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Racial disparities in ovarian cancer care persist until death
Even at the end of life, nonwhite patients with ovarian cancer are more likely to receive suboptimal care.
That’s the finding of investigators who looked at Medicare-enrolled patients with end-stage ovarian cancer in Texas. They found that compared with white patients, nonwhites were less likely to be enrolled in or die in hospice, more likely to be admitted to an intensive care unit, more likely to have an emergency department visit, and more likely to be subjected to some kind of putatively life-extending intervention.
“More investigation is needed to determine not only how to best reduce the overall number of patients with ovarian cancer who receive aggressive and invasive care but also how to lessen the disparity of who receives more aggressive and invasive care. With regard to end-of-life care for patients with ovarian cancer, less may be more,” wrote Jolyn S. Taylor, MD, MPH, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues (J Clin Oncol. 2017 April 7 doi: 10.1200/JCO.2016.70.2894).
Quality-of-care recommendations from the American Society of Clinical Oncology Quality Oncology Practice Initiative, Physician Consortium for Performance Improvement, and National Quality Forum call on clinicians to recognize that excessive or aggressive end-of-life interventions can have a negative effect on the quality of life for patients with limited life expectancy, the authors noted.
“Although changes have occurred over the last decade leading to increased hospice use by patients with ovarian cancer before death, many patients still receive intensive and invasive care in the last month of life. Similar to other disease sites, patients of minority race and ethnicity and lower socioeconomic status who have ovarian cancer have been reported to have less hospice use and more intensive end-of-life care,” the researchers wrote.
To see whether these disparities still existed, the investigators examined Texas Cancer Registry–Medicare data on patients who died from ovarian cancer from 2000 to 2012 who had least 13 months of continuous Medicare coverage before their deaths. They looked for specific measures of end-of-life care quality, including chemotherapy use within 2 weeks of death, ICU admission in the last month of life, and emergency department visits, hospital admissions, or invasive or life-extending procedures, all during the last 30 days of a patient’s life.
Of the 3,666 patients studied, 2,819 (77%) were white, 553 (15%) were Hispanic, 256 (7%) were black, and 38 (1%) were classified as “other.”
In multivariate regression models adjusted for year of death, age at death, time from diagnosis to death, Charlson comorbidity index score, disease stage at diagnosis, educational and poverty level by census tract, and geography (rural versus urban), the researchers found that both black and Hispanic patients were significantly less likely than were white patients to enroll in and die in hospice, with odds ratios (OR) of 0.66 for black patients (P = .004), and 0.76 for Hispanics (P = .01).
Black but not Hispanic patients were more likely to have had more than one emergency department visit within 30 days of death (OR 2.20, P less than .001), or a life-extending procedure (OR 2.13, P less than .001). Hispanic but not black patients were more likely to have been admitted to an ICU within a month of death (OR 1.37, P = .02).
The study was supported by grants from the Cancer Prevention & Research Institute of Texas, National Institutes of Health, National Cancer Institute, and Duncan Family Institute.
Even at the end of life, nonwhite patients with ovarian cancer are more likely to receive suboptimal care.
That’s the finding of investigators who looked at Medicare-enrolled patients with end-stage ovarian cancer in Texas. They found that compared with white patients, nonwhites were less likely to be enrolled in or die in hospice, more likely to be admitted to an intensive care unit, more likely to have an emergency department visit, and more likely to be subjected to some kind of putatively life-extending intervention.
“More investigation is needed to determine not only how to best reduce the overall number of patients with ovarian cancer who receive aggressive and invasive care but also how to lessen the disparity of who receives more aggressive and invasive care. With regard to end-of-life care for patients with ovarian cancer, less may be more,” wrote Jolyn S. Taylor, MD, MPH, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues (J Clin Oncol. 2017 April 7 doi: 10.1200/JCO.2016.70.2894).
Quality-of-care recommendations from the American Society of Clinical Oncology Quality Oncology Practice Initiative, Physician Consortium for Performance Improvement, and National Quality Forum call on clinicians to recognize that excessive or aggressive end-of-life interventions can have a negative effect on the quality of life for patients with limited life expectancy, the authors noted.
“Although changes have occurred over the last decade leading to increased hospice use by patients with ovarian cancer before death, many patients still receive intensive and invasive care in the last month of life. Similar to other disease sites, patients of minority race and ethnicity and lower socioeconomic status who have ovarian cancer have been reported to have less hospice use and more intensive end-of-life care,” the researchers wrote.
To see whether these disparities still existed, the investigators examined Texas Cancer Registry–Medicare data on patients who died from ovarian cancer from 2000 to 2012 who had least 13 months of continuous Medicare coverage before their deaths. They looked for specific measures of end-of-life care quality, including chemotherapy use within 2 weeks of death, ICU admission in the last month of life, and emergency department visits, hospital admissions, or invasive or life-extending procedures, all during the last 30 days of a patient’s life.
Of the 3,666 patients studied, 2,819 (77%) were white, 553 (15%) were Hispanic, 256 (7%) were black, and 38 (1%) were classified as “other.”
In multivariate regression models adjusted for year of death, age at death, time from diagnosis to death, Charlson comorbidity index score, disease stage at diagnosis, educational and poverty level by census tract, and geography (rural versus urban), the researchers found that both black and Hispanic patients were significantly less likely than were white patients to enroll in and die in hospice, with odds ratios (OR) of 0.66 for black patients (P = .004), and 0.76 for Hispanics (P = .01).
Black but not Hispanic patients were more likely to have had more than one emergency department visit within 30 days of death (OR 2.20, P less than .001), or a life-extending procedure (OR 2.13, P less than .001). Hispanic but not black patients were more likely to have been admitted to an ICU within a month of death (OR 1.37, P = .02).
The study was supported by grants from the Cancer Prevention & Research Institute of Texas, National Institutes of Health, National Cancer Institute, and Duncan Family Institute.
Even at the end of life, nonwhite patients with ovarian cancer are more likely to receive suboptimal care.
