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Black patients less likely to receive opioids for advanced cancer
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Difficulty fitting family into career: Female oncologists
In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.
The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.
One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.
The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),
These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.
The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.
“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.
“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
Survey details
The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.
Most respondents (84.4%) were married, and 71% were currently working full-time.
About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.
A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.
Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).
Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.
The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.
When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.
However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”
“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.
The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.
The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.
Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.
The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.
One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.
The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),
These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.
The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.
“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.
“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
Survey details
The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.
Most respondents (84.4%) were married, and 71% were currently working full-time.
About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.
A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.
Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).
Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.
The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.
When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.
However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”
“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.
The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.
The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.
Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.
The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.
One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.
The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),
These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.
The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.
“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.
“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
Survey details
The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.
Most respondents (84.4%) were married, and 71% were currently working full-time.
About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.
A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.
Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).
Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.
The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.
When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.
However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”
“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.
The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.
The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.
Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
FDA OKs zanubrutinib for CLL or SLL
By giving the nod to these uses of this second-generation Bruton’s tyrosine kinase inhibitor, the FDA expanded on its previous approvals of this drug in mantle cell and marginal zone lymphoma.
“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient subtypes, including the high-risk del17p/TP53-mutated population, and regardless of treatment setting,” Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute in Boston, said in a press release from drug developer BeiGene.
The FDA’s decision was based on two phase 3 trials – SEQUOIA and ALPINE. The SEQUOIA trial assessed 479 patients with treatment-naive CLL/SLL who either received zanubrutinib until disease progression or unacceptable toxicity or bendamustine plus rituximab for six cycles. Median progression-free survival was not reached in the zanubrutinib arm and was 33.7 months in the bendamustine plus rituximab arm (hazard ratio, 0.42).
In a separate, nonrandomized SEQUOIA cohort, investigators assessed zanubrutinib in patients with a 17p deletion and found an overall response rate of 88%. In addition, over the 25-month follow-up, the median duration of response was not reached.
The ALPINE trial included 652 patients with relapsed or refractory CLL/SLL who received either zanubrutinib or ibrutinib. The overall response rate was 80% in the zanubrutinib arm versus 73% in the ibrutinib arm, and the median duration of response was not reached in either arm over the 14-month follow-up period. Median progression-free survival was not reached in the zanubrutinib arm and was 35 months in the ibrutinib group.
Dr. Brown, a lead investigator on both drug trials, suggested that, given the improvements observed in progression-free survival, zanubrutinib could become the standard of care in this setting.
In the ALPINE trial, treatment discontinuation rate was lower among patients receiving zanubrutinib (26%) versus ibrutinib (41.2%), with most discontinuations a result of adverse events or progressive disease.
And across both trials, the most common adverse reactions were decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).
A version of this article first appeared on Medscape.com.
By giving the nod to these uses of this second-generation Bruton’s tyrosine kinase inhibitor, the FDA expanded on its previous approvals of this drug in mantle cell and marginal zone lymphoma.
“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient subtypes, including the high-risk del17p/TP53-mutated population, and regardless of treatment setting,” Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute in Boston, said in a press release from drug developer BeiGene.
The FDA’s decision was based on two phase 3 trials – SEQUOIA and ALPINE. The SEQUOIA trial assessed 479 patients with treatment-naive CLL/SLL who either received zanubrutinib until disease progression or unacceptable toxicity or bendamustine plus rituximab for six cycles. Median progression-free survival was not reached in the zanubrutinib arm and was 33.7 months in the bendamustine plus rituximab arm (hazard ratio, 0.42).
In a separate, nonrandomized SEQUOIA cohort, investigators assessed zanubrutinib in patients with a 17p deletion and found an overall response rate of 88%. In addition, over the 25-month follow-up, the median duration of response was not reached.
The ALPINE trial included 652 patients with relapsed or refractory CLL/SLL who received either zanubrutinib or ibrutinib. The overall response rate was 80% in the zanubrutinib arm versus 73% in the ibrutinib arm, and the median duration of response was not reached in either arm over the 14-month follow-up period. Median progression-free survival was not reached in the zanubrutinib arm and was 35 months in the ibrutinib group.
Dr. Brown, a lead investigator on both drug trials, suggested that, given the improvements observed in progression-free survival, zanubrutinib could become the standard of care in this setting.
In the ALPINE trial, treatment discontinuation rate was lower among patients receiving zanubrutinib (26%) versus ibrutinib (41.2%), with most discontinuations a result of adverse events or progressive disease.
And across both trials, the most common adverse reactions were decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).
A version of this article first appeared on Medscape.com.
By giving the nod to these uses of this second-generation Bruton’s tyrosine kinase inhibitor, the FDA expanded on its previous approvals of this drug in mantle cell and marginal zone lymphoma.
“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient subtypes, including the high-risk del17p/TP53-mutated population, and regardless of treatment setting,” Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute in Boston, said in a press release from drug developer BeiGene.
