Melanoma

EDINBURGH – Variants in the pigment-associated MC1R gene have been implicated in an increased risk for melanoma and nonmelanoma skin cancers, although the extent of that risk has been inconsistent across studies, according to Dr. Eugene Healy of the University of Southampton (England). In an interview at the 15th World Congress on Cancers of the Skin sponsored by the Skin Cancer Foundation, Dr. Healy discussed how the MC1R gene variants might impact skin cancer risk and the challenges of pinning down genetic data into practical applications for patients.

[email protected]

EDINBURGH – Variants in the pigment-associated MC1R gene have been implicated in an increased risk for melanoma and nonmelanoma skin cancers, although the extent of that risk has been inconsistent across studies, according to Dr. Eugene Healy of the University of Southampton (England). In an interview at the 15th World Congress on Cancers of the Skin sponsored by the Skin Cancer Foundation, Dr. Healy discussed how the MC1R gene variants might impact skin cancer risk and the challenges of pinning down genetic data into practical applications for patients.

[email protected]

EDINBURGH – Variants in the pigment-associated MC1R gene have been implicated in an increased risk for melanoma and nonmelanoma skin cancers, although the extent of that risk has been inconsistent across studies, according to Dr. Eugene Healy of the University of Southampton (England). In an interview at the 15th World Congress on Cancers of the Skin sponsored by the Skin Cancer Foundation, Dr. Healy discussed how the MC1R gene variants might impact skin cancer risk and the challenges of pinning down genetic data into practical applications for patients.

[email protected]

The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.

The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).

©mark wragg/iStockphoto.com

“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.

The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).

The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.

At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.

The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.

The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.

“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.

Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.

“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.

Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.

The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.

[email protected]

On Twitter @aliciaault

The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.

The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).

©mark wragg/iStockphoto.com

“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.

The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).

The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.

At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.

The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.

The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.

“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.

Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.

“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.

Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.

The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.

[email protected]

On Twitter @aliciaault

The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.

The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).

©mark wragg/iStockphoto.com

“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.

The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).

The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.

At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.

The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.

The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.

“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.

Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.

“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.

Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.

“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.

The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.

[email protected]

On Twitter @aliciaault

EDINBURGH –Kinase fusions have been well described in hematologic malignancies and are the newest genetic aberration to be identified in Spitz tumors.

Kinase fusions are actually quite common in Spitzoid neoplasms, with 51% of Spitzoid tumors and melanomas harboring a kinase fusion in a recent analysis of 140 tumors (Nat. Commun. 2014;5:3116. doi:10.1038/ncommons4116 ).

The fusions were identified across the entire biological spectrum of Spitzoid neoplasms, including 55% of Spitz nevi, 56% of atypical Spitz tumors, and 39% of Spitzoid melanomas. Therefore, kinase fusions are not useful to distinguish benign from malignant tumors, study author Dr. Thomas Wiesner said at the 15^thWorld Congress on Cancers of the Skin.

However, the kinase fusions were mutually exclusive, meaning that only one fusion activates the oncogenic pathway in a tumor. Small molecule kinase inhibitors have become mainstays of modern oncologic therapy in recent years and thus may be useful in Spitz tumors, which typically affect the young.

“These genetic aberrations represent targets for therapeutic interventions and offer investigational treatment options for patients with metastatic disease,” said Dr. Wiesner, a research associate at Memorial Sloan-Kettering Cancer Center in New York City.

ROS1 (c-ros oncogene 1) fusions were the most frequent in the series at 17% and have been shown in mouse models to respond to crizotinib (Xalkori). ALK fusions, present in 10% of tumors, are also sensitive to this drug.

“I think Spitzoid melanoma that is metastatic should be stained for ROS1 or ALK fusions because crizotinib might help these patients,” he said. “We have good evidence that it helps, at least in lung cancer and lymphoma.”

Other drugs target NTRK1 (neurotrophic tyrosine kinase receptor type 1) fusions, which were identified in 16% of Spitzoid tumors, and are in preclinical trials.

The researchers have also published a description of the morphological features that point to the underlying genetic aberrations (Am. J. Surg. Pathol. Jul 2014;38:925-33)). The study, involving 17 patients, aged 2 to 35 years, indicates that BAP1 loss and BRAF mutations are common in epithelioid Spitz tumors, HRAS mutations and gains of 11p are seen in desmoplastic Spitz nevi, while ALK fusions usually point to plexiform Spitz tumors, Dr. Wiesner said.

Clinicians can use the morphological features along with basic immunohistochemistry to identify the distinct subsets of tumors with BAP1 loss or ALK, NTRK1, or ROS1 fusions.

BAP1 loss Spitz tumors are important to identify because they are associated with a hereditary tumor syndrome very similar to Peutz-Jeghers or Muir-Torre syndrome, Dr. Wiesner said.

“When we see multiple epithelioid Spitz tumors in one patient, we have to think about a hereditary tumor syndrome,” he said at the meeting, sponsored by the Skin Cancer Foundation.

EDINBURGH –Kinase fusions have been well described in hematologic malignancies and are the newest genetic aberration to be identified in Spitz tumors.

Kinase fusions are actually quite common in Spitzoid neoplasms, with 51% of Spitzoid tumors and melanomas harboring a kinase fusion in a recent analysis of 140 tumors (Nat. Commun. 2014;5:3116. doi:10.1038/ncommons4116 ).

The fusions were identified across the entire biological spectrum of Spitzoid neoplasms, including 55% of Spitz nevi, 56% of atypical Spitz tumors, and 39% of Spitzoid melanomas. Therefore, kinase fusions are not useful to distinguish benign from malignant tumors, study author Dr. Thomas Wiesner said at the 15^thWorld Congress on Cancers of the Skin.

However, the kinase fusions were mutually exclusive, meaning that only one fusion activates the oncogenic pathway in a tumor. Small molecule kinase inhibitors have become mainstays of modern oncologic therapy in recent years and thus may be useful in Spitz tumors, which typically affect the young.

“These genetic aberrations represent targets for therapeutic interventions and offer investigational treatment options for patients with metastatic disease,” said Dr. Wiesner, a research associate at Memorial Sloan-Kettering Cancer Center in New York City.

ROS1 (c-ros oncogene 1) fusions were the most frequent in the series at 17% and have been shown in mouse models to respond to crizotinib (Xalkori). ALK fusions, present in 10% of tumors, are also sensitive to this drug.

