CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.

The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.

“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”

If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.

Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.

“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.

Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.

“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”

Alicia Gallegos/Frontline Medical News

Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.

Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.

“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”

Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.

“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”

Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.

Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.

“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”

[email protected]

On Twitter @legal_med

CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.

The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.

“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”

If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.

Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.

“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.

Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.

“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”

Alicia Gallegos/Frontline Medical News

Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.

Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.

“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”

Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.

“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”

Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.

Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.

“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”

[email protected]

On Twitter @legal_med

CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.

The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.

“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”

If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.

Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.

“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.

Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.

“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”

Alicia Gallegos/Frontline Medical News

Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.

Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.

“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”

Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.

“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”

Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.

Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.

“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”

[email protected]

On Twitter @legal_med

Advanced Valve Disease Educational Fellowship

Sponsored by Medtronic
Offers surgeons the opportunity to interactively observe valvular heart disease specialists and connect with them about treatment, technical skills, and management of perioperative patients for a minimum of one month and three months.

Deadline: July 1, 2016

Information/Application 

Evarts A. Graham Memorial Traveling Fellowship
Enhances the training of international academic CT surgeons and increases their international contacts by underwriting one-year of study at North American institutions. Includes a $75,000 stipend and round-trip airfare. Since 1951, fellows have included 64 individuals from 32 countries.

Deadline: July 1, 2016

Information/Application

Third John Alexander Research Scholarship
Supports North American surgeons with a two-year $160,000 grant to pursue research, training and clinical experience. Scholarships are named after past presidents of the Association. To date, 34 awardees have received over $4 million in grants.

Deadline: July 1, 2016

Information/Application 

Advanced Valve Disease Educational Fellowship

Sponsored by Medtronic
Offers surgeons the opportunity to interactively observe valvular heart disease specialists and connect with them about treatment, technical skills, and management of perioperative patients for a minimum of one month and three months.

Deadline: July 1, 2016

Information/Application 

Evarts A. Graham Memorial Traveling Fellowship
Enhances the training of international academic CT surgeons and increases their international contacts by underwriting one-year of study at North American institutions. Includes a $75,000 stipend and round-trip airfare. Since 1951, fellows have included 64 individuals from 32 countries.

Deadline: July 1, 2016

Information/Application

Third John Alexander Research Scholarship
Supports North American surgeons with a two-year $160,000 grant to pursue research, training and clinical experience. Scholarships are named after past presidents of the Association. To date, 34 awardees have received over $4 million in grants.

Deadline: July 1, 2016

Information/Application 

Advanced Valve Disease Educational Fellowship

Sponsored by Medtronic
Offers surgeons the opportunity to interactively observe valvular heart disease specialists and connect with them about treatment, technical skills, and management of perioperative patients for a minimum of one month and three months.

Deadline: July 1, 2016

Information/Application 

Evarts A. Graham Memorial Traveling Fellowship
Enhances the training of international academic CT surgeons and increases their international contacts by underwriting one-year of study at North American institutions. Includes a $75,000 stipend and round-trip airfare. Since 1951, fellows have included 64 individuals from 32 countries.

Deadline: July 1, 2016

Information/Application

Third John Alexander Research Scholarship
Supports North American surgeons with a two-year $160,000 grant to pursue research, training and clinical experience. Scholarships are named after past presidents of the Association. To date, 34 awardees have received over $4 million in grants.

Deadline: July 1, 2016

Information/Application 

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A Taiwanese study published in Hepatology demonstrated the importance of identifying and tracking viral mutations for monitoring hepatitis B progression and early detection of hepatocellular carcinoma. The authors found that the mutation score for predicting short-term hepatocellular carcinoma risk outperformed other factors, including hepatitis B virus (HBV) DNA levels, viral genotype, and various combinations of risk factors.

Courtesy NIH

Early combination antiretroviral therapy and wider hepatitis C virus (HCV) treatment have the potential to markedly reduce hepatitis C–related mortality, as well as increase survival overall for HIV-infected populations, according to a recent analysis. However, the authors said HCV treatment will need to be greatly scaled up.

Treating all chronic hepatitis C–screened patients for more than 5 years in France with new direct-acting antivirals, regardless of fibrosis stage, would be cost effective, a report revealed. However, the authors warned this would add a cost of 3.5-7.2 billion euros to an already overburdened medical care system.

Most German adolescents who received a full course of hepatitis B virus booster vaccine during infancy were still protected against hepatitis B infection almost 14 years later, according to a study in Human Vaccines & Immunotherapeutics.

Chronic HCV infection is associated with both former and excessive current alcohol consumption, according to an analysis of data from the 2003-2010 National Health and Nutrition Examination Survey. Researchers said public health HCV strategies should implement interventions with emphasis on alcohol abuse, which negatively impacts disease progression for HCV-infected individuals.

Treating patients with hepatitis delta virus genotype 3 with pegylated interferon alpha-2a was correlated with a possible cure rate higher than expected, according to a study in the International Journal of Infectious Diseases.

Widespread media reports in China of infant deaths following hepatitis B vaccine administration was associated with a decline in parental confidence in a vaccine that had been proved safe, and an increased refusal of vaccination, according to a report in the International Journal of Epidemiology. The authors recommended proactive outreach to stakeholders and the media to help mitigate any negative impact of future coincidental adverse events following immunization.

The platelet-to-lymphocyte ratio (PLR) is closely related to disease severity in patients with HCV-related liver disease and to the virologic response in patients with chronic hepatitis C, a recent study revealed. Investigators said dynamic continuous monitoring of the PLR, rather than a single high or low PLR value at a certain time point, will contribute to disease surveillance, with an increasing tendency predicting a good virologic response.

Ledipasvir/sofosbuvir (LDV/SOF) and sofosbuvir plus ribavirin (SOF+RBV) demonstrate a high barrier to resistance in Japanese patients with HCV genotype 1 and 2 infection, according to a study in the Journal of Viral Hepatitis. The authors said the presence of baseline NS5A resistance–associated variants did not impact treatment outcome in genotype 1 Japanese patients treated with LDV/SOF for 12 weeks.

Multilateral cooperation among Chinese vaccine manufacturers, the Chinese National Regulatory Authorization, and the World Health Organization is expediting the entrance of the hepatitis E vaccine Hecolin into the international market, according to a review in Human Vaccines & Immunotherapeutics.

A study in HIV Medicine found that psychiatric disorders were frequent in HIV/HCV-coinfected patients and their rates comparable between groups, even for patients achieving a sustained virologic response.

