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Study: Few HCV-infected heroin users linked to outpatient care
The results of a hepatitis C virus screening program in a suburban New Jersey acute opioid detoxification program reveal that, despite the ease of access to HCV screening and the availability of curative therapies, linkage to care after detection of infection in persons who inject drugs continues to present a challenge.
Eda Akyar, a clinical research coordinator at ID Care, New Jersey’s largest network of infectious disease specialists, and her colleagues examined the results of an HIV, HCV, and HBV infection screening program instituted between Oct. 1, 2014, and June 9, 2015, for patients admitted to an acute opioid detoxification program at Princeton House in suburban New Jersey. Study goals included assessing the prevalence of HIV, HCV, and HBV infections for these patients, the HCV genotype (GT) carried, and the subsequent linkage to care after discharge from the program. The report was published online April 13 in Emerging Infectious Diseases.
During the screening period, patients representing 10 of New Jersey’s 21 counties were tested for the presence of HCV antibodies. Approximately two-thirds of all study participants (66.6%) were between 17 and 35 years of age. In this important age demographic, 237 patients (41.4%) screened positive for HCV antibodies, and 187 were available for further study.
HCV viral load data were available from 172 patients (92.0%), with approximately one-fifth (18.6%) screening undetectable. The HCV GTs obtained from 102 patients revealed that most (62.7%) were GT1a, followed by GT3 (25.5%). In a very surprising result, all HCV antibody positive patients were also HIV antibody negative, the researchers noted.
Regarding linkage to care, 16 of the patients (8.6%) in the 17- to 35-year-old age group attended outpatient follow-up appointments, with three (1.6%) starting on an oral, direct-acting antiviral treatment regimen. Two of these three patients were nonadherent to their treatment regimens. Two additional patients expressed willingness to accept treatment, but were denied their prescriptions by their insurance providers. None of the other participants returned for continued care.
The authors said that their results indicated a high prevalence of HCV among young suburban heroin users attending an acute detoxification program serving a wide geographic area, suggesting that New Jersey is part of the second wave of HCV infection following that seen in those born from 1946 to 1964. They also highlighted their findings of a GT3 prevalence more than twice the national average, a complete lack of HIV infection in a population known to be susceptible to it, and disappointing linkage to care outcomes.
The authors said that easy-to-use curative therapy should underscore a need for improved linkage to care and treatment of HCV-infected persons who inject drugs as part of an important public health effort to prevent its continued spread.
This work was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. Conflict of interest information was not disclosed.
The results of a hepatitis C virus screening program in a suburban New Jersey acute opioid detoxification program reveal that, despite the ease of access to HCV screening and the availability of curative therapies, linkage to care after detection of infection in persons who inject drugs continues to present a challenge.
Eda Akyar, a clinical research coordinator at ID Care, New Jersey’s largest network of infectious disease specialists, and her colleagues examined the results of an HIV, HCV, and HBV infection screening program instituted between Oct. 1, 2014, and June 9, 2015, for patients admitted to an acute opioid detoxification program at Princeton House in suburban New Jersey. Study goals included assessing the prevalence of HIV, HCV, and HBV infections for these patients, the HCV genotype (GT) carried, and the subsequent linkage to care after discharge from the program. The report was published online April 13 in Emerging Infectious Diseases.
During the screening period, patients representing 10 of New Jersey’s 21 counties were tested for the presence of HCV antibodies. Approximately two-thirds of all study participants (66.6%) were between 17 and 35 years of age. In this important age demographic, 237 patients (41.4%) screened positive for HCV antibodies, and 187 were available for further study.
HCV viral load data were available from 172 patients (92.0%), with approximately one-fifth (18.6%) screening undetectable. The HCV GTs obtained from 102 patients revealed that most (62.7%) were GT1a, followed by GT3 (25.5%). In a very surprising result, all HCV antibody positive patients were also HIV antibody negative, the researchers noted.
Regarding linkage to care, 16 of the patients (8.6%) in the 17- to 35-year-old age group attended outpatient follow-up appointments, with three (1.6%) starting on an oral, direct-acting antiviral treatment regimen. Two of these three patients were nonadherent to their treatment regimens. Two additional patients expressed willingness to accept treatment, but were denied their prescriptions by their insurance providers. None of the other participants returned for continued care.
The authors said that their results indicated a high prevalence of HCV among young suburban heroin users attending an acute detoxification program serving a wide geographic area, suggesting that New Jersey is part of the second wave of HCV infection following that seen in those born from 1946 to 1964. They also highlighted their findings of a GT3 prevalence more than twice the national average, a complete lack of HIV infection in a population known to be susceptible to it, and disappointing linkage to care outcomes.
The authors said that easy-to-use curative therapy should underscore a need for improved linkage to care and treatment of HCV-infected persons who inject drugs as part of an important public health effort to prevent its continued spread.
This work was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. Conflict of interest information was not disclosed.
The results of a hepatitis C virus screening program in a suburban New Jersey acute opioid detoxification program reveal that, despite the ease of access to HCV screening and the availability of curative therapies, linkage to care after detection of infection in persons who inject drugs continues to present a challenge.
