Over-the-counter consumer antiseptic wash products with active ingredients such as triclosan and triclocarban will be pulled from the market, following a final rule issued Sept. 2 by the Food and Drug Administration.

Companies will no longer be able to sell antibacterial washes with those ingredients, the FDA said, because manufacturers failed to show the ingredients are safe for long-term daily use and are better than plain soap and water at preventing illness and the spread of infections.

kosziv ( Thinkstockphotos)

The final rule targets consumer antiseptic wash products containing 1 or more of 19 active ingredients, including the 2 most commonly used ingredients, triclosan and triclocarban. Companies have 1 year to comply with the new rule.

The FDA’s rule does not apply to hand sanitizers, wipes, or antibacterial products used in health care settings.

The agency has deferred for 1 year a decision on the continued use of three other ingredients in consumer wash products: benzalkonium chloride, benzethonium chloride, and chloroxylenol.

The FDA’s decision was driven in part by concerns about the risks posed by long-term exposure to such products, including bacterial resistance or hormonal effects.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term.”

Washing with plain soap and water remains one of the most important steps consumers can take to prevent illness and the spread of infection, the FDA advised. The agency also recommended use of alcohol-based hand sanitizer with at least 60% alcohol.

Read the full press release on the FDA website.

[email protected]

Over-the-counter consumer antiseptic wash products with active ingredients such as triclosan and triclocarban will be pulled from the market, following a final rule issued Sept. 2 by the Food and Drug Administration.

Companies will no longer be able to sell antibacterial washes with those ingredients, the FDA said, because manufacturers failed to show the ingredients are safe for long-term daily use and are better than plain soap and water at preventing illness and the spread of infections.

kosziv ( Thinkstockphotos)

The final rule targets consumer antiseptic wash products containing 1 or more of 19 active ingredients, including the 2 most commonly used ingredients, triclosan and triclocarban. Companies have 1 year to comply with the new rule.

The FDA’s rule does not apply to hand sanitizers, wipes, or antibacterial products used in health care settings.

The agency has deferred for 1 year a decision on the continued use of three other ingredients in consumer wash products: benzalkonium chloride, benzethonium chloride, and chloroxylenol.

The FDA’s decision was driven in part by concerns about the risks posed by long-term exposure to such products, including bacterial resistance or hormonal effects.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term.”

Washing with plain soap and water remains one of the most important steps consumers can take to prevent illness and the spread of infection, the FDA advised. The agency also recommended use of alcohol-based hand sanitizer with at least 60% alcohol.

Read the full press release on the FDA website.

[email protected]

Over-the-counter consumer antiseptic wash products with active ingredients such as triclosan and triclocarban will be pulled from the market, following a final rule issued Sept. 2 by the Food and Drug Administration.

Companies will no longer be able to sell antibacterial washes with those ingredients, the FDA said, because manufacturers failed to show the ingredients are safe for long-term daily use and are better than plain soap and water at preventing illness and the spread of infections.

kosziv ( Thinkstockphotos)

The final rule targets consumer antiseptic wash products containing 1 or more of 19 active ingredients, including the 2 most commonly used ingredients, triclosan and triclocarban. Companies have 1 year to comply with the new rule.

The FDA’s rule does not apply to hand sanitizers, wipes, or antibacterial products used in health care settings.

The agency has deferred for 1 year a decision on the continued use of three other ingredients in consumer wash products: benzalkonium chloride, benzethonium chloride, and chloroxylenol.

The FDA’s decision was driven in part by concerns about the risks posed by long-term exposure to such products, including bacterial resistance or hormonal effects.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term.”

Washing with plain soap and water remains one of the most important steps consumers can take to prevent illness and the spread of infection, the FDA advised. The agency also recommended use of alcohol-based hand sanitizer with at least 60% alcohol.

Read the full press release on the FDA website.

[email protected]

BOSTON – Preventing repeated occurrences of bed bug bites means eliminating infestations or – if the bites occur during travel – avoiding bringing the bugs home, according to Theodore Rosen, MD.

Bed bugs are “very, very, very hardy,” and can live months or maybe even years between blood meals, Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston, said at the American Academy of Dermatology summer meeting.

“They lay lots of eggs and have lots of offspring,” he said, adding that bed bugs have evolved and developed mutations that make them resistant to insecticides, and can survive up to a week at a continuous temperature of 10 degrees Fahrenheit.

Courtesy CDC/Piotr Naskrecki

Advise patients who will be traveling to check whether the area they are traveling to has known bed bug infestations. Recommend that they always check areas within 3 feet or so of hotel beds for evidence of bed bugs, he said.

Bed bugs like right angles, so they may be found on headboards, bed frames, mattress piping, drawers, and windows. They can also be found hiding under peeling paint, and or in the piping or under surfaces of furniture in hotel rooms.

Dr. Rosen is often asked by patients if he really looks for bed bugs when he travels. “I do look – and I’ve found them,” he said, noting that they can be found in the nicest of hotels. He found some lurking beneath the drawer of a nightstand in one luxury hotel.

Bugs can be seen, but droppings are another telltale sign of infestation; bed bug excrement stains fabrics, so if round brown splotches are seen on mattress or other fabric, bed bugs have been there and probably still are there, Dr. Rosen said.

“I pull up the sheets, look at the piping on the mattress, pull up the mattress and look at the frame, look at the coils, look at the night stand,” he said.

A pricey monitoring and trapping device called the NightWatch can be purchased to help in the event of an infestation. The device emits heated carbon dioxide and pheromones that attract and trap bed bugs, but the $300-$400 price tag can be prohibitive, he noted.

The best bet is to avoid bringing home bugs by keeping all bags and clothes off the floor. Bags should be kept on a dresser or stand, clothes should be hung.

If infestation occurs, let patients know that the bites aren’t dangerous. There is no convincing evidence that bed bugs transmit any diseases. Anemia with heavy infestation and repeated bites could theoretically be a concern, but other than itching and looking bad, bites are rarely an issue.

Bed bug bites usually respond well to topical steroid treatment, and only in rare cases are oral steroids or antihistamines needed. Home bites will recur if there is infestation, and the problem can be a source of depression and anxiety, which in some patients can be severe and lead to suicidal ideation.

Infestation should be addressed by heavy vacuuming and steaming, which kills bed bugs if he temperatures are high enough. Mattress encasement can also help, but insecticides are rarely effective. Freezing smaller objects can be tried, but bed bugs can withstand freezing temperatures for long periods of time, he said.

“If you bring bed bugs home, you have to treat the whole environment,” he said.