That’s the finding of investigators who looked at Medicare-enrolled patients with end-stage ovarian cancer in Texas. They found that compared with white patients, nonwhites were less likely to be enrolled in or die in hospice, more likely to be admitted to an intensive care unit, more likely to have an emergency department visit, and more likely to be subjected to some kind of putatively life-extending intervention.
“More investigation is needed to determine not only how to best reduce the overall number of patients with ovarian cancer who receive aggressive and invasive care but also how to lessen the disparity of who receives more aggressive and invasive care. With regard to end-of-life care for patients with ovarian cancer, less may be more,” wrote Jolyn S. Taylor, MD, MPH, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues (J Clin Oncol. 2017 April 7 doi: 10.1200/JCO.2016.70.2894).
Quality-of-care recommendations from the American Society of Clinical Oncology Quality Oncology Practice Initiative, Physician Consortium for Performance Improvement, and National Quality Forum call on clinicians to recognize that excessive or aggressive end-of-life interventions can have a negative effect on the quality of life for patients with limited life expectancy, the authors noted.
“Although changes have occurred over the last decade leading to increased hospice use by patients with ovarian cancer before death, many patients still receive intensive and invasive care in the last month of life. Similar to other disease sites, patients of minority race and ethnicity and lower socioeconomic status who have ovarian cancer have been reported to have less hospice use and more intensive end-of-life care,” the researchers wrote.
To see whether these disparities still existed, the investigators examined Texas Cancer Registry–Medicare data on patients who died from ovarian cancer from 2000 to 2012 who had least 13 months of continuous Medicare coverage before their deaths. They looked for specific measures of end-of-life care quality, including chemotherapy use within 2 weeks of death, ICU admission in the last month of life, and emergency department visits, hospital admissions, or invasive or life-extending procedures, all during the last 30 days of a patient’s life.
Of the 3,666 patients studied, 2,819 (77%) were white, 553 (15%) were Hispanic, 256 (7%) were black, and 38 (1%) were classified as “other.”
In multivariate regression models adjusted for year of death, age at death, time from diagnosis to death, Charlson comorbidity index score, disease stage at diagnosis, educational and poverty level by census tract, and geography (rural versus urban), the researchers found that both black and Hispanic patients were significantly less likely than were white patients to enroll in and die in hospice, with odds ratios (OR) of 0.66 for black patients (P = .004), and 0.76 for Hispanics (P = .01).
Black but not Hispanic patients were more likely to have had more than one emergency department visit within 30 days of death (OR 2.20, P less than .001), or a life-extending procedure (OR 2.13, P less than .001). Hispanic but not black patients were more likely to have been admitted to an ICU within a month of death (OR 1.37, P = .02).
The study was supported by grants from the Cancer Prevention & Research Institute of Texas, National Institutes of Health, National Cancer Institute, and Duncan Family Institute.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Nonwhite patients with ovarian cancer are more likely to receive suboptimal care at the end of life.
Major finding: Black and Hispanic women with ovarian cancer were significantly less likely than were whites to enroll in and die in hospice, more likely to be admitted to an intensive care unit, more likely to have an emergency department visit, and more likely to be subjected to some kind of putatively life-extending intervention.
Data source: Retrospective analysis of Texas Cancer Registry–Medicare data on 3,666 patients.
Disclosures: The study was supported by grants from the Cancer Prevention & Research Institute of Texas, National Institutes of Health, National Cancer Institute, and Duncan Family Institute.
Where are they now? Two Shark Tank innovators share their tales of success
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
[email protected]
On Twitter @whitneymcknight
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
[email protected]
On Twitter @whitneymcknight
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
[email protected]
On Twitter @whitneymcknight
FROM THE 2017 AGA TECH SUMMIT
Study shows no adverse events with long-term denosumab in postmenopausal women
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
Key clinical point: Denosumab, taken long term, is not linked with any adverse events.
Major finding: Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis showed no increasing rates of either common adverse events or of specific adverse events identified in the original trial.
Data source: Extended (6-year) follow-up of 4,550 women in the international phase III randomized, double-blind FREEDOM trial.
Disclosures: This study was funded by Amgen, maker of denosumab. Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Neurokinin receptor antagonist nearly halves hot flashes
ORLANDO – A novel antagonist of a neurokinin pathway effectively reduced hot flashes in postmenopausal women, according to results of a phase II trial.
The neurokinin 3 receptor (NK3R) antagonist, termed MLE4901, cut the number of hot flashes nearly in half compared to the effect of a placebo, and also improved overall menopause-related quality of life symptoms.
The medication has the potential to fulfill an unmet clinical need, since 70% of women experience hot flashes and the median duration of symptoms is more than 7 years, Julia K. Prague, MD, said at the annual meeting of the Endocrine Society.
The study results were published concurrently with Dr. Prague’s presentation (Lancet. 2017 Apr 3. doi: 10.1016/S0140-6736[17]30823-1).
Evidence from postmortem studies of postmenopausal women, said Dr. Prague, pointed to NKB (neurokinin B)/NK3R signaling as playing a role in hot flashes. The brains of these women showed hypertrophy of NKB neurons and increased neuronal activity, as well as increased NKB gene expression. The same effects were seen in monkeys whose ovaries had been removed, and the effect was reversed when the monkeys were given estrogen. 
Also, previous work has shown that administering NKB to premenopausal women gave them hot flashes (Sci Rep. 2015 Feb 6;5:8466). The preclinical work laid the groundwork for the hypothesis that taking an oral NK3R antagonist could mitigate hot flashes in menopausal women.
The randomized, placebo-controlled, double-blind 2-way crossover study enrolled 37 healthy women aged 40-62 who were at least 12 months out from their last menses. To qualify for enrollment, they needed to be experiencing at least seven hot flashes per 24 hours; the actual mean total number in the study group was 13 per 24 hours and 85 per week. A total of 28 women completed the full protocol.
The mean age of the women was 55 years, and the mean body mass index was 25.8 kg/m2. Three quarters of the women were white.
The women had an initial 2-week baseline period, during which they kept a symptom diary, and then were randomized to receive either an oral NK3R antagonist or a placebo twice daily. Then, each patient went through a 2-week washout period, after which they were crossed over to the other arm of the study. Finally, patients were monitored for a further 2 weeks after taking the study drug.
