User login
AVAHO
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
div[contains(@class, 'main-prefix')]
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]


Gut bacteria may fuel prostate cancer treatment resistance
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.
Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.
A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.
Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.
Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.
But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.
The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.
A version of this article first appeared on WebMD.com.
No advantages to using ADM in implant-based breast reconstruction
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A European study involving 155 women found that the use of acellular dermal matrix (ADM) did not lead to fewer reoperations, nor was it superior in terms of health-related quality of life or patient-reported cosmetic outcomes.
“We feel that women considering implant-based reconstructions for breast cancer should be informed about the lack of evidence supporting its advantage,” said lead author Fredrik Lohmander MD, department of breast and endocrine surgery, section of breast urgery, Karolinska University Hospital, Stockholm.
It is difficult to say generally whether ADM should be used in IBBR, he noted. “We can only conclude from our trial that there is no hard evidence that ADM is beneficial when performing breast reconstructions with implants,” he said in an interview. “In selected patients, ADM might be indicated.”
The study was conducted in Sweden and the United Kingdom. “Mostly because of high costs, ADM in implant-based breast reconstructions in Sweden is not frequently used,” Dr. Lohmander said. “It is slightly more common in the U.K., but much more common in the U.S.A.”
Although biological meshes have received regulatory approval by the U.S. Food and Drug Administration for reconstructive purposes, ADM has not been approved for use in breast reconstruction surgery, and its use in this setting is off label.
The study was published online October 1 in JAMA Network Open.
Any advantage to using mesh device?
Previous studies of ADMs suggested that the mesh device conferred several benefits, including superior cosmetic results, less need for tissue expanders, fewer elective reoperations, and less capsular contracture. The use of a mesh device also enlarges the subpectoral pocket, which allows for larger fixed-volume implants, the authors note.
However, these suggested advantages have not been universally accepted, and the authors note that there have been reports of associated harm, such as higher rates of infection and implant loss.
The new study included 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and had planned to undergo mastectomy and immediate IBBR between 2014 and May 2017.
The primary endpoint was the number of repeat surgeries at 2 years.
At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, vs 35 (54%) in the control group (P = .54). Results were similar for the contralateral side: 34 (53%) vs 31 (48%).
Two patients in the ADM group and three patients in the control group underwent a risk-reducing mastectomy on the contralateral side. These five surgeries were included in the final analysis.
For nine patients (14%) in the ADM arm, the implant was removed. Four of the removals took place within 6 months after early surgical complications. In the control group, seven patients (11%) underwent implant removal; four were removed within 6 months, owing to early surgical complications.
The secondary endpoint was postoperative health-related quality of life, including perception of body image and satisfaction with cosmetic outcome. There were no significant differences between the two groups.
Some questions remain
Approached for comment on the study, Sameer A. Patel, MD, FACS, chief of plastic and reconstructive surgery at Fox Chase Cancer Center, Philadelphia, noted that the practice of using AMD for breast reconstruction is quite common in the United States, so these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that the use of ADM would reduce the number of reoperations within the first 24 months, which it did not,” he said. “This is despite the fact that the ADM group had a significantly higher number of direct-to-implant reconstructions.”
Importantly, the study showed that patient-reported outcomes, as opposed to surgeon’s evaluation of outcomes, were also not different for the most part between the two groups, Dr. Patel pointed out. “The only exception of small favorable advantage in the ADM group was for fitting bras,” he said.
However, there were limitations to the study’s endpoint. “I would add that there are some purported advantages of using ADM, such as reduction in postoperative pain and reduction in length of hospital stay, which are not evaluated by this study,” Patel explained. “Also, I am not certain that they can conclude from this study that capsular contracture is not reduced, because it is not designed to evaluate that.”
But the biggest limitation is one that study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is rapidly replacing the dual plane reconstruction that this paper used in the ADM group,” Dr. Patel said. “The role of ADM in prepectoral reconstruction is somewhat different than in the dual plane reconstruction, and so these results may not necessarily be extrapolated to prepectoral reconstruction.”
The study was funded with grants from the Swedish Breast Cancer Association and Stockholm City Council. The trial was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) supplied the study with acellular dermal matrix meshes. Dr. Lohmander and Dr. Patel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Watchful waiting sometimes best for asymptomatic basal cell carcinoma
“Patient preferences, treatment goals, and the option for proceeding with a watchful waiting approach should be discussed as part of personalized shared decision-making,” wrote Marieke van Winden, MD, MSc, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues. “In patients with a limited life expectancy and asymptomatic low-risk tumors, the time to benefit from treatment might exceed life expectancy, and watchful waiting should be discussed as a potentially appropriate approach.”
As little research has been undertaken on watchful waiting in patients with BCC, the expected tumor growth, progression and the chance of developing symptoms while taking this approach are poorly understood. Patients with limited life expectancy might not live long enough to develop BCC symptoms and may benefit more from watchful waiting than active treatment, authors of the study wrote.
This observational cohort study evaluated the reasons for watchful waiting, along with the natural course of 280 BCCs in 89 patients (53% men, median age 83 years) who chose this approach. Patients had one or more untreated BCCs for at least 3 months and the median follow-up was 9 months. The researchers also looked at the reasons for initiating later treatment.
Patient-related factors, including limited life expectancy, comorbidity prioritizations, and frailty, were the most important reasons to choose watchful waiting in 83% of patients, followed by tumor-related factors in 55% of patients. Of the tumors, 47% increased in size. The estimated tumor diameter increase in 1 year was 4.46 mm for infiltrative/micronodular BCCs and 1.06 mm for nodular, superficial, or clinical BCCs. Tumor growth was not associated with initial tumor size and location.
