AVAHO

Ascend Laboratories is recalling 10 lots of the oral anticoagulant dabigatran etexilate capsules (75 mg and 150 mg) because of unacceptable levels of a potential carcinogen.

The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.

To date, Ascend Laboratories has not received any reports of adverse events related to this recall.

The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.

Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.

The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.

Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.

Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).

Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.

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

Ascend Laboratories is recalling 10 lots of the oral anticoagulant dabigatran etexilate capsules (75 mg and 150 mg) because of unacceptable levels of a potential carcinogen.

The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.

To date, Ascend Laboratories has not received any reports of adverse events related to this recall.

The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.

Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.

The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.

Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.

Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).

Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.

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

Ascend Laboratories is recalling 10 lots of the oral anticoagulant dabigatran etexilate capsules (75 mg and 150 mg) because of unacceptable levels of a potential carcinogen.

The nationwide recall, to the consumer level, is because of the detection of the nitrosamine impurity, N-nitroso-dabigatran, which may increase the risk of cancer with prolonged exposure to levels higher than acceptable.

To date, Ascend Laboratories has not received any reports of adverse events related to this recall.

The recalled product was distributed nationwide to wholesalers, distributors, and retailers in the United States from June 2022 to October 2022.

Complete details of the recalled product, including national drug code, lot numbers, expiration dates, and configuration/counts, are provided in a company announcement that was posted on the Food and Drug Administration website.

The company is advising patients who have any dabigatran that has been recalled to continue taking their medication and to contact their physician for advice regarding an alternative treatment.

Wholesalers/distributors and pharmacies with an existing inventory of the affected lots should stop use and distribution and quarantine the product immediately. Wholesalers and distributors should also recall the distributed product.

Questions regarding this recall can call Ascend Laboratories at 877.272.7901 (24 hours, 7 days a week).

Problems with this product should be reported to the FDA through MedWatch, its adverse event reporting program.

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

In a small cohort of patients with hematologic cancer and their caregivers, the use of a financial navigator helped secure cost savings of approximately $2,500 per person. This saving was achieved by helping participants to optimize health insurance, identify different types of assistance for out-of-pocket expenses, or apply for disability or family medical leave.

Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.

Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.

The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.

“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.

“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.

The study was published in JCO Oncology Practice.

The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.

The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.

A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.

The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.

Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).

With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).

Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).

“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”

The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
 

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

In a small cohort of patients with hematologic cancer and their caregivers, the use of a financial navigator helped secure cost savings of approximately $2,500 per person. This saving was achieved by helping participants to optimize health insurance, identify different types of assistance for out-of-pocket expenses, or apply for disability or family medical leave.

Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.

Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.

The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.

“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.

“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.

The study was published in JCO Oncology Practice.

The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.

The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.

A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.

The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.

Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).

With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).

Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).

“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”

The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
 

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

In a small cohort of patients with hematologic cancer and their caregivers, the use of a financial navigator helped secure cost savings of approximately $2,500 per person. This saving was achieved by helping participants to optimize health insurance, identify different types of assistance for out-of-pocket expenses, or apply for disability or family medical leave.

Cancer patients in the United States face complex financial issues in navigating with medical insurance companies to cover their care. This “financial toxicity” has come to be regarded as a side effect of cancer treatment.

Patients with hematologic malignancies may be particularly vulnerable to financial toxicity, owing to the nature of their treatment, which often includes bone marrow transplantation, lengthy hospital stays, and prolonged intensive follow-up, as well as potential treatment-related complications, such as graft vs. host disease.

The results from this small study suggest that using an oncology financial navigator could be helpful. But not all cancer patients have access to such a person, explained lead author Jean S. Edward, PhD, RN, associate professor in the college of nursing at the University of Kentucky, Lexington.

“Unfortunately, it’s not as common as we would like, especially in underserved areas with patient and caregiver populations that need it the most,” she said. Dr. Edward is hopeful that the results from this study, even though it is small, might help to boost use of this intervention. “OFN [oncology financial navigation] is not necessarily a cutting-edge program or ‘novel’ intervention, but the lack of programs and limitations in implementing in cancer centers does make it a gap in practice,” Dr. Edward told this news organization.

“There are gaps in evidence on how to incorporate an oncology financial navigator in current workflows and sustainability of positions, but as our study has shown, the return on investment to the health care system and/or financial benefits to patients/caregivers could help cover the cost of implementing such programs,” she said.

The study was published in JCO Oncology Practice.

The intervention used in this study, Coverage and Cost-of-Care Links (CC Links), was designed specifically to address financial toxicity among patients with hematologic cancers.