The NK3R antagonist, said Dr. Prague, “significantly reduced the total weekly number of hot [flashes] compared to placebo in the fourth week of treatment.” Patients taking placebo experienced 49.01 hot flashes per week (range, 40.81-58.86), while those taking the NK3R antagonist had 19.35 (range, 15.99-23.42, P less than .0001). This amounted to a 45% reduction in number of hot flashes compared to placebo.
Dr. Prague, a clinical research fellow at Imperial College, London, said that the treatment effect size seen was similar regardless of whether patients received the active study drug or placebo first.
Using the Menopause-Related Quality of Life questionnaire, Dr. Prague and her colleagues determined that when women were taking the NK3R antagonist, in addition to a significant reduction in vasomotor symptoms, menopause-related psychosocial symptoms were reduced by 15% (P = .0083) and physical symptoms by 19% (P = .0002). As expected for the nonhormonal medication, she said, sexual symptoms were reduced by a nonsignificant 8% (P = .24).
A subset of patients received more intensive study, with external validation of hot flashes and a series of 3-day-long stays during which an intravenous catheter was placed for blood sampling every 10 minutes.
Data from this group of patients showed that, while the NK3R antagonist did not significantly affect the number of luteinizing hormone pulses detected compared with placebo (P = .41), it did increase the mean amplitude of each pulse (P = .0243). Also, the active drug made the luteinizing hormone pulses more orderly (P = .0006 compared to placebo).
The NK3R antagonist was well tolerated. Though no serious adverse events were seen, three patients taking the NK3R antagonist did have a transient and asymptomatic elevation of transaminases without hyperbilirubinemia at 28 days after starting treatment. The elevation resolved for all patients within 90 days of stopping the medication.
The novel drug could represent “a potentially practice-changing therapeutic,” said Dr. Prague, since it “significantly relieves hot [flash] symptoms without the need for estrogen exposure.” She added that planning is underway for longer studies involving more patients.
The study was supported by AstraZeneca and Millendo Therapeutics, which are involved with manufacturing MLE4901.
[email protected]
On Twitter @karioakes
ORLANDO – A novel antagonist of a neurokinin pathway effectively reduced hot flashes in postmenopausal women, according to results of a phase II trial.
The neurokinin 3 receptor (NK3R) antagonist, termed MLE4901, cut the number of hot flashes nearly in half compared to the effect of a placebo, and also improved overall menopause-related quality of life symptoms.
The medication has the potential to fulfill an unmet clinical need, since 70% of women experience hot flashes and the median duration of symptoms is more than 7 years, Julia K. Prague, MD, said at the annual meeting of the Endocrine Society.
The study results were published concurrently with Dr. Prague’s presentation (Lancet. 2017 Apr 3. doi: 10.1016/S0140-6736[17]30823-1).
Evidence from postmortem studies of postmenopausal women, said Dr. Prague, pointed to NKB (neurokinin B)/NK3R signaling as playing a role in hot flashes. The brains of these women showed hypertrophy of NKB neurons and increased neuronal activity, as well as increased NKB gene expression. The same effects were seen in monkeys whose ovaries had been removed, and the effect was reversed when the monkeys were given estrogen.
Also, previous work has shown that administering NKB to premenopausal women gave them hot flashes (Sci Rep. 2015 Feb 6;5:8466). The preclinical work laid the groundwork for the hypothesis that taking an oral NK3R antagonist could mitigate hot flashes in menopausal women.
The randomized, placebo-controlled, double-blind 2-way crossover study enrolled 37 healthy women aged 40-62 who were at least 12 months out from their last menses. To qualify for enrollment, they needed to be experiencing at least seven hot flashes per 24 hours; the actual mean total number in the study group was 13 per 24 hours and 85 per week. A total of 28 women completed the full protocol.
The mean age of the women was 55 years, and the mean body mass index was 25.8 kg/m2. Three quarters of the women were white.
The women had an initial 2-week baseline period, during which they kept a symptom diary, and then were randomized to receive either an oral NK3R antagonist or a placebo twice daily. Then, each patient went through a 2-week washout period, after which they were crossed over to the other arm of the study. Finally, patients were monitored for a further 2 weeks after taking the study drug.
The NK3R antagonist, said Dr. Prague, “significantly reduced the total weekly number of hot [flashes] compared to placebo in the fourth week of treatment.” Patients taking placebo experienced 49.01 hot flashes per week (range, 40.81-58.86), while those taking the NK3R antagonist had 19.35 (range, 15.99-23.42, P less than .0001). This amounted to a 45% reduction in number of hot flashes compared to placebo.
Dr. Prague, a clinical research fellow at Imperial College, London, said that the treatment effect size seen was similar regardless of whether patients received the active study drug or placebo first.
Using the Menopause-Related Quality of Life questionnaire, Dr. Prague and her colleagues determined that when women were taking the NK3R antagonist, in addition to a significant reduction in vasomotor symptoms, menopause-related psychosocial symptoms were reduced by 15% (P = .0083) and physical symptoms by 19% (P = .0002). As expected for the nonhormonal medication, she said, sexual symptoms were reduced by a nonsignificant 8% (P = .24).
A subset of patients received more intensive study, with external validation of hot flashes and a series of 3-day-long stays during which an intravenous catheter was placed for blood sampling every 10 minutes.
Data from this group of patients showed that, while the NK3R antagonist did not significantly affect the number of luteinizing hormone pulses detected compared with placebo (P = .41), it did increase the mean amplitude of each pulse (P = .0243). Also, the active drug made the luteinizing hormone pulses more orderly (P = .0006 compared to placebo).
The NK3R antagonist was well tolerated. Though no serious adverse events were seen, three patients taking the NK3R antagonist did have a transient and asymptomatic elevation of transaminases without hyperbilirubinemia at 28 days after starting treatment. The elevation resolved for all patients within 90 days of stopping the medication.
The novel drug could represent “a potentially practice-changing therapeutic,” said Dr. Prague, since it “significantly relieves hot [flash] symptoms without the need for estrogen exposure.” She added that planning is underway for longer studies involving more patients.
