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FDA approves nivolumab for advanced squamous cell carcinoma of the head and neck
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
NCCN: Deliver vincristine by mini IV drip bag
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
One psychiatrist’s take on election anxiety
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
I have to start this column with a disclaimer: I live in Maryland, and like most Marylanders, I am a Democrat. We’re one of the bluest states – today, you’re welcome to give that statement two meanings – and as such, I live in what today has been somewhat pejoratively called the educated, liberal, elitist, East Coast, “Hillary bubble,” where I can be one of the first to admit that I’m not in touch with the country as a whole. I’ll add one more disclaimer: I married a man I fell in love with during my freshman year of college.
As a teenager, I didn’t care much about politics, but my then-boyfriend was a political science major who was a Republican and spent a summer on Capitol Hill. So my blue world is just a bit influenced by decades of living, quite happily, in a bipartisan household. The adult children seem to have settled in as Democrats; the dogs have split parties.
“I thought Donald Trump was a joke, a reality TV thing.”
I hadn’t been paying much attention, and my husband, who remains calm and wise, reassured me that it was months until the primaries, and that Trump would not be the Republican nominee.
Time went on, and my anxiety grew. I found myself caught up in Facebook posts, and I mostly read like-minded rhetoric. In March, I was on vacation and found myself terribly distraught about a colleague’s post. He talked about his anxiety about the election, likened Trump to Hitler or Stalin, and asked what people would do if they found out their friends supported Trump. Should one end their friendship? I have strong viewpoints, and if I limited my friends only to those who agree with me on controversial issues, I would be rather lonely. I started to argue with my colleague’s friends – they likened voting for Trump to being anti-Semitic, and many felt one should end friendships with people who supported him. I decided I didn’t want to be Facebook friends with people who made their friendships contingent on how I vote. This was different, I was told, because of Trump’s xenophobia, and I ended up “unfriending” my colleague (only on Facebook), and turning off all my social media for a while.
When Trump won the Republican nomination, my husband told me I should be happy: This ensured that Hillary Clinton would win the election. He would not vote for Trump; our Republican governor, Larry Hogan, was not supporting Trump; it seemed that neither the Republicans nor the Democrats were enthusiastic about his nomination, and my anxiety waned.
A colleague noted he was having trouble listening to Trump supporters in therapy sessions. In my entire practice, only one patient mentioned being a Trump supporter, a transplant from a Southern state. It was not a major focus of therapy, except that he used it as an example of how he felt out of place in Maryland, and I had sympathy for his sense of isolation here.
My anxiety waned in the weeks before the election, though my patients talked more and more about it. I posted a countdown on Facebook – this nightmare of an election has divided our country, and given a voice to vulgarity and hate speech. While I still would not end a good friendship over a vote, I see Trump as unkind and undignified. He invests energy in being purposely cruel. And since I apparently don’t understand the “non-elitist” voter, it doesn’t make sense to me that disenfranchised blue collar workers hope a privileged billionaire with a history of deceit and mistreating others will be anyone’s savior. At one point, The New York Times’ The Upshot gave Trump a 9% chance of winning. If you are a Trump supporter, please don’t feel insulted, and I would be happy to try to understand your enthusiasm for his presidency.
On Tuesday night, my husband had to be out of town. My friend, psychiatrist Anne Hanson, came to “babysit” me as I didn’t want to be alone as the returns came in – perhaps I had some sense that Clinton could possibly lose. We ordered Indian food, and together, we sat in front of the television, completely dumbfounded.
The morning after came, and Maryland psychiatrists started posting about their despair on our listserv. Others offered support; one suggested that Trump might be just what our country needs; and numerous psychiatrists have said this a call to action, a time to get more involved. On Thursday morning, one psychiatrist noted: “Seeing my patients the day after the election this week felt very much like seeing patients the day after 9/11. What was different though was that on 9/11, we were all in high distress, sadness, and fear. However, unlike 9/11, this time I have the uncanny experience of a few patients that were rejoicing or simply glad that Trump had won.”
My social media sites looked the same – disbelief, distress, obscenities, words of comfort, calls to action. Journalist Andrew Solomon posted on Twitter this morning: “It’s begun. A friend was walking in NYC and someone driving a U-Haul yelled, ‘Hey, homo. So what do you think of President Donald Trump?’” Meanwhile, Trump supporters were reportedly attacked with punches, eggs, and bottles at a protest rally in California. The country remains divided: President Obama and Hillary Clinton remind us that we should give Mr. Trump a chance and support his efforts as we are all one country, while thousands protest his victory in cities across the country.
What will President Trump’s election mean for psychiatry? The American Psychiatric Association gave money to support both candidates, and in the spirit of working together, President Maria A. Oquendo has sent him a letter of congratulations. There is nothing to be gained by having an antagonistic relationship with our country’s leader.
Trump has promised to repeal the Affordable Care Act on his first day in office. What will that mean? Will those covered by ACA policies suddenly lose their coverage? I can’t imagine that would be the case, or at least I hope not. And what about all the time, money, and effort that have been invested in Meaningful Use and the planned transition to MACRA to collect data? Do those systems vanish? I have a son who is about to turn 26 and works as a freelance writer for a fantasy sports website. Will he be able to get health insurance?
And Mr. Trump is a bit unpredictable. He has changed his political party affiliation seven times over the last 2 decades, and until 3 years ago, he was a registered Democrat. Perhaps he won’t repeal the ACA on day 1. Or day 2. We’ll have to wait and see, but in the long run, I think we all have to worry that there might be people with health insurance now who won’t have it in the future.
The mystery of Trump is that he ran a campaign without exposing any strategies. His health care plan boiled down to, We’ll get rid of the lines around the states; there will be open competition with health insurers; and it will be a beautiful thing. (My quote may be inexact, but I took careful note of it during one of the debates.)