One treatment that has shown promise is ivermectin in the host. Studies suggest this approach kills some bugs, but it is not 100% effective and is probably best reserved for widespread infestation, such as in a nursing home, Dr. Rosen said.

He disclosed financial or other relationships with Anacor Pharmaceuticals; Innocutis; Sandoz, a Novartis company; and Valeant Pharmaceuticals International.

[email protected]

BOSTON – Preventing repeated occurrences of bed bug bites means eliminating infestations or – if the bites occur during travel – avoiding bringing the bugs home, according to Theodore Rosen, MD.

Bed bugs are “very, very, very hardy,” and can live months or maybe even years between blood meals, Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston, said at the American Academy of Dermatology summer meeting.

“They lay lots of eggs and have lots of offspring,” he said, adding that bed bugs have evolved and developed mutations that make them resistant to insecticides, and can survive up to a week at a continuous temperature of 10 degrees Fahrenheit.

Courtesy CDC/Piotr Naskrecki

Advise patients who will be traveling to check whether the area they are traveling to has known bed bug infestations. Recommend that they always check areas within 3 feet or so of hotel beds for evidence of bed bugs, he said.

Bed bugs like right angles, so they may be found on headboards, bed frames, mattress piping, drawers, and windows. They can also be found hiding under peeling paint, and or in the piping or under surfaces of furniture in hotel rooms.

Dr. Rosen is often asked by patients if he really looks for bed bugs when he travels. “I do look – and I’ve found them,” he said, noting that they can be found in the nicest of hotels. He found some lurking beneath the drawer of a nightstand in one luxury hotel.

Bugs can be seen, but droppings are another telltale sign of infestation; bed bug excrement stains fabrics, so if round brown splotches are seen on mattress or other fabric, bed bugs have been there and probably still are there, Dr. Rosen said.

“I pull up the sheets, look at the piping on the mattress, pull up the mattress and look at the frame, look at the coils, look at the night stand,” he said.

A pricey monitoring and trapping device called the NightWatch can be purchased to help in the event of an infestation. The device emits heated carbon dioxide and pheromones that attract and trap bed bugs, but the $300-$400 price tag can be prohibitive, he noted.

The best bet is to avoid bringing home bugs by keeping all bags and clothes off the floor. Bags should be kept on a dresser or stand, clothes should be hung.

If infestation occurs, let patients know that the bites aren’t dangerous. There is no convincing evidence that bed bugs transmit any diseases. Anemia with heavy infestation and repeated bites could theoretically be a concern, but other than itching and looking bad, bites are rarely an issue.

Bed bug bites usually respond well to topical steroid treatment, and only in rare cases are oral steroids or antihistamines needed. Home bites will recur if there is infestation, and the problem can be a source of depression and anxiety, which in some patients can be severe and lead to suicidal ideation.

Infestation should be addressed by heavy vacuuming and steaming, which kills bed bugs if he temperatures are high enough. Mattress encasement can also help, but insecticides are rarely effective. Freezing smaller objects can be tried, but bed bugs can withstand freezing temperatures for long periods of time, he said.

“If you bring bed bugs home, you have to treat the whole environment,” he said.

One treatment that has shown promise is ivermectin in the host. Studies suggest this approach kills some bugs, but it is not 100% effective and is probably best reserved for widespread infestation, such as in a nursing home, Dr. Rosen said.

He disclosed financial or other relationships with Anacor Pharmaceuticals; Innocutis; Sandoz, a Novartis company; and Valeant Pharmaceuticals International.

[email protected]

BOSTON – Preventing repeated occurrences of bed bug bites means eliminating infestations or – if the bites occur during travel – avoiding bringing the bugs home, according to Theodore Rosen, MD.

Bed bugs are “very, very, very hardy,” and can live months or maybe even years between blood meals, Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston, said at the American Academy of Dermatology summer meeting.

“They lay lots of eggs and have lots of offspring,” he said, adding that bed bugs have evolved and developed mutations that make them resistant to insecticides, and can survive up to a week at a continuous temperature of 10 degrees Fahrenheit.

Courtesy CDC/Piotr Naskrecki

Advise patients who will be traveling to check whether the area they are traveling to has known bed bug infestations. Recommend that they always check areas within 3 feet or so of hotel beds for evidence of bed bugs, he said.

Bed bugs like right angles, so they may be found on headboards, bed frames, mattress piping, drawers, and windows. They can also be found hiding under peeling paint, and or in the piping or under surfaces of furniture in hotel rooms.

Dr. Rosen is often asked by patients if he really looks for bed bugs when he travels. “I do look – and I’ve found them,” he said, noting that they can be found in the nicest of hotels. He found some lurking beneath the drawer of a nightstand in one luxury hotel.

Bugs can be seen, but droppings are another telltale sign of infestation; bed bug excrement stains fabrics, so if round brown splotches are seen on mattress or other fabric, bed bugs have been there and probably still are there, Dr. Rosen said.

“I pull up the sheets, look at the piping on the mattress, pull up the mattress and look at the frame, look at the coils, look at the night stand,” he said.

A pricey monitoring and trapping device called the NightWatch can be purchased to help in the event of an infestation. The device emits heated carbon dioxide and pheromones that attract and trap bed bugs, but the $300-$400 price tag can be prohibitive, he noted.

The best bet is to avoid bringing home bugs by keeping all bags and clothes off the floor. Bags should be kept on a dresser or stand, clothes should be hung.

If infestation occurs, let patients know that the bites aren’t dangerous. There is no convincing evidence that bed bugs transmit any diseases. Anemia with heavy infestation and repeated bites could theoretically be a concern, but other than itching and looking bad, bites are rarely an issue.

Bed bug bites usually respond well to topical steroid treatment, and only in rare cases are oral steroids or antihistamines needed. Home bites will recur if there is infestation, and the problem can be a source of depression and anxiety, which in some patients can be severe and lead to suicidal ideation.

Infestation should be addressed by heavy vacuuming and steaming, which kills bed bugs if he temperatures are high enough. Mattress encasement can also help, but insecticides are rarely effective. Freezing smaller objects can be tried, but bed bugs can withstand freezing temperatures for long periods of time, he said.

“If you bring bed bugs home, you have to treat the whole environment,” he said.

One treatment that has shown promise is ivermectin in the host. Studies suggest this approach kills some bugs, but it is not 100% effective and is probably best reserved for widespread infestation, such as in a nursing home, Dr. Rosen said.

