“The licensed vaccines HPV-16/18 AS04–adjuvanted (Cervarix; GSK Vaccines) and HPV-6/11/16/18 (Gardasil; Merck) were first approved as regimen including three doses (3D) with administration over a 6-month period,” reported Thanyawee Puthanakit, MD, of Chulalongkorn University in Bangkok, and her associates. “Reduced dose schedules could make vaccination easier to implement and more affordable, creating the potential for higher vaccination coverage and improved cervical cancer protection (J Infect Dis. 2016;214:525-36).”

©jarun011/Thinkstock

The investigators enrolled girls aged 9-25 years starting in June 2011, from 33 clinical sites in Canada, Germany, Italy, Taiwan, and Thailand. The study lasted through January 2013, during which time 1,447 girls were enrolled and 1,428 were randomized into one of three cohorts: one receiving the two-dose, 6-month regimen; one receiving the two-dose, 12-month regime; and one receiving the three-dose, 6-month regimen. In the former two cohorts, girls aged 9-14 years would receive their doses at 0 months and either 6 or 12 months, depending on the cohort. In the three-dose regimen, girls aged 15-25 years received doses at 0, 1, and 6 months. At enrollment, 550 girls were randomized into the two-dose, 6-month regimen; 415 girls into the two-dose, 12-month regimen; and 482 girls into the three-dose, 6-month regimen. Follow-up occurred at 1 month after they received the final dose for all three cohorts.

Ultimately, 534 girls in the two-dose, 6-month cohort; 394 in the two-dose, 12-month cohort; and 427 in the three-dose, 6-month cohort completed the study through the 1-month follow-up. Serologic testing indicated that girls in both the two-dose cohorts were not immunologically worse off than those who were in the three-dose cohort, with seroconversion differences of 0.00 when comparing HPV-16 and HPV-18 antibodies between any two of the three regimens. Furthermore, geometric mean antibody titer ratios for HPV-16 and HPV-18 were 1.09 (95% confidence interval, 0.97-1.22) and 0.85 (95% CI, 0.76-0.95) for the 6-month two-dose regimen vs. three-dose, and 0.89 (95% CI, 0.79-1.01) and 0.75 (95% CI, 0.67-0.85) for 12-month two-dose regimen vs.three-dose, indicating little statistically significant difference.

“The flexibility around the timing of the second dose, giving the option of annual vaccination over 2 consecutive years, is an added benefit [because] reduced dose schedules of HPV vaccines may facilitate vaccination implementation and reduce cost, allowing for higher vaccination coverage and potentially more girls being protected from cervical cancer,” the investigators noted.

The study was supported by GlaxoSmithKline Biologicals SA. Dr. Puthanakit received a grant from GSK through her institution. Some of her many coauthors disclosed relationships with GSK and/or other pharmaceutical companies.

dchitnis@frontlinemedcom.com

“The licensed vaccines HPV-16/18 AS04–adjuvanted (Cervarix; GSK Vaccines) and HPV-6/11/16/18 (Gardasil; Merck) were first approved as regimen including three doses (3D) with administration over a 6-month period,” reported Thanyawee Puthanakit, MD, of Chulalongkorn University in Bangkok, and her associates. “Reduced dose schedules could make vaccination easier to implement and more affordable, creating the potential for higher vaccination coverage and improved cervical cancer protection (J Infect Dis. 2016;214:525-36).”

©jarun011/Thinkstock

The investigators enrolled girls aged 9-25 years starting in June 2011, from 33 clinical sites in Canada, Germany, Italy, Taiwan, and Thailand. The study lasted through January 2013, during which time 1,447 girls were enrolled and 1,428 were randomized into one of three cohorts: one receiving the two-dose, 6-month regimen; one receiving the two-dose, 12-month regime; and one receiving the three-dose, 6-month regimen. In the former two cohorts, girls aged 9-14 years would receive their doses at 0 months and either 6 or 12 months, depending on the cohort. In the three-dose regimen, girls aged 15-25 years received doses at 0, 1, and 6 months. At enrollment, 550 girls were randomized into the two-dose, 6-month regimen; 415 girls into the two-dose, 12-month regimen; and 482 girls into the three-dose, 6-month regimen. Follow-up occurred at 1 month after they received the final dose for all three cohorts.

Ultimately, 534 girls in the two-dose, 6-month cohort; 394 in the two-dose, 12-month cohort; and 427 in the three-dose, 6-month cohort completed the study through the 1-month follow-up. Serologic testing indicated that girls in both the two-dose cohorts were not immunologically worse off than those who were in the three-dose cohort, with seroconversion differences of 0.00 when comparing HPV-16 and HPV-18 antibodies between any two of the three regimens. Furthermore, geometric mean antibody titer ratios for HPV-16 and HPV-18 were 1.09 (95% confidence interval, 0.97-1.22) and 0.85 (95% CI, 0.76-0.95) for the 6-month two-dose regimen vs. three-dose, and 0.89 (95% CI, 0.79-1.01) and 0.75 (95% CI, 0.67-0.85) for 12-month two-dose regimen vs.three-dose, indicating little statistically significant difference.

“The flexibility around the timing of the second dose, giving the option of annual vaccination over 2 consecutive years, is an added benefit [because] reduced dose schedules of HPV vaccines may facilitate vaccination implementation and reduce cost, allowing for higher vaccination coverage and potentially more girls being protected from cervical cancer,” the investigators noted.

The study was supported by GlaxoSmithKline Biologicals SA. Dr. Puthanakit received a grant from GSK through her institution. Some of her many coauthors disclosed relationships with GSK and/or other pharmaceutical companies.

dchitnis@frontlinemedcom.com

“The licensed vaccines HPV-16/18 AS04–adjuvanted (Cervarix; GSK Vaccines) and HPV-6/11/16/18 (Gardasil; Merck) were first approved as regimen including three doses (3D) with administration over a 6-month period,” reported Thanyawee Puthanakit, MD, of Chulalongkorn University in Bangkok, and her associates. “Reduced dose schedules could make vaccination easier to implement and more affordable, creating the potential for higher vaccination coverage and improved cervical cancer protection (J Infect Dis. 2016;214:525-36).”

©jarun011/Thinkstock

The investigators enrolled girls aged 9-25 years starting in June 2011, from 33 clinical sites in Canada, Germany, Italy, Taiwan, and Thailand. The study lasted through January 2013, during which time 1,447 girls were enrolled and 1,428 were randomized into one of three cohorts: one receiving the two-dose, 6-month regimen; one receiving the two-dose, 12-month regime; and one receiving the three-dose, 6-month regimen. In the former two cohorts, girls aged 9-14 years would receive their doses at 0 months and either 6 or 12 months, depending on the cohort. In the three-dose regimen, girls aged 15-25 years received doses at 0, 1, and 6 months. At enrollment, 550 girls were randomized into the two-dose, 6-month regimen; 415 girls into the two-dose, 12-month regimen; and 482 girls into the three-dose, 6-month regimen. Follow-up occurred at 1 month after they received the final dose for all three cohorts.

