Diabetic ketoacidosis (DKA) is life threatening, but preventable. It was good news that between 2000-2009, rates of DKA began to decline, but researchers from the Centers for Disease Control and Prevention (CDC) say it is “concerning” to find that those rates began to reverse between 2009-2014 , increasing 54.9%. All age groups saw an increase of ≥ 6% annually. The highest rates were among people aged < 45 years: approximately 27 times higher than among people aged > 65 years.

The causes for the reversal are not clear, the researchers say, but they offer several possibilities, including changes in case definition, new medications that might raise the risk of DKA, and higher admission rates for people with less serious disease.

Because DKA rates were highest among people aged > 45 years, the researchers say information from studies in that age group might help determine whether prevention strategies should focus on factors such as symptom recognition, adherence to treatment, self-management skills, access to care, or cost of treatment.

Diabetic ketoacidosis (DKA) is life threatening, but preventable. It was good news that between 2000-2009, rates of DKA began to decline, but researchers from the Centers for Disease Control and Prevention (CDC) say it is “concerning” to find that those rates began to reverse between 2009-2014 , increasing 54.9%. All age groups saw an increase of ≥ 6% annually. The highest rates were among people aged < 45 years: approximately 27 times higher than among people aged > 65 years.

The causes for the reversal are not clear, the researchers say, but they offer several possibilities, including changes in case definition, new medications that might raise the risk of DKA, and higher admission rates for people with less serious disease.

Because DKA rates were highest among people aged > 45 years, the researchers say information from studies in that age group might help determine whether prevention strategies should focus on factors such as symptom recognition, adherence to treatment, self-management skills, access to care, or cost of treatment.

Diabetic ketoacidosis (DKA) is life threatening, but preventable. It was good news that between 2000-2009, rates of DKA began to decline, but researchers from the Centers for Disease Control and Prevention (CDC) say it is “concerning” to find that those rates began to reverse between 2009-2014 , increasing 54.9%. All age groups saw an increase of ≥ 6% annually. The highest rates were among people aged < 45 years: approximately 27 times higher than among people aged > 65 years.

The causes for the reversal are not clear, the researchers say, but they offer several possibilities, including changes in case definition, new medications that might raise the risk of DKA, and higher admission rates for people with less serious disease.

Because DKA rates were highest among people aged > 45 years, the researchers say information from studies in that age group might help determine whether prevention strategies should focus on factors such as symptom recognition, adherence to treatment, self-management skills, access to care, or cost of treatment.

Photo by Bill Branson

The addition of nelarabine can improve treatment outcomes for certain patients with T-cell acute lymphoblastic leukemia (T-ALL), according to a phase 3 trial.

Patients with newly diagnosed, intermediate- or high-risk T-ALL had a significant improvement in 4-year disease-free survival (DFS) if they received nelarabine in addition to chemotherapy and cranial irradiation.

The DFS benefit with nelarabine was significant for patients who received high-dose methotrexate but not for those who received escalating-dose methotrexate.

This study also included patients with T-cell lymphoblastic lymphoma (T-LL), and they did not experience an improvement in DFS with the addition of nelarabine.

Kimberly Dunsmore, MD, of Virginia Tech Carilion School of Medicine in Roanoke, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting. Additional results are scheduled to be presented at the meeting as abstract 10500.

This research was supported by the National Cancer Institute/National Institutes of Health and St. Baldrick’s Foundation. The researchers’ disclosures are listed with the abstract.

Patients and treatment

The trial enrolled 1895 patients, ages 1 to 30, who were newly diagnosed with T-ALL (94%) or T-LL (6%).

Patients received standard 4-drug induction chemotherapy, and 1307 of these patients were then randomized to 1 of 4 treatment arms.

Regardless of which arm they were randomized to, patients received an 11-drug chemotherapy regimen—the augmented Berlin-Frankfurt-Munster regimen. Intermediate- and high-risk patients in all 4 arms also received cranial irradiation.

In the first treatment arm, T-LL (n=58) and T-ALL (n=372) patients received escalating-dose methotrexate without leucovorin rescue and pegaspargase (C-MTX).

In the second treatment arm, patients with intermediate- and high-risk T-ALL (n=147) and T-LL (n=60) received C-MTX plus nelarabine (six 5-day courses at 650 mg/m²/day).

In the third arm, T-ALL patients (n=451) received high-dose methotrexate with leucovorin rescue (HD-MTX). T-LL patients were not eligible for this arm or the fourth treatment arm.

In the fourth arm, intermediate- and high-risk T-ALL patients (n=219) received HD-MTX and nelarabine (same schedule as above). This included 43 T-ALL patients who had induction failure and were assigned to this arm non-randomly.

Results

For T-ALL patients, the 4-year disease-free survival (DFS) rate was 84%, and the 4-year overall survival rate was 90%.

There was a significant improvement in DFS for T-ALL patients who received nelarabine compared to those who did not—89% and 83%, respectively (P=0.0332).

“Historically, about 80% of people [with T-ALL] live at least 4 years after being treated for their disease, but we felt we could and must do better,” Dr Dunsmore said. “Our trial shows that we could further increase survival rates by about 10%, which is very encouraging.”

Dr Dunsmore also noted that patients who received nelarabine had fewer central nervous system relapses.

Among T-ALL patients who received C-MTX, there was no significant difference in DFS for those who received nelarabine and those who did not—92% and 90%, respectively (P=0.3825).

However, for patients who received HD-MTX, the difference in DFS was significant. The DFS rate was 86% in patients who received nelarabine and 78% in those who did not (P=0.024).

For the T-ALL patients who failed induction and were assigned to HD-MTX and nelarabine, the 4-year DFS rate was 55%.

Patients with T-LL did not benefit from the addition of nelarabine. The 4-year DFS rate was 85% in the nelarabine recipients and 89% in non-recipients (P=0.2788).

There were no significant differences in overall toxicity or peripheral neurotoxicity between the treatment arms.

Dr Dunsmore said the next step with this research will be to examine the implications and potential benefits of using nelarabine in treatment protocols that do not include cranial radiation.

Photo by Bill Branson

The addition of nelarabine can improve treatment outcomes for certain patients with T-cell acute lymphoblastic leukemia (T-ALL), according to a phase 3 trial.

