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VIDEO: CTCs may identify asymptomatic late breast cancer recurrences
SAN ANTONIO – Although the initial ardor over the use of circulating tumor cells (CTCs) in cancer diagnosis has cooled, new research suggests that they may play a role in identifying late breast cancer recurrences in otherwise asymptomatic patients, according to members of the ECOG-ACRIN cancer research group.
In this video interview from the the San Antonio Breast Cancer Symposium, Joseph A. Sparano, MD, of Montefiore Medical Center and Albert Einstein College of Medicine in New York, describes ECOG-ACRIN’s experiments showing that patients with hormone receptor–positive disease and HER2-negative breast cancer have a significantly elevated risk for recurrence, supporting CTCs as prognostic biomarkers for late recurrences.
If the findings can be replicated in prospective clinical trials, CTC assay results could help clinicians choose treatments for patients who are at risk for late recurrence.
ECOG-ACRIN received funding for this study from the Breast Cancer Research Foundation, Susan G. Komen, and the National Cancer Institute. Dr. Sparano declared no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Although the initial ardor over the use of circulating tumor cells (CTCs) in cancer diagnosis has cooled, new research suggests that they may play a role in identifying late breast cancer recurrences in otherwise asymptomatic patients, according to members of the ECOG-ACRIN cancer research group.
In this video interview from the the San Antonio Breast Cancer Symposium, Joseph A. Sparano, MD, of Montefiore Medical Center and Albert Einstein College of Medicine in New York, describes ECOG-ACRIN’s experiments showing that patients with hormone receptor–positive disease and HER2-negative breast cancer have a significantly elevated risk for recurrence, supporting CTCs as prognostic biomarkers for late recurrences.
If the findings can be replicated in prospective clinical trials, CTC assay results could help clinicians choose treatments for patients who are at risk for late recurrence.
ECOG-ACRIN received funding for this study from the Breast Cancer Research Foundation, Susan G. Komen, and the National Cancer Institute. Dr. Sparano declared no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Although the initial ardor over the use of circulating tumor cells (CTCs) in cancer diagnosis has cooled, new research suggests that they may play a role in identifying late breast cancer recurrences in otherwise asymptomatic patients, according to members of the ECOG-ACRIN cancer research group.
In this video interview from the the San Antonio Breast Cancer Symposium, Joseph A. Sparano, MD, of Montefiore Medical Center and Albert Einstein College of Medicine in New York, describes ECOG-ACRIN’s experiments showing that patients with hormone receptor–positive disease and HER2-negative breast cancer have a significantly elevated risk for recurrence, supporting CTCs as prognostic biomarkers for late recurrences.
If the findings can be replicated in prospective clinical trials, CTC assay results could help clinicians choose treatments for patients who are at risk for late recurrence.
ECOG-ACRIN received funding for this study from the Breast Cancer Research Foundation, Susan G. Komen, and the National Cancer Institute. Dr. Sparano declared no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM SABCS 2017
Virtual reality enters the rheumatology realm
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
SAN DIEGO – When pain strikes arthritis patients, a beach trip may be the last thing on their minds. But a Los Angeles rheumatologist says a virtual voyage to the shore – or the fjords of Iceland or a Cirque du Soleil performance – may be just what they need to find relief without leaving their chairs.
Swamy Venuturupalli, MD, has been testing virtual reality (VR) software on patients as part of a clinical feasibility study into its use to treat rheumatologic pain. It appears to be the first VR study in rheumatology.
Dr. Venuturupalli is working with gastroenterologist Brennan Spiegel, MD, a VR researcher who talked about the power of the treatment in a presentation at the annual meeting of the American College of Rheumatology.
“Like a drug, we have to understand when and how to use this. It can be very powerful,” Dr. Spiegel, professor of medicine and public health at UCLA and director of Health Services Research at Cedars-Sinai Health System, said in his presentation.
“In recent years, VR technology has become increasingly affordable, immersive, flexible, and portable, enabling its use in a broad range of environments, including the inpatient medical setting,” wrote researchers in a 2017 systematic review of 11 randomized, controlled VR trials. “The capacity of VR to modulate subjective experience makes it a compelling intervention in inpatient medical settings, where VR may offer respite from the confining nature of medical wards, or where it may augment or replace analgesics in pain management” (Innov Clin Neurosci. 2017 Jan-Feb;14[1-2]:14-21).
In his ACR presentation, Dr. Spiegel said VR allows patients to escape the “psychosocial jail cell” of a hospital room. “We can put them on a helicopter and fly them over Icelandic fjords or let them sit on stage during a Cirque du Soleil performance.”
In terms of pain, he pointed to a 2017 study that he conducted with colleagues at Cedars-Sinai Medical Center. In 100 inpatients with pain scores of 3 or more on a 10-point scale, researchers compared a onetime 3-dimensional VR immersion via headset to exposure to a 2-dimensional nature video. Both interventions lasted 15 minutes.
Those in the VR group (n = 50) had greater pain improvement than did those in the 2-D group (–1.3 vs –0.6 points; P = .008), and the percentage of patients whose pain diminished was higher (65% vs. 40%; P = .01; number needed to treat = 4) (JMIR Ment Health. 2017 Jan-Mar;4[1]:e9).
Researchers reported no adverse events in the study. However, Dr. Spiegel said patients who undergo VR treatments may feel vertigo, especially if the technology is subpar, and there is a theoretical risk of seizure.
He also noted that VR can cause other negative effects. One patient had a panic attack during an immersive experience of simply throwing balls at cartoon teddy bears in a virtual environment. In this patient, “any concept of violence was enough to trigger a panic attack,” Dr. Spiegel said.
But another immersive virtual experience, putting her on a stage at Cirque du Soleil performance, was a success. “It empowered her, it made her feel brave,” Dr. Spiegel said.