The most common reasons to initiate active treatment were tumor burden, resolved reasons for watchful waiting, and reevaluation of patient-related factors.
“All patients should be followed up regularly to determine whether a watchful waiting approach is still suited and if patients still prefer watchful waiting to reconsider the consequences of refraining from treatment,” the authors wrote.
In an accompanying editorial, Mackenzie R. Wehner, MD, MPhil, of the University of Texas MD Anderson Cancer Center in Houston, said that, while the observational and retrospective design was a limitation of the study, this allowed the authors to observe patients avoiding or delaying treatment for BCC in real clinical practice.
The study “shows that few patients developed new symptoms, and few patients who decided to treat after a delay had more invasive interventions than originally anticipated, an encouraging result as we continue to study the option and hone the details of active surveillance in BCC,” Dr. Wehner wrote. “It is important to note that the authors did not perform actual active surveillance. This study did not prospectively enroll patients and see them in follow-up at set times, nor did it have prespecified end points for recommending treatment.”
“Before evidence-based active surveillance in BCC can become a viable option, prospective studies of active surveillance, with specified follow-up times and clear outcome measures, are needed,” Dr. Wehner wrote.
Dr. van Winden did not report any conflicts of interest.
“Patient preferences, treatment goals, and the option for proceeding with a watchful waiting approach should be discussed as part of personalized shared decision-making,” wrote Marieke van Winden, MD, MSc, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues. “In patients with a limited life expectancy and asymptomatic low-risk tumors, the time to benefit from treatment might exceed life expectancy, and watchful waiting should be discussed as a potentially appropriate approach.”
As little research has been undertaken on watchful waiting in patients with BCC, the expected tumor growth, progression and the chance of developing symptoms while taking this approach are poorly understood. Patients with limited life expectancy might not live long enough to develop BCC symptoms and may benefit more from watchful waiting than active treatment, authors of the study wrote.
This observational cohort study evaluated the reasons for watchful waiting, along with the natural course of 280 BCCs in 89 patients (53% men, median age 83 years) who chose this approach. Patients had one or more untreated BCCs for at least 3 months and the median follow-up was 9 months. The researchers also looked at the reasons for initiating later treatment.
Patient-related factors, including limited life expectancy, comorbidity prioritizations, and frailty, were the most important reasons to choose watchful waiting in 83% of patients, followed by tumor-related factors in 55% of patients. Of the tumors, 47% increased in size. The estimated tumor diameter increase in 1 year was 4.46 mm for infiltrative/micronodular BCCs and 1.06 mm for nodular, superficial, or clinical BCCs. Tumor growth was not associated with initial tumor size and location.
The most common reasons to initiate active treatment were tumor burden, resolved reasons for watchful waiting, and reevaluation of patient-related factors.
“All patients should be followed up regularly to determine whether a watchful waiting approach is still suited and if patients still prefer watchful waiting to reconsider the consequences of refraining from treatment,” the authors wrote.
In an accompanying editorial, Mackenzie R. Wehner, MD, MPhil, of the University of Texas MD Anderson Cancer Center in Houston, said that, while the observational and retrospective design was a limitation of the study, this allowed the authors to observe patients avoiding or delaying treatment for BCC in real clinical practice.
The study “shows that few patients developed new symptoms, and few patients who decided to treat after a delay had more invasive interventions than originally anticipated, an encouraging result as we continue to study the option and hone the details of active surveillance in BCC,” Dr. Wehner wrote. “It is important to note that the authors did not perform actual active surveillance. This study did not prospectively enroll patients and see them in follow-up at set times, nor did it have prespecified end points for recommending treatment.”
“Before evidence-based active surveillance in BCC can become a viable option, prospective studies of active surveillance, with specified follow-up times and clear outcome measures, are needed,” Dr. Wehner wrote.
Dr. van Winden did not report any conflicts of interest.
“Patient preferences, treatment goals, and the option for proceeding with a watchful waiting approach should be discussed as part of personalized shared decision-making,” wrote Marieke van Winden, MD, MSc, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues. “In patients with a limited life expectancy and asymptomatic low-risk tumors, the time to benefit from treatment might exceed life expectancy, and watchful waiting should be discussed as a potentially appropriate approach.”
As little research has been undertaken on watchful waiting in patients with BCC, the expected tumor growth, progression and the chance of developing symptoms while taking this approach are poorly understood. Patients with limited life expectancy might not live long enough to develop BCC symptoms and may benefit more from watchful waiting than active treatment, authors of the study wrote.
This observational cohort study evaluated the reasons for watchful waiting, along with the natural course of 280 BCCs in 89 patients (53% men, median age 83 years) who chose this approach. Patients had one or more untreated BCCs for at least 3 months and the median follow-up was 9 months. The researchers also looked at the reasons for initiating later treatment.
Patient-related factors, including limited life expectancy, comorbidity prioritizations, and frailty, were the most important reasons to choose watchful waiting in 83% of patients, followed by tumor-related factors in 55% of patients. Of the tumors, 47% increased in size. The estimated tumor diameter increase in 1 year was 4.46 mm for infiltrative/micronodular BCCs and 1.06 mm for nodular, superficial, or clinical BCCs. Tumor growth was not associated with initial tumor size and location.
The most common reasons to initiate active treatment were tumor burden, resolved reasons for watchful waiting, and reevaluation of patient-related factors.
“All patients should be followed up regularly to determine whether a watchful waiting approach is still suited and if patients still prefer watchful waiting to reconsider the consequences of refraining from treatment,” the authors wrote.