Finally, we can ask what will happen with the Mental Health Reform Act of 2016, originally known as the Murphy bill or The Helping Families in Mental Health Crisis Act. The bill, calling for major mental health reforms, passed in the House by a vote of 422-2, and awaits a vote in the Senate during the lame duck session. While the APA supports passage of the bill, there is a great deal of controversy surrounding it, and in a Politico article, former congressman and current mental advocate Patrick Kennedy is quoted as saying that in its current form, the bill should not be passed. The latest version is “‘watered down’ and does nothing more than ‘reallocate money around block grants’ when it should instead ‘try for higher reimbursement rates’ for behavioral health providers. ‘Passing that bill will take the wind out of the sails for real reform,’” he added. “‘Kick it to the next Congress and the new administration to do this the right way.’” How the new administration will react to mental health reform is anyone’s guess.
Anne and I were scheduled to be on NPR’s Diane Rehm radio show this morning to talk about our new book; the unexpected election results led to a postponement while coverage of the election continues. My countdown until the end of this nightmare election reached 0, and I had planned to extend a Facebook re-friend request to my colleague and see if he’d have me back, but election coverage and speculation continue. It may be time for me to take another social media break.
The sun is shining in Baltimore today, and we certainly live in interesting times.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care,” which was released Nov. 1 by Johns Hopkins University Press.
Friday/Saturday Debates
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
FRIDAY
Session 75: More Carotid Disease And Treatment Related Topics And Controversies; Transcervical Cas (Tcar) And New Mesh Covered Carotid Stents
1:18 p.m. – 1:23 p.m.
Debate: Early CEA After Symptom Onset Is Beneficial To Patients: The Earlier The Better After Certain Requirements Are Met
Presenter: Ross Naylor, MD, FRCS
1:24 p.m. – 1:29 p.m.
Debate: Early CEA after Symptoms (TIA or Small Stroke):
Timing is Everything: Within 48 Hours is Bad:
Within 3-14 Days is Good: Why
Presenter: Ian Loftus, MD
1:30 p.m. – 1:35 p.m.
Presenter: Laura Capoccia, MD, PhD
1:36 p.m. – 1:41 p.m.
Debate: Another Balanced View: When is Early CEA after Symptom Onset in Patients with Carotid Stenosis Safe and Beneficial and When is It Not
Presenter: Martin Bjorck, MD, PhD
Session 77: New Carotid Concepts and Updates
4:12 p.m. – 4:17 p.m.
Debate: CAS Has No Increased Cost Consequences Compared to CEA
Presenters: Brajesh K. Lal, MD / Thomas G. Brott, MD
4:18 p.m. – 4:23 p.m.
Debate: Not So: CEA Costs Less Than CAS: Why the Discrepancy
Presenter: Kosmas I. Paraskevas, MD
Session 79: New Developments in the Treatment of Aneurysms and Other Diseases Involving the Popliteal Artery
6:52 a.m. – 6:57 a.m.
Debate: Endovascular Repair of Popliteal Aneurysms is Less Risky Than Open Repair and Should Be the Procedure of Choice: What Percent of Patients Should Be Treated Endo
Presenter: Irwin V. Mohan, MBBS, MD, FRCS, FEBVS, FRACS
6:58 a.m. – 7:03 a.m.
Debate: Not So: Open Repair is Better for Most Popliteal Aneurysm Patients: Endo Repair Is Sometimes a Failed Experiment
Presenter: Martin Bjorck, MD, PhD
Session 80: Infected Arteries and Arterial Grafts and Their Treatment: Infected EVARs; Mycotic AAAs; Infected Aortic/Arterial Prosthetic Grafts; Treatment Of Aorto-Esophageal Fistula
7:40 a.m. – 7:45 a.m.
Debate: Update on Treatment of Infected Aortic Endografts: Open Surgical Graft Excision is Always Indicated
Presenter: Kamphol Laohapensang, MD
7:46 a.m. – 7:51 a.m.
Debate: Not So: Semi-Conservative Treatment Without Graft Excision and with Drainage and Antibiotic Irrigation of AAA Sac Can be Effective Treatment: Longer-Term Results Prove It
Presenter: Martin Malina, MD, PhD
Session 87: Venous Cross-Sectional Imaging Techniques, Pelvic Venous Disorders
8:35 a.m. – 8:40 a.m.
Debate: Renal Vein Transposition (with Patch) is the Ideal Treatment for Nutcracker Syndrome, Not Stenting
Presenter: Olivier Hartung, MD
8:41 a.m. – 8:46 a.m.
Debate: Gonadal Vein Transposition is the Ideal Treatment for Nutcracker Syndrome
Presenter: Cynthia K. Shortell, MD
8:47 a.m. – 8:52 a.m.
Debate: Stenting is the Ideal Treatment or Nutcracker Syndrome
Presenter: Thomas S. Maldonado, MD
8:53 a.m. – 8:58 a.m.
Debate: Hybrid Endo-Open Surgery is the Ideal Treatment for Nutcracker Syndrome
Manju Kalra, MBBS
Session 88: Femoro-Iliocaval Interventional Strategies to Reduce Venous Hypertension, Hot Ideas for Recanalizing Chronic Total Occlusions
9:11 a.m. – 9:16 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is of Limited Value in the Endovascular Era
Presenter: Jose I. Almeida, MD, FACS, RPVI, RVT
9:17 a.m. – 9:22 a.m.
Debate: Open Excisional Surgery for Post-Thrombotic Common Femoral Vein Obstruction (Endophlebectomy) is Standard of Care
Presenter: Cees H.A. Wittens, MD, PhD
Session Tackles Vascular Malformations
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
A session on Friday morning entitled “Introduction to Vascular Malformations” will consider the classification, imaging, and surgical approaches to the congenital anomalies that occur in veins, lymph nodes, both, or in arteries and veins. The session will be co-moderated by Dr. Krassi Ivancev, University Hospital Hamburg-Eppendorf, Hamburg, Germany, and Dr. Furuzan Numan, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.