The study’s primary outcomes were defined as improvements in financial distress as well as in physical and mental quality of life.

A total of 54 patients and 32 caregivers completed the intervention and pre-/postintervention surveys. More than half of participants were women. The average age was 63 years. Less than a quarter of the patients were employed (23%), about one-third had income that was below the federal poverty level, and almost all had insurance. About 59% of the caregivers were employed.

The navigators’ functions included screening for financial toxicity using FACIT-Comprehensive Score for Financial Toxicity (COST) and the National Comprehensive Cancer Network’s Distress Thermometer and Problem List. They also helped patients to estimate cost of care, assessed health insurance coverage, and connected patients/caregivers with disease-specific resources and other external assistance programs, among other things.

Participants had an average of three in-person meetings and five telephone interactions with the financial navigator. The most common concern was in regard to high out-of-pocket costs. The most frequently provided services from the navigator were helping with financial assistance programs and grant applications. Overall, the navigator was able to obtain $124,600 in financial benefits for 48 participants, as well as money for travel ($24,000), urgent needs ($16,000), patient financial assistance ($9,100), and copay assistance grants ($75,500).

With regard to scores on the screening tools, the only significant change from pre- to postintervention was in the psychological response score, or COST. It decreased by an average of 2.30 points (P = .019; Hedges’ g = 0.33). For caregivers, there was a significant improvement in COST (average decrease, 2.97 points; P = .021; g = 0.43), material condition scores (average decrease, 0.63 points; P = .031; g = 0.39), and total financial toxicity scores (average decrease, 0.13 points; P = .041; g = 0.37).

Most of the participants gave the intervention high ratings for acceptability (89%) and appropriateness (88%).

“Standardized screening for financial toxicity in cancer care settings is essential to support early identification of financial needs that serve as barriers to care,” the authors conclude. “Close collaboration and coordination with existing services and workflows are essential for the seamless integration of OFN interventions within health systems and to help facilitate contact and communication with participants.”

The study was supported by the National Cancer Institute; the University of Kentucky’s Markey Cancer Center; the Research Communications Office of the Patient Oriented and Population Science Shared Resource Facilities; Joan Scales, LCSW, and the Psych-Oncology Program at the University of Kentucky Markey Cancer Center; and UK HealthCare’s Patient Financial Services. Dr. Edward has disclosed no relevant financial relationships.
 

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

Researchers are homing in on a new connection between colon cancer and Clostridioides difficile.

C. diff. is a bacterium that infects the large intestine, causing difficult GI symptoms like frequent diarrhea. C. diff. is a widespread infection among patients who have been hospitalized, estimated at almost a half-million cases per year. It’s extremely contagious. 

C. diff. has been known to lead to dangerous problems like sepsis if left untreated. Previous research has found there is a higher amount of C. diff. in cancerous lesions than in healthy body tissue, but a recent study published in Cancer Discovery by Johns Hopkins and Vanderbilt University has expanded upon the link between C. diff. and colon cancer. This study, which was conducted in mice, found that C. diff. bacteria may change normal cells to cancer cells. 

In colon cancer, the surface of the colon tends to be covered in biofilms – or dense amounts of bacteria. In this study, researchers found that C. diff. was capable of producing colorectal tumors in a cascade.

“Big picture, we’re working to learn what the exact mechanism for this is,” said Julia L. Drewes, PhD, assistant professor of medicine at Johns Hopkins University, Baltimore, and a coauthor of the study.

Anyone can get C. diff., but certain people are more susceptible. 

“People who are over 65, have weakened immune systems, live in nursing homes, or work in health care settings are most at risk for C. diff.,” said Lilian Chen, MD, a colon and rectal surgeon at Tufts Medical Centerand assistant professor of surgery at Tufts University, both in Boston. “People with C. diff. can also get it again. One in six patients will end up with recurrent infections.”

Another risk factor: taking antibiotics. “Trillions of microbes are normally found in and on our body, including both good and bad bacteria,” said Caroline Um, PhD, MPH, principal scientist in epidemiology research for the American Cancer Society. “Normally, good bacteria help us fight against bad bacteria such as C. diff. However, you may have a greater chance of C. diff. infection after taking antibiotics, since they usually wipe out both good and bad bacteria in our gut.”

C. diff. is transmitted through stool, often if someone doesn’t wash their hands after using the bathroom. If you touch that person’s skin or a surface that person touched, your body can be “colonized” with the bacteria. 