In an accompanying editorial, Mackenzie R. Wehner, MD, MPhil, of the University of Texas MD Anderson Cancer Center in Houston, said that, while the observational and retrospective design was a limitation of the study, this allowed the authors to observe patients avoiding or delaying treatment for BCC in real clinical practice.
The study “shows that few patients developed new symptoms, and few patients who decided to treat after a delay had more invasive interventions than originally anticipated, an encouraging result as we continue to study the option and hone the details of active surveillance in BCC,” Dr. Wehner wrote. “It is important to note that the authors did not perform actual active surveillance. This study did not prospectively enroll patients and see them in follow-up at set times, nor did it have prespecified end points for recommending treatment.”
“Before evidence-based active surveillance in BCC can become a viable option, prospective studies of active surveillance, with specified follow-up times and clear outcome measures, are needed,” Dr. Wehner wrote.
Dr. van Winden did not report any conflicts of interest.
FROM JAMA DERMATOLOGY
Community mourns nurse knocked over, killed in Times Square
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
in New York City. The Mass was promoted by the local consulate general of the Philippines.
Maria Ambrocio, 58, was visiting Times Square with a friend on October 1 when she was shoved to the ground by a man who reportedly snatched a cellphone and was running away. He later collided with a police officer before being arrested.
Ms. Ambrosio, of Bayonne, N.J., was taken to Bellevue Hospital in Manhattan with a traumatic brain injury. She was taken off life support a day later.
Jermaine Foster, 26, was charged with murder and robbery and is scheduled to appear in New York Criminal Court Thursday, according to court records.
Ms. Ambrocio, who had been a nurse for 25 years at Bayonne Medical Center in New Jersey, treated cancer patients, even during the height of the pandemic. The medical community at the hospital posted on social media, “Maria’s untimely death is a profound loss to us all, especially those whose lives she touched each day at Bayonne Medical Center.”
New York organizations expressed sympathy after the incident. Tom Harris, president of the Times Square Alliance, said in a statement shared with this news organization, “Our deepest condolences to the family of Maria Ambrocio. The killing of Maria Ambrocio near Times Square highlights one of our city’s greatest public safety challenges, the proliferation of people with untreated mental illness and drug addictions on our streets committing crimes without an effective strategy to address them. Our city needs to come together and solve these problems and those of us who work in these areas are willing and able to help. Let her death not be in vain.”
The New York Philippine consulate reported on its Facebook page that Ms. Ambrocio had just visited its office when the incident occurred. “We grieve with the rest of the Filipino Community over the death of our kababayan [countryman], Maria Ambrocio, a 58-year-old health frontliner from Bayonne, New Jersey....
“Maria’s passing was announced shortly after she was removed from life support a few hours ago. She had been on life support for the head trauma she sustained on Friday afternoon after she was knocked down by someone who was described as a mentally disturbed homeless man. Maria was walking with a kababayan near Times Square after visiting the Philippine consulate general when she was struck by the suspect, who was reportedly being chased after grabbing a mobile phone from someone.”
On the day she passed away, Bayonne Mayor Jimmy Davis shared an emotional message on Facebook: “I’m asking for all Bayonne people to say a prayer for Maria Ambrocio. Maria, an Oncology nurse at Bayonne Medical Center, was viciously attacked in an unprovoked assault by a deranged man in Times Square yesterday.
“Please keep Maria and her family in your thoughts through these difficult days.”
A version of this article first appeared on Medscape.com.
Benzene prompts recalls of spray antifungals and sunscreens
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
‘Regionalized’ care tied to better survival in tough cancer
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The Kaiser Permanente Northern California (KPNC) Gastric-Esophageal Cancer Program was established in 2016 to consolidate the care of patients with gastric cancer and increase physician specialization and standardization.
In a retrospective study, Kaiser Permanente investigators compared the outcomes of the 942 patients diagnosed before the regional gastric cancer team was established with the outcomes of the 487 patients treated after it was implemented. Overall, the transformation appears to enhance the delivery of care and improves clinical and oncologic outcomes.
For example, among 394 patients who received curative-intent surgery, overall survival at 2 years increased from 72.7% before the program to 85.5% afterward.
“The regionalized gastric cancer program combines the benefits of community-based care, which is local and convenient, with the expertise of a specialized cancer center,” said coauthor Lisa Herrinton, PhD, a research scientist at the Kaiser Permanente division of research, in a statement.
She added that, in their integrated care system, “it is easy for the different physicians that treat cancer patients – including surgical oncologists, medical oncologists, and radiation oncologists, among others – to come together and collaborate and tie their work flows together.”
The study was published in the Journal of Clinical Oncology.
Gastric cancer accounts for about 27,600 cases diagnosed annually in the United States, but the overall 5-year survival is still only 32%. About half of the cases are locoregional (stage I-III) and potentially eligible for curative-intent surgery and adjuvant therapy, the authors pointed out in the study.
As compared with North America, the incidence rate is five to six times higher in East Asia, but they have developed better surveillance for early detection and treatment is highly effective, as the increased incidence allows oncologists and surgeons to achieve greater specialization. Laparoscopic gastrectomy and extended (D2) lymph node dissection are more commonly performed in East Asia as compared with the United States, and surgical outcomes appear to be better in East Asia.
Regionalizing care
The rationale for regionalizing care was that increasing and concentrating the volume of cases to a specific location would make it more possible to introduce new surgical procedures as well as allow medical oncologists to uniformly introduce and standardize the use of the newest chemotherapy regimens.