He cautioned about limits of VR: Not every patient is eligible, will want to use it, or will benefit. And while the headsets used in VR have improved, he said, there’s still a way to go to make them more comfortable.
As for cost, VR equipment can be pricey. Hunter Hoffman, director of a virtual reality research center at the University of Washington, Seattle, told MIT Technology Review that the equipment for a VR pain study cost $35,000.
Dr. Venuturupalli, the rheumatologist who’s working with Dr. Spiegel, said his clinic is testing VR technology in patients with chronic pain syndromes. They’re immersed in environments such as one that simulates swimming with dolphins. “Some of my patients try to reach out and touch the dolphin in that state,” he said.
The feasibility study, now in progress, aims to enroll 20 patients and be completed by next March, Dr. Venuturupalli said. So far, the time span of improvement in patients has been variable, he said.
“Our goal is to have a full-fledged virtual reality clinic,” he said. “Like we prescribe physical therapy, we might have a VR therapy prescription that might include certain experiences. And as this technology gets cheaper and cheaper, our patients can have it at their own homes.”
Dr. Spiegel and Dr. Venuturupalli reported no relevant disclosures. Dr. Venuturupalli reports that his study is using donated VR technology from AppliedVR. The firm has created a partnership with Cedars-Sinai Medical Center.
REPORTING FROM ACR 2017
Developmental disabilities up significantly since 2014
In 2016, the prevalence of any diagnosed developmental disability in children aged 3-17 years was 6.99% – a statistically significant increase of 21% over the 5.76% recorded in 2014, the NCHS said in a recent Data Brief.
Autism spectrum disorder was up by a similar amount: 23% from 2014, when prevalence was 2.24%, to 2016, when the prevalence was 2.76% among children aged 3-17 years. Intellectual disability rose in 2015 but dropped in 2016, so the overall increase in prevalence was just 3.6%. The prevalence of other developmental delays, on the other hand, held steady from 2014 to 2015 and then took a big jump, 27.5%, in 2016, the NCHS investigators reported.
The estimates are based on reports by parents or guardians of ever receiving a diagnosis of each developmental disability from a physician or other medical professional.
In 2016, the prevalence of any diagnosed developmental disability in children aged 3-17 years was 6.99% – a statistically significant increase of 21% over the 5.76% recorded in 2014, the NCHS said in a recent Data Brief.
Autism spectrum disorder was up by a similar amount: 23% from 2014, when prevalence was 2.24%, to 2016, when the prevalence was 2.76% among children aged 3-17 years. Intellectual disability rose in 2015 but dropped in 2016, so the overall increase in prevalence was just 3.6%. The prevalence of other developmental delays, on the other hand, held steady from 2014 to 2015 and then took a big jump, 27.5%, in 2016, the NCHS investigators reported.
The estimates are based on reports by parents or guardians of ever receiving a diagnosis of each developmental disability from a physician or other medical professional.
In 2016, the prevalence of any diagnosed developmental disability in children aged 3-17 years was 6.99% – a statistically significant increase of 21% over the 5.76% recorded in 2014, the NCHS said in a recent Data Brief.
Autism spectrum disorder was up by a similar amount: 23% from 2014, when prevalence was 2.24%, to 2016, when the prevalence was 2.76% among children aged 3-17 years. Intellectual disability rose in 2015 but dropped in 2016, so the overall increase in prevalence was just 3.6%. The prevalence of other developmental delays, on the other hand, held steady from 2014 to 2015 and then took a big jump, 27.5%, in 2016, the NCHS investigators reported.
The estimates are based on reports by parents or guardians of ever receiving a diagnosis of each developmental disability from a physician or other medical professional.
Activating the Immune System to Treat Multiple Myeloma
Sagar Lonial, MD
Chief Medical Officer, Winship Cancer Institute of Emory University
Chair, Dept. of Hematology and Medical Oncology, Emory School of Medicine
Faculty/Faculty Disclosure
Dr. Lonial reports that he is a compensated consultant for Bristol-Myers Squibb; Celgene Corporation; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Millennium Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; and Onyx Pharmaceuticals, Inc.
Sagar Lonial, MD
Chief Medical Officer, Winship Cancer Institute of Emory University
Chair, Dept. of Hematology and Medical Oncology, Emory School of Medicine
Faculty/Faculty Disclosure
Dr. Lonial reports that he is a compensated consultant for Bristol-Myers Squibb; Celgene Corporation; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Millennium Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; and Onyx Pharmaceuticals, Inc.
Sagar Lonial, MD
Chief Medical Officer, Winship Cancer Institute of Emory University
Chair, Dept. of Hematology and Medical Oncology, Emory School of Medicine
Faculty/Faculty Disclosure
Dr. Lonial reports that he is a compensated consultant for Bristol-Myers Squibb; Celgene Corporation; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Millennium Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; and Onyx Pharmaceuticals, Inc.
MACRA Monday: BMI screening and follow-up
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Measure #128: Preventive Care and Screening: Body Mass Index Screening and Follow-Up Plan
This measure is aimed at capturing the percentage of patients aged 18 years and older who have had their body mass index (BMI) calculated and documented in the last 6 months and a follow-up plan developed if the BMI was too high or too low.
What you need to do: Assess the patient’s BMI during the visit or document that it was done in the last 6 months. Patient-reported height and weight values cannot be used. If the BMI is outside of normal parameters (18.5 kg/m2 to 25 kg/m2), develop a follow-up plan or document that one was made in the last 6 months.
Eligible cases include patients who were aged 18 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 96150, 96151, 96152, 97161, 97162, 97163, 97165, 97166, 97167, 97802, 97803, 98960, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, D7140, D7210, G0101, G0108, G0270, G0271, G0402, G0438, G0439, G0447 without telehealth modifiers GQ or GT.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8420 indicates that BMI has been documented within normal parameters and no follow-up plan is required, while G8417 and G8418 indicate BMI above and below normal parameters, respectively, with a documented follow-up plan.