“Once someone is colonized with C. diff., you find it everywhere in their environment. In fact, C. diff. is all around all of us,” said Aasma Shaukat, MD, MPH, a gastroenterologist at the NYU Langone Medical Center and director of GI outcomes research at New York University. “In a healthy person, this kind of exposure doesn’t matter because C. diff. will not make them sick. It’s when someone has a compromised immune system that C. diff. becomes a concern.”

C. diff. may kickstart the process of how cancer begins to form through inflammation

“There are two types of toxins present in C. diff.: toxin A and toxin B,” said Dr. Drewes. “We need to do more work in order to determine an exact mechanism, but toxin B, or TcdB, which is found in a majority of C. diff. infections, appears to drive inflammation in the body. This inflammation contributes to cell damage in the colon, which may then be connected to a mutation that can cause cancer.” 

The findings could help researchers understand why so many people under the age of 50 are now being diagnosed with colon cancer. 

“We need a better understanding of the potential role of C. diff. in colorectal cancer before we can determine whether this changes current colorectal cancer screening guidelines,” said Dr. Um. “However, it’s a good idea to talk with your health care professional about colorectal cancer screening, regardless of whether you have had C. diff.. Various factors like smoking, poor diet, being overweight, or having a family history of colorectal cancer can affect an individual’s risk.”

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

Researchers are homing in on a new connection between colon cancer and Clostridioides difficile.

C. diff. is a bacterium that infects the large intestine, causing difficult GI symptoms like frequent diarrhea. C. diff. is a widespread infection among patients who have been hospitalized, estimated at almost a half-million cases per year. It’s extremely contagious. 

C. diff. has been known to lead to dangerous problems like sepsis if left untreated. Previous research has found there is a higher amount of C. diff. in cancerous lesions than in healthy body tissue, but a recent study published in Cancer Discovery by Johns Hopkins and Vanderbilt University has expanded upon the link between C. diff. and colon cancer. This study, which was conducted in mice, found that C. diff. bacteria may change normal cells to cancer cells. 

In colon cancer, the surface of the colon tends to be covered in biofilms – or dense amounts of bacteria. In this study, researchers found that C. diff. was capable of producing colorectal tumors in a cascade.

“Big picture, we’re working to learn what the exact mechanism for this is,” said Julia L. Drewes, PhD, assistant professor of medicine at Johns Hopkins University, Baltimore, and a coauthor of the study.

Anyone can get C. diff., but certain people are more susceptible. 

“People who are over 65, have weakened immune systems, live in nursing homes, or work in health care settings are most at risk for C. diff.,” said Lilian Chen, MD, a colon and rectal surgeon at Tufts Medical Centerand assistant professor of surgery at Tufts University, both in Boston. “People with C. diff. can also get it again. One in six patients will end up with recurrent infections.”

Another risk factor: taking antibiotics. “Trillions of microbes are normally found in and on our body, including both good and bad bacteria,” said Caroline Um, PhD, MPH, principal scientist in epidemiology research for the American Cancer Society. “Normally, good bacteria help us fight against bad bacteria such as C. diff. However, you may have a greater chance of C. diff. infection after taking antibiotics, since they usually wipe out both good and bad bacteria in our gut.”

C. diff. is transmitted through stool, often if someone doesn’t wash their hands after using the bathroom. If you touch that person’s skin or a surface that person touched, your body can be “colonized” with the bacteria. 

“Once someone is colonized with C. diff., you find it everywhere in their environment. In fact, C. diff. is all around all of us,” said Aasma Shaukat, MD, MPH, a gastroenterologist at the NYU Langone Medical Center and director of GI outcomes research at New York University. “In a healthy person, this kind of exposure doesn’t matter because C. diff. will not make them sick. It’s when someone has a compromised immune system that C. diff. becomes a concern.”

C. diff. may kickstart the process of how cancer begins to form through inflammation

“There are two types of toxins present in C. diff.: toxin A and toxin B,” said Dr. Drewes. “We need to do more work in order to determine an exact mechanism, but toxin B, or TcdB, which is found in a majority of C. diff. infections, appears to drive inflammation in the body. This inflammation contributes to cell damage in the colon, which may then be connected to a mutation that can cause cancer.” 

The findings could help researchers understand why so many people under the age of 50 are now being diagnosed with colon cancer. 

“We need a better understanding of the potential role of C. diff. in colorectal cancer before we can determine whether this changes current colorectal cancer screening guidelines,” said Dr. Um. “However, it’s a good idea to talk with your health care professional about colorectal cancer screening, regardless of whether you have had C. diff.. Various factors like smoking, poor diet, being overweight, or having a family history of colorectal cancer can affect an individual’s risk.”