Eda Akyar, a clinical research coordinator at ID Care, New Jersey’s largest network of infectious disease specialists, and her colleagues examined the results of an HIV, HCV, and HBV infection screening program instituted between Oct. 1, 2014, and June 9, 2015, for patients admitted to an acute opioid detoxification program at Princeton House in suburban New Jersey. Study goals included assessing the prevalence of HIV, HCV, and HBV infections for these patients, the HCV genotype (GT) carried, and the subsequent linkage to care after discharge from the program. The report was published online April 13 in Emerging Infectious Diseases.
During the screening period, patients representing 10 of New Jersey’s 21 counties were tested for the presence of HCV antibodies. Approximately two-thirds of all study participants (66.6%) were between 17 and 35 years of age. In this important age demographic, 237 patients (41.4%) screened positive for HCV antibodies, and 187 were available for further study.
HCV viral load data were available from 172 patients (92.0%), with approximately one-fifth (18.6%) screening undetectable. The HCV GTs obtained from 102 patients revealed that most (62.7%) were GT1a, followed by GT3 (25.5%). In a very surprising result, all HCV antibody positive patients were also HIV antibody negative, the researchers noted.
Regarding linkage to care, 16 of the patients (8.6%) in the 17- to 35-year-old age group attended outpatient follow-up appointments, with three (1.6%) starting on an oral, direct-acting antiviral treatment regimen. Two of these three patients were nonadherent to their treatment regimens. Two additional patients expressed willingness to accept treatment, but were denied their prescriptions by their insurance providers. None of the other participants returned for continued care.
The authors said that their results indicated a high prevalence of HCV among young suburban heroin users attending an acute detoxification program serving a wide geographic area, suggesting that New Jersey is part of the second wave of HCV infection following that seen in those born from 1946 to 1964. They also highlighted their findings of a GT3 prevalence more than twice the national average, a complete lack of HIV infection in a population known to be susceptible to it, and disappointing linkage to care outcomes.
The authors said that easy-to-use curative therapy should underscore a need for improved linkage to care and treatment of HCV-infected persons who inject drugs as part of an important public health effort to prevent its continued spread.
This work was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. Conflict of interest information was not disclosed.
FROM EMERGING INFECTIOUS DISEASES
Key clinical point: Despite the ease of access to hepatitis C virus screening and the availability of curative therapies, linkage to care after detection of infection in persons who inject drugs continues to present a challenge, with larger implications for public health efforts to prevent its spread.
Major finding: Hepatitis C virus genotype 3 infection was highly prevalent in individuals who inject drugs who were participating in an acute heroin detoxification program serving a wide geographic area in suburban New Jersey.
Data sources: Patients admitted to Princeton House, a psychiatric facility in suburban New Jersey with an active opioid detoxification program, screened for hepatitis C virus between Oct. 1, 2014, and June 9, 2015.
Disclosures: This work was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp. Conflict of interest information was not disclosed.
VIDEO: Serial lung fluid measurement improved heart failure outcomes
CHICAGO – Regular assessment of a heart failure patient’s lung fluid volume using a device that measures electrical conduction through the chest – lung impedance – helped guide clinicians to make timely adjustments in a patient’s medications and thereby significantly reduce mortality and hospitalizations during an average 4 years of follow-up in a randomized, controlled study with 256 patients.
Monthly measurement of lung impedance and medication adjustments based on the information led to a 58% reduction in hospitalizations for acute heart failure during the first year of the study, compared with control patients, and a 56% reduction in heart failure hospitalizations, compared with controls, during the entire course of the study, the study’s two primary endpoints, Dr. Michael K. Shochat reported at the annual meeting of the American College of Cardiology.
The results also showed that performing regular lung impedance measurements and using the results to guide treatment led to a 43% reduction in all-cause mortality and a 62% drop in heart failure mortality during the average 4-year course of the study, said Dr. Shochat, a cardiologist at the Heart Institute of Hillel Yaffe Medical Center in Hadera, Israel. Concurrent with Dr. Shochat’s report at the meeting the results also appeared in an article published online (J Card Failure. 2016;doi:10.1016/j.cardfail.2016.03.015).
A key aspect of the study was that the clinicians who treated the enrolled patients who underwent lung impedance monitoring used this information to adjust medications the patients received. Overall, patients who underwent monitoring had more than twice the number of medication dose adjustments, compared with the control patients. These adjustments particularly focused on diuretic dosages, which changed three times as often in the monitored patients, compared with controls, Dr. Shochat reported. Changes in the dosages of beta-blockers and ACE inhibitors also showed marked increases in the monitored patients, compared with the controls.
The Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients (IMPEDANCE-HF) trial enrolled 256 patients at two centers in Israel during 2005-2014. Patients had New York Heart Association class II-IV heart failure and a left ventricular ejection fraction of 35% or less. The enrolled patients averaged 67 years of age, and 80% were men.
Clinicians measured lung impedance using a proprietary device that places external electrodes on opposite sides of the patient’s chest. Calculation of impedance used a formula that eliminated the noise from chest wall impedance and focused exclusively on lung impedance. Once the electrodes are placed collection of the impedance data takes about 1 minute, Dr. Shochat said. The study protocol called for impedance data to be collected monthly, and in practice it occurred about 11 times a year during the study.
The investigators calculated for each patient in the active arm of the study a “basal” lung impedance level that reflected their level of lung conductivity when their lungs were clear of excess fluid. Participating clinicians were instructed to intervene by altering medications when the impedance level dropped more than 18% below the basal level. Their goal was to prevent impedance from dropping to more than 24% below the basal level, which correlated with when heart failure patients usually required hospitalization for acute decompensation. The specifics of how to adjust medications to manage patients who showed these signs of fluid overload were left to the discretion of each attending physician.