He disclosed financial or other relationships with Anacor Pharmaceuticals; Innocutis; Sandoz, a Novartis company; and Valeant Pharmaceuticals International.

[email protected]

Zika virus shows no signs of slowing down, as the number of pregnant women with laboratory evidence of possible infection in the United States and its territories took its largest jump yet during the week ending Aug. 25, according to the Centers for Disease Control and Prevention.

There were 199 new cases of Zika that week: 159 in the U.S. territories and 40 in the 50 states and the District of Columbia. The previous high had been 189 for the week ending Aug. 11. Cases in pregnant women for 2016 so far number 971 in the territories and 624 in the states and D.C. – a total of 1,595, the CDC reported Sept. 1.

The number of poor outcomes among pregnant women with Zika virus infection did not change for the week ending Aug. 25. The number of live-born infants with Zika-related birth defects remained at 17 – 16 in the states/D.C. and 1 in the territories – and the number of pregnancy losses with birth defects was still 6 – 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

Among the entire U.S. population, 16,832 cases of Zika have been reported to the CDC Arboviral Disease Branch in 2015-2016, with 5,304 reported for the week ending Aug. 31 (Puerto Rico retroactively reported 5,000 cases that had been identified between June 4 and Aug. 6). The states/D.C. account for 2,722 of total cases, and the territories have reported 14,110 cases, of which Puerto Rico accounts for 13,791, the CDC noted.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

Zika virus shows no signs of slowing down, as the number of pregnant women with laboratory evidence of possible infection in the United States and its territories took its largest jump yet during the week ending Aug. 25, according to the Centers for Disease Control and Prevention.

There were 199 new cases of Zika that week: 159 in the U.S. territories and 40 in the 50 states and the District of Columbia. The previous high had been 189 for the week ending Aug. 11. Cases in pregnant women for 2016 so far number 971 in the territories and 624 in the states and D.C. – a total of 1,595, the CDC reported Sept. 1.

The number of poor outcomes among pregnant women with Zika virus infection did not change for the week ending Aug. 25. The number of live-born infants with Zika-related birth defects remained at 17 – 16 in the states/D.C. and 1 in the territories – and the number of pregnancy losses with birth defects was still 6 – 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

Among the entire U.S. population, 16,832 cases of Zika have been reported to the CDC Arboviral Disease Branch in 2015-2016, with 5,304 reported for the week ending Aug. 31 (Puerto Rico retroactively reported 5,000 cases that had been identified between June 4 and Aug. 6). The states/D.C. account for 2,722 of total cases, and the territories have reported 14,110 cases, of which Puerto Rico accounts for 13,791, the CDC noted.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

Zika virus shows no signs of slowing down, as the number of pregnant women with laboratory evidence of possible infection in the United States and its territories took its largest jump yet during the week ending Aug. 25, according to the Centers for Disease Control and Prevention.

There were 199 new cases of Zika that week: 159 in the U.S. territories and 40 in the 50 states and the District of Columbia. The previous high had been 189 for the week ending Aug. 11. Cases in pregnant women for 2016 so far number 971 in the territories and 624 in the states and D.C. – a total of 1,595, the CDC reported Sept. 1.

The number of poor outcomes among pregnant women with Zika virus infection did not change for the week ending Aug. 25. The number of live-born infants with Zika-related birth defects remained at 17 – 16 in the states/D.C. and 1 in the territories – and the number of pregnancy losses with birth defects was still 6 – 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

Among the entire U.S. population, 16,832 cases of Zika have been reported to the CDC Arboviral Disease Branch in 2015-2016, with 5,304 reported for the week ending Aug. 31 (Puerto Rico retroactively reported 5,000 cases that had been identified between June 4 and Aug. 6). The states/D.C. account for 2,722 of total cases, and the territories have reported 14,110 cases, of which Puerto Rico accounts for 13,791, the CDC noted.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

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BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

Extending docetaxel chemotherapy significantly improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC), regardless of whether they received lenalidomide, according to a retrospective analysis of 1,059 patients from a randomized, phase III trial.

“We found a robust and independent effect on overall survival by the number of docetaxel cycles administered in the setting of mCRPC,” wrote Ellen de Morree of Erasmus MC Cancer Institute (Rotterdam, the Netherlands) and her associates (JAMA Oncol. 2016 Aug 25. doi: 10.1001/jamaoncol.2016.3000).

The association was independent of performance status (Eastern Cooperative Oncology Group score) or baseline levels of lactate dehydrogenase level, hemoglobin, and albumin, they noted. “These data indicate that patients who appear to have clinical, radiological, or biochemical benefit by docetaxel should continue beyond 6 cycles as long as they tolerate their treatment well,” they concluded.

This study, the first to investigate the optimal number of docetaxel cycles in mCRPC, analyzed data from the multicenter Mainsail trial, in which patients received docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP) until they developed progressive disease or unacceptable adverse effects. Although dose intensity was similar between the two trial arms, DPL patients developed myelotoxicity with lenalidomide and therefore received a median of only six treatment cycles, while DP patients received a median of eight cycles. That difference enabled this analysis, the investigators noted.

Cumulative dose of docetaxel, duration of lenalidomide treatment, and allocated treatment regimen were significant predictors of overall survival in the univariate analysis. Overall survival was associated with treatment arm in a multivariable analysis that did not account for number of docetaxel cycles (hazard ratio, 1.6; 95% confidence interval, 1.2 to 2.1; P less than .001). But that changed after the addition of a number of docetaxel cycles to the model, the researchers said. In this final model, treatment with eight or more cycles of docetaxel led to substantially improved overall survival (hazard ratio, 1.9; P less than .001), regardless of lenalidomide treatment (HR, 1.1; 95% CI, 0.9 to 1.2; P = .4). Sensitivity analyses confirmed the association – patients who received more than 10 cycles of docetaxel had a median overall survival of 33 months (30-37 months), versus 27 months (24-30 months) with 8-10 cycles and about 23 months (18-27 months) with 5-7 cycles (P less than .001).

Extending docetaxel chemotherapy significantly improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC), regardless of whether they received lenalidomide, according to a retrospective analysis of 1,059 patients from a randomized, phase III trial.

“We found a robust and independent effect on overall survival by the number of docetaxel cycles administered in the setting of mCRPC,” wrote Ellen de Morree of Erasmus MC Cancer Institute (Rotterdam, the Netherlands) and her associates (JAMA Oncol. 2016 Aug 25. doi: 10.1001/jamaoncol.2016.3000).