The study was supported by AstraZeneca and Millendo Therapeutics, which are involved with manufacturing MLE4901.
[email protected]
On Twitter @karioakes
ORLANDO – A novel antagonist of a neurokinin pathway effectively reduced hot flashes in postmenopausal women, according to results of a phase II trial.
The neurokinin 3 receptor (NK3R) antagonist, termed MLE4901, cut the number of hot flashes nearly in half compared to the effect of a placebo, and also improved overall menopause-related quality of life symptoms.
The medication has the potential to fulfill an unmet clinical need, since 70% of women experience hot flashes and the median duration of symptoms is more than 7 years, Julia K. Prague, MD, said at the annual meeting of the Endocrine Society.
The study results were published concurrently with Dr. Prague’s presentation (Lancet. 2017 Apr 3. doi: 10.1016/S0140-6736[17]30823-1).
Evidence from postmortem studies of postmenopausal women, said Dr. Prague, pointed to NKB (neurokinin B)/NK3R signaling as playing a role in hot flashes. The brains of these women showed hypertrophy of NKB neurons and increased neuronal activity, as well as increased NKB gene expression. The same effects were seen in monkeys whose ovaries had been removed, and the effect was reversed when the monkeys were given estrogen.
Also, previous work has shown that administering NKB to premenopausal women gave them hot flashes (Sci Rep. 2015 Feb 6;5:8466). The preclinical work laid the groundwork for the hypothesis that taking an oral NK3R antagonist could mitigate hot flashes in menopausal women.
The randomized, placebo-controlled, double-blind 2-way crossover study enrolled 37 healthy women aged 40-62 who were at least 12 months out from their last menses. To qualify for enrollment, they needed to be experiencing at least seven hot flashes per 24 hours; the actual mean total number in the study group was 13 per 24 hours and 85 per week. A total of 28 women completed the full protocol.
The mean age of the women was 55 years, and the mean body mass index was 25.8 kg/m2. Three quarters of the women were white.
The women had an initial 2-week baseline period, during which they kept a symptom diary, and then were randomized to receive either an oral NK3R antagonist or a placebo twice daily. Then, each patient went through a 2-week washout period, after which they were crossed over to the other arm of the study. Finally, patients were monitored for a further 2 weeks after taking the study drug.
The NK3R antagonist, said Dr. Prague, “significantly reduced the total weekly number of hot [flashes] compared to placebo in the fourth week of treatment.” Patients taking placebo experienced 49.01 hot flashes per week (range, 40.81-58.86), while those taking the NK3R antagonist had 19.35 (range, 15.99-23.42, P less than .0001). This amounted to a 45% reduction in number of hot flashes compared to placebo.
Dr. Prague, a clinical research fellow at Imperial College, London, said that the treatment effect size seen was similar regardless of whether patients received the active study drug or placebo first.
Using the Menopause-Related Quality of Life questionnaire, Dr. Prague and her colleagues determined that when women were taking the NK3R antagonist, in addition to a significant reduction in vasomotor symptoms, menopause-related psychosocial symptoms were reduced by 15% (P = .0083) and physical symptoms by 19% (P = .0002). As expected for the nonhormonal medication, she said, sexual symptoms were reduced by a nonsignificant 8% (P = .24).
A subset of patients received more intensive study, with external validation of hot flashes and a series of 3-day-long stays during which an intravenous catheter was placed for blood sampling every 10 minutes.
Data from this group of patients showed that, while the NK3R antagonist did not significantly affect the number of luteinizing hormone pulses detected compared with placebo (P = .41), it did increase the mean amplitude of each pulse (P = .0243). Also, the active drug made the luteinizing hormone pulses more orderly (P = .0006 compared to placebo).
The NK3R antagonist was well tolerated. Though no serious adverse events were seen, three patients taking the NK3R antagonist did have a transient and asymptomatic elevation of transaminases without hyperbilirubinemia at 28 days after starting treatment. The elevation resolved for all patients within 90 days of stopping the medication.
The novel drug could represent “a potentially practice-changing therapeutic,” said Dr. Prague, since it “significantly relieves hot [flash] symptoms without the need for estrogen exposure.” She added that planning is underway for longer studies involving more patients.
The study was supported by AstraZeneca and Millendo Therapeutics, which are involved with manufacturing MLE4901.
[email protected]
On Twitter @karioakes
AT ENDO 2017
Key clinical point:
Major finding: The neurokinin 3 receptor antagonist reduced hot flashes from a mean of 85 per week at baseline to a mean of 49 per week.
Data source: Phase II randomized, double-blind, placebo-controlled two-way crossover study of 37 postmenopausal women with moderate to severe hot flashes.
Disclosures: The study was funded by AstraZeneca and Millendo Therapeutics, which are involved with the manufacture of the medicine, termed MLE4901.
Same-day discharge for lap hiatal procedures found feasible, safe
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
AT SAGES 2017
Key clinical point: Same-day surgery for benign laparoscopic hiatal procedures have outcomes comparable with those of inpatient procedures.
Major finding: Postoperative complications were 9.2% for outpatient operations vs. 19% for inpatient, and 81.7% of patients who had same-day surgery did not have an unplanned admission.
Data source: Retrospective single-center study of 261 patients who had inpatient and outpatient laparoscopic hiatal procedures from April 2011 to August 2016.
Disclosures: Dr. Molina-Franjola reported having no financial disclosures.
VIDEO: AGA Center chair seeks to streamline innovation
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
Leukemia, NHL more common in African-born blacks than US-born blacks
The cancer profile of black US immigrants born in sub-Saharan Africa (ABs) differs from that of US-born black individuals (USBs) and varies by region of birth, according to a new study.
For instance, the data showed that ABs who immigrated to the US had a higher incidence of leukemia and non-Hodgkin lymphoma (NHL) than USBs.
And there was a higher incidence of NHL among ABs born in Eastern Africa than among those born in Western Africa.