MPEDANCE-HF was sponsored by the RSMM Company, which is developing the lung impedance measurement device used in the study. Dr. Shochat is a cofounder of RSMM and is a member of the company’s board of directors.
On Twitter @mitchelzoler
The very exciting results reported by Dr. Shochat came from a small, positive trial that showed impedance monitoring was an effective way to detect an increased amount of fluid in a heart failure patient’s lungs. This resulted in improved outcomes, compared with patients managed using usual care, including fewer hospitalizations and reduced mortality.
These results suggest that when physicians had lung impedance information, they identified episodes of acute heart failure decompensation sooner and that they used this alert to change treatment and prevent patient worsening. Heart failure exacerbations and decompensation events are a recurring problem for heart failure patients, and the earlier they are identified and addressed with altered treatment, the better it is for the patient’s well being. The next step is to see if these positive results can be confirmed by other research groups and in larger numbers of patients.
These results contrast with the findings from a German study reported in 2015 that used lung impedance information collected by implantable cardioverter defibrillators in heart failure patients to identify episodes of fluid buildup and decompensation. That study failed to show a statistically significant impact on patient outcomes. The researchers speculated that this may have been because patients often did not go online to allow their information to get transmitted to their physician, and physicians often did not act on the information because the patients reported no coincident change in symptoms.
This problem with the German study highlights that collecting lung impedance information will only improve outcomes if physicians then act on the information and modify a patient’s treatment. In the new study reported by Dr. Shochat, patients consistently underwent evaluation for their lung impedance status every month, and when the results suggested a growing problem of fluid overload the physicians consistently acted on the information by adjusting medication dosages.
Use of lung impedance measurement is similar to another approach for monitoring patients with heart failure that recently entered routine U.S. practice, an implanted device to monitor pulmonary artery pressure and identify episodes of fluid overload and acute decompensation. In the future, it will be interesting to compare the efficacy and ease of use of managing heart failure patients with pulmonary artery pressure monitoring with an implanted device and monitoring fluid build up in the lungs with lung impedance.
Dr. John A. Jarcho is a cardiologist at Brigham and Women’s Hospital, Boston. He had no disclosures. He made these comments as a discussant of Dr. Shochat’s report and in an interview.
The very exciting results reported by Dr. Shochat came from a small, positive trial that showed impedance monitoring was an effective way to detect an increased amount of fluid in a heart failure patient’s lungs. This resulted in improved outcomes, compared with patients managed using usual care, including fewer hospitalizations and reduced mortality.
These results suggest that when physicians had lung impedance information, they identified episodes of acute heart failure decompensation sooner and that they used this alert to change treatment and prevent patient worsening. Heart failure exacerbations and decompensation events are a recurring problem for heart failure patients, and the earlier they are identified and addressed with altered treatment, the better it is for the patient’s well being. The next step is to see if these positive results can be confirmed by other research groups and in larger numbers of patients.
These results contrast with the findings from a German study reported in 2015 that used lung impedance information collected by implantable cardioverter defibrillators in heart failure patients to identify episodes of fluid buildup and decompensation. That study failed to show a statistically significant impact on patient outcomes. The researchers speculated that this may have been because patients often did not go online to allow their information to get transmitted to their physician, and physicians often did not act on the information because the patients reported no coincident change in symptoms.
This problem with the German study highlights that collecting lung impedance information will only improve outcomes if physicians then act on the information and modify a patient’s treatment. In the new study reported by Dr. Shochat, patients consistently underwent evaluation for their lung impedance status every month, and when the results suggested a growing problem of fluid overload the physicians consistently acted on the information by adjusting medication dosages.
Use of lung impedance measurement is similar to another approach for monitoring patients with heart failure that recently entered routine U.S. practice, an implanted device to monitor pulmonary artery pressure and identify episodes of fluid overload and acute decompensation. In the future, it will be interesting to compare the efficacy and ease of use of managing heart failure patients with pulmonary artery pressure monitoring with an implanted device and monitoring fluid build up in the lungs with lung impedance.
Dr. John A. Jarcho is a cardiologist at Brigham and Women’s Hospital, Boston. He had no disclosures. He made these comments as a discussant of Dr. Shochat’s report and in an interview.
The very exciting results reported by Dr. Shochat came from a small, positive trial that showed impedance monitoring was an effective way to detect an increased amount of fluid in a heart failure patient’s lungs. This resulted in improved outcomes, compared with patients managed using usual care, including fewer hospitalizations and reduced mortality.
These results suggest that when physicians had lung impedance information, they identified episodes of acute heart failure decompensation sooner and that they used this alert to change treatment and prevent patient worsening. Heart failure exacerbations and decompensation events are a recurring problem for heart failure patients, and the earlier they are identified and addressed with altered treatment, the better it is for the patient’s well being. The next step is to see if these positive results can be confirmed by other research groups and in larger numbers of patients.
These results contrast with the findings from a German study reported in 2015 that used lung impedance information collected by implantable cardioverter defibrillators in heart failure patients to identify episodes of fluid buildup and decompensation. That study failed to show a statistically significant impact on patient outcomes. The researchers speculated that this may have been because patients often did not go online to allow their information to get transmitted to their physician, and physicians often did not act on the information because the patients reported no coincident change in symptoms.
