The likelihood that a trauma or acute care surgeon will encounter or treat a transgender patient in an emergency setting is increasing every year.

The number of patients who self-identify as transgender and who have undergone both medical and/or surgical gender-affirming treatment is on the rise. The trend has accelerated since private insurers, Medicare, and Medicaid are now covering some of the costs (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).

Privacy concerns can be of particular sensitivity. “Care must be taken to maintain privacy for the patient, as others outside of the hospital may not know they are transgender. Consultation with the patient’s primary care provider may be beneficial to determine the extent of gender-affirmation and the patient’s disclosure to family and friends,” the investigator advised. In addition, the clinician needs to establish which if any nonmedical interventions the transgender patients has had. These may include nonprescription hormone therapy and silicone injections.

The encounter should include an evaluation for injury to genitalia. “Transgender patients may have significant dysphoria associated with their preoperative genitals,” Dr. Mandell and his coauthors said. In these cases, “involvement of providers experienced with examination of transgender patients should be sought, if possible.” These patients should be screened for potential abuse by a companion or self-injury, the investigators suggested.

Dr. Mandell and his coauthors also discussed some of the nuances of trauma care for this population. For example, transgender women may need a smaller endotracheal tube for establishing an airway as intubation to avoid damaging surgically altered vocal chords. Other craniofacial alterations can get in the way of establishing an airway. Clinicians also should keep in mind the increased likelihood of a venous thromboembolism from estrogen hormone therapy in immobilized transgender patients in the trauma setting. Implants and surgical alterations can add a layer of complexity to reading images. Anatomical rearrangement can make catheterization challenging.

Dr. Mandell and his coauthors concluded, “Further research is needed on the appropriate management of cross-gender hormones, dosing of medications and nutrition, and the special considerations for injury patterns and risks in transgender patients. Development of a system for quickly determining the state of gender-affirmation of the patient in regards to hormone therapy, surgeries, and social aspects may prove beneficial to providers in the setting of trauma, but involvement of the transgender population in the development of any such system is crucial.”

Eileen M. Bulger, MD, FACS, Chair ACS Committee on Trauma and one of the coauthors of the study, views the findings as potentially useful to meet the training deficit on transgender trauma issues. “As trauma surgeons, we strive to provide optimal care by attending to the physical, psychological, and social needs of our patients. This review raises awareness of critical issues to consider when caring for transgender patients and should be included in our educational programs for trauma fellowship training and used as a resource to raise awareness in our trauma centers.”

Dr. Mandell and his coauthors reported having no financial disclosures.

The likelihood that a trauma or acute care surgeon will encounter or treat a transgender patient in an emergency setting is increasing every year.

The number of patients who self-identify as transgender and who have undergone both medical and/or surgical gender-affirming treatment is on the rise. The trend has accelerated since private insurers, Medicare, and Medicaid are now covering some of the costs (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).

Privacy concerns can be of particular sensitivity. “Care must be taken to maintain privacy for the patient, as others outside of the hospital may not know they are transgender. Consultation with the patient’s primary care provider may be beneficial to determine the extent of gender-affirmation and the patient’s disclosure to family and friends,” the investigator advised. In addition, the clinician needs to establish which if any nonmedical interventions the transgender patients has had. These may include nonprescription hormone therapy and silicone injections.

The encounter should include an evaluation for injury to genitalia. “Transgender patients may have significant dysphoria associated with their preoperative genitals,” Dr. Mandell and his coauthors said. In these cases, “involvement of providers experienced with examination of transgender patients should be sought, if possible.” These patients should be screened for potential abuse by a companion or self-injury, the investigators suggested.

Dr. Mandell and his coauthors also discussed some of the nuances of trauma care for this population. For example, transgender women may need a smaller endotracheal tube for establishing an airway as intubation to avoid damaging surgically altered vocal chords. Other craniofacial alterations can get in the way of establishing an airway. Clinicians also should keep in mind the increased likelihood of a venous thromboembolism from estrogen hormone therapy in immobilized transgender patients in the trauma setting. Implants and surgical alterations can add a layer of complexity to reading images. Anatomical rearrangement can make catheterization challenging.

Dr. Mandell and his coauthors concluded, “Further research is needed on the appropriate management of cross-gender hormones, dosing of medications and nutrition, and the special considerations for injury patterns and risks in transgender patients. Development of a system for quickly determining the state of gender-affirmation of the patient in regards to hormone therapy, surgeries, and social aspects may prove beneficial to providers in the setting of trauma, but involvement of the transgender population in the development of any such system is crucial.”

Eileen M. Bulger, MD, FACS, Chair ACS Committee on Trauma and one of the coauthors of the study, views the findings as potentially useful to meet the training deficit on transgender trauma issues. “As trauma surgeons, we strive to provide optimal care by attending to the physical, psychological, and social needs of our patients. This review raises awareness of critical issues to consider when caring for transgender patients and should be included in our educational programs for trauma fellowship training and used as a resource to raise awareness in our trauma centers.”

Dr. Mandell and his coauthors reported having no financial disclosures.

The likelihood that a trauma or acute care surgeon will encounter or treat a transgender patient in an emergency setting is increasing every year.

The number of patients who self-identify as transgender and who have undergone both medical and/or surgical gender-affirming treatment is on the rise. The trend has accelerated since private insurers, Medicare, and Medicaid are now covering some of the costs (JAMA Surg. 2018 Feb 28. doi: 10.1001/jamasurg.2017.6231).

Privacy concerns can be of particular sensitivity. “Care must be taken to maintain privacy for the patient, as others outside of the hospital may not know they are transgender. Consultation with the patient’s primary care provider may be beneficial to determine the extent of gender-affirmation and the patient’s disclosure to family and friends,” the investigator advised. In addition, the clinician needs to establish which if any nonmedical interventions the transgender patients has had. These may include nonprescription hormone therapy and silicone injections.

The encounter should include an evaluation for injury to genitalia. “Transgender patients may have significant dysphoria associated with their preoperative genitals,” Dr. Mandell and his coauthors said. In these cases, “involvement of providers experienced with examination of transgender patients should be sought, if possible.” These patients should be screened for potential abuse by a companion or self-injury, the investigators suggested.

Dr. Mandell and his coauthors also discussed some of the nuances of trauma care for this population. For example, transgender women may need a smaller endotracheal tube for establishing an airway as intubation to avoid damaging surgically altered vocal chords. Other craniofacial alterations can get in the way of establishing an airway. Clinicians also should keep in mind the increased likelihood of a venous thromboembolism from estrogen hormone therapy in immobilized transgender patients in the trauma setting. Implants and surgical alterations can add a layer of complexity to reading images. Anatomical rearrangement can make catheterization challenging.