Patients with newly diagnosed, intermediate- or high-risk T-ALL had a significant improvement in 4-year disease-free survival (DFS) if they received nelarabine in addition to chemotherapy and cranial irradiation.

The DFS benefit with nelarabine was significant for patients who received high-dose methotrexate but not for those who received escalating-dose methotrexate.

This study also included patients with T-cell lymphoblastic lymphoma (T-LL), and they did not experience an improvement in DFS with the addition of nelarabine.

Kimberly Dunsmore, MD, of Virginia Tech Carilion School of Medicine in Roanoke, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting. Additional results are scheduled to be presented at the meeting as abstract 10500.

This research was supported by the National Cancer Institute/National Institutes of Health and St. Baldrick’s Foundation. The researchers’ disclosures are listed with the abstract.

Patients and treatment

The trial enrolled 1895 patients, ages 1 to 30, who were newly diagnosed with T-ALL (94%) or T-LL (6%).

Patients received standard 4-drug induction chemotherapy, and 1307 of these patients were then randomized to 1 of 4 treatment arms.

Regardless of which arm they were randomized to, patients received an 11-drug chemotherapy regimen—the augmented Berlin-Frankfurt-Munster regimen. Intermediate- and high-risk patients in all 4 arms also received cranial irradiation.

In the first treatment arm, T-LL (n=58) and T-ALL (n=372) patients received escalating-dose methotrexate without leucovorin rescue and pegaspargase (C-MTX).

In the second treatment arm, patients with intermediate- and high-risk T-ALL (n=147) and T-LL (n=60) received C-MTX plus nelarabine (six 5-day courses at 650 mg/m²/day).

In the third arm, T-ALL patients (n=451) received high-dose methotrexate with leucovorin rescue (HD-MTX). T-LL patients were not eligible for this arm or the fourth treatment arm.

In the fourth arm, intermediate- and high-risk T-ALL patients (n=219) received HD-MTX and nelarabine (same schedule as above). This included 43 T-ALL patients who had induction failure and were assigned to this arm non-randomly.

Results

For T-ALL patients, the 4-year disease-free survival (DFS) rate was 84%, and the 4-year overall survival rate was 90%.

There was a significant improvement in DFS for T-ALL patients who received nelarabine compared to those who did not—89% and 83%, respectively (P=0.0332).

“Historically, about 80% of people [with T-ALL] live at least 4 years after being treated for their disease, but we felt we could and must do better,” Dr Dunsmore said. “Our trial shows that we could further increase survival rates by about 10%, which is very encouraging.”

Dr Dunsmore also noted that patients who received nelarabine had fewer central nervous system relapses.

Among T-ALL patients who received C-MTX, there was no significant difference in DFS for those who received nelarabine and those who did not—92% and 90%, respectively (P=0.3825).

However, for patients who received HD-MTX, the difference in DFS was significant. The DFS rate was 86% in patients who received nelarabine and 78% in those who did not (P=0.024).

For the T-ALL patients who failed induction and were assigned to HD-MTX and nelarabine, the 4-year DFS rate was 55%.

Patients with T-LL did not benefit from the addition of nelarabine. The 4-year DFS rate was 85% in the nelarabine recipients and 89% in non-recipients (P=0.2788).

There were no significant differences in overall toxicity or peripheral neurotoxicity between the treatment arms.

Dr Dunsmore said the next step with this research will be to examine the implications and potential benefits of using nelarabine in treatment protocols that do not include cranial radiation.

Photo by Bill Branson

The addition of nelarabine can improve treatment outcomes for certain patients with T-cell acute lymphoblastic leukemia (T-ALL), according to a phase 3 trial.

Patients with newly diagnosed, intermediate- or high-risk T-ALL had a significant improvement in 4-year disease-free survival (DFS) if they received nelarabine in addition to chemotherapy and cranial irradiation.

The DFS benefit with nelarabine was significant for patients who received high-dose methotrexate but not for those who received escalating-dose methotrexate.

This study also included patients with T-cell lymphoblastic lymphoma (T-LL), and they did not experience an improvement in DFS with the addition of nelarabine.

Kimberly Dunsmore, MD, of Virginia Tech Carilion School of Medicine in Roanoke, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting. Additional results are scheduled to be presented at the meeting as abstract 10500.

This research was supported by the National Cancer Institute/National Institutes of Health and St. Baldrick’s Foundation. The researchers’ disclosures are listed with the abstract.

Patients and treatment

The trial enrolled 1895 patients, ages 1 to 30, who were newly diagnosed with T-ALL (94%) or T-LL (6%).

Patients received standard 4-drug induction chemotherapy, and 1307 of these patients were then randomized to 1 of 4 treatment arms.

Regardless of which arm they were randomized to, patients received an 11-drug chemotherapy regimen—the augmented Berlin-Frankfurt-Munster regimen. Intermediate- and high-risk patients in all 4 arms also received cranial irradiation.

In the first treatment arm, T-LL (n=58) and T-ALL (n=372) patients received escalating-dose methotrexate without leucovorin rescue and pegaspargase (C-MTX).

In the second treatment arm, patients with intermediate- and high-risk T-ALL (n=147) and T-LL (n=60) received C-MTX plus nelarabine (six 5-day courses at 650 mg/m²/day).

In the third arm, T-ALL patients (n=451) received high-dose methotrexate with leucovorin rescue (HD-MTX). T-LL patients were not eligible for this arm or the fourth treatment arm.

In the fourth arm, intermediate- and high-risk T-ALL patients (n=219) received HD-MTX and nelarabine (same schedule as above). This included 43 T-ALL patients who had induction failure and were assigned to this arm non-randomly.

Results

For T-ALL patients, the 4-year disease-free survival (DFS) rate was 84%, and the 4-year overall survival rate was 90%.

There was a significant improvement in DFS for T-ALL patients who received nelarabine compared to those who did not—89% and 83%, respectively (P=0.0332).

“Historically, about 80% of people [with T-ALL] live at least 4 years after being treated for their disease, but we felt we could and must do better,” Dr Dunsmore said. “Our trial shows that we could further increase survival rates by about 10%, which is very encouraging.”