A review essay in Current Opinion in Infectious Diseases concluded that patients with recurrent HCV following liver transplant will significantly benefit from all oral new direct-acting antivirals, but that ongoing studies would determine the optimal timing and combination in this unique population.

Health care utilization and costs were higher among patients with diabetes and HBV than in those with diabetes alone, according to a recent study. The authors said the results support the need for HBV vaccination among unvaccinated diabetes patients.

A study in the Journal of Acquried Immune deficiency Syndromes provides additional support for the use of the CD4/CD8 ratio for routine monitoring of immune activation and inflammation in HIV-positive patients, including those coinfected with the hepatitis C virus. However, the authors said an unexpected association between cleared HCV and a lower CD4/CD8 ratio requires additional study.

A study of hepatitis B vaccination found that dosages of both 5-mcg HBV vaccine and 10-mcg HBV vaccine could be used to immunize children safely, while the 10-mcg vaccine could be used for adults aged 15-24 years, and a higher dosage of the HBV vaccine might be required for adults aged 25 years and older.

Levels of the let-7 family of microRNAs circulating in plasma and extracellular vesicles correlate with hepatic fibrosis progression in chronic HCV infection, according to a study in Hepatology.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A Taiwanese study published in Hepatology demonstrated the importance of identifying and tracking viral mutations for monitoring hepatitis B progression and early detection of hepatocellular carcinoma. The authors found that the mutation score for predicting short-term hepatocellular carcinoma risk outperformed other factors, including hepatitis B virus (HBV) DNA levels, viral genotype, and various combinations of risk factors.

Courtesy NIH

Early combination antiretroviral therapy and wider hepatitis C virus (HCV) treatment have the potential to markedly reduce hepatitis C–related mortality, as well as increase survival overall for HIV-infected populations, according to a recent analysis. However, the authors said HCV treatment will need to be greatly scaled up.

Treating all chronic hepatitis C–screened patients for more than 5 years in France with new direct-acting antivirals, regardless of fibrosis stage, would be cost effective, a report revealed. However, the authors warned this would add a cost of 3.5-7.2 billion euros to an already overburdened medical care system.

Most German adolescents who received a full course of hepatitis B virus booster vaccine during infancy were still protected against hepatitis B infection almost 14 years later, according to a study in Human Vaccines & Immunotherapeutics.

Chronic HCV infection is associated with both former and excessive current alcohol consumption, according to an analysis of data from the 2003-2010 National Health and Nutrition Examination Survey. Researchers said public health HCV strategies should implement interventions with emphasis on alcohol abuse, which negatively impacts disease progression for HCV-infected individuals.

Treating patients with hepatitis delta virus genotype 3 with pegylated interferon alpha-2a was correlated with a possible cure rate higher than expected, according to a study in the International Journal of Infectious Diseases.

Widespread media reports in China of infant deaths following hepatitis B vaccine administration was associated with a decline in parental confidence in a vaccine that had been proved safe, and an increased refusal of vaccination, according to a report in the International Journal of Epidemiology. The authors recommended proactive outreach to stakeholders and the media to help mitigate any negative impact of future coincidental adverse events following immunization.

The platelet-to-lymphocyte ratio (PLR) is closely related to disease severity in patients with HCV-related liver disease and to the virologic response in patients with chronic hepatitis C, a recent study revealed. Investigators said dynamic continuous monitoring of the PLR, rather than a single high or low PLR value at a certain time point, will contribute to disease surveillance, with an increasing tendency predicting a good virologic response.

Ledipasvir/sofosbuvir (LDV/SOF) and sofosbuvir plus ribavirin (SOF+RBV) demonstrate a high barrier to resistance in Japanese patients with HCV genotype 1 and 2 infection, according to a study in the Journal of Viral Hepatitis. The authors said the presence of baseline NS5A resistance–associated variants did not impact treatment outcome in genotype 1 Japanese patients treated with LDV/SOF for 12 weeks.

Multilateral cooperation among Chinese vaccine manufacturers, the Chinese National Regulatory Authorization, and the World Health Organization is expediting the entrance of the hepatitis E vaccine Hecolin into the international market, according to a review in Human Vaccines & Immunotherapeutics.

A study in HIV Medicine found that psychiatric disorders were frequent in HIV/HCV-coinfected patients and their rates comparable between groups, even for patients achieving a sustained virologic response.

A review essay in Current Opinion in Infectious Diseases concluded that patients with recurrent HCV following liver transplant will significantly benefit from all oral new direct-acting antivirals, but that ongoing studies would determine the optimal timing and combination in this unique population.

Health care utilization and costs were higher among patients with diabetes and HBV than in those with diabetes alone, according to a recent study. The authors said the results support the need for HBV vaccination among unvaccinated diabetes patients.

A study in the Journal of Acquried Immune deficiency Syndromes provides additional support for the use of the CD4/CD8 ratio for routine monitoring of immune activation and inflammation in HIV-positive patients, including those coinfected with the hepatitis C virus. However, the authors said an unexpected association between cleared HCV and a lower CD4/CD8 ratio requires additional study.

A study of hepatitis B vaccination found that dosages of both 5-mcg HBV vaccine and 10-mcg HBV vaccine could be used to immunize children safely, while the 10-mcg vaccine could be used for adults aged 15-24 years, and a higher dosage of the HBV vaccine might be required for adults aged 25 years and older.

Levels of the let-7 family of microRNAs circulating in plasma and extracellular vesicles correlate with hepatic fibrosis progression in chronic HCV infection, according to a study in Hepatology.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A Taiwanese study published in Hepatology demonstrated the importance of identifying and tracking viral mutations for monitoring hepatitis B progression and early detection of hepatocellular carcinoma. The authors found that the mutation score for predicting short-term hepatocellular carcinoma risk outperformed other factors, including hepatitis B virus (HBV) DNA levels, viral genotype, and various combinations of risk factors.

Courtesy NIH

Early combination antiretroviral therapy and wider hepatitis C virus (HCV) treatment have the potential to markedly reduce hepatitis C–related mortality, as well as increase survival overall for HIV-infected populations, according to a recent analysis. However, the authors said HCV treatment will need to be greatly scaled up.

Treating all chronic hepatitis C–screened patients for more than 5 years in France with new direct-acting antivirals, regardless of fibrosis stage, would be cost effective, a report revealed. However, the authors warned this would add a cost of 3.5-7.2 billion euros to an already overburdened medical care system.