“I think Spitzoid melanoma that is metastatic should be stained for ROS1 or ALK fusions because crizotinib might help these patients,” he said. “We have good evidence that it helps, at least in lung cancer and lymphoma.”

Other drugs target NTRK1 (neurotrophic tyrosine kinase receptor type 1) fusions, which were identified in 16% of Spitzoid tumors, and are in preclinical trials.

The researchers have also published a description of the morphological features that point to the underlying genetic aberrations (Am. J. Surg. Pathol. Jul 2014;38:925-33)). The study, involving 17 patients, aged 2 to 35 years, indicates that BAP1 loss and BRAF mutations are common in epithelioid Spitz tumors, HRAS mutations and gains of 11p are seen in desmoplastic Spitz nevi, while ALK fusions usually point to plexiform Spitz tumors, Dr. Wiesner said.

Clinicians can use the morphological features along with basic immunohistochemistry to identify the distinct subsets of tumors with BAP1 loss or ALK, NTRK1, or ROS1 fusions.

BAP1 loss Spitz tumors are important to identify because they are associated with a hereditary tumor syndrome very similar to Peutz-Jeghers or Muir-Torre syndrome, Dr. Wiesner said.

“When we see multiple epithelioid Spitz tumors in one patient, we have to think about a hereditary tumor syndrome,” he said at the meeting, sponsored by the Skin Cancer Foundation.

EDINBURGH –Kinase fusions have been well described in hematologic malignancies and are the newest genetic aberration to be identified in Spitz tumors.

Kinase fusions are actually quite common in Spitzoid neoplasms, with 51% of Spitzoid tumors and melanomas harboring a kinase fusion in a recent analysis of 140 tumors (Nat. Commun. 2014;5:3116. doi:10.1038/ncommons4116 ).

The fusions were identified across the entire biological spectrum of Spitzoid neoplasms, including 55% of Spitz nevi, 56% of atypical Spitz tumors, and 39% of Spitzoid melanomas. Therefore, kinase fusions are not useful to distinguish benign from malignant tumors, study author Dr. Thomas Wiesner said at the 15^thWorld Congress on Cancers of the Skin.

However, the kinase fusions were mutually exclusive, meaning that only one fusion activates the oncogenic pathway in a tumor. Small molecule kinase inhibitors have become mainstays of modern oncologic therapy in recent years and thus may be useful in Spitz tumors, which typically affect the young.

“These genetic aberrations represent targets for therapeutic interventions and offer investigational treatment options for patients with metastatic disease,” said Dr. Wiesner, a research associate at Memorial Sloan-Kettering Cancer Center in New York City.

ROS1 (c-ros oncogene 1) fusions were the most frequent in the series at 17% and have been shown in mouse models to respond to crizotinib (Xalkori). ALK fusions, present in 10% of tumors, are also sensitive to this drug.

“I think Spitzoid melanoma that is metastatic should be stained for ROS1 or ALK fusions because crizotinib might help these patients,” he said. “We have good evidence that it helps, at least in lung cancer and lymphoma.”

Other drugs target NTRK1 (neurotrophic tyrosine kinase receptor type 1) fusions, which were identified in 16% of Spitzoid tumors, and are in preclinical trials.

The researchers have also published a description of the morphological features that point to the underlying genetic aberrations (Am. J. Surg. Pathol. Jul 2014;38:925-33)). The study, involving 17 patients, aged 2 to 35 years, indicates that BAP1 loss and BRAF mutations are common in epithelioid Spitz tumors, HRAS mutations and gains of 11p are seen in desmoplastic Spitz nevi, while ALK fusions usually point to plexiform Spitz tumors, Dr. Wiesner said.

Clinicians can use the morphological features along with basic immunohistochemistry to identify the distinct subsets of tumors with BAP1 loss or ALK, NTRK1, or ROS1 fusions.

BAP1 loss Spitz tumors are important to identify because they are associated with a hereditary tumor syndrome very similar to Peutz-Jeghers or Muir-Torre syndrome, Dr. Wiesner said.

“When we see multiple epithelioid Spitz tumors in one patient, we have to think about a hereditary tumor syndrome,” he said at the meeting, sponsored by the Skin Cancer Foundation.

MELBOURNE – High-grade squamous intraepithelial lesions are prevalent among HIV-positive gay men and a significant number of these anal lesions resolve spontaneously, according to data from a longitudinal observational cohort study.

The Study of the Prevention of Anal Cancer (SPANC) is a 3-year prospective study of the natural history of anal HPV infection, which has so far enrolled 350 homosexual men over 35 years old. Dr. Andrew Grulich from the Kirby Institute, University of New South Wales, Sydney, presented trial data at the 20th International AIDS Conference that showed a 42% clearance rate for high-grade squamous intraepithelial lesions (HSIL).

Bianca Nogrady/Frontline Medical News

Anal lesions that result from human papillomavirus infection are difficult to treat, and there is no evidence for the effectiveness of treatment, Dr. Grulich said. Further, anal lesions are far less likely than cervical lesions to progress to cancer. However, questions remain about which men are more likely to have persistent high-grade disease and therefore are at a higher risk of progression to cancer.

Interim data from the SPANC study found a 46% prevalence of HSIL among HIV-positive gay men and a 34% prevalence among HIV-negative gay men. The higher rate among HIV-positive individuals was largely driven by a higher prevalence of more advanced anal intraepithelial neoplasia.

Men with persistent infections due to human papillomavirus (HPV) 16 – the subtype most commonly associated with anal cancer – were much less likely to clear the high-grade lesions (hazard ratio = 0.22, 95% confidence interval, 0.11-0.46), as were men with multiple subtypes of HPV.

"What we’ve been able to show is that high-grade disease is very dynamic, with one in six [gay] men getting it and of those who get it about 40% clearing it each year," Dr. Grulich told the conference.

"Not all high-grade disease requires treatment," he said. "These data suggest that treatment can be targeted at those with persistent high-grade disease because much high-grade disease diagnosed on a single occasion will simply go away."

Treatment practices for HSIL vary with some choosing a ‘watch and wait’ approach and others choosing ablative treatment. Dr. Grulich suggested treatment based on "red flags" that suggest a higher risk of progression to cancer.

"If [the patient] is HPV 16–positive, that’s a definite red flag because 90% of anal cancer is caused by that one subtype," Dr. Grulich said. Also, high-grade disease that doesn’t clear is another red flag.

"I think it’s perfectly reasonable, given the state of the science, if you’re doing high-resolution anoscopy and you diagnose (HSIL), to explain to the patient that it’s highly likely to go away but it may not, and therefore get the patient back in about a year," he said.