The FDA’s decision was based on two phase 3 trials – SEQUOIA and ALPINE. The SEQUOIA trial assessed 479 patients with treatment-naive CLL/SLL who either received zanubrutinib until disease progression or unacceptable toxicity or bendamustine plus rituximab for six cycles. Median progression-free survival was not reached in the zanubrutinib arm and was 33.7 months in the bendamustine plus rituximab arm (hazard ratio, 0.42).
In a separate, nonrandomized SEQUOIA cohort, investigators assessed zanubrutinib in patients with a 17p deletion and found an overall response rate of 88%. In addition, over the 25-month follow-up, the median duration of response was not reached.
The ALPINE trial included 652 patients with relapsed or refractory CLL/SLL who received either zanubrutinib or ibrutinib. The overall response rate was 80% in the zanubrutinib arm versus 73% in the ibrutinib arm, and the median duration of response was not reached in either arm over the 14-month follow-up period. Median progression-free survival was not reached in the zanubrutinib arm and was 35 months in the ibrutinib group.
Dr. Brown, a lead investigator on both drug trials, suggested that, given the improvements observed in progression-free survival, zanubrutinib could become the standard of care in this setting.
In the ALPINE trial, treatment discontinuation rate was lower among patients receiving zanubrutinib (26%) versus ibrutinib (41.2%), with most discontinuations a result of adverse events or progressive disease.
And across both trials, the most common adverse reactions were decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).
A version of this article first appeared on Medscape.com.
Health risks low for children exposed in utero to cancer and chemo
Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.
The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.
Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.
“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.
The paper was published online in the Journal of Clinical Oncology.
Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”
“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.
The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.
Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.
Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.
No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.
Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.
“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.
The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
A version of this article first appeared on Medscape.com.
Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.
The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.
Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.
“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.
The paper was published online in the Journal of Clinical Oncology.
Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”
“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.
The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.
Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.
Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.
No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.
Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.
“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.
The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
A version of this article first appeared on Medscape.com.
Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.
The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.
Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.
“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.
The paper was published online in the Journal of Clinical Oncology.
Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”
“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.
The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.
Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.
Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.
No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.
Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.
“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.
The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
A version of this article first appeared on Medscape.com.
Study of beliefs about what causes cancer sparks debate
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
The study, entitled, “Everything Causes Cancer? Beliefs and Attitudes Towards Cancer Prevention Among Anti-Vaxxers, Flat Earthers, and Reptilian Conspiracists: Online Cross Sectional Survey,” was published in the Christmas 2022 issue of The British Medical Journal (BMJ).
The authors explain that they set out to evaluate “the patterns of beliefs about cancer among people who believed in conspiracies, rejected the COVID-19 vaccine, or preferred alternative medicine.”
They sought such people on social media and online chat platforms and asked them questions about real and mythical causes of cancer.
Almost half of survey participants agreed with the statement, “It seems like everything causes cancer.”
Overall, among all participants, awareness of the actual causes of cancer was greater than awareness of the mythical causes of cancer, the authors report. However, awareness of the actual causes of cancer was lower among the unvaccinated and members of conspiracy groups than among their counterparts.
The authors are concerned that their findings suggest “a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer.”
Backlash and criticism
The study “highlights the difficulty society encounters in distinguishing the actual causes of cancer from mythical causes,” The BMJ commented on Twitter.
However, both the study and the journal received some backlash.
This is a “horrible article seeking to smear people with concerns about COVID vaccines,” commented Clare Craig, a British consultant pathologist who specializes in cancer diagnostics.
The study and its methodology were also harshly criticized on Twitter by Normal Fenton, professor of risk information management at the Queen Mary University of London.
The senior author of the study, Laura Costas, a medical epidemiologist with the Catalan Institute of Oncology, Barcelona, told this news organization that the naysayers on social media, many of whom focused their comments on the COVID-19 vaccine, prove the purpose of the study – that misinformation spreads widely on the internet.
“Most comments focused on spreading COVID-19 myths, which were not the direct subject of the study, and questioned the motivations of BMJ authors and the scientific community, assuming they had a common malevolent hidden agenda,” Ms. Costas said.
“They stated the need of having critical thinking, a trait in common with the scientific method, but dogmatically dismissed any information that comes from official sources,” she added.
Ms. Costas commented that “society encounters difficulty in differentiating actual from mythical causes of cancer owing to mass information. We therefore planned this study with a certain satire, which is in line with the essence of The BMJ Christmas issue.”
The BMJ has a long history of publishing a lighthearted Christmas edition full of original, satirical, and nontraditional studies. Previous years have seen studies that explored potential harms from holly and ivy, survival time of chocolates on hospital wards, and the question, “Were James Bond’s drinks shaken because of alcohol induced tremor?”
Study details
Ms. Costas and colleagues sought participants for their survey from online forums that included 4chan and Reddit, which are known for their controversial content posted by anonymous users. Data were also collected from ForoCoches and HispaChan, well-known Spanish online forums. These online sites were intentionally chosen because researchers thought “conspiracy beliefs would be more prevalent,” according to Ms. Costas.
Across the multiple forums, there were 1,494 participants. Of these, 209 participants were unvaccinated against COVID-19, 112 preferred alternatives rather than conventional medicine, and 62 reported that they believed the earth was flat or believed that humanoids take reptilian forms to manipulate human societies.