Use exclusion code G8938 if the BMI has been documented as being outside of normal limits, but a follow-up plan is not documented because the patient is not eligible. For example, patients are considered not eligible if they are 65 years or older and weight reduction or gain would complicate an underlying health condition.
CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Measure #128: Preventive Care and Screening: Body Mass Index Screening and Follow-Up Plan
This measure is aimed at capturing the percentage of patients aged 18 years and older who have had their body mass index (BMI) calculated and documented in the last 6 months and a follow-up plan developed if the BMI was too high or too low.
What you need to do: Assess the patient’s BMI during the visit or document that it was done in the last 6 months. Patient-reported height and weight values cannot be used. If the BMI is outside of normal parameters (18.5 kg/m2 to 25 kg/m2), develop a follow-up plan or document that one was made in the last 6 months.
Eligible cases include patients who were aged 18 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 96150, 96151, 96152, 97161, 97162, 97163, 97165, 97166, 97167, 97802, 97803, 98960, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, D7140, D7210, G0101, G0108, G0270, G0271, G0402, G0438, G0439, G0447 without telehealth modifiers GQ or GT.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8420 indicates that BMI has been documented within normal parameters and no follow-up plan is required, while G8417 and G8418 indicate BMI above and below normal parameters, respectively, with a documented follow-up plan.
Use exclusion code G8938 if the BMI has been documented as being outside of normal limits, but a follow-up plan is not documented because the patient is not eligible. For example, patients are considered not eligible if they are 65 years or older and weight reduction or gain would complicate an underlying health condition.
CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Measure #128: Preventive Care and Screening: Body Mass Index Screening and Follow-Up Plan
This measure is aimed at capturing the percentage of patients aged 18 years and older who have had their body mass index (BMI) calculated and documented in the last 6 months and a follow-up plan developed if the BMI was too high or too low.
What you need to do: Assess the patient’s BMI during the visit or document that it was done in the last 6 months. Patient-reported height and weight values cannot be used. If the BMI is outside of normal parameters (18.5 kg/m2 to 25 kg/m2), develop a follow-up plan or document that one was made in the last 6 months.
Eligible cases include patients who were aged 18 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 96150, 96151, 96152, 97161, 97162, 97163, 97165, 97166, 97167, 97802, 97803, 98960, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, D7140, D7210, G0101, G0108, G0270, G0271, G0402, G0438, G0439, G0447 without telehealth modifiers GQ or GT.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8420 indicates that BMI has been documented within normal parameters and no follow-up plan is required, while G8417 and G8418 indicate BMI above and below normal parameters, respectively, with a documented follow-up plan.
Use exclusion code G8938 if the BMI has been documented as being outside of normal limits, but a follow-up plan is not documented because the patient is not eligible. For example, patients are considered not eligible if they are 65 years or older and weight reduction or gain would complicate an underlying health condition.
CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
A Medication Tracker That Patients Swallow
Making sure some patients are taking their medication correctly may be a little easier now. The FDA has approved Abilify MyCite (apiprazole), which has an ingestible sensor.
Abilify MyCite is approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar 1 disorder, and as an add-on treatment for depression in adults.
The sensor, embedded in the pill, records when the medicine was taken, and sends a message to a wearable patch, which then transmits information to a mobile application. Patients can track the ingestion of the medication on their smartphone and can allow their caregivers and physicians to access information through a web-based portal.
However, the FDA notes that Abilify MyCite’s prescribing information includes a caution that the product has not been shown to improve patient adherence with a treatment regimen. Moreover, Ability MyCite should not be used to track drug ingestion in real time or during an emergency, because detection may be delayed or may not occur. Before prescribing it for a patient, health care professionals should make sure the patient is capable and willing to use the drug, patch, and app.
Making sure some patients are taking their medication correctly may be a little easier now. The FDA has approved Abilify MyCite (apiprazole), which has an ingestible sensor.
Abilify MyCite is approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar 1 disorder, and as an add-on treatment for depression in adults.
The sensor, embedded in the pill, records when the medicine was taken, and sends a message to a wearable patch, which then transmits information to a mobile application. Patients can track the ingestion of the medication on their smartphone and can allow their caregivers and physicians to access information through a web-based portal.
However, the FDA notes that Abilify MyCite’s prescribing information includes a caution that the product has not been shown to improve patient adherence with a treatment regimen. Moreover, Ability MyCite should not be used to track drug ingestion in real time or during an emergency, because detection may be delayed or may not occur. Before prescribing it for a patient, health care professionals should make sure the patient is capable and willing to use the drug, patch, and app.
Making sure some patients are taking their medication correctly may be a little easier now. The FDA has approved Abilify MyCite (apiprazole), which has an ingestible sensor.
Abilify MyCite is approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar 1 disorder, and as an add-on treatment for depression in adults.
The sensor, embedded in the pill, records when the medicine was taken, and sends a message to a wearable patch, which then transmits information to a mobile application. Patients can track the ingestion of the medication on their smartphone and can allow their caregivers and physicians to access information through a web-based portal.
However, the FDA notes that Abilify MyCite’s prescribing information includes a caution that the product has not been shown to improve patient adherence with a treatment regimen. Moreover, Ability MyCite should not be used to track drug ingestion in real time or during an emergency, because detection may be delayed or may not occur. Before prescribing it for a patient, health care professionals should make sure the patient is capable and willing to use the drug, patch, and app.
When the Fix Fails
ANSWER
The radiograph shows an adequately positioned endotracheal tube. It also shows bilateral infiltrates, greater in the right than in the left lung.