This problem with the German study highlights that collecting lung impedance information will only improve outcomes if physicians then act on the information and modify a patient’s treatment. In the new study reported by Dr. Shochat, patients consistently underwent evaluation for their lung impedance status every month, and when the results suggested a growing problem of fluid overload the physicians consistently acted on the information by adjusting medication dosages.
Use of lung impedance measurement is similar to another approach for monitoring patients with heart failure that recently entered routine U.S. practice, an implanted device to monitor pulmonary artery pressure and identify episodes of fluid overload and acute decompensation. In the future, it will be interesting to compare the efficacy and ease of use of managing heart failure patients with pulmonary artery pressure monitoring with an implanted device and monitoring fluid build up in the lungs with lung impedance.
Dr. John A. Jarcho is a cardiologist at Brigham and Women’s Hospital, Boston. He had no disclosures. He made these comments as a discussant of Dr. Shochat’s report and in an interview.
CHICAGO – Regular assessment of a heart failure patient’s lung fluid volume using a device that measures electrical conduction through the chest – lung impedance – helped guide clinicians to make timely adjustments in a patient’s medications and thereby significantly reduce mortality and hospitalizations during an average 4 years of follow-up in a randomized, controlled study with 256 patients.
Monthly measurement of lung impedance and medication adjustments based on the information led to a 58% reduction in hospitalizations for acute heart failure during the first year of the study, compared with control patients, and a 56% reduction in heart failure hospitalizations, compared with controls, during the entire course of the study, the study’s two primary endpoints, Dr. Michael K. Shochat reported at the annual meeting of the American College of Cardiology.
The results also showed that performing regular lung impedance measurements and using the results to guide treatment led to a 43% reduction in all-cause mortality and a 62% drop in heart failure mortality during the average 4-year course of the study, said Dr. Shochat, a cardiologist at the Heart Institute of Hillel Yaffe Medical Center in Hadera, Israel. Concurrent with Dr. Shochat’s report at the meeting the results also appeared in an article published online (J Card Failure. 2016;doi:10.1016/j.cardfail.2016.03.015).
A key aspect of the study was that the clinicians who treated the enrolled patients who underwent lung impedance monitoring used this information to adjust medications the patients received. Overall, patients who underwent monitoring had more than twice the number of medication dose adjustments, compared with the control patients. These adjustments particularly focused on diuretic dosages, which changed three times as often in the monitored patients, compared with controls, Dr. Shochat reported. Changes in the dosages of beta-blockers and ACE inhibitors also showed marked increases in the monitored patients, compared with the controls.
The Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients (IMPEDANCE-HF) trial enrolled 256 patients at two centers in Israel during 2005-2014. Patients had New York Heart Association class II-IV heart failure and a left ventricular ejection fraction of 35% or less. The enrolled patients averaged 67 years of age, and 80% were men.
Clinicians measured lung impedance using a proprietary device that places external electrodes on opposite sides of the patient’s chest. Calculation of impedance used a formula that eliminated the noise from chest wall impedance and focused exclusively on lung impedance. Once the electrodes are placed collection of the impedance data takes about 1 minute, Dr. Shochat said. The study protocol called for impedance data to be collected monthly, and in practice it occurred about 11 times a year during the study.
The investigators calculated for each patient in the active arm of the study a “basal” lung impedance level that reflected their level of lung conductivity when their lungs were clear of excess fluid. Participating clinicians were instructed to intervene by altering medications when the impedance level dropped more than 18% below the basal level. Their goal was to prevent impedance from dropping to more than 24% below the basal level, which correlated with when heart failure patients usually required hospitalization for acute decompensation. The specifics of how to adjust medications to manage patients who showed these signs of fluid overload were left to the discretion of each attending physician.
MPEDANCE-HF was sponsored by the RSMM Company, which is developing the lung impedance measurement device used in the study. Dr. Shochat is a cofounder of RSMM and is a member of the company’s board of directors.
On Twitter @mitchelzoler
CHICAGO – Regular assessment of a heart failure patient’s lung fluid volume using a device that measures electrical conduction through the chest – lung impedance – helped guide clinicians to make timely adjustments in a patient’s medications and thereby significantly reduce mortality and hospitalizations during an average 4 years of follow-up in a randomized, controlled study with 256 patients.
Monthly measurement of lung impedance and medication adjustments based on the information led to a 58% reduction in hospitalizations for acute heart failure during the first year of the study, compared with control patients, and a 56% reduction in heart failure hospitalizations, compared with controls, during the entire course of the study, the study’s two primary endpoints, Dr. Michael K. Shochat reported at the annual meeting of the American College of Cardiology.
The results also showed that performing regular lung impedance measurements and using the results to guide treatment led to a 43% reduction in all-cause mortality and a 62% drop in heart failure mortality during the average 4-year course of the study, said Dr. Shochat, a cardiologist at the Heart Institute of Hillel Yaffe Medical Center in Hadera, Israel. Concurrent with Dr. Shochat’s report at the meeting the results also appeared in an article published online (J Card Failure. 2016;doi:10.1016/j.cardfail.2016.03.015).