Vascular malformations are present at birth and become apparent sometime later in life. Surgery often does not completely remove a malformation, which can lead to recurrence.
“Vascular malformations constitute the most difficult challenge in the world of vascular medicine and as a group are the most challenging of all vascular disease entities. Compounding their inherent difficulty in clinical management is the extreme rarity of these complex vascular lesions. Most malformations are in surgically difficult anatomies and many are impossible to resect, save by amputation,” said Dr. Ivancev.
Since vascular anomalies represent a spectrum of disorders, incorrect identification and misdiagnosis can occur, which can lead clinicians in the wrong direction when treating patients. As will be discussed by Dr. Leo J. Schultze Kool of Radboud University Nijmegen in the Netherlands, the International Society for the Study of Vascular Anomalies (ISSVA) classification system stratifies vascular lesions into vascular malformations and proliferative vascular lesions.
Dr. Wayne Yakes of the Yakes Vascular Malformation Center, will discuss an arteriovenous malformation (AVM) classification system he pioneered that defines all the angioarchitectures and their associated treatment strategies. Dr. Yakes will also talk about the therapeutic implications of the AVM classification when confronting challenging cases.
Diagnostic classification of vascular anomalies based on their visual appearance has been an area of innovation and invention in recent years. Imaging of congenital vascular malformations using magnetic resonance and using this information as a guide to treatment will be addressed by Dr. R. Sean Pakbaz of Scripps Healthcare.
Embolization techniques began to be used about 30 years ago, and have proven to be effective. Dr. James Donaldson of Northwestern University Feinberg School of Medicine will discuss endovascular access and embolization in neonates and children.
Session 92: Introduction to Vascular Malformations
Friday 6:45 a.m. – 7:30 a.m.
Gramercy Suites East and West, 2nd Floor
Include quality of life measures in evaluating treatment success of psoriasis
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
No matter what the disease, physician judgment of disease severity correlates poorly with the patient’s quality of life, Dr. Joel Gelfand said during a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
“Patients with similar objective findings have varying health-related quality of life,” said Dr. Gelfand, professor of dermatology at the University of Pennsylvania, Philadelphia.
Dermatologists have several tools to measure quality of life and treatment, with varying levels of validation. For example, the Psoriasis Symptom Inventory measures symptoms including redness, itching, scaling, burning, stinging, cracking, flaking, and pain (J Dermatolog Treat. 2013 Oct;24[5]:356-60).
The Dermatology Life Quality Index (DLQI) is commonly used in clinical trials of psoriasis therapeutics and is frequently used in clinical practice in Europe, Dr. Gelfand said. The DLQI asks about symptoms, feelings, daily activities, leisure time, work/school functioning, and relationships, as well as the treatment itself.
He and his associates used this tool in a study of psoriasis patients seen in routine clinical follow-up in dermatology practices across the United States. The study found that approximately 19% of those who were almost clear (compared with 2% of those who were clear) met DLQI criteria for a treatment change (J Am Acad Dermatol. 2014 Oct;71[4]:633-41). European guidelines, he added, suggest that patients achieving a Psoriasis Area and Severity Index (PASI) score between 50 and 75 and a DLQI greater than 5 should modify their treatment regimens (Arch Dermatol Res. 2011 Jan; 303[1]: 1-10).
Dr. Gelfand described his clinical approach to psoriasis and evaluating quality of life in patients, which involves a global assessment (conducted by a medical assistant) with both a physical and emotional component.
First, patients are asked to think about how severe their physical symptoms of psoriasis have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. Next, patients are asked to think about how severe their psoriasis-related emotional symptoms (such as embarrassment, frustration, depression) have been over the past week on a scale of 0-10, with 0 being no symptoms and 10 being the worst. The patient’s responses help direct treatment plans.
Another reason to attend to quality of life in psoriasis patients: suicide risk. Suicide risk in psoriasis patients has not been well studied, said Dr. Gelfand, whose PubMed search of “psoriasis and suicide” in September yielded only 48 hits. However, one study of 217 patients who completed the Carroll Rating Scale for Depression showed that almost 10% reported a wish to be dead, and almost 6% reported active thoughts of suicide (Int J Dermatol. 1993 Mar;32[3]:188-90).
Another large study that used data from the National Health Service in England included 119,304 patients with psoriasis and found a high risk for suicide attempts and/or suicide in these patients (J R Soc Med. 2014 Feb 13;107[5]:194-204). High risk also was noted for patients with eczema, diabetes, epilepsy, asthma, and inflammatory joint disease, he said. In addition, the Centers for Disease Control and Prevention’s research on suicide risk factors includes medical conditions such as psoriasis, as well as demographic factors with rates being higher in middle-aged white males.
Dr. Gelfand disclosed serving as an investigator and/or consultant for multiple companies including AbbVie, AstraZeneca, Celgene, Coherus, Eli Lilly, Janssen, Merck, Pfizer, Regeneron, Sanofi, and Valeant.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF LAS VEGAS DERMATOLOGY SEMINAR
Caval Interruption Strategies in the Spotlight
Caval interruption, typically by the installation of a filter, traps dislodged blood clots in the inferior vena cava, before they can reach the heart and lungs. The strategy will be the topic of the second half of the Friday afternoon session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occlusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
The first half of the session will focus on the general topic of interventions of the inferior vena cava. This will include everything from percutaneous recanalization for occluded IVC filters to open and robotic vena cava reconstruction for the removal of benign and malignant tumors. The second half will cover the current controversies involving inferior vena cava filter indications for placement, retrieval, and the management of their complications.
“Session attendees will be able to understand current methods and indications for IVC filter placement, follow-up and retrieval. In addition, they will get an update on current research to improve the care of our patients requiring IVC interruption. The session will aid practitioners to better understand the requirements for open and endovascular management of vena cava tumors and obstruction,” said Dr. Gillespie.