A pigtail catheter is present, up high near the apex; despite this, a pneumothorax of moderate size remains on the right. The likely explanation is that the catheter is either not properly positioned or is kinked.
Prompt surgical consultation for new chest tube placement was obtained.
ANSWER
The radiograph shows an adequately positioned endotracheal tube. It also shows bilateral infiltrates, greater in the right than in the left lung.
A pigtail catheter is present, up high near the apex; despite this, a pneumothorax of moderate size remains on the right. The likely explanation is that the catheter is either not properly positioned or is kinked.
Prompt surgical consultation for new chest tube placement was obtained.
ANSWER
The radiograph shows an adequately positioned endotracheal tube. It also shows bilateral infiltrates, greater in the right than in the left lung.
A pigtail catheter is present, up high near the apex; despite this, a pneumothorax of moderate size remains on the right. The likely explanation is that the catheter is either not properly positioned or is kinked.
Prompt surgical consultation for new chest tube placement was obtained.
A 60-year-old woman is transferred to your facility from an outside hospital for tertiary care. She was reportedly at home with family when she suddenly collapsed and became unresponsive. She was taken to a nearby hospital, where she was resuscitated, stabilized, and urgently sent to your facility for possible cardiac intervention.
You assess the patient immediately upon arrival;with no family present, history is limited to the chart. You note an intubated female on mild sedation. Her vital signs include a temperature of 37.0°C; blood pressure, 130/80 mm Hg; heart rate, 70 beats/min; and O2 saturation, 98% on 100% FiO2.
The heart rate monitor shows sinus rhythm. A right chest tube is in place. Auscultation reveals bilateral rhonchi.
Portable chest radiograph is obtained (shown). What is your impression?
AHRQ Practice Toolbox: Health Literacy
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
MAVORIC: Mogamulizumab tops vorinostat in pretreated CTCL
ATLANTA – Intravenous treatment with mogamulizumab, an investigational antibody targeting CC chemokine receptor 4, more than doubled progression-free survival (PFS), compared with oral vorinostat in a phase 3 trial of 372 patients with heavily pretreated cutaneous T-cell lymphoma (CTCL).
After a median of three treatment cycles, median PFS with mogamulizumab was 7.7 months vs. 3.1 months with vorinostat (hazard ratio, 0.53; 95% confidence interval, 0.41-0.69; P less than .0001), Youn H. Kim, MD, reported at the annual meeting of the American Society of Hematology.
, said Dr. Kim, the Joanne and Peter Haas, Jr. Professor for Cutaneous Lymphoma Research at Stanford (Calif.) University. Adverse effects, such as infusion reactions, were expected and manageable, she added.
Mogamulizumab is approved in Japan for treating CTCL and received an FDA breakthrough therapy designation in August 2017.
Based on audits so far, the agency might green-light mogamulizumab for previously treated CTCL by early 2018 – its first approval in the United States, Dr. Kim said in an interview.
Cutaneous T-cell lymphoma responds poorly to treatments that work in other, more common types of non-Hodgkin lymphoma. Moreover, extensive disease can destroy quality of life.
“There’s a major psychosocial impact because if you’re infected, you smell bad,” Dr. Kim said during a press briefing. “Itch is very severe – patients often cannot sleep because of it.”
Mogamulizumab is a humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4), which facilitates trafficking of lymphocytes to skin and other organs. It is defucosylated, augmenting its toxicity against malignant T cells. In a prior phase 1/2 study in the United States, mogamulizumab showed a tolerable safety profile and a 37% overall response rate – “a good response, considering that other CTCL drugs are usually in the 30% range,” Dr. Kim said.
For the phase 3 study (MAVORIC), 372 patients with previously treated stage IB to stage IVB CTCL (mycosis fungoides or Sézary syndrome) without large-cell transformation received mogamulizumab (1.0 mg/kg IV weekly for 28 days; days 1 and 15 of subsequent 28-day cycles) or vorinostat (400 mg per oral daily). Treatment continued until disease progression or intolerable toxicity. Researchers evaluated PFS based on a global composite response score that covers the skin, blood, lymph nodes, and viscera, in accordance with international consensus guidelines (J Clin Oncol. 2011 Jun 20;29(18):2598-607; doi: 10.1200/JCO.2010.32.0630).
Treatment groups resembled each other at baseline. Most had received three systemic therapies for CTCL, and some had received as many as 18. Median duration of response was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. Patients tended to respond to mogamulizumab 2 months sooner than to vorinostat (3.3 vs. 5.1 months), Dr. Kim said.
Mogamulizumab also significantly improved quality of life on the Skindex-29 Symptoms (P less than .05), Skindex-29 Function (P less than 05), and FACT-G Functional Well-Being (P less than .05) quality of life scales, which is part of what earned it a breakthrough therapy designation, Dr. Kim said.
MAVORIC is the largest randomized study to compare systemic therapies in CTCL and the first to use PFS as the primary endpoint, Dr. Kim noted. Patients’ level of CCR4 expression was not a criterion for enrollment because CCR4 is consistently and highly expressed in this disease, she noted. Thus, using mogamulizumab to treat CTCL in the United States would not require CCR4 testing.
Joseph M. Connors, MD, who specializes in lymphoid cancers at the BC Cancer Agency, a division of the British Columbia Provincial Health Services Authority, and who was not involved in the study, agreed that these data represent real headway in treating CTCL.
“I can state unequivocally that we just haven’t had effective therapy for CTCL,” he said at the press briefing. “We’ve had treatments that might help patients feel somewhat better, but we’ve had no consensus on a treatment that is right for this disease. These data provide an opportunity to have that consensus. They could create a platform for making further progress.”
Kyowa Kirin Pharmaceutical Development provided funding. Dr. Kim disclosed research and advisory relationships with Kyowa Kirin and ties to Millennium Pharmaceuticals, Seattle Genetics, Soligenix, and other companies.