Most German adolescents who received a full course of hepatitis B virus booster vaccine during infancy were still protected against hepatitis B infection almost 14 years later, according to a study in Human Vaccines & Immunotherapeutics.

Chronic HCV infection is associated with both former and excessive current alcohol consumption, according to an analysis of data from the 2003-2010 National Health and Nutrition Examination Survey. Researchers said public health HCV strategies should implement interventions with emphasis on alcohol abuse, which negatively impacts disease progression for HCV-infected individuals.

Treating patients with hepatitis delta virus genotype 3 with pegylated interferon alpha-2a was correlated with a possible cure rate higher than expected, according to a study in the International Journal of Infectious Diseases.

Widespread media reports in China of infant deaths following hepatitis B vaccine administration was associated with a decline in parental confidence in a vaccine that had been proved safe, and an increased refusal of vaccination, according to a report in the International Journal of Epidemiology. The authors recommended proactive outreach to stakeholders and the media to help mitigate any negative impact of future coincidental adverse events following immunization.

The platelet-to-lymphocyte ratio (PLR) is closely related to disease severity in patients with HCV-related liver disease and to the virologic response in patients with chronic hepatitis C, a recent study revealed. Investigators said dynamic continuous monitoring of the PLR, rather than a single high or low PLR value at a certain time point, will contribute to disease surveillance, with an increasing tendency predicting a good virologic response.

Ledipasvir/sofosbuvir (LDV/SOF) and sofosbuvir plus ribavirin (SOF+RBV) demonstrate a high barrier to resistance in Japanese patients with HCV genotype 1 and 2 infection, according to a study in the Journal of Viral Hepatitis. The authors said the presence of baseline NS5A resistance–associated variants did not impact treatment outcome in genotype 1 Japanese patients treated with LDV/SOF for 12 weeks.

Multilateral cooperation among Chinese vaccine manufacturers, the Chinese National Regulatory Authorization, and the World Health Organization is expediting the entrance of the hepatitis E vaccine Hecolin into the international market, according to a review in Human Vaccines & Immunotherapeutics.

A study in HIV Medicine found that psychiatric disorders were frequent in HIV/HCV-coinfected patients and their rates comparable between groups, even for patients achieving a sustained virologic response.

A review essay in Current Opinion in Infectious Diseases concluded that patients with recurrent HCV following liver transplant will significantly benefit from all oral new direct-acting antivirals, but that ongoing studies would determine the optimal timing and combination in this unique population.

Health care utilization and costs were higher among patients with diabetes and HBV than in those with diabetes alone, according to a recent study. The authors said the results support the need for HBV vaccination among unvaccinated diabetes patients.

A study in the Journal of Acquried Immune deficiency Syndromes provides additional support for the use of the CD4/CD8 ratio for routine monitoring of immune activation and inflammation in HIV-positive patients, including those coinfected with the hepatitis C virus. However, the authors said an unexpected association between cleared HCV and a lower CD4/CD8 ratio requires additional study.

A study of hepatitis B vaccination found that dosages of both 5-mcg HBV vaccine and 10-mcg HBV vaccine could be used to immunize children safely, while the 10-mcg vaccine could be used for adults aged 15-24 years, and a higher dosage of the HBV vaccine might be required for adults aged 25 years and older.

Levels of the let-7 family of microRNAs circulating in plasma and extracellular vesicles correlate with hepatic fibrosis progression in chronic HCV infection, according to a study in Hepatology.

[email protected]

On Twitter @richpizzi

PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.

At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.

“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.

The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.

In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.

Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.

In contrast, verapamil was not linked to severe hypotension.

Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.

When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.

Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.

“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.

He reported having no financial conflicts regarding his presentation.

[email protected]

PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.

At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.

“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.

The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.

In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.

Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.

In contrast, verapamil was not linked to severe hypotension.

Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.

When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.

Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.

“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.

He reported having no financial conflicts regarding his presentation.

[email protected]

PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.

At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.

“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.

The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.

In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.

Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.

In contrast, verapamil was not linked to severe hypotension.

Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.

When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.

Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.

“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.

He reported having no financial conflicts regarding his presentation.

[email protected]

CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.

“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.

As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.

In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).

The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.

“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.

Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.

They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.

Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.

“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.

Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.

Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.

CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.

“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.

As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.

In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).

The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.

“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.

Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.

They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.

Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.

“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.

Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.

Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.

CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.

“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.

As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.

In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).

The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.

“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.

Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.

They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.

Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.

“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.

Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.

Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.

Dr. Geeta Arora is a locum tenens hospitalist; James Levy is a PA who hires locums as the VP of Human Resources for Indigo Health Partners in Northern Michigan. They share their experiences navigating "freelance hospital medicine," from both the medical practice and business perspective.

Dr. Geeta Arora is a locum tenens hospitalist; James Levy is a PA who hires locums as the VP of Human Resources for Indigo Health Partners in Northern Michigan. They share their experiences navigating "freelance hospital medicine," from both the medical practice and business perspective.

Dr. Geeta Arora is a locum tenens hospitalist; James Levy is a PA who hires locums as the VP of Human Resources for Indigo Health Partners in Northern Michigan. They share their experiences navigating "freelance hospital medicine," from both the medical practice and business perspective.

On Wednesday morning, the Society for Vascular Surgery bumped into SVS Past President Dr. Peter Gloviczki. Here’s what we learned about one of our leaders – who is stepping into a new role with the Society – and his participation at VAM this year.

The first thing to note is that he was wearing the very first SVS tie! “It’s the one I designed,” he said.

©Martin Allred

Dr. Gloviczki is about to start his term, with Dr. Peter Lawrence, as editors-in-chief of the Journal of Vascular Surgery. “We’re very excited,” he said. “We have a new cover and a new format."

The two are expanding the Journal to include much more public media, Dr. Gloviczki said. They have set up a recording studio (National Harbor 1), and after participants give their presentations at VAM, they can record a five-minute video of his or her presentation, Dr. Gloviczki said. When their articles of original research are published, these interviews will be posted online on JVS, SVS and YouTube websites.

As for what he hopes to take from VAM this year: “I’m looking for ideas, for new topics we can include in the Journal. There are differences between European and U.S. colleagues on how to treat vascular disease. I want to learn about that.”

And how many VAMs has he attended? “Almost all of them,” he allowed.

On Wednesday morning, the Society for Vascular Surgery bumped into SVS Past President Dr. Peter Gloviczki. Here’s what we learned about one of our leaders – who is stepping into a new role with the Society – and his participation at VAM this year.