Dr Dunsmore also noted that patients who received nelarabine had fewer central nervous system relapses.

Among T-ALL patients who received C-MTX, there was no significant difference in DFS for those who received nelarabine and those who did not—92% and 90%, respectively (P=0.3825).

However, for patients who received HD-MTX, the difference in DFS was significant. The DFS rate was 86% in patients who received nelarabine and 78% in those who did not (P=0.024).

For the T-ALL patients who failed induction and were assigned to HD-MTX and nelarabine, the 4-year DFS rate was 55%.

Patients with T-LL did not benefit from the addition of nelarabine. The 4-year DFS rate was 85% in the nelarabine recipients and 89% in non-recipients (P=0.2788).

There were no significant differences in overall toxicity or peripheral neurotoxicity between the treatment arms.

Dr Dunsmore said the next step with this research will be to examine the implications and potential benefits of using nelarabine in treatment protocols that do not include cranial radiation.

Photo by Petr Kratochvil

Treatment with acupuncture or cognitive behavioral therapy (CBT) can decrease the severity of insomnia among cancer survivors, according to new research.

Overall, improvements in insomnia were greatest in patients treated with CBT, and patients with mild insomnia at baseline had a significantly greater improvement with CBT than with acupuncture.

However, among patients who had moderate to severe insomnia at baseline, there was no significant difference in results with CBT and acupuncture.

Jun J. Mao, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting.

Additional results are scheduled to be presented at the meeting as abstract 10001.

“Up to 60% of cancer survivors have some form of insomnia, but it is often underdiagnosed and undertreated,” Dr Mao said. “Our trial showed that both CBT-I [CBT for insomnia] and acupuncture were effective in treating moderate to severe insomnia, although CBT-I was more effective for those with mild symptoms of insomnia. Now, patients have more choices to manage their insomnia.”

Dr Mao and his colleagues studied 160 individuals who had completed cancer treatment. Their mean time since cancer diagnosis was about 6 years.

The subjects had received treatment for hematologic malignancies (8%) as well as breast (31%), prostate (23%), head and neck (7%), colorectal (6%), gynecological (4%), and other cancers (14%). Six percent of subjects had been treated for more than 1 type of cancer.

All subjects had been clinically diagnosed with insomnia. Seventy-nine percent had moderate (n=94) to severe (n=33) insomnia, and 21% had mild insomnia (n=33).

Interventions

Subjects were randomized to receive CBT or acupuncture for 8 weeks. Those who received CBT worked with a therapist to re-establish a restorative sleep schedule by:

• Reducing the amount of time spent in bed
• Limiting activities performed in bed to sleep and sexual activity
• Modifying unhelpful beliefs about sleep
• Promoting good sleep hygiene (setting a regular sleep schedule and avoiding activities that include light from tablets and cellphones, eating too late, and performing vigorous activities).

The study’s primary outcome was reduction in insomnia severity, as measured by the Insomnia Severity Index (ISI), from study entry to the end of treatment at week 8. Subjects were also reassessed at 20 weeks.

The ISI is a questionnaire that asks people to rate the severity of insomnia problems, such as difficulty falling asleep and staying asleep, and the impact of insomnia on their daily functioning and quality of life.

ISI scoring ranges from 0 to 28. Scores of 0 to 7 denote no clinically significant insomnia, 8 to 14 denote mild insomnia, 15 to 21 denote moderate insomnia, and 22 to 28 denote severe insomnia.

Results

At 8 weeks, the mean ISI score fell 10.9 points (from 18.5 to 7.5) for subjects who received CBT and 8.3 points (from 17.55 to 9.23) for those who received acupuncture (P=0.0007).

Among subjects with mild insomnia at baseline, far more responded to CBT than to acupuncture—85% and 18%, respectively (P<0.0001).

However, response rates were similar in subjects who had moderate to severe insomnia at baseline. Seventy-five percent of those who received CBT achieved a response, as did 66% of those who received acupuncture (P=0.26).

Both treatment groups had few mild adverse events, and all subjects maintained their improvements in insomnia at the 20-week assessment.

This study was funded by the Patient-Centered Outcomes Research Institute. The researchers’ disclosures are listed with the abstract.

Photo by Petr Kratochvil

Treatment with acupuncture or cognitive behavioral therapy (CBT) can decrease the severity of insomnia among cancer survivors, according to new research.

Overall, improvements in insomnia were greatest in patients treated with CBT, and patients with mild insomnia at baseline had a significantly greater improvement with CBT than with acupuncture.

However, among patients who had moderate to severe insomnia at baseline, there was no significant difference in results with CBT and acupuncture.

Jun J. Mao, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting.

Additional results are scheduled to be presented at the meeting as abstract 10001.

“Up to 60% of cancer survivors have some form of insomnia, but it is often underdiagnosed and undertreated,” Dr Mao said. “Our trial showed that both CBT-I [CBT for insomnia] and acupuncture were effective in treating moderate to severe insomnia, although CBT-I was more effective for those with mild symptoms of insomnia. Now, patients have more choices to manage their insomnia.”

Dr Mao and his colleagues studied 160 individuals who had completed cancer treatment. Their mean time since cancer diagnosis was about 6 years.

The subjects had received treatment for hematologic malignancies (8%) as well as breast (31%), prostate (23%), head and neck (7%), colorectal (6%), gynecological (4%), and other cancers (14%). Six percent of subjects had been treated for more than 1 type of cancer.

All subjects had been clinically diagnosed with insomnia. Seventy-nine percent had moderate (n=94) to severe (n=33) insomnia, and 21% had mild insomnia (n=33).

Interventions

Subjects were randomized to receive CBT or acupuncture for 8 weeks. Those who received CBT worked with a therapist to re-establish a restorative sleep schedule by:

• Reducing the amount of time spent in bed
• Limiting activities performed in bed to sleep and sexual activity
• Modifying unhelpful beliefs about sleep
• Promoting good sleep hygiene (setting a regular sleep schedule and avoiding activities that include light from tablets and cellphones, eating too late, and performing vigorous activities).

The study’s primary outcome was reduction in insomnia severity, as measured by the Insomnia Severity Index (ISI), from study entry to the end of treatment at week 8. Subjects were also reassessed at 20 weeks.