The study is funded by the National Health and Medical Research Council of Australia, and the Cancer Council NSW. Some authors declared financial ties to pharmaceutical companies including a manufacturer of HPV vaccines.

MELBOURNE – High-grade squamous intraepithelial lesions are prevalent among HIV-positive gay men and a significant number of these anal lesions resolve spontaneously, according to data from a longitudinal observational cohort study.

The Study of the Prevention of Anal Cancer (SPANC) is a 3-year prospective study of the natural history of anal HPV infection, which has so far enrolled 350 homosexual men over 35 years old. Dr. Andrew Grulich from the Kirby Institute, University of New South Wales, Sydney, presented trial data at the 20th International AIDS Conference that showed a 42% clearance rate for high-grade squamous intraepithelial lesions (HSIL).

Bianca Nogrady/Frontline Medical News

Anal lesions that result from human papillomavirus infection are difficult to treat, and there is no evidence for the effectiveness of treatment, Dr. Grulich said. Further, anal lesions are far less likely than cervical lesions to progress to cancer. However, questions remain about which men are more likely to have persistent high-grade disease and therefore are at a higher risk of progression to cancer.

Interim data from the SPANC study found a 46% prevalence of HSIL among HIV-positive gay men and a 34% prevalence among HIV-negative gay men. The higher rate among HIV-positive individuals was largely driven by a higher prevalence of more advanced anal intraepithelial neoplasia.

Men with persistent infections due to human papillomavirus (HPV) 16 – the subtype most commonly associated with anal cancer – were much less likely to clear the high-grade lesions (hazard ratio = 0.22, 95% confidence interval, 0.11-0.46), as were men with multiple subtypes of HPV.

"What we’ve been able to show is that high-grade disease is very dynamic, with one in six [gay] men getting it and of those who get it about 40% clearing it each year," Dr. Grulich told the conference.

"Not all high-grade disease requires treatment," he said. "These data suggest that treatment can be targeted at those with persistent high-grade disease because much high-grade disease diagnosed on a single occasion will simply go away."

Treatment practices for HSIL vary with some choosing a ‘watch and wait’ approach and others choosing ablative treatment. Dr. Grulich suggested treatment based on "red flags" that suggest a higher risk of progression to cancer.

"If [the patient] is HPV 16–positive, that’s a definite red flag because 90% of anal cancer is caused by that one subtype," Dr. Grulich said. Also, high-grade disease that doesn’t clear is another red flag.

"I think it’s perfectly reasonable, given the state of the science, if you’re doing high-resolution anoscopy and you diagnose (HSIL), to explain to the patient that it’s highly likely to go away but it may not, and therefore get the patient back in about a year," he said.

The study is funded by the National Health and Medical Research Council of Australia, and the Cancer Council NSW. Some authors declared financial ties to pharmaceutical companies including a manufacturer of HPV vaccines.

MELBOURNE – High-grade squamous intraepithelial lesions are prevalent among HIV-positive gay men and a significant number of these anal lesions resolve spontaneously, according to data from a longitudinal observational cohort study.

The Study of the Prevention of Anal Cancer (SPANC) is a 3-year prospective study of the natural history of anal HPV infection, which has so far enrolled 350 homosexual men over 35 years old. Dr. Andrew Grulich from the Kirby Institute, University of New South Wales, Sydney, presented trial data at the 20th International AIDS Conference that showed a 42% clearance rate for high-grade squamous intraepithelial lesions (HSIL).

Bianca Nogrady/Frontline Medical News

Anal lesions that result from human papillomavirus infection are difficult to treat, and there is no evidence for the effectiveness of treatment, Dr. Grulich said. Further, anal lesions are far less likely than cervical lesions to progress to cancer. However, questions remain about which men are more likely to have persistent high-grade disease and therefore are at a higher risk of progression to cancer.

Interim data from the SPANC study found a 46% prevalence of HSIL among HIV-positive gay men and a 34% prevalence among HIV-negative gay men. The higher rate among HIV-positive individuals was largely driven by a higher prevalence of more advanced anal intraepithelial neoplasia.

Men with persistent infections due to human papillomavirus (HPV) 16 – the subtype most commonly associated with anal cancer – were much less likely to clear the high-grade lesions (hazard ratio = 0.22, 95% confidence interval, 0.11-0.46), as were men with multiple subtypes of HPV.

"What we’ve been able to show is that high-grade disease is very dynamic, with one in six [gay] men getting it and of those who get it about 40% clearing it each year," Dr. Grulich told the conference.

"Not all high-grade disease requires treatment," he said. "These data suggest that treatment can be targeted at those with persistent high-grade disease because much high-grade disease diagnosed on a single occasion will simply go away."

Treatment practices for HSIL vary with some choosing a ‘watch and wait’ approach and others choosing ablative treatment. Dr. Grulich suggested treatment based on "red flags" that suggest a higher risk of progression to cancer.

"If [the patient] is HPV 16–positive, that’s a definite red flag because 90% of anal cancer is caused by that one subtype," Dr. Grulich said. Also, high-grade disease that doesn’t clear is another red flag.

"I think it’s perfectly reasonable, given the state of the science, if you’re doing high-resolution anoscopy and you diagnose (HSIL), to explain to the patient that it’s highly likely to go away but it may not, and therefore get the patient back in about a year," he said.

The study is funded by the National Health and Medical Research Council of Australia, and the Cancer Council NSW. Some authors declared financial ties to pharmaceutical companies including a manufacturer of HPV vaccines.

EDINBURGH – Mobile phone apps that provide real-time, personalized sun risk and protection information are gaining ground in the fight against skin cancer.

The SunSmart app uses geolocation to alert iPhone, Android, and Samsung phones users in Australia when the UV Index reaches 3 or more and protection is required.

Patrice Wendling/Frontline Medical News

"The great advantage of a smartphone app for communicating the UV Index is that it can really communicate very directly to individuals based on their location," Craig Sinclair said at the 15th World Congress on Cancers of the Skin.

The SunSmart app also provides precise information related to the UV index and behavior prompts associated with it. It can, for example, calculate how much sunscreen should be applied based on the user’s height, weight, and choice of clothing; provide reminders to reapply sunscreen every 2 hours; and track whether a user is getting enough vitamin D based on their skin type, time spent outdoors, and clothing choices, said Mr. Sinclair of the Cancer Council Australia, Victoria, developer of the app.