“Typically, cancer occurrence among blacks in the United States is presented as one homogeneous group, with no breakdown by country or region of birth,” said Ahemdin Jemal, DVM, PhD, of the American Cancer Society in Atlanta, Georgia.
“Our study shows that approach masks important potential differences that may be key to guiding cancer prevention programs for African-born black immigrants.”
Dr Jemal and his colleagues described this study in the journal Cancer.
The team reviewed cancer incidence data from the Surveillance, Epidemiology, and End Results (SEER 17) program covering the period from 2000 through 2012.
They calculated age-standardized proportional incidence ratios (PIRs), comparing the frequency of the top 15 cancers in ABs with that of USBs, by sex and region of birth.
ABs had a significantly higher proportion of hematologic malignancies (leukemia and NHL), infection-related cancers (liver, stomach, and Kaposi sarcoma), prostate cancer, and thyroid cancers (in females only), when compared to USBs.
In females, the incidence of NHL was 3.4% in ABs and 2.5% in USBs, with a PIR of 1.19. The incidence of leukemia was 3.0% in ABs and 1.9% in USBs, with a PIR of 1.62.
In males, the incidence of NHL was 5.9% in ABs and 3.0% in USBs, with a PIR of 1.34. The incidence of leukemia was 3.0% in ABs and 2.2% in USBs, with a PIR of 1.40.
The investigators also calculated the PIRs of the 5 most frequent cancers in ABs compared to USBs by region of origin (Western Africa vs Eastern Africa).
For both sexes, the incidence of NHL was 4.0% in ABs born in Western Africa (PIR=1.17) and 5.5% in ABs born in Eastern Africa (PIR=1.44).
Leukemia was not included in this analysis because it was not among the top 5 cancers. 
The cancer profile of black US immigrants born in sub-Saharan Africa (ABs) differs from that of US-born black individuals (USBs) and varies by region of birth, according to a new study.
For instance, the data showed that ABs who immigrated to the US had a higher incidence of leukemia and non-Hodgkin lymphoma (NHL) than USBs.
And there was a higher incidence of NHL among ABs born in Eastern Africa than among those born in Western Africa.
“Typically, cancer occurrence among blacks in the United States is presented as one homogeneous group, with no breakdown by country or region of birth,” said Ahemdin Jemal, DVM, PhD, of the American Cancer Society in Atlanta, Georgia.
“Our study shows that approach masks important potential differences that may be key to guiding cancer prevention programs for African-born black immigrants.”
Dr Jemal and his colleagues described this study in the journal Cancer.
The team reviewed cancer incidence data from the Surveillance, Epidemiology, and End Results (SEER 17) program covering the period from 2000 through 2012.
They calculated age-standardized proportional incidence ratios (PIRs), comparing the frequency of the top 15 cancers in ABs with that of USBs, by sex and region of birth.
ABs had a significantly higher proportion of hematologic malignancies (leukemia and NHL), infection-related cancers (liver, stomach, and Kaposi sarcoma), prostate cancer, and thyroid cancers (in females only), when compared to USBs.
In females, the incidence of NHL was 3.4% in ABs and 2.5% in USBs, with a PIR of 1.19. The incidence of leukemia was 3.0% in ABs and 1.9% in USBs, with a PIR of 1.62.
In males, the incidence of NHL was 5.9% in ABs and 3.0% in USBs, with a PIR of 1.34. The incidence of leukemia was 3.0% in ABs and 2.2% in USBs, with a PIR of 1.40.
The investigators also calculated the PIRs of the 5 most frequent cancers in ABs compared to USBs by region of origin (Western Africa vs Eastern Africa).
For both sexes, the incidence of NHL was 4.0% in ABs born in Western Africa (PIR=1.17) and 5.5% in ABs born in Eastern Africa (PIR=1.44).
Leukemia was not included in this analysis because it was not among the top 5 cancers.
The cancer profile of black US immigrants born in sub-Saharan Africa (ABs) differs from that of US-born black individuals (USBs) and varies by region of birth, according to a new study.
For instance, the data showed that ABs who immigrated to the US had a higher incidence of leukemia and non-Hodgkin lymphoma (NHL) than USBs.
And there was a higher incidence of NHL among ABs born in Eastern Africa than among those born in Western Africa.
“Typically, cancer occurrence among blacks in the United States is presented as one homogeneous group, with no breakdown by country or region of birth,” said Ahemdin Jemal, DVM, PhD, of the American Cancer Society in Atlanta, Georgia.
“Our study shows that approach masks important potential differences that may be key to guiding cancer prevention programs for African-born black immigrants.”
Dr Jemal and his colleagues described this study in the journal Cancer.
The team reviewed cancer incidence data from the Surveillance, Epidemiology, and End Results (SEER 17) program covering the period from 2000 through 2012.
They calculated age-standardized proportional incidence ratios (PIRs), comparing the frequency of the top 15 cancers in ABs with that of USBs, by sex and region of birth.
ABs had a significantly higher proportion of hematologic malignancies (leukemia and NHL), infection-related cancers (liver, stomach, and Kaposi sarcoma), prostate cancer, and thyroid cancers (in females only), when compared to USBs.
In females, the incidence of NHL was 3.4% in ABs and 2.5% in USBs, with a PIR of 1.19. The incidence of leukemia was 3.0% in ABs and 1.9% in USBs, with a PIR of 1.62.
In males, the incidence of NHL was 5.9% in ABs and 3.0% in USBs, with a PIR of 1.34. The incidence of leukemia was 3.0% in ABs and 2.2% in USBs, with a PIR of 1.40.
The investigators also calculated the PIRs of the 5 most frequent cancers in ABs compared to USBs by region of origin (Western Africa vs Eastern Africa).
For both sexes, the incidence of NHL was 4.0% in ABs born in Western Africa (PIR=1.17) and 5.5% in ABs born in Eastern Africa (PIR=1.44).
Leukemia was not included in this analysis because it was not among the top 5 cancers.
Therapy increases factor IX activity in hemophilia B
SCOTTSDALE, ARIZONA—The investigational therapy SPK-9001 delivers “consistent and sustained” increases in factor IX (FIX) activity in patients with hemophilia B, according to researchers.