Prior to regionalization, gastric cancer surgery was performed at 19 medical centers in the Kaiser system. Now, curative-intent laparoscopic gastrectomy with Roux-en-Y gastrojejunostomy or esophagojejunostomy and side-to-side jejunojejunostomy is subsequently performed at only two centers by five surgeons.
“The two centers were selected based on how skilled the surgeons were at performing advanced minimally invasive oncologic surgery,” said lead author Swee H. Teh, MD, surgical director, gastric cancer surgery, Kaiser Permanente Northern California. “We also looked at the center’s retrospective gastrectomy outcomes and the strength of the leadership that would be collaborating with the regional multidisciplinary team.”
Dr. Teh said in an interview that it was imperative that their regional gastric cancer centers have surgeons highly skilled in advanced minimally invasive gastrointestinal surgery. “This is a newer technique and not one of our more senior surgeons had been trained in [it],” he said. “With this change, some surgeons were now no longer performing gastric cancer surgery.”
Not only were the centers selected based on the surgical skills of the surgeons already there, but they also took into account the locations and geographical membership distribution. “We have found that our patients’ traveling distance to receive surgical care has not changed significantly,” Dr. Teh said.
Improved outcomes
The cohort included 1,429 eligible patients all stages of gastric cancer; one-third were treated after regionalization, 650 had stage I-III disease, and 394 underwent curative-intent surgery.
Overall survival at 2 years was 32.8% pre- and 37.3% post regionalization (P = .20) for all stages of cancer; stage I-III cases with or without surgery, 55.6% and 61.1%, respectively (P = .25); and among all surgery patients, 72.7% and 85.5%, respectively (P < .03).
Among patients who underwent surgery, the use of neoadjuvant chemotherapy increased from 35% to 66% (P < .0001), as did laparoscopic gastrectomy from 18% to 92% (P < .0001), and D2 lymphadenectomy from 2% to 80% (P < .0001). In addition, dissection of 15 or more lymph nodes also rose from 61% to 95% (P < .0001). Post regionalization, the resection margin was more often negative, and the resection less often involved other organs.
The median length of hospitalization declined from 7 to 3 days (P < .001) after regionalization but all-cause readmissions and reoperation at 30 and 90 days were similar in both cohorts. The risk of bowel obstruction was less frequent post regionalization (P = .01 at both 30 and 90 days), as was risk of infection (P = .03 at 30 days and P = .01 at 90 days).
The risk of one or more serious adverse events was also lower (P < .01), and 30-day mortality did not change (pre 0.7% and post 0.0%, P = .34).
Generalizability may not be feasible
But although this was successful for Kaiser, the authors note that a key limitation of the study is generalizability – and that regionalization may not be feasible in many U.S. settings.
“There needs to be a standardized workflow that all stakeholders agree upon,” Dr. Teh explained. “For example, in our gastric cancer staging pathway, all patients who are considered candidates for surgery have four staging tests: CT scan, PET scan and endoscopic ultrasound [EUS], and staging laparoscopy.”
Another important aspect is that in order to make sure the workflow is smooth and timely, all subspecialties responsible for the staging modalities need to create a “special access.” What this means, he continued, is for example, that the radiology department must ensure that these patients will have their CT scan and PET scans promptly. “Similarly, the GI department must provide quick access to EUS, and the surgery department must quickly provide a staging laparoscopy,” Dr. Teh said. “We have been extremely successful in achieving this goal.”
Dr. Teh also noted that a skilled patient navigator and a team where each member brings high-level expertise and experience to the table are also necessary. And innovative technology is also needed.
“We use artificial intelligence to identify all newly diagnosed cases of gastric [cancer], and within 24 hours of a patient’s diagnosis, a notification is sent to entire team about this new patient,” he added. “We also use AI to extract data to create a dashboard that will track each patient’s progress and outcomes, so that the results are accessible to every member of the team. The innovative technology has also helped us build a comprehensive survivorship program.”
They also noted in their study that European and Canadian systems, as well as the Department of Veterans Affairs, could probably implement components of this, including enhanced recovery after surgery.
The study had no specific funding. Dr. Teh and Dr. Herrinton have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Genes related to osteosarcoma survival identified
When they combined them into a risk score and added one additional factor – metastases at diagnosis – the model was an “excellent” predictor of 1-year survival, the team said (area under the curve, 0.947; 95% confidence interval, 0.832-0.972).
“The survival-associated” immune-related genes (IRGs) “examined in this study have potential for identifying prognosis in osteosarcoma and may be clinically useful as relevant clinical biomarkers and candidate targets for anticancer therapy,” said investigators led by Wangmi Liu, MD, of Zhejiang University in Hangzhou, China. The study was published in JAMA Network Open.
They explained that it’s often difficult to distinguish high- and low-risk patients at osteosarcoma diagnosis. To address the issue, they analyzed the genomic signatures of 84 patients in the Cancer Genome Atlas and their associated clinical information.
The team split their subjects evenly into high-risk and low-risk groups based on a score developed from their genetic signatures. A total of 26 patients in the high-risk group (61.9%) died over a median follow up of 4.1 years versus only 1 (2.4%) in the low-risk group.
The risk score also correlated positively with B-cell tumor infiltration, and negatively with infiltration of CD8 T cells and macrophages.
Overall, 16 genes were significantly up-regulated, and 187 genes were significantly down-regulated in the high-risk group, including three survival-associated IRGs: CCL2, CD79A, and FPR1.
The differentially expressed genes were most significantly associated with transmembrane signaling receptor activity and inflammatory response. The team noted that “it has been reported that inflammatory response plays a critical role in tumor initiation, promotion, malignant conversion, invasion, and metastases.”