Dr. John Rectenwald, the co-moderator, will consider the indications for IVC filters and discuss whether these are being observed in clinical practice. He will be followed by Dr. David Rosenthal of the Medical College of Georgia, who will provide an update on the Sentry bioconvertible non-retrieval IVS filter. The Sentry device is designed to provide protection against pulmonary embolism at the time of highest risk of embolism, followed by bioconversion to leave an unobstructed IVC lumen. The next speaker will be Dr. Gillespie, who will discuss the retrieval of IVC filters and the influence on retrieval rate by the filter design, institutional practice, and the individual surgeon. Dr. Steven Abramowitz of Georgetown University School of Medicine will talk about ulcer healing and quality of life following endovascular iliocaval reconstructive stenting in patients who have both IVC and iliac occlusive disease.
Dr. Rectenwald will discuss the Prevention du Risque d’Embolie Pulmonaire par Interruption Cav (PREPIC) trial of over 400 patients randomized to receive or not receive a filter along with standard anticoagulation treatment. Recommendations regarding IVC filters have been based on the PREPIC trial and follow-up data. The follow-up data showed no survival benefit. Whether the evidence supports the use of IVC filters will be discussed. Continuing this theme, Dr. Gillespie will update the physician-initiated, Investigational Device Exemption vena cava PRESERVE study, a large-scale, multi-specialty, prospective study launched in October 2016, which is assessing the use of IVC filters in the United States. The study involves all commercially available inferior vena cava filters placed in subjects for the prevention of death from fatal or symptomatic pulmonary embolism.
IVC filters are subject to complications. How to deal with these is a major challenge. Complications and how to avoid them will be the topic of a presentation by Dr. Clifford Sales of Mount Sinai School of Medicine, and how best to deal with filters that are difficult to retrieve will be discussed by Dr. Brian DeRubertis of UCLA Division of Vascular Surgery, Los Angeles, Calif. What to do when filters actually fracture and generate embolic fragments will be the topic of a presentation by Dr. Constantino Peña, University of South Florida. Finally, Dr. Nicholas Gargiulo, III, of The Clinch Valley Medical Center will consider prophylactic caval filtration in term of bariatric surgery patients who are the best candidates.
“There are special challenges involved in the open and endovascular management of inferior vena cava problems. These represent opportunities for practitioners to grow their practice. These patients are some of the most complicated patients we care for. Their management requires advanced techniques and dedicated clinicians to their care and management,” said Dr. Gillespie.
Session 91:
Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Caval Interruption
Friday 4:00 p.m. to 4:53 p.m.
Trianon Ballroom, 3rd Floor
Caval interruption, typically by the installation of a filter, traps dislodged blood clots in the inferior vena cava, before they can reach the heart and lungs. The strategy will be the topic of the second half of the Friday afternoon session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occlusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
The first half of the session will focus on the general topic of interventions of the inferior vena cava. This will include everything from percutaneous recanalization for occluded IVC filters to open and robotic vena cava reconstruction for the removal of benign and malignant tumors. The second half will cover the current controversies involving inferior vena cava filter indications for placement, retrieval, and the management of their complications.
“Session attendees will be able to understand current methods and indications for IVC filter placement, follow-up and retrieval. In addition, they will get an update on current research to improve the care of our patients requiring IVC interruption. The session will aid practitioners to better understand the requirements for open and endovascular management of vena cava tumors and obstruction,” said Dr. Gillespie.
Dr. John Rectenwald, the co-moderator, will consider the indications for IVC filters and discuss whether these are being observed in clinical practice. He will be followed by Dr. David Rosenthal of the Medical College of Georgia, who will provide an update on the Sentry bioconvertible non-retrieval IVS filter. The Sentry device is designed to provide protection against pulmonary embolism at the time of highest risk of embolism, followed by bioconversion to leave an unobstructed IVC lumen. The next speaker will be Dr. Gillespie, who will discuss the retrieval of IVC filters and the influence on retrieval rate by the filter design, institutional practice, and the individual surgeon. Dr. Steven Abramowitz of Georgetown University School of Medicine will talk about ulcer healing and quality of life following endovascular iliocaval reconstructive stenting in patients who have both IVC and iliac occlusive disease.
Dr. Rectenwald will discuss the Prevention du Risque d’Embolie Pulmonaire par Interruption Cav (PREPIC) trial of over 400 patients randomized to receive or not receive a filter along with standard anticoagulation treatment. Recommendations regarding IVC filters have been based on the PREPIC trial and follow-up data. The follow-up data showed no survival benefit. Whether the evidence supports the use of IVC filters will be discussed. Continuing this theme, Dr. Gillespie will update the physician-initiated, Investigational Device Exemption vena cava PRESERVE study, a large-scale, multi-specialty, prospective study launched in October 2016, which is assessing the use of IVC filters in the United States. The study involves all commercially available inferior vena cava filters placed in subjects for the prevention of death from fatal or symptomatic pulmonary embolism.
IVC filters are subject to complications. How to deal with these is a major challenge. Complications and how to avoid them will be the topic of a presentation by Dr. Clifford Sales of Mount Sinai School of Medicine, and how best to deal with filters that are difficult to retrieve will be discussed by Dr. Brian DeRubertis of UCLA Division of Vascular Surgery, Los Angeles, Calif. What to do when filters actually fracture and generate embolic fragments will be the topic of a presentation by Dr. Constantino Peña, University of South Florida. Finally, Dr. Nicholas Gargiulo, III, of The Clinch Valley Medical Center will consider prophylactic caval filtration in term of bariatric surgery patients who are the best candidates.
“There are special challenges involved in the open and endovascular management of inferior vena cava problems. These represent opportunities for practitioners to grow their practice. These patients are some of the most complicated patients we care for. Their management requires advanced techniques and dedicated clinicians to their care and management,” said Dr. Gillespie.