The association was independent of performance status (Eastern Cooperative Oncology Group score) or baseline levels of lactate dehydrogenase level, hemoglobin, and albumin, they noted. “These data indicate that patients who appear to have clinical, radiological, or biochemical benefit by docetaxel should continue beyond 6 cycles as long as they tolerate their treatment well,” they concluded.

This study, the first to investigate the optimal number of docetaxel cycles in mCRPC, analyzed data from the multicenter Mainsail trial, in which patients received docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP) until they developed progressive disease or unacceptable adverse effects. Although dose intensity was similar between the two trial arms, DPL patients developed myelotoxicity with lenalidomide and therefore received a median of only six treatment cycles, while DP patients received a median of eight cycles. That difference enabled this analysis, the investigators noted.

Cumulative dose of docetaxel, duration of lenalidomide treatment, and allocated treatment regimen were significant predictors of overall survival in the univariate analysis. Overall survival was associated with treatment arm in a multivariable analysis that did not account for number of docetaxel cycles (hazard ratio, 1.6; 95% confidence interval, 1.2 to 2.1; P less than .001). But that changed after the addition of a number of docetaxel cycles to the model, the researchers said. In this final model, treatment with eight or more cycles of docetaxel led to substantially improved overall survival (hazard ratio, 1.9; P less than .001), regardless of lenalidomide treatment (HR, 1.1; 95% CI, 0.9 to 1.2; P = .4). Sensitivity analyses confirmed the association – patients who received more than 10 cycles of docetaxel had a median overall survival of 33 months (30-37 months), versus 27 months (24-30 months) with 8-10 cycles and about 23 months (18-27 months) with 5-7 cycles (P less than .001).

Extending docetaxel chemotherapy significantly improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC), regardless of whether they received lenalidomide, according to a retrospective analysis of 1,059 patients from a randomized, phase III trial.

“We found a robust and independent effect on overall survival by the number of docetaxel cycles administered in the setting of mCRPC,” wrote Ellen de Morree of Erasmus MC Cancer Institute (Rotterdam, the Netherlands) and her associates (JAMA Oncol. 2016 Aug 25. doi: 10.1001/jamaoncol.2016.3000).

The association was independent of performance status (Eastern Cooperative Oncology Group score) or baseline levels of lactate dehydrogenase level, hemoglobin, and albumin, they noted. “These data indicate that patients who appear to have clinical, radiological, or biochemical benefit by docetaxel should continue beyond 6 cycles as long as they tolerate their treatment well,” they concluded.

This study, the first to investigate the optimal number of docetaxel cycles in mCRPC, analyzed data from the multicenter Mainsail trial, in which patients received docetaxel, prednisone, and lenalidomide (DPL) or docetaxel, prednisone, and a placebo (DP) until they developed progressive disease or unacceptable adverse effects. Although dose intensity was similar between the two trial arms, DPL patients developed myelotoxicity with lenalidomide and therefore received a median of only six treatment cycles, while DP patients received a median of eight cycles. That difference enabled this analysis, the investigators noted.

Cumulative dose of docetaxel, duration of lenalidomide treatment, and allocated treatment regimen were significant predictors of overall survival in the univariate analysis. Overall survival was associated with treatment arm in a multivariable analysis that did not account for number of docetaxel cycles (hazard ratio, 1.6; 95% confidence interval, 1.2 to 2.1; P less than .001). But that changed after the addition of a number of docetaxel cycles to the model, the researchers said. In this final model, treatment with eight or more cycles of docetaxel led to substantially improved overall survival (hazard ratio, 1.9; P less than .001), regardless of lenalidomide treatment (HR, 1.1; 95% CI, 0.9 to 1.2; P = .4). Sensitivity analyses confirmed the association – patients who received more than 10 cycles of docetaxel had a median overall survival of 33 months (30-37 months), versus 27 months (24-30 months) with 8-10 cycles and about 23 months (18-27 months) with 5-7 cycles (P less than .001).

TORONTO – Patients with mild cognitive impairment have a greater likelihood of having neuropsychiatric symptoms if they test positive for amyloid pathology on PET imaging, according to a study of patients in the Alzheimer’s Disease Neuroimaging Initiative.

Amyloid-positive patients were significantly more likely to develop agitation, anxiety, apathy, and other symptoms over 4 years than were amyloid-negative patients, Naira Goukasian said at the Alzheimer’s Association International Conference 2016.

“In MCI [mild cognitive impairment], we found that amyloid pathology was a significant risk factor for developing these symptoms,” said Ms. Goukasian, a researcher at the University of California, Los Angeles.

©giocalde/Thinkstock

She investigated the presence and development of neuropsychiatric symptoms in 1,077 subjects drawn from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. The cohort comprised 275 cognitively normal subjects, 100 with subjective memory complaint, 559 with MCI, and 143 with Alzheimer’s disease. As part of ADNI, all patients had baseline neurocognitive and neuropsychiatric testing, and florbetapir F 18 (Amyvid) scans to determine brain amyloid status. Neuropsychiatric symptoms were measured with the Neuropsychiatric Inventory (NPI) and the Neuropsychiatric Inventory Questionnaire (NPI-Q) at baseline and during every annual visit. Patients were followed for up to 4 years.

At baseline, amyloid pathology was associated with some neuropsychiatric symptomatology in every group except those with subjective memory complaints.

Amyloid-positive control subjects were significantly more likely to present with depression than were amyloid-negative controls. Amyloid-positive MCI patients were significantly more likely to present with anxiety when they had amyloid pathology than when they did not. Amyloid-positive dementia patients were significantly more likely to present with apathy than were amyloid-negative dementia patients.

There were no amyloid-dependent differences in neuropsychiatric symptoms among those with subjective memory complaints.

Over the 4-year follow-up period, no new neuropsychiatric symptoms developed in the control, subjective memory complaint, or dementia groups, whether they were amyloid positive or negative.

Amyloid-positive MCI patients, however, were significantly more likely to develop new symptoms than were amyloid-negative MCI patients, including delusions (13% vs. 2%), hallucinations (8% vs. 2%), anxiety (36% vs. 25%), apathy (38% vs. 22%), agitation (36% vs. 27%), disinhibition (24% vs. 15%), irritability (46% vs. 33%), and motor disturbances (18% vs. 9%).

Ms. Goukasian did not elaborate on the pathophysiologic relationship between amyloid and these symptoms. However, a 2015 study using a similar ADNI cohort localized some of them to specific amyloid-burdened brain regions (J Alzheimers Dis. 2016;49[2]:387-98).

The study by David Bensamoun, MD, and colleagues comprised 657 ADNI participants (230 controls, 308 MCI patients, and 119 Alzheimer’s patients).

