessment in low-risk patients to patient education and cardiovascular risk factor optimization, alongside regular transthoracic echocardiography in high-risk groups.

Finally, Dr. Lyon said the guidelines turn their attention to special populations, such as patients with cardiac masses and tumors, those with carcinoid heart disease, pregnant women receiving cancer therapy, as well as those with cardiac implantable electronic devices undergoing radiotherapy.

The guidelines were developed by the task force on cardio-oncology of the ESC, in collaboration with the European Hematology Association, the European Society for Therapeutic Radiology and Oncology, and the International Cardio-Oncology Society. Dr. Lyon declares relationships with Akcea, Takeda Pharmaceuticals, Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, Ferring Pharmaceuticals, Heartfelt Technologies, Brainstorm, and Myocardial Solutions. Dr. López-Fernández declares relationships with Daiichi Sankyo, Almirall Spain, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.

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

BARCELONA – Cardiovascular disease risk factors, as well as established disease, in patients undergoing cancer therapy can be safely managed to minimize cancer therapy–related cardiovascular toxicity (CVR-CVT), conclude the first cardio-oncology guidelines from the European Society of Cardiology.

The guidelines were presented at the annual congress of the European Society of Cardiology and published simultaneously in the European Heart Journal.

Guideline cochair Alexander R. Lyon, MD, PhD, told this news organization that the aim of the guideline was to “personalize the decision-making of a patient with cancer who has cardiovascular disease or is at risk of developing it from their treatment ... because it’s not one size fits all.”

A “very strong theme throughout the guideline is risk assessment, and the fact that that risk is dynamic, it can change ... because how you manage someone who’s at high risk is going to be different” than managing someone who is at moderate or low risk, he said.

“We’re doing a lot of surveillance because one of the big advantages of cardio-oncology is we know when someone is about to get treated,” Dr. Lyon, from the National Heart and Lung Institute, Imperial College London, and Cardio-Oncology Service, Royal Brompton Hospital, London, said.

“You don’t know in nature when someone’s going to have an acute myocardial infarction or acute viral myocarditis, but we do know when they’re coming into an oncology clinic to get an infusion of chemotherapy or tablets,” he noted.

The guidelines offer recommendations so that patients can “have their treatment safely and minimize interruptions.”

“We know these cancer therapies work; we’re here to get the best of both worlds” by minimizing cardiotoxicity, Dr. Lyon said.
 

Steady decline in cancer-related mortality

The guidelines note that since the 1990s there has been a “steady decline in cancer-related mortality, mirrored by a steady increase in cancer survival,” and the result is that “treatment-related side effects have gained more significance.”

Dr. Lyon said that between 2011 and 2021, there was a fivefold increase in the number of new referrals of cancer patients with cardiological consequences to his institution.

He said that one of main drivers is modifiable factors, such as smoking, obesity, and inactivity, which increase the risk for both cancer and cardiovascular disease.

“Allied to that, there’s been an improvement in treating cardiovascular diseases in people in their 40s, 50s, and 60s, so they’re surviving their heart failure, myocardial infarction, atrial fibrillation to develop cancers in later life.”

Combined with the aging population, the result is that “not only are many more people being diagnosed with cancer, because they’re living longer, but they have all these pre-existing heart risk factors, whether as confirmed disease or just the risk factors associated with that,” he said.

Another aspect is that many of the newer, targeted cancer therapies confer a cardiovascular risk.

Dr. Lyon said that the “most famous one” is trastuzumab, a monoclonal antibody that is used to treat HER2-positive breast cancer but that also causes left ventricular impairment “in about 15%-20% of the women taking it and can cause severe heart failure if it is missed.”

That, he continued, was the “forerunner of designer, targeted therapies,” and the subsequent “explosion” in the availability of modern cancer therapies has included many that confer cardiac issues.

The final reason for the greater interest in cardio-oncology, Dr. Lyon added, is the increasing awareness in oncology and hematology teams of the potential for cardiac problems among their patients.

“We have been reaching out to our oncology and hematology colleagues over the last 5-10 years to explain we’re here to help. We’re not here to stop their treatments, we’re here to support them.”

Presenting the guidelines, cochair Teresa López-Fernández, MD, cardiology department, La Paz University Hospital, IdiPAZ Research Institute, Madrid, said that the “spectrum of CVR-CVT presentations” includes arterial hypertension, cardiac arrhythmias, coronary artery disease, heart failure, and myocarditis.

She explained that cytotoxic cancer therapies are associated with an increased risk for cardiac toxicity that is most acute during the treatment phase but is not entirely diminished once it is over, then typically accumulates during long-term follow-up.

Crucially, the impact of cancer therapy on cardiovascular risk is dependent on several factors, such as patient age, cancer history, pre-existing cardiovascular risk factors or cardiovascular disease, and previous cardiotoxic cancer therapy.

There are nevertheless a number of potential strategies to reduce the risk for cardiac toxicity, including primary and secondary prevention prior to the start of cancer therapy and early CVR-CVT management during treatment, as well as cardiovascular risk assessment in the first year after treatment completion and cancer-survivorship programs.