The World UV app, created by the British Association of Dermatologists (BAD) and the United Kingdom’s Met Office (national weather service), takes sun protection one step further by providing a guide to the Fitzpatrick skin classification scale so users can determine the effects of the current UV rating on their specific skin type.

The app uses simple icons to relay the current UV index in real time and whether skin protection is required. Separate tabs allow access to more information on their Fitzpatrick skin type, what type of protection is required, and sun protection tips.

The app uses geolocation to pinpoint users but also allows them to select from more than 10,000 locations worldwide – making it a truly global app, Nina Goad, head of communications at BAD, said at the meeting.

Since its informal launch in 2012, more than 150,000 people in 200 countries have downloaded the free World UV app. The app has been most popular in the United States, United Kingdom, Belgium, Spain, and Australia, she said.

The launch of the SunSmart app in late 2010 has prompted roughly 130,000 Australians to download the free app. An online survey of 78 users in February 2011 showed that 85% felt it was easy to use and 87% said it met or exceeded expectations, Mr. Sinclair said at the meeting, which was sponsored by the Skin Cancer Foundation.

Patrice Wendling/Frontline Medical News

A follow-up survey of 380 persons revealed that 72% "agreed" or "strongly agreed" that using the app improved their sun protection that summer.

Another 86% said that it made them more aware of the times of day when sun protection is required and 81% said they were able to recognize the difference between UV level and temperature, which is "always a difficult issue to communicate," Mr. Sinclair said.

"These are self-reports, so there is undoubtedly some bias associated with them, but nonetheless, showing reasonably promising results," he added.

Both Mr. Sinclair and Ms. Goad said the apps will continue to be refined to increase downloads and return visits but noted that their respective nonprofits do not have the funding for large-scale advertising campaigns.

[email protected]

EDINBURGH – Mobile phone apps that provide real-time, personalized sun risk and protection information are gaining ground in the fight against skin cancer.

The SunSmart app uses geolocation to alert iPhone, Android, and Samsung phones users in Australia when the UV Index reaches 3 or more and protection is required.

Patrice Wendling/Frontline Medical News

"The great advantage of a smartphone app for communicating the UV Index is that it can really communicate very directly to individuals based on their location," Craig Sinclair said at the 15th World Congress on Cancers of the Skin.

The SunSmart app also provides precise information related to the UV index and behavior prompts associated with it. It can, for example, calculate how much sunscreen should be applied based on the user’s height, weight, and choice of clothing; provide reminders to reapply sunscreen every 2 hours; and track whether a user is getting enough vitamin D based on their skin type, time spent outdoors, and clothing choices, said Mr. Sinclair of the Cancer Council Australia, Victoria, developer of the app.

The World UV app, created by the British Association of Dermatologists (BAD) and the United Kingdom’s Met Office (national weather service), takes sun protection one step further by providing a guide to the Fitzpatrick skin classification scale so users can determine the effects of the current UV rating on their specific skin type.

The app uses simple icons to relay the current UV index in real time and whether skin protection is required. Separate tabs allow access to more information on their Fitzpatrick skin type, what type of protection is required, and sun protection tips.

The app uses geolocation to pinpoint users but also allows them to select from more than 10,000 locations worldwide – making it a truly global app, Nina Goad, head of communications at BAD, said at the meeting.

Since its informal launch in 2012, more than 150,000 people in 200 countries have downloaded the free World UV app. The app has been most popular in the United States, United Kingdom, Belgium, Spain, and Australia, she said.

The launch of the SunSmart app in late 2010 has prompted roughly 130,000 Australians to download the free app. An online survey of 78 users in February 2011 showed that 85% felt it was easy to use and 87% said it met or exceeded expectations, Mr. Sinclair said at the meeting, which was sponsored by the Skin Cancer Foundation.

Patrice Wendling/Frontline Medical News

A follow-up survey of 380 persons revealed that 72% "agreed" or "strongly agreed" that using the app improved their sun protection that summer.

Another 86% said that it made them more aware of the times of day when sun protection is required and 81% said they were able to recognize the difference between UV level and temperature, which is "always a difficult issue to communicate," Mr. Sinclair said.

"These are self-reports, so there is undoubtedly some bias associated with them, but nonetheless, showing reasonably promising results," he added.

Both Mr. Sinclair and Ms. Goad said the apps will continue to be refined to increase downloads and return visits but noted that their respective nonprofits do not have the funding for large-scale advertising campaigns.

[email protected]

EDINBURGH – Mobile phone apps that provide real-time, personalized sun risk and protection information are gaining ground in the fight against skin cancer.

The SunSmart app uses geolocation to alert iPhone, Android, and Samsung phones users in Australia when the UV Index reaches 3 or more and protection is required.

Patrice Wendling/Frontline Medical News

"The great advantage of a smartphone app for communicating the UV Index is that it can really communicate very directly to individuals based on their location," Craig Sinclair said at the 15th World Congress on Cancers of the Skin.

The SunSmart app also provides precise information related to the UV index and behavior prompts associated with it. It can, for example, calculate how much sunscreen should be applied based on the user’s height, weight, and choice of clothing; provide reminders to reapply sunscreen every 2 hours; and track whether a user is getting enough vitamin D based on their skin type, time spent outdoors, and clothing choices, said Mr. Sinclair of the Cancer Council Australia, Victoria, developer of the app.

The World UV app, created by the British Association of Dermatologists (BAD) and the United Kingdom’s Met Office (national weather service), takes sun protection one step further by providing a guide to the Fitzpatrick skin classification scale so users can determine the effects of the current UV rating on their specific skin type.

The app uses simple icons to relay the current UV index in real time and whether skin protection is required. Separate tabs allow access to more information on their Fitzpatrick skin type, what type of protection is required, and sun protection tips.

The app uses geolocation to pinpoint users but also allows them to select from more than 10,000 locations worldwide – making it a truly global app, Nina Goad, head of communications at BAD, said at the meeting.

Since its informal launch in 2012, more than 150,000 people in 200 countries have downloaded the free World UV app. The app has been most popular in the United States, United Kingdom, Belgium, Spain, and Australia, she said.

The launch of the SunSmart app in late 2010 has prompted roughly 130,000 Australians to download the free app. An online survey of 78 users in February 2011 showed that 85% felt it was easy to use and 87% said it met or exceeded expectations, Mr. Sinclair said at the meeting, which was sponsored by the Skin Cancer Foundation.