The team then sought to assess beliefs about actual and mythical (nonestablished) causes of cancer by presenting the participants with the closed risk factor questions on two validated scales – the Cancer Awareness Measure (CAM) and CAM–Mythical Causes Scale (CAM-MYCS).
Responses to both were recorded on a five-point scale; answers ranged from “strongly disagree” to “strongly agree.”
The CAM assesses cancer risk perceptions of 11 established risk factors for cancer: smoking actively or passively, consuming alcohol, low levels of physical activity, consuming red or processed meat, getting sunburnt as a child, family history of cancer, human papillomavirus infection, being overweight, age greater than or equal to 70 years, and low vegetable and fruit consumption.
The CAM-MYCS measure includes 12 questions on risk perceptions of mythical causes of cancer – nonestablished causes that are commonly believed to cause cancer but for which there is no supporting scientific evidence, the authors explain. These items include drinking from plastic bottles; eating food containing artificial sweeteners or additives and genetically modified food; using microwave ovens, aerosol containers, mobile phones, and cleaning products; living near power lines; feeling stressed; experiencing physical trauma; and being exposed to electromagnetic frequencies/non-ionizing radiation, such as wi-fi networks, radio, and television.
The most endorsed mythical causes of cancer were eating food containing additives (63.9%) or sweeteners (50.7%), feeling stressed (59.7%), and eating genetically modified foods (38.4%).
A version of this article first appeared on Medscape.com.
Multiple myeloma diagnosed more via emergency care during COVID
The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.
Key takeaway
Why this matters
While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.
Study design
Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.
Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
Key results
Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.
Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; P = .03).
Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.
Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; P = .014).
Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID.
Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
Limitations
The study does not provide a clear time frame of delays in diagnosis.
Disclosures
The study authors did not report any conflicts of interest.
A version of this article first appeared on Medscape.com .
The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.
Key takeaway
Why this matters
While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.
Study design
Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.
Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
Key results
Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.
Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; P = .03).
Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.
Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; P = .014).
Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID.
Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
Limitations
The study does not provide a clear time frame of delays in diagnosis.
Disclosures
The study authors did not report any conflicts of interest.
A version of this article first appeared on Medscape.com .
The study covered in this summary was published on Research Square as a preprint and has not yet been peer reviewed.
Key takeaway
Why this matters
While trying to avoid COVID-19 infection, patients ultimately diagnosed with multiple myeloma may have delayed interactions with healthcare professionals and consequently delayed their cancer diagnosis.
Study design
Researchers collected data on newly diagnosed patients with multiple myeloma from January 2019 until July 2021 across five institutions (three universities and two hospitals) in England. In total, 323 patients with multiple myeloma were identified.
Patients were divided into two groups: those diagnosed between Jan. 1, 2019, until Jan. 31, 2020, or pre-COVID, and those diagnosed from Feb. 1, 2020, to July 31, 2021, or post COVID.
Key results
Among all patients, 80 (24.8%) were diagnosed with smoldering multiple myeloma and 243 (75.2%) were diagnosed with multiple myeloma requiring treatment.
Significantly more patients in the post-COVID group were diagnosed with myeloma through the emergency route (45.5% post COVID vs. 32.7% pre-COVID; P = .03).
Clinical complications leading to emergency admission prior to a myeloma diagnosis also differed between the two cohorts: Acute kidney injury accounted for most emergency admissions in the pre-COVID cohort while skeletal-related events, including spinal cord compression, were the major causes for diagnosis through the emergency route in the post-COVID cohort.
Patients who were diagnosed with symptomatic myeloma pre-COVID were more likely to be treated with a triplet rather than doublet combination compared with those diagnosed in the post-COVID period (triplet pre-COVID 79.1%, post COVID 63.75%; P = .014).
Overall survival at 1 year was not significantly different between the pre-COVID and post-COVID groups: 88.2% pre-COVID, compared with 87.8% post COVID.
Overall, the authors concluded that the COVID pandemic “resulted in a shift in the symptomatology, disease burden, and routes of diagnosis of patients presenting with myeloma” and “this may have significant consequences” over the long term.
Limitations
The study does not provide a clear time frame of delays in diagnosis.
Disclosures
The study authors did not report any conflicts of interest.
A version of this article first appeared on Medscape.com .
Link between PCOS and increased risk of pancreatic cancer?
Women with polycystic ovary syndrome (PCOS) may be at a higher risk of developing pancreatic cancer, say researchers reporting a single-center case-control study.
A diagnosis of PCOS was associated with a 1.9-fold higher risk of pancreatic cancer after adjusting for age, race, ethnicity, estrogen level, and diabetes.
This is the second study to find such an association.
“Our study findings combined with those from the 2019 Swedish Registry study offer compelling evidence that PCOS may be a novel risk factor for pancreatic cancer,” said corresponding author Mengmeng Du, ScD, department of epidemiology and biostatistics, Memorial Sloan Kettering Cancer Center.
“These data suggest some individuals may have unknown metabolic derangements that may underlie the development of both conditions,” the team concluded.
The findings were published in JAMA Oncology.