Dr. Mandell and his coauthors concluded, “Further research is needed on the appropriate management of cross-gender hormones, dosing of medications and nutrition, and the special considerations for injury patterns and risks in transgender patients. Development of a system for quickly determining the state of gender-affirmation of the patient in regards to hormone therapy, surgeries, and social aspects may prove beneficial to providers in the setting of trauma, but involvement of the transgender population in the development of any such system is crucial.”

Eileen M. Bulger, MD, FACS, Chair ACS Committee on Trauma and one of the coauthors of the study, views the findings as potentially useful to meet the training deficit on transgender trauma issues. “As trauma surgeons, we strive to provide optimal care by attending to the physical, psychological, and social needs of our patients. This review raises awareness of critical issues to consider when caring for transgender patients and should be included in our educational programs for trauma fellowship training and used as a resource to raise awareness in our trauma centers.”

Dr. Mandell and his coauthors reported having no financial disclosures.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

CHICAGO – Women who have treatment for breast cancer seldom talk about the costs of care with their medical team, but a study out of Duke University has found that more than one-third reported having a financial burden from their breast cancer treatment, even among women with health insurance, according to a report presented at the Society of Surgical Oncology Annual Cancer Symposium.

“The financial harm associated with cancer treatment is now known as ‘financial toxicity,’ ” Rachel A. Greenup, MD, MPH, said in reporting the results of an 88-item survey completed by 654 adult women who had treatment for breast cancer. The women were recruited through the Army of Women of the Dr. Susan Love Research Foundation and The Sister’s Network of North Carolina, an African-American breast cancer survivors’ organization.

Overall, 69% of survey respondents had private insurance and 26% had Medicare. Of the patients surveyed, 94% had breast cancer surgery: 40.6% lumpectomy, 23.7% mastectomy, and 29.7% bilateral mastectomy; 34% also had breast reconstruction. Among those surveyed, 43% reported considering costs in their treatment decision. Of these, 29% considered costs when making surgical treatment decisions, including 14% who reported that costs were “extremely” important.

Despite the high levels of insurance coverage, 35% of the study participants reported a financial burden resulting from cancer treatment, ranging from “somewhat” burdensome to “catastrophic.” The median out-of-pocket cost for the study participants was $4,000, and 5% exceeded $40,000 in such costs, Dr. Greenup said. “The risk of financial harm and increased out-of-pocket costs to patients differed by surgery type,” with higher financial burdens seen in women who underwent bilateral mastectomy.

Cost was one of many factors survey participants reported considering when making surgical treatment decisions, but the most important factors were the opinions and advice of the medical team and the individual patient’s fear of recurrence. However, in lower-income women, cost factored more significantly in decision making. “In a subset of women who reported an annual income of $45,000 a year or less, cost of treatment gained importance and, interestingly, became more important than many variables we routinely discuss – for example, appearance of the breast, sexuality, avoiding radiation, and breast preservation,” Dr. Greenup said. “An income of $74,000 a year was the tipping point at which women reported incorporating costs into their cancer treatment decisions.”

She added that younger, minority women who did not have Medicare coverage were more likely to consider costs in breast cancer treatment decisions.

Most women surveyed (79%) said they preferred to know their out-of-pocket costs before they begin treatment, Dr. Greenup said, “and 40% believed that we as physicians should be considering out-of-pocket costs while making medical decisions.” However, 78% of those surveyed said they never discussed costs with their cancer team – despite American Society of Clinical Oncologists guidelines, she pointed out – and 35% said their treatment costs were higher than expected.

Dr. Greenup described the study population as “well engaged … with good insurance and strong educational background that likely does not reflect the general population.” The results may not be generalizable. “We expect that in a general cohort of women, our findings would be even more exaggerated,” she said.

The study points out the need to better understand how cost transparency may affect breast cancer treatment decisions, Dr. Greenup said. “As eligible women with breast cancer choose between surgical options, it’s important that we consider the potential risk of financial harm as we guide them through these difficult treatment decisions,” she said.

Dr. Greenup and her study coauthors reported having no financial disclosures.

[email protected]

SOURCE: Greenup RA. SSO 2018, Abstract No. 24.

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

SILVER SPRING, MD.  – Members of the Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 11 to 1 to recommend approval of lofexidine as the first nonopioid treatment option for the symptomatic treatment of opioid withdrawal.

Opioid withdrawal symptoms are the largest barrier to discontinuing opioid use, according to Louis Baxter, MD, executive medical director of the Professional Assistance Program in Princeton, N.J., who presented on behalf of U.S. WorldMeds, which plans to market lofexidine as Lucemyra.

Lofexidine, a selective alpha2-adrenergic receptor agonist that regulates norepinephrine release has been approved for management of opioid withdrawal in the United Kingdom since 1992.

The advisory committee voted to recommend lofexidine on the strength of the results of two randomized, double-blind, and placebo controlled phase 3 studies on the safety and efficacy of lofexidine for symptomatic treatment of opioid withdrawal between days 1 through 7. One study randomized 264 patients to lofexidine (134) or placebo (130), with patients in the treatment arm received 3.2 mg of lofexidine on days 1-5, then placebo until day 7. The second study randomized 603 patients to three groups, comparing high dose (3.2 mg/day) and low dose (2.4 mg/day) regimens of lofexidine to placebo; patients in the treatment arms took four smaller doses of lofexidine throughout the day to achieve the cumulative dose.

Researchers enrolled heavy users of short-acting opioids; heroin was the predominant agent. Both studies were conducted in the scenario of abrupt withdrawal, or the most intense withdrawal situation.

Symptomatic benefit was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), a patient reported outcome. Patients were asked to rank their symptoms as none, mild, moderate or severe across measures like feeling sick, stomach cramps, and heart pounding among other symptoms.  

Lofexidine increased completion of withdrawal treatment compared to placebo. Patients in the first study had a 5-day completion rate of 53%, compared to 35% for the placebo group. Researchers observed similar results in the 7-day completion rates the second study, with low and high dose completion rates of 42% and 40%, respectively, both of which were much higher than placebo (28%).

Lofexidine also reduced patient withdrawal symptoms, according to SOWS-Gossop scores during peak withdrawal. In the first study, SOWS-Gossop scores were 2-4 points lower in the lofexidine group compared to placebo. Similarly, the scores were significantly better in both lofexidine groups in the second study, compared to placebo, particularly on days 1 to 4. Decreasing withdrawal symptoms during this period is particularly important because this is the most vulnerable window for patient dropout, briefing documents from US WorldMeds.