Session 91:
Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Caval Interruption
Friday 4:00 p.m. to 4:53 p.m.
Trianon Ballroom, 3rd Floor
Caval interruption, typically by the installation of a filter, traps dislodged blood clots in the inferior vena cava, before they can reach the heart and lungs. The strategy will be the topic of the second half of the Friday afternoon session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occlusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
The first half of the session will focus on the general topic of interventions of the inferior vena cava. This will include everything from percutaneous recanalization for occluded IVC filters to open and robotic vena cava reconstruction for the removal of benign and malignant tumors. The second half will cover the current controversies involving inferior vena cava filter indications for placement, retrieval, and the management of their complications.
“Session attendees will be able to understand current methods and indications for IVC filter placement, follow-up and retrieval. In addition, they will get an update on current research to improve the care of our patients requiring IVC interruption. The session will aid practitioners to better understand the requirements for open and endovascular management of vena cava tumors and obstruction,” said Dr. Gillespie.
Dr. John Rectenwald, the co-moderator, will consider the indications for IVC filters and discuss whether these are being observed in clinical practice. He will be followed by Dr. David Rosenthal of the Medical College of Georgia, who will provide an update on the Sentry bioconvertible non-retrieval IVS filter. The Sentry device is designed to provide protection against pulmonary embolism at the time of highest risk of embolism, followed by bioconversion to leave an unobstructed IVC lumen. The next speaker will be Dr. Gillespie, who will discuss the retrieval of IVC filters and the influence on retrieval rate by the filter design, institutional practice, and the individual surgeon. Dr. Steven Abramowitz of Georgetown University School of Medicine will talk about ulcer healing and quality of life following endovascular iliocaval reconstructive stenting in patients who have both IVC and iliac occlusive disease.
Dr. Rectenwald will discuss the Prevention du Risque d’Embolie Pulmonaire par Interruption Cav (PREPIC) trial of over 400 patients randomized to receive or not receive a filter along with standard anticoagulation treatment. Recommendations regarding IVC filters have been based on the PREPIC trial and follow-up data. The follow-up data showed no survival benefit. Whether the evidence supports the use of IVC filters will be discussed. Continuing this theme, Dr. Gillespie will update the physician-initiated, Investigational Device Exemption vena cava PRESERVE study, a large-scale, multi-specialty, prospective study launched in October 2016, which is assessing the use of IVC filters in the United States. The study involves all commercially available inferior vena cava filters placed in subjects for the prevention of death from fatal or symptomatic pulmonary embolism.
IVC filters are subject to complications. How to deal with these is a major challenge. Complications and how to avoid them will be the topic of a presentation by Dr. Clifford Sales of Mount Sinai School of Medicine, and how best to deal with filters that are difficult to retrieve will be discussed by Dr. Brian DeRubertis of UCLA Division of Vascular Surgery, Los Angeles, Calif. What to do when filters actually fracture and generate embolic fragments will be the topic of a presentation by Dr. Constantino Peña, University of South Florida. Finally, Dr. Nicholas Gargiulo, III, of The Clinch Valley Medical Center will consider prophylactic caval filtration in term of bariatric surgery patients who are the best candidates.
“There are special challenges involved in the open and endovascular management of inferior vena cava problems. These represent opportunities for practitioners to grow their practice. These patients are some of the most complicated patients we care for. Their management requires advanced techniques and dedicated clinicians to their care and management,” said Dr. Gillespie.
Session 91:
Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Caval Interruption
Friday 4:00 p.m. to 4:53 p.m.
Trianon Ballroom, 3rd Floor
Updates Presented on Robotic Vena Cava Surgery
Developments in robotic vena cava surgery will be presented Friday afternoon during the session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
“The selective use of robotic surgery on the vena cava is a tremendous step forward because of its minimal invasiveness and also because of the magnification that the robot gives and the technical advantages the robot gives over open surgery or laparoscopic surgery,” said Dr. Money.
Traditionally, inferior vena cava thrombectomy is done using a large open incision, since it is difficult otherwise to gain access to the vein. The surgery is done most often to address involvement of the inferior vena cava by an adjacent tumor. In addition, surgery may be needed to remove filters inserted to prevent migration of pulmonary emboli when problems develop with the filter.
The open incision approach carries a considerable risk of morbidity with the approach. A minimally invasive treatment option has been needed. Minimally invasive laparoscopy is an option. But drawbacks include the technically challenging nature of the procedure which makes for a steep learning curve.
Within the past decade, the use of robotic surgery has been utilized for interior vena cava thrombectomy. The approach involves multiple but smaller incisions to allow access of robotic tools. The robotic approach provides better visualization with magnification, three-dimensional vision, tremor filtration, and seven degrees of freedom, among other advantages.
“The overall take-home message from my presentation is that robotic vena caval surgery can be done and it should be used. Overall, robotic surgery for the vena cava is a field that is developing. It requires collaboration with other specialties and a realization that minimally invasive procedures are not just endovascular procedures but may be laparoscopic or robotic in nature,” said Dr. Money.
Dr. Money will describe the outcomes of a prospective study undertaken at the Scottsdale Mayo Clinic that evaluated the efficacy of a vena cava surgical system for radical nephrectomy and inferior vena cava tumor thrombectomy and, in a few patients, inferior vena cava filter removal. More recently, the robotic surgery was used to treat compression of the left renal vein between the superior mesenteric artery and aorta.
A focus of the presentation will be the key importance of the collaboration between vascular and robotic surgeons. “As time has developed I have become more aware and more adept at what the robot can do. However, it is not a routine part of my practice. By collaborating with others who use it more frequently, we have developed a practice where vena caval surgery can be done in a minimally invasive fashion with patients going home following a shorter length of stay, with less significant blood loss, and overall an easier recovery,” said Dr. Money.
Session 91:Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Robotic Vena Cava Surgery
Friday, 3:48 p.m. – 3:53 p.m.