The ISI is a questionnaire that asks people to rate the severity of insomnia problems, such as difficulty falling asleep and staying asleep, and the impact of insomnia on their daily functioning and quality of life.

ISI scoring ranges from 0 to 28. Scores of 0 to 7 denote no clinically significant insomnia, 8 to 14 denote mild insomnia, 15 to 21 denote moderate insomnia, and 22 to 28 denote severe insomnia.

Results

At 8 weeks, the mean ISI score fell 10.9 points (from 18.5 to 7.5) for subjects who received CBT and 8.3 points (from 17.55 to 9.23) for those who received acupuncture (P=0.0007).

Among subjects with mild insomnia at baseline, far more responded to CBT than to acupuncture—85% and 18%, respectively (P<0.0001).

However, response rates were similar in subjects who had moderate to severe insomnia at baseline. Seventy-five percent of those who received CBT achieved a response, as did 66% of those who received acupuncture (P=0.26).

Both treatment groups had few mild adverse events, and all subjects maintained their improvements in insomnia at the 20-week assessment.

This study was funded by the Patient-Centered Outcomes Research Institute. The researchers’ disclosures are listed with the abstract.

Photo by Petr Kratochvil

Treatment with acupuncture or cognitive behavioral therapy (CBT) can decrease the severity of insomnia among cancer survivors, according to new research.

Overall, improvements in insomnia were greatest in patients treated with CBT, and patients with mild insomnia at baseline had a significantly greater improvement with CBT than with acupuncture.

However, among patients who had moderate to severe insomnia at baseline, there was no significant difference in results with CBT and acupuncture.

Jun J. Mao, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, presented these results in a press briefing in advance of the 2018 ASCO Annual Meeting.

Additional results are scheduled to be presented at the meeting as abstract 10001.

“Up to 60% of cancer survivors have some form of insomnia, but it is often underdiagnosed and undertreated,” Dr Mao said. “Our trial showed that both CBT-I [CBT for insomnia] and acupuncture were effective in treating moderate to severe insomnia, although CBT-I was more effective for those with mild symptoms of insomnia. Now, patients have more choices to manage their insomnia.”

Dr Mao and his colleagues studied 160 individuals who had completed cancer treatment. Their mean time since cancer diagnosis was about 6 years.

The subjects had received treatment for hematologic malignancies (8%) as well as breast (31%), prostate (23%), head and neck (7%), colorectal (6%), gynecological (4%), and other cancers (14%). Six percent of subjects had been treated for more than 1 type of cancer.

All subjects had been clinically diagnosed with insomnia. Seventy-nine percent had moderate (n=94) to severe (n=33) insomnia, and 21% had mild insomnia (n=33).

Interventions

Subjects were randomized to receive CBT or acupuncture for 8 weeks. Those who received CBT worked with a therapist to re-establish a restorative sleep schedule by:

• Reducing the amount of time spent in bed
• Limiting activities performed in bed to sleep and sexual activity
• Modifying unhelpful beliefs about sleep
• Promoting good sleep hygiene (setting a regular sleep schedule and avoiding activities that include light from tablets and cellphones, eating too late, and performing vigorous activities).

The study’s primary outcome was reduction in insomnia severity, as measured by the Insomnia Severity Index (ISI), from study entry to the end of treatment at week 8. Subjects were also reassessed at 20 weeks.

The ISI is a questionnaire that asks people to rate the severity of insomnia problems, such as difficulty falling asleep and staying asleep, and the impact of insomnia on their daily functioning and quality of life.

ISI scoring ranges from 0 to 28. Scores of 0 to 7 denote no clinically significant insomnia, 8 to 14 denote mild insomnia, 15 to 21 denote moderate insomnia, and 22 to 28 denote severe insomnia.

Results

At 8 weeks, the mean ISI score fell 10.9 points (from 18.5 to 7.5) for subjects who received CBT and 8.3 points (from 17.55 to 9.23) for those who received acupuncture (P=0.0007).

Among subjects with mild insomnia at baseline, far more responded to CBT than to acupuncture—85% and 18%, respectively (P<0.0001).

However, response rates were similar in subjects who had moderate to severe insomnia at baseline. Seventy-five percent of those who received CBT achieved a response, as did 66% of those who received acupuncture (P=0.26).

Both treatment groups had few mild adverse events, and all subjects maintained their improvements in insomnia at the 20-week assessment.

This study was funded by the Patient-Centered Outcomes Research Institute. The researchers’ disclosures are listed with the abstract.

The FP suspected that this was a melanoma.

He thought through the ABCDEs of melanoma and saw that it was Asymmetric, had an irregular Border, had varied Colors, the Diameter was larger than 6 mm, and it was Evolving. The FP also noted that one area was elevated and another area (the center) seemed to be regressing. Using his dermatoscope, he noted strong evidence of regression in the center and an “atypical network.” He told the patient that this was very suspicious for melanoma and recommended a skin biopsy without delay. The patient agreed and after local anesthesia with lidocaine with epinephrine, a saucerization biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The FP easily removed all of the visible tumor with the saucerization (deep shave). The bleeding was stopped with topical aluminum chloride, and the specimen was sent in formalin to the pathologist. The pathology report came back as a melanoma of 2.1 mm depth arising in a pre-existing nevus.

The patient was referred to a surgical oncologist for sentinel lymph node biopsy and excision with wide margins.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP suspected that this was a melanoma.

He thought through the ABCDEs of melanoma and saw that it was Asymmetric, had an irregular Border, had varied Colors, the Diameter was larger than 6 mm, and it was Evolving. The FP also noted that one area was elevated and another area (the center) seemed to be regressing. Using his dermatoscope, he noted strong evidence of regression in the center and an “atypical network.” He told the patient that this was very suspicious for melanoma and recommended a skin biopsy without delay. The patient agreed and after local anesthesia with lidocaine with epinephrine, a saucerization biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The FP easily removed all of the visible tumor with the saucerization (deep shave). The bleeding was stopped with topical aluminum chloride, and the specimen was sent in formalin to the pathologist. The pathology report came back as a melanoma of 2.1 mm depth arising in a pre-existing nevus.