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

Researchers are homing in on a new connection between colon cancer and Clostridioides difficile.

C. diff. is a bacterium that infects the large intestine, causing difficult GI symptoms like frequent diarrhea. C. diff. is a widespread infection among patients who have been hospitalized, estimated at almost a half-million cases per year. It’s extremely contagious. 

C. diff. has been known to lead to dangerous problems like sepsis if left untreated. Previous research has found there is a higher amount of C. diff. in cancerous lesions than in healthy body tissue, but a recent study published in Cancer Discovery by Johns Hopkins and Vanderbilt University has expanded upon the link between C. diff. and colon cancer. This study, which was conducted in mice, found that C. diff. bacteria may change normal cells to cancer cells. 

In colon cancer, the surface of the colon tends to be covered in biofilms – or dense amounts of bacteria. In this study, researchers found that C. diff. was capable of producing colorectal tumors in a cascade.

“Big picture, we’re working to learn what the exact mechanism for this is,” said Julia L. Drewes, PhD, assistant professor of medicine at Johns Hopkins University, Baltimore, and a coauthor of the study.

Anyone can get C. diff., but certain people are more susceptible. 

“People who are over 65, have weakened immune systems, live in nursing homes, or work in health care settings are most at risk for C. diff.,” said Lilian Chen, MD, a colon and rectal surgeon at Tufts Medical Centerand assistant professor of surgery at Tufts University, both in Boston. “People with C. diff. can also get it again. One in six patients will end up with recurrent infections.”

Another risk factor: taking antibiotics. “Trillions of microbes are normally found in and on our body, including both good and bad bacteria,” said Caroline Um, PhD, MPH, principal scientist in epidemiology research for the American Cancer Society. “Normally, good bacteria help us fight against bad bacteria such as C. diff. However, you may have a greater chance of C. diff. infection after taking antibiotics, since they usually wipe out both good and bad bacteria in our gut.”

C. diff. is transmitted through stool, often if someone doesn’t wash their hands after using the bathroom. If you touch that person’s skin or a surface that person touched, your body can be “colonized” with the bacteria. 

“Once someone is colonized with C. diff., you find it everywhere in their environment. In fact, C. diff. is all around all of us,” said Aasma Shaukat, MD, MPH, a gastroenterologist at the NYU Langone Medical Center and director of GI outcomes research at New York University. “In a healthy person, this kind of exposure doesn’t matter because C. diff. will not make them sick. It’s when someone has a compromised immune system that C. diff. becomes a concern.”

C. diff. may kickstart the process of how cancer begins to form through inflammation

“There are two types of toxins present in C. diff.: toxin A and toxin B,” said Dr. Drewes. “We need to do more work in order to determine an exact mechanism, but toxin B, or TcdB, which is found in a majority of C. diff. infections, appears to drive inflammation in the body. This inflammation contributes to cell damage in the colon, which may then be connected to a mutation that can cause cancer.” 

The findings could help researchers understand why so many people under the age of 50 are now being diagnosed with colon cancer. 

“We need a better understanding of the potential role of C. diff. in colorectal cancer before we can determine whether this changes current colorectal cancer screening guidelines,” said Dr. Um. “However, it’s a good idea to talk with your health care professional about colorectal cancer screening, regardless of whether you have had C. diff.. Various factors like smoking, poor diet, being overweight, or having a family history of colorectal cancer can affect an individual’s risk.”

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

Even after endorsement in updated guidelines, hydroxyurea is substantially underused in youth with sickle cell anemia (SCA), new research indicates.

SCA can lead to pain crises, stroke, and early death. Hydroxyurea, an oral disease-modifying medication, can reduce the complications.

In 2014, the National Heart, Lung, and Blood Institute published revised guidelines that hydroxyurea should be offered as the primary therapy to all patients who were at least 9 months old and living with SCA, regardless of disease severity.
 

Low uptake even after guideline revision

Yet, a research team led by Sarah L. Reeves, PhD, MPH, with the Child Health Evaluation and Research Center at University of Michigan, Ann Arbor, found in their study of use in two sample states – Michigan and New York – that hydroxyurea use was low in children and adolescents enrolled in Medicaid and increased only slightly in Michigan and not at all in New York after the guideline revision.

After the guidelines were updated, the researchers observed that, on average, children and adolescents were getting the medication less than a third of the days in a year (32% maximum in the year with the highest uptake). The data were gathered from a study population that included 4,302 youths aged 1-17 years with SCA.