Trianon Ballroom, 3rd Floor
Developments in robotic vena cava surgery will be presented Friday afternoon during the session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
“The selective use of robotic surgery on the vena cava is a tremendous step forward because of its minimal invasiveness and also because of the magnification that the robot gives and the technical advantages the robot gives over open surgery or laparoscopic surgery,” said Dr. Money.
Traditionally, inferior vena cava thrombectomy is done using a large open incision, since it is difficult otherwise to gain access to the vein. The surgery is done most often to address involvement of the inferior vena cava by an adjacent tumor. In addition, surgery may be needed to remove filters inserted to prevent migration of pulmonary emboli when problems develop with the filter.
The open incision approach carries a considerable risk of morbidity with the approach. A minimally invasive treatment option has been needed. Minimally invasive laparoscopy is an option. But drawbacks include the technically challenging nature of the procedure which makes for a steep learning curve.
Within the past decade, the use of robotic surgery has been utilized for interior vena cava thrombectomy. The approach involves multiple but smaller incisions to allow access of robotic tools. The robotic approach provides better visualization with magnification, three-dimensional vision, tremor filtration, and seven degrees of freedom, among other advantages.
“The overall take-home message from my presentation is that robotic vena caval surgery can be done and it should be used. Overall, robotic surgery for the vena cava is a field that is developing. It requires collaboration with other specialties and a realization that minimally invasive procedures are not just endovascular procedures but may be laparoscopic or robotic in nature,” said Dr. Money.
Dr. Money will describe the outcomes of a prospective study undertaken at the Scottsdale Mayo Clinic that evaluated the efficacy of a vena cava surgical system for radical nephrectomy and inferior vena cava tumor thrombectomy and, in a few patients, inferior vena cava filter removal. More recently, the robotic surgery was used to treat compression of the left renal vein between the superior mesenteric artery and aorta.
A focus of the presentation will be the key importance of the collaboration between vascular and robotic surgeons. “As time has developed I have become more aware and more adept at what the robot can do. However, it is not a routine part of my practice. By collaborating with others who use it more frequently, we have developed a practice where vena caval surgery can be done in a minimally invasive fashion with patients going home following a shorter length of stay, with less significant blood loss, and overall an easier recovery,” said Dr. Money.
Session 91:Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Robotic Vena Cava Surgery
Friday, 3:48 p.m. – 3:53 p.m.
Trianon Ballroom, 3rd Floor
Developments in robotic vena cava surgery will be presented Friday afternoon during the session entitled “Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting.”
“The selective use of robotic surgery on the vena cava is a tremendous step forward because of its minimal invasiveness and also because of the magnification that the robot gives and the technical advantages the robot gives over open surgery or laparoscopic surgery,” said Dr. Money.
Traditionally, inferior vena cava thrombectomy is done using a large open incision, since it is difficult otherwise to gain access to the vein. The surgery is done most often to address involvement of the inferior vena cava by an adjacent tumor. In addition, surgery may be needed to remove filters inserted to prevent migration of pulmonary emboli when problems develop with the filter.
The open incision approach carries a considerable risk of morbidity with the approach. A minimally invasive treatment option has been needed. Minimally invasive laparoscopy is an option. But drawbacks include the technically challenging nature of the procedure which makes for a steep learning curve.
Within the past decade, the use of robotic surgery has been utilized for interior vena cava thrombectomy. The approach involves multiple but smaller incisions to allow access of robotic tools. The robotic approach provides better visualization with magnification, three-dimensional vision, tremor filtration, and seven degrees of freedom, among other advantages.
“The overall take-home message from my presentation is that robotic vena caval surgery can be done and it should be used. Overall, robotic surgery for the vena cava is a field that is developing. It requires collaboration with other specialties and a realization that minimally invasive procedures are not just endovascular procedures but may be laparoscopic or robotic in nature,” said Dr. Money.
Dr. Money will describe the outcomes of a prospective study undertaken at the Scottsdale Mayo Clinic that evaluated the efficacy of a vena cava surgical system for radical nephrectomy and inferior vena cava tumor thrombectomy and, in a few patients, inferior vena cava filter removal. More recently, the robotic surgery was used to treat compression of the left renal vein between the superior mesenteric artery and aorta.
A focus of the presentation will be the key importance of the collaboration between vascular and robotic surgeons. “As time has developed I have become more aware and more adept at what the robot can do. However, it is not a routine part of my practice. By collaborating with others who use it more frequently, we have developed a practice where vena caval surgery can be done in a minimally invasive fashion with patients going home following a shorter length of stay, with less significant blood loss, and overall an easier recovery,” said Dr. Money.
Session 91:Endovascular and Open Solutions for Inferior Vena Cava Tumors and Occusions, Vena Cava Filtration Strategies, Pitfalls, and Complications and More About Iliac Vein Stenting
Robotic Vena Cava Surgery
Friday, 3:48 p.m. – 3:53 p.m.
Trianon Ballroom, 3rd Floor
Nutraceutical cocktail protects against postpartum blues
VIENNA – A dietary supplement blend virtually eliminated postpartum blues in a promising proof-of-concept controlled trial, Yekta Dowlati, PhD, reported during the annual congress of the European College of Neuropsychopharmacology.
The nutraceutical cocktail is designed to compensate for the effects of the early postpartum surge in monoamine oxidase A (MAO-A) activity that her research group previously has reported. They found that as estrogen levels plunge by 100-fold in the first 3 days postpartum, brain MAO-A levels rise by 40% in affect-controlling regions, including the prefrontal cortex and anterior cingulate cortex (Arch Gen Psychiatry. 2010 May;67[5]:468-74).
That suggests a potential causal relationship with postpartum blues, since MAO-A is an enzyme whose effects include promotion of oxidative stress, apoptosis, and metabolizing serotonin, norepinephrine, and dopamine, explained Dr. Dowlati of the department of psychiatry at the University of Toronto.