The first thing to note is that he was wearing the very first SVS tie! “It’s the one I designed,” he said.

©Martin Allred

Dr. Gloviczki is about to start his term, with Dr. Peter Lawrence, as editors-in-chief of the Journal of Vascular Surgery. “We’re very excited,” he said. “We have a new cover and a new format."

The two are expanding the Journal to include much more public media, Dr. Gloviczki said. They have set up a recording studio (National Harbor 1), and after participants give their presentations at VAM, they can record a five-minute video of his or her presentation, Dr. Gloviczki said. When their articles of original research are published, these interviews will be posted online on JVS, SVS and YouTube websites.

As for what he hopes to take from VAM this year: “I’m looking for ideas, for new topics we can include in the Journal. There are differences between European and U.S. colleagues on how to treat vascular disease. I want to learn about that.”

And how many VAMs has he attended? “Almost all of them,” he allowed.

On Wednesday morning, the Society for Vascular Surgery bumped into SVS Past President Dr. Peter Gloviczki. Here’s what we learned about one of our leaders – who is stepping into a new role with the Society – and his participation at VAM this year.

The first thing to note is that he was wearing the very first SVS tie! “It’s the one I designed,” he said.

©Martin Allred

Dr. Gloviczki is about to start his term, with Dr. Peter Lawrence, as editors-in-chief of the Journal of Vascular Surgery. “We’re very excited,” he said. “We have a new cover and a new format."

The two are expanding the Journal to include much more public media, Dr. Gloviczki said. They have set up a recording studio (National Harbor 1), and after participants give their presentations at VAM, they can record a five-minute video of his or her presentation, Dr. Gloviczki said. When their articles of original research are published, these interviews will be posted online on JVS, SVS and YouTube websites.

As for what he hopes to take from VAM this year: “I’m looking for ideas, for new topics we can include in the Journal. There are differences between European and U.S. colleagues on how to treat vascular disease. I want to learn about that.”

And how many VAMs has he attended? “Almost all of them,” he allowed.

CHICAGO – The RET tyrosine kinase inhibitor vandetanib shows marked yet variable antitumor activity and toxicity in patients whose RET-positive non–small cell lung cancer (NSCLC) was unsuccessfully treated with chemotherapy, according to results of two small phase II trials presented at the annual meeting of the American Society of Clinical Oncology.

The overall response rates were 53% and 61% in two independent trials conducted by Dr. Takashi Seto of the National Kyushu Cancer Center, Japan, and by Dr. Se-Hoon Lee of Sungkyunkwan University, South Korea, respectively.

Compared to previous studies with other RET inhibitors, though all had small cohorts, there were many similarities in response rates. Progression-free survival was the most variable, but was much higher in the cabozantinib data reported at the 2015 ASCO annual meeting, according to moderator Dr. Karen Reckamp of the City of Hope Comprehensive Cancer Center, Duarte, Calif. “Vandetanib may have lower response rates than some of the others,” she said.

RET is a tyrosine kinase domain that fuses to and undergoes rearrangements with KIF5B and CCDC6 genes. This fusion and subsequent rearrangement results in ligand-dependent dimerization, which causes tumor growth. RET rearrangements were first identified in thyroid cancers.

“RET fusions were identified as new driver oncogenes of NSCLC in 2012 and observed in 1%-2% of all NSCLC,” Dr. Seto said. “Non–small cell lung cancer with RET rearrangement is regarded as a unique entity in terms of pathogenesis,” said Dr. Lee. There are currently multiple RET inhibitors in various stages of development.

In the trial headed by Dr. Seto, the Japanese genetic screening network was utilized to identify 34 NSCLC patients with RET rearrangements. Among the 34 patients, 17 met the eligibility requirements of having failed at least one prior chemotherapy treatment. Of those 17 patients, the median age was 59 years, 74% were female, all had adenocarcinomas, and 68% were nonsmokers.

All 17 patients received vandetanib at a dose of 300 mg once daily. The overall response rate was 53% (90% confidence interval, 31-74), and the disease control rate was 88%. The median progression-free survival was 4.7 months (90% CI, 2.8-8.3).

There was a marked difference in overall response rate and progression-free survival among RET fusion subtypes. For CCDC6-RET, the overall response was 83% and the progression-free survival was 8.3 months. For KIF5B-RET, the overall response was 20% with a median progression-free survival of 2.9 months.

Dr. Seto noted that there was no known biological explanation for the observed discrepancy in response rate or survival.

Dr. Seto/National Kyushu Cancer Center

Dr. Seto reported that the safety profile was similar to previous reports. Four patients ended treatment due to adverse events while 16 experienced dose interruptions due to treatment-related toxicities. The most common grade three and four toxicities were hypertension (58%), rash (16%), and diarrhea (11%).

In the trial headed by Dr. Lee, 18 patients with RET rearrangements (confirmed by fluorescent in situ hybridization) met the eligibility requirement of having failed platinum-based chemotherapy. The median age of the cohort was 55 years, and 33% were female.

Similar to Dr. Seto’s study, all 18 patients received vandetanib at 300 mg once daily. Of the 18 patient cohort, 17% achieved partial remission and 44% achieved stable disease. Seven patients had no remission or stabilization. There were no treatment-related mortalities or grade 4 adverse events. Two grade 3 adverse events were reported.

“Looking at these two studies together, I think the important thing about the characteristics you see [is] that the age range is very similar [with a] median in the 50’s,” commented Dr. Reckamp. “The male to female ratio is actually opposite in both so [this] can occur in both men and women. The smoking status, interestingly is similar in both, where about a third of patients were former smokers. Most of the patients had adenocarcinoma. Many of these patients were highly previously treated. Only the Seto group looked at RET fusion partner, which may be important in looking at efficacy for these agents.” Vandetanib is a “challenging drug to tolerate,” Dr. Reckamp also noted.

“Is there a preferred RET inhibitor in small cell lung cancer?” Dr. Reckamp asked. “There are many RET inhibitors approved for other cancer types at this point, and they are multitargeted tyrosine kinases. In small studies they have similar efficacy. Toxicities vary because of the off-target effects, and most of the [treatment] decisions were made based on potential toxicities rather than differing efficacy. So none is really differentiated as the best choice, and it is unlikely that we are going to have the trials to evaluate them head to head.”