SOURCE: Kim YH et al. ASH 2017 Abstract 817.
ATLANTA – Intravenous treatment with mogamulizumab, an investigational antibody targeting CC chemokine receptor 4, more than doubled progression-free survival (PFS), compared with oral vorinostat in a phase 3 trial of 372 patients with heavily pretreated cutaneous T-cell lymphoma (CTCL).
After a median of three treatment cycles, median PFS with mogamulizumab was 7.7 months vs. 3.1 months with vorinostat (hazard ratio, 0.53; 95% confidence interval, 0.41-0.69; P less than .0001), Youn H. Kim, MD, reported at the annual meeting of the American Society of Hematology.
, said Dr. Kim, the Joanne and Peter Haas, Jr. Professor for Cutaneous Lymphoma Research at Stanford (Calif.) University. Adverse effects, such as infusion reactions, were expected and manageable, she added.
Mogamulizumab is approved in Japan for treating CTCL and received an FDA breakthrough therapy designation in August 2017.
Based on audits so far, the agency might green-light mogamulizumab for previously treated CTCL by early 2018 – its first approval in the United States, Dr. Kim said in an interview.
Cutaneous T-cell lymphoma responds poorly to treatments that work in other, more common types of non-Hodgkin lymphoma. Moreover, extensive disease can destroy quality of life.
“There’s a major psychosocial impact because if you’re infected, you smell bad,” Dr. Kim said during a press briefing. “Itch is very severe – patients often cannot sleep because of it.”
Mogamulizumab is a humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4), which facilitates trafficking of lymphocytes to skin and other organs. It is defucosylated, augmenting its toxicity against malignant T cells. In a prior phase 1/2 study in the United States, mogamulizumab showed a tolerable safety profile and a 37% overall response rate – “a good response, considering that other CTCL drugs are usually in the 30% range,” Dr. Kim said.
For the phase 3 study (MAVORIC), 372 patients with previously treated stage IB to stage IVB CTCL (mycosis fungoides or Sézary syndrome) without large-cell transformation received mogamulizumab (1.0 mg/kg IV weekly for 28 days; days 1 and 15 of subsequent 28-day cycles) or vorinostat (400 mg per oral daily). Treatment continued until disease progression or intolerable toxicity. Researchers evaluated PFS based on a global composite response score that covers the skin, blood, lymph nodes, and viscera, in accordance with international consensus guidelines (J Clin Oncol. 2011 Jun 20;29(18):2598-607; doi: 10.1200/JCO.2010.32.0630).
Treatment groups resembled each other at baseline. Most had received three systemic therapies for CTCL, and some had received as many as 18. Median duration of response was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. Patients tended to respond to mogamulizumab 2 months sooner than to vorinostat (3.3 vs. 5.1 months), Dr. Kim said.
Mogamulizumab also significantly improved quality of life on the Skindex-29 Symptoms (P less than .05), Skindex-29 Function (P less than 05), and FACT-G Functional Well-Being (P less than .05) quality of life scales, which is part of what earned it a breakthrough therapy designation, Dr. Kim said.
MAVORIC is the largest randomized study to compare systemic therapies in CTCL and the first to use PFS as the primary endpoint, Dr. Kim noted. Patients’ level of CCR4 expression was not a criterion for enrollment because CCR4 is consistently and highly expressed in this disease, she noted. Thus, using mogamulizumab to treat CTCL in the United States would not require CCR4 testing.
Joseph M. Connors, MD, who specializes in lymphoid cancers at the BC Cancer Agency, a division of the British Columbia Provincial Health Services Authority, and who was not involved in the study, agreed that these data represent real headway in treating CTCL.
“I can state unequivocally that we just haven’t had effective therapy for CTCL,” he said at the press briefing. “We’ve had treatments that might help patients feel somewhat better, but we’ve had no consensus on a treatment that is right for this disease. These data provide an opportunity to have that consensus. They could create a platform for making further progress.”
Kyowa Kirin Pharmaceutical Development provided funding. Dr. Kim disclosed research and advisory relationships with Kyowa Kirin and ties to Millennium Pharmaceuticals, Seattle Genetics, Soligenix, and other companies.
SOURCE: Kim YH et al. ASH 2017 Abstract 817.
ATLANTA – Intravenous treatment with mogamulizumab, an investigational antibody targeting CC chemokine receptor 4, more than doubled progression-free survival (PFS), compared with oral vorinostat in a phase 3 trial of 372 patients with heavily pretreated cutaneous T-cell lymphoma (CTCL).
After a median of three treatment cycles, median PFS with mogamulizumab was 7.7 months vs. 3.1 months with vorinostat (hazard ratio, 0.53; 95% confidence interval, 0.41-0.69; P less than .0001), Youn H. Kim, MD, reported at the annual meeting of the American Society of Hematology.
, said Dr. Kim, the Joanne and Peter Haas, Jr. Professor for Cutaneous Lymphoma Research at Stanford (Calif.) University. Adverse effects, such as infusion reactions, were expected and manageable, she added.
Mogamulizumab is approved in Japan for treating CTCL and received an FDA breakthrough therapy designation in August 2017.
Based on audits so far, the agency might green-light mogamulizumab for previously treated CTCL by early 2018 – its first approval in the United States, Dr. Kim said in an interview.
Cutaneous T-cell lymphoma responds poorly to treatments that work in other, more common types of non-Hodgkin lymphoma. Moreover, extensive disease can destroy quality of life.
“There’s a major psychosocial impact because if you’re infected, you smell bad,” Dr. Kim said during a press briefing. “Itch is very severe – patients often cannot sleep because of it.”
