Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.

AML cells

The US Food and Drug Administration (FDA) has granted annamycin orphan designation for the treatment of acute myeloid leukemia (AML).

Annamycin is a liposomal anthracycline under development by Moleculin Biotech, Inc.

The company said it is working with the FDA on an investigative new drug application for a phase 1/2 trial of annamycin in patients with relapsed or refractory AML.

Annamycin has already been tested in 6 clinical trials, 3 of which focused on leukemia.

Results from one of these trials, in adults with relapsed/refractory acute lymphoblastic leukemia, were published in Clinical Lymphoma, Myeloma & Leukemia in 2013.

Annamycin has been under development by several other pharmaceutical companies. Moleculin Biotech, Inc. acquired rights and development assets relating to the drug in 2015.

About orphan designation

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

AML cells

The US Food and Drug Administration (FDA) has granted annamycin orphan designation for the treatment of acute myeloid leukemia (AML).

Annamycin is a liposomal anthracycline under development by Moleculin Biotech, Inc.

The company said it is working with the FDA on an investigative new drug application for a phase 1/2 trial of annamycin in patients with relapsed or refractory AML.

Annamycin has already been tested in 6 clinical trials, 3 of which focused on leukemia.

Results from one of these trials, in adults with relapsed/refractory acute lymphoblastic leukemia, were published in Clinical Lymphoma, Myeloma & Leukemia in 2013.

Annamycin has been under development by several other pharmaceutical companies. Moleculin Biotech, Inc. acquired rights and development assets relating to the drug in 2015.

About orphan designation

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

AML cells

The US Food and Drug Administration (FDA) has granted annamycin orphan designation for the treatment of acute myeloid leukemia (AML).

Annamycin is a liposomal anthracycline under development by Moleculin Biotech, Inc.

The company said it is working with the FDA on an investigative new drug application for a phase 1/2 trial of annamycin in patients with relapsed or refractory AML.

Annamycin has already been tested in 6 clinical trials, 3 of which focused on leukemia.

Results from one of these trials, in adults with relapsed/refractory acute lymphoblastic leukemia, were published in Clinical Lymphoma, Myeloma & Leukemia in 2013.

Annamycin has been under development by several other pharmaceutical companies. Moleculin Biotech, Inc. acquired rights and development assets relating to the drug in 2015.

About orphan designation

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

Overweight or obese children in a cohort study were more likely to have adult nonalcoholic fatty liver disease (NAFLD) and elevated levels of the liver enzyme alanine aminotransferase than were healthy weight children of both sexes, but this association can be mitigated by weight loss in adulthood.

“These findings underscore the importance of both early prevention and lifelong treatment of overweight and obesity to reduce the risk of adverse liver outcome in adulthood,” Yinkun Yan, PhD, an epidemiologist at the Capital Institute of Pediatrics, Beijing, and associates wrote (Pediatrics. 2017;139[4]:e20162738).

©SolStock/iStock

[email protected]
 

Overweight or obese children in a cohort study were more likely to have adult nonalcoholic fatty liver disease (NAFLD) and elevated levels of the liver enzyme alanine aminotransferase than were healthy weight children of both sexes, but this association can be mitigated by weight loss in adulthood.

“These findings underscore the importance of both early prevention and lifelong treatment of overweight and obesity to reduce the risk of adverse liver outcome in adulthood,” Yinkun Yan, PhD, an epidemiologist at the Capital Institute of Pediatrics, Beijing, and associates wrote (Pediatrics. 2017;139[4]:e20162738).

©SolStock/iStock

[email protected]
 

Overweight or obese children in a cohort study were more likely to have adult nonalcoholic fatty liver disease (NAFLD) and elevated levels of the liver enzyme alanine aminotransferase than were healthy weight children of both sexes, but this association can be mitigated by weight loss in adulthood.

“These findings underscore the importance of both early prevention and lifelong treatment of overweight and obesity to reduce the risk of adverse liver outcome in adulthood,” Yinkun Yan, PhD, an epidemiologist at the Capital Institute of Pediatrics, Beijing, and associates wrote (Pediatrics. 2017;139[4]:e20162738).

©SolStock/iStock

[email protected]
 

CHICAGO – Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.

CHICAGO – Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.

CHICAGO – Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.