A key aspect of the study was that the clinicians who treated the enrolled patients who underwent lung impedance monitoring used this information to adjust medications the patients received. Overall, patients who underwent monitoring had more than twice the number of medication dose adjustments, compared with the control patients. These adjustments particularly focused on diuretic dosages, which changed three times as often in the monitored patients, compared with controls, Dr. Shochat reported. Changes in the dosages of beta-blockers and ACE inhibitors also showed marked increases in the monitored patients, compared with the controls.
The Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients (IMPEDANCE-HF) trial enrolled 256 patients at two centers in Israel during 2005-2014. Patients had New York Heart Association class II-IV heart failure and a left ventricular ejection fraction of 35% or less. The enrolled patients averaged 67 years of age, and 80% were men.
Clinicians measured lung impedance using a proprietary device that places external electrodes on opposite sides of the patient’s chest. Calculation of impedance used a formula that eliminated the noise from chest wall impedance and focused exclusively on lung impedance. Once the electrodes are placed collection of the impedance data takes about 1 minute, Dr. Shochat said. The study protocol called for impedance data to be collected monthly, and in practice it occurred about 11 times a year during the study.
The investigators calculated for each patient in the active arm of the study a “basal” lung impedance level that reflected their level of lung conductivity when their lungs were clear of excess fluid. Participating clinicians were instructed to intervene by altering medications when the impedance level dropped more than 18% below the basal level. Their goal was to prevent impedance from dropping to more than 24% below the basal level, which correlated with when heart failure patients usually required hospitalization for acute decompensation. The specifics of how to adjust medications to manage patients who showed these signs of fluid overload were left to the discretion of each attending physician.
MPEDANCE-HF was sponsored by the RSMM Company, which is developing the lung impedance measurement device used in the study. Dr. Shochat is a cofounder of RSMM and is a member of the company’s board of directors.
On Twitter @mitchelzoler
AT ACC 2016
Key clinical point: Monthly, noninvasive measurement of lung fluid levels using lung impedance produced better fluid control in heart failure patients and significantly fewer deaths and heart failure hospitalizations.
Major finding: Lung impedance–based management produced a 56% cut in heart failure hospitalizations, compared with standard care.
Data source: IMPEDANCE-HF, a randomized study with 256 heart failure patients at two Israeli centers.
Disclosures: IMPEDANCE-HF was sponsored by the RSMM Company, which is developing the lung impedance measurement device used in the study. Dr. Shochat is a cofounder of RSMM and is a member of the company’s board of directors.
It’s imperative to protect adolescents with HPV vaccine
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
It’s imperative to protect adolescents with HPV vaccine
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
Low vaccination rates in the United States are in large part due to parental and religious objections to this vaccination that can be overcome by better education and support by pediatricians. It’s been demonstrated that physicians encourage the HPV vaccine less strongly than the other adolescent vaccinations such as Tdap and the meningococcal conjugate vaccine1. In addition, there is a lack of legislation promoting this vaccine. There are only two states and Washington, D.C., that currently have opt-out state mandates for HPV immunization, compared with 46 states plus Washington, D.C., with similar policies for Tdap2. The HPV vaccine is safe, efficacious, and has been demonstrated to reduce mortality and morbidity in our population. It is imperative that we, as pediatricians, strongly encourage and provide these vaccinations to our adolescent patients to help protect our community.
The human papillomavirus (HPV) vaccine was approved for girls in 2008 and for boys in 20113. However, the adoption rate for HPV immunization in the United States has been dismal. Data from 2014 show only 60% of adolescent girls have received at least one HPV vaccine dose, and only 40% have received three doses4. The rates for boys are far worse, with 42% of adolescent boys receiving at least one dose, and only 22% receiving three doses4.
HPV is currently the most common sexually transmitted infection in the United States, with an estimated 14 million new infections per year3. Of these, approximately 11,000 will progress to cervical cancers and 9,000 to male anogenital cancers each year. Annually there are about 4,000 cervical cancer deaths in the United States3.
Three vaccines are approved by the Food and Drug Administration to prevent HPV infection: Gardasil, Gardasil 9, and Cervarix. All three vaccines prevent infections with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers (as well as oropharyngeal and other anogenital cancers). Gardasil also prevents infection with HPV types 6 and 11, associated with approximately 90% of anogenital warts. Gardasil 9 prevents infection with the same four HPV types plus five other high-risk HPV types (31, 33, 45, 52, and 58); it is called a nonavalent, or 9-valent, vaccine.
The HPV vaccines have the ability to reduce mortality and morbidity in our patients. A study published in the New England Journal of Medicine in 2011 demonstrated that vaccination with the full HPV series in males 16-26 years prior to HPV exposure led to a 90% efficacy in preventing HPV-related disease5, compared with a 60% efficacy if given after HPV exposure or if the individual received an incomplete dose series.
A recent Pediatrics study reported data since initiation of the vaccination program in American adolescent and young adult women6. The data showed a reduction in HPV-related disease of 64% in the 14- to 19-year age group and a reduction of 34% in the older age group (aged 20-24 years). This is impressive given our currently low vaccination rates.
A Lancet meta-analysis shows evidence of herd immunity and cross-protective effects when vaccination rates are greater than 50% in the population7. This allows groups that aren’t currently approved for vaccination to have a reduction in disease and allows for some protection against HPV types that aren’t currently covered by the vaccines.
So we pediatricians have a job to do in protecting our patients by encouraging HPV immunization.