Approached for comment, Srinivas Gaddam, MD, MPH, associate director of pancreatic biliary research medicine, Cedars-Sinai, suggested that the findings may pave the way for a better understanding of the two diseases, but he emphasized that more research is needed.
“I think there’s more research to be done because now we’re seeing more younger women get pancreatic cancer,” Dr. Gaddam said. “So that makes it interesting whether PCOS itself contributes to pancreatic cancer. I still think the jury is out there.”
Dr. Gaddam drew attention to the confidence interval for the finding – the adjusted odds ratio was 1.88 (95% confidence interval, 1.02-3.46). “Because their odds ratio includes 1, I’m left with the question as to whether or not this is truly associated. I’m not certain that we can draw any conclusions based on this,” he commented.
The investigators acknowledge that they did “not observe statistically significant interactions” and comment that “prospective studies are needed to examine underlying biologic mechanisms and confirm our findings.”
For the study, the team used data from the Memorial Sloan Kettering Cancer Center Pancreatic Tumor Registry. They identified patients with pancreatic cancer who also self-reported a diagnosis of PCOS.
The investigators compared data from 446 women with pathologically or cytologically confirmed pancreatic adenocarcinoma with 209 women who had no history of cancer. The mean age at cancer diagnosis or enrollment was 63.8 years among patients with pancreatic cancer and 57.7 years in the control group.
The study found that having PCOS nearly doubled a person’s risk of developing pancreatic cancer.
When adjusted for type 2 diabetes diagnosis, the odds ratio fell slightly to 1.78 (95% CI, 0.95-3.34).
Dr. Du, along with lead author Noah Peeri, PhD, were surprised that even after adjusting for body mass index and the presence of type 2 diabetes, PCOS remained strongly associated with pancreatic cancer risk.
“We originally thought type 2 diabetes may drive this association, given more than half of those with PCOS develop type 2 diabetes by age 40, according to the CDC, and type 2 diabetes has also been linked with increased pancreatic cancer risk,” said Dr. Du.
“While the association was slightly weaker and no longer statistically significant after we controlled for type 2 diabetes, the magnitude of the association remained largely unchanged,” he said.
Dr. Peeri believes that some of the factors that have been causally related to PCOS may increase an individual’s pancreatic cancer risk.
“PCOS itself does not likely cause pancreatic cancer, but metabolic problems (for example, improper breakdown of insulin) and chronic inflammation can contribute to both PCOS and pancreatic cancer risk,” Dr. Peeri said.
He concluded that the study results “suggest other underlying metabolic dysfunction may increase an individual’s pancreatic cancer risk.”
An important limitation of this study was that women in the study self-reported PCOS and may have incorrectly recalled their diagnosis. However, the authors believe it is unlikely that that had a bearing on the study findings.
The study was supported by National Cancer Institute grants, the Geoffrey Beene Foundation, and the Arnold and Arlene Goldstein Family Foundation.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) may be at a higher risk of developing pancreatic cancer, say researchers reporting a single-center case-control study.
A diagnosis of PCOS was associated with a 1.9-fold higher risk of pancreatic cancer after adjusting for age, race, ethnicity, estrogen level, and diabetes.
This is the second study to find such an association.
“Our study findings combined with those from the 2019 Swedish Registry study offer compelling evidence that PCOS may be a novel risk factor for pancreatic cancer,” said corresponding author Mengmeng Du, ScD, department of epidemiology and biostatistics, Memorial Sloan Kettering Cancer Center.
“These data suggest some individuals may have unknown metabolic derangements that may underlie the development of both conditions,” the team concluded.
The findings were published in JAMA Oncology.
Approached for comment, Srinivas Gaddam, MD, MPH, associate director of pancreatic biliary research medicine, Cedars-Sinai, suggested that the findings may pave the way for a better understanding of the two diseases, but he emphasized that more research is needed.
“I think there’s more research to be done because now we’re seeing more younger women get pancreatic cancer,” Dr. Gaddam said. “So that makes it interesting whether PCOS itself contributes to pancreatic cancer. I still think the jury is out there.”
Dr. Gaddam drew attention to the confidence interval for the finding – the adjusted odds ratio was 1.88 (95% confidence interval, 1.02-3.46). “Because their odds ratio includes 1, I’m left with the question as to whether or not this is truly associated. I’m not certain that we can draw any conclusions based on this,” he commented.
The investigators acknowledge that they did “not observe statistically significant interactions” and comment that “prospective studies are needed to examine underlying biologic mechanisms and confirm our findings.”
For the study, the team used data from the Memorial Sloan Kettering Cancer Center Pancreatic Tumor Registry. They identified patients with pancreatic cancer who also self-reported a diagnosis of PCOS.
The investigators compared data from 446 women with pathologically or cytologically confirmed pancreatic adenocarcinoma with 209 women who had no history of cancer. The mean age at cancer diagnosis or enrollment was 63.8 years among patients with pancreatic cancer and 57.7 years in the control group.
The study found that having PCOS nearly doubled a person’s risk of developing pancreatic cancer.