Dr. Reckamp suggested that “most patients with adenocarcinoma” should be tested for RET rearrangements. “Both men and women, both smokers and nonsmokers. And if you don’t test, you won’t find it. And if you don’t find it, you won’t be able to treat.” Dr. Reckamp also noted that next generation sequencing (NGS) should be the preferred method of identifying RET status because NGS uses less tissue, provides genetic sequencing, and allows for the identification of binding partners.

“Does targeting RET improve patient outcomes?” she continued. “Because that is really the question we need to answer if we need to move forward with RET inhibition for lung cancer. So there are variable response rates, less than other inhibitors of other oncogenic-driven tumors, that’s for sure... But if you look at the data, and these are [for] heavily pretreated patients for the most part, the response rates are better than second-line cytotoxic chemotherapy that we have had in the past and similar to unselected checkpoint inhibition. So there is potential for improving outcomes, and again if we don’t know someone is RET, we potentially are not going to offer a treatment that could help them live longer or better.”

When asked how she would treat a newly-diagnosed patient with RET-positive NSCLC, Dr. Reckamp said she would treat with first-line chemotherapy rather than a tyrosine kinase inhibitor (TKI) but would enroll the patient in whatever TKI trial was ongoing at that point in time.

“There are multiple trials that are ongoing,” Dr. Reckamp said. “It is unlikely that a comparison trial will be completed and so we are going to have to look at these trials next to each other and differentiate based on toxicity [and] perceived efficacy.”

Specifically, Dr. Reckamp believes the medical community needs to move toward “universal testing” for RET status in lung cancer patients. Resistance and combination therapies will also need to be assessed in future studies.

“RET is important in lung cancer, and should be targeted. We now need to find the best way to do that,” Dr. Reckamp concluded.

The trial headed by Dr. Seto was funded by the Japan Agency for Medical Research and Development, AMED, and AstraZeneca. Dr. Seto reported receiving honoraria and research funding from multiple companies including AstraZeneca. The trial headed by Dr. Lee was funded by AstraZeneca Korea. Dr. Lee reported having a consulting or advisory role and receiving honoraria and research funding from AstraZeneca, Pfizer, and Roche/Genentech.

[email protected]

CHICAGO – The RET tyrosine kinase inhibitor vandetanib shows marked yet variable antitumor activity and toxicity in patients whose RET-positive non–small cell lung cancer (NSCLC) was unsuccessfully treated with chemotherapy, according to results of two small phase II trials presented at the annual meeting of the American Society of Clinical Oncology.

The overall response rates were 53% and 61% in two independent trials conducted by Dr. Takashi Seto of the National Kyushu Cancer Center, Japan, and by Dr. Se-Hoon Lee of Sungkyunkwan University, South Korea, respectively.

Compared to previous studies with other RET inhibitors, though all had small cohorts, there were many similarities in response rates. Progression-free survival was the most variable, but was much higher in the cabozantinib data reported at the 2015 ASCO annual meeting, according to moderator Dr. Karen Reckamp of the City of Hope Comprehensive Cancer Center, Duarte, Calif. “Vandetanib may have lower response rates than some of the others,” she said.

RET is a tyrosine kinase domain that fuses to and undergoes rearrangements with KIF5B and CCDC6 genes. This fusion and subsequent rearrangement results in ligand-dependent dimerization, which causes tumor growth. RET rearrangements were first identified in thyroid cancers.

“RET fusions were identified as new driver oncogenes of NSCLC in 2012 and observed in 1%-2% of all NSCLC,” Dr. Seto said. “Non–small cell lung cancer with RET rearrangement is regarded as a unique entity in terms of pathogenesis,” said Dr. Lee. There are currently multiple RET inhibitors in various stages of development.

In the trial headed by Dr. Seto, the Japanese genetic screening network was utilized to identify 34 NSCLC patients with RET rearrangements. Among the 34 patients, 17 met the eligibility requirements of having failed at least one prior chemotherapy treatment. Of those 17 patients, the median age was 59 years, 74% were female, all had adenocarcinomas, and 68% were nonsmokers.

All 17 patients received vandetanib at a dose of 300 mg once daily. The overall response rate was 53% (90% confidence interval, 31-74), and the disease control rate was 88%. The median progression-free survival was 4.7 months (90% CI, 2.8-8.3).

There was a marked difference in overall response rate and progression-free survival among RET fusion subtypes. For CCDC6-RET, the overall response was 83% and the progression-free survival was 8.3 months. For KIF5B-RET, the overall response was 20% with a median progression-free survival of 2.9 months.

Dr. Seto noted that there was no known biological explanation for the observed discrepancy in response rate or survival.

Dr. Seto/National Kyushu Cancer Center

Dr. Seto reported that the safety profile was similar to previous reports. Four patients ended treatment due to adverse events while 16 experienced dose interruptions due to treatment-related toxicities. The most common grade three and four toxicities were hypertension (58%), rash (16%), and diarrhea (11%).

In the trial headed by Dr. Lee, 18 patients with RET rearrangements (confirmed by fluorescent in situ hybridization) met the eligibility requirement of having failed platinum-based chemotherapy. The median age of the cohort was 55 years, and 33% were female.

Similar to Dr. Seto’s study, all 18 patients received vandetanib at 300 mg once daily. Of the 18 patient cohort, 17% achieved partial remission and 44% achieved stable disease. Seven patients had no remission or stabilization. There were no treatment-related mortalities or grade 4 adverse events. Two grade 3 adverse events were reported.

“Looking at these two studies together, I think the important thing about the characteristics you see [is] that the age range is very similar [with a] median in the 50’s,” commented Dr. Reckamp. “The male to female ratio is actually opposite in both so [this] can occur in both men and women. The smoking status, interestingly is similar in both, where about a third of patients were former smokers. Most of the patients had adenocarcinoma. Many of these patients were highly previously treated. Only the Seto group looked at RET fusion partner, which may be important in looking at efficacy for these agents.” Vandetanib is a “challenging drug to tolerate,” Dr. Reckamp also noted.

“Is there a preferred RET inhibitor in small cell lung cancer?” Dr. Reckamp asked. “There are many RET inhibitors approved for other cancer types at this point, and they are multitargeted tyrosine kinases. In small studies they have similar efficacy. Toxicities vary because of the off-target effects, and most of the [treatment] decisions were made based on potential toxicities rather than differing efficacy. So none is really differentiated as the best choice, and it is unlikely that we are going to have the trials to evaluate them head to head.”