Findings were published online in JAMA Network Open.
 

‘A national issue’

Russell Ware, MD, PhD, chair of hematology translational research at Cincinnati Children’s Hospital, who was not part of the research, says that though data were gathered from Michigan and New York, “this is a national issue.”

Dr. Ware says the main problem is the way the health system describes the importance of hydroxyurea.

“There needs to be a realization that hydroxyurea is the standard of care for children with sickle cell anemia. It’s not just something they should take when they’re sick,” Dr. Ware said.

He added, “If you have diabetes, should you only take insulin if you’re really sick and hospitalized with a diabetic coma? Of course not.”

He said often providers aren’t giving a clear and consistent message to families.

“They’re not all sure they want to recommend it. They might offer it,” Dr. Ware said, which jeopardizes uptake. “Providers need to be more committed to it. They need to know how to dose it.”
 

Bad rap from past indications

Dr. Ware says hydroxyurea also gets a bad rap from use decades ago as a chemotherapeutic agent for cancer and then as an anti-HIV medication.

Now it’s used in a completely different way with SCA, but the fear of the association lingers.

“This label as a chemotherapeutic agent has really dogged hydroxyurea,” he said. “It’s a completely different mechanism. It’s a different dose. It’s a different purpose.”

The message to families should be more direct, he says: “Your child has sickle cell anemia and needs to be on disease-modifying therapy because this is a life-threatening disease.”

The underuse of this drug is particularly ironic, he says, as each capsule, taken daily, “costs about fifty cents.”
 

Medicaid support critical

Authors conclude that multifaceted interventions may be necessary to increase the number of filled prescriptions and use. They also point out that the interventions rely on states’ Medicaid support regarding hydroxyurea use. From 70% to 90% of young people with SCA are covered by Medicaid at some point, the researchers write.

“Variation may exist across states, as well as within states, in the coverage of hydroxyurea, outpatient visits, and associated lab monitoring,” they note.

The authors point to interventions in clinical trials that have had some success in hydroxyurea use.

Creary et al., for example, found that electronic directly observed therapy was associated with high adherence. That involved sending daily texts to patients to take hydroxyurea and patients recording and sending daily videos that show they took the medication.

The authors add that incorporating clinical pharmacists into the care team to provide education and support for families has been shown to be associated with successful outcomes for other chronic conditions – this approach may be particularly well suited to hydroxyurea given that this medication requires significant dosage monitoring.

Dr. Ware, however, says that solutions should focus on the health system more clearly communicating that hydroxyurea is the standard of care for all kids with SCA.

“We need to dispel these myths and these labels that are unfairly attributed to it. Then we’d probably do a lot better,” he said.

He added that children with SCA, “are a marginalized, neglected population of patients historically,” and addressing social determinants of health is also important in getting better uptake.

“Our pharmacy, for example, ships the drug to the families if they’re just getting a refill rather than making them drive all the way in,” Dr. Ware says.

Dr. Ware said given the interruption in doctor/patient relationships in the pandemic, the poor uptake of hydroxyurea could be even worse now.

The work was funded by the Agency for Healthcare Research and Quality and National Heart, Lung, and Blood Institute. Coauthor Dr. Green was the principal investigator of an NIH-funded trial of hydroxyurea in Uganda with a study drug provided by Siklos. No other author disclosures were reported. In addition to receiving research funding from the National Institutes of Health, Dr. Ware receives research donations from Bristol Myers Squibb, Addmedica, and Hemex Health. He is a medical adviser for Nova Laboratories and Octapharma, and serves on Data Safety Monitoring Boards for Novartis and Editas.
 

Even after endorsement in updated guidelines, hydroxyurea is substantially underused in youth with sickle cell anemia (SCA), new research indicates.

SCA can lead to pain crises, stroke, and early death. Hydroxyurea, an oral disease-modifying medication, can reduce the complications.

In 2014, the National Heart, Lung, and Blood Institute published revised guidelines that hydroxyurea should be offered as the primary therapy to all patients who were at least 9 months old and living with SCA, regardless of disease severity.
 

Low uptake even after guideline revision

Yet, a research team led by Sarah L. Reeves, PhD, MPH, with the Child Health Evaluation and Research Center at University of Michigan, Ann Arbor, found in their study of use in two sample states – Michigan and New York – that hydroxyurea use was low in children and adolescents enrolled in Medicaid and increased only slightly in Michigan and not at all in New York after the guideline revision.