Mogamulizumab is a humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4), which facilitates trafficking of lymphocytes to skin and other organs. It is defucosylated, augmenting its toxicity against malignant T cells. In a prior phase 1/2 study in the United States, mogamulizumab showed a tolerable safety profile and a 37% overall response rate – “a good response, considering that other CTCL drugs are usually in the 30% range,” Dr. Kim said.
For the phase 3 study (MAVORIC), 372 patients with previously treated stage IB to stage IVB CTCL (mycosis fungoides or Sézary syndrome) without large-cell transformation received mogamulizumab (1.0 mg/kg IV weekly for 28 days; days 1 and 15 of subsequent 28-day cycles) or vorinostat (400 mg per oral daily). Treatment continued until disease progression or intolerable toxicity. Researchers evaluated PFS based on a global composite response score that covers the skin, blood, lymph nodes, and viscera, in accordance with international consensus guidelines (J Clin Oncol. 2011 Jun 20;29(18):2598-607; doi: 10.1200/JCO.2010.32.0630).
Treatment groups resembled each other at baseline. Most had received three systemic therapies for CTCL, and some had received as many as 18. Median duration of response was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. Patients tended to respond to mogamulizumab 2 months sooner than to vorinostat (3.3 vs. 5.1 months), Dr. Kim said.
Mogamulizumab also significantly improved quality of life on the Skindex-29 Symptoms (P less than .05), Skindex-29 Function (P less than 05), and FACT-G Functional Well-Being (P less than .05) quality of life scales, which is part of what earned it a breakthrough therapy designation, Dr. Kim said.
MAVORIC is the largest randomized study to compare systemic therapies in CTCL and the first to use PFS as the primary endpoint, Dr. Kim noted. Patients’ level of CCR4 expression was not a criterion for enrollment because CCR4 is consistently and highly expressed in this disease, she noted. Thus, using mogamulizumab to treat CTCL in the United States would not require CCR4 testing.
Joseph M. Connors, MD, who specializes in lymphoid cancers at the BC Cancer Agency, a division of the British Columbia Provincial Health Services Authority, and who was not involved in the study, agreed that these data represent real headway in treating CTCL.
“I can state unequivocally that we just haven’t had effective therapy for CTCL,” he said at the press briefing. “We’ve had treatments that might help patients feel somewhat better, but we’ve had no consensus on a treatment that is right for this disease. These data provide an opportunity to have that consensus. They could create a platform for making further progress.”
Kyowa Kirin Pharmaceutical Development provided funding. Dr. Kim disclosed research and advisory relationships with Kyowa Kirin and ties to Millennium Pharmaceuticals, Seattle Genetics, Soligenix, and other companies.
SOURCE: Kim YH et al. ASH 2017 Abstract 817.
REPORTING FROM ASH 2017
Key clinical point: Mogamulizumab more than doubled median progression-free survival, compared with vorinostat in patients with previously treated cutaneous T-cell lymphoma.
Major finding: Median progression-free survival was 7.7 months vs. 3.1 months (HR, 0.53; 95% CI, 0.41 to 0.69; P less than .0001).
Data source: An open-label phase 3 trial of 372 patients with previously treated cutaneous T-cell lymphoma (MAVORIC).
Disclosures: Kyowa Kirin Pharmaceutical Development provided funding. Dr. Kim disclosed research and advisory relationships with Kyowa Kirin and ties to Millennium Pharmaceuticals, Seattle Genetics, Soligenix, and other companies.
Source: Kim YH et al. ASH 2017 Abstract 817.
CLARITY: Ibrutinib/venetoclax combo results look promising for relapsed/refractory CLL
ATLANTA – Combination therapy with ibrutinib and venetoclax is well tolerated and shows promise for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL), according to initial results from the CLARITY feasibility trial.
Of 38 patients who received at least 6 months of treatment with combination ibrutinib (Imbruvica)/venetoclax (Venclexta) and reached month 8 – and therefore had computed tomography, clinical data, and peripheral blood and marrow assessments available – 15 (37%) achieved peripheral blood minimal residual disease (MRD) negativity, and 12 (32%) achieved bone marrow MRD negativity, Peter Hillmen, MBChB, PhD, reported during a press briefing at the annual meeting of the American Society of Hematology.
The rates of MRD negativity in the blood and marrow, and of normal trephine biopsy, were similar in subsets of patients who relapsed within 36 months of prior treatment with fludarabine/cyclophosphamide/rituximab (FCR) or bendamustine/rituximab (BR), and with prior idelalisib exposure, he noted.
“In terms of [International Workshop on Chronic Lymphocytic Leukemia] response criteria, which is a secondary endpoint, 47% of patients achieved a [complete remission or complete remission with incomplete hematologic recovery] and every patient has had an overall response, which for this group of patients is impressive,” he said.
Again, the findings were similar in those who were refractory to prior FCR/BR or to previous idelalisib, he noted.
Both ibrutinib and venetoclax are approved as single agents for the treatment of CLL. Ibrutinib is a Bruton’s tyrosine kinase inhibitor that has had a major effect on patient outcomes, showing overall survival advantages in numerous trials, Dr. Hillmen said.
“However, ibrutinib does not eradicate disease, and patients remain on treatment indefinitely or until progression,” he said.
Venetoclax is a highly selective B cell lymphoma–2 inhibitor approved for refractory CLL in patients with 17p deletion. It has a rapid effect, which can lead to tumor lysis syndrome, but also leads to eradication of MRD in some patients, which can lead to prolonged survival, he said.
The CLARITY trial was designed to investigate the safety and efficacy of the two in combination in relapsed/refractory CLL patients.
The primary endpoint of the study is MRD eradication in the marrow after 12 months of treatment. The current analysis looks at a key secondary endpoint of the study – MRD eradication in the marrow after 6 months of treatment.