Of the 14 survival-associated IRGs, 5 have been reported before in osteosarcoma. The other nine were deduced from computational analysis and may be potential treatment targets, including bone morphogenetic protein 8b (BMP8b). Another member of the BMP family, BMP9, has been shown to promote the proliferation of osteosarcoma cells, “which is similar to this study’s finding that BMP8b was a risk factor in osteosarcoma. Therefore, the role of BMP8b in osteosarcoma needs further research,” the team said.
“Because the database provides limited clinical information, other important factors, such as staging and grading, were not included in our analysis. Therefore, extrapolation based on the findings must be done very carefully,” they cautioned.
The work was supported by the National Natural Science Foundation of China and others. The investigators didn’t have any disclosures.
When they combined them into a risk score and added one additional factor – metastases at diagnosis – the model was an “excellent” predictor of 1-year survival, the team said (area under the curve, 0.947; 95% confidence interval, 0.832-0.972).
“The survival-associated” immune-related genes (IRGs) “examined in this study have potential for identifying prognosis in osteosarcoma and may be clinically useful as relevant clinical biomarkers and candidate targets for anticancer therapy,” said investigators led by Wangmi Liu, MD, of Zhejiang University in Hangzhou, China. The study was published in JAMA Network Open.
They explained that it’s often difficult to distinguish high- and low-risk patients at osteosarcoma diagnosis. To address the issue, they analyzed the genomic signatures of 84 patients in the Cancer Genome Atlas and their associated clinical information.
The team split their subjects evenly into high-risk and low-risk groups based on a score developed from their genetic signatures. A total of 26 patients in the high-risk group (61.9%) died over a median follow up of 4.1 years versus only 1 (2.4%) in the low-risk group.
The risk score also correlated positively with B-cell tumor infiltration, and negatively with infiltration of CD8 T cells and macrophages.
Overall, 16 genes were significantly up-regulated, and 187 genes were significantly down-regulated in the high-risk group, including three survival-associated IRGs: CCL2, CD79A, and FPR1.
The differentially expressed genes were most significantly associated with transmembrane signaling receptor activity and inflammatory response. The team noted that “it has been reported that inflammatory response plays a critical role in tumor initiation, promotion, malignant conversion, invasion, and metastases.”
Of the 14 survival-associated IRGs, 5 have been reported before in osteosarcoma. The other nine were deduced from computational analysis and may be potential treatment targets, including bone morphogenetic protein 8b (BMP8b). Another member of the BMP family, BMP9, has been shown to promote the proliferation of osteosarcoma cells, “which is similar to this study’s finding that BMP8b was a risk factor in osteosarcoma. Therefore, the role of BMP8b in osteosarcoma needs further research,” the team said.
“Because the database provides limited clinical information, other important factors, such as staging and grading, were not included in our analysis. Therefore, extrapolation based on the findings must be done very carefully,” they cautioned.
The work was supported by the National Natural Science Foundation of China and others. The investigators didn’t have any disclosures.
When they combined them into a risk score and added one additional factor – metastases at diagnosis – the model was an “excellent” predictor of 1-year survival, the team said (area under the curve, 0.947; 95% confidence interval, 0.832-0.972).
“The survival-associated” immune-related genes (IRGs) “examined in this study have potential for identifying prognosis in osteosarcoma and may be clinically useful as relevant clinical biomarkers and candidate targets for anticancer therapy,” said investigators led by Wangmi Liu, MD, of Zhejiang University in Hangzhou, China. The study was published in JAMA Network Open.
They explained that it’s often difficult to distinguish high- and low-risk patients at osteosarcoma diagnosis. To address the issue, they analyzed the genomic signatures of 84 patients in the Cancer Genome Atlas and their associated clinical information.
The team split their subjects evenly into high-risk and low-risk groups based on a score developed from their genetic signatures. A total of 26 patients in the high-risk group (61.9%) died over a median follow up of 4.1 years versus only 1 (2.4%) in the low-risk group.
The risk score also correlated positively with B-cell tumor infiltration, and negatively with infiltration of CD8 T cells and macrophages.
Overall, 16 genes were significantly up-regulated, and 187 genes were significantly down-regulated in the high-risk group, including three survival-associated IRGs: CCL2, CD79A, and FPR1.
The differentially expressed genes were most significantly associated with transmembrane signaling receptor activity and inflammatory response. The team noted that “it has been reported that inflammatory response plays a critical role in tumor initiation, promotion, malignant conversion, invasion, and metastases.”
Of the 14 survival-associated IRGs, 5 have been reported before in osteosarcoma. The other nine were deduced from computational analysis and may be potential treatment targets, including bone morphogenetic protein 8b (BMP8b). Another member of the BMP family, BMP9, has been shown to promote the proliferation of osteosarcoma cells, “which is similar to this study’s finding that BMP8b was a risk factor in osteosarcoma. Therefore, the role of BMP8b in osteosarcoma needs further research,” the team said.
“Because the database provides limited clinical information, other important factors, such as staging and grading, were not included in our analysis. Therefore, extrapolation based on the findings must be done very carefully,” they cautioned.
The work was supported by the National Natural Science Foundation of China and others. The investigators didn’t have any disclosures.
FROM JAMA NETWORK OPEN
MRI screening cost effective for women with dense breasts
Alternatively, if a woman worries that the 4-year screening interval is too long, screening mammography may be offered every 2 years, with MRI screening offered for the second 2-year interval, according to the findings. This strategy would still require the patient to undergo MRI breast cancer screening every 4 years.