Ultimately, 534 girls in the two-dose, 6-month cohort; 394 in the two-dose, 12-month cohort; and 427 in the three-dose, 6-month cohort completed the study through the 1-month follow-up. Serologic testing indicated that girls in both the two-dose cohorts were not immunologically worse off than those who were in the three-dose cohort, with seroconversion differences of 0.00 when comparing HPV-16 and HPV-18 antibodies between any two of the three regimens. Furthermore, geometric mean antibody titer ratios for HPV-16 and HPV-18 were 1.09 (95% confidence interval, 0.97-1.22) and 0.85 (95% CI, 0.76-0.95) for the 6-month two-dose regimen vs. three-dose, and 0.89 (95% CI, 0.79-1.01) and 0.75 (95% CI, 0.67-0.85) for 12-month two-dose regimen vs.three-dose, indicating little statistically significant difference.

“The flexibility around the timing of the second dose, giving the option of annual vaccination over 2 consecutive years, is an added benefit [because] reduced dose schedules of HPV vaccines may facilitate vaccination implementation and reduce cost, allowing for higher vaccination coverage and potentially more girls being protected from cervical cancer,” the investigators noted.

The study was supported by GlaxoSmithKline Biologicals SA. Dr. Puthanakit received a grant from GSK through her institution. Some of her many coauthors disclosed relationships with GSK and/or other pharmaceutical companies.

dchitnis@frontlinemedcom.com

SEATTLE – It’s better to place gastrostomy tubes before head and neck cancer surgery rather than after, according to a review of 184 patients.

The 73 patients in the study who got preoperative gastrostomy tubes (G-tubes) were sicker than the 111 who had G-tubes placed after surgery, with significantly higher American Society of Anesthesiologists scores, lower body mass indexes, and greater likelihoods of having both prior radiation and more extensive resections requiring flap reconstructions. They were, overall, a higher-risk population with a greater potential for bad outcomes, which is why tubes were placed preemptively.

Even so, at 6 months, the total average cost for the preop G-tube group was $39,751 versus $48,999 for the postoperative group, a savings of $9,248 per patient. The difference was driven by inpatient savings; the preop group left the hospital an average of 3.2 days sooner than their postop G-tube peers (9.4 days versus 12.6 days; P less than .001). Readmissions and other postdischarge costs were similar between the two groups, as were wound and nonwound complications.

“This data suggests that preoperative placement of G-tubes is associated with lower total health care costs. It appears there’s a potential for health care cost savings if candidates for G-tubes can be identified” before surgery and the tubes placed preoperatively, said investigator Joshua Waltonen, MD, of Wake Forest University, Winston-Salem, N.C.

That’s exactly what Wake Forest is doing now. Physicians there use a scoring system to determine how likely patients are to need G-tubes after surgery. If the risk is high, patients are counseled that putting one in beforehand is a good idea, he said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The team previously found that risk factors include, among others, supracricoid laryngectomy, prior radiation, flap reconstruction, tracheostomy placement, and preop dysphagia and weight loss (JAMA Otolaryngol Head Neck Surg. 2014 Dec;140[12]:1198-206).

Two factors probably account for the shorter lengths of stay, Dr. Waltonen said. First, patients with preop feeding tubes go into surgery with a nutritional boost, which helps with recovery. Also, with a preop tube, patients don’t have to wait for general surgery to get around to placing one postoperatively.

Both groups were about 60 years old on average. The mean body mass index of the preop group was 23 kg/m^{2 and} 26 kg/m^{2 in the postop group} (P = .009). Almost two-thirds of preop patients had prior radiation versus a quarter of postop patients (P less than .001). Tumor and nodal stages were similar.

There was no outside funding for the work, and Dr. Waltonen had no disclosures.

aotto@frontlinemedcom.com

SEATTLE – It’s better to place gastrostomy tubes before head and neck cancer surgery rather than after, according to a review of 184 patients.

The 73 patients in the study who got preoperative gastrostomy tubes (G-tubes) were sicker than the 111 who had G-tubes placed after surgery, with significantly higher American Society of Anesthesiologists scores, lower body mass indexes, and greater likelihoods of having both prior radiation and more extensive resections requiring flap reconstructions. They were, overall, a higher-risk population with a greater potential for bad outcomes, which is why tubes were placed preemptively.

Even so, at 6 months, the total average cost for the preop G-tube group was $39,751 versus $48,999 for the postoperative group, a savings of $9,248 per patient. The difference was driven by inpatient savings; the preop group left the hospital an average of 3.2 days sooner than their postop G-tube peers (9.4 days versus 12.6 days; P less than .001). Readmissions and other postdischarge costs were similar between the two groups, as were wound and nonwound complications.

“This data suggests that preoperative placement of G-tubes is associated with lower total health care costs. It appears there’s a potential for health care cost savings if candidates for G-tubes can be identified” before surgery and the tubes placed preoperatively, said investigator Joshua Waltonen, MD, of Wake Forest University, Winston-Salem, N.C.

That’s exactly what Wake Forest is doing now. Physicians there use a scoring system to determine how likely patients are to need G-tubes after surgery. If the risk is high, patients are counseled that putting one in beforehand is a good idea, he said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The team previously found that risk factors include, among others, supracricoid laryngectomy, prior radiation, flap reconstruction, tracheostomy placement, and preop dysphagia and weight loss (JAMA Otolaryngol Head Neck Surg. 2014 Dec;140[12]:1198-206).

Two factors probably account for the shorter lengths of stay, Dr. Waltonen said. First, patients with preop feeding tubes go into surgery with a nutritional boost, which helps with recovery. Also, with a preop tube, patients don’t have to wait for general surgery to get around to placing one postoperatively.

Both groups were about 60 years old on average. The mean body mass index of the preop group was 23 kg/m^{2 and} 26 kg/m^{2 in the postop group} (P = .009). Almost two-thirds of preop patients had prior radiation versus a quarter of postop patients (P less than .001). Tumor and nodal stages were similar.

There was no outside funding for the work, and Dr. Waltonen had no disclosures.

aotto@frontlinemedcom.com

SEATTLE – It’s better to place gastrostomy tubes before head and neck cancer surgery rather than after, according to a review of 184 patients.

The 73 patients in the study who got preoperative gastrostomy tubes (G-tubes) were sicker than the 111 who had G-tubes placed after surgery, with significantly higher American Society of Anesthesiologists scores, lower body mass indexes, and greater likelihoods of having both prior radiation and more extensive resections requiring flap reconstructions. They were, overall, a higher-risk population with a greater potential for bad outcomes, which is why tubes were placed preemptively.

Even so, at 6 months, the total average cost for the preop G-tube group was $39,751 versus $48,999 for the postoperative group, a savings of $9,248 per patient. The difference was driven by inpatient savings; the preop group left the hospital an average of 3.2 days sooner than their postop G-tube peers (9.4 days versus 12.6 days; P less than .001). Readmissions and other postdischarge costs were similar between the two groups, as were wound and nonwound complications.

“This data suggests that preoperative placement of G-tubes is associated with lower total health care costs. It appears there’s a potential for health care cost savings if candidates for G-tubes can be identified” before surgery and the tubes placed preoperatively, said investigator Joshua Waltonen, MD, of Wake Forest University, Winston-Salem, N.C.