After the guidelines were updated, the researchers observed that, on average, children and adolescents were getting the medication less than a third of the days in a year (32% maximum in the year with the highest uptake). The data were gathered from a study population that included 4,302 youths aged 1-17 years with SCA.

Findings were published online in JAMA Network Open.
 

‘A national issue’

Russell Ware, MD, PhD, chair of hematology translational research at Cincinnati Children’s Hospital, who was not part of the research, says that though data were gathered from Michigan and New York, “this is a national issue.”

Dr. Ware says the main problem is the way the health system describes the importance of hydroxyurea.

“There needs to be a realization that hydroxyurea is the standard of care for children with sickle cell anemia. It’s not just something they should take when they’re sick,” Dr. Ware said.

He added, “If you have diabetes, should you only take insulin if you’re really sick and hospitalized with a diabetic coma? Of course not.”

He said often providers aren’t giving a clear and consistent message to families.

“They’re not all sure they want to recommend it. They might offer it,” Dr. Ware said, which jeopardizes uptake. “Providers need to be more committed to it. They need to know how to dose it.”
 

Bad rap from past indications

Dr. Ware says hydroxyurea also gets a bad rap from use decades ago as a chemotherapeutic agent for cancer and then as an anti-HIV medication.

Now it’s used in a completely different way with SCA, but the fear of the association lingers.

“This label as a chemotherapeutic agent has really dogged hydroxyurea,” he said. “It’s a completely different mechanism. It’s a different dose. It’s a different purpose.”

The message to families should be more direct, he says: “Your child has sickle cell anemia and needs to be on disease-modifying therapy because this is a life-threatening disease.”

The underuse of this drug is particularly ironic, he says, as each capsule, taken daily, “costs about fifty cents.”
 

Medicaid support critical

Authors conclude that multifaceted interventions may be necessary to increase the number of filled prescriptions and use. They also point out that the interventions rely on states’ Medicaid support regarding hydroxyurea use. From 70% to 90% of young people with SCA are covered by Medicaid at some point, the researchers write.

“Variation may exist across states, as well as within states, in the coverage of hydroxyurea, outpatient visits, and associated lab monitoring,” they note.

The authors point to interventions in clinical trials that have had some success in hydroxyurea use.

Creary et al., for example, found that electronic directly observed therapy was associated with high adherence. That involved sending daily texts to patients to take hydroxyurea and patients recording and sending daily videos that show they took the medication.

The authors add that incorporating clinical pharmacists into the care team to provide education and support for families has been shown to be associated with successful outcomes for other chronic conditions – this approach may be particularly well suited to hydroxyurea given that this medication requires significant dosage monitoring.

Dr. Ware, however, says that solutions should focus on the health system more clearly communicating that hydroxyurea is the standard of care for all kids with SCA.

“We need to dispel these myths and these labels that are unfairly attributed to it. Then we’d probably do a lot better,” he said.

He added that children with SCA, “are a marginalized, neglected population of patients historically,” and addressing social determinants of health is also important in getting better uptake.

“Our pharmacy, for example, ships the drug to the families if they’re just getting a refill rather than making them drive all the way in,” Dr. Ware says.

Dr. Ware said given the interruption in doctor/patient relationships in the pandemic, the poor uptake of hydroxyurea could be even worse now.

The work was funded by the Agency for Healthcare Research and Quality and National Heart, Lung, and Blood Institute. Coauthor Dr. Green was the principal investigator of an NIH-funded trial of hydroxyurea in Uganda with a study drug provided by Siklos. No other author disclosures were reported. In addition to receiving research funding from the National Institutes of Health, Dr. Ware receives research donations from Bristol Myers Squibb, Addmedica, and Hemex Health. He is a medical adviser for Nova Laboratories and Octapharma, and serves on Data Safety Monitoring Boards for Novartis and Editas.
 

Even after endorsement in updated guidelines, hydroxyurea is substantially underused in youth with sickle cell anemia (SCA), new research indicates.

SCA can lead to pain crises, stroke, and early death. Hydroxyurea, an oral disease-modifying medication, can reduce the complications.

In 2014, the National Heart, Lung, and Blood Institute published revised guidelines that hydroxyurea should be offered as the primary therapy to all patients who were at least 9 months old and living with SCA, regardless of disease severity.
 

Low uptake even after guideline revision

Yet, a research team led by Sarah L. Reeves, PhD, MPH, with the Child Health Evaluation and Research Center at University of Michigan, Ann Arbor, found in their study of use in two sample states – Michigan and New York – that hydroxyurea use was low in children and adolescents enrolled in Medicaid and increased only slightly in Michigan and not at all in New York after the guideline revision.