All 10 subjects who received SPK-9001 in a phase 1/2 trial have consistently achieved the targeted therapeutic range of FIX activity.
There have been no confirmed bleeds, and 9 of the subjects have not received any infusions of FIX therapy since receiving SPK-9001.
SPK-9001 reduced the patients’ annualized bleeding rate by 96% and the annualized infusion rate by 99%.
Adam Cuker, MD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and his colleagues presented these results at the Hemostasis and Thrombosis Research Society 2017 Scientific Symposium.
The trial is sponsored by Spark Therapeutics and Pfizer, the companies developing SPK-9001.
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human FIX variant enabling endogenous production of FIX.
In the phase 1/2 trial, 10 hemophilia B patients received a single administration of SPK-9001 (5 x 1011 vector genomes/kg body weight).
As of the data cutoff (March 24, 2017), 9 of the 10 patients have not taken FIX concentrates to prevent or control bleeding events since they received SPK-9001.
One patient with severe joint disease has self-administered infusions. The patient self-infused FIX therapy for a suspected ankle bleed on day 2 after receiving SPK-9001 and self-administered precautionary infusions another 9 times between December 2, 2016, and January 2, 2017, for persistent knee pain. The patient has not used additional FIX therapy since January 2.
For all 10 patients, the mean steady-state FIX activity level 12 weeks after SPK-9001 administration was a sustained 33% (range as of the data cutoff: 14% to 81%).
Based on individual patient history prior to the study, the annualized bleeding rate was reduced by 96% to a mean of 0.39 annual bleeds, compared with 9.2 bleeds before SPK-9001 administration.
The annualized infusion rate was reduced 99% to a mean of 0.98 annual infusions, compared with 68.5 infusions before SPK-9001 administration.
To date, no serious adverse events have been reported, including no FIX inhibitors and no thrombotic events.
Two of the 10 patients experienced an asymptomatic, transient elevation in liver enzymes, or decline in FIX activity, potentially indicative of an immune response to the Spark100 vector capsid, that occurred several weeks post-infusion.
Both patients received a tapering dose of oral corticosteroids, after which their alanine aminotransferase levels returned to baseline.
The FIX activity level of one of these patients has stabilized at approximately 15% for more than 9 weeks post-corticosteroid use. The other patient had a FIX activity level between 70% and 80% upon completion of steroid use.
SCOTTSDALE, ARIZONA—The investigational therapy SPK-9001 delivers “consistent and sustained” increases in factor IX (FIX) activity in patients with hemophilia B, according to researchers.
All 10 subjects who received SPK-9001 in a phase 1/2 trial have consistently achieved the targeted therapeutic range of FIX activity.
There have been no confirmed bleeds, and 9 of the subjects have not received any infusions of FIX therapy since receiving SPK-9001.
SPK-9001 reduced the patients’ annualized bleeding rate by 96% and the annualized infusion rate by 99%.
Adam Cuker, MD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and his colleagues presented these results at the Hemostasis and Thrombosis Research Society 2017 Scientific Symposium.
The trial is sponsored by Spark Therapeutics and Pfizer, the companies developing SPK-9001.
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human FIX variant enabling endogenous production of FIX.
In the phase 1/2 trial, 10 hemophilia B patients received a single administration of SPK-9001 (5 x 1011 vector genomes/kg body weight).
As of the data cutoff (March 24, 2017), 9 of the 10 patients have not taken FIX concentrates to prevent or control bleeding events since they received SPK-9001.
One patient with severe joint disease has self-administered infusions. The patient self-infused FIX therapy for a suspected ankle bleed on day 2 after receiving SPK-9001 and self-administered precautionary infusions another 9 times between December 2, 2016, and January 2, 2017, for persistent knee pain. The patient has not used additional FIX therapy since January 2.
For all 10 patients, the mean steady-state FIX activity level 12 weeks after SPK-9001 administration was a sustained 33% (range as of the data cutoff: 14% to 81%).
Based on individual patient history prior to the study, the annualized bleeding rate was reduced by 96% to a mean of 0.39 annual bleeds, compared with 9.2 bleeds before SPK-9001 administration.
The annualized infusion rate was reduced 99% to a mean of 0.98 annual infusions, compared with 68.5 infusions before SPK-9001 administration.
To date, no serious adverse events have been reported, including no FIX inhibitors and no thrombotic events.
Two of the 10 patients experienced an asymptomatic, transient elevation in liver enzymes, or decline in FIX activity, potentially indicative of an immune response to the Spark100 vector capsid, that occurred several weeks post-infusion.
Both patients received a tapering dose of oral corticosteroids, after which their alanine aminotransferase levels returned to baseline.
The FIX activity level of one of these patients has stabilized at approximately 15% for more than 9 weeks post-corticosteroid use. The other patient had a FIX activity level between 70% and 80% upon completion of steroid use.
SCOTTSDALE, ARIZONA—The investigational therapy SPK-9001 delivers “consistent and sustained” increases in factor IX (FIX) activity in patients with hemophilia B, according to researchers.
All 10 subjects who received SPK-9001 in a phase 1/2 trial have consistently achieved the targeted therapeutic range of FIX activity.
There have been no confirmed bleeds, and 9 of the subjects have not received any infusions of FIX therapy since receiving SPK-9001.
SPK-9001 reduced the patients’ annualized bleeding rate by 96% and the annualized infusion rate by 99%.
Adam Cuker, MD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and his colleagues presented these results at the Hemostasis and Thrombosis Research Society 2017 Scientific Symposium.
The trial is sponsored by Spark Therapeutics and Pfizer, the companies developing SPK-9001.
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human FIX variant enabling endogenous production of FIX.
In the phase 1/2 trial, 10 hemophilia B patients received a single administration of SPK-9001 (5 x 1011 vector genomes/kg body weight).
As of the data cutoff (March 24, 2017), 9 of the 10 patients have not taken FIX concentrates to prevent or control bleeding events since they received SPK-9001.