To those ends, Dr. López-Fernández said the guidelines incorporate 272 new recommendations that cover the entire cardio-oncology care pathway, beginning with cardiovascular risk stratification before anticancer therapy.

They offer a risk-assessment checklist and make a series of recommendations for patients to be treated with potentially cardiotoxic drugs, such as anthracyclines, as well as recommendations on cardiac imaging.

The guidelines provide a range of recommendations for primary and secondary cancer therapy–related cardiovascular toxicity prevention, including minimization of the use of cardiotoxic drugs and the use of angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, beta blockers, and statins for primary prevention.

They establish CVR-CVT monitoring protocols across the gamut of cancer therapies, from HER-targeted therapies, through immune checkpoint inhibitors, Bruton tyrosine kinase, CDK4/6, EGFR, VEGF, and ALK inhibitors, and androgen-deprivation and endocrine therapies, to the more novel CAR-T-cell therapies.

A section on radiotherapy-induced cardiovascular toxicity has its own protocol for the establishment of an individual’s mean heart dose of radiation or the amount of radiation exposure to the heart during treatment.

Next, Dr. Lyon looked at recommendations for the management of cardiovascular disease and cancer therapy–related cardiovascular toxicity in patients receiving anticancer treatment.

He underlined that treatment decisions should consider the cancer and cardiovascular symptom burden, the cancer prognosis, the requirements for cancer treatment, including alternative options, drug-drug interactions, and patient preferences.

Dr. Lyon highlighted the algorithms designed to aid the management of cardiac dysfunction related to anthracycline chemotherapy, HER2-targeted therapy, and immune checkpoint inhibitors, as well as QTc-prolonging anticancer drugs.

In the first 12 months after the completions of therapy, there are a number of risk factors for future cardiovascular disease, he continued.

These include high and very high baseline cardiovascular toxicity risk, anticancer treatments known to have a high risk for long-term cardiovascular complications, such as doxorubicin and radiotherapy, and moderate or severe CTR-CVT during anticancer treatment.

Over the long term, the guidelines recommend that surveillance in asymptomatic cancer survivors range from an annual cardiovascular risk assessment in low-risk patients to patient education and cardiovascular risk factor optimization, alongside regular transthoracic echocardiography in high-risk groups.

Finally, Dr. Lyon said the guidelines turn their attention to special populations, such as patients with cardiac masses and tumors, those with carcinoid heart disease, pregnant women receiving cancer therapy, as well as those with cardiac implantable electronic devices undergoing radiotherapy.

The guidelines were developed by the task force on cardio-oncology of the ESC, in collaboration with the European Hematology Association, the European Society for Therapeutic Radiology and Oncology, and the International Cardio-Oncology Society. Dr. Lyon declares relationships with Akcea, Takeda Pharmaceuticals, Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, Ferring Pharmaceuticals, Heartfelt Technologies, Brainstorm, and Myocardial Solutions. Dr. López-Fernández declares relationships with Daiichi Sankyo, Almirall Spain, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.

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

BARCELONA – Cardiovascular disease risk factors, as well as established disease, in patients undergoing cancer therapy can be safely managed to minimize cancer therapy–related cardiovascular toxicity (CVR-CVT), conclude the first cardio-oncology guidelines from the European Society of Cardiology.

The guidelines were presented at the annual congress of the European Society of Cardiology and published simultaneously in the European Heart Journal.

Guideline cochair Alexander R. Lyon, MD, PhD, told this news organization that the aim of the guideline was to “personalize the decision-making of a patient with cancer who has cardiovascular disease or is at risk of developing it from their treatment ... because it’s not one size fits all.”

A “very strong theme throughout the guideline is risk assessment, and the fact that that risk is dynamic, it can change ... because how you manage someone who’s at high risk is going to be different” than managing someone who is at moderate or low risk, he said.

“We’re doing a lot of surveillance because one of the big advantages of cardio-oncology is we know when someone is about to get treated,” Dr. Lyon, from the National Heart and Lung Institute, Imperial College London, and Cardio-Oncology Service, Royal Brompton Hospital, London, said.

“You don’t know in nature when someone’s going to have an acute myocardial infarction or acute viral myocarditis, but we do know when they’re coming into an oncology clinic to get an infusion of chemotherapy or tablets,” he noted.

The guidelines offer recommendations so that patients can “have their treatment safely and minimize interruptions.”

“We know these cancer therapies work; we’re here to get the best of both worlds” by minimizing cardiotoxicity, Dr. Lyon said.
 

Steady decline in cancer-related mortality

The guidelines note that since the 1990s there has been a “steady decline in cancer-related mortality, mirrored by a steady increase in cancer survival,” and the result is that “treatment-related side effects have gained more significance.”

Dr. Lyon said that between 2011 and 2021, there was a fivefold increase in the number of new referrals of cancer patients with cardiological consequences to his institution.

He said that one of main drivers is modifiable factors, such as smoking, obesity, and inactivity, which increase the risk for both cancer and cardiovascular disease.

“Allied to that, there’s been an improvement in treating cardiovascular diseases in people in their 40s, 50s, and 60s, so they’re surviving their heart failure, myocardial infarction, atrial fibrillation to develop cancers in later life.”