After the guidelines were updated, the researchers observed that, on average, children and adolescents were getting the medication less than a third of the days in a year (32% maximum in the year with the highest uptake). The data were gathered from a study population that included 4,302 youths aged 1-17 years with SCA.

Findings were published online in JAMA Network Open.
 

‘A national issue’

Russell Ware, MD, PhD, chair of hematology translational research at Cincinnati Children’s Hospital, who was not part of the research, says that though data were gathered from Michigan and New York, “this is a national issue.”

Dr. Ware says the main problem is the way the health system describes the importance of hydroxyurea.

“There needs to be a realization that hydroxyurea is the standard of care for children with sickle cell anemia. It’s not just something they should take when they’re sick,” Dr. Ware said.

He added, “If you have diabetes, should you only take insulin if you’re really sick and hospitalized with a diabetic coma? Of course not.”

He said often providers aren’t giving a clear and consistent message to families.

“They’re not all sure they want to recommend it. They might offer it,” Dr. Ware said, which jeopardizes uptake. “Providers need to be more committed to it. They need to know how to dose it.”
 

Bad rap from past indications

Dr. Ware says hydroxyurea also gets a bad rap from use decades ago as a chemotherapeutic agent for cancer and then as an anti-HIV medication.

Now it’s used in a completely different way with SCA, but the fear of the association lingers.

“This label as a chemotherapeutic agent has really dogged hydroxyurea,” he said. “It’s a completely different mechanism. It’s a different dose. It’s a different purpose.”

The message to families should be more direct, he says: “Your child has sickle cell anemia and needs to be on disease-modifying therapy because this is a life-threatening disease.”

The underuse of this drug is particularly ironic, he says, as each capsule, taken daily, “costs about fifty cents.”
 

Medicaid support critical

Authors conclude that multifaceted interventions may be necessary to increase the number of filled prescriptions and use. They also point out that the interventions rely on states’ Medicaid support regarding hydroxyurea use. From 70% to 90% of young people with SCA are covered by Medicaid at some point, the researchers write.

“Variation may exist across states, as well as within states, in the coverage of hydroxyurea, outpatient visits, and associated lab monitoring,” they note.

The authors point to interventions in clinical trials that have had some success in hydroxyurea use.

Creary et al., for example, found that electronic directly observed therapy was associated with high adherence. That involved sending daily texts to patients to take hydroxyurea and patients recording and sending daily videos that show they took the medication.

The authors add that incorporating clinical pharmacists into the care team to provide education and support for families has been shown to be associated with successful outcomes for other chronic conditions – this approach may be particularly well suited to hydroxyurea given that this medication requires significant dosage monitoring.

Dr. Ware, however, says that solutions should focus on the health system more clearly communicating that hydroxyurea is the standard of care for all kids with SCA.

“We need to dispel these myths and these labels that are unfairly attributed to it. Then we’d probably do a lot better,” he said.

He added that children with SCA, “are a marginalized, neglected population of patients historically,” and addressing social determinants of health is also important in getting better uptake.

“Our pharmacy, for example, ships the drug to the families if they’re just getting a refill rather than making them drive all the way in,” Dr. Ware says.

Dr. Ware said given the interruption in doctor/patient relationships in the pandemic, the poor uptake of hydroxyurea could be even worse now.

The work was funded by the Agency for Healthcare Research and Quality and National Heart, Lung, and Blood Institute. Coauthor Dr. Green was the principal investigator of an NIH-funded trial of hydroxyurea in Uganda with a study drug provided by Siklos. No other author disclosures were reported. In addition to receiving research funding from the National Institutes of Health, Dr. Ware receives research donations from Bristol Myers Squibb, Addmedica, and Hemex Health. He is a medical adviser for Nova Laboratories and Octapharma, and serves on Data Safety Monitoring Boards for Novartis and Editas.
 

The Food and Drug Administration has approved retifanlimab-dlwr (Zynyz), an intravenous programmed death–1 (PD-1) inhibitor, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), the agency announced.

This marks the first regulatory approval for the PD-1 inhibitor. The FDA granted accelerated approval for the drug on the basis of tumor response rate and duration of response from the POD1UM-201 trial. Drugmaker Incyte said that “continued approval of Zynyz for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

MCC is a rare and aggressive skin cancer with a high rate of metastatic disease and an estimated 5-year overall survival of just 14% among those who present with metastatic disease. Incidence is rapidly increasing in the United States, particularly among adults older than 65 years, Incyte noted.