Patrice Wendling/Frontline Medical News

A follow-up survey of 380 persons revealed that 72% "agreed" or "strongly agreed" that using the app improved their sun protection that summer.

Another 86% said that it made them more aware of the times of day when sun protection is required and 81% said they were able to recognize the difference between UV level and temperature, which is "always a difficult issue to communicate," Mr. Sinclair said.

"These are self-reports, so there is undoubtedly some bias associated with them, but nonetheless, showing reasonably promising results," he added.

Both Mr. Sinclair and Ms. Goad said the apps will continue to be refined to increase downloads and return visits but noted that their respective nonprofits do not have the funding for large-scale advertising campaigns.

[email protected]

Dermatologists frequently encounter patients who inquire about the need to buy special clothing and hats that claim to block UV light rather than using their regular clothing and hats. A patient may argue that he/she has never gotten sunburned through his/her favorite T-shirt while fishing, so why does he/she need to buy special clothing? The answer to this question is not straightforward. The dermatologist could easily say yes and advise patients to buy special sun-protective clothing, which could be especially tempting if a practitioner actually sells these items in the office. However, when considering evidence-based medicine, one needs to look at the data to appropriately answer the question.

Although it is still evolving, a standard has been set for UV protection factor (UPF) in the United States as well as other countries.¹ Clothing with the maximum UPF rating of 50 blocks 98% of UVA/UVB radiation. Although there are data published in the literature regarding sun-protective clothing, there are scant data in the clinical dermatologic literature.^2-5 To give patients an educated answer to this question, we measured and compared UVA/UVB radiation transmittance through regular (ie, non–UPF rated) clothing versus sun-protective clothing with a UPF rating.

Materials and Methods

A digital handheld UVA/UVB meter with an absorption spectrum of 280 to 400 nm was used to measure UV energy transmitted through sample clothing articles. The meter measured UVA/UVB light with a maximum reading of 40 mW/cm². Clothing articles were selected of varied material/color and intended use.

Regular clothing articles included a straw golf hat (Figure 1A), an off-white and blue baseball hat (70% wool)(Figure 1B), a black baseball hat (100% wool)(Figure 1C), a white athletic tank shirt (100% cotton), a white T-shirt/undershirt (100% cotton), a thin-weave blue T-shirt (100% cotton), and a conventional-weave blue T-shirt (100% cotton)(Figure 1D). The regular clothing items, with the exception of the hats, had been laundered in conventional (ie, non–UV blocking) laundry detergent and no chemicals were applied to enhance UVA/UVB blocking properties. The exact number of times the items were laundered was unknown.

Figure 1. Regular clothing articles included a straw golf hat (A), an off-white and blue baseball hat (B), a black baseball hat (C), and white and blue T-shirts (D).

Sun-protective clothing articles included a polyester floral splash bucket hat and a polyester ruffled swim romper (Figure 2), both with a UPF rating of 50+. These items were purchased from a manufacturer who regularly promotes sun-protective clothing to both dermatologists and the general public. The company “guarantees” a UPF rating of 50 and advertises that these clothing articles block 98% of harmful UV rays. These items were not laundered prior to the study, and no chemicals were applied to enhance UVA/UVB blocking properties.

Figure 2. Sun-protective clothing articles included a floral splash bucket hat and a ruffled swim romper (UV protection factor 50+).

The UVA/UVB meter was calibrated on a clear cloudless July day in Frankfort, Illinois. An initial reading was taken without any obstruction to the sunlight. The regular and sun-protective clothing articles then were placed over the meter to measure the amount of UVA/UVB transmitted through each item. Measurements were taken for each article of clothing after the meter was covered by the respective material for 10 seconds. Care was taken to cover the meter with only 1 layer of material for each article, which was intended to mimic the degree of UVA/UVB blocking and transmittance during normal wear.

Results

The full results from the study are outlined in the Table. The unobstructed sunlight exposure exceeded the maximum measure of 40 mW/cm², indicating there was a sufficient amount of sunlight to conduct testing.

The data show that both regular and sun-protective clothing blocked UVA/UVB rays in the 280- to 400-nm range. The Table outlines the level of UVA/UVB transmittance for each article of clothing; a lower number indicates less UVA/UVB transmittance occurred and more radiation was blocked.

Several of the regular clothing blocked more UV radiation than the sun-protective clothing; specifically, the data indicate that the baseball hats or the straw golf hat provided better protection than the sun-protective bucket hat. The black baseball hat provided the best UV protection. However, the straw golf hat provided adequate protection and better coverage, making it the best recommendation for patients.

Comment

Several of the regular items included in the study allowed less UVA/UVB transmission than the sun-protective clothing. Although our small study tested a limited number and type of articles, we assert that similar regular clothing would have similar transmittance.

There are various factors that affect UVA/UVB transmittance. Fabric construction, weight, thickness, composition, and color will affect the degree of UVA/UVB transmittance.¹ In our study, the thickness, weave, and color of the fabric of the regular hats may have contributed to the superior results compared with the sun-protective hat. It could be postulated that cotton is inherently a superior fabric to the polyester sun-protective clothing fabric. With regard to the regular T-shirts, thickness, weave, and color also may have played a role in blocking UVA/UVB transmittance.

Patients may be assured of a sufficient amount of UVA/UVB blocking with sun-protective clothing. However, our study indicated that the regular clothing articles we tested provided similar, if not better, protection against UV radiation compared with the sun-protective clothing articles.

Conclusion

Based on the data, we would advise patients that they do not need to buy special sun-protective clothing that claims to block UV radiation, as regular clothing will provide equivalent protection against UVA/UVB radiation. However, these findings do not suggest that the claims for sun-protective clothing are inaccurate. Nevertheless, similar UVA/UVB blocking may be achieved with clothing already owned by patients.

Dermatologists frequently encounter patients who inquire about the need to buy special clothing and hats that claim to block UV light rather than using their regular clothing and hats. A patient may argue that he/she has never gotten sunburned through his/her favorite T-shirt while fishing, so why does he/she need to buy special clothing? The answer to this question is not straightforward. The dermatologist could easily say yes and advise patients to buy special sun-protective clothing, which could be especially tempting if a practitioner actually sells these items in the office. However, when considering evidence-based medicine, one needs to look at the data to appropriately answer the question.