When adjusted for type 2 diabetes diagnosis, the odds ratio fell slightly to 1.78 (95% CI, 0.95-3.34).
Dr. Du, along with lead author Noah Peeri, PhD, were surprised that even after adjusting for body mass index and the presence of type 2 diabetes, PCOS remained strongly associated with pancreatic cancer risk.
“We originally thought type 2 diabetes may drive this association, given more than half of those with PCOS develop type 2 diabetes by age 40, according to the CDC, and type 2 diabetes has also been linked with increased pancreatic cancer risk,” said Dr. Du.
“While the association was slightly weaker and no longer statistically significant after we controlled for type 2 diabetes, the magnitude of the association remained largely unchanged,” he said.
Dr. Peeri believes that some of the factors that have been causally related to PCOS may increase an individual’s pancreatic cancer risk.
“PCOS itself does not likely cause pancreatic cancer, but metabolic problems (for example, improper breakdown of insulin) and chronic inflammation can contribute to both PCOS and pancreatic cancer risk,” Dr. Peeri said.
He concluded that the study results “suggest other underlying metabolic dysfunction may increase an individual’s pancreatic cancer risk.”
An important limitation of this study was that women in the study self-reported PCOS and may have incorrectly recalled their diagnosis. However, the authors believe it is unlikely that that had a bearing on the study findings.
The study was supported by National Cancer Institute grants, the Geoffrey Beene Foundation, and the Arnold and Arlene Goldstein Family Foundation.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) may be at a higher risk of developing pancreatic cancer, say researchers reporting a single-center case-control study.
A diagnosis of PCOS was associated with a 1.9-fold higher risk of pancreatic cancer after adjusting for age, race, ethnicity, estrogen level, and diabetes.
This is the second study to find such an association.
“Our study findings combined with those from the 2019 Swedish Registry study offer compelling evidence that PCOS may be a novel risk factor for pancreatic cancer,” said corresponding author Mengmeng Du, ScD, department of epidemiology and biostatistics, Memorial Sloan Kettering Cancer Center.
“These data suggest some individuals may have unknown metabolic derangements that may underlie the development of both conditions,” the team concluded.
The findings were published in JAMA Oncology.
Approached for comment, Srinivas Gaddam, MD, MPH, associate director of pancreatic biliary research medicine, Cedars-Sinai, suggested that the findings may pave the way for a better understanding of the two diseases, but he emphasized that more research is needed.
“I think there’s more research to be done because now we’re seeing more younger women get pancreatic cancer,” Dr. Gaddam said. “So that makes it interesting whether PCOS itself contributes to pancreatic cancer. I still think the jury is out there.”
Dr. Gaddam drew attention to the confidence interval for the finding – the adjusted odds ratio was 1.88 (95% confidence interval, 1.02-3.46). “Because their odds ratio includes 1, I’m left with the question as to whether or not this is truly associated. I’m not certain that we can draw any conclusions based on this,” he commented.
The investigators acknowledge that they did “not observe statistically significant interactions” and comment that “prospective studies are needed to examine underlying biologic mechanisms and confirm our findings.”
For the study, the team used data from the Memorial Sloan Kettering Cancer Center Pancreatic Tumor Registry. They identified patients with pancreatic cancer who also self-reported a diagnosis of PCOS.
The investigators compared data from 446 women with pathologically or cytologically confirmed pancreatic adenocarcinoma with 209 women who had no history of cancer. The mean age at cancer diagnosis or enrollment was 63.8 years among patients with pancreatic cancer and 57.7 years in the control group.
The study found that having PCOS nearly doubled a person’s risk of developing pancreatic cancer.
When adjusted for type 2 diabetes diagnosis, the odds ratio fell slightly to 1.78 (95% CI, 0.95-3.34).
Dr. Du, along with lead author Noah Peeri, PhD, were surprised that even after adjusting for body mass index and the presence of type 2 diabetes, PCOS remained strongly associated with pancreatic cancer risk.
“We originally thought type 2 diabetes may drive this association, given more than half of those with PCOS develop type 2 diabetes by age 40, according to the CDC, and type 2 diabetes has also been linked with increased pancreatic cancer risk,” said Dr. Du.
“While the association was slightly weaker and no longer statistically significant after we controlled for type 2 diabetes, the magnitude of the association remained largely unchanged,” he said.
Dr. Peeri believes that some of the factors that have been causally related to PCOS may increase an individual’s pancreatic cancer risk.
“PCOS itself does not likely cause pancreatic cancer, but metabolic problems (for example, improper breakdown of insulin) and chronic inflammation can contribute to both PCOS and pancreatic cancer risk,” Dr. Peeri said.
He concluded that the study results “suggest other underlying metabolic dysfunction may increase an individual’s pancreatic cancer risk.”
An important limitation of this study was that women in the study self-reported PCOS and may have incorrectly recalled their diagnosis. However, the authors believe it is unlikely that that had a bearing on the study findings.
The study was supported by National Cancer Institute grants, the Geoffrey Beene Foundation, and the Arnold and Arlene Goldstein Family Foundation.
A version of this article first appeared on Medscape.com.