The study enrolled 54 patients, including 37 men and 17 women with a median age of 64 years; 20% have 17p deletion, and the population was heavily pretreated, with 81% having prior FCR or BR (44% with relapse within 3 years of treatment), and 20% with previous idelalisib exposure. Patients were excluded if they had prior exposure to ibrutinib or venetoclax.
Treatment involves ibrutinib monotherapy at a dose of 420 mg/day for 2 months to debulk the disease, after which venetoclax is added at a dose escalating from 20 mg to 400 mg/day over 2 months to reduce the risk of tumor lysis syndrome.
Bone marrow biopsies are performed at 6, 12, and 24 months. Treatment is discontinued at 12 months in those who achieve MRD negativity at 6 months, and is discontinued at 24 months in those who achieve MRD negativity at 12 months.
The combination treatment was well tolerated in the first 38 patients. Bruising (mainly grade 1) occurred in 33 patients, and neutropenia (including 16 grade 3 cases and 6 grade 4 cases) occurred in 25, and some GI toxicity occurred, but was largely grade 1 or 2, Dr. Hillmen said.
“There really was otherwise very acceptable toxicity,” he added, noting that a single case of tumor lysis syndrome occurred, but was managed successfully by delaying venetoclax.
“That patient re-escalated back onto treatment and is doing well,” he said.
No patients stopped treatment, and only seven had treatment interruption, and then only for a few days, he noted.
The findings are encouraging, and suggest a potent synergy between ibrutinib and venetoclax, said Dr. Hillmen.
“We’re seeing, even at this very early stage, over 30% of patients achieving MRD negative remission, which was our target at the 12-month bone marrow stage with this combination,” he said.
In light of these results, the ongoing phase 3 FLAIR trial, which is actively recruiting, has been modified to include combination ibrutinib and venetoclax in front-line CLL, he said.
Dr. Hillmen reported financial relationships with AbbVie and several other pharmaceutical companies. The CLARITY trial is supported by AbbVie, Bloodwise, Experimental Cancer Medicine Centre, Janssen-Cilag, the National Institute for Health Research Clinical Research Network: Cancer, and the University of Birmingham (England).
sworcester@frontlinemedcom.com
SOURCE: Hillmen P et al., ASH abstract 428.
ATLANTA – Combination therapy with ibrutinib and venetoclax is well tolerated and shows promise for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL), according to initial results from the CLARITY feasibility trial.
Of 38 patients who received at least 6 months of treatment with combination ibrutinib (Imbruvica)/venetoclax (Venclexta) and reached month 8 – and therefore had computed tomography, clinical data, and peripheral blood and marrow assessments available – 15 (37%) achieved peripheral blood minimal residual disease (MRD) negativity, and 12 (32%) achieved bone marrow MRD negativity, Peter Hillmen, MBChB, PhD, reported during a press briefing at the annual meeting of the American Society of Hematology.
The rates of MRD negativity in the blood and marrow, and of normal trephine biopsy, were similar in subsets of patients who relapsed within 36 months of prior treatment with fludarabine/cyclophosphamide/rituximab (FCR) or bendamustine/rituximab (BR), and with prior idelalisib exposure, he noted.
“In terms of [International Workshop on Chronic Lymphocytic Leukemia] response criteria, which is a secondary endpoint, 47% of patients achieved a [complete remission or complete remission with incomplete hematologic recovery] and every patient has had an overall response, which for this group of patients is impressive,” he said.
Again, the findings were similar in those who were refractory to prior FCR/BR or to previous idelalisib, he noted.
Both ibrutinib and venetoclax are approved as single agents for the treatment of CLL. Ibrutinib is a Bruton’s tyrosine kinase inhibitor that has had a major effect on patient outcomes, showing overall survival advantages in numerous trials, Dr. Hillmen said.
“However, ibrutinib does not eradicate disease, and patients remain on treatment indefinitely or until progression,” he said.
Venetoclax is a highly selective B cell lymphoma–2 inhibitor approved for refractory CLL in patients with 17p deletion. It has a rapid effect, which can lead to tumor lysis syndrome, but also leads to eradication of MRD in some patients, which can lead to prolonged survival, he said.
The CLARITY trial was designed to investigate the safety and efficacy of the two in combination in relapsed/refractory CLL patients.
The primary endpoint of the study is MRD eradication in the marrow after 12 months of treatment. The current analysis looks at a key secondary endpoint of the study – MRD eradication in the marrow after 6 months of treatment.
The study enrolled 54 patients, including 37 men and 17 women with a median age of 64 years; 20% have 17p deletion, and the population was heavily pretreated, with 81% having prior FCR or BR (44% with relapse within 3 years of treatment), and 20% with previous idelalisib exposure. Patients were excluded if they had prior exposure to ibrutinib or venetoclax.
Treatment involves ibrutinib monotherapy at a dose of 420 mg/day for 2 months to debulk the disease, after which venetoclax is added at a dose escalating from 20 mg to 400 mg/day over 2 months to reduce the risk of tumor lysis syndrome.
Bone marrow biopsies are performed at 6, 12, and 24 months. Treatment is discontinued at 12 months in those who achieve MRD negativity at 6 months, and is discontinued at 24 months in those who achieve MRD negativity at 12 months.
The combination treatment was well tolerated in the first 38 patients. Bruising (mainly grade 1) occurred in 33 patients, and neutropenia (including 16 grade 3 cases and 6 grade 4 cases) occurred in 25, and some GI toxicity occurred, but was largely grade 1 or 2, Dr. Hillmen said.
“There really was otherwise very acceptable toxicity,” he added, noting that a single case of tumor lysis syndrome occurred, but was managed successfully by delaying venetoclax.
“That patient re-escalated back onto treatment and is doing well,” he said.
No patients stopped treatment, and only seven had treatment interruption, and then only for a few days, he noted.
The findings are encouraging, and suggest a potent synergy between ibrutinib and venetoclax, said Dr. Hillmen.