References
1. Pediatrics. 2016 Feb;137(2):1-9.
3. www.cdc.gov/hpv/hcp/clinician-factsheet.html
5. N Engl J Med. 2011;364(5):401-11.
6. Pediatrics. 2016;137(3):1-9.
7. Lancet Infect Dis. 2015;15(5):565-80.
Dr. Denby is a second-year internal medicine/pediatrics resident at Vanderbilt University Medical Center in Nashville, Tenn.
ED bedside flu test accurate across flu seasons
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
FROM DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Key clinical point: A rapid bedside diagnostic test for influenza was accurate across four consecutive flu seasons in a pediatric ED.
Major finding: The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19.
Data source: A prospective analysis of the sensitivity and specificity of one rapid bedside diagnostic test in 764 children seen over a 4-year period.
Disclosures: Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
ED bedside flu test accurate across flu seasons
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.
During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.
To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.
The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H1N1 flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).
These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.
Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
FROM DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Key clinical point: A rapid bedside diagnostic test for influenza was accurate across four consecutive flu seasons in a pediatric ED.
Major finding: The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19.
Data source: A prospective analysis of the sensitivity and specificity of one rapid bedside diagnostic test in 764 children seen over a 4-year period.
Disclosures: Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.
Laparoscopic cystectomy for large, bilateral ovarian dermoids
For more videos from the Society of Gynecologic Surgeons, click here
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For more videos from the Society of Gynecologic Surgeons, click here
Visit the Society of Gynecologic Surgeons online: sgsonline.org
For more videos from the Society of Gynecologic Surgeons, click here
Visit the Society of Gynecologic Surgeons online: sgsonline.org
Prostate cancer’s future seen in molecular tests
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
EXPERT ANALYSIS FROM THE NCCN ANNUAL CONFERENCE
Prostate cancer’s future seen in molecular tests
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
HOLLYWOOD, FLA. – Current evidence suggests that molecular tests for prostate cancer are prognostic and can help clinicians and patients with difficult treatment decisions. In the not-too-distant future, gene tests could also guide choice of therapies.
“I think that the largest impact is going to come in areas of both the greatest treatment uncertainty and areas where we can be predictive about the response to treatment,” said Dr. Ashley Ross, a urologic oncologist and pathologist at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore.
Multigene panels may soon be able help identify which patients might benefit more from radical prostatectomy or radiation therapy, whether radiation therapy effects could be enhanced with the addition of androgen-deprivation therapy, and whether early use of docetaxel might add therapeutic benefit, he said at the annual conference of the National Comprehensive Cancer Network.
The 2016 iteration of the NCCN guidelines for the treatment of prostate cancer include a note stating that “men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.”
The use of molecular assays may inform treatment decisions by helping to predict the likelihood of death if a patient is managed conservatively, risks for biochemical progression after radical prostatectomy or external beam therapy, and the likelihood that a patient could develop metastatic disease after radical prostatectomy or salvage radiotherapy, the guidelines say.
Dr. Ross reviewed the molecular biology of localized prostate cancer and the benefits and risks of currently available molecular tests.
“We’ve had an increased ability to get molecular information or genomic information from very limited amounts of routinely-stored pathologic tissue, and that’s resulted in the generation of many molecular-based tissue tests in prostate cancer. With the emergence of those tests and a lot of aggressive marketing, there has been a lot of confusion for patients and providers about whether we should use them or not and in what context,” he said.
Prostate cancer is genomically complex, even in the localized stage, with copy number alterations, deletions, and amplifications; chromosomal rearrangements; and point mutations, he said.
One of the best characterized genomic events is the early loss of the tumor suppressor gene PTEN (phosphatase and tensin homolog). This gene works within the PI3 kinase (PI3K)/AKT pathway. PI3K pathway mutations have been identified in up to 40% of all primary prostate cancers and 100% of mutations, Dr. Ross explained.
Loss of PTEN itself has been detected in about 15%-40% of primary prostate cancers and 50% of metastases, and the loss correlates with disease stage and tumor grade.
The NCCN guidelines list six available tissue-based tests for prostate cancer prognosis, including tests based on general cancer features such as cell-cycle proliferation, and those based on specific molecular features of cancer.
An example of the general type of test is the Ki-67 immunohistochemistry (IHC) test, which looks for a cellular marker of proliferation, and has been shown to have independent prognostic significance after radiation therapy or radical prostatectomy. This test is not currently recommended by the Medicare Molecular Diagnostic Services (MolDx) program, however.
Another general-type test is the Polaris quantitative reverse-transcriptase polymerase chain reaction (RT-PCR) panel, which tests for 31 cell-cycle-related genes and 15 “housekeeping” controls. This test is recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy. It has been shown to independently predict prostate cancer–specific mortality, biochemical failure/recurrence, and metastasis, the guidelines say.
Tests based on molecular features include:
• PTEN/ERG, an IHC or fluorescent in situ hybridization test that has been shown to predict prostate cancer–specific mortality, upgrading to Gleason pattern 4 on radical prostatectomy, and biochemical recurrence (not MolDx recommended).
• Decipher, a whole-transcriptome 1.4M RNA expression oligonucleotide microarray shown to predict biochemical failure, metastasis, and prostate cancer–specific mortality (recommended for postradical prostatectomy for patients with pT2 tumors with positive margins, and pT3 disease, and rising PSA above nadir);
• Oncotype DX, an RT-PCR assay for 12 prostate cancer genes and five housekeeping controls (recommended for post-biopsy evaluation of men with very-low-risk or low-risk prostate cancer who at the time of diagnosis have at least 10 years of life expectancy).