FROM JAMA ONCOLOGY
FDA OKs selpercatinib for adults with RET-fusion+ solid tumors
that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.
In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.
The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.
Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.
“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”
The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).
The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.
The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
A version of this article first appeared on Medscape.com.
that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.
In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.
The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.
Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.
“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”
The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).
The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.
The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
A version of this article first appeared on Medscape.com.
that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.
In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on Sept. 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.
The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion–positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one-third receiving three or more. Primary efficacy measures were overall response rate and duration of response.
Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.
“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” Vivek Subbiah, MD, coinvestigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”
The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).
The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh less than 110 pounds or 160 mg orally twice daily for who weigh 110 pounds or more.
The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
A version of this article first appeared on Medscape.com.
FDA OKs sodium thiosulfate injection to reduce ototoxicity risk in children with cancer
This approval makes sodium thiosulfate the first and only treatment FDA-approved in this area.
“Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss,” said David R. Freyer, DO, of Children’s Hospital Los Angeles and primary investigator of one of the two trials, COG ACCL0431. The FDA’s approval “addresses an enormous unmet need for many children and young adults.”
The approval was based on safety and efficacy data from two multicenter open-label, randomized controlled phase 3 trials – SIOPEL 6 and COG ACCL0431 – comparing sodium thiosulfate plus a cisplatin-based regimen to a cisplatin-based regimen alone in pediatric patients. SIOPEL 6 included patients with standard risk hepatoblastoma, and COG ACCL0431 included pediatric patients with solid tumors.
In both studies, the incidence of hearing loss was significantly lower in the sodium thiosulfate group, compared with the cisplatin-only group. In SIOPEL 6, hearing loss of grade 1 or higher occurred in 33% of children (18 of 55) in the cisplatin–sodium thiosulfate group and 63% (29 of 46) in the cisplatin-only group, indicating a 48% lower incidence of hearing loss for those receiving sodium thiosulfate. In COG ACCL0431, hearing loss was identified in 28.6% of patients (14 of 49) receiving sodium thiosulfate, compared with 56.4% (31 of 55) in the control group, indicating a 69% lower risk for hearing loss in the sodium thiosulfate group.
The FDA reported the same overall trend but highlighted slightly different figures. In SIOPEL 6, hearing loss incidence occurred in 39% of patients (24 of 61) in the sodium thiosulfate arm versus 68% (36 of 53) in the control group; in COG ACCL0431, hearing loss incidence occurred among 44% of patients (17 of 39) in the sodium thiosulfate group versus 58% (22 of 38) in the control group.
The recommended dose is based on surface area according to body weight. Sodium thiosulfate is administered as an intravenous infusion over 15 minutes following cisplatin infusions that are 1 to 6 hours in duration.
Serious adverse reactions occurred in 40% of patients who received cisplatin–sodium thiosulfate in SIOPEL 6 and 36% of these patients in COG ACCL0431. The most common adverse reactions in the trials included vomiting, infection, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.
A version of this article first appeared on Medscape.com.
This approval makes sodium thiosulfate the first and only treatment FDA-approved in this area.
“Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss,” said David R. Freyer, DO, of Children’s Hospital Los Angeles and primary investigator of one of the two trials, COG ACCL0431. The FDA’s approval “addresses an enormous unmet need for many children and young adults.”
The approval was based on safety and efficacy data from two multicenter open-label, randomized controlled phase 3 trials – SIOPEL 6 and COG ACCL0431 – comparing sodium thiosulfate plus a cisplatin-based regimen to a cisplatin-based regimen alone in pediatric patients. SIOPEL 6 included patients with standard risk hepatoblastoma, and COG ACCL0431 included pediatric patients with solid tumors.
In both studies, the incidence of hearing loss was significantly lower in the sodium thiosulfate group, compared with the cisplatin-only group. In SIOPEL 6, hearing loss of grade 1 or higher occurred in 33% of children (18 of 55) in the cisplatin–sodium thiosulfate group and 63% (29 of 46) in the cisplatin-only group, indicating a 48% lower incidence of hearing loss for those receiving sodium thiosulfate. In COG ACCL0431, hearing loss was identified in 28.6% of patients (14 of 49) receiving sodium thiosulfate, compared with 56.4% (31 of 55) in the control group, indicating a 69% lower risk for hearing loss in the sodium thiosulfate group.
The FDA reported the same overall trend but highlighted slightly different figures. In SIOPEL 6, hearing loss incidence occurred in 39% of patients (24 of 61) in the sodium thiosulfate arm versus 68% (36 of 53) in the control group; in COG ACCL0431, hearing loss incidence occurred among 44% of patients (17 of 39) in the sodium thiosulfate group versus 58% (22 of 38) in the control group.
The recommended dose is based on surface area according to body weight. Sodium thiosulfate is administered as an intravenous infusion over 15 minutes following cisplatin infusions that are 1 to 6 hours in duration.
Serious adverse reactions occurred in 40% of patients who received cisplatin–sodium thiosulfate in SIOPEL 6 and 36% of these patients in COG ACCL0431. The most common adverse reactions in the trials included vomiting, infection, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.