Dr. Reckamp suggested that “most patients with adenocarcinoma” should be tested for RET rearrangements. “Both men and women, both smokers and nonsmokers. And if you don’t test, you won’t find it. And if you don’t find it, you won’t be able to treat.” Dr. Reckamp also noted that next generation sequencing (NGS) should be the preferred method of identifying RET status because NGS uses less tissue, provides genetic sequencing, and allows for the identification of binding partners.

“Does targeting RET improve patient outcomes?” she continued. “Because that is really the question we need to answer if we need to move forward with RET inhibition for lung cancer. So there are variable response rates, less than other inhibitors of other oncogenic-driven tumors, that’s for sure... But if you look at the data, and these are [for] heavily pretreated patients for the most part, the response rates are better than second-line cytotoxic chemotherapy that we have had in the past and similar to unselected checkpoint inhibition. So there is potential for improving outcomes, and again if we don’t know someone is RET, we potentially are not going to offer a treatment that could help them live longer or better.”

When asked how she would treat a newly-diagnosed patient with RET-positive NSCLC, Dr. Reckamp said she would treat with first-line chemotherapy rather than a tyrosine kinase inhibitor (TKI) but would enroll the patient in whatever TKI trial was ongoing at that point in time.

“There are multiple trials that are ongoing,” Dr. Reckamp said. “It is unlikely that a comparison trial will be completed and so we are going to have to look at these trials next to each other and differentiate based on toxicity [and] perceived efficacy.”

Specifically, Dr. Reckamp believes the medical community needs to move toward “universal testing” for RET status in lung cancer patients. Resistance and combination therapies will also need to be assessed in future studies.

“RET is important in lung cancer, and should be targeted. We now need to find the best way to do that,” Dr. Reckamp concluded.

The trial headed by Dr. Seto was funded by the Japan Agency for Medical Research and Development, AMED, and AstraZeneca. Dr. Seto reported receiving honoraria and research funding from multiple companies including AstraZeneca. The trial headed by Dr. Lee was funded by AstraZeneca Korea. Dr. Lee reported having a consulting or advisory role and receiving honoraria and research funding from AstraZeneca, Pfizer, and Roche/Genentech.

[email protected]

CHICAGO – The RET tyrosine kinase inhibitor vandetanib shows marked yet variable antitumor activity and toxicity in patients whose RET-positive non–small cell lung cancer (NSCLC) was unsuccessfully treated with chemotherapy, according to results of two small phase II trials presented at the annual meeting of the American Society of Clinical Oncology.

The overall response rates were 53% and 61% in two independent trials conducted by Dr. Takashi Seto of the National Kyushu Cancer Center, Japan, and by Dr. Se-Hoon Lee of Sungkyunkwan University, South Korea, respectively.

Compared to previous studies with other RET inhibitors, though all had small cohorts, there were many similarities in response rates. Progression-free survival was the most variable, but was much higher in the cabozantinib data reported at the 2015 ASCO annual meeting, according to moderator Dr. Karen Reckamp of the City of Hope Comprehensive Cancer Center, Duarte, Calif. “Vandetanib may have lower response rates than some of the others,” she said.

RET is a tyrosine kinase domain that fuses to and undergoes rearrangements with KIF5B and CCDC6 genes. This fusion and subsequent rearrangement results in ligand-dependent dimerization, which causes tumor growth. RET rearrangements were first identified in thyroid cancers.

“RET fusions were identified as new driver oncogenes of NSCLC in 2012 and observed in 1%-2% of all NSCLC,” Dr. Seto said. “Non–small cell lung cancer with RET rearrangement is regarded as a unique entity in terms of pathogenesis,” said Dr. Lee. There are currently multiple RET inhibitors in various stages of development.

In the trial headed by Dr. Seto, the Japanese genetic screening network was utilized to identify 34 NSCLC patients with RET rearrangements. Among the 34 patients, 17 met the eligibility requirements of having failed at least one prior chemotherapy treatment. Of those 17 patients, the median age was 59 years, 74% were female, all had adenocarcinomas, and 68% were nonsmokers.

All 17 patients received vandetanib at a dose of 300 mg once daily. The overall response rate was 53% (90% confidence interval, 31-74), and the disease control rate was 88%. The median progression-free survival was 4.7 months (90% CI, 2.8-8.3).

There was a marked difference in overall response rate and progression-free survival among RET fusion subtypes. For CCDC6-RET, the overall response was 83% and the progression-free survival was 8.3 months. For KIF5B-RET, the overall response was 20% with a median progression-free survival of 2.9 months.

Dr. Seto noted that there was no known biological explanation for the observed discrepancy in response rate or survival.

Dr. Seto/National Kyushu Cancer Center

Dr. Seto reported that the safety profile was similar to previous reports. Four patients ended treatment due to adverse events while 16 experienced dose interruptions due to treatment-related toxicities. The most common grade three and four toxicities were hypertension (58%), rash (16%), and diarrhea (11%).

In the trial headed by Dr. Lee, 18 patients with RET rearrangements (confirmed by fluorescent in situ hybridization) met the eligibility requirement of having failed platinum-based chemotherapy. The median age of the cohort was 55 years, and 33% were female.

Similar to Dr. Seto’s study, all 18 patients received vandetanib at 300 mg once daily. Of the 18 patient cohort, 17% achieved partial remission and 44% achieved stable disease. Seven patients had no remission or stabilization. There were no treatment-related mortalities or grade 4 adverse events. Two grade 3 adverse events were reported.

“Looking at these two studies together, I think the important thing about the characteristics you see [is] that the age range is very similar [with a] median in the 50’s,” commented Dr. Reckamp. “The male to female ratio is actually opposite in both so [this] can occur in both men and women. The smoking status, interestingly is similar in both, where about a third of patients were former smokers. Most of the patients had adenocarcinoma. Many of these patients were highly previously treated. Only the Seto group looked at RET fusion partner, which may be important in looking at efficacy for these agents.” Vandetanib is a “challenging drug to tolerate,” Dr. Reckamp also noted.

“Is there a preferred RET inhibitor in small cell lung cancer?” Dr. Reckamp asked. “There are many RET inhibitors approved for other cancer types at this point, and they are multitargeted tyrosine kinases. In small studies they have similar efficacy. Toxicities vary because of the off-target effects, and most of the [treatment] decisions were made based on potential toxicities rather than differing efficacy. So none is really differentiated as the best choice, and it is unlikely that we are going to have the trials to evaluate them head to head.”