One patient with severe joint disease has self-administered infusions. The patient self-infused FIX therapy for a suspected ankle bleed on day 2 after receiving SPK-9001 and self-administered precautionary infusions another 9 times between December 2, 2016, and January 2, 2017, for persistent knee pain. The patient has not used additional FIX therapy since January 2.
For all 10 patients, the mean steady-state FIX activity level 12 weeks after SPK-9001 administration was a sustained 33% (range as of the data cutoff: 14% to 81%).
Based on individual patient history prior to the study, the annualized bleeding rate was reduced by 96% to a mean of 0.39 annual bleeds, compared with 9.2 bleeds before SPK-9001 administration.
The annualized infusion rate was reduced 99% to a mean of 0.98 annual infusions, compared with 68.5 infusions before SPK-9001 administration.
To date, no serious adverse events have been reported, including no FIX inhibitors and no thrombotic events.
Two of the 10 patients experienced an asymptomatic, transient elevation in liver enzymes, or decline in FIX activity, potentially indicative of an immune response to the Spark100 vector capsid, that occurred several weeks post-infusion.
Both patients received a tapering dose of oral corticosteroids, after which their alanine aminotransferase levels returned to baseline.
The FIX activity level of one of these patients has stabilized at approximately 15% for more than 9 weeks post-corticosteroid use. The other patient had a FIX activity level between 70% and 80% upon completion of steroid use.
CAR T-cell therapy demonstrates efficacy in mice with MM
WASHINGTON, DC—A chimeric antigen receptor (CAR) T-cell therapy is active against multiple myeloma (MM), according to preclinical research.
The therapy, known as P-BCMA-101, demonstrated persistent anti-tumor activity in a mouse model of MM.
Treatment with P-BCMA-101 eliminated tumors after relapse and prolonged survival in the mice, when compared to other CAR-T cell therapies.
These results were presented in a poster at the AACR Annual Meeting 2017 (abstract 3759).
The research was conducted by employees of Poseida Therapeutics Inc., the company developing P-BCMA-101, as well as others.
About P-BCMA-101
The researchers explained that P-BCMA-101 employs a B-cell maturation antigen (BCMA)-specific Centyrin™ rather than a single-chain variable fragment (scFv) for antigen detection.
Centyrins™ are fully human and have similar binding affinities as scFvs. However, Centyrins are smaller, more thermostable, and predicted to be less immunogenic.
P-BCMA-101 is engineered using the PiggyBac™ DNA modification system. PiggyBac eliminates the need to use lentivirus or gamma-retrovirus as a gene delivery mechanism, resulting in improved manufacturing and cost savings.
In addition, the increased cargo capacity of PiggyBac allows for the incorporation of a safety switch and a selectable gene. The safety switch can be “flipped” to enable depletion in case adverse events occur. And the selectable gene allows for enrichment of CARTyrin+ cells using a non-genotoxic drug.
Findings
The researchers found that more than 70% of P-BCMA-101 cells possessed a stem cell memory phenotype, creating a significant population of self-renewing, multipotent progenitors capable of reconstituting the entire spectrum of memory and effector T-cell subsets required to prevent cancer relapse. Similar competitor products typically report 0% to 20% stem cell memory phenotype.
In addition, P-BCMA-101 was enriched with more than 95% of T cells successfully modified, which compares favorably to the roughly 30% to 50% commonly expected with clinical manufacture using lentivirus.
P-BCMA-101 did not exhibit effects of CAR-mediated tonic signaling, a common cause of T-cell exhaustion that leads to poor durability. Tonic signaling is caused by oligomerization of unstable binding domains commonly seen with traditional scFv CARs.
The researchers tested P-BCMA-101 in NSG mice bearing luciferase+ MM.1S cells. The mice received a single administration of either 4 x 106 or 12 x 106 P-BCMA-101 cells.
P-BCMA-101 treatment reduced tumor burden to the limit of detection within 7 days. Conversely, all untreated control mice succumbed to MM within 4 weeks.
P-BCMA-101 expanded and persisted in the treated mice, eliminated tumors following relapse, and prolonged survival.
Most treated mice survived 110 days, and none of them died from tumor burden during the study. This compares favorably to lentivirus-based products that have shown roughly 50-day survival in the same model.
Based on these results, Poseida plans to initiate a phase 1 trial of P-BCMA-101 in patients with relapsed or refractory MM.
WASHINGTON, DC—A chimeric antigen receptor (CAR) T-cell therapy is active against multiple myeloma (MM), according to preclinical research.
The therapy, known as P-BCMA-101, demonstrated persistent anti-tumor activity in a mouse model of MM.
Treatment with P-BCMA-101 eliminated tumors after relapse and prolonged survival in the mice, when compared to other CAR-T cell therapies.
These results were presented in a poster at the AACR Annual Meeting 2017 (abstract 3759).
The research was conducted by employees of Poseida Therapeutics Inc., the company developing P-BCMA-101, as well as others.
About P-BCMA-101
The researchers explained that P-BCMA-101 employs a B-cell maturation antigen (BCMA)-specific Centyrin™ rather than a single-chain variable fragment (scFv) for antigen detection.
Centyrins™ are fully human and have similar binding affinities as scFvs. However, Centyrins are smaller, more thermostable, and predicted to be less immunogenic.
P-BCMA-101 is engineered using the PiggyBac™ DNA modification system. PiggyBac eliminates the need to use lentivirus or gamma-retrovirus as a gene delivery mechanism, resulting in improved manufacturing and cost savings.
In addition, the increased cargo capacity of PiggyBac allows for the incorporation of a safety switch and a selectable gene. The safety switch can be “flipped” to enable depletion in case adverse events occur. And the selectable gene allows for enrichment of CARTyrin+ cells using a non-genotoxic drug.
Findings
The researchers found that more than 70% of P-BCMA-101 cells possessed a stem cell memory phenotype, creating a significant population of self-renewing, multipotent progenitors capable of reconstituting the entire spectrum of memory and effector T-cell subsets required to prevent cancer relapse. Similar competitor products typically report 0% to 20% stem cell memory phenotype.
In addition, P-BCMA-101 was enriched with more than 95% of T cells successfully modified, which compares favorably to the roughly 30% to 50% commonly expected with clinical manufacture using lentivirus.