Several notable adverse events occurred during the study, particularly at higher doses of lofexidine. The risk of bradycardia and hypotension are prominent in patients taking lofexidine, but these are risks associated with this class of drug, according to Mark Pirner, MD, senior medical director at US WorldMeds, who noted that “the lower dose, if that’s what ultimately gets approved [by the FDA], is safe and effective too.”

Development of lofexidine was conducted in collaboration with the National Institute on Drug Abuse and the FDA, according to briefing documents from US WorldMeds.

The Prescription Drug User Fee Act (PDUFA) for lofexidine is May 26; FDA actions on new drug applications often occur at near the PDUFA date.

The FDA is not obligated to follow the recommendations of its advisory committees.

[email protected]

On March 15, 2018, I had the opportunity to present on behalf of the ACS at a roundtable discussion on Capitol Hill to members of the House Ways and Means Committee on the topic of Medicare red tape relief

The roundtable provided members of this key committee of jurisdiction over Medicare policy the opportunity to hear from representatives from a variety of health care professional organizations on how Congress can improve Medicare to work more effectively and efficiently for both patients and providers. Each group was allotted just three minutes for their presentation. A summary of my presentation is included below:
 

E/M Documentation Guidelines

The ACS has significant concerns regarding Evaluation and Management (E/M) Documentation Guidelines. Though CMS created the E/M documentation guidelines 23 years ago with the laudable goal of adding structure to the various levels of E/M services, and in an effort to create a sense of equivalency of E/M services across the multitude of specialties, ACS believes the time has come to re-examine and revise these guidelines to be more appropriate in the modern digital information era.

US House Ways and Means Committee

Meaningful Measurement of Surgical Quality

I also addressed concerns relative to the meaningful measurement of surgical quality. Despite having expended significant human and financial resources toward helping Fellows succeed in MIPS, the College is becoming increasingly concerned that MIPS is not actually measuring surgical quality, and therefore, is not a quality program for surgery and serves primarily as a payment program.

As evidence, the most recent quality metric data available (from the 2015 Physician Quality Reporting System) show that many of the CMS quality measures reported by surgeons have little to do with improving the quality of the actual surgical care provided to patients. For general surgeons, the two most commonly reported measures were the documentation of a patient’s medications in the medical record and tobacco use screening. While no one would deny the importance of either of these activities, neither is of much real value in the effort to measure the quality of surgical care provided. In another, perhaps even more illustrative example, one of the most common quality measures reported by urologists was inquiring of their patients whether they had received a pneumovax. This obviously has little to do with why one would see an urologist, much less the quality of care provided.

As an organization, the ACS and its members are absolutely dedicated to improving the quality of care they provide to their patients. However, the quality measures forming the basis of the assessment of their care must first be relevant to the surgical care they provide, and second be achievable. Fellows are increasingly expressing concerns about the burdens imposed by the Quality component of MIPS and believe their efforts to participate do little to meaningfully measure the quality of surgical care they provide. I asked that the Ways and Means Committee hold a hearing specifically addressing issues relative to the Quality component of MIPS.
 

Standardizing Electronic Prior Authorization for Safe Prescribing Act

I expressed ACS’ support for the Standardizing Electronic Prior Authorization for Safe Prescribing Act, H.R. 4841, which would allow for electronic prior authorization under Medicare Part D and allow for the creation of technical standards for the electronic transmission of prior authorization. While the College believes this legislation is a good first step for electronic prior authorization, I asked that the scope of the legislation be expanded to include all medical services, supplies, and prescription drugs covered by the Medicare program, and also requested prior authorization policies be standardized across all insurers and that prior authorization requests, decisions, and appeals processes be automated through uniform electronic transaction portals for all services and supplies.

As evidence, I provided data from a 2017 ACS survey of nearly 300 surgeons and their staff, which indicated that, on average, a medical practice receives approximately 37 prior authorization requests per provider, per week. Action on these requests requires 25 hours to complete. This exorbitant expenditure of time and resources required for prior authorization is largely due to a lack of automated prior authorization processes that integrate with current electronic health record systems. The ACS is committed to working with the bill’s sponsors and the Ways and Means Committee toward a goal of swift passage.

Questions from and discussion with members of the Ways and Means Committee were truncated because of votes on the House floor. We look forward to continuing the dialogue in the coming weeks when the roundtable is reconvened.

Until next month ….

On March 15, 2018, I had the opportunity to present on behalf of the ACS at a roundtable discussion on Capitol Hill to members of the House Ways and Means Committee on the topic of Medicare red tape relief

The roundtable provided members of this key committee of jurisdiction over Medicare policy the opportunity to hear from representatives from a variety of health care professional organizations on how Congress can improve Medicare to work more effectively and efficiently for both patients and providers. Each group was allotted just three minutes for their presentation. A summary of my presentation is included below:
 

E/M Documentation Guidelines

The ACS has significant concerns regarding Evaluation and Management (E/M) Documentation Guidelines. Though CMS created the E/M documentation guidelines 23 years ago with the laudable goal of adding structure to the various levels of E/M services, and in an effort to create a sense of equivalency of E/M services across the multitude of specialties, ACS believes the time has come to re-examine and revise these guidelines to be more appropriate in the modern digital information era.

US House Ways and Means Committee

Meaningful Measurement of Surgical Quality

I also addressed concerns relative to the meaningful measurement of surgical quality. Despite having expended significant human and financial resources toward helping Fellows succeed in MIPS, the College is becoming increasingly concerned that MIPS is not actually measuring surgical quality, and therefore, is not a quality program for surgery and serves primarily as a payment program.

As evidence, the most recent quality metric data available (from the 2015 Physician Quality Reporting System) show that many of the CMS quality measures reported by surgeons have little to do with improving the quality of the actual surgical care provided to patients. For general surgeons, the two most commonly reported measures were the documentation of a patient’s medications in the medical record and tobacco use screening. While no one would deny the importance of either of these activities, neither is of much real value in the effort to measure the quality of surgical care provided. In another, perhaps even more illustrative example, one of the most common quality measures reported by urologists was inquiring of their patients whether they had received a pneumovax. This obviously has little to do with why one would see an urologist, much less the quality of care provided.

As an organization, the ACS and its members are absolutely dedicated to improving the quality of care they provide to their patients. However, the quality measures forming the basis of the assessment of their care must first be relevant to the surgical care they provide, and second be achievable. Fellows are increasingly expressing concerns about the burdens imposed by the Quality component of MIPS and believe their efforts to participate do little to meaningfully measure the quality of surgical care they provide. I asked that the Ways and Means Committee hold a hearing specifically addressing issues relative to the Quality component of MIPS.
 