Combined with the aging population, the result is that “not only are many more people being diagnosed with cancer, because they’re living longer, but they have all these pre-existing heart risk factors, whether as confirmed disease or just the risk factors associated with that,” he said.

Another aspect is that many of the newer, targeted cancer therapies confer a cardiovascular risk.

Dr. Lyon said that the “most famous one” is trastuzumab, a monoclonal antibody that is used to treat HER2-positive breast cancer but that also causes left ventricular impairment “in about 15%-20% of the women taking it and can cause severe heart failure if it is missed.”

That, he continued, was the “forerunner of designer, targeted therapies,” and the subsequent “explosion” in the availability of modern cancer therapies has included many that confer cardiac issues.

The final reason for the greater interest in cardio-oncology, Dr. Lyon added, is the increasing awareness in oncology and hematology teams of the potential for cardiac problems among their patients.

“We have been reaching out to our oncology and hematology colleagues over the last 5-10 years to explain we’re here to help. We’re not here to stop their treatments, we’re here to support them.”

Presenting the guidelines, cochair Teresa López-Fernández, MD, cardiology department, La Paz University Hospital, IdiPAZ Research Institute, Madrid, said that the “spectrum of CVR-CVT presentations” includes arterial hypertension, cardiac arrhythmias, coronary artery disease, heart failure, and myocarditis.

She explained that cytotoxic cancer therapies are associated with an increased risk for cardiac toxicity that is most acute during the treatment phase but is not entirely diminished once it is over, then typically accumulates during long-term follow-up.

Crucially, the impact of cancer therapy on cardiovascular risk is dependent on several factors, such as patient age, cancer history, pre-existing cardiovascular risk factors or cardiovascular disease, and previous cardiotoxic cancer therapy.

There are nevertheless a number of potential strategies to reduce the risk for cardiac toxicity, including primary and secondary prevention prior to the start of cancer therapy and early CVR-CVT management during treatment, as well as cardiovascular risk assessment in the first year after treatment completion and cancer-survivorship programs.

To those ends, Dr. López-Fernández said the guidelines incorporate 272 new recommendations that cover the entire cardio-oncology care pathway, beginning with cardiovascular risk stratification before anticancer therapy.

They offer a risk-assessment checklist and make a series of recommendations for patients to be treated with potentially cardiotoxic drugs, such as anthracyclines, as well as recommendations on cardiac imaging.

The guidelines provide a range of recommendations for primary and secondary cancer therapy–related cardiovascular toxicity prevention, including minimization of the use of cardiotoxic drugs and the use of angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, beta blockers, and statins for primary prevention.

They establish CVR-CVT monitoring protocols across the gamut of cancer therapies, from HER-targeted therapies, through immune checkpoint inhibitors, Bruton tyrosine kinase, CDK4/6, EGFR, VEGF, and ALK inhibitors, and androgen-deprivation and endocrine therapies, to the more novel CAR-T-cell therapies.

A section on radiotherapy-induced cardiovascular toxicity has its own protocol for the establishment of an individual’s mean heart dose of radiation or the amount of radiation exposure to the heart during treatment.

Next, Dr. Lyon looked at recommendations for the management of cardiovascular disease and cancer therapy–related cardiovascular toxicity in patients receiving anticancer treatment.

He underlined that treatment decisions should consider the cancer and cardiovascular symptom burden, the cancer prognosis, the requirements for cancer treatment, including alternative options, drug-drug interactions, and patient preferences.

Dr. Lyon highlighted the algorithms designed to aid the management of cardiac dysfunction related to anthracycline chemotherapy, HER2-targeted therapy, and immune checkpoint inhibitors, as well as QTc-prolonging anticancer drugs.

In the first 12 months after the completions of therapy, there are a number of risk factors for future cardiovascular disease, he continued.

These include high and very high baseline cardiovascular toxicity risk, anticancer treatments known to have a high risk for long-term cardiovascular complications, such as doxorubicin and radiotherapy, and moderate or severe CTR-CVT during anticancer treatment.

Over the long term, the guidelines recommend that surveillance in asymptomatic cancer survivors range from an annual cardiovascular risk assessment in low-risk patients to patient education and cardiovascular risk factor optimization, alongside regular transthoracic echocardiography in high-risk groups.

Finally, Dr. Lyon said the guidelines turn their attention to special populations, such as patients with cardiac masses and tumors, those with carcinoid heart disease, pregnant women receiving cancer therapy, as well as those with cardiac implantable electronic devices undergoing radiotherapy.

The guidelines were developed by the task force on cardio-oncology of the ESC, in collaboration with the European Hematology Association, the European Society for Therapeutic Radiology and Oncology, and the International Cardio-Oncology Society. Dr. Lyon declares relationships with Akcea, Takeda Pharmaceuticals, Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, Ferring Pharmaceuticals, Heartfelt Technologies, Brainstorm, and Myocardial Solutions. Dr. López-Fernández declares relationships with Daiichi Sankyo, Almirall Spain, Janssen-Cilag, Bayer, Roche, Philips, and Incyte.

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