“MRI is more effective not only for selected patients. It is actually more effective than mammography for all women,” editorialist Christiane Kuhl, MD, PhD, University of Aachen (Germany), said in an interview.
“But the superior diagnostic accuracy of MRI is more often needed for women who are at higher risk for breast cancer, and therefore the cost-effectiveness is easier to achieve in women who are at higher risk,” she added.
The study was published online Sept. 29 in the Journal of the National Cancer Institute.
DENSE trial
The simulation model used for the study was based on results from the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, which showed that additional MRI screening for women with extremely dense breast tissue led to significantly fewer interval cancers in comparison with mammography alone (P < .001). In the DENSE trial, MRI participants underwent mammography plus MRI at 2-year intervals; the control group underwent mammography alone at 2-year intervals.
In the current study, “screening strategies varied in the number of MRIs and mammograms offered to women aged 50-75 years,” explains Amarens Geuzinge, MSc, University Medical Center, Rotterdam, the Netherlands, and colleagues, “and incremental cost-effectiveness ratios (ICERs) were calculated ... with a willingness-to-pay threshold of 22,000 euros (>$25,000 U.S.),” the investigators add.
Analyses indicated that screening every 2 years with mammography alone cost the least of all strategies that were evaluated, but it also resulted in the lowest number of quality-adjusted life years (QALYs) – in other words, it delivered the least amount of benefit for patients, coauthor Eveline Heijnsdijk, PhD, University Medical Center, Rotterdam, the Netherlands, explained to this news organization.
Offering an additional MRI every 2 years resulted in the highest costs but not the highest number of QALYs and was inferior to the other screening strategies analyzed, she added. Alternating mammography with MRI breast cancer screening, each conducted every 2 years, came close to providing the same benefits to patients as the every-4-year MRI screening strategy, Dr. Heijnsdijk noted.
However, when the authors applied the National Institute for Health and Care Excellence (NICE) threshold, MRI screening every 4 years yielded the highest acceptable incremental cost-effectiveness ratio (ICER), at 15,620 euros per QALYs, whereas screening every 3 years with MRI alone yielded an ICER of 37,181 euros per QALY.
If decision-makers are willing to pay more than 22,000 euros per QALY gained, “MRI every 2 or 3 years can also become cost effective,” the authors add.
Asked how acceptable MRI screening might be if performed only once every 4 years, Dr. Heijnsdijk noted that, in another of their studies, most of the women who had undergone MRI screening for breast cancer said that they would do so again. “MRI is not a pleasant test, but mammography is also not a pleasant test,” she said.
“So many women prefer MRI above mammography, especially because the detection rate with MRI is better than mammography,” she noted. Dr. Heijnsdijk also said that the percentage of women with extremely dense breasts who would be candidates for MRI screening is small – no more than 10% of women.
At a unit cost of slightly under 300 euros for MRI screening – compared with about 100 euros for screening mammography in the Netherlands – the cost of offering 10% of women MRI instead of mammography might increase, but any additional screening costs could be offset by reductions in the need to treat late-stage breast cancer more aggressively.
‘Interval’ cancers
Commenting further on the study, Dr. Kuhl pointed out that from 25% to 45% of cancers that occur in women who have undergone screening mammography are diagnosed as “interval” cancers, even among women who participate in the best mammography programs. “For a long time, people argued that these interval cancers developed only after the last respective mammogram, but that’s not true at all, because we know that with MRI screening, we can reduce the interval cancer rate down to zero,” Dr. Kuhl emphasized.
This is partially explained by the fact that mammography is “particularly blind” when it comes to detecting rapidly growing tumors. “The fact is that mammography has a modality-inherent tendency to preferentially detect slow-growing cancers, whereas rapidly growing tumors are indistinguishable from ubiquitous benign changes like cysts. [This] is why women who undergo screening mammography are frequently not diagnosed with the cancers that we really need to find,” she said.
Although there is ample talk about overdiagnosis when it comes to screening mammography, the overwhelmingly important problem is underdiagnosis. Even in exemplary mammography screening programs, at least 20% of tumors that are diagnosed on mammography have already advanced to a stage that is too late, Dr. Kuhl noted.
This means that at least half of women do not benefit from screening mammography nearly to the extent that they – and their health care practitioners – believe they should, she added. Dr. Kuhl underscored that this does not mean that clinicians should abandon screening mammography.
What it does mean is that physicians need to abandon the one-size-fits-all approach to screening mammography and start stratifying women on the basis of their individual risk of developing breast cancer by taking a family or personal history. Most women do undergo screening mammography at least once, Dr. Kuhl pointed out. From that mammogram, physicians can use information on breast density and breast architecture to better determine individual risk.
“We have good ideas about how to achieve risk stratification, but we’re not using them, because as long as mammography is the answer for everybody, there isn’t much motivation to dig deeper into the issue of how to determine risk,” Dr. Kuhl said.
“But we have to ensure the early diagnosis of aggressive cancers, and it’s exactly MRI that can do this, and we should start with women with very dense breasts because they are doubly underserved by mammography,” she said.
The study was supported by the University Medical Center Utrecht, Bayer HealthCare Medical Care, Matakina, and others. Ms. Geuzinge, Dr. Heijnsdijk, and Dr. Kuhl have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Alternatively, if a woman worries that the 4-year screening interval is too long, screening mammography may be offered every 2 years, with MRI screening offered for the second 2-year interval, according to the findings. This strategy would still require the patient to undergo MRI breast cancer screening every 4 years.
“MRI is more effective not only for selected patients. It is actually more effective than mammography for all women,” editorialist Christiane Kuhl, MD, PhD, University of Aachen (Germany), said in an interview.