Standardizing Electronic Prior Authorization for Safe Prescribing Act

I expressed ACS’ support for the Standardizing Electronic Prior Authorization for Safe Prescribing Act, H.R. 4841, which would allow for electronic prior authorization under Medicare Part D and allow for the creation of technical standards for the electronic transmission of prior authorization. While the College believes this legislation is a good first step for electronic prior authorization, I asked that the scope of the legislation be expanded to include all medical services, supplies, and prescription drugs covered by the Medicare program, and also requested prior authorization policies be standardized across all insurers and that prior authorization requests, decisions, and appeals processes be automated through uniform electronic transaction portals for all services and supplies.

As evidence, I provided data from a 2017 ACS survey of nearly 300 surgeons and their staff, which indicated that, on average, a medical practice receives approximately 37 prior authorization requests per provider, per week. Action on these requests requires 25 hours to complete. This exorbitant expenditure of time and resources required for prior authorization is largely due to a lack of automated prior authorization processes that integrate with current electronic health record systems. The ACS is committed to working with the bill’s sponsors and the Ways and Means Committee toward a goal of swift passage.

Questions from and discussion with members of the Ways and Means Committee were truncated because of votes on the House floor. We look forward to continuing the dialogue in the coming weeks when the roundtable is reconvened.

Until next month ….

On March 15, 2018, I had the opportunity to present on behalf of the ACS at a roundtable discussion on Capitol Hill to members of the House Ways and Means Committee on the topic of Medicare red tape relief

The roundtable provided members of this key committee of jurisdiction over Medicare policy the opportunity to hear from representatives from a variety of health care professional organizations on how Congress can improve Medicare to work more effectively and efficiently for both patients and providers. Each group was allotted just three minutes for their presentation. A summary of my presentation is included below:
 

E/M Documentation Guidelines

The ACS has significant concerns regarding Evaluation and Management (E/M) Documentation Guidelines. Though CMS created the E/M documentation guidelines 23 years ago with the laudable goal of adding structure to the various levels of E/M services, and in an effort to create a sense of equivalency of E/M services across the multitude of specialties, ACS believes the time has come to re-examine and revise these guidelines to be more appropriate in the modern digital information era.

US House Ways and Means Committee

Meaningful Measurement of Surgical Quality

I also addressed concerns relative to the meaningful measurement of surgical quality. Despite having expended significant human and financial resources toward helping Fellows succeed in MIPS, the College is becoming increasingly concerned that MIPS is not actually measuring surgical quality, and therefore, is not a quality program for surgery and serves primarily as a payment program.

As evidence, the most recent quality metric data available (from the 2015 Physician Quality Reporting System) show that many of the CMS quality measures reported by surgeons have little to do with improving the quality of the actual surgical care provided to patients. For general surgeons, the two most commonly reported measures were the documentation of a patient’s medications in the medical record and tobacco use screening. While no one would deny the importance of either of these activities, neither is of much real value in the effort to measure the quality of surgical care provided. In another, perhaps even more illustrative example, one of the most common quality measures reported by urologists was inquiring of their patients whether they had received a pneumovax. This obviously has little to do with why one would see an urologist, much less the quality of care provided.

As an organization, the ACS and its members are absolutely dedicated to improving the quality of care they provide to their patients. However, the quality measures forming the basis of the assessment of their care must first be relevant to the surgical care they provide, and second be achievable. Fellows are increasingly expressing concerns about the burdens imposed by the Quality component of MIPS and believe their efforts to participate do little to meaningfully measure the quality of surgical care they provide. I asked that the Ways and Means Committee hold a hearing specifically addressing issues relative to the Quality component of MIPS.
 

Standardizing Electronic Prior Authorization for Safe Prescribing Act

I expressed ACS’ support for the Standardizing Electronic Prior Authorization for Safe Prescribing Act, H.R. 4841, which would allow for electronic prior authorization under Medicare Part D and allow for the creation of technical standards for the electronic transmission of prior authorization. While the College believes this legislation is a good first step for electronic prior authorization, I asked that the scope of the legislation be expanded to include all medical services, supplies, and prescription drugs covered by the Medicare program, and also requested prior authorization policies be standardized across all insurers and that prior authorization requests, decisions, and appeals processes be automated through uniform electronic transaction portals for all services and supplies.

As evidence, I provided data from a 2017 ACS survey of nearly 300 surgeons and their staff, which indicated that, on average, a medical practice receives approximately 37 prior authorization requests per provider, per week. Action on these requests requires 25 hours to complete. This exorbitant expenditure of time and resources required for prior authorization is largely due to a lack of automated prior authorization processes that integrate with current electronic health record systems. The ACS is committed to working with the bill’s sponsors and the Ways and Means Committee toward a goal of swift passage.

Questions from and discussion with members of the Ways and Means Committee were truncated because of votes on the House floor. We look forward to continuing the dialogue in the coming weeks when the roundtable is reconvened.

Until next month ….

NEW ORLEANS – Pelvic radiation was as effective for producing recurrence-free survival as vaginal cuff brachytherapy plus chemotherapy but with less acute toxicity and fewer local recurrences in women with high-risk stage I or stage II endometrial cancer in a multicenter, randomized trial with 601 patients.

These findings should result in wider use of pelvic radiation as the preferred treatment for these patients, Marcus E. Randall, MD, said at the annual meeting of the Society of Gynecologic Oncology. “It will change practice,” he predicted.

Dr. Randall and his colleagues from the Gynecologic Oncology Group (which recently became part of NRG Oncology) designed the trial, GOG-0249, to address recent interest in using vaginal cuff brachytherapy plus chemotherapy with carboplatin and paclitaxel as an alternative to the more standard approach of pelvic radiation for treating women with either high-risk stage I or stage II endometrial cancers. Clinicians had considered the brachytherapy plus chemotherapy approach a reasonable option by “extrapolating from studies with advanced” endometrial cancer, but with no direct evidence to support this alternative, Dr. Randall explained in a video interview.

To generate evidence, the researchers enrolled 601 patients at several participating U.S. centers and followed them for a median of 53 months (4.4 years), with 259 patients treated and followed in the pelvic radiation arm and 268 patients treated and followed in the brachytherapy plus chemotherapy arm. Clinicians administered the complete planned treatment regimen to 91% of patients assigned to pelvic radiation and to 87% of those assigned to brachytherapy plus chemotherapy. Three quarters of enrolled patients had high-risk stage I disease, and the entire study group averaged about 62 years old.