Postpartum blues is a common prodrome for postpartum depression, the most frequent complication of childbearing, which has an estimated incidence of 13%. Severe postpartum blues is a strong predictor of subsequent postpartum depression. Yet, despite the large burden of illness imposed by postpartum depression, there is no proven preventive strategy. The hypothesis being pursued in developing this nutraceutical is that a safe dietary intervention that prevents postpartum blues also may prevent postpartum depression.
The nutraceutical cocktail developed by Dr. Dowlati and her coinvestigators consists of monoamine precursors: 2 g of tryptophan, 10 g of tyrosine, and blueberry juice plus blueberry extract.
She reported on 41 healthy breast-feeding mothers who on day 5 postpartum, when postpartum blues typically peaks, were assigned to drink the dietary supplement or not. Later that day, they underwent a quantified assessment of their severity of postpartum blues based upon change from baseline in depressed mood scores on a 0-100 visual analog scale after undergoing a standardized sad mood induction procedure. This is a simple protocol widely used by psychiatrists and psychologists researching the neurobiology of mood states. Dr. Dowlati and her colleagues used the Velten protocol, in which subjects read depressing sentences while listening to sad music.
Mean scores on the Visual Analog Scale for sadness following the standardized mood induction procedure jumped by 43.8 points in the control group but were unchanged, with a mere 0.5-point increase, in the 21 women in the active treatment arm.
“The results of the present study, albeit in an open-label trial, reflect by far the most robust effects of a dietary supplement ever seen on postpartum blues. Our effect size was 2.9. Previous trials have reported effect sizes of 0.07-0.28,” she noted.
An effect size of 2.9 means that if a postpartum woman did not experience a plunge in mood after the induction protocol, there was statistically a 98%-99% chance that she had consumed the supplement.
“One explanation to account for an active effect is that the supplement is compensating for the effects of monoamine metabolism and increased oxidative stress by elevated postpartum MAO-A levels,” according to Dr. Dowlati. “Given the effect size of 2.9 and minimal effects of tryptophan and tyrosine supplementation on total levels in breast milk, there is excellent reason to pursue this supplement in a randomized, double-blind, placebo-controlled trial to further assess its effects.”
Before conducting this efficacy study, the investigators evaluated the safety of their planned intervention by randomizing 54 healthy breast-feeding women to single larger doses of oral tyrosine or tryptophan than were used in the nutraceutical cocktail or to no supplements. They found no subsequent increase in total tyrosine or total tryptophan levels in the subjects’ breast milk, although dose-dependent increases were found in free tyrosine and free tryptophan in maternal plasma. Free tyrosine was increased in breast milk; however, the level was significantly lower than what the investigators found in laboratory analysis of a dozen popular brands of infant formula.
The safety and open-label efficacy studies were funded by the Canadian Institutes of Health Research, the Ontario Mental Health Foundation, and university research grants. Dr. Dowlati reported having no financial conflicts of interest.
VIENNA – A dietary supplement blend virtually eliminated postpartum blues in a promising proof-of-concept controlled trial, Yekta Dowlati, PhD, reported during the annual congress of the European College of Neuropsychopharmacology.
The nutraceutical cocktail is designed to compensate for the effects of the early postpartum surge in monoamine oxidase A (MAO-A) activity that her research group previously has reported. They found that as estrogen levels plunge by 100-fold in the first 3 days postpartum, brain MAO-A levels rise by 40% in affect-controlling regions, including the prefrontal cortex and anterior cingulate cortex (Arch Gen Psychiatry. 2010 May;67[5]:468-74).
That suggests a potential causal relationship with postpartum blues, since MAO-A is an enzyme whose effects include promotion of oxidative stress, apoptosis, and metabolizing serotonin, norepinephrine, and dopamine, explained Dr. Dowlati of the department of psychiatry at the University of Toronto.
Postpartum blues is a common prodrome for postpartum depression, the most frequent complication of childbearing, which has an estimated incidence of 13%. Severe postpartum blues is a strong predictor of subsequent postpartum depression. Yet, despite the large burden of illness imposed by postpartum depression, there is no proven preventive strategy. The hypothesis being pursued in developing this nutraceutical is that a safe dietary intervention that prevents postpartum blues also may prevent postpartum depression.
The nutraceutical cocktail developed by Dr. Dowlati and her coinvestigators consists of monoamine precursors: 2 g of tryptophan, 10 g of tyrosine, and blueberry juice plus blueberry extract.
She reported on 41 healthy breast-feeding mothers who on day 5 postpartum, when postpartum blues typically peaks, were assigned to drink the dietary supplement or not. Later that day, they underwent a quantified assessment of their severity of postpartum blues based upon change from baseline in depressed mood scores on a 0-100 visual analog scale after undergoing a standardized sad mood induction procedure. This is a simple protocol widely used by psychiatrists and psychologists researching the neurobiology of mood states. Dr. Dowlati and her colleagues used the Velten protocol, in which subjects read depressing sentences while listening to sad music.
Mean scores on the Visual Analog Scale for sadness following the standardized mood induction procedure jumped by 43.8 points in the control group but were unchanged, with a mere 0.5-point increase, in the 21 women in the active treatment arm.
“The results of the present study, albeit in an open-label trial, reflect by far the most robust effects of a dietary supplement ever seen on postpartum blues. Our effect size was 2.9. Previous trials have reported effect sizes of 0.07-0.28,” she noted.
An effect size of 2.9 means that if a postpartum woman did not experience a plunge in mood after the induction protocol, there was statistically a 98%-99% chance that she had consumed the supplement.
“One explanation to account for an active effect is that the supplement is compensating for the effects of monoamine metabolism and increased oxidative stress by elevated postpartum MAO-A levels,” according to Dr. Dowlati. “Given the effect size of 2.9 and minimal effects of tryptophan and tyrosine supplementation on total levels in breast milk, there is excellent reason to pursue this supplement in a randomized, double-blind, placebo-controlled trial to further assess its effects.”