“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” principal author Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, said in a news release. “The approval of Zynyz offers health care providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease.”

POD1UM-201 was an open-label, single-arm, phase 2 study that evaluated the agent in 65 systemic treatment–naive adults with metastatic or recurrent locally advanced MCC.

Overall, 52% of patients had an objective response rate. A complete response was observed in 12 patients (18%), and a partial response was observed in 22 patients (34%).

Duration of response ranged from 1.1 to 24.9 months; 76% of responders experienced responses of 6 months or longer, and 62% experienced responses of 12 months or longer.

Study participants received a 500-mg dose of retifanlimab every 4 weeks for up to 24 weeks or until disease progression or unacceptable toxicity. Serious adverse events occurred in 22% of patients and most often included fatigue, arrhythmia, and pneumonitis; 11% of patients discontinued treatment because of serious adverse events.

Retifanlimab may cause a severe or life-threatening immune response during treatment or after discontinuation. Patients should be advised to immediately report any new or worsening signs or symptoms to their health care provider. Side effects can also be reported to the FDA.

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

The Food and Drug Administration has approved retifanlimab-dlwr (Zynyz), an intravenous programmed death–1 (PD-1) inhibitor, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), the agency announced.

This marks the first regulatory approval for the PD-1 inhibitor. The FDA granted accelerated approval for the drug on the basis of tumor response rate and duration of response from the POD1UM-201 trial. Drugmaker Incyte said that “continued approval of Zynyz for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

MCC is a rare and aggressive skin cancer with a high rate of metastatic disease and an estimated 5-year overall survival of just 14% among those who present with metastatic disease. Incidence is rapidly increasing in the United States, particularly among adults older than 65 years, Incyte noted.

“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” principal author Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, said in a news release. “The approval of Zynyz offers health care providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease.”

POD1UM-201 was an open-label, single-arm, phase 2 study that evaluated the agent in 65 systemic treatment–naive adults with metastatic or recurrent locally advanced MCC.

Overall, 52% of patients had an objective response rate. A complete response was observed in 12 patients (18%), and a partial response was observed in 22 patients (34%).

Duration of response ranged from 1.1 to 24.9 months; 76% of responders experienced responses of 6 months or longer, and 62% experienced responses of 12 months or longer.

Study participants received a 500-mg dose of retifanlimab every 4 weeks for up to 24 weeks or until disease progression or unacceptable toxicity. Serious adverse events occurred in 22% of patients and most often included fatigue, arrhythmia, and pneumonitis; 11% of patients discontinued treatment because of serious adverse events.

Retifanlimab may cause a severe or life-threatening immune response during treatment or after discontinuation. Patients should be advised to immediately report any new or worsening signs or symptoms to their health care provider. Side effects can also be reported to the FDA.

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

The Food and Drug Administration has approved retifanlimab-dlwr (Zynyz), an intravenous programmed death–1 (PD-1) inhibitor, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), the agency announced.

This marks the first regulatory approval for the PD-1 inhibitor. The FDA granted accelerated approval for the drug on the basis of tumor response rate and duration of response from the POD1UM-201 trial. Drugmaker Incyte said that “continued approval of Zynyz for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

MCC is a rare and aggressive skin cancer with a high rate of metastatic disease and an estimated 5-year overall survival of just 14% among those who present with metastatic disease. Incidence is rapidly increasing in the United States, particularly among adults older than 65 years, Incyte noted.

“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” principal author Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, both in Seattle, said in a news release. “The approval of Zynyz offers health care providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease.”

POD1UM-201 was an open-label, single-arm, phase 2 study that evaluated the agent in 65 systemic treatment–naive adults with metastatic or recurrent locally advanced MCC.

Overall, 52% of patients had an objective response rate. A complete response was observed in 12 patients (18%), and a partial response was observed in 22 patients (34%).

Duration of response ranged from 1.1 to 24.9 months; 76% of responders experienced responses of 6 months or longer, and 62% experienced responses of 12 months or longer.

Study participants received a 500-mg dose of retifanlimab every 4 weeks for up to 24 weeks or until disease progression or unacceptable toxicity. Serious adverse events occurred in 22% of patients and most often included fatigue, arrhythmia, and pneumonitis; 11% of patients discontinued treatment because of serious adverse events.

Retifanlimab may cause a severe or life-threatening immune response during treatment or after discontinuation. Patients should be advised to immediately report any new or worsening signs or symptoms to their health care provider. Side effects can also be reported to the FDA.

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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