That’s exactly what Wake Forest is doing now. Physicians there use a scoring system to determine how likely patients are to need G-tubes after surgery. If the risk is high, patients are counseled that putting one in beforehand is a good idea, he said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The team previously found that risk factors include, among others, supracricoid laryngectomy, prior radiation, flap reconstruction, tracheostomy placement, and preop dysphagia and weight loss (JAMA Otolaryngol Head Neck Surg. 2014 Dec;140[12]:1198-206).

Two factors probably account for the shorter lengths of stay, Dr. Waltonen said. First, patients with preop feeding tubes go into surgery with a nutritional boost, which helps with recovery. Also, with a preop tube, patients don’t have to wait for general surgery to get around to placing one postoperatively.

Both groups were about 60 years old on average. The mean body mass index of the preop group was 23 kg/m^{2 and} 26 kg/m^{2 in the postop group} (P = .009). Almost two-thirds of preop patients had prior radiation versus a quarter of postop patients (P less than .001). Tumor and nodal stages were similar.

There was no outside funding for the work, and Dr. Waltonen had no disclosures.

aotto@frontlinemedcom.com

Low-income adults living in two states that expanded Medicaid enrollment are showing significant increases in outpatient utilization and preventive care, improved health care quality, and reductions in emergency department use, compared with those living in a state that did not expand Medicaid, according to a new study.

The study also found similar improvements in care whether a state expanded traditional Medicaid or increased coverage through a private insurance option.

©Karen Roach/Fotolia

Benjamin D. Sommers, MD, PhD, of Harvard University, Boston, and his colleagues examined outcomes for nearly 9,000 low-income Medicaid enrollees in Kentucky (where officials expanded traditional Medicaid), Arkansas (where the state used funds to purchase private insurance to expand coverage), and Texas (which did not expand Medicaid) in November and December of 2013, 2014, and 2015. They looked specifically at changes in use of healthcare services, preventive care, and self-reported health (JAMA Intern Med. 2016 Aug 8. doi: 10.1001/jamainternmed.2016.4419).

“By the end of 2015, we found marked increases in coverage and reduced cost-related barriers to care in the expansion states, with associated increases in preventive care, outpatient visits, annual checkups, and chronic disease care, as well as decreased reliance on the [emergency department],” the researchers wrote.

They found that by 2015 there was a 6 percentage point drop in the likelihood of ED visits (P = 0.04), an increase of 0.69 office visits per person in the outpatient setting (P = 0.04), and an increase likelihood of getting a checkup (16.1 percentage points, P less than .001) in Medicaid expansion states. In Medicaid expansion states the share of adults obtaining regular care for chronic conditions increased by 12 percentage points after expansion (P = .008), compared with Texas. Additionally, adults reporting fair or poor quality of care dropped by 7.1 percentage points (P = .03).

One significant difference between the expansion states was changes in glucose monitoring rates for patients with diabetes were lower in Arkansas than Kentucky (–11.6 percentage points, P = .04).

“Of note, we found improvements in receipt of checkups, care for chronic conditions, and quality of care even in areas with primary care shortages, suggesting that while clinician capacity is undoubtedly an important consideration, insurance expansion can have a demonstrable positive impact even in areas with relative shortages, perhaps partially due to increased use of safety net providers,” the researchers added.

The study was supported by a research grant from the Commonwealth Fund and a grant from the Agency for Healthcare Research and Quality. The researchers reported having no financial disclosures.

gtwachtman@frontlinemedcom.com

Low-income adults living in two states that expanded Medicaid enrollment are showing significant increases in outpatient utilization and preventive care, improved health care quality, and reductions in emergency department use, compared with those living in a state that did not expand Medicaid, according to a new study.

The study also found similar improvements in care whether a state expanded traditional Medicaid or increased coverage through a private insurance option.

©Karen Roach/Fotolia

Benjamin D. Sommers, MD, PhD, of Harvard University, Boston, and his colleagues examined outcomes for nearly 9,000 low-income Medicaid enrollees in Kentucky (where officials expanded traditional Medicaid), Arkansas (where the state used funds to purchase private insurance to expand coverage), and Texas (which did not expand Medicaid) in November and December of 2013, 2014, and 2015. They looked specifically at changes in use of healthcare services, preventive care, and self-reported health (JAMA Intern Med. 2016 Aug 8. doi: 10.1001/jamainternmed.2016.4419).

“By the end of 2015, we found marked increases in coverage and reduced cost-related barriers to care in the expansion states, with associated increases in preventive care, outpatient visits, annual checkups, and chronic disease care, as well as decreased reliance on the [emergency department],” the researchers wrote.

They found that by 2015 there was a 6 percentage point drop in the likelihood of ED visits (P = 0.04), an increase of 0.69 office visits per person in the outpatient setting (P = 0.04), and an increase likelihood of getting a checkup (16.1 percentage points, P less than .001) in Medicaid expansion states. In Medicaid expansion states the share of adults obtaining regular care for chronic conditions increased by 12 percentage points after expansion (P = .008), compared with Texas. Additionally, adults reporting fair or poor quality of care dropped by 7.1 percentage points (P = .03).

One significant difference between the expansion states was changes in glucose monitoring rates for patients with diabetes were lower in Arkansas than Kentucky (–11.6 percentage points, P = .04).

“Of note, we found improvements in receipt of checkups, care for chronic conditions, and quality of care even in areas with primary care shortages, suggesting that while clinician capacity is undoubtedly an important consideration, insurance expansion can have a demonstrable positive impact even in areas with relative shortages, perhaps partially due to increased use of safety net providers,” the researchers added.

The study was supported by a research grant from the Commonwealth Fund and a grant from the Agency for Healthcare Research and Quality. The researchers reported having no financial disclosures.

gtwachtman@frontlinemedcom.com

Low-income adults living in two states that expanded Medicaid enrollment are showing significant increases in outpatient utilization and preventive care, improved health care quality, and reductions in emergency department use, compared with those living in a state that did not expand Medicaid, according to a new study.

The study also found similar improvements in care whether a state expanded traditional Medicaid or increased coverage through a private insurance option.

©Karen Roach/Fotolia

Benjamin D. Sommers, MD, PhD, of Harvard University, Boston, and his colleagues examined outcomes for nearly 9,000 low-income Medicaid enrollees in Kentucky (where officials expanded traditional Medicaid), Arkansas (where the state used funds to purchase private insurance to expand coverage), and Texas (which did not expand Medicaid) in November and December of 2013, 2014, and 2015. They looked specifically at changes in use of healthcare services, preventive care, and self-reported health (JAMA Intern Med. 2016 Aug 8. doi: 10.1001/jamainternmed.2016.4419).

“By the end of 2015, we found marked increases in coverage and reduced cost-related barriers to care in the expansion states, with associated increases in preventive care, outpatient visits, annual checkups, and chronic disease care, as well as decreased reliance on the [emergency department],” the researchers wrote.

They found that by 2015 there was a 6 percentage point drop in the likelihood of ED visits (P = 0.04), an increase of 0.69 office visits per person in the outpatient setting (P = 0.04), and an increase likelihood of getting a checkup (16.1 percentage points, P less than .001) in Medicaid expansion states. In Medicaid expansion states the share of adults obtaining regular care for chronic conditions increased by 12 percentage points after expansion (P = .008), compared with Texas. Additionally, adults reporting fair or poor quality of care dropped by 7.1 percentage points (P = .03).