The patient was referred to a surgical oncologist for sentinel lymph node biopsy and excision with wide margins.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP suspected that this was a melanoma.

He thought through the ABCDEs of melanoma and saw that it was Asymmetric, had an irregular Border, had varied Colors, the Diameter was larger than 6 mm, and it was Evolving. The FP also noted that one area was elevated and another area (the center) seemed to be regressing. Using his dermatoscope, he noted strong evidence of regression in the center and an “atypical network.” He told the patient that this was very suspicious for melanoma and recommended a skin biopsy without delay. The patient agreed and after local anesthesia with lidocaine with epinephrine, a saucerization biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The FP easily removed all of the visible tumor with the saucerization (deep shave). The bleeding was stopped with topical aluminum chloride, and the specimen was sent in formalin to the pathologist. The pathology report came back as a melanoma of 2.1 mm depth arising in a pre-existing nevus.

The patient was referred to a surgical oncologist for sentinel lymph node biopsy and excision with wide margins.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Congenital nevi. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:953-957.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.

In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.

They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).

Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.

“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.

This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.

However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.

SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.

Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.

In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.

They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).

Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.

“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.

This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.

However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.

SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.

Cancer immunotherapy using checkpoint inhibitors may achieve greater mortality reductions in men than they do in women, new research has suggested.

In a meta-analysis and systematic review published in Lancet Oncology, researchers analyzed 20 randomized, controlled trials of immune checkpoint inhibitors that included detail on overall survival and patients’ sex; altogether, these studies involved 11,351 patients with advanced or metastatic cancers.

They found that while men treated with checkpoint inhibitors had a significant 28% reduced risk of death, compared with male controls, the survival benefit in women was smaller (14% reduced risk of death, compared with female controls).

Fabio Conforti, MD, from the European Institute of Oncology, Milan, and coauthors commented that the magnitude of the difference between the effect seen men and that in women was clinically significant.

“The pooled reduction of risk of death was double the size for male patients than for female patients – a difference that is similar to the size of the difference in survival benefit observed between patients with non–small cell lung cancer with PD-L1 positive (greater than 1%) tumors versus negative tumors, who were treated with anti-PD-1,” they wrote.

This difference between the benefit seen men and that in women was evident across all the subgroups in the study, which included subgroups based on cancer histotype, line of treatment, drugs used, and type of control.

However there was greater heterogeneity in the magnitude of the effect of checkpoint inhibitors on mortality in men than there was in women. The authors suggested this could be explained by the fact that the drugs have lower efficacy in women and this may therefore reduce the variability of results when compared with those in men.

SOURCE: Conforti F et al. Lancet Oncol. 2018 May 16. doi: 10.1016/S1470-2045(18)30261-4.

Formoterol plus budesonide prevented exacerbations when inhaled as needed by patients with mild persistent asthma, according to the results of two large, double-blind, 52-week, randomized phase 3 trials.

In the SYGMA1 (Symbicort Given as Needed in Mild Asthma) trial, the regimen outperformed as-needed terbutaline in terms of asthma control (34.4% vs. 31.1% of weeks; P = .046) and exacerbations (rate ratio, 0.36; 95% confidence interval, 0.27-0.49). In the SYGMA2 study, it was noninferior to twice-daily budesonide for preventing severe exacerbations (RR, 0.97; upper one-sided 95% CI, 1.16). The findings were published in two reports in the New England Journal of Medicine.

tupungato/Thinkstock

Results from both trials suggested that as-needed budesonide-formoterol provided better symptom control than did terbutaline but worse symptom control than did twice-daily budesonide. In SYGMA1, the change from baseline on the Asthma Control Questionnaire-5 (ACQ-5) favored budesonide-formoterol over terbutaline by an average of 0.15 units and similarly favored twice-daily budesonide over budesonide-formoterol. In SYGMA2, the budesonide maintenance group averaged 0.11 units greater improvement on the ACQ-5 and 0.10 better improvement on the standardized Asthma Quality of Life Questionnaire, compared with as-needed budesonide-formoterol recipients.

Finally, lung function assessments favored as-needed budesonide-formoterol over terbutaline but not over maintenance budesonide. SYGMA1, mean changes (from baseline) in FEV₁ before bronchodilator use were 11.2 mL with terbutaline, 65.0 mL with budesonide-formoterol, and 119.3 mL with maintenance budesonide. In SYGMA2, these values were 104 mL with budesonide-formoterol and 136.6 mL with maintenance budesonide.

AstraZeneca provided funding. For SYGMA1, Dr. Byrne disclosed ties to AstraZeneca, Novartis, GlaxoSmithKline, Medimmune, and Genentech. For SYGMA2, Dr. Bateman disclosed ties to AstraZeneca, Novartis, Cipla, Vectura, Boehringer Ingelheim, and a number of other pharmaceutical companies.

SOURCES: O’Byrne PM et al. N Engl J Med. 2018;378(20):1865-76.Bateman ED et al. N Engl J Med. 2018;378(20):1877-87.

Formoterol plus budesonide prevented exacerbations when inhaled as needed by patients with mild persistent asthma, according to the results of two large, double-blind, 52-week, randomized phase 3 trials.

In the SYGMA1 (Symbicort Given as Needed in Mild Asthma) trial, the regimen outperformed as-needed terbutaline in terms of asthma control (34.4% vs. 31.1% of weeks; P = .046) and exacerbations (rate ratio, 0.36; 95% confidence interval, 0.27-0.49). In the SYGMA2 study, it was noninferior to twice-daily budesonide for preventing severe exacerbations (RR, 0.97; upper one-sided 95% CI, 1.16). The findings were published in two reports in the New England Journal of Medicine.

tupungato/Thinkstock

Results from both trials suggested that as-needed budesonide-formoterol provided better symptom control than did terbutaline but worse symptom control than did twice-daily budesonide. In SYGMA1, the change from baseline on the Asthma Control Questionnaire-5 (ACQ-5) favored budesonide-formoterol over terbutaline by an average of 0.15 units and similarly favored twice-daily budesonide over budesonide-formoterol. In SYGMA2, the budesonide maintenance group averaged 0.11 units greater improvement on the ACQ-5 and 0.10 better improvement on the standardized Asthma Quality of Life Questionnaire, compared with as-needed budesonide-formoterol recipients.