Although it is still evolving, a standard has been set for UV protection factor (UPF) in the United States as well as other countries.¹ Clothing with the maximum UPF rating of 50 blocks 98% of UVA/UVB radiation. Although there are data published in the literature regarding sun-protective clothing, there are scant data in the clinical dermatologic literature.^2-5 To give patients an educated answer to this question, we measured and compared UVA/UVB radiation transmittance through regular (ie, non–UPF rated) clothing versus sun-protective clothing with a UPF rating.

Materials and Methods

A digital handheld UVA/UVB meter with an absorption spectrum of 280 to 400 nm was used to measure UV energy transmitted through sample clothing articles. The meter measured UVA/UVB light with a maximum reading of 40 mW/cm². Clothing articles were selected of varied material/color and intended use.

Regular clothing articles included a straw golf hat (Figure 1A), an off-white and blue baseball hat (70% wool)(Figure 1B), a black baseball hat (100% wool)(Figure 1C), a white athletic tank shirt (100% cotton), a white T-shirt/undershirt (100% cotton), a thin-weave blue T-shirt (100% cotton), and a conventional-weave blue T-shirt (100% cotton)(Figure 1D). The regular clothing items, with the exception of the hats, had been laundered in conventional (ie, non–UV blocking) laundry detergent and no chemicals were applied to enhance UVA/UVB blocking properties. The exact number of times the items were laundered was unknown.

Figure 1. Regular clothing articles included a straw golf hat (A), an off-white and blue baseball hat (B), a black baseball hat (C), and white and blue T-shirts (D).

Sun-protective clothing articles included a polyester floral splash bucket hat and a polyester ruffled swim romper (Figure 2), both with a UPF rating of 50+. These items were purchased from a manufacturer who regularly promotes sun-protective clothing to both dermatologists and the general public. The company “guarantees” a UPF rating of 50 and advertises that these clothing articles block 98% of harmful UV rays. These items were not laundered prior to the study, and no chemicals were applied to enhance UVA/UVB blocking properties.

Figure 2. Sun-protective clothing articles included a floral splash bucket hat and a ruffled swim romper (UV protection factor 50+).

The UVA/UVB meter was calibrated on a clear cloudless July day in Frankfort, Illinois. An initial reading was taken without any obstruction to the sunlight. The regular and sun-protective clothing articles then were placed over the meter to measure the amount of UVA/UVB transmitted through each item. Measurements were taken for each article of clothing after the meter was covered by the respective material for 10 seconds. Care was taken to cover the meter with only 1 layer of material for each article, which was intended to mimic the degree of UVA/UVB blocking and transmittance during normal wear.

Results

The full results from the study are outlined in the Table. The unobstructed sunlight exposure exceeded the maximum measure of 40 mW/cm², indicating there was a sufficient amount of sunlight to conduct testing.

The data show that both regular and sun-protective clothing blocked UVA/UVB rays in the 280- to 400-nm range. The Table outlines the level of UVA/UVB transmittance for each article of clothing; a lower number indicates less UVA/UVB transmittance occurred and more radiation was blocked.

Several of the regular clothing blocked more UV radiation than the sun-protective clothing; specifically, the data indicate that the baseball hats or the straw golf hat provided better protection than the sun-protective bucket hat. The black baseball hat provided the best UV protection. However, the straw golf hat provided adequate protection and better coverage, making it the best recommendation for patients.

Comment

Several of the regular items included in the study allowed less UVA/UVB transmission than the sun-protective clothing. Although our small study tested a limited number and type of articles, we assert that similar regular clothing would have similar transmittance.

There are various factors that affect UVA/UVB transmittance. Fabric construction, weight, thickness, composition, and color will affect the degree of UVA/UVB transmittance.¹ In our study, the thickness, weave, and color of the fabric of the regular hats may have contributed to the superior results compared with the sun-protective hat. It could be postulated that cotton is inherently a superior fabric to the polyester sun-protective clothing fabric. With regard to the regular T-shirts, thickness, weave, and color also may have played a role in blocking UVA/UVB transmittance.

Patients may be assured of a sufficient amount of UVA/UVB blocking with sun-protective clothing. However, our study indicated that the regular clothing articles we tested provided similar, if not better, protection against UV radiation compared with the sun-protective clothing articles.

Conclusion

Based on the data, we would advise patients that they do not need to buy special sun-protective clothing that claims to block UV radiation, as regular clothing will provide equivalent protection against UVA/UVB radiation. However, these findings do not suggest that the claims for sun-protective clothing are inaccurate. Nevertheless, similar UVA/UVB blocking may be achieved with clothing already owned by patients.

Dermatologists frequently encounter patients who inquire about the need to buy special clothing and hats that claim to block UV light rather than using their regular clothing and hats. A patient may argue that he/she has never gotten sunburned through his/her favorite T-shirt while fishing, so why does he/she need to buy special clothing? The answer to this question is not straightforward. The dermatologist could easily say yes and advise patients to buy special sun-protective clothing, which could be especially tempting if a practitioner actually sells these items in the office. However, when considering evidence-based medicine, one needs to look at the data to appropriately answer the question.

Although it is still evolving, a standard has been set for UV protection factor (UPF) in the United States as well as other countries.¹ Clothing with the maximum UPF rating of 50 blocks 98% of UVA/UVB radiation. Although there are data published in the literature regarding sun-protective clothing, there are scant data in the clinical dermatologic literature.^2-5 To give patients an educated answer to this question, we measured and compared UVA/UVB radiation transmittance through regular (ie, non–UPF rated) clothing versus sun-protective clothing with a UPF rating.

Materials and Methods

A digital handheld UVA/UVB meter with an absorption spectrum of 280 to 400 nm was used to measure UV energy transmitted through sample clothing articles. The meter measured UVA/UVB light with a maximum reading of 40 mW/cm². Clothing articles were selected of varied material/color and intended use.

Regular clothing articles included a straw golf hat (Figure 1A), an off-white and blue baseball hat (70% wool)(Figure 1B), a black baseball hat (100% wool)(Figure 1C), a white athletic tank shirt (100% cotton), a white T-shirt/undershirt (100% cotton), a thin-weave blue T-shirt (100% cotton), and a conventional-weave blue T-shirt (100% cotton)(Figure 1D). The regular clothing items, with the exception of the hats, had been laundered in conventional (ie, non–UV blocking) laundry detergent and no chemicals were applied to enhance UVA/UVB blocking properties. The exact number of times the items were laundered was unknown.

Figure 1. Regular clothing articles included a straw golf hat (A), an off-white and blue baseball hat (B), a black baseball hat (C), and white and blue T-shirts (D).