One significant difference between the expansion states was changes in glucose monitoring rates for patients with diabetes were lower in Arkansas than Kentucky (–11.6 percentage points, P = .04).

“Of note, we found improvements in receipt of checkups, care for chronic conditions, and quality of care even in areas with primary care shortages, suggesting that while clinician capacity is undoubtedly an important consideration, insurance expansion can have a demonstrable positive impact even in areas with relative shortages, perhaps partially due to increased use of safety net providers,” the researchers added.

The study was supported by a research grant from the Commonwealth Fund and a grant from the Agency for Healthcare Research and Quality. The researchers reported having no financial disclosures.

gtwachtman@frontlinemedcom.com

SEATTLE – Direct, intraoperative electrical stimulation of the spinal accessory nerve reduced shoulder pain and dysfunction from oncologic neck dissection in a small, randomized trial.

Shoulder problems are common after neck dissection because of traction and compression of the spinal accessory nerve. Although brief electrical stimulation (BES) has been shown before to improve regeneration and recovery of injured peripheral nerves, it hasn’t been shown until now to help patients recover from neck surgery, said investigator Brittany Barber, MD, a fifth-year resident at the University of Alberta, Edmonton.

After neck dissection in 21 patients, the investigators wrapped a small electrode (Automatic Periodic Stimulation [APS] electrode, Medtronic) around the spinal accessory nerve at the base of the skull on the side of the neck with the most extensive nodal burden; the electrode delivered 100-msec pulses at 20 Hz and 3-5 V for an hour, and then the neck was closed. The team compared outcomes with 20 controls who had neck dissections without BES.

At 12 months, the BES group had an 8.4 point drop from baseline on the 100-point Constant Murley Shoulder Outcome Score, while the controls lost a mean of 29.4 points. The Murley score measures shoulder pain, performance of daily tasks, range of motion, and strength; higher scores are better. Similarly, BES patients lost a mean of 16.2 points on the 50-point Neck Dissection Impairment Index, while controls lost 30.1 points, and controls performed markedly worse on nerve conduction studies. In short, BES patients “were less likely to have clinically significant shoulder dysfunction” after surgery, Dr. Barber said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The APS electrode is a tiny silicone cuff with a metal conductor. The device was originally designed to monitor recurrent laryngeal nerve function during thyroid surgery. “We had [Medtronic] write a software patch” so it could be used for stimulation, she said.

The team is planning a larger, multicenter trial to shore up their findings, and also plans to test the device for hypoglossal nerve preservation after resection.

Transcutaneous nerve stimulation is another option, but it’s a bit uncomfortable and patients often don’t complete their sessions. “Compliance is not as good as with a single intraoperative procedure,” and the results aren’t that great. “We thought this might be a better alternative,” Dr. Barber said.

The two groups were well matched: Mean age was about 60 years and most patients had advanced-stage tumors. There was no difference in preop shoulder problems or risks for poor postop shoulder outcomes, and no difference in the number of level 5 neck dissections or mean number of lymph nodes removed during surgery.

There was no outside funding for the work. Dr. Barber had no disclosures; a coinvestigator was a Medtronic consultant.

aotto@frontlinemedcom.com

SEATTLE – Direct, intraoperative electrical stimulation of the spinal accessory nerve reduced shoulder pain and dysfunction from oncologic neck dissection in a small, randomized trial.

Shoulder problems are common after neck dissection because of traction and compression of the spinal accessory nerve. Although brief electrical stimulation (BES) has been shown before to improve regeneration and recovery of injured peripheral nerves, it hasn’t been shown until now to help patients recover from neck surgery, said investigator Brittany Barber, MD, a fifth-year resident at the University of Alberta, Edmonton.

After neck dissection in 21 patients, the investigators wrapped a small electrode (Automatic Periodic Stimulation [APS] electrode, Medtronic) around the spinal accessory nerve at the base of the skull on the side of the neck with the most extensive nodal burden; the electrode delivered 100-msec pulses at 20 Hz and 3-5 V for an hour, and then the neck was closed. The team compared outcomes with 20 controls who had neck dissections without BES.

At 12 months, the BES group had an 8.4 point drop from baseline on the 100-point Constant Murley Shoulder Outcome Score, while the controls lost a mean of 29.4 points. The Murley score measures shoulder pain, performance of daily tasks, range of motion, and strength; higher scores are better. Similarly, BES patients lost a mean of 16.2 points on the 50-point Neck Dissection Impairment Index, while controls lost 30.1 points, and controls performed markedly worse on nerve conduction studies. In short, BES patients “were less likely to have clinically significant shoulder dysfunction” after surgery, Dr. Barber said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The APS electrode is a tiny silicone cuff with a metal conductor. The device was originally designed to monitor recurrent laryngeal nerve function during thyroid surgery. “We had [Medtronic] write a software patch” so it could be used for stimulation, she said.

The team is planning a larger, multicenter trial to shore up their findings, and also plans to test the device for hypoglossal nerve preservation after resection.

Transcutaneous nerve stimulation is another option, but it’s a bit uncomfortable and patients often don’t complete their sessions. “Compliance is not as good as with a single intraoperative procedure,” and the results aren’t that great. “We thought this might be a better alternative,” Dr. Barber said.

The two groups were well matched: Mean age was about 60 years and most patients had advanced-stage tumors. There was no difference in preop shoulder problems or risks for poor postop shoulder outcomes, and no difference in the number of level 5 neck dissections or mean number of lymph nodes removed during surgery.

There was no outside funding for the work. Dr. Barber had no disclosures; a coinvestigator was a Medtronic consultant.

aotto@frontlinemedcom.com

SEATTLE – Direct, intraoperative electrical stimulation of the spinal accessory nerve reduced shoulder pain and dysfunction from oncologic neck dissection in a small, randomized trial.

Shoulder problems are common after neck dissection because of traction and compression of the spinal accessory nerve. Although brief electrical stimulation (BES) has been shown before to improve regeneration and recovery of injured peripheral nerves, it hasn’t been shown until now to help patients recover from neck surgery, said investigator Brittany Barber, MD, a fifth-year resident at the University of Alberta, Edmonton.

After neck dissection in 21 patients, the investigators wrapped a small electrode (Automatic Periodic Stimulation [APS] electrode, Medtronic) around the spinal accessory nerve at the base of the skull on the side of the neck with the most extensive nodal burden; the electrode delivered 100-msec pulses at 20 Hz and 3-5 V for an hour, and then the neck was closed. The team compared outcomes with 20 controls who had neck dissections without BES.

At 12 months, the BES group had an 8.4 point drop from baseline on the 100-point Constant Murley Shoulder Outcome Score, while the controls lost a mean of 29.4 points. The Murley score measures shoulder pain, performance of daily tasks, range of motion, and strength; higher scores are better. Similarly, BES patients lost a mean of 16.2 points on the 50-point Neck Dissection Impairment Index, while controls lost 30.1 points, and controls performed markedly worse on nerve conduction studies. In short, BES patients “were less likely to have clinically significant shoulder dysfunction” after surgery, Dr. Barber said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The APS electrode is a tiny silicone cuff with a metal conductor. The device was originally designed to monitor recurrent laryngeal nerve function during thyroid surgery. “We had [Medtronic] write a software patch” so it could be used for stimulation, she said.