A version of this article first appeared on Medscape.com.
This approval makes sodium thiosulfate the first and only treatment FDA-approved in this area.
“Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss,” said David R. Freyer, DO, of Children’s Hospital Los Angeles and primary investigator of one of the two trials, COG ACCL0431. The FDA’s approval “addresses an enormous unmet need for many children and young adults.”
The approval was based on safety and efficacy data from two multicenter open-label, randomized controlled phase 3 trials – SIOPEL 6 and COG ACCL0431 – comparing sodium thiosulfate plus a cisplatin-based regimen to a cisplatin-based regimen alone in pediatric patients. SIOPEL 6 included patients with standard risk hepatoblastoma, and COG ACCL0431 included pediatric patients with solid tumors.
In both studies, the incidence of hearing loss was significantly lower in the sodium thiosulfate group, compared with the cisplatin-only group. In SIOPEL 6, hearing loss of grade 1 or higher occurred in 33% of children (18 of 55) in the cisplatin–sodium thiosulfate group and 63% (29 of 46) in the cisplatin-only group, indicating a 48% lower incidence of hearing loss for those receiving sodium thiosulfate. In COG ACCL0431, hearing loss was identified in 28.6% of patients (14 of 49) receiving sodium thiosulfate, compared with 56.4% (31 of 55) in the control group, indicating a 69% lower risk for hearing loss in the sodium thiosulfate group.
The FDA reported the same overall trend but highlighted slightly different figures. In SIOPEL 6, hearing loss incidence occurred in 39% of patients (24 of 61) in the sodium thiosulfate arm versus 68% (36 of 53) in the control group; in COG ACCL0431, hearing loss incidence occurred among 44% of patients (17 of 39) in the sodium thiosulfate group versus 58% (22 of 38) in the control group.
The recommended dose is based on surface area according to body weight. Sodium thiosulfate is administered as an intravenous infusion over 15 minutes following cisplatin infusions that are 1 to 6 hours in duration.
Serious adverse reactions occurred in 40% of patients who received cisplatin–sodium thiosulfate in SIOPEL 6 and 36% of these patients in COG ACCL0431. The most common adverse reactions in the trials included vomiting, infection, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.
A version of this article first appeared on Medscape.com.
Date with adult model leads to testicular cancer diagnosis
For 7 years, Belle Grace had been working with children and adults diagnosed with autism. But during the COVID-19 pandemic, like many other people, she began to look for alternative streams of revenue.
In May 2020, Ms. Grace created a profile on the adult content subscription site OnlyFans.
“I was taking some time off of work and found myself on OnlyFans as a bit of a side hustle,” said Ms. Grace. “It wasn’t until I started earning five times more than my standard wage that I decided to go full-time and make that career change.”
She soon built up a regular clientele, hosting intimate video chats.
While video chatting with one of her loyal subscribers, Ms. Grace noticed something different about his testicles. Hesitantly, she mentioned that one testicle was a lot larger than the other – a change she hadn’t noticed before during their 2 years of interacting.
Ms. Grace says she was nervous about bringing up the subject with her subscriber. She suggested that he should see a doctor to have his testicles checked out, but her client didn’t go right away.
Ms. Grace says he waited a couple of months to go in for a check-up because he was slightly embarrassed. When he finally went to the doctor, he was given a diagnosis of testicular cancer.
Although Ms. Grace says that the conversation with her subscriber was a bit awkward, she’s happy she gathered the courage to bring it to his attention.
Testicular cancer is relatively rare, but it usually has a good prognosis – the survival rate is about 95%, according to Alexander Kutikov, MD, professor of surgical oncology at Fox Chase Cancer Center in Philadelphia.
Dr. Kutikov emphasized that men shouldn’t wait if they notice any changes in their genitals. The quicker they go see a doctor, the better the outcome is likely to be if it does turn out to be something serious.
For testicular cancer, “the treatment can be much more simple if it’s caught early – avoiding chemotherapy and avoiding major surgery,” Dr. Kutikov said.
“But even testicular cancers that present after they have spread can be cured. So a delay is suboptimal, but it’s not as devastating as some other cancers,” he added.
Most men who are diagnosed with testicular cancer present after noticing changes in the scrotum where one testicle feels and looks different from the other, Dr. Kutikov commented. In addition, there is usually a very firm mass or nodule that can be felt under the skin.
“Another common symptom is back pain, because testicular cancer can go to the lymph nodes in the back as well,” he said.
Dr. Kutikov says it all comes down to being aware of your body and noticing any major changes.
Ms. Grace suggests that sexual intimacy offers an opportunity for noting physical changes, “because you and your sexual partner are able to see each other’s bodies in the most intimate [manner].”
“People should be telling their partners if they notice any changes,” she says, for example, on their skin, such as sores or rashes, or lumps under the skin. “Even a change in a mole could be essential for your partner’s health,” she said.
A version of this article first appeared on Medscape.com.
For 7 years, Belle Grace had been working with children and adults diagnosed with autism. But during the COVID-19 pandemic, like many other people, she began to look for alternative streams of revenue.