Finally, lung function assessments favored as-needed budesonide-formoterol over terbutaline but not over maintenance budesonide. SYGMA1, mean changes (from baseline) in FEV₁ before bronchodilator use were 11.2 mL with terbutaline, 65.0 mL with budesonide-formoterol, and 119.3 mL with maintenance budesonide. In SYGMA2, these values were 104 mL with budesonide-formoterol and 136.6 mL with maintenance budesonide.

AstraZeneca provided funding. For SYGMA1, Dr. Byrne disclosed ties to AstraZeneca, Novartis, GlaxoSmithKline, Medimmune, and Genentech. For SYGMA2, Dr. Bateman disclosed ties to AstraZeneca, Novartis, Cipla, Vectura, Boehringer Ingelheim, and a number of other pharmaceutical companies.

SOURCES: O’Byrne PM et al. N Engl J Med. 2018;378(20):1865-76.Bateman ED et al. N Engl J Med. 2018;378(20):1877-87.

Formoterol plus budesonide prevented exacerbations when inhaled as needed by patients with mild persistent asthma, according to the results of two large, double-blind, 52-week, randomized phase 3 trials.

In the SYGMA1 (Symbicort Given as Needed in Mild Asthma) trial, the regimen outperformed as-needed terbutaline in terms of asthma control (34.4% vs. 31.1% of weeks; P = .046) and exacerbations (rate ratio, 0.36; 95% confidence interval, 0.27-0.49). In the SYGMA2 study, it was noninferior to twice-daily budesonide for preventing severe exacerbations (RR, 0.97; upper one-sided 95% CI, 1.16). The findings were published in two reports in the New England Journal of Medicine.

tupungato/Thinkstock

Results from both trials suggested that as-needed budesonide-formoterol provided better symptom control than did terbutaline but worse symptom control than did twice-daily budesonide. In SYGMA1, the change from baseline on the Asthma Control Questionnaire-5 (ACQ-5) favored budesonide-formoterol over terbutaline by an average of 0.15 units and similarly favored twice-daily budesonide over budesonide-formoterol. In SYGMA2, the budesonide maintenance group averaged 0.11 units greater improvement on the ACQ-5 and 0.10 better improvement on the standardized Asthma Quality of Life Questionnaire, compared with as-needed budesonide-formoterol recipients.

Finally, lung function assessments favored as-needed budesonide-formoterol over terbutaline but not over maintenance budesonide. SYGMA1, mean changes (from baseline) in FEV₁ before bronchodilator use were 11.2 mL with terbutaline, 65.0 mL with budesonide-formoterol, and 119.3 mL with maintenance budesonide. In SYGMA2, these values were 104 mL with budesonide-formoterol and 136.6 mL with maintenance budesonide.

AstraZeneca provided funding. For SYGMA1, Dr. Byrne disclosed ties to AstraZeneca, Novartis, GlaxoSmithKline, Medimmune, and Genentech. For SYGMA2, Dr. Bateman disclosed ties to AstraZeneca, Novartis, Cipla, Vectura, Boehringer Ingelheim, and a number of other pharmaceutical companies.

SOURCES: O’Byrne PM et al. N Engl J Med. 2018;378(20):1865-76.Bateman ED et al. N Engl J Med. 2018;378(20):1877-87.

Bortezomib added to an alternating chemoimmunotherapy regimen did not improve time to treatment failure in patients with newly diagnosed mantle cell lymphoma (MCL), results of a phase 2 study have suggested.

Response rates and time to treatment failure were similar to what has been seen historically without the addition of bortezomib, according to study investigator Jorge E. Romaguera, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

The phase 2 study included 95 patients with newly diagnosed MCL treated with alternating cycles of bortezomib added to rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (BzR-hyperCVAD) and bortezomib added to rituximab plus high-dose methotrexate and high-dose cytarabine (BzR-MA).

Of 87 patients evaluable for response, alternating BzR-hyperCVAD/BzR-MA resulted in an overall response rate of 100% and a complete response rate of 82%, Dr. Romaguera and his colleagues reported in the journal Cancer. At a median follow-up of 44 months, median time to treatment failure was 55 months, and median overall survival had not yet been reached, according to the report.

Dr. Romaguera and his coauthors compared these results with those from a previous study of alternating R-hyperCVAD/R-MA, in which the median time to treatment failure was 56.4 months. “This suggests that the addition of bortezomib does not improve the outcome,” they wrote in the current report.

Although more follow-up is needed, the landscape of MCL treatment is changing quickly, they added. In particular, lenalidomide and ibrutinib, already approved for relapsed/refractory MCL, are now being evaluated as part of first-line MCL regimens. “These drugs will offer strategies of either consolidation or maintenance after induction and will hopefully help continue to improve the duration of the initial response and the overall outcome,” the researchers wrote.

In the current phase 2 study, the fact that 100% of patients achieved complete response suggested that relapses come from minimal residual disease, which “has clearly become a clinical factor for the outcomes of patients with MCL and will likely become the next endpoint,” they wrote.

The researchers reported having no financial disclosures related to the study, which was supported by Takeda Oncology.

SOURCE: Romaguera JE et al. Cancer. 2018 May 3. doi: 10.1002/cncr.31361.

Bortezomib added to an alternating chemoimmunotherapy regimen did not improve time to treatment failure in patients with newly diagnosed mantle cell lymphoma (MCL), results of a phase 2 study have suggested.

Response rates and time to treatment failure were similar to what has been seen historically without the addition of bortezomib, according to study investigator Jorge E. Romaguera, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

The phase 2 study included 95 patients with newly diagnosed MCL treated with alternating cycles of bortezomib added to rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (BzR-hyperCVAD) and bortezomib added to rituximab plus high-dose methotrexate and high-dose cytarabine (BzR-MA).

Of 87 patients evaluable for response, alternating BzR-hyperCVAD/BzR-MA resulted in an overall response rate of 100% and a complete response rate of 82%, Dr. Romaguera and his colleagues reported in the journal Cancer. At a median follow-up of 44 months, median time to treatment failure was 55 months, and median overall survival had not yet been reached, according to the report.