The trial’s primary endpoint was recurrence-free survival, which occurred in 78% of the pelvic radiation patients and 79% of brachytherapy plus chemotherapy patients after 5 years when analyzed on an intention-to-treat basis. The two subgroups also showed similar rates of overall survival during follow-up.

Although the two treatments produced essentially identical outcomes for the primary result, they showed two important differences on secondary outcomes, reported Dr. Randall, professor and chair of radiation medicine at the University of Kentucky in Lexington.

Acute adverse effects rated as grade 3 severity or higher occurred in 11% of the pelvic radiation patients and in 64% of the brachytherapy plus chemotherapy patients, although late toxicities occurred at similar rates (13% and 12%, respectively) in the two subgroups.

Local pelvic and para-aortic nodal recurrences occurred in 4% of the pelvic radiation patients and in 9% of the brachytherapy plus chemotherapy patients, a 53% relative risk reduction with pelvic radiation. The difference in the nodal recurrences was apparent within the first year of follow-up, and the difference in rates continued to steadily widen over time after that. However the rates of both vaginal and distant recurrences were very similar in the two treatment arms. Distant recurrences were the most common type of treatment failure, occurring in about 18% of patients in both subgroups during complete follow-up.

“Pelvic radiation therapy remains an appropriate and preferable treatment for high-risk, early stage endometrial carcinoma,” Dr. Randall concluded.

[email protected]

SOURCE: Randall ME et al. SGO 2018.
 

NEW ORLEANS – Pelvic radiation was as effective for producing recurrence-free survival as vaginal cuff brachytherapy plus chemotherapy but with less acute toxicity and fewer local recurrences in women with high-risk stage I or stage II endometrial cancer in a multicenter, randomized trial with 601 patients.

These findings should result in wider use of pelvic radiation as the preferred treatment for these patients, Marcus E. Randall, MD, said at the annual meeting of the Society of Gynecologic Oncology. “It will change practice,” he predicted.

Dr. Randall and his colleagues from the Gynecologic Oncology Group (which recently became part of NRG Oncology) designed the trial, GOG-0249, to address recent interest in using vaginal cuff brachytherapy plus chemotherapy with carboplatin and paclitaxel as an alternative to the more standard approach of pelvic radiation for treating women with either high-risk stage I or stage II endometrial cancers. Clinicians had considered the brachytherapy plus chemotherapy approach a reasonable option by “extrapolating from studies with advanced” endometrial cancer, but with no direct evidence to support this alternative, Dr. Randall explained in a video interview.

To generate evidence, the researchers enrolled 601 patients at several participating U.S. centers and followed them for a median of 53 months (4.4 years), with 259 patients treated and followed in the pelvic radiation arm and 268 patients treated and followed in the brachytherapy plus chemotherapy arm. Clinicians administered the complete planned treatment regimen to 91% of patients assigned to pelvic radiation and to 87% of those assigned to brachytherapy plus chemotherapy. Three quarters of enrolled patients had high-risk stage I disease, and the entire study group averaged about 62 years old.

The trial’s primary endpoint was recurrence-free survival, which occurred in 78% of the pelvic radiation patients and 79% of brachytherapy plus chemotherapy patients after 5 years when analyzed on an intention-to-treat basis. The two subgroups also showed similar rates of overall survival during follow-up.

Although the two treatments produced essentially identical outcomes for the primary result, they showed two important differences on secondary outcomes, reported Dr. Randall, professor and chair of radiation medicine at the University of Kentucky in Lexington.

Acute adverse effects rated as grade 3 severity or higher occurred in 11% of the pelvic radiation patients and in 64% of the brachytherapy plus chemotherapy patients, although late toxicities occurred at similar rates (13% and 12%, respectively) in the two subgroups.

Local pelvic and para-aortic nodal recurrences occurred in 4% of the pelvic radiation patients and in 9% of the brachytherapy plus chemotherapy patients, a 53% relative risk reduction with pelvic radiation. The difference in the nodal recurrences was apparent within the first year of follow-up, and the difference in rates continued to steadily widen over time after that. However the rates of both vaginal and distant recurrences were very similar in the two treatment arms. Distant recurrences were the most common type of treatment failure, occurring in about 18% of patients in both subgroups during complete follow-up.

“Pelvic radiation therapy remains an appropriate and preferable treatment for high-risk, early stage endometrial carcinoma,” Dr. Randall concluded.

[email protected]

SOURCE: Randall ME et al. SGO 2018.
 

NEW ORLEANS – Pelvic radiation was as effective for producing recurrence-free survival as vaginal cuff brachytherapy plus chemotherapy but with less acute toxicity and fewer local recurrences in women with high-risk stage I or stage II endometrial cancer in a multicenter, randomized trial with 601 patients.

These findings should result in wider use of pelvic radiation as the preferred treatment for these patients, Marcus E. Randall, MD, said at the annual meeting of the Society of Gynecologic Oncology. “It will change practice,” he predicted.

Dr. Randall and his colleagues from the Gynecologic Oncology Group (which recently became part of NRG Oncology) designed the trial, GOG-0249, to address recent interest in using vaginal cuff brachytherapy plus chemotherapy with carboplatin and paclitaxel as an alternative to the more standard approach of pelvic radiation for treating women with either high-risk stage I or stage II endometrial cancers. Clinicians had considered the brachytherapy plus chemotherapy approach a reasonable option by “extrapolating from studies with advanced” endometrial cancer, but with no direct evidence to support this alternative, Dr. Randall explained in a video interview.

To generate evidence, the researchers enrolled 601 patients at several participating U.S. centers and followed them for a median of 53 months (4.4 years), with 259 patients treated and followed in the pelvic radiation arm and 268 patients treated and followed in the brachytherapy plus chemotherapy arm. Clinicians administered the complete planned treatment regimen to 91% of patients assigned to pelvic radiation and to 87% of those assigned to brachytherapy plus chemotherapy. Three quarters of enrolled patients had high-risk stage I disease, and the entire study group averaged about 62 years old.

The trial’s primary endpoint was recurrence-free survival, which occurred in 78% of the pelvic radiation patients and 79% of brachytherapy plus chemotherapy patients after 5 years when analyzed on an intention-to-treat basis. The two subgroups also showed similar rates of overall survival during follow-up.

Although the two treatments produced essentially identical outcomes for the primary result, they showed two important differences on secondary outcomes, reported Dr. Randall, professor and chair of radiation medicine at the University of Kentucky in Lexington.