The team is planning a larger, multicenter trial to shore up their findings, and also plans to test the device for hypoglossal nerve preservation after resection.

Transcutaneous nerve stimulation is another option, but it’s a bit uncomfortable and patients often don’t complete their sessions. “Compliance is not as good as with a single intraoperative procedure,” and the results aren’t that great. “We thought this might be a better alternative,” Dr. Barber said.

The two groups were well matched: Mean age was about 60 years and most patients had advanced-stage tumors. There was no difference in preop shoulder problems or risks for poor postop shoulder outcomes, and no difference in the number of level 5 neck dissections or mean number of lymph nodes removed during surgery.

There was no outside funding for the work. Dr. Barber had no disclosures; a coinvestigator was a Medtronic consultant.

aotto@frontlinemedcom.com

Veteran suicides increased 32% from 2001 to 2014 according to a new VA report. The report also noted that rates for adult nonveterans also increased by 23% over the same period. However, veterans still account for 18% of all suicides in the U.S.

The report also highlighted a number of positive developments. For example, a previous study, conducted in 2012, estimated that 22 veterans committed suicide per day. That study included information from 3 million records obtained from mortality records in 20 states or data from veterans who used VHA health services. The more recent study, which examines 55 million veteran records from every state from 1979 to 2014, found that an average of 20 veterans per day die  by suicide.

“Twenty a day is not that different from 22,” said David J. Shulkin, MD, VA Under Secretary for Health, in an interview. “It is far too high.”

Preventing veteran suicide is a top priority for the VA, and the recent report showed that the VA’s efforts are making an impact. For example, the rate of suicide among veterans who use VA services increased by 8.8% from 2001 to 2014, compared with a 38.6% increase in suicide among veterans who do not use VA services. These services include mental health treatment at VA medical centers, community-based outpatient clinics, and Vet Centers offering readjustment counseling.

In addition, the Veterans Crisis Line, launched in 2007, offers immediate support to veterans experiencing suicidal thoughts. To date, staffers have answered nearly 2.4 million calls and initiated the dispatch of emergency services to callers in crisis more than 62,000 times. The VA announced that it is expanding its Veterans Crisis Line by creating a satellite site in Atlanta, Georgia, and adding 200 additional responders.

“This collaborative effort provides both updated and comprehensive data that allow us to make better informed decisions on how to prevent this national tragedy,” said Dr. Shulkin, in a statement that previewed the survey results. “We as a nation must focus on bringing the number of veteran suicides to zero.”

Veteran suicides increased 32% from 2001 to 2014 according to a new VA report. The report also noted that rates for adult nonveterans also increased by 23% over the same period. However, veterans still account for 18% of all suicides in the U.S.

The report also highlighted a number of positive developments. For example, a previous study, conducted in 2012, estimated that 22 veterans committed suicide per day. That study included information from 3 million records obtained from mortality records in 20 states or data from veterans who used VHA health services. The more recent study, which examines 55 million veteran records from every state from 1979 to 2014, found that an average of 20 veterans per day die  by suicide.

“Twenty a day is not that different from 22,” said David J. Shulkin, MD, VA Under Secretary for Health, in an interview. “It is far too high.”

Preventing veteran suicide is a top priority for the VA, and the recent report showed that the VA’s efforts are making an impact. For example, the rate of suicide among veterans who use VA services increased by 8.8% from 2001 to 2014, compared with a 38.6% increase in suicide among veterans who do not use VA services. These services include mental health treatment at VA medical centers, community-based outpatient clinics, and Vet Centers offering readjustment counseling.

In addition, the Veterans Crisis Line, launched in 2007, offers immediate support to veterans experiencing suicidal thoughts. To date, staffers have answered nearly 2.4 million calls and initiated the dispatch of emergency services to callers in crisis more than 62,000 times. The VA announced that it is expanding its Veterans Crisis Line by creating a satellite site in Atlanta, Georgia, and adding 200 additional responders.

“This collaborative effort provides both updated and comprehensive data that allow us to make better informed decisions on how to prevent this national tragedy,” said Dr. Shulkin, in a statement that previewed the survey results. “We as a nation must focus on bringing the number of veteran suicides to zero.”

Veteran suicides increased 32% from 2001 to 2014 according to a new VA report. The report also noted that rates for adult nonveterans also increased by 23% over the same period. However, veterans still account for 18% of all suicides in the U.S.

The report also highlighted a number of positive developments. For example, a previous study, conducted in 2012, estimated that 22 veterans committed suicide per day. That study included information from 3 million records obtained from mortality records in 20 states or data from veterans who used VHA health services. The more recent study, which examines 55 million veteran records from every state from 1979 to 2014, found that an average of 20 veterans per day die  by suicide.

“Twenty a day is not that different from 22,” said David J. Shulkin, MD, VA Under Secretary for Health, in an interview. “It is far too high.”

Preventing veteran suicide is a top priority for the VA, and the recent report showed that the VA’s efforts are making an impact. For example, the rate of suicide among veterans who use VA services increased by 8.8% from 2001 to 2014, compared with a 38.6% increase in suicide among veterans who do not use VA services. These services include mental health treatment at VA medical centers, community-based outpatient clinics, and Vet Centers offering readjustment counseling.

In addition, the Veterans Crisis Line, launched in 2007, offers immediate support to veterans experiencing suicidal thoughts. To date, staffers have answered nearly 2.4 million calls and initiated the dispatch of emergency services to callers in crisis more than 62,000 times. The VA announced that it is expanding its Veterans Crisis Line by creating a satellite site in Atlanta, Georgia, and adding 200 additional responders.

“This collaborative effort provides both updated and comprehensive data that allow us to make better informed decisions on how to prevent this national tragedy,” said Dr. Shulkin, in a statement that previewed the survey results. “We as a nation must focus on bringing the number of veteran suicides to zero.”

In order to achieve optimal treatment results, clinicians must consider the anatomy of the head and neck when injecting cutaneous fillers in these areas. Dr. Anthony Rossi discusses the importance of knowing where and how to place the filler to attain the desired effect and provides practical tips for injecting the lateral cheeks, temple area, and masseter muscle.

In order to achieve optimal treatment results, clinicians must consider the anatomy of the head and neck when injecting cutaneous fillers in these areas. Dr. Anthony Rossi discusses the importance of knowing where and how to place the filler to attain the desired effect and provides practical tips for injecting the lateral cheeks, temple area, and masseter muscle.

In order to achieve optimal treatment results, clinicians must consider the anatomy of the head and neck when injecting cutaneous fillers in these areas. Dr. Anthony Rossi discusses the importance of knowing where and how to place the filler to attain the desired effect and provides practical tips for injecting the lateral cheeks, temple area, and masseter muscle.

A quadrivalent human papillomavirus vaccine provided adequate seroconversion response rates in immunocompromised children, according to Dr. C. Raina MacIntyre, MBBS, PhD, and her associates.

In a clinical trial of 59 immunocompromised children aged 5-18, seroconversion rates for HPV types 6, 11, 16, and 18 were 93.3%, 100%, 100%, and 88.9%, respectively, 7 months after receiving the first dose of vaccine. After 2 years, seroconversion rates for HPV types 6, 11, 16, and 18 were 82.2%, 91.1%, 91.1%, and 68.9%, respectively.