“But the superior diagnostic accuracy of MRI is more often needed for women who are at higher risk for breast cancer, and therefore the cost-effectiveness is easier to achieve in women who are at higher risk,” she added.
The study was published online Sept. 29 in the Journal of the National Cancer Institute.
DENSE trial
The simulation model used for the study was based on results from the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, which showed that additional MRI screening for women with extremely dense breast tissue led to significantly fewer interval cancers in comparison with mammography alone (P < .001). In the DENSE trial, MRI participants underwent mammography plus MRI at 2-year intervals; the control group underwent mammography alone at 2-year intervals.
In the current study, “screening strategies varied in the number of MRIs and mammograms offered to women aged 50-75 years,” explains Amarens Geuzinge, MSc, University Medical Center, Rotterdam, the Netherlands, and colleagues, “and incremental cost-effectiveness ratios (ICERs) were calculated ... with a willingness-to-pay threshold of 22,000 euros (>$25,000 U.S.),” the investigators add.
Analyses indicated that screening every 2 years with mammography alone cost the least of all strategies that were evaluated, but it also resulted in the lowest number of quality-adjusted life years (QALYs) – in other words, it delivered the least amount of benefit for patients, coauthor Eveline Heijnsdijk, PhD, University Medical Center, Rotterdam, the Netherlands, explained to this news organization.
Offering an additional MRI every 2 years resulted in the highest costs but not the highest number of QALYs and was inferior to the other screening strategies analyzed, she added. Alternating mammography with MRI breast cancer screening, each conducted every 2 years, came close to providing the same benefits to patients as the every-4-year MRI screening strategy, Dr. Heijnsdijk noted.
However, when the authors applied the National Institute for Health and Care Excellence (NICE) threshold, MRI screening every 4 years yielded the highest acceptable incremental cost-effectiveness ratio (ICER), at 15,620 euros per QALYs, whereas screening every 3 years with MRI alone yielded an ICER of 37,181 euros per QALY.
If decision-makers are willing to pay more than 22,000 euros per QALY gained, “MRI every 2 or 3 years can also become cost effective,” the authors add.
Asked how acceptable MRI screening might be if performed only once every 4 years, Dr. Heijnsdijk noted that, in another of their studies, most of the women who had undergone MRI screening for breast cancer said that they would do so again. “MRI is not a pleasant test, but mammography is also not a pleasant test,” she said.
“So many women prefer MRI above mammography, especially because the detection rate with MRI is better than mammography,” she noted. Dr. Heijnsdijk also said that the percentage of women with extremely dense breasts who would be candidates for MRI screening is small – no more than 10% of women.
At a unit cost of slightly under 300 euros for MRI screening – compared with about 100 euros for screening mammography in the Netherlands – the cost of offering 10% of women MRI instead of mammography might increase, but any additional screening costs could be offset by reductions in the need to treat late-stage breast cancer more aggressively.
‘Interval’ cancers
Commenting further on the study, Dr. Kuhl pointed out that from 25% to 45% of cancers that occur in women who have undergone screening mammography are diagnosed as “interval” cancers, even among women who participate in the best mammography programs. “For a long time, people argued that these interval cancers developed only after the last respective mammogram, but that’s not true at all, because we know that with MRI screening, we can reduce the interval cancer rate down to zero,” Dr. Kuhl emphasized.
This is partially explained by the fact that mammography is “particularly blind” when it comes to detecting rapidly growing tumors. “The fact is that mammography has a modality-inherent tendency to preferentially detect slow-growing cancers, whereas rapidly growing tumors are indistinguishable from ubiquitous benign changes like cysts. [This] is why women who undergo screening mammography are frequently not diagnosed with the cancers that we really need to find,” she said.
Although there is ample talk about overdiagnosis when it comes to screening mammography, the overwhelmingly important problem is underdiagnosis. Even in exemplary mammography screening programs, at least 20% of tumors that are diagnosed on mammography have already advanced to a stage that is too late, Dr. Kuhl noted.
This means that at least half of women do not benefit from screening mammography nearly to the extent that they – and their health care practitioners – believe they should, she added. Dr. Kuhl underscored that this does not mean that clinicians should abandon screening mammography.
What it does mean is that physicians need to abandon the one-size-fits-all approach to screening mammography and start stratifying women on the basis of their individual risk of developing breast cancer by taking a family or personal history. Most women do undergo screening mammography at least once, Dr. Kuhl pointed out. From that mammogram, physicians can use information on breast density and breast architecture to better determine individual risk.
“We have good ideas about how to achieve risk stratification, but we’re not using them, because as long as mammography is the answer for everybody, there isn’t much motivation to dig deeper into the issue of how to determine risk,” Dr. Kuhl said.
“But we have to ensure the early diagnosis of aggressive cancers, and it’s exactly MRI that can do this, and we should start with women with very dense breasts because they are doubly underserved by mammography,” she said.
The study was supported by the University Medical Center Utrecht, Bayer HealthCare Medical Care, Matakina, and others. Ms. Geuzinge, Dr. Heijnsdijk, and Dr. Kuhl have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Alternatively, if a woman worries that the 4-year screening interval is too long, screening mammography may be offered every 2 years, with MRI screening offered for the second 2-year interval, according to the findings. This strategy would still require the patient to undergo MRI breast cancer screening every 4 years.
“MRI is more effective not only for selected patients. It is actually more effective than mammography for all women,” editorialist Christiane Kuhl, MD, PhD, University of Aachen (Germany), said in an interview.
“But the superior diagnostic accuracy of MRI is more often needed for women who are at higher risk for breast cancer, and therefore the cost-effectiveness is easier to achieve in women who are at higher risk,” she added.