In the entire group, Dr. Bensamoun, of the Regional Memory Center, Nice, France, found positive significant correlations between anxiety and global cerebral florbetapir F 18 uptake, as well as uptake in the frontal and cingulate regions. Irritability was associated with global florbetapir F 18 uptake and increased signal in the frontal, cingulate, and parietal regions.

In the MCI subgroup, there was an association between anxiety and frontal and global cerebral uptake. In the Alzheimer’s subgroup, there was an association between irritability and parietal uptake.

“Anxiety and irritability appear to be associated with greater amyloid deposition in the neurodegenerative process leading to Alzheimer’s,” the investigators said.

Ms. Goukasian had no financial disclosures.

[email protected]

On Twitter @alz_gal

TORONTO – Patients with mild cognitive impairment have a greater likelihood of having neuropsychiatric symptoms if they test positive for amyloid pathology on PET imaging, according to a study of patients in the Alzheimer’s Disease Neuroimaging Initiative.

Amyloid-positive patients were significantly more likely to develop agitation, anxiety, apathy, and other symptoms over 4 years than were amyloid-negative patients, Naira Goukasian said at the Alzheimer’s Association International Conference 2016.

“In MCI [mild cognitive impairment], we found that amyloid pathology was a significant risk factor for developing these symptoms,” said Ms. Goukasian, a researcher at the University of California, Los Angeles.

©giocalde/Thinkstock

She investigated the presence and development of neuropsychiatric symptoms in 1,077 subjects drawn from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. The cohort comprised 275 cognitively normal subjects, 100 with subjective memory complaint, 559 with MCI, and 143 with Alzheimer’s disease. As part of ADNI, all patients had baseline neurocognitive and neuropsychiatric testing, and florbetapir F 18 (Amyvid) scans to determine brain amyloid status. Neuropsychiatric symptoms were measured with the Neuropsychiatric Inventory (NPI) and the Neuropsychiatric Inventory Questionnaire (NPI-Q) at baseline and during every annual visit. Patients were followed for up to 4 years.

At baseline, amyloid pathology was associated with some neuropsychiatric symptomatology in every group except those with subjective memory complaints.

Amyloid-positive control subjects were significantly more likely to present with depression than were amyloid-negative controls. Amyloid-positive MCI patients were significantly more likely to present with anxiety when they had amyloid pathology than when they did not. Amyloid-positive dementia patients were significantly more likely to present with apathy than were amyloid-negative dementia patients.

There were no amyloid-dependent differences in neuropsychiatric symptoms among those with subjective memory complaints.

Over the 4-year follow-up period, no new neuropsychiatric symptoms developed in the control, subjective memory complaint, or dementia groups, whether they were amyloid positive or negative.

Amyloid-positive MCI patients, however, were significantly more likely to develop new symptoms than were amyloid-negative MCI patients, including delusions (13% vs. 2%), hallucinations (8% vs. 2%), anxiety (36% vs. 25%), apathy (38% vs. 22%), agitation (36% vs. 27%), disinhibition (24% vs. 15%), irritability (46% vs. 33%), and motor disturbances (18% vs. 9%).

Ms. Goukasian did not elaborate on the pathophysiologic relationship between amyloid and these symptoms. However, a 2015 study using a similar ADNI cohort localized some of them to specific amyloid-burdened brain regions (J Alzheimers Dis. 2016;49[2]:387-98).

The study by David Bensamoun, MD, and colleagues comprised 657 ADNI participants (230 controls, 308 MCI patients, and 119 Alzheimer’s patients).

In the entire group, Dr. Bensamoun, of the Regional Memory Center, Nice, France, found positive significant correlations between anxiety and global cerebral florbetapir F 18 uptake, as well as uptake in the frontal and cingulate regions. Irritability was associated with global florbetapir F 18 uptake and increased signal in the frontal, cingulate, and parietal regions.

In the MCI subgroup, there was an association between anxiety and frontal and global cerebral uptake. In the Alzheimer’s subgroup, there was an association between irritability and parietal uptake.

“Anxiety and irritability appear to be associated with greater amyloid deposition in the neurodegenerative process leading to Alzheimer’s,” the investigators said.

Ms. Goukasian had no financial disclosures.

[email protected]

On Twitter @alz_gal

TORONTO – Patients with mild cognitive impairment have a greater likelihood of having neuropsychiatric symptoms if they test positive for amyloid pathology on PET imaging, according to a study of patients in the Alzheimer’s Disease Neuroimaging Initiative.

Amyloid-positive patients were significantly more likely to develop agitation, anxiety, apathy, and other symptoms over 4 years than were amyloid-negative patients, Naira Goukasian said at the Alzheimer’s Association International Conference 2016.

“In MCI [mild cognitive impairment], we found that amyloid pathology was a significant risk factor for developing these symptoms,” said Ms. Goukasian, a researcher at the University of California, Los Angeles.

©giocalde/Thinkstock

She investigated the presence and development of neuropsychiatric symptoms in 1,077 subjects drawn from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. The cohort comprised 275 cognitively normal subjects, 100 with subjective memory complaint, 559 with MCI, and 143 with Alzheimer’s disease. As part of ADNI, all patients had baseline neurocognitive and neuropsychiatric testing, and florbetapir F 18 (Amyvid) scans to determine brain amyloid status. Neuropsychiatric symptoms were measured with the Neuropsychiatric Inventory (NPI) and the Neuropsychiatric Inventory Questionnaire (NPI-Q) at baseline and during every annual visit. Patients were followed for up to 4 years.

At baseline, amyloid pathology was associated with some neuropsychiatric symptomatology in every group except those with subjective memory complaints.

Amyloid-positive control subjects were significantly more likely to present with depression than were amyloid-negative controls. Amyloid-positive MCI patients were significantly more likely to present with anxiety when they had amyloid pathology than when they did not. Amyloid-positive dementia patients were significantly more likely to present with apathy than were amyloid-negative dementia patients.

There were no amyloid-dependent differences in neuropsychiatric symptoms among those with subjective memory complaints.

Over the 4-year follow-up period, no new neuropsychiatric symptoms developed in the control, subjective memory complaint, or dementia groups, whether they were amyloid positive or negative.

Amyloid-positive MCI patients, however, were significantly more likely to develop new symptoms than were amyloid-negative MCI patients, including delusions (13% vs. 2%), hallucinations (8% vs. 2%), anxiety (36% vs. 25%), apathy (38% vs. 22%), agitation (36% vs. 27%), disinhibition (24% vs. 15%), irritability (46% vs. 33%), and motor disturbances (18% vs. 9%).