Thinkstockimages (yangna)

Local adverse events occurred in 16 patients after the first dose, but incidence decreased after the second and third doses. Injection site erythema, pain, and swelling were the most commonly reported adverse events. Minor disease flare occurred in two patients during the follow-up period, and one patient developed a squamous cell oral carcinoma, but the tumor could not be tested for HPV.

The data suggest “that HPV vaccine could be given earlier for immunosuppressed children, who are at higher risk of earlier onset cancers, but long-term follow-up studies are required to determine persistence of immunity,” the investigators said.

Find the full study in Vaccine (doi: 10.1016/j.vaccine.2016.06.049).

lfranki@frontlinemedcom.com

A quadrivalent human papillomavirus vaccine provided adequate seroconversion response rates in immunocompromised children, according to Dr. C. Raina MacIntyre, MBBS, PhD, and her associates.

In a clinical trial of 59 immunocompromised children aged 5-18, seroconversion rates for HPV types 6, 11, 16, and 18 were 93.3%, 100%, 100%, and 88.9%, respectively, 7 months after receiving the first dose of vaccine. After 2 years, seroconversion rates for HPV types 6, 11, 16, and 18 were 82.2%, 91.1%, 91.1%, and 68.9%, respectively.

Thinkstockimages (yangna)

Local adverse events occurred in 16 patients after the first dose, but incidence decreased after the second and third doses. Injection site erythema, pain, and swelling were the most commonly reported adverse events. Minor disease flare occurred in two patients during the follow-up period, and one patient developed a squamous cell oral carcinoma, but the tumor could not be tested for HPV.

The data suggest “that HPV vaccine could be given earlier for immunosuppressed children, who are at higher risk of earlier onset cancers, but long-term follow-up studies are required to determine persistence of immunity,” the investigators said.

Find the full study in Vaccine (doi: 10.1016/j.vaccine.2016.06.049).

lfranki@frontlinemedcom.com

A quadrivalent human papillomavirus vaccine provided adequate seroconversion response rates in immunocompromised children, according to Dr. C. Raina MacIntyre, MBBS, PhD, and her associates.

In a clinical trial of 59 immunocompromised children aged 5-18, seroconversion rates for HPV types 6, 11, 16, and 18 were 93.3%, 100%, 100%, and 88.9%, respectively, 7 months after receiving the first dose of vaccine. After 2 years, seroconversion rates for HPV types 6, 11, 16, and 18 were 82.2%, 91.1%, 91.1%, and 68.9%, respectively.

Thinkstockimages (yangna)

Local adverse events occurred in 16 patients after the first dose, but incidence decreased after the second and third doses. Injection site erythema, pain, and swelling were the most commonly reported adverse events. Minor disease flare occurred in two patients during the follow-up period, and one patient developed a squamous cell oral carcinoma, but the tumor could not be tested for HPV.

The data suggest “that HPV vaccine could be given earlier for immunosuppressed children, who are at higher risk of earlier onset cancers, but long-term follow-up studies are required to determine persistence of immunity,” the investigators said.

Find the full study in Vaccine (doi: 10.1016/j.vaccine.2016.06.049).

lfranki@frontlinemedcom.com

BOSTON – Patients with rosacea, particularly the erythrotelangiectatic form, are considered good candidates for treatment with lasers and light therapies, but for acne, treatments with these therapies are still in the development stage.

For acne, treatments that are being studied include those that target the sebaceous glands, according to Mathew M. Avram, MD, who spoke about laser and light therapies for acne and rosacea at the American Academy of Dermatology summer meeting.

Light therapies for rosacea

Oxyhemoglobin in the blood absorbs light from lasers at wavelengths of about 595 nm (pulsed dye laser) and 532 nm (KTP laser), creating heat that helps destroy capillaries that contribute to the appearance of rosacea. Over a period of 3-4 weeks, the vessels are resorbed, and facial redness diminishes.

Patients with rosacea that are expected to do best with laser therapy are those with telangiectasia. Laser therapy is also effective for background redness but will be less effective for people with the papules associated with rosacea and “almost not effective at all for preventing flushing,” Dr. Avram said in an interview at the meeting.

Intense pulsed light (IPL) is another modality for treating rosacea. As with lasers, the mode of action is heating of certain structures and chromophores, causing their destruction and resorption, but unlike lasers, IPL output is broad spectrum and can be modified using filters.

With IPL, “basically, the endpoint that you want to see is transient purpural change, just a fleeting period of some black and blue, or if you’re treating vessels, you want to see vessel clearance when you’re firing the laser or the intense pulsed light,” said Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston.

On-screen settings of laser or IPL devices are essential, “but ultimately, if you want to have an effective treatment you really have to see what’s happening to your target … you need to pay attention to clinical endpoints, which is seeing that black and blue or that vessel clearance, not just paying attention to what’s on the screen.”

With IPL, too much pressure can compress vessels and blanch the skin, resulting in a less effective treatment, he added. He noted that tissue graying, whitening, or contraction indicates overly aggressive treatment, with the risk of scarring.

Certain factors can reduce the efficacy of IPL treatments of rosacea. Dr. Avram recommended against treating tanned skin and pointed out that anemic patients may benefit less from this approach since less hemoglobin presents a less-absorptive target for the treatments. He also advised particular caution when treating darker skin phototypes. But the most common factor that may make these treatments less effective is when a patient is on any type of anticoagulant, including NSAIDs or warfarin (Coumadin), because the mechanism of action is immediate microvascular hemorrhage, thrombosis, and eventual resorption.

For best results, Dr. Avram advises “appropriate overlap with the laser” to get an even and uniform improvement in the redness, with about a 15% overlap. Spacing laser spots too far apart can result in “foot printing,” the appearance of clearance in the areas of the laser pulse, but not in areas immediately around it “so it looks almost polka dotted.” After treatments, all patients should avoid the sun, he added.

What’s ahead for acne treatment

Until now, laser and light-based treatments for acne, “have provided inconsistent benefits for patients and all too often disappointing results,” Dr. Avram said in the interview. But several developments on the horizon may offer more effective therapies based on completely different technologies than are currently available. “Each of these therapies will be targeting the sebaceous glands in order to provide improved treatment for acne.”

One is a cryolysis device that uses cooling to selectively target lipids in the sebaceous glands. (Cryolysis is similar to cryolipolysis, which uses cooling to target fat cells.) The lipid-filled adipocytes are more sensitive to cold than is the water-rich dermis, thereby preserving the surrounding structures. There are also laser wavelengths that are absorbed by lipids, one of which is at about 1720 nm. In this case, heating rather than cooling targets the lipids.

Another technology in development is the use of nanoparticles coated with elements such as gold that are massaged through the skin into the sebaceous glands. Laser treatment with multiple different wavelengths targets the nanoparticles, heating them within the sebaceous glands, resulting in improvements in acne. In this case, treatment does not depend on the absorption spectrum of lipids. Clinical trials of this approach are now underway.

It is too early to tell which of these technologies is going to be effective or what potential side effects may occur. “However, the exciting news is that there will be multiple different technologies” designed to improve acne by targeting the sebaceous gland, and there is “the promise of potentially more effective noninvasive treatments that don’t require topical medications or oral medications,” Dr. Avram said.