The study was published online Sept. 29 in the Journal of the National Cancer Institute.
DENSE trial
The simulation model used for the study was based on results from the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial, which showed that additional MRI screening for women with extremely dense breast tissue led to significantly fewer interval cancers in comparison with mammography alone (P < .001). In the DENSE trial, MRI participants underwent mammography plus MRI at 2-year intervals; the control group underwent mammography alone at 2-year intervals.
In the current study, “screening strategies varied in the number of MRIs and mammograms offered to women aged 50-75 years,” explains Amarens Geuzinge, MSc, University Medical Center, Rotterdam, the Netherlands, and colleagues, “and incremental cost-effectiveness ratios (ICERs) were calculated ... with a willingness-to-pay threshold of 22,000 euros (>$25,000 U.S.),” the investigators add.
Analyses indicated that screening every 2 years with mammography alone cost the least of all strategies that were evaluated, but it also resulted in the lowest number of quality-adjusted life years (QALYs) – in other words, it delivered the least amount of benefit for patients, coauthor Eveline Heijnsdijk, PhD, University Medical Center, Rotterdam, the Netherlands, explained to this news organization.
Offering an additional MRI every 2 years resulted in the highest costs but not the highest number of QALYs and was inferior to the other screening strategies analyzed, she added. Alternating mammography with MRI breast cancer screening, each conducted every 2 years, came close to providing the same benefits to patients as the every-4-year MRI screening strategy, Dr. Heijnsdijk noted.
However, when the authors applied the National Institute for Health and Care Excellence (NICE) threshold, MRI screening every 4 years yielded the highest acceptable incremental cost-effectiveness ratio (ICER), at 15,620 euros per QALYs, whereas screening every 3 years with MRI alone yielded an ICER of 37,181 euros per QALY.
If decision-makers are willing to pay more than 22,000 euros per QALY gained, “MRI every 2 or 3 years can also become cost effective,” the authors add.
Asked how acceptable MRI screening might be if performed only once every 4 years, Dr. Heijnsdijk noted that, in another of their studies, most of the women who had undergone MRI screening for breast cancer said that they would do so again. “MRI is not a pleasant test, but mammography is also not a pleasant test,” she said.
“So many women prefer MRI above mammography, especially because the detection rate with MRI is better than mammography,” she noted. Dr. Heijnsdijk also said that the percentage of women with extremely dense breasts who would be candidates for MRI screening is small – no more than 10% of women.
At a unit cost of slightly under 300 euros for MRI screening – compared with about 100 euros for screening mammography in the Netherlands – the cost of offering 10% of women MRI instead of mammography might increase, but any additional screening costs could be offset by reductions in the need to treat late-stage breast cancer more aggressively.
‘Interval’ cancers
Commenting further on the study, Dr. Kuhl pointed out that from 25% to 45% of cancers that occur in women who have undergone screening mammography are diagnosed as “interval” cancers, even among women who participate in the best mammography programs. “For a long time, people argued that these interval cancers developed only after the last respective mammogram, but that’s not true at all, because we know that with MRI screening, we can reduce the interval cancer rate down to zero,” Dr. Kuhl emphasized.
This is partially explained by the fact that mammography is “particularly blind” when it comes to detecting rapidly growing tumors. “The fact is that mammography has a modality-inherent tendency to preferentially detect slow-growing cancers, whereas rapidly growing tumors are indistinguishable from ubiquitous benign changes like cysts. [This] is why women who undergo screening mammography are frequently not diagnosed with the cancers that we really need to find,” she said.
Although there is ample talk about overdiagnosis when it comes to screening mammography, the overwhelmingly important problem is underdiagnosis. Even in exemplary mammography screening programs, at least 20% of tumors that are diagnosed on mammography have already advanced to a stage that is too late, Dr. Kuhl noted.
This means that at least half of women do not benefit from screening mammography nearly to the extent that they – and their health care practitioners – believe they should, she added. Dr. Kuhl underscored that this does not mean that clinicians should abandon screening mammography.
What it does mean is that physicians need to abandon the one-size-fits-all approach to screening mammography and start stratifying women on the basis of their individual risk of developing breast cancer by taking a family or personal history. Most women do undergo screening mammography at least once, Dr. Kuhl pointed out. From that mammogram, physicians can use information on breast density and breast architecture to better determine individual risk.
“We have good ideas about how to achieve risk stratification, but we’re not using them, because as long as mammography is the answer for everybody, there isn’t much motivation to dig deeper into the issue of how to determine risk,” Dr. Kuhl said.
“But we have to ensure the early diagnosis of aggressive cancers, and it’s exactly MRI that can do this, and we should start with women with very dense breasts because they are doubly underserved by mammography,” she said.
The study was supported by the University Medical Center Utrecht, Bayer HealthCare Medical Care, Matakina, and others. Ms. Geuzinge, Dr. Heijnsdijk, and Dr. Kuhl have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Many patients, doctors unaware of advancements in cancer care
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
Opioid prescriptions following Mohs surgery dropped over the last decade
by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.
The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.
“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”
As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.
“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”
The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.
The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.
“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.
In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.
“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”
State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.
“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”
Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”
Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.
“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”
The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.
by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.
The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.
“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”
As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.
“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”
The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.
The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.
“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.
In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.
“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”
State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.
“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”
Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”
Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.
“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”
The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.
by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.
The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.
“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”
As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.
“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”
The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.
The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.
“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.
In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.
“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”
State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.
“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”
Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”
Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.
“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”
The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.
FROM JAMA DERMATOLOGY