Acute adverse effects rated as grade 3 severity or higher occurred in 11% of the pelvic radiation patients and in 64% of the brachytherapy plus chemotherapy patients, although late toxicities occurred at similar rates (13% and 12%, respectively) in the two subgroups.

Local pelvic and para-aortic nodal recurrences occurred in 4% of the pelvic radiation patients and in 9% of the brachytherapy plus chemotherapy patients, a 53% relative risk reduction with pelvic radiation. The difference in the nodal recurrences was apparent within the first year of follow-up, and the difference in rates continued to steadily widen over time after that. However the rates of both vaginal and distant recurrences were very similar in the two treatment arms. Distant recurrences were the most common type of treatment failure, occurring in about 18% of patients in both subgroups during complete follow-up.

“Pelvic radiation therapy remains an appropriate and preferable treatment for high-risk, early stage endometrial carcinoma,” Dr. Randall concluded.

[email protected]

SOURCE: Randall ME et al. SGO 2018.
 

The total direct and indirect costs of diabetes jumped over 25% from 2012 to 2017, which was enough to make it “the most costly chronic illness in the country,” the American Diabetes Association said.

The estimated total economic burden of diabetes went from an inflation-adjusted estimate of $261 billion in 2012 to $327 billion – $237 billion in direct medical costs and $90 billion in indirect costs such as absenteeism, reduced productivity, and premature mortality – in 2017, according to a new report from the ADA published in Diabetes Care.

“One of every four health care dollars is incurred by someone with diagnosed diabetes, and one of every seven health care dollars is spent directly treating diabetes and its complications,” the ADA said in a written statement.

The study used data from a large number of sources, including the American Community Survey, the OptumInsight de-identified Normative Health Information database, the Medical Expenditure Panel Survey, and the Medicare 5% sample Standard Analytical Files. All cost estimates were extrapolated to the 2017 U.S. population and adjusted to 2017 dollars.

[email protected]

SOURCE: Diabetes Care. 2018 Mar 22. doi: 10.2337/dci18-0007.

The total direct and indirect costs of diabetes jumped over 25% from 2012 to 2017, which was enough to make it “the most costly chronic illness in the country,” the American Diabetes Association said.

The estimated total economic burden of diabetes went from an inflation-adjusted estimate of $261 billion in 2012 to $327 billion – $237 billion in direct medical costs and $90 billion in indirect costs such as absenteeism, reduced productivity, and premature mortality – in 2017, according to a new report from the ADA published in Diabetes Care.

“One of every four health care dollars is incurred by someone with diagnosed diabetes, and one of every seven health care dollars is spent directly treating diabetes and its complications,” the ADA said in a written statement.

The study used data from a large number of sources, including the American Community Survey, the OptumInsight de-identified Normative Health Information database, the Medical Expenditure Panel Survey, and the Medicare 5% sample Standard Analytical Files. All cost estimates were extrapolated to the 2017 U.S. population and adjusted to 2017 dollars.

[email protected]

SOURCE: Diabetes Care. 2018 Mar 22. doi: 10.2337/dci18-0007.

The total direct and indirect costs of diabetes jumped over 25% from 2012 to 2017, which was enough to make it “the most costly chronic illness in the country,” the American Diabetes Association said.

The estimated total economic burden of diabetes went from an inflation-adjusted estimate of $261 billion in 2012 to $327 billion – $237 billion in direct medical costs and $90 billion in indirect costs such as absenteeism, reduced productivity, and premature mortality – in 2017, according to a new report from the ADA published in Diabetes Care.

“One of every four health care dollars is incurred by someone with diagnosed diabetes, and one of every seven health care dollars is spent directly treating diabetes and its complications,” the ADA said in a written statement.

The study used data from a large number of sources, including the American Community Survey, the OptumInsight de-identified Normative Health Information database, the Medical Expenditure Panel Survey, and the Medicare 5% sample Standard Analytical Files. All cost estimates were extrapolated to the 2017 U.S. population and adjusted to 2017 dollars.

[email protected]

SOURCE: Diabetes Care. 2018 Mar 22. doi: 10.2337/dci18-0007.

BOSTON – In persons infected with HIV-1, with or without hepatitis C coinfections, specific circulating microRNAs may signal the presence of liver injury and progression, investigators stated.

An analysis of small RNA expression in plasma samples from 144 HIV-infected patients showed that two microRNAs (miRNAs) in the same family of RNA fragments were significantly upregulated in patients with HIV-1 and HCV coinfections that progressed to liver cirrhosis, despite the patients having no evidence of liver fibrosis at the time of plasma sampling, reported Miguel Angel Martinez, PhD, of IrsiCaixa AIDS Research Institute in Badalona, Spain.

SOURCE: Martinez MA et al. CROI 2018, abstract 639.

BOSTON – In persons infected with HIV-1, with or without hepatitis C coinfections, specific circulating microRNAs may signal the presence of liver injury and progression, investigators stated.

An analysis of small RNA expression in plasma samples from 144 HIV-infected patients showed that two microRNAs (miRNAs) in the same family of RNA fragments were significantly upregulated in patients with HIV-1 and HCV coinfections that progressed to liver cirrhosis, despite the patients having no evidence of liver fibrosis at the time of plasma sampling, reported Miguel Angel Martinez, PhD, of IrsiCaixa AIDS Research Institute in Badalona, Spain.

SOURCE: Martinez MA et al. CROI 2018, abstract 639.

BOSTON – In persons infected with HIV-1, with or without hepatitis C coinfections, specific circulating microRNAs may signal the presence of liver injury and progression, investigators stated.

An analysis of small RNA expression in plasma samples from 144 HIV-infected patients showed that two microRNAs (miRNAs) in the same family of RNA fragments were significantly upregulated in patients with HIV-1 and HCV coinfections that progressed to liver cirrhosis, despite the patients having no evidence of liver fibrosis at the time of plasma sampling, reported Miguel Angel Martinez, PhD, of IrsiCaixa AIDS Research Institute in Badalona, Spain.

SOURCE: Martinez MA et al. CROI 2018, abstract 639.

Answer to “What’s your diagnosis?”  Chilaiditi syndrome

Abdominal CT images display the Chilaiditi sign, which is the radiographic term used to describe interposition of the colon, usually at the hepatic flexure, with the liver and right diaphragm.1 This is considered an incidental radiographic finding and is generally asymptomatic; however, when one develops clinical symptoms such as abdominal pain, bloating or distension, anorexia, constipation, or nausea it is called Chilaiditi syndrome.