Dr. Reckamp suggested that “most patients with adenocarcinoma” should be tested for RET rearrangements. “Both men and women, both smokers and nonsmokers. And if you don’t test, you won’t find it. And if you don’t find it, you won’t be able to treat.” Dr. Reckamp also noted that next generation sequencing (NGS) should be the preferred method of identifying RET status because NGS uses less tissue, provides genetic sequencing, and allows for the identification of binding partners.

“Does targeting RET improve patient outcomes?” she continued. “Because that is really the question we need to answer if we need to move forward with RET inhibition for lung cancer. So there are variable response rates, less than other inhibitors of other oncogenic-driven tumors, that’s for sure... But if you look at the data, and these are [for] heavily pretreated patients for the most part, the response rates are better than second-line cytotoxic chemotherapy that we have had in the past and similar to unselected checkpoint inhibition. So there is potential for improving outcomes, and again if we don’t know someone is RET, we potentially are not going to offer a treatment that could help them live longer or better.”

When asked how she would treat a newly-diagnosed patient with RET-positive NSCLC, Dr. Reckamp said she would treat with first-line chemotherapy rather than a tyrosine kinase inhibitor (TKI) but would enroll the patient in whatever TKI trial was ongoing at that point in time.

“There are multiple trials that are ongoing,” Dr. Reckamp said. “It is unlikely that a comparison trial will be completed and so we are going to have to look at these trials next to each other and differentiate based on toxicity [and] perceived efficacy.”

Specifically, Dr. Reckamp believes the medical community needs to move toward “universal testing” for RET status in lung cancer patients. Resistance and combination therapies will also need to be assessed in future studies.

“RET is important in lung cancer, and should be targeted. We now need to find the best way to do that,” Dr. Reckamp concluded.

The trial headed by Dr. Seto was funded by the Japan Agency for Medical Research and Development, AMED, and AstraZeneca. Dr. Seto reported receiving honoraria and research funding from multiple companies including AstraZeneca. The trial headed by Dr. Lee was funded by AstraZeneca Korea. Dr. Lee reported having a consulting or advisory role and receiving honoraria and research funding from AstraZeneca, Pfizer, and Roche/Genentech.

[email protected]

Dr. Michael Conte issued an urgent call Thursday for vascular surgeons to enroll patients in the BEST-CLI Trial, designed to answer this question: What’s the best treatment for advanced critical limb ischemia?

“This is a key opportunity to define optimal care for patients with critical limb-threatening ischemia,” said Dr. Conte to the audience at the E. Stanley Crawford Critical Issues Forum. “Vascular surgeons are the dominant providers, and we must be the leaders.”

Investigators hope to enroll 2,100 patients; to date the trial is at “barely one-third of that enrollment,” he said.

The National Institutes of Health is closely monitoring the trial, officially the “Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia” trial, he said, adding, “and we must execute on this important opportunity.

“Most importantly, the trial will help us define an evidenced-based standard of care. Vascular surgeons must play a leading role in this landmark trial,” he said.

To participate and learn more, visit: www.bestcli.com.

Dr. Michael Conte issued an urgent call Thursday for vascular surgeons to enroll patients in the BEST-CLI Trial, designed to answer this question: What’s the best treatment for advanced critical limb ischemia?

“This is a key opportunity to define optimal care for patients with critical limb-threatening ischemia,” said Dr. Conte to the audience at the E. Stanley Crawford Critical Issues Forum. “Vascular surgeons are the dominant providers, and we must be the leaders.”

Investigators hope to enroll 2,100 patients; to date the trial is at “barely one-third of that enrollment,” he said.

The National Institutes of Health is closely monitoring the trial, officially the “Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia” trial, he said, adding, “and we must execute on this important opportunity.

“Most importantly, the trial will help us define an evidenced-based standard of care. Vascular surgeons must play a leading role in this landmark trial,” he said.

To participate and learn more, visit: www.bestcli.com.

Dr. Michael Conte issued an urgent call Thursday for vascular surgeons to enroll patients in the BEST-CLI Trial, designed to answer this question: What’s the best treatment for advanced critical limb ischemia?

“This is a key opportunity to define optimal care for patients with critical limb-threatening ischemia,” said Dr. Conte to the audience at the E. Stanley Crawford Critical Issues Forum. “Vascular surgeons are the dominant providers, and we must be the leaders.”

Investigators hope to enroll 2,100 patients; to date the trial is at “barely one-third of that enrollment,” he said.

The National Institutes of Health is closely monitoring the trial, officially the “Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia” trial, he said, adding, “and we must execute on this important opportunity.

“Most importantly, the trial will help us define an evidenced-based standard of care. Vascular surgeons must play a leading role in this landmark trial,” he said.

To participate and learn more, visit: www.bestcli.com.

CHICAGO – The anti-CCR4 monoclonal antibody mogamulizumab was superior to other investigator-selected therapies for the treatment of patients with relapsed/refractory adult T-cell leukemia-lymphoma (ATL), based on results from 71 patients in a prospective, multicenter, randomized study reported at the annual meeting of the American Society of Clinical Oncology.

Commonly used cytotoxic regimens provided limited therapeutic benefit for these patients, but mogamulizumab resulted in an objective response rate that supports its therapeutic potential in this setting, reported Dr. Adrienne Alise Phillips of New York Presbyterian/Weill Cornell Medical College, New York.

Mary Jo Dales/Frontline Medical News

A malignancy of T-cells infected with HTLV-1, ATL has a poor prognosis with a median overall survival of less than 3 months in patients with relapsed/refractory disease. CCR4 is expressed in over 90% of ATL patients, and mogamulizumab is approved in Japan for ATL as well as for peripheral T-cell lymphoma and cutaneous T-cell lymphoma.

The 71 patients in the study were from the United States, the European Union and Latin America. The study is the largest randomized clinical trial of relapsed/refractory adult T-cell leukemia-lymphoma thus far conducted. The patients were randomized in 2:1 fashion 47:24 patients) to mogamulizumab, 1.0 mg/kg, given weekly for the first 4-week cycle and then biweekly, or to one of three investigator choice regimens [gemcitabine and oxaliplatin, DHAP (dexamethasone, high-dose cytarabine, and cisplatin), or pralatrexate]. Patients who were in the investigator-choice arm and whose disease progressed were permitted to cross over to mogamulizumab.

The primary endpoint was objective response rate based on modified Tsukasaki criteria and assessed by the treating investigator and in blinded fashion by independent review.