Dr. Romaguera and his coauthors compared these results with those from a previous study of alternating R-hyperCVAD/R-MA, in which the median time to treatment failure was 56.4 months. “This suggests that the addition of bortezomib does not improve the outcome,” they wrote in the current report.

Although more follow-up is needed, the landscape of MCL treatment is changing quickly, they added. In particular, lenalidomide and ibrutinib, already approved for relapsed/refractory MCL, are now being evaluated as part of first-line MCL regimens. “These drugs will offer strategies of either consolidation or maintenance after induction and will hopefully help continue to improve the duration of the initial response and the overall outcome,” the researchers wrote.

In the current phase 2 study, the fact that 100% of patients achieved complete response suggested that relapses come from minimal residual disease, which “has clearly become a clinical factor for the outcomes of patients with MCL and will likely become the next endpoint,” they wrote.

The researchers reported having no financial disclosures related to the study, which was supported by Takeda Oncology.

SOURCE: Romaguera JE et al. Cancer. 2018 May 3. doi: 10.1002/cncr.31361.

Bortezomib added to an alternating chemoimmunotherapy regimen did not improve time to treatment failure in patients with newly diagnosed mantle cell lymphoma (MCL), results of a phase 2 study have suggested.

Response rates and time to treatment failure were similar to what has been seen historically without the addition of bortezomib, according to study investigator Jorge E. Romaguera, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his colleagues.

The phase 2 study included 95 patients with newly diagnosed MCL treated with alternating cycles of bortezomib added to rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (BzR-hyperCVAD) and bortezomib added to rituximab plus high-dose methotrexate and high-dose cytarabine (BzR-MA).

Of 87 patients evaluable for response, alternating BzR-hyperCVAD/BzR-MA resulted in an overall response rate of 100% and a complete response rate of 82%, Dr. Romaguera and his colleagues reported in the journal Cancer. At a median follow-up of 44 months, median time to treatment failure was 55 months, and median overall survival had not yet been reached, according to the report.

Dr. Romaguera and his coauthors compared these results with those from a previous study of alternating R-hyperCVAD/R-MA, in which the median time to treatment failure was 56.4 months. “This suggests that the addition of bortezomib does not improve the outcome,” they wrote in the current report.

Although more follow-up is needed, the landscape of MCL treatment is changing quickly, they added. In particular, lenalidomide and ibrutinib, already approved for relapsed/refractory MCL, are now being evaluated as part of first-line MCL regimens. “These drugs will offer strategies of either consolidation or maintenance after induction and will hopefully help continue to improve the duration of the initial response and the overall outcome,” the researchers wrote.

In the current phase 2 study, the fact that 100% of patients achieved complete response suggested that relapses come from minimal residual disease, which “has clearly become a clinical factor for the outcomes of patients with MCL and will likely become the next endpoint,” they wrote.

The researchers reported having no financial disclosures related to the study, which was supported by Takeda Oncology.

SOURCE: Romaguera JE et al. Cancer. 2018 May 3. doi: 10.1002/cncr.31361.

Abdominal migraine is a common cause of chronic and recurrent abdominal pain in children, according to a recent review. It is characterized by paroxysms of moderate to severe abdominal pain that is midline, periumbilical, or diffuse in location and accompanied by other symptoms including headache, anorexia, nausea, vomiting, or pallor. Despite the presence of comprehensive diagnostic criteria, it continues to be an underdiagnosed entity. Key points include:

• The average age of diagnosis is 3 to 10 years with peak incidence at 7 years.
• Most of the patients have a personal or family history of migraine.
• Pathophysiology of the condition is believed to be similar to that of other functional gastrointestinal disorders and cephalic migraine; it is also well recognized as a type of pediatric migraine variant.
• A careful history, thorough physical examination, and use of well-defined, symptom-based guidelines are needed to make a diagnosis.
• Although it resolves completely in most of the patients, these patients have a strong propensity to develop migraine later in life.
• Nonpharmacologic treatment options, including avoidance of triggers, behavior therapy, and dietary modifications should be the initial line of management.

Pediatric abdominal migraine: current perspectives on a lesser known entity. [Published online ahead of print April 24, 2018]. Pediatric Health Med Ther. doi:10.2147%2FPHMT.S127210.

Abdominal migraine is a common cause of chronic and recurrent abdominal pain in children, according to a recent review. It is characterized by paroxysms of moderate to severe abdominal pain that is midline, periumbilical, or diffuse in location and accompanied by other symptoms including headache, anorexia, nausea, vomiting, or pallor. Despite the presence of comprehensive diagnostic criteria, it continues to be an underdiagnosed entity. Key points include:

• The average age of diagnosis is 3 to 10 years with peak incidence at 7 years.
• Most of the patients have a personal or family history of migraine.
• Pathophysiology of the condition is believed to be similar to that of other functional gastrointestinal disorders and cephalic migraine; it is also well recognized as a type of pediatric migraine variant.
• A careful history, thorough physical examination, and use of well-defined, symptom-based guidelines are needed to make a diagnosis.
• Although it resolves completely in most of the patients, these patients have a strong propensity to develop migraine later in life.
• Nonpharmacologic treatment options, including avoidance of triggers, behavior therapy, and dietary modifications should be the initial line of management.

Pediatric abdominal migraine: current perspectives on a lesser known entity. [Published online ahead of print April 24, 2018]. Pediatric Health Med Ther. doi:10.2147%2FPHMT.S127210.

Abdominal migraine is a common cause of chronic and recurrent abdominal pain in children, according to a recent review. It is characterized by paroxysms of moderate to severe abdominal pain that is midline, periumbilical, or diffuse in location and accompanied by other symptoms including headache, anorexia, nausea, vomiting, or pallor. Despite the presence of comprehensive diagnostic criteria, it continues to be an underdiagnosed entity. Key points include:

• The average age of diagnosis is 3 to 10 years with peak incidence at 7 years.
• Most of the patients have a personal or family history of migraine.
• Pathophysiology of the condition is believed to be similar to that of other functional gastrointestinal disorders and cephalic migraine; it is also well recognized as a type of pediatric migraine variant.
• A careful history, thorough physical examination, and use of well-defined, symptom-based guidelines are needed to make a diagnosis.
• Although it resolves completely in most of the patients, these patients have a strong propensity to develop migraine later in life.
• Nonpharmacologic treatment options, including avoidance of triggers, behavior therapy, and dietary modifications should be the initial line of management.