• ProMark, multiplex immunofluorescent staining of eight proteins, which has been shown to independently predict non–organ-confined pT3 disease or Gleason pattern 4 disease on radical prostatectomy (not reviewed).
Dr. Ross said that in his practice, he generally does not order molecular testing for surveillance of men older than 65 who have very-low-risk disease. For men with low-risk disease, however, molecular testing may help in clinical decision making to predict upgrading or disease progression.
“There’s limited data from surveillance populations, but these tests can be used in this context with retrospective data available, realizing that in most cases the tests will be confirmative, or another way of thinking about it is ‘noninformative,’ so there are some considerations about cost in that context,” he said. For men with intermediate or high-risk disease, however, currently available tests are not good at predicting what an individual patient’s response would be to a specific type of therapy, whether surgery, radiation, androgen deprivation, chemotherapy, or a combination.
“This is an area where predictive biomarkers would be very informative. There is ongoing research, and I think this is an area of potentially large advancement in how we risk-stratify our patients,” Dr. Ross said.
EXPERT ANALYSIS FROM THE NCCN ANNUAL CONFERENCE
In newly diagnosed CLL, mutation tests are advised
Patients with newly diagnosed chronic lymphocytic leukemia should standardly undergo immunoglobulin heavy-chain variable region gene (IGHV) mutation status and interphase fluorescence in situ hybridization (FISH) tests, based on the results of a meta-analysis published in Blood.
“This change will help define the minimal standard initial prognostic evaluation for patients with CLL and help facilitate use of the powerful, recently developed, integrated prognostic indices, all of which are dependent on these 2 variables,” wrote Dr. Sameer A. Parikh of Mayo Clinic, Rochester, Minn., and associates.
IGHV and FISH have prognostic value independent of clinical stage in patients with newly diagnosed and previously untreated CLL, they said (Blood. 2016;127[14]:1752-60). Better understanding of the patient’s risk of disease progression at diagnosis can guide counseling and follow-up intervals, and could potentially influence the decision to treat high-risk patients on early intervention protocols.
IGHV and FISH also appear to provide additional information on progression-free and overall survival.
The researchers cautioned, however, that the results of these tests should not be used to initiate CLL-specific therapy. Only patients who meet indications for therapy based on the 2008 International Workshop on Chronic Lymphocytic Leukemia guidelines should receive treatment.
Further, they noted, the median age of patients included in studies that they analyzed was 64 years; the median age of patients with CLL is 72 years. The prognostic abilities of IGHV mutation and FISH may differ in these older individuals with CLL.
The researchers analyzed 31 studies that met the criteria for inclusion – full-length publications that included at least 200 patients and reported on the prognostic value of IGHV and/or FISH for predicting progression-free or overall survival in patients with newly diagnosed CLL.
They found that the median progression-free survival (range, about 1-5 years) was significantly shorter for patients with unmutated IGHV genes, than was the median progression-free survival (range, about 9-19 years) for those with mutated IGHV genes. Similarly, the median overall survival was significantly shorter for patients with unmutated IGHV (range, about 3-10 years) than for those with mutated IGHV (range, about 18-26 years).
For patients with high-risk FISH (including del17p13 and del11q23), the median progression-free survival was significantly shorter (range, about 0.1-5 years) than for those with low/intermediate-risk FISH (including del13q, normal, and trisomy 12; range, about 1.5-22 years). Median overall survival also significantly differed, ranging from about 3-10 years for patients with high-risk FISH and from about 7.5-20.5 years for those with low/intermediate-risk FISH.
In multivariable analyses, the hazard ratio for high-risk FISH ranged from 1.3 to 4.7 for progression-free survival and from 0.9 to 8.2 for overall survival. In studies reporting the results of multivariable analysis, high-risk FISH remained an independent predictor of progression-free survival in 8 of 17 studies and of overall survival in 10 of 14 studies, including in 10 of 13 studies adjusting for the prognostic impact of IGHV.
In multivariable analyses, IGHV remained an independent predictor of progression-free survival in 15 of 18 studies, including 12 of 15 studies adjusting for the prognostic impact of FISH. IGHV remained an independent predictor of overall survival in 11 of 15 studies reporting the results of multivariable analysis, including 10 of 14 studies adjusting for the prognostic impact of FISH.
Patients with newly diagnosed chronic lymphocytic leukemia should standardly undergo immunoglobulin heavy-chain variable region gene (IGHV) mutation status and interphase fluorescence in situ hybridization (FISH) tests, based on the results of a meta-analysis published in Blood.
“This change will help define the minimal standard initial prognostic evaluation for patients with CLL and help facilitate use of the powerful, recently developed, integrated prognostic indices, all of which are dependent on these 2 variables,” wrote Dr. Sameer A. Parikh of Mayo Clinic, Rochester, Minn., and associates.
IGHV and FISH have prognostic value independent of clinical stage in patients with newly diagnosed and previously untreated CLL, they said (Blood. 2016;127[14]:1752-60). Better understanding of the patient’s risk of disease progression at diagnosis can guide counseling and follow-up intervals, and could potentially influence the decision to treat high-risk patients on early intervention protocols.