Ms. Goukasian did not elaborate on the pathophysiologic relationship between amyloid and these symptoms. However, a 2015 study using a similar ADNI cohort localized some of them to specific amyloid-burdened brain regions (J Alzheimers Dis. 2016;49[2]:387-98).

The study by David Bensamoun, MD, and colleagues comprised 657 ADNI participants (230 controls, 308 MCI patients, and 119 Alzheimer’s patients).

In the entire group, Dr. Bensamoun, of the Regional Memory Center, Nice, France, found positive significant correlations between anxiety and global cerebral florbetapir F 18 uptake, as well as uptake in the frontal and cingulate regions. Irritability was associated with global florbetapir F 18 uptake and increased signal in the frontal, cingulate, and parietal regions.

In the MCI subgroup, there was an association between anxiety and frontal and global cerebral uptake. In the Alzheimer’s subgroup, there was an association between irritability and parietal uptake.

“Anxiety and irritability appear to be associated with greater amyloid deposition in the neurodegenerative process leading to Alzheimer’s,” the investigators said.

Ms. Goukasian had no financial disclosures.

[email protected]

On Twitter @alz_gal

Ocular melanoma is the most common primary intraocular malignancy and can often be fatal. It is relatively uncommon and presents in about 5.1 cases per million population per year. Oftentimes, the patient is asymptomatic at diagnosis and the presentation is highly variable. We present a case of ocular melanoma.

A 68-year-old man with a history of hypertension, osteoarthritis, and coronary artery disease came in after having worsening pain in multiple joints. Review of systems revealed worsening blurry vision and eye floaters. He denied eye pain or other associated complaints. He had no past history of any ocular pigmented lesions or history of skin cancer. Ophthalmology evaluation a few years earlier did not identify any abnormalities. Approximately 10 years prior to presentation, he did have LASIK surgery on both eyes. Subsequent ophthalmological evaluation showed an iris mass, elevated pressure, intra-retinal hemorrhages, and evidence of involvement in the choroid and conjunctivae. This was highly suspicious for iris melanoma of the right eye. He was started on intraocular pressure lowering medications and further workup was initiated. Biopsy confirmed the diagnoses of choroidal melanoma with an iris mass measuring 1 mm radially by 4 mm circumferentially. The mass extended posteriorly and involved well over half his iridocorneal angle resulting in very high intraocular pressure. A metastatic workup was done and was negative at the time. He underwent successful enucleation surgery with prostheses placement. Patient did well until about 1.5 years later when he was found to have multiple liver lesions suggestive of metastasis. This is currently being further evaluated.

No current guidelines exist for the screening of primary ocular melanoma as well as for screening for metastasis in those already diagnosed. Unfortunately, up to 50% of patients with ocular melanoma develop metastases. This case opens the discussion of needing current guidelines for screening and better surveillance in ocular melanomas. It highlights the importance of looking into screening using genomics and also developing targeted therapies, as well as focusing on immunotherapies for these cases.

Ocular melanoma is the most common primary intraocular malignancy and can often be fatal. It is relatively uncommon and presents in about 5.1 cases per million population per year. Oftentimes, the patient is asymptomatic at diagnosis and the presentation is highly variable. We present a case of ocular melanoma.

A 68-year-old man with a history of hypertension, osteoarthritis, and coronary artery disease came in after having worsening pain in multiple joints. Review of systems revealed worsening blurry vision and eye floaters. He denied eye pain or other associated complaints. He had no past history of any ocular pigmented lesions or history of skin cancer. Ophthalmology evaluation a few years earlier did not identify any abnormalities. Approximately 10 years prior to presentation, he did have LASIK surgery on both eyes. Subsequent ophthalmological evaluation showed an iris mass, elevated pressure, intra-retinal hemorrhages, and evidence of involvement in the choroid and conjunctivae. This was highly suspicious for iris melanoma of the right eye. He was started on intraocular pressure lowering medications and further workup was initiated. Biopsy confirmed the diagnoses of choroidal melanoma with an iris mass measuring 1 mm radially by 4 mm circumferentially. The mass extended posteriorly and involved well over half his iridocorneal angle resulting in very high intraocular pressure. A metastatic workup was done and was negative at the time. He underwent successful enucleation surgery with prostheses placement. Patient did well until about 1.5 years later when he was found to have multiple liver lesions suggestive of metastasis. This is currently being further evaluated.

No current guidelines exist for the screening of primary ocular melanoma as well as for screening for metastasis in those already diagnosed. Unfortunately, up to 50% of patients with ocular melanoma develop metastases. This case opens the discussion of needing current guidelines for screening and better surveillance in ocular melanomas. It highlights the importance of looking into screening using genomics and also developing targeted therapies, as well as focusing on immunotherapies for these cases.

Ocular melanoma is the most common primary intraocular malignancy and can often be fatal. It is relatively uncommon and presents in about 5.1 cases per million population per year. Oftentimes, the patient is asymptomatic at diagnosis and the presentation is highly variable. We present a case of ocular melanoma.

A 68-year-old man with a history of hypertension, osteoarthritis, and coronary artery disease came in after having worsening pain in multiple joints. Review of systems revealed worsening blurry vision and eye floaters. He denied eye pain or other associated complaints. He had no past history of any ocular pigmented lesions or history of skin cancer. Ophthalmology evaluation a few years earlier did not identify any abnormalities. Approximately 10 years prior to presentation, he did have LASIK surgery on both eyes. Subsequent ophthalmological evaluation showed an iris mass, elevated pressure, intra-retinal hemorrhages, and evidence of involvement in the choroid and conjunctivae. This was highly suspicious for iris melanoma of the right eye. He was started on intraocular pressure lowering medications and further workup was initiated. Biopsy confirmed the diagnoses of choroidal melanoma with an iris mass measuring 1 mm radially by 4 mm circumferentially. The mass extended posteriorly and involved well over half his iridocorneal angle resulting in very high intraocular pressure. A metastatic workup was done and was negative at the time. He underwent successful enucleation surgery with prostheses placement. Patient did well until about 1.5 years later when he was found to have multiple liver lesions suggestive of metastasis. This is currently being further evaluated.

No current guidelines exist for the screening of primary ocular melanoma as well as for screening for metastasis in those already diagnosed. Unfortunately, up to 50% of patients with ocular melanoma develop metastases. This case opens the discussion of needing current guidelines for screening and better surveillance in ocular melanomas. It highlights the importance of looking into screening using genomics and also developing targeted therapies, as well as focusing on immunotherapies for these cases.