Before conducting this efficacy study, the investigators evaluated the safety of their planned intervention by randomizing 54 healthy breast-feeding women to single larger doses of oral tyrosine or tryptophan than were used in the nutraceutical cocktail or to no supplements. They found no subsequent increase in total tyrosine or total tryptophan levels in the subjects’ breast milk, although dose-dependent increases were found in free tyrosine and free tryptophan in maternal plasma. Free tyrosine was increased in breast milk; however, the level was significantly lower than what the investigators found in laboratory analysis of a dozen popular brands of infant formula.
The safety and open-label efficacy studies were funded by the Canadian Institutes of Health Research, the Ontario Mental Health Foundation, and university research grants. Dr. Dowlati reported having no financial conflicts of interest.
VIENNA – A dietary supplement blend virtually eliminated postpartum blues in a promising proof-of-concept controlled trial, Yekta Dowlati, PhD, reported during the annual congress of the European College of Neuropsychopharmacology.
The nutraceutical cocktail is designed to compensate for the effects of the early postpartum surge in monoamine oxidase A (MAO-A) activity that her research group previously has reported. They found that as estrogen levels plunge by 100-fold in the first 3 days postpartum, brain MAO-A levels rise by 40% in affect-controlling regions, including the prefrontal cortex and anterior cingulate cortex (Arch Gen Psychiatry. 2010 May;67[5]:468-74).
That suggests a potential causal relationship with postpartum blues, since MAO-A is an enzyme whose effects include promotion of oxidative stress, apoptosis, and metabolizing serotonin, norepinephrine, and dopamine, explained Dr. Dowlati of the department of psychiatry at the University of Toronto.
Postpartum blues is a common prodrome for postpartum depression, the most frequent complication of childbearing, which has an estimated incidence of 13%. Severe postpartum blues is a strong predictor of subsequent postpartum depression. Yet, despite the large burden of illness imposed by postpartum depression, there is no proven preventive strategy. The hypothesis being pursued in developing this nutraceutical is that a safe dietary intervention that prevents postpartum blues also may prevent postpartum depression.
The nutraceutical cocktail developed by Dr. Dowlati and her coinvestigators consists of monoamine precursors: 2 g of tryptophan, 10 g of tyrosine, and blueberry juice plus blueberry extract.
She reported on 41 healthy breast-feeding mothers who on day 5 postpartum, when postpartum blues typically peaks, were assigned to drink the dietary supplement or not. Later that day, they underwent a quantified assessment of their severity of postpartum blues based upon change from baseline in depressed mood scores on a 0-100 visual analog scale after undergoing a standardized sad mood induction procedure. This is a simple protocol widely used by psychiatrists and psychologists researching the neurobiology of mood states. Dr. Dowlati and her colleagues used the Velten protocol, in which subjects read depressing sentences while listening to sad music.
Mean scores on the Visual Analog Scale for sadness following the standardized mood induction procedure jumped by 43.8 points in the control group but were unchanged, with a mere 0.5-point increase, in the 21 women in the active treatment arm.
“The results of the present study, albeit in an open-label trial, reflect by far the most robust effects of a dietary supplement ever seen on postpartum blues. Our effect size was 2.9. Previous trials have reported effect sizes of 0.07-0.28,” she noted.
An effect size of 2.9 means that if a postpartum woman did not experience a plunge in mood after the induction protocol, there was statistically a 98%-99% chance that she had consumed the supplement.
“One explanation to account for an active effect is that the supplement is compensating for the effects of monoamine metabolism and increased oxidative stress by elevated postpartum MAO-A levels,” according to Dr. Dowlati. “Given the effect size of 2.9 and minimal effects of tryptophan and tyrosine supplementation on total levels in breast milk, there is excellent reason to pursue this supplement in a randomized, double-blind, placebo-controlled trial to further assess its effects.”
Before conducting this efficacy study, the investigators evaluated the safety of their planned intervention by randomizing 54 healthy breast-feeding women to single larger doses of oral tyrosine or tryptophan than were used in the nutraceutical cocktail or to no supplements. They found no subsequent increase in total tyrosine or total tryptophan levels in the subjects’ breast milk, although dose-dependent increases were found in free tyrosine and free tryptophan in maternal plasma. Free tyrosine was increased in breast milk; however, the level was significantly lower than what the investigators found in laboratory analysis of a dozen popular brands of infant formula.
The safety and open-label efficacy studies were funded by the Canadian Institutes of Health Research, the Ontario Mental Health Foundation, and university research grants. Dr. Dowlati reported having no financial conflicts of interest.
Key clinical point:
Major finding: Postpartum women who consumed a dietary supplement designed to compensate for the effects of a surge in monoamine oxidase A activity did not experience any lowering of mood after completing a standardized sad mood induction protocol, while a control group showed a steep rise in sadness scores.
Data source: An open-label proof-of-concept study in which 41 women undertook a standardized sad mood induction protocol on day 5 postpartum, after 21 of them had consumed a dietary supplement blend designed to ward off postpartum blues.
Disclosures: The safety and open-label efficacy studies were funded by the Canadian Institutes of Health Research, the Ontario Mental Health Foundation, and university research grants. Dr. Dowlati reported having no financial conflicts of interest.
MARIANNE: Same PFS but TDM-1 more tolerable than trastuzumab + chemo
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: Median progression-free survival for trastuzumab plus taxane was 13.7 months; for T-DM1, 14.1 months; and for T-DM1 plus pertuzumab, 15.2 months.
Data source: MARIANNE, a phase III trial of 1,095 patients with HER2-positive advanced breast cancer.
Disclosures: Dr. Perez disclosed employment with Genentech. Several other authors disclosed employment or other relationships with Genentech or Roche. The trial was sponsored by Genentech.