IGHV and FISH also appear to provide additional information on progression-free and overall survival.
The researchers cautioned, however, that the results of these tests should not be used to initiate CLL-specific therapy. Only patients who meet indications for therapy based on the 2008 International Workshop on Chronic Lymphocytic Leukemia guidelines should receive treatment.
Further, they noted, the median age of patients included in studies that they analyzed was 64 years; the median age of patients with CLL is 72 years. The prognostic abilities of IGHV mutation and FISH may differ in these older individuals with CLL.
The researchers analyzed 31 studies that met the criteria for inclusion – full-length publications that included at least 200 patients and reported on the prognostic value of IGHV and/or FISH for predicting progression-free or overall survival in patients with newly diagnosed CLL.
They found that the median progression-free survival (range, about 1-5 years) was significantly shorter for patients with unmutated IGHV genes, than was the median progression-free survival (range, about 9-19 years) for those with mutated IGHV genes. Similarly, the median overall survival was significantly shorter for patients with unmutated IGHV (range, about 3-10 years) than for those with mutated IGHV (range, about 18-26 years).
For patients with high-risk FISH (including del17p13 and del11q23), the median progression-free survival was significantly shorter (range, about 0.1-5 years) than for those with low/intermediate-risk FISH (including del13q, normal, and trisomy 12; range, about 1.5-22 years). Median overall survival also significantly differed, ranging from about 3-10 years for patients with high-risk FISH and from about 7.5-20.5 years for those with low/intermediate-risk FISH.
In multivariable analyses, the hazard ratio for high-risk FISH ranged from 1.3 to 4.7 for progression-free survival and from 0.9 to 8.2 for overall survival. In studies reporting the results of multivariable analysis, high-risk FISH remained an independent predictor of progression-free survival in 8 of 17 studies and of overall survival in 10 of 14 studies, including in 10 of 13 studies adjusting for the prognostic impact of IGHV.
In multivariable analyses, IGHV remained an independent predictor of progression-free survival in 15 of 18 studies, including 12 of 15 studies adjusting for the prognostic impact of FISH. IGHV remained an independent predictor of overall survival in 11 of 15 studies reporting the results of multivariable analysis, including 10 of 14 studies adjusting for the prognostic impact of FISH.
Patients with newly diagnosed chronic lymphocytic leukemia should standardly undergo immunoglobulin heavy-chain variable region gene (IGHV) mutation status and interphase fluorescence in situ hybridization (FISH) tests, based on the results of a meta-analysis published in Blood.
“This change will help define the minimal standard initial prognostic evaluation for patients with CLL and help facilitate use of the powerful, recently developed, integrated prognostic indices, all of which are dependent on these 2 variables,” wrote Dr. Sameer A. Parikh of Mayo Clinic, Rochester, Minn., and associates.
IGHV and FISH have prognostic value independent of clinical stage in patients with newly diagnosed and previously untreated CLL, they said (Blood. 2016;127[14]:1752-60). Better understanding of the patient’s risk of disease progression at diagnosis can guide counseling and follow-up intervals, and could potentially influence the decision to treat high-risk patients on early intervention protocols.
IGHV and FISH also appear to provide additional information on progression-free and overall survival.
The researchers cautioned, however, that the results of these tests should not be used to initiate CLL-specific therapy. Only patients who meet indications for therapy based on the 2008 International Workshop on Chronic Lymphocytic Leukemia guidelines should receive treatment.
Further, they noted, the median age of patients included in studies that they analyzed was 64 years; the median age of patients with CLL is 72 years. The prognostic abilities of IGHV mutation and FISH may differ in these older individuals with CLL.
The researchers analyzed 31 studies that met the criteria for inclusion – full-length publications that included at least 200 patients and reported on the prognostic value of IGHV and/or FISH for predicting progression-free or overall survival in patients with newly diagnosed CLL.
They found that the median progression-free survival (range, about 1-5 years) was significantly shorter for patients with unmutated IGHV genes, than was the median progression-free survival (range, about 9-19 years) for those with mutated IGHV genes. Similarly, the median overall survival was significantly shorter for patients with unmutated IGHV (range, about 3-10 years) than for those with mutated IGHV (range, about 18-26 years).
For patients with high-risk FISH (including del17p13 and del11q23), the median progression-free survival was significantly shorter (range, about 0.1-5 years) than for those with low/intermediate-risk FISH (including del13q, normal, and trisomy 12; range, about 1.5-22 years). Median overall survival also significantly differed, ranging from about 3-10 years for patients with high-risk FISH and from about 7.5-20.5 years for those with low/intermediate-risk FISH.
In multivariable analyses, the hazard ratio for high-risk FISH ranged from 1.3 to 4.7 for progression-free survival and from 0.9 to 8.2 for overall survival. In studies reporting the results of multivariable analysis, high-risk FISH remained an independent predictor of progression-free survival in 8 of 17 studies and of overall survival in 10 of 14 studies, including in 10 of 13 studies adjusting for the prognostic impact of IGHV.
In multivariable analyses, IGHV remained an independent predictor of progression-free survival in 15 of 18 studies, including 12 of 15 studies adjusting for the prognostic impact of FISH. IGHV remained an independent predictor of overall survival in 11 of 15 studies reporting the results of multivariable analysis, including 10 of 14 studies adjusting for the prognostic impact of FISH.
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