“We’re seeing, even at this very early stage, over 30% of patients achieving MRD negative remission, which was our target at the 12-month bone marrow stage with this combination,” he said.
In light of these results, the ongoing phase 3 FLAIR trial, which is actively recruiting, has been modified to include combination ibrutinib and venetoclax in front-line CLL, he said.
Dr. Hillmen reported financial relationships with AbbVie and several other pharmaceutical companies. The CLARITY trial is supported by AbbVie, Bloodwise, Experimental Cancer Medicine Centre, Janssen-Cilag, the National Institute for Health Research Clinical Research Network: Cancer, and the University of Birmingham (England).
sworcester@frontlinemedcom.com
SOURCE: Hillmen P et al., ASH abstract 428.
ATLANTA – Combination therapy with ibrutinib and venetoclax is well tolerated and shows promise for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL), according to initial results from the CLARITY feasibility trial.
Of 38 patients who received at least 6 months of treatment with combination ibrutinib (Imbruvica)/venetoclax (Venclexta) and reached month 8 – and therefore had computed tomography, clinical data, and peripheral blood and marrow assessments available – 15 (37%) achieved peripheral blood minimal residual disease (MRD) negativity, and 12 (32%) achieved bone marrow MRD negativity, Peter Hillmen, MBChB, PhD, reported during a press briefing at the annual meeting of the American Society of Hematology.
The rates of MRD negativity in the blood and marrow, and of normal trephine biopsy, were similar in subsets of patients who relapsed within 36 months of prior treatment with fludarabine/cyclophosphamide/rituximab (FCR) or bendamustine/rituximab (BR), and with prior idelalisib exposure, he noted.
“In terms of [International Workshop on Chronic Lymphocytic Leukemia] response criteria, which is a secondary endpoint, 47% of patients achieved a [complete remission or complete remission with incomplete hematologic recovery] and every patient has had an overall response, which for this group of patients is impressive,” he said.
Again, the findings were similar in those who were refractory to prior FCR/BR or to previous idelalisib, he noted.
Both ibrutinib and venetoclax are approved as single agents for the treatment of CLL. Ibrutinib is a Bruton’s tyrosine kinase inhibitor that has had a major effect on patient outcomes, showing overall survival advantages in numerous trials, Dr. Hillmen said.
“However, ibrutinib does not eradicate disease, and patients remain on treatment indefinitely or until progression,” he said.
Venetoclax is a highly selective B cell lymphoma–2 inhibitor approved for refractory CLL in patients with 17p deletion. It has a rapid effect, which can lead to tumor lysis syndrome, but also leads to eradication of MRD in some patients, which can lead to prolonged survival, he said.
The CLARITY trial was designed to investigate the safety and efficacy of the two in combination in relapsed/refractory CLL patients.
The primary endpoint of the study is MRD eradication in the marrow after 12 months of treatment. The current analysis looks at a key secondary endpoint of the study – MRD eradication in the marrow after 6 months of treatment.
The study enrolled 54 patients, including 37 men and 17 women with a median age of 64 years; 20% have 17p deletion, and the population was heavily pretreated, with 81% having prior FCR or BR (44% with relapse within 3 years of treatment), and 20% with previous idelalisib exposure. Patients were excluded if they had prior exposure to ibrutinib or venetoclax.
Treatment involves ibrutinib monotherapy at a dose of 420 mg/day for 2 months to debulk the disease, after which venetoclax is added at a dose escalating from 20 mg to 400 mg/day over 2 months to reduce the risk of tumor lysis syndrome.
Bone marrow biopsies are performed at 6, 12, and 24 months. Treatment is discontinued at 12 months in those who achieve MRD negativity at 6 months, and is discontinued at 24 months in those who achieve MRD negativity at 12 months.
The combination treatment was well tolerated in the first 38 patients. Bruising (mainly grade 1) occurred in 33 patients, and neutropenia (including 16 grade 3 cases and 6 grade 4 cases) occurred in 25, and some GI toxicity occurred, but was largely grade 1 or 2, Dr. Hillmen said.
“There really was otherwise very acceptable toxicity,” he added, noting that a single case of tumor lysis syndrome occurred, but was managed successfully by delaying venetoclax.
“That patient re-escalated back onto treatment and is doing well,” he said.
No patients stopped treatment, and only seven had treatment interruption, and then only for a few days, he noted.
The findings are encouraging, and suggest a potent synergy between ibrutinib and venetoclax, said Dr. Hillmen.
“We’re seeing, even at this very early stage, over 30% of patients achieving MRD negative remission, which was our target at the 12-month bone marrow stage with this combination,” he said.
In light of these results, the ongoing phase 3 FLAIR trial, which is actively recruiting, has been modified to include combination ibrutinib and venetoclax in front-line CLL, he said.
Dr. Hillmen reported financial relationships with AbbVie and several other pharmaceutical companies. The CLARITY trial is supported by AbbVie, Bloodwise, Experimental Cancer Medicine Centre, Janssen-Cilag, the National Institute for Health Research Clinical Research Network: Cancer, and the University of Birmingham (England).
sworcester@frontlinemedcom.com
SOURCE: Hillmen P et al., ASH abstract 428.
REPORTING FROM ASH 2017
Key clinical point:
Major finding: 37% and 32% of patients achieved peripheral blood and marrow MRD negativity, respectively.
Study details: Initial results from 38 patients in the CLARITY feasibility trial.
Disclosures: Dr. Hillmen reported financial relationships with AbbVie and several other pharmaceutical companies. The CLARITY trial is supported by AbbVie, Bloodwise, Experimental Cancer Medicine Centre, Janssen-Cilag, the National Institute for Health Research Clinical Research Network: Cancer, and the University of Birmingham.
Source: Hillmen P et al. ASH Abstract 428.