Pediatric abdominal migraine: current perspectives on a lesser known entity. [Published online ahead of print April 24, 2018]. Pediatric Health Med Ther. doi:10.2147%2FPHMT.S127210.

BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that a much better measure of ablation’s success is the extent to which it cuts atrial fibrillation burden, the overall percentage of time a patient spends in the arrhythmic state.

The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.

Mitchel L. Zoler/MDedge News

One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.

CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.

[email protected]

SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
 

BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that a much better measure of ablation’s success is the extent to which it cuts atrial fibrillation burden, the overall percentage of time a patient spends in the arrhythmic state.

The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.

Mitchel L. Zoler/MDedge News

One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.

CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.

[email protected]

SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
 

BOSTON – From the earliest days of using catheter ablation to treat atrial fibrillation (AF), in the 1990s, clinicians have defined ablation success based on whether patients had recurrence of their arrhythmia following treatment. New findings suggest that this standard was off, and that a much better measure of ablation’s success is the extent to which it cuts atrial fibrillation burden, the overall percentage of time a patient spends in the arrhythmic state.

The new study used data collected in the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) multicenter trial, which compared the efficacy of AF ablation with antiarrhythmic drug treatment in patients with heart failure for improving survival and freedom from hospitalization for heart failure. The trial’s primary finding showed that, in 363 randomized patients, AF ablation cut the primary adverse event rate by 38% relative to antiarrhythmic drug therapy (New Engl J Med. 2018 Feb 1;378[5]:417-27)

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Ablation was significantly more effective than drug therapy for cutting atrial fibrillation burden, which started at an average of about 50% in all patients at baseline. AF burden fell to an average of about 10%-15% among the ablated patients when measured at several time points during follow-up, whereas AF burden remained at an average of about 50% or higher among the drug-treated patients.

Mitchel L. Zoler/MDedge News

One further observation in the new analysis was that a drop in AF burden was linked with improved outcomes regardless of whether or not a “blanking period” was imposed on the data. Researchers applied a 90-day blanking period after ablation when assessing the treatment’s efficacy to censor from the analysis recurrences that occurred soon after ablation. The need for a blanking period during the first 90 days “was put to rest” by this new analysis, Dr. Brachmann said.

CASTLE-AF was sponsored by Biotronik. Dr. Brachmann has been a consultant to and has received research funding from Biotronik and several other companies. Dr. Krahn has been a consultant to Medtronic and has received research support from Medtronic and Boston Scientific. Dr. Link had no disclosures.

[email protected]

SOURCE: Brachmann J et al. Heart Rhythm 2018, Abstract B-LBCT02-04.
 

Athletes with a pre-injury migraine history may be at an elevated risk for a protracted return to school after concussion, especially girls and women, according to a recent study. High school and collegiate athletes (n=1265; 42% female) who sustained a sport-related concussion were monitored by athletic trainers using a web-based surveillance system that collects information about concussion recovery. Researchers found:

• There were 117 athletes (9.2%) who reported a pre-injury migraine history.
• Athletes with a history of migraine took a median of 6 days to return to academics and 15.5 days to return to athletics, while those with no migraine history took a median of 5 days to return to academics and 14 days to return to athletics.
• There were no statistically significant differences in days to return to school or athletics between the groups.
• However, a lower percentage of athletes with a history of migraine had returned to school after 7 days, 14 days, and 21 days post-injury.
• Stratifying the analyses by sex showed that this effect was significant in girls and women with pre-existing migraines, but not boys and men with pre-existing migraines.

Pre-injury migraine history as a risk factor for prolonged return to school and sports following concussion. [Published online ahead of print May 5, 2018]. J Neurotrauma. doi:10.1089/neu.2017.5443.

Athletes with a pre-injury migraine history may be at an elevated risk for a protracted return to school after concussion, especially girls and women, according to a recent study. High school and collegiate athletes (n=1265; 42% female) who sustained a sport-related concussion were monitored by athletic trainers using a web-based surveillance system that collects information about concussion recovery. Researchers found:

• There were 117 athletes (9.2%) who reported a pre-injury migraine history.
• Athletes with a history of migraine took a median of 6 days to return to academics and 15.5 days to return to athletics, while those with no migraine history took a median of 5 days to return to academics and 14 days to return to athletics.
• There were no statistically significant differences in days to return to school or athletics between the groups.
• However, a lower percentage of athletes with a history of migraine had returned to school after 7 days, 14 days, and 21 days post-injury.
• Stratifying the analyses by sex showed that this effect was significant in girls and women with pre-existing migraines, but not boys and men with pre-existing migraines.

Pre-injury migraine history as a risk factor for prolonged return to school and sports following concussion. [Published online ahead of print May 5, 2018]. J Neurotrauma. doi:10.1089/neu.2017.5443.

Athletes with a pre-injury migraine history may be at an elevated risk for a protracted return to school after concussion, especially girls and women, according to a recent study. High school and collegiate athletes (n=1265; 42% female) who sustained a sport-related concussion were monitored by athletic trainers using a web-based surveillance system that collects information about concussion recovery. Researchers found:

• There were 117 athletes (9.2%) who reported a pre-injury migraine history.
• Athletes with a history of migraine took a median of 6 days to return to academics and 15.5 days to return to athletics, while those with no migraine history took a median of 5 days to return to academics and 14 days to return to athletics.
• There were no statistically significant differences in days to return to school or athletics between the groups.
• However, a lower percentage of athletes with a history of migraine had returned to school after 7 days, 14 days, and 21 days post-injury.
• Stratifying the analyses by sex showed that this effect was significant in girls and women with pre-existing migraines, but not boys and men with pre-existing migraines.

Pre-injury migraine history as a risk factor for prolonged return to school and sports following concussion. [Published online ahead of print May 5, 2018]. J Neurotrauma. doi:10.1089/neu.2017.5443.