Purpose: Our objective is to comprehensively describe cancer incidence as reported in the VA Central Cancer Registry (VACCR).

Background: Approximately 3% of US cancer cases are diagnosed and treated in the VA healthcare system each year. These cancer cases are reported in the VACCR. In 2012, we published the first comprehensive description of cancer incidence as reported in the VACCR for patients diagnosed in 2007. In our current analysis, we provide an updated description of cancer incidence as reported in the VACCR for patients diagnosed in 2010.

Methods: This was a retrospective, cross-sectional study. We obtained data from 2 sources: (1) VACCR for incident cancer cases; (2) VHA Support Service Center (VSSC) for underlying population of VA healthcare system users.

Data Analysis: Analyses focused on diagnoses in 2010. Noninvasive cancers and those missing TNM stage were excluded from analyses. Cancer incidence among VA patients was descriptively
compared to the general US cancer population.

Results: In 2010, 49,857 cases were reported in VACCR. We excluded non-invasive cases (n = 3,687) and those with missing/unknown stage (n = 8,645). There were 37,525 reported invasive, incident cancers, and 97% (n = 36,454) of those were diagnosed among men. Almost 80% (n = 29,364) of newly diagnosed patients were white, 20% (n = 7,293) were black, and less than 2% (n = 450) were another race. The median age at diagnosis was 64 years. The six most frequently diagnosed cancers were prostate (33%, n = 12,431), lung/bronchus (19%, n = 7,159), colon/rectum (9%, n = 3,419), kidney/renal pelvis (4%, n = 1,657), and urinary bladder (4%, n = 1,427) and skin melanomas (4%, n = 1,421). The most common cancers reported in VACCR have remained stable from 2007 to 2010. Approximately 87% (n = 10,845) of prostate, 33% (n = 2,391) of lung/bronchus, and 59% (n = 2,013) of colon/rectum cancers were diagnosed with early stage (stage I or II) disease. Compared to SEER, cases reported in the VACCR tend to be diagnosed at earlier stages. The overall cancer incidence rate among VA users was 414.8 per 100,000 person-years.

Implications: The VA continues to be a large provider of cancer care in the US. VACCR data indicate that incident cancers in VA in 2010 approximately mirrored those observed among US men.

Purpose: Our objective is to comprehensively describe cancer incidence as reported in the VA Central Cancer Registry (VACCR).

Background: Approximately 3% of US cancer cases are diagnosed and treated in the VA healthcare system each year. These cancer cases are reported in the VACCR. In 2012, we published the first comprehensive description of cancer incidence as reported in the VACCR for patients diagnosed in 2007. In our current analysis, we provide an updated description of cancer incidence as reported in the VACCR for patients diagnosed in 2010.

Methods: This was a retrospective, cross-sectional study. We obtained data from 2 sources: (1) VACCR for incident cancer cases; (2) VHA Support Service Center (VSSC) for underlying population of VA healthcare system users.

Data Analysis: Analyses focused on diagnoses in 2010. Noninvasive cancers and those missing TNM stage were excluded from analyses. Cancer incidence among VA patients was descriptively
compared to the general US cancer population.

Results: In 2010, 49,857 cases were reported in VACCR. We excluded non-invasive cases (n = 3,687) and those with missing/unknown stage (n = 8,645). There were 37,525 reported invasive, incident cancers, and 97% (n = 36,454) of those were diagnosed among men. Almost 80% (n = 29,364) of newly diagnosed patients were white, 20% (n = 7,293) were black, and less than 2% (n = 450) were another race. The median age at diagnosis was 64 years. The six most frequently diagnosed cancers were prostate (33%, n = 12,431), lung/bronchus (19%, n = 7,159), colon/rectum (9%, n = 3,419), kidney/renal pelvis (4%, n = 1,657), and urinary bladder (4%, n = 1,427) and skin melanomas (4%, n = 1,421). The most common cancers reported in VACCR have remained stable from 2007 to 2010. Approximately 87% (n = 10,845) of prostate, 33% (n = 2,391) of lung/bronchus, and 59% (n = 2,013) of colon/rectum cancers were diagnosed with early stage (stage I or II) disease. Compared to SEER, cases reported in the VACCR tend to be diagnosed at earlier stages. The overall cancer incidence rate among VA users was 414.8 per 100,000 person-years.

Implications: The VA continues to be a large provider of cancer care in the US. VACCR data indicate that incident cancers in VA in 2010 approximately mirrored those observed among US men.

Purpose: Our objective is to comprehensively describe cancer incidence as reported in the VA Central Cancer Registry (VACCR).

Background: Approximately 3% of US cancer cases are diagnosed and treated in the VA healthcare system each year. These cancer cases are reported in the VACCR. In 2012, we published the first comprehensive description of cancer incidence as reported in the VACCR for patients diagnosed in 2007. In our current analysis, we provide an updated description of cancer incidence as reported in the VACCR for patients diagnosed in 2010.

Methods: This was a retrospective, cross-sectional study. We obtained data from 2 sources: (1) VACCR for incident cancer cases; (2) VHA Support Service Center (VSSC) for underlying population of VA healthcare system users.

Data Analysis: Analyses focused on diagnoses in 2010. Noninvasive cancers and those missing TNM stage were excluded from analyses. Cancer incidence among VA patients was descriptively
compared to the general US cancer population.

Results: In 2010, 49,857 cases were reported in VACCR. We excluded non-invasive cases (n = 3,687) and those with missing/unknown stage (n = 8,645). There were 37,525 reported invasive, incident cancers, and 97% (n = 36,454) of those were diagnosed among men. Almost 80% (n = 29,364) of newly diagnosed patients were white, 20% (n = 7,293) were black, and less than 2% (n = 450) were another race. The median age at diagnosis was 64 years. The six most frequently diagnosed cancers were prostate (33%, n = 12,431), lung/bronchus (19%, n = 7,159), colon/rectum (9%, n = 3,419), kidney/renal pelvis (4%, n = 1,657), and urinary bladder (4%, n = 1,427) and skin melanomas (4%, n = 1,421). The most common cancers reported in VACCR have remained stable from 2007 to 2010. Approximately 87% (n = 10,845) of prostate, 33% (n = 2,391) of lung/bronchus, and 59% (n = 2,013) of colon/rectum cancers were diagnosed with early stage (stage I or II) disease. Compared to SEER, cases reported in the VACCR tend to be diagnosed at earlier stages. The overall cancer incidence rate among VA users was 414.8 per 100,000 person-years.