First described by Greek radiologist Demetrius Chilaiditi in 1910, Chilaiditi syndrome is a rare occurrence with an incidence rate of 0.25%-0.28% in the general population.2 The etiology of Chilaiditi syndrome is felt to be congenital or acquired with predisposing congenital abnormalities such as absent suspensory or falciform ligaments, redundant colon, malposition of the colon, dolichocolon, and paralysis of the right diaphragm. Other risk factors for development of Chilaiditi syndrome include chronic constipation, cirrhosis, ascites, and obesity. Men are times times as likely as women to develop Chilaiditi syndrome and it is more common in the elderly, occurring in 1% of the elderly population.3 Chilaiditi sign is diagnosed with radiographic imaging meeting the following criteria: the right hemidiaphragm must be elevated above the liver by the intestine, the bowel must be distended by air to illustrate pseudopneumoperitoneum, and the superior margin of the liver must be depressed below the level of the left hemidiaphragm.1

Chilaiditi syndrome is managed conservatively with close observation. Recurrent symptoms can be treated with colopexy. This syndrome has been known to cause severe complications including volvulus of the cecum, splenic flexure, or transverse colon, cecal perforation, and subdiaphragmatic perforated appendicitis, which all require surgical intervention.3 It is important to recognize Chilaiditi syndrome on presentation to prevent unnecessary diagnostic studies and unwarranted surgical intervention.

References
1. Uygungul, E., Uygungul, D., Ayrik, C., et al. Chilaiditi sign: why are clinical findings more important in ED?. Am J Emerg Med. 2015;33:733.e1-733.e2.
2. Ho, M.P., Cheung, W.K., Tsai, K.C., et al. Chilaiditi syndrome mimicking subdiaphragmatic free air in an elderly adult. J Am Geriatr Soc. 2014;62:2019-21.
3. Kang, D., Pan, A.S., Lopez, M.A., et al. Acute abdominal pain secondary to Chilaiditi syndrome. Case Rep Surg. 2013;2013:756590.

Answer to “What’s your diagnosis?”  Chilaiditi syndrome

Abdominal CT images display the Chilaiditi sign, which is the radiographic term used to describe interposition of the colon, usually at the hepatic flexure, with the liver and right diaphragm.1 This is considered an incidental radiographic finding and is generally asymptomatic; however, when one develops clinical symptoms such as abdominal pain, bloating or distension, anorexia, constipation, or nausea it is called Chilaiditi syndrome.

First described by Greek radiologist Demetrius Chilaiditi in 1910, Chilaiditi syndrome is a rare occurrence with an incidence rate of 0.25%-0.28% in the general population.2 The etiology of Chilaiditi syndrome is felt to be congenital or acquired with predisposing congenital abnormalities such as absent suspensory or falciform ligaments, redundant colon, malposition of the colon, dolichocolon, and paralysis of the right diaphragm. Other risk factors for development of Chilaiditi syndrome include chronic constipation, cirrhosis, ascites, and obesity. Men are times times as likely as women to develop Chilaiditi syndrome and it is more common in the elderly, occurring in 1% of the elderly population.3 Chilaiditi sign is diagnosed with radiographic imaging meeting the following criteria: the right hemidiaphragm must be elevated above the liver by the intestine, the bowel must be distended by air to illustrate pseudopneumoperitoneum, and the superior margin of the liver must be depressed below the level of the left hemidiaphragm.1

Chilaiditi syndrome is managed conservatively with close observation. Recurrent symptoms can be treated with colopexy. This syndrome has been known to cause severe complications including volvulus of the cecum, splenic flexure, or transverse colon, cecal perforation, and subdiaphragmatic perforated appendicitis, which all require surgical intervention.3 It is important to recognize Chilaiditi syndrome on presentation to prevent unnecessary diagnostic studies and unwarranted surgical intervention.

References
1. Uygungul, E., Uygungul, D., Ayrik, C., et al. Chilaiditi sign: why are clinical findings more important in ED?. Am J Emerg Med. 2015;33:733.e1-733.e2.
2. Ho, M.P., Cheung, W.K., Tsai, K.C., et al. Chilaiditi syndrome mimicking subdiaphragmatic free air in an elderly adult. J Am Geriatr Soc. 2014;62:2019-21.
3. Kang, D., Pan, A.S., Lopez, M.A., et al. Acute abdominal pain secondary to Chilaiditi syndrome. Case Rep Surg. 2013;2013:756590.

Answer to “What’s your diagnosis?”  Chilaiditi syndrome

Abdominal CT images display the Chilaiditi sign, which is the radiographic term used to describe interposition of the colon, usually at the hepatic flexure, with the liver and right diaphragm.1 This is considered an incidental radiographic finding and is generally asymptomatic; however, when one develops clinical symptoms such as abdominal pain, bloating or distension, anorexia, constipation, or nausea it is called Chilaiditi syndrome.

First described by Greek radiologist Demetrius Chilaiditi in 1910, Chilaiditi syndrome is a rare occurrence with an incidence rate of 0.25%-0.28% in the general population.2 The etiology of Chilaiditi syndrome is felt to be congenital or acquired with predisposing congenital abnormalities such as absent suspensory or falciform ligaments, redundant colon, malposition of the colon, dolichocolon, and paralysis of the right diaphragm. Other risk factors for development of Chilaiditi syndrome include chronic constipation, cirrhosis, ascites, and obesity. Men are times times as likely as women to develop Chilaiditi syndrome and it is more common in the elderly, occurring in 1% of the elderly population.3 Chilaiditi sign is diagnosed with radiographic imaging meeting the following criteria: the right hemidiaphragm must be elevated above the liver by the intestine, the bowel must be distended by air to illustrate pseudopneumoperitoneum, and the superior margin of the liver must be depressed below the level of the left hemidiaphragm.1

Chilaiditi syndrome is managed conservatively with close observation. Recurrent symptoms can be treated with colopexy. This syndrome has been known to cause severe complications including volvulus of the cecum, splenic flexure, or transverse colon, cecal perforation, and subdiaphragmatic perforated appendicitis, which all require surgical intervention.3 It is important to recognize Chilaiditi syndrome on presentation to prevent unnecessary diagnostic studies and unwarranted surgical intervention.

References
1. Uygungul, E., Uygungul, D., Ayrik, C., et al. Chilaiditi sign: why are clinical findings more important in ED?. Am J Emerg Med. 2015;33:733.e1-733.e2.
2. Ho, M.P., Cheung, W.K., Tsai, K.C., et al. Chilaiditi syndrome mimicking subdiaphragmatic free air in an elderly adult. J Am Geriatr Soc. 2014;62:2019-21.
3. Kang, D., Pan, A.S., Lopez, M.A., et al. Acute abdominal pain secondary to Chilaiditi syndrome. Case Rep Surg. 2013;2013:756590.