In May 2020, Ms. Grace created a profile on the adult content subscription site OnlyFans.
“I was taking some time off of work and found myself on OnlyFans as a bit of a side hustle,” said Ms. Grace. “It wasn’t until I started earning five times more than my standard wage that I decided to go full-time and make that career change.”
She soon built up a regular clientele, hosting intimate video chats.
While video chatting with one of her loyal subscribers, Ms. Grace noticed something different about his testicles. Hesitantly, she mentioned that one testicle was a lot larger than the other – a change she hadn’t noticed before during their 2 years of interacting.
Ms. Grace says she was nervous about bringing up the subject with her subscriber. She suggested that he should see a doctor to have his testicles checked out, but her client didn’t go right away.
Ms. Grace says he waited a couple of months to go in for a check-up because he was slightly embarrassed. When he finally went to the doctor, he was given a diagnosis of testicular cancer.
Although Ms. Grace says that the conversation with her subscriber was a bit awkward, she’s happy she gathered the courage to bring it to his attention.
Testicular cancer is relatively rare, but it usually has a good prognosis – the survival rate is about 95%, according to Alexander Kutikov, MD, professor of surgical oncology at Fox Chase Cancer Center in Philadelphia.
Dr. Kutikov emphasized that men shouldn’t wait if they notice any changes in their genitals. The quicker they go see a doctor, the better the outcome is likely to be if it does turn out to be something serious.
For testicular cancer, “the treatment can be much more simple if it’s caught early – avoiding chemotherapy and avoiding major surgery,” Dr. Kutikov said.
“But even testicular cancers that present after they have spread can be cured. So a delay is suboptimal, but it’s not as devastating as some other cancers,” he added.
Most men who are diagnosed with testicular cancer present after noticing changes in the scrotum where one testicle feels and looks different from the other, Dr. Kutikov commented. In addition, there is usually a very firm mass or nodule that can be felt under the skin.
“Another common symptom is back pain, because testicular cancer can go to the lymph nodes in the back as well,” he said.
Dr. Kutikov says it all comes down to being aware of your body and noticing any major changes.
Ms. Grace suggests that sexual intimacy offers an opportunity for noting physical changes, “because you and your sexual partner are able to see each other’s bodies in the most intimate [manner].”
“People should be telling their partners if they notice any changes,” she says, for example, on their skin, such as sores or rashes, or lumps under the skin. “Even a change in a mole could be essential for your partner’s health,” she said.
A version of this article first appeared on Medscape.com.
For 7 years, Belle Grace had been working with children and adults diagnosed with autism. But during the COVID-19 pandemic, like many other people, she began to look for alternative streams of revenue.
In May 2020, Ms. Grace created a profile on the adult content subscription site OnlyFans.
“I was taking some time off of work and found myself on OnlyFans as a bit of a side hustle,” said Ms. Grace. “It wasn’t until I started earning five times more than my standard wage that I decided to go full-time and make that career change.”
She soon built up a regular clientele, hosting intimate video chats.
While video chatting with one of her loyal subscribers, Ms. Grace noticed something different about his testicles. Hesitantly, she mentioned that one testicle was a lot larger than the other – a change she hadn’t noticed before during their 2 years of interacting.
Ms. Grace says she was nervous about bringing up the subject with her subscriber. She suggested that he should see a doctor to have his testicles checked out, but her client didn’t go right away.
Ms. Grace says he waited a couple of months to go in for a check-up because he was slightly embarrassed. When he finally went to the doctor, he was given a diagnosis of testicular cancer.
Although Ms. Grace says that the conversation with her subscriber was a bit awkward, she’s happy she gathered the courage to bring it to his attention.
Testicular cancer is relatively rare, but it usually has a good prognosis – the survival rate is about 95%, according to Alexander Kutikov, MD, professor of surgical oncology at Fox Chase Cancer Center in Philadelphia.
Dr. Kutikov emphasized that men shouldn’t wait if they notice any changes in their genitals. The quicker they go see a doctor, the better the outcome is likely to be if it does turn out to be something serious.
For testicular cancer, “the treatment can be much more simple if it’s caught early – avoiding chemotherapy and avoiding major surgery,” Dr. Kutikov said.
“But even testicular cancers that present after they have spread can be cured. So a delay is suboptimal, but it’s not as devastating as some other cancers,” he added.
Most men who are diagnosed with testicular cancer present after noticing changes in the scrotum where one testicle feels and looks different from the other, Dr. Kutikov commented. In addition, there is usually a very firm mass or nodule that can be felt under the skin.
“Another common symptom is back pain, because testicular cancer can go to the lymph nodes in the back as well,” he said.
Dr. Kutikov says it all comes down to being aware of your body and noticing any major changes.
Ms. Grace suggests that sexual intimacy offers an opportunity for noting physical changes, “because you and your sexual partner are able to see each other’s bodies in the most intimate [manner].”
“People should be telling their partners if they notice any changes,” she says, for example, on their skin, such as sores or rashes, or lumps under the skin. “Even a change in a mole could be essential for your partner’s health,” she said.
A version of this article first appeared on Medscape.com.