Sun-protective clothing articles included a polyester floral splash bucket hat and a polyester ruffled swim romper (Figure 2), both with a UPF rating of 50+. These items were purchased from a manufacturer who regularly promotes sun-protective clothing to both dermatologists and the general public. The company “guarantees” a UPF rating of 50 and advertises that these clothing articles block 98% of harmful UV rays. These items were not laundered prior to the study, and no chemicals were applied to enhance UVA/UVB blocking properties.

Figure 2. Sun-protective clothing articles included a floral splash bucket hat and a ruffled swim romper (UV protection factor 50+).

The UVA/UVB meter was calibrated on a clear cloudless July day in Frankfort, Illinois. An initial reading was taken without any obstruction to the sunlight. The regular and sun-protective clothing articles then were placed over the meter to measure the amount of UVA/UVB transmitted through each item. Measurements were taken for each article of clothing after the meter was covered by the respective material for 10 seconds. Care was taken to cover the meter with only 1 layer of material for each article, which was intended to mimic the degree of UVA/UVB blocking and transmittance during normal wear.

Results

The full results from the study are outlined in the Table. The unobstructed sunlight exposure exceeded the maximum measure of 40 mW/cm², indicating there was a sufficient amount of sunlight to conduct testing.

The data show that both regular and sun-protective clothing blocked UVA/UVB rays in the 280- to 400-nm range. The Table outlines the level of UVA/UVB transmittance for each article of clothing; a lower number indicates less UVA/UVB transmittance occurred and more radiation was blocked.

Several of the regular clothing blocked more UV radiation than the sun-protective clothing; specifically, the data indicate that the baseball hats or the straw golf hat provided better protection than the sun-protective bucket hat. The black baseball hat provided the best UV protection. However, the straw golf hat provided adequate protection and better coverage, making it the best recommendation for patients.

Comment

Several of the regular items included in the study allowed less UVA/UVB transmission than the sun-protective clothing. Although our small study tested a limited number and type of articles, we assert that similar regular clothing would have similar transmittance.

There are various factors that affect UVA/UVB transmittance. Fabric construction, weight, thickness, composition, and color will affect the degree of UVA/UVB transmittance.¹ In our study, the thickness, weave, and color of the fabric of the regular hats may have contributed to the superior results compared with the sun-protective hat. It could be postulated that cotton is inherently a superior fabric to the polyester sun-protective clothing fabric. With regard to the regular T-shirts, thickness, weave, and color also may have played a role in blocking UVA/UVB transmittance.

Patients may be assured of a sufficient amount of UVA/UVB blocking with sun-protective clothing. However, our study indicated that the regular clothing articles we tested provided similar, if not better, protection against UV radiation compared with the sun-protective clothing articles.

Conclusion

Based on the data, we would advise patients that they do not need to buy special sun-protective clothing that claims to block UV radiation, as regular clothing will provide equivalent protection against UVA/UVB radiation. However, these findings do not suggest that the claims for sun-protective clothing are inaccurate. Nevertheless, similar UVA/UVB blocking may be achieved with clothing already owned by patients.

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

SILVER SPRING, MD. – The widespread and long-term use of sunscreens demands that manufacturers provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions, according to an expert panel called by the Food and Drug Administration.

Sunscreen safety has become an increasingly more important concern, especially since they are intended to be applied over the entire body, multiple times a day, and for a lifetime, Dr. Theresa Michele, director of the FDA’s division of nonprescription clinical evaluation, said Sept. 5 at a meeting of the agency’s Nonprescription Drugs Advisory Committee. "We’re essentially talking about a cradle-to-grave product."

© Vesna Andjic/iStockphoto.com

FDA has been under pressure from physicians, consumers, manufacturers, and Congress to approve a backlog of eight ingredients that are generally available outside of the United States and to improve the process for reviewing new ingredients. The agency proposes to add carcinogenicity and developmental and reproductive toxicity to the required safety testing prior to approval.

Speaking at the meeting, a coalition of sunscreen manufacturers said that most of what was being requested by the FDA is redundant or not necessary. "Today’s sunscreen ingredients have a wealth of data to support their safety," said the Personal Care Products Council (PCPC) in a statement. The group also said that many of the ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues.

Advisory committee members, however, said that their concerns were not allayed.

"If you don’t look for a signal you’re not going to find a signal," said Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Margolis said he was concerned about safety over the long term, and about perhaps too much reliance on rodent models.

"The penetration through rodent skin is different than the penetration through human skin," he said.

Dr. Geoffrey L. Rosenthal, professor of pediatrics at the University of Maryland, Baltimore, said that he was bothered by the lack of specific studies in children. "Unless you study them in kids, you just don’t know," he said.

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia, agreed and said that the agency should also consider requiring studies in pregnant and lactating women.

Dr. Perman, who spoke on behalf of the American Academy of Pediatrics during the public section of the meeting, said that AAP also would like to see studies based on actual – not directed – sunscreen use and investigations of the effects of spray sunscreens and of nanoparticles on children.

Several panel members also said that they were concerned about the disconnect between real-world use of sunscreens and the amounts studied during trials. The PCPC said in its background materials that market data indicate that many people use sunscreen only once a week, and that among users, only about 22% reapply as often as directed on the label.

Some committee members said that they viewed sunscreens as drugs that should always be subject to the same review and approval process.

"It’s really shocking to me that these are not being regulated through the process by which drugs are regulated," said Lorraine Gudas, Ph.D., chairman of pharmacology at Cornell University, New York. She noted that little was known about the potential systemic effects of sunscreen ingredients.

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has granted an accelerated approval to pembrolizumab, a PD-1 inhibitor, for the treatment of patients with advanced or unresectable melanoma that is no longer responding to other drugs.

Pembrolizumab (Keytruda; Merck) is intended for use following treatment with ipilimumab. For BRAF V600-positive patients, the drug should be used after treatment with both ipilimumab and a BRAF inhibitor, according to an FDA press statement.

The approved dose is 2 mg/kg every 3 weeks for patients with unresectable or metastatic melanoma and disease progression following the initial treatments.

According to a Merck press statement, "This indication is approved ... based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established." Additional studies are underway, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials, the statement noted.

The pivotal trial comprised 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. All participants were treated with pembrolizumab, either at the recommended dose of 2 mg/kg or at a higher dose of 10 mg/kg. In the half of the participants who received pembrolizumab at the recommended dose of 2 mg/kg, approximately 24% had their tumors shrink. This effect lasted at least 1.4-8.5 months and continued beyond this period in most patients, the FDA statement said.