SAN DIEGO – Although the intrusion of private equity in the ownership and operation of U.S. dermatology practices that has been snowballing for a little under a decade is often bemoaned by dermatologists, at least some physicians in the field may see it as a positive development.

“I think private equity investment is good for dermatology,” Clifford Perlis, MD, said at the annual meeting of the American Academy of Dermatology. “Dermatologists should be thrilled that private equity is here.” Investment by private equity companies into dermatology practices “adds value to practices, creates more practice options, enhances advocacy, and better manages the complexity” of practices, claimed Dr. Perlis, a dermatologist and Mohs surgeon who practices in King of Prussia, Pa. The debate on this topic was presented during a forum on dermatoethics at the meeting, structured as a pro and con conversation. The organizers, including Dr. Perlis and Jane Grant-Kels, MD., chose the topics and assigned positions to each presenter, which do not necessarily represent their personal views.*

Mitchel L. Zoler/MDedge News

*This article was updated on April 4, 2018.

[email protected]

SAN DIEGO – Although the intrusion of private equity in the ownership and operation of U.S. dermatology practices that has been snowballing for a little under a decade is often bemoaned by dermatologists, at least some physicians in the field may see it as a positive development.

“I think private equity investment is good for dermatology,” Clifford Perlis, MD, said at the annual meeting of the American Academy of Dermatology. “Dermatologists should be thrilled that private equity is here.” Investment by private equity companies into dermatology practices “adds value to practices, creates more practice options, enhances advocacy, and better manages the complexity” of practices, claimed Dr. Perlis, a dermatologist and Mohs surgeon who practices in King of Prussia, Pa. The debate on this topic was presented during a forum on dermatoethics at the meeting, structured as a pro and con conversation. The organizers, including Dr. Perlis and Jane Grant-Kels, MD., chose the topics and assigned positions to each presenter, which do not necessarily represent their personal views.*

Mitchel L. Zoler/MDedge News

*This article was updated on April 4, 2018.

[email protected]

SAN DIEGO – Although the intrusion of private equity in the ownership and operation of U.S. dermatology practices that has been snowballing for a little under a decade is often bemoaned by dermatologists, at least some physicians in the field may see it as a positive development.

“I think private equity investment is good for dermatology,” Clifford Perlis, MD, said at the annual meeting of the American Academy of Dermatology. “Dermatologists should be thrilled that private equity is here.” Investment by private equity companies into dermatology practices “adds value to practices, creates more practice options, enhances advocacy, and better manages the complexity” of practices, claimed Dr. Perlis, a dermatologist and Mohs surgeon who practices in King of Prussia, Pa. The debate on this topic was presented during a forum on dermatoethics at the meeting, structured as a pro and con conversation. The organizers, including Dr. Perlis and Jane Grant-Kels, MD., chose the topics and assigned positions to each presenter, which do not necessarily represent their personal views.*

Mitchel L. Zoler/MDedge News

*This article was updated on April 4, 2018.

[email protected]

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.

ORLANDO – The novel combination of entinostat and nivolumab with or without ipilimumab showed encouraging safety, tolerability, and antitumor activity in early results from an ongoing phase 1 trial of patients with advanced breast cancer.

Of 30 patients who were enrolled and treated in the dose-escalation phase of the study as of Feb. 24, 2018, 20 had evaluable responses, and of those, 3 had a partial response for an overall response rate of 15%. An additional 12 had stable disease, and 5 had disease progression, Roisin M. Connolly, MD, reported in a poster at the annual conference of the National Comprehensive Cancer Network.

Sharon Worcester/MDedge News

“The rationale for the study was based on preclinical work suggesting that epigenetic modifiers might be able to enhance the efficacy of immune therapies, and this would be particularly important for ‘colder’ tumor types like breast cancer that might not have the same sort of responses that we see in other tumor types,” Dr. Connolly explained in an interview. “The lab work suggested, for example, that the [histone deacetylase] inhibitor entinostat might affect myeloid-derived suppressor and regulatory T cells that might prevent cytotoxic T cells from fighting the cancer.”

There may be other mechanisms for this activity as well, she noted.

The run-in period with entinostat alone allowed collection of pre- and posttreatment biopsies to examine the effects on the tissues, such as whether treatment affects T cells, myeloid-derived suppressor cells, or their pathways, she said.

“We’re seeing [the] same types of toxicities seen with combination immune-oncology strategies, and we’re seeing some tumor responses that are of interest. Now we will delve into the tissue biopsies and blood samples we’ve collected to explore the mechanisms in more detail. In the near future we will open our breast cancer expansion cohort to look in more detail at what these drugs might be doing in breast cancer,” she added.

Specifically, she and her colleagues are evaluating the effects of treatment on immune-related biomarkers, measuring tumor-specific mutations and mutant neoantigens recognized by patient T cells in tumor biopsies, evaluating changes in the frequency of T cells recognizing tumor-specific mutant neoantigens in peripheral blood lymphocytes pre- and posttherapy, and looking at epigenetic changes pre- and posttherapy.

These preliminary findings suggest that the combination of entinostat and nivolumab with or without ipilimumab is safe and tolerable, with expected rates of immune-related adverse events, Dr. Connolly said, noting that the recommended phase 2 dose to be used in the dose expansion phase of the study has yet to be determined.

The findings, should they be confirmed as the trial progresses, could have important implications because immune checkpoint inhibitors, which work best in patients with immunogenic cancers that naturally attract T-cell infiltration into their tumor microenvironment, have limited single-agent activity in tumors, such as breast cancer, that are not believed to be immunogenic, she reported. Such cancers have thus far had only modest responses to single-agent immune checkpoint inhibition in advanced triple-negative and HER2+ breast cancer, with overall response rates of 5%-20%.

However, women who do respond to immune checkpoint inhibition tend to have durable and sustainable responses, she said, explaining that suboptimal immune responsiveness is likely a result of a lack of tumor antigen expression and/or recognition, as well as multiple suppressive signals in the tumor microenvironment.

Should the novel strategy tested in this study for converting breast cancers into immune responsive tumors facilitate improved response to immune checkpoint agents, it has the potential to significantly extend survival in breast cancer patients, she concluded.

This study was funded by grants from the National Institutes of Health, Bloomberg Kimmel Institute for Immunotherapy, NCCN, and the Mary Kay Foundation, as well as a V Foundation award. Dr. Connolly reported having no disclosures

[email protected]

SOURCE: Connolly RM et al. NCCN, Poster 3.