The objective response rate in the mogamulizumab-treated group was 23.4% (11 of 47) by independent review and 34% (16 of 47) by the treating investigator. In the investigator choice group, the overall response rate was 2 of 24 by independent review and 0 of 24 by the treating investigator.

The confirmed objective response rate after 1 month in the mogamulizumab-treated group was 10.6% by independent review and 14.9% by the treating investigator; there were no confirmed responses in the investigator-choice arm. Of 18 patients who crossed over to mogamulizumab, 3 responded. The median duration of response for mogamulizumab was 5 months; one patient had a complete response that lasted over 9 months and the survival data are not yet mature.

Mogamulizumab had few drug-related adverse events, primarily infusion reactions (46.8%), rash/drug eruption (25.5%) and infections (14.9%).

Dr. Phillips disclosed ties to Celgene, Genentech, and Takeda, as well as research funding from Kyowa Hakko Kirin, the sponsor of the study.

Abstract 7501

[email protected]

On Twitter @maryjodales

CHICAGO – The anti-CCR4 monoclonal antibody mogamulizumab was superior to other investigator-selected therapies for the treatment of patients with relapsed/refractory adult T-cell leukemia-lymphoma (ATL), based on results from 71 patients in a prospective, multicenter, randomized study reported at the annual meeting of the American Society of Clinical Oncology.

Commonly used cytotoxic regimens provided limited therapeutic benefit for these patients, but mogamulizumab resulted in an objective response rate that supports its therapeutic potential in this setting, reported Dr. Adrienne Alise Phillips of New York Presbyterian/Weill Cornell Medical College, New York.

Mary Jo Dales/Frontline Medical News

A malignancy of T-cells infected with HTLV-1, ATL has a poor prognosis with a median overall survival of less than 3 months in patients with relapsed/refractory disease. CCR4 is expressed in over 90% of ATL patients, and mogamulizumab is approved in Japan for ATL as well as for peripheral T-cell lymphoma and cutaneous T-cell lymphoma.

The 71 patients in the study were from the United States, the European Union and Latin America. The study is the largest randomized clinical trial of relapsed/refractory adult T-cell leukemia-lymphoma thus far conducted. The patients were randomized in 2:1 fashion 47:24 patients) to mogamulizumab, 1.0 mg/kg, given weekly for the first 4-week cycle and then biweekly, or to one of three investigator choice regimens [gemcitabine and oxaliplatin, DHAP (dexamethasone, high-dose cytarabine, and cisplatin), or pralatrexate]. Patients who were in the investigator-choice arm and whose disease progressed were permitted to cross over to mogamulizumab.

The primary endpoint was objective response rate based on modified Tsukasaki criteria and assessed by the treating investigator and in blinded fashion by independent review.

The objective response rate in the mogamulizumab-treated group was 23.4% (11 of 47) by independent review and 34% (16 of 47) by the treating investigator. In the investigator choice group, the overall response rate was 2 of 24 by independent review and 0 of 24 by the treating investigator.

The confirmed objective response rate after 1 month in the mogamulizumab-treated group was 10.6% by independent review and 14.9% by the treating investigator; there were no confirmed responses in the investigator-choice arm. Of 18 patients who crossed over to mogamulizumab, 3 responded. The median duration of response for mogamulizumab was 5 months; one patient had a complete response that lasted over 9 months and the survival data are not yet mature.

Mogamulizumab had few drug-related adverse events, primarily infusion reactions (46.8%), rash/drug eruption (25.5%) and infections (14.9%).

Dr. Phillips disclosed ties to Celgene, Genentech, and Takeda, as well as research funding from Kyowa Hakko Kirin, the sponsor of the study.

Abstract 7501

[email protected]

On Twitter @maryjodales

CHICAGO – The anti-CCR4 monoclonal antibody mogamulizumab was superior to other investigator-selected therapies for the treatment of patients with relapsed/refractory adult T-cell leukemia-lymphoma (ATL), based on results from 71 patients in a prospective, multicenter, randomized study reported at the annual meeting of the American Society of Clinical Oncology.

Commonly used cytotoxic regimens provided limited therapeutic benefit for these patients, but mogamulizumab resulted in an objective response rate that supports its therapeutic potential in this setting, reported Dr. Adrienne Alise Phillips of New York Presbyterian/Weill Cornell Medical College, New York.

Mary Jo Dales/Frontline Medical News

A malignancy of T-cells infected with HTLV-1, ATL has a poor prognosis with a median overall survival of less than 3 months in patients with relapsed/refractory disease. CCR4 is expressed in over 90% of ATL patients, and mogamulizumab is approved in Japan for ATL as well as for peripheral T-cell lymphoma and cutaneous T-cell lymphoma.

The 71 patients in the study were from the United States, the European Union and Latin America. The study is the largest randomized clinical trial of relapsed/refractory adult T-cell leukemia-lymphoma thus far conducted. The patients were randomized in 2:1 fashion 47:24 patients) to mogamulizumab, 1.0 mg/kg, given weekly for the first 4-week cycle and then biweekly, or to one of three investigator choice regimens [gemcitabine and oxaliplatin, DHAP (dexamethasone, high-dose cytarabine, and cisplatin), or pralatrexate]. Patients who were in the investigator-choice arm and whose disease progressed were permitted to cross over to mogamulizumab.

The primary endpoint was objective response rate based on modified Tsukasaki criteria and assessed by the treating investigator and in blinded fashion by independent review.

The objective response rate in the mogamulizumab-treated group was 23.4% (11 of 47) by independent review and 34% (16 of 47) by the treating investigator. In the investigator choice group, the overall response rate was 2 of 24 by independent review and 0 of 24 by the treating investigator.

The confirmed objective response rate after 1 month in the mogamulizumab-treated group was 10.6% by independent review and 14.9% by the treating investigator; there were no confirmed responses in the investigator-choice arm. Of 18 patients who crossed over to mogamulizumab, 3 responded. The median duration of response for mogamulizumab was 5 months; one patient had a complete response that lasted over 9 months and the survival data are not yet mature.

Mogamulizumab had few drug-related adverse events, primarily infusion reactions (46.8%), rash/drug eruption (25.5%) and infections (14.9%).

Dr. Phillips disclosed ties to Celgene, Genentech, and Takeda, as well as research funding from Kyowa Hakko Kirin, the sponsor of the study.

Abstract 7501

[email protected]

On Twitter @maryjodales