For these potential new treatments, some objective outcome measure is needed to judge their efficacy. Right now, all that can be said is that they target the sebaceous gland, and clinical work still needs to be done to determine whether they will be effective, the degree of effectiveness, and how to optimize treatment, he noted.

Dr. Avram reported financial relationships with Cytrellis Biosystems, Invasix, Kythera, Masters of Aesthetics, Sciton, Zalea, and Zeltiq Aesthetics.

BOSTON – Patients with rosacea, particularly the erythrotelangiectatic form, are considered good candidates for treatment with lasers and light therapies, but for acne, treatments with these therapies are still in the development stage.

For acne, treatments that are being studied include those that target the sebaceous glands, according to Mathew M. Avram, MD, who spoke about laser and light therapies for acne and rosacea at the American Academy of Dermatology summer meeting.

Light therapies for rosacea

Oxyhemoglobin in the blood absorbs light from lasers at wavelengths of about 595 nm (pulsed dye laser) and 532 nm (KTP laser), creating heat that helps destroy capillaries that contribute to the appearance of rosacea. Over a period of 3-4 weeks, the vessels are resorbed, and facial redness diminishes.

Patients with rosacea that are expected to do best with laser therapy are those with telangiectasia. Laser therapy is also effective for background redness but will be less effective for people with the papules associated with rosacea and “almost not effective at all for preventing flushing,” Dr. Avram said in an interview at the meeting.

Intense pulsed light (IPL) is another modality for treating rosacea. As with lasers, the mode of action is heating of certain structures and chromophores, causing their destruction and resorption, but unlike lasers, IPL output is broad spectrum and can be modified using filters.

With IPL, “basically, the endpoint that you want to see is transient purpural change, just a fleeting period of some black and blue, or if you’re treating vessels, you want to see vessel clearance when you’re firing the laser or the intense pulsed light,” said Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston.

On-screen settings of laser or IPL devices are essential, “but ultimately, if you want to have an effective treatment you really have to see what’s happening to your target … you need to pay attention to clinical endpoints, which is seeing that black and blue or that vessel clearance, not just paying attention to what’s on the screen.”

With IPL, too much pressure can compress vessels and blanch the skin, resulting in a less effective treatment, he added. He noted that tissue graying, whitening, or contraction indicates overly aggressive treatment, with the risk of scarring.

Certain factors can reduce the efficacy of IPL treatments of rosacea. Dr. Avram recommended against treating tanned skin and pointed out that anemic patients may benefit less from this approach since less hemoglobin presents a less-absorptive target for the treatments. He also advised particular caution when treating darker skin phototypes. But the most common factor that may make these treatments less effective is when a patient is on any type of anticoagulant, including NSAIDs or warfarin (Coumadin), because the mechanism of action is immediate microvascular hemorrhage, thrombosis, and eventual resorption.

For best results, Dr. Avram advises “appropriate overlap with the laser” to get an even and uniform improvement in the redness, with about a 15% overlap. Spacing laser spots too far apart can result in “foot printing,” the appearance of clearance in the areas of the laser pulse, but not in areas immediately around it “so it looks almost polka dotted.” After treatments, all patients should avoid the sun, he added.

What’s ahead for acne treatment

Until now, laser and light-based treatments for acne, “have provided inconsistent benefits for patients and all too often disappointing results,” Dr. Avram said in the interview. But several developments on the horizon may offer more effective therapies based on completely different technologies than are currently available. “Each of these therapies will be targeting the sebaceous glands in order to provide improved treatment for acne.”

One is a cryolysis device that uses cooling to selectively target lipids in the sebaceous glands. (Cryolysis is similar to cryolipolysis, which uses cooling to target fat cells.) The lipid-filled adipocytes are more sensitive to cold than is the water-rich dermis, thereby preserving the surrounding structures. There are also laser wavelengths that are absorbed by lipids, one of which is at about 1720 nm. In this case, heating rather than cooling targets the lipids.

Another technology in development is the use of nanoparticles coated with elements such as gold that are massaged through the skin into the sebaceous glands. Laser treatment with multiple different wavelengths targets the nanoparticles, heating them within the sebaceous glands, resulting in improvements in acne. In this case, treatment does not depend on the absorption spectrum of lipids. Clinical trials of this approach are now underway.

It is too early to tell which of these technologies is going to be effective or what potential side effects may occur. “However, the exciting news is that there will be multiple different technologies” designed to improve acne by targeting the sebaceous gland, and there is “the promise of potentially more effective noninvasive treatments that don’t require topical medications or oral medications,” Dr. Avram said.

For these potential new treatments, some objective outcome measure is needed to judge their efficacy. Right now, all that can be said is that they target the sebaceous gland, and clinical work still needs to be done to determine whether they will be effective, the degree of effectiveness, and how to optimize treatment, he noted.

Dr. Avram reported financial relationships with Cytrellis Biosystems, Invasix, Kythera, Masters of Aesthetics, Sciton, Zalea, and Zeltiq Aesthetics.

BOSTON – Patients with rosacea, particularly the erythrotelangiectatic form, are considered good candidates for treatment with lasers and light therapies, but for acne, treatments with these therapies are still in the development stage.

For acne, treatments that are being studied include those that target the sebaceous glands, according to Mathew M. Avram, MD, who spoke about laser and light therapies for acne and rosacea at the American Academy of Dermatology summer meeting.

Light therapies for rosacea

Oxyhemoglobin in the blood absorbs light from lasers at wavelengths of about 595 nm (pulsed dye laser) and 532 nm (KTP laser), creating heat that helps destroy capillaries that contribute to the appearance of rosacea. Over a period of 3-4 weeks, the vessels are resorbed, and facial redness diminishes.

Patients with rosacea that are expected to do best with laser therapy are those with telangiectasia. Laser therapy is also effective for background redness but will be less effective for people with the papules associated with rosacea and “almost not effective at all for preventing flushing,” Dr. Avram said in an interview at the meeting.

Intense pulsed light (IPL) is another modality for treating rosacea. As with lasers, the mode of action is heating of certain structures and chromophores, causing their destruction and resorption, but unlike lasers, IPL output is broad spectrum and can be modified using filters.

With IPL, “basically, the endpoint that you want to see is transient purpural change, just a fleeting period of some black and blue, or if you’re treating vessels, you want to see vessel clearance when you’re firing the laser or the intense pulsed light,” said Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston.

On-screen settings of laser or IPL devices are essential, “but ultimately, if you want to have an effective treatment you really have to see what’s happening to your target … you need to pay attention to clinical endpoints, which is seeing that black and blue or that vessel clearance, not just paying attention to what’s on the screen.”

With IPL, too much pressure can compress vessels and blanch the skin, resulting in a less effective treatment, he added. He noted that tissue graying, whitening, or contraction indicates overly aggressive treatment, with the risk of scarring.

Certain factors can reduce the efficacy of IPL treatments of rosacea. Dr. Avram recommended against treating tanned skin and pointed out that anemic patients may benefit less from this approach since less hemoglobin presents a less-absorptive target for the treatments. He also advised particular caution when treating darker skin phototypes. But the most common factor that may make these treatments less effective is when a patient is on any type of anticoagulant, including NSAIDs or warfarin (Coumadin), because the mechanism of action is immediate microvascular hemorrhage, thrombosis, and eventual resorption.