Implications: The VA continues to be a large provider of cancer care in the US. VACCR data indicate that incident cancers in VA in 2010 approximately mirrored those observed among US men.

Purpose: Intravenous unfractionated heparin (UFH) remains an important anticoagulation (AC) agent, particularly in the inpatient setting. Historically, the activated partial thromboplastin time (aPTT) has been the primary laboratory test used to monitor and adjust UFH. Given that several biologic factors can influence the aPTT, independent of the effects of UFH, institutions have transitioned to monitoring heparin with anti-Xa levels. Clinical data show that conversion from aPTT to anti-Xa monitoring may offer a smoother dose-response curve, such that levels remain more stable, requiring fewer blood samples and dosage adjustments.

Background/Problem: The Cleveland VA Medical Center (CVAMC) provides annual care to over 105,000 veterans. It was recently designated as a center for implantation of left ventricular assist devices (LVADs.) As part of the AC monitoring for these patients, a hematologist introduced the use of anti-Xa assay as the test of choice to monitor heparin. Favorable results in this patient cohort prompted consideration for a hospital-wide change in heparin monitoring and a new heparin dosing protocol.

Methods: A multidisciplinary group assembled in November 2015 and developed a low-intensity and high-intensity heparin protocol with anti-Xa as the test to monitor heparin. Laboratory staffing was increased to accommodate phlebotomy rounds. Alaris IV pumps were re-programmed. Physicians developed a specific order set. Nurses designed an AC nurse’s note, and pharmacists devised safe-guard strategies when dose changes are made. Clinical Nurse Specialists developed an educational program for all 228 inpatient registered nurses which will be completed on July 3rd. All stakeholders are expected to meet and confirm their readiness to fully implement the new protocol.

Data Analysis: Anti-Xa equipment was purchased and validation tests were completed. In LVAD patients, therapeutic levels within 24 hours were noted in 86% of the cases.

Results: Hospital-wide implementation of the new heparin protocol is projected for August 1, 2016.

Implications: Presently, there are only 9 VAMCs using the anti-Xa assay to manage heparin anticoagulation. The CVAMC has developed a comprehensive implementation process that consists of new order sets, templates, training programs, and tools for common references. A poster at the AVAHO meeting will illustrate the process and provide postimplementation updates.

Purpose: Intravenous unfractionated heparin (UFH) remains an important anticoagulation (AC) agent, particularly in the inpatient setting. Historically, the activated partial thromboplastin time (aPTT) has been the primary laboratory test used to monitor and adjust UFH. Given that several biologic factors can influence the aPTT, independent of the effects of UFH, institutions have transitioned to monitoring heparin with anti-Xa levels. Clinical data show that conversion from aPTT to anti-Xa monitoring may offer a smoother dose-response curve, such that levels remain more stable, requiring fewer blood samples and dosage adjustments.

Background/Problem: The Cleveland VA Medical Center (CVAMC) provides annual care to over 105,000 veterans. It was recently designated as a center for implantation of left ventricular assist devices (LVADs.) As part of the AC monitoring for these patients, a hematologist introduced the use of anti-Xa assay as the test of choice to monitor heparin. Favorable results in this patient cohort prompted consideration for a hospital-wide change in heparin monitoring and a new heparin dosing protocol.

Methods: A multidisciplinary group assembled in November 2015 and developed a low-intensity and high-intensity heparin protocol with anti-Xa as the test to monitor heparin. Laboratory staffing was increased to accommodate phlebotomy rounds. Alaris IV pumps were re-programmed. Physicians developed a specific order set. Nurses designed an AC nurse’s note, and pharmacists devised safe-guard strategies when dose changes are made. Clinical Nurse Specialists developed an educational program for all 228 inpatient registered nurses which will be completed on July 3rd. All stakeholders are expected to meet and confirm their readiness to fully implement the new protocol.

Data Analysis: Anti-Xa equipment was purchased and validation tests were completed. In LVAD patients, therapeutic levels within 24 hours were noted in 86% of the cases.

Results: Hospital-wide implementation of the new heparin protocol is projected for August 1, 2016.

Implications: Presently, there are only 9 VAMCs using the anti-Xa assay to manage heparin anticoagulation. The CVAMC has developed a comprehensive implementation process that consists of new order sets, templates, training programs, and tools for common references. A poster at the AVAHO meeting will illustrate the process and provide postimplementation updates.

Purpose: Intravenous unfractionated heparin (UFH) remains an important anticoagulation (AC) agent, particularly in the inpatient setting. Historically, the activated partial thromboplastin time (aPTT) has been the primary laboratory test used to monitor and adjust UFH. Given that several biologic factors can influence the aPTT, independent of the effects of UFH, institutions have transitioned to monitoring heparin with anti-Xa levels. Clinical data show that conversion from aPTT to anti-Xa monitoring may offer a smoother dose-response curve, such that levels remain more stable, requiring fewer blood samples and dosage adjustments.

Background/Problem: The Cleveland VA Medical Center (CVAMC) provides annual care to over 105,000 veterans. It was recently designated as a center for implantation of left ventricular assist devices (LVADs.) As part of the AC monitoring for these patients, a hematologist introduced the use of anti-Xa assay as the test of choice to monitor heparin. Favorable results in this patient cohort prompted consideration for a hospital-wide change in heparin monitoring and a new heparin dosing protocol.

Methods: A multidisciplinary group assembled in November 2015 and developed a low-intensity and high-intensity heparin protocol with anti-Xa as the test to monitor heparin. Laboratory staffing was increased to accommodate phlebotomy rounds. Alaris IV pumps were re-programmed. Physicians developed a specific order set. Nurses designed an AC nurse’s note, and pharmacists devised safe-guard strategies when dose changes are made. Clinical Nurse Specialists developed an educational program for all 228 inpatient registered nurses which will be completed on July 3rd. All stakeholders are expected to meet and confirm their readiness to fully implement the new protocol.

Data Analysis: Anti-Xa equipment was purchased and validation tests were completed. In LVAD patients, therapeutic levels within 24 hours were noted in 86% of the cases.

Results: Hospital-wide implementation of the new heparin protocol is projected for August 1, 2016.

Implications: Presently, there are only 9 VAMCs using the anti-Xa assay to manage heparin anticoagulation. The CVAMC has developed a comprehensive implementation process that consists of new order sets, templates, training programs, and tools for common references. A poster at the AVAHO meeting will illustrate the process and provide postimplementation updates.