The drug was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving pembrolizumab. The most common serious adverse reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis. Adverse reactions occurring in at least 20% of the 411 patients across doses were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The FDA cautions that pembrolizumab also has the potential for severe immune-mediated side effects. In the 411 participants with advanced melanoma, severe immune-mediated side effects involving healthy organs, including the lung, colon, hormone-producing glands, and liver, occurred uncommonly, they said.

It is the sixth drug to be approved for melanoma since 2011, joining ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).

The Melanoma Research Alliance applauded FDA’s action in a press statement.

"The news of FDA’s first approval of an anti-PD-1 drug is extremely exciting and shows just how far the field has come in the last few years," said Debra Black, MRA cofounder. "When we started MRA there was little hope for melanoma patients. Today we are seeing a real sea change, with several new therapies and proof of concept that these new treatments can save lives."

[email protected]

The Food and Drug Administration has granted an accelerated approval to pembrolizumab, a PD-1 inhibitor, for the treatment of patients with advanced or unresectable melanoma that is no longer responding to other drugs.

Pembrolizumab (Keytruda; Merck) is intended for use following treatment with ipilimumab. For BRAF V600-positive patients, the drug should be used after treatment with both ipilimumab and a BRAF inhibitor, according to an FDA press statement.

The approved dose is 2 mg/kg every 3 weeks for patients with unresectable or metastatic melanoma and disease progression following the initial treatments.

According to a Merck press statement, "This indication is approved ... based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established." Additional studies are underway, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials, the statement noted.

The pivotal trial comprised 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. All participants were treated with pembrolizumab, either at the recommended dose of 2 mg/kg or at a higher dose of 10 mg/kg. In the half of the participants who received pembrolizumab at the recommended dose of 2 mg/kg, approximately 24% had their tumors shrink. This effect lasted at least 1.4-8.5 months and continued beyond this period in most patients, the FDA statement said.

The drug was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving pembrolizumab. The most common serious adverse reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis. Adverse reactions occurring in at least 20% of the 411 patients across doses were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The FDA cautions that pembrolizumab also has the potential for severe immune-mediated side effects. In the 411 participants with advanced melanoma, severe immune-mediated side effects involving healthy organs, including the lung, colon, hormone-producing glands, and liver, occurred uncommonly, they said.

It is the sixth drug to be approved for melanoma since 2011, joining ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).

The Melanoma Research Alliance applauded FDA’s action in a press statement.

"The news of FDA’s first approval of an anti-PD-1 drug is extremely exciting and shows just how far the field has come in the last few years," said Debra Black, MRA cofounder. "When we started MRA there was little hope for melanoma patients. Today we are seeing a real sea change, with several new therapies and proof of concept that these new treatments can save lives."

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The Food and Drug Administration has granted an accelerated approval to pembrolizumab, a PD-1 inhibitor, for the treatment of patients with advanced or unresectable melanoma that is no longer responding to other drugs.

Pembrolizumab (Keytruda; Merck) is intended for use following treatment with ipilimumab. For BRAF V600-positive patients, the drug should be used after treatment with both ipilimumab and a BRAF inhibitor, according to an FDA press statement.

The approved dose is 2 mg/kg every 3 weeks for patients with unresectable or metastatic melanoma and disease progression following the initial treatments.

According to a Merck press statement, "This indication is approved ... based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established." Additional studies are underway, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials, the statement noted.

The pivotal trial comprised 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. All participants were treated with pembrolizumab, either at the recommended dose of 2 mg/kg or at a higher dose of 10 mg/kg. In the half of the participants who received pembrolizumab at the recommended dose of 2 mg/kg, approximately 24% had their tumors shrink. This effect lasted at least 1.4-8.5 months and continued beyond this period in most patients, the FDA statement said.

The drug was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving pembrolizumab. The most common serious adverse reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis. Adverse reactions occurring in at least 20% of the 411 patients across doses were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The FDA cautions that pembrolizumab also has the potential for severe immune-mediated side effects. In the 411 participants with advanced melanoma, severe immune-mediated side effects involving healthy organs, including the lung, colon, hormone-producing glands, and liver, occurred uncommonly, they said.

It is the sixth drug to be approved for melanoma since 2011, joining ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).

The Melanoma Research Alliance applauded FDA’s action in a press statement.

"The news of FDA’s first approval of an anti-PD-1 drug is extremely exciting and shows just how far the field has come in the last few years," said Debra Black, MRA cofounder. "When we started MRA there was little hope for melanoma patients. Today we are seeing a real sea change, with several new therapies and proof of concept that these new treatments can save lives."

[email protected]

EDINBURGH – Is population screening for skin cancer worthwhile?

Yes, Dr. Eckhard Breitbart said in a debate at the 15th World Congress on Cancers of the Skin. "Screening is not a diagnostic procedure," he noted. But the potential benefits of screening, including a significant reduction in medical costs, outweigh the potential harms related to false negative or false positive findings, added Dr. Breitbart, a dermatologist in Hamburg, Germany.

In an interview at the meeting, Dr. Breitbart reviewed the findings from his study of the impact of a population-based skin cancer screening program in Germany, and he discussed what research is needed to support such screening elsewhere.

[email protected]

EDINBURGH – Is population screening for skin cancer worthwhile?

Yes, Dr. Eckhard Breitbart said in a debate at the 15th World Congress on Cancers of the Skin. "Screening is not a diagnostic procedure," he noted. But the potential benefits of screening, including a significant reduction in medical costs, outweigh the potential harms related to false negative or false positive findings, added Dr. Breitbart, a dermatologist in Hamburg, Germany.

In an interview at the meeting, Dr. Breitbart reviewed the findings from his study of the impact of a population-based skin cancer screening program in Germany, and he discussed what research is needed to support such screening elsewhere.

[email protected]

EDINBURGH – Is population screening for skin cancer worthwhile?

Yes, Dr. Eckhard Breitbart said in a debate at the 15th World Congress on Cancers of the Skin. "Screening is not a diagnostic procedure," he noted. But the potential benefits of screening, including a significant reduction in medical costs, outweigh the potential harms related to false negative or false positive findings, added Dr. Breitbart, a dermatologist in Hamburg, Germany.

In an interview at the meeting, Dr. Breitbart reviewed the findings from his study of the impact of a population-based skin cancer screening program in Germany, and he discussed what research is needed to support such screening elsewhere.

[email protected]