For best results, Dr. Avram advises “appropriate overlap with the laser” to get an even and uniform improvement in the redness, with about a 15% overlap. Spacing laser spots too far apart can result in “foot printing,” the appearance of clearance in the areas of the laser pulse, but not in areas immediately around it “so it looks almost polka dotted.” After treatments, all patients should avoid the sun, he added.

What’s ahead for acne treatment

Until now, laser and light-based treatments for acne, “have provided inconsistent benefits for patients and all too often disappointing results,” Dr. Avram said in the interview. But several developments on the horizon may offer more effective therapies based on completely different technologies than are currently available. “Each of these therapies will be targeting the sebaceous glands in order to provide improved treatment for acne.”

One is a cryolysis device that uses cooling to selectively target lipids in the sebaceous glands. (Cryolysis is similar to cryolipolysis, which uses cooling to target fat cells.) The lipid-filled adipocytes are more sensitive to cold than is the water-rich dermis, thereby preserving the surrounding structures. There are also laser wavelengths that are absorbed by lipids, one of which is at about 1720 nm. In this case, heating rather than cooling targets the lipids.

Another technology in development is the use of nanoparticles coated with elements such as gold that are massaged through the skin into the sebaceous glands. Laser treatment with multiple different wavelengths targets the nanoparticles, heating them within the sebaceous glands, resulting in improvements in acne. In this case, treatment does not depend on the absorption spectrum of lipids. Clinical trials of this approach are now underway.

It is too early to tell which of these technologies is going to be effective or what potential side effects may occur. “However, the exciting news is that there will be multiple different technologies” designed to improve acne by targeting the sebaceous gland, and there is “the promise of potentially more effective noninvasive treatments that don’t require topical medications or oral medications,” Dr. Avram said.

For these potential new treatments, some objective outcome measure is needed to judge their efficacy. Right now, all that can be said is that they target the sebaceous gland, and clinical work still needs to be done to determine whether they will be effective, the degree of effectiveness, and how to optimize treatment, he noted.

Dr. Avram reported financial relationships with Cytrellis Biosystems, Invasix, Kythera, Masters of Aesthetics, Sciton, Zalea, and Zeltiq Aesthetics.

The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.

The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.

The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.

Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.

The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.

lnikolaides@frontlinemedcom.com

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.

The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.

The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.

Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.

The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.

lnikolaides@frontlinemedcom.com

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.

The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.

The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.

Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.

The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.

lnikolaides@frontlinemedcom.com

On Twitter @NikolaidesLaura

Six months of stable international normalized ratio values [INRs] while on warfarin therapy doesn’t predict continued INR stability, according to a Research Letter to the Editor published August 9 in JAMA.

Whether or not to switch patients with atrial fibrillation from warfarin to non–vitamin K anticoagulants remains controversial. “A common belief has been that patients with stable INRs while taking warfarin would continue to be stable and derive less benefit from switching to non–vitamin K oral anticoagulants,” said Sean D. Pokorney, MD, of the division of cardiology, Duke University Medical Center, Durham, N.C., and his associates.

But the results of their observational study of 3,749 patients enrolled in an atrial fibrillation registry show that such stability cannot be predicted, and “challenge the notion that patients who have done well taking warfarin should maintain taking warfarin,” the investigators said (JAMA. 2016;316:661-3).

They assessed INRs over the course of 3 years of follow-up using data from patients enrolled in the registry through 176 clinics. INR stability was defined as having 80% or more of INRs in the therapeutic range (2-3). The mean patient age was 75 years, and 43% were women.

A total of 968 patients showed such INR stability throughout the first 6 months of the study. However, 36% of them went on to have at least one “well out of range” INR during the following year. Even in the subgroup of 376 patients who had 100% of their INRs within the therapeutic range during the first 6 months, 33% went on to have at least one “well out of range” INR during the following year, according to Dr. Pokorney and his associates.

No sponsor was cited for this study. Dr. Pokorney reported ties to AstraZeneca, Boston Scientific, Gilead, Janssen, and Medtronic; his associates reported ties to numerous industry sources.

Six months of stable international normalized ratio values [INRs] while on warfarin therapy doesn’t predict continued INR stability, according to a Research Letter to the Editor published August 9 in JAMA.

Whether or not to switch patients with atrial fibrillation from warfarin to non–vitamin K anticoagulants remains controversial. “A common belief has been that patients with stable INRs while taking warfarin would continue to be stable and derive less benefit from switching to non–vitamin K oral anticoagulants,” said Sean D. Pokorney, MD, of the division of cardiology, Duke University Medical Center, Durham, N.C., and his associates.

But the results of their observational study of 3,749 patients enrolled in an atrial fibrillation registry show that such stability cannot be predicted, and “challenge the notion that patients who have done well taking warfarin should maintain taking warfarin,” the investigators said (JAMA. 2016;316:661-3).

They assessed INRs over the course of 3 years of follow-up using data from patients enrolled in the registry through 176 clinics. INR stability was defined as having 80% or more of INRs in the therapeutic range (2-3). The mean patient age was 75 years, and 43% were women.

A total of 968 patients showed such INR stability throughout the first 6 months of the study. However, 36% of them went on to have at least one “well out of range” INR during the following year. Even in the subgroup of 376 patients who had 100% of their INRs within the therapeutic range during the first 6 months, 33% went on to have at least one “well out of range” INR during the following year, according to Dr. Pokorney and his associates.

No sponsor was cited for this study. Dr. Pokorney reported ties to AstraZeneca, Boston Scientific, Gilead, Janssen, and Medtronic; his associates reported ties to numerous industry sources.

Six months of stable international normalized ratio values [INRs] while on warfarin therapy doesn’t predict continued INR stability, according to a Research Letter to the Editor published August 9 in JAMA.

Whether or not to switch patients with atrial fibrillation from warfarin to non–vitamin K anticoagulants remains controversial. “A common belief has been that patients with stable INRs while taking warfarin would continue to be stable and derive less benefit from switching to non–vitamin K oral anticoagulants,” said Sean D. Pokorney, MD, of the division of cardiology, Duke University Medical Center, Durham, N.C., and his associates.

But the results of their observational study of 3,749 patients enrolled in an atrial fibrillation registry show that such stability cannot be predicted, and “challenge the notion that patients who have done well taking warfarin should maintain taking warfarin,” the investigators said (JAMA. 2016;316:661-3).

They assessed INRs over the course of 3 years of follow-up using data from patients enrolled in the registry through 176 clinics. INR stability was defined as having 80% or more of INRs in the therapeutic range (2-3). The mean patient age was 75 years, and 43% were women.

A total of 968 patients showed such INR stability throughout the first 6 months of the study. However, 36% of them went on to have at least one “well out of range” INR during the following year. Even in the subgroup of 376 patients who had 100% of their INRs within the therapeutic range during the first 6 months, 33% went on to have at least one “well out of range” INR during the following year, according to Dr. Pokorney and his associates.

No sponsor was cited for this study. Dr. Pokorney reported ties to AstraZeneca, Boston Scientific, Gilead, Janssen, and Medtronic; his associates reported ties to numerous industry sources.