P-BCMA-101 did not exhibit effects of CAR-mediated tonic signaling, a common cause of T-cell exhaustion that leads to poor durability. Tonic signaling is caused by oligomerization of unstable binding domains commonly seen with traditional scFv CARs.
The researchers tested P-BCMA-101 in NSG mice bearing luciferase+ MM.1S cells. The mice received a single administration of either 4 x 106 or 12 x 106 P-BCMA-101 cells.
P-BCMA-101 treatment reduced tumor burden to the limit of detection within 7 days. Conversely, all untreated control mice succumbed to MM within 4 weeks.
P-BCMA-101 expanded and persisted in the treated mice, eliminated tumors following relapse, and prolonged survival.
Most treated mice survived 110 days, and none of them died from tumor burden during the study. This compares favorably to lentivirus-based products that have shown roughly 50-day survival in the same model.
Based on these results, Poseida plans to initiate a phase 1 trial of P-BCMA-101 in patients with relapsed or refractory MM.
WASHINGTON, DC—A chimeric antigen receptor (CAR) T-cell therapy is active against multiple myeloma (MM), according to preclinical research.
The therapy, known as P-BCMA-101, demonstrated persistent anti-tumor activity in a mouse model of MM.
Treatment with P-BCMA-101 eliminated tumors after relapse and prolonged survival in the mice, when compared to other CAR-T cell therapies.
These results were presented in a poster at the AACR Annual Meeting 2017 (abstract 3759).
The research was conducted by employees of Poseida Therapeutics Inc., the company developing P-BCMA-101, as well as others.
About P-BCMA-101
The researchers explained that P-BCMA-101 employs a B-cell maturation antigen (BCMA)-specific Centyrin™ rather than a single-chain variable fragment (scFv) for antigen detection.
Centyrins™ are fully human and have similar binding affinities as scFvs. However, Centyrins are smaller, more thermostable, and predicted to be less immunogenic.
P-BCMA-101 is engineered using the PiggyBac™ DNA modification system. PiggyBac eliminates the need to use lentivirus or gamma-retrovirus as a gene delivery mechanism, resulting in improved manufacturing and cost savings.
In addition, the increased cargo capacity of PiggyBac allows for the incorporation of a safety switch and a selectable gene. The safety switch can be “flipped” to enable depletion in case adverse events occur. And the selectable gene allows for enrichment of CARTyrin+ cells using a non-genotoxic drug.
Findings
The researchers found that more than 70% of P-BCMA-101 cells possessed a stem cell memory phenotype, creating a significant population of self-renewing, multipotent progenitors capable of reconstituting the entire spectrum of memory and effector T-cell subsets required to prevent cancer relapse. Similar competitor products typically report 0% to 20% stem cell memory phenotype.
In addition, P-BCMA-101 was enriched with more than 95% of T cells successfully modified, which compares favorably to the roughly 30% to 50% commonly expected with clinical manufacture using lentivirus.
P-BCMA-101 did not exhibit effects of CAR-mediated tonic signaling, a common cause of T-cell exhaustion that leads to poor durability. Tonic signaling is caused by oligomerization of unstable binding domains commonly seen with traditional scFv CARs.
The researchers tested P-BCMA-101 in NSG mice bearing luciferase+ MM.1S cells. The mice received a single administration of either 4 x 106 or 12 x 106 P-BCMA-101 cells.
P-BCMA-101 treatment reduced tumor burden to the limit of detection within 7 days. Conversely, all untreated control mice succumbed to MM within 4 weeks.
P-BCMA-101 expanded and persisted in the treated mice, eliminated tumors following relapse, and prolonged survival.
Most treated mice survived 110 days, and none of them died from tumor burden during the study. This compares favorably to lentivirus-based products that have shown roughly 50-day survival in the same model.
Based on these results, Poseida plans to initiate a phase 1 trial of P-BCMA-101 in patients with relapsed or refractory MM.
FDA: REMS for ESAs no longer needed, though risks persist
The US Food and Drug Administration (FDA) has determined that the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs) is no longer necessary.
The REMS was limited to the use of epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) to treat patients with anemia due to myelosuppressive chemotherapy.
The FDA said the REMS is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh the risks these drugs pose, which include shortened overall survival and an increased risk of tumor progression or recurrence in patients with cancer.
The FDA has released the REMS requirements for these ESAs and said the risks the drugs pose can be communicated by the current product prescribing information.
The FDA decided the REMS is no longer needed based on its own analyses and an evaluation of the REMS assessment submitted by Amgen, Inc., the company that markets Epogen/Procrit and Aranesp.
Details on the analyses and evaluation are available from the following page on the FDA website: Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp).
The US Food and Drug Administration (FDA) has determined that the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs) is no longer necessary.
The REMS was limited to the use of epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) to treat patients with anemia due to myelosuppressive chemotherapy.
The FDA said the REMS is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh the risks these drugs pose, which include shortened overall survival and an increased risk of tumor progression or recurrence in patients with cancer.
The FDA has released the REMS requirements for these ESAs and said the risks the drugs pose can be communicated by the current product prescribing information.
The FDA decided the REMS is no longer needed based on its own analyses and an evaluation of the REMS assessment submitted by Amgen, Inc., the company that markets Epogen/Procrit and Aranesp.
Details on the analyses and evaluation are available from the following page on the FDA website: Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp).
The US Food and Drug Administration (FDA) has determined that the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs) is no longer necessary.
The REMS was limited to the use of epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) to treat patients with anemia due to myelosuppressive chemotherapy.
The FDA said the REMS is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh the risks these drugs pose, which include shortened overall survival and an increased risk of tumor progression or recurrence in patients with cancer.
The FDA has released the REMS requirements for these ESAs and said the risks the drugs pose can be communicated by the current product prescribing information.
The FDA decided the REMS is no longer needed based on its own analyses and an evaluation of the REMS assessment submitted by Amgen, Inc., the company that markets Epogen/Procrit and Aranesp.
Details on the analyses and evaluation are available from the following page on the FDA website: Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp).