Melanoma

Almost one-third of white female high school students and one-quarter of white women aged 18-34 years used indoor tanning devices over a 12-month period, researchers at the Centers for Disease Control and Prevention reported.

Data from the 2011 Youth Risk Behavior Survey showed that 29.3% of the 2,527 non-Hispanic white female high school respondents reported using a sunlamp, sun bed, or tanning booth in the previous 12 months, and 16.7% reported frequent (at least 10 times in the previous year) use of tanning devices, said Gery P. Guy Jr., Ph.D., of the CDC’s Division of Cancer Prevention and Control and his associates (JAMA Intern. Med. 2013 Aug. 19 [doi:10.1001/jamainternmed.2013.10013]).

Among white women aged 18-34 years, 24.9% had used a tanning device at least once in the previous 12 months and 15.1% had used one at least 10 times, according to data from the 2010 National Health Interview Survey. The younger women in that age range were more likely to use tanning devices; 31.8% of women aged 18-21 years reported any use and 21.3% reported frequent use, compared with 17.4% and 10.7%, respectively, in women aged 30-34 years, the investigators wrote.

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Almost one-third of white female high school students and one-quarter of white women aged 18-34 years used indoor tanning devices over a 12-month period, researchers at the Centers for Disease Control and Prevention reported.

Data from the 2011 Youth Risk Behavior Survey showed that 29.3% of the 2,527 non-Hispanic white female high school respondents reported using a sunlamp, sun bed, or tanning booth in the previous 12 months, and 16.7% reported frequent (at least 10 times in the previous year) use of tanning devices, said Gery P. Guy Jr., Ph.D., of the CDC’s Division of Cancer Prevention and Control and his associates (JAMA Intern. Med. 2013 Aug. 19 [doi:10.1001/jamainternmed.2013.10013]).

Among white women aged 18-34 years, 24.9% had used a tanning device at least once in the previous 12 months and 15.1% had used one at least 10 times, according to data from the 2010 National Health Interview Survey. The younger women in that age range were more likely to use tanning devices; 31.8% of women aged 18-21 years reported any use and 21.3% reported frequent use, compared with 17.4% and 10.7%, respectively, in women aged 30-34 years, the investigators wrote.

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Almost one-third of white female high school students and one-quarter of white women aged 18-34 years used indoor tanning devices over a 12-month period, researchers at the Centers for Disease Control and Prevention reported.

Data from the 2011 Youth Risk Behavior Survey showed that 29.3% of the 2,527 non-Hispanic white female high school respondents reported using a sunlamp, sun bed, or tanning booth in the previous 12 months, and 16.7% reported frequent (at least 10 times in the previous year) use of tanning devices, said Gery P. Guy Jr., Ph.D., of the CDC’s Division of Cancer Prevention and Control and his associates (JAMA Intern. Med. 2013 Aug. 19 [doi:10.1001/jamainternmed.2013.10013]).

Among white women aged 18-34 years, 24.9% had used a tanning device at least once in the previous 12 months and 15.1% had used one at least 10 times, according to data from the 2010 National Health Interview Survey. The younger women in that age range were more likely to use tanning devices; 31.8% of women aged 18-21 years reported any use and 21.3% reported frequent use, compared with 17.4% and 10.7%, respectively, in women aged 30-34 years, the investigators wrote.

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Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

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On Twitter @naseemsmiller

Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

[email protected]

On Twitter @naseemsmiller

Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

[email protected]

On Twitter @naseemsmiller

Fair-skinned people are known to be at higher risk for skin cancer and other problems associated with too much exposure to the sun. But people with skin of color are also vulnerable to the harmful effects of ultraviolet rays emitted by both the sun and indoor tanning beds, said Dr. Adam Friedman, director of dermatologic research, division of dermatology, Montefiore Medical Center in New York.

"Darker skin has more reactive melanocytes, or pigment-making cells, and has more and stronger melanosomes, which are small packets that contain skin pigment, both of which provide some inherent protection against UV rays but not enough, he said. "This unique biological difference in darker skin causes the harmful effects of UV exposure to occur more slowly in people of color, and the effects require more direct sun exposure. But the damage does happen, from cosmetic problems such as premature aging of the skin to serious conditions such as skin cancer."

"There are three major misconceptions that I encounter with my patients in the Bronx," Dr. Friedman said.

• Darker skin makes one immune to the harmful effects of the sun.

• There is no risk of exposure on cloudy days.

• One needs to get vitamin D via sun exposure.

"All three are completely false, and ultimately they perpetuate and result in improper skin protection," he noted.

"Skin cancer is rarer in people with skin of color, but it does occur and can be extremely serious when diagnosis is delayed," Dr. Friedman said. For example, melanoma, the most deadly form of skin cancer, is more than 20 times more common in whites than in African Americans, but people with darker skin are at greater risk of late diagnosis with advanced, thicker melanomas and lower survival rates. In fact, the overall 5-year melanoma survival rate for African Americans is only 77%, versus 91% for Caucasians, he said.

"I advise all of my patients to routinely check their own skin for any changes in appearance, and to see a dermatologist annually for a full body exam," Dr. Friedman emphasized.

Traditional sunscreens, especially those containing mineral-based agents such as titanium dioxide and zinc oxide, do not blend well when used on darker skin. The resulting chalky appearance is unacceptable to many patients, Dr. Friedman said. Fortunately, new formulations are changing that.

The newer sunscreens combine several agents to both decrease the concentration needed of each and allow for a synergistic effect between them, "ultimately offering a better sunscreen formula that can blend well into any skin type," said Dr. Friedman. Patients should look for products containing micronized or nanosized zinc oxide or titanium dioxide, which do not scatter light in the visible spectrum (to which older versions of these products owe their chalky appearance) but are highly effective at blocking UV radiation, he advised. Products that combine these mineral agents with multiple chemical blockers such as ecamsule, avobenzone, and cinoxate are particularly effective and cosmetically acceptable. Patients may be most likely to use sunscreens that utilize vehicles that enhance dispersal of these ingredients to limit clumping and phase separation, such as talc and Bentone gel.

In addition, pH stabilizers such as dimethicone are important, as the skin acidity in skin of color is lower and needs to be maintained to prevent degradation of skin adhesion proteins. Dr. Friedman recommends that his skin of color patients use SPF 30 broad-spectrum sunscreen, generously applied, and lip balm with an SPF of at least 30.

Dr. Friedman often hears from patients that they avoid sunscreen because it prevents them from getting vitamin D from the sun, which they believe is the best source. "You can enjoy the best of both worlds – use sunscreen when you spend time outdoors and take a vitamin D supplement, which is a very effective way to get adequate daily intake," he said. He advises his patients to remain vigilant about how much sun exposure they get. "Sunscreen alone is not enough to protect you from skin cancer, especially between the hours of 10:00 a.m. and 2:00 p.m. I encourage all of my patients to seek shade during that time of day and wear hats, sunglasses, and protective clothing if possible," he said.

Dr. Friedman had no financial conflicts to disclose.

[email protected]

On Twitter @hsplete

Fair-skinned people are known to be at higher risk for skin cancer and other problems associated with too much exposure to the sun. But people with skin of color are also vulnerable to the harmful effects of ultraviolet rays emitted by both the sun and indoor tanning beds, said Dr. Adam Friedman, director of dermatologic research, division of dermatology, Montefiore Medical Center in New York.

"Darker skin has more reactive melanocytes, or pigment-making cells, and has more and stronger melanosomes, which are small packets that contain skin pigment, both of which provide some inherent protection against UV rays but not enough, he said. "This unique biological difference in darker skin causes the harmful effects of UV exposure to occur more slowly in people of color, and the effects require more direct sun exposure. But the damage does happen, from cosmetic problems such as premature aging of the skin to serious conditions such as skin cancer."

"There are three major misconceptions that I encounter with my patients in the Bronx," Dr. Friedman said.

• Darker skin makes one immune to the harmful effects of the sun.

• There is no risk of exposure on cloudy days.

• One needs to get vitamin D via sun exposure.

"All three are completely false, and ultimately they perpetuate and result in improper skin protection," he noted.

"Skin cancer is rarer in people with skin of color, but it does occur and can be extremely serious when diagnosis is delayed," Dr. Friedman said. For example, melanoma, the most deadly form of skin cancer, is more than 20 times more common in whites than in African Americans, but people with darker skin are at greater risk of late diagnosis with advanced, thicker melanomas and lower survival rates. In fact, the overall 5-year melanoma survival rate for African Americans is only 77%, versus 91% for Caucasians, he said.

"I advise all of my patients to routinely check their own skin for any changes in appearance, and to see a dermatologist annually for a full body exam," Dr. Friedman emphasized.

Traditional sunscreens, especially those containing mineral-based agents such as titanium dioxide and zinc oxide, do not blend well when used on darker skin. The resulting chalky appearance is unacceptable to many patients, Dr. Friedman said. Fortunately, new formulations are changing that.

The newer sunscreens combine several agents to both decrease the concentration needed of each and allow for a synergistic effect between them, "ultimately offering a better sunscreen formula that can blend well into any skin type," said Dr. Friedman. Patients should look for products containing micronized or nanosized zinc oxide or titanium dioxide, which do not scatter light in the visible spectrum (to which older versions of these products owe their chalky appearance) but are highly effective at blocking UV radiation, he advised. Products that combine these mineral agents with multiple chemical blockers such as ecamsule, avobenzone, and cinoxate are particularly effective and cosmetically acceptable. Patients may be most likely to use sunscreens that utilize vehicles that enhance dispersal of these ingredients to limit clumping and phase separation, such as talc and Bentone gel.

In addition, pH stabilizers such as dimethicone are important, as the skin acidity in skin of color is lower and needs to be maintained to prevent degradation of skin adhesion proteins. Dr. Friedman recommends that his skin of color patients use SPF 30 broad-spectrum sunscreen, generously applied, and lip balm with an SPF of at least 30.

Dr. Friedman often hears from patients that they avoid sunscreen because it prevents them from getting vitamin D from the sun, which they believe is the best source. "You can enjoy the best of both worlds – use sunscreen when you spend time outdoors and take a vitamin D supplement, which is a very effective way to get adequate daily intake," he said. He advises his patients to remain vigilant about how much sun exposure they get. "Sunscreen alone is not enough to protect you from skin cancer, especially between the hours of 10:00 a.m. and 2:00 p.m. I encourage all of my patients to seek shade during that time of day and wear hats, sunglasses, and protective clothing if possible," he said.

Dr. Friedman had no financial conflicts to disclose.

[email protected]

On Twitter @hsplete

Fair-skinned people are known to be at higher risk for skin cancer and other problems associated with too much exposure to the sun. But people with skin of color are also vulnerable to the harmful effects of ultraviolet rays emitted by both the sun and indoor tanning beds, said Dr. Adam Friedman, director of dermatologic research, division of dermatology, Montefiore Medical Center in New York.

"Darker skin has more reactive melanocytes, or pigment-making cells, and has more and stronger melanosomes, which are small packets that contain skin pigment, both of which provide some inherent protection against UV rays but not enough, he said. "This unique biological difference in darker skin causes the harmful effects of UV exposure to occur more slowly in people of color, and the effects require more direct sun exposure. But the damage does happen, from cosmetic problems such as premature aging of the skin to serious conditions such as skin cancer."

"There are three major misconceptions that I encounter with my patients in the Bronx," Dr. Friedman said.

• Darker skin makes one immune to the harmful effects of the sun.

• There is no risk of exposure on cloudy days.

• One needs to get vitamin D via sun exposure.

"All three are completely false, and ultimately they perpetuate and result in improper skin protection," he noted.

"Skin cancer is rarer in people with skin of color, but it does occur and can be extremely serious when diagnosis is delayed," Dr. Friedman said. For example, melanoma, the most deadly form of skin cancer, is more than 20 times more common in whites than in African Americans, but people with darker skin are at greater risk of late diagnosis with advanced, thicker melanomas and lower survival rates. In fact, the overall 5-year melanoma survival rate for African Americans is only 77%, versus 91% for Caucasians, he said.

"I advise all of my patients to routinely check their own skin for any changes in appearance, and to see a dermatologist annually for a full body exam," Dr. Friedman emphasized.

Traditional sunscreens, especially those containing mineral-based agents such as titanium dioxide and zinc oxide, do not blend well when used on darker skin. The resulting chalky appearance is unacceptable to many patients, Dr. Friedman said. Fortunately, new formulations are changing that.

The newer sunscreens combine several agents to both decrease the concentration needed of each and allow for a synergistic effect between them, "ultimately offering a better sunscreen formula that can blend well into any skin type," said Dr. Friedman. Patients should look for products containing micronized or nanosized zinc oxide or titanium dioxide, which do not scatter light in the visible spectrum (to which older versions of these products owe their chalky appearance) but are highly effective at blocking UV radiation, he advised. Products that combine these mineral agents with multiple chemical blockers such as ecamsule, avobenzone, and cinoxate are particularly effective and cosmetically acceptable. Patients may be most likely to use sunscreens that utilize vehicles that enhance dispersal of these ingredients to limit clumping and phase separation, such as talc and Bentone gel.

In addition, pH stabilizers such as dimethicone are important, as the skin acidity in skin of color is lower and needs to be maintained to prevent degradation of skin adhesion proteins. Dr. Friedman recommends that his skin of color patients use SPF 30 broad-spectrum sunscreen, generously applied, and lip balm with an SPF of at least 30.

Dr. Friedman often hears from patients that they avoid sunscreen because it prevents them from getting vitamin D from the sun, which they believe is the best source. "You can enjoy the best of both worlds – use sunscreen when you spend time outdoors and take a vitamin D supplement, which is a very effective way to get adequate daily intake," he said. He advises his patients to remain vigilant about how much sun exposure they get. "Sunscreen alone is not enough to protect you from skin cancer, especially between the hours of 10:00 a.m. and 2:00 p.m. I encourage all of my patients to seek shade during that time of day and wear hats, sunglasses, and protective clothing if possible," he said.

Dr. Friedman had no financial conflicts to disclose.

[email protected]

On Twitter @hsplete

NEW YORK – A national, population-based melanoma screening program underway in Germany may provide the data to drive similar initiatives elsewhere, including the United States, but complex issues surround cancer screening programs of any kind, Dr. Allan C. Halpern said in a key address at the American Academy of Dermatology summer meeting.

Even if reduced mortality from the melanoma screening program in Germany equals the numbers seen in the regional initiative that prompted the national program, Dr. Halpern, chief of the dermatology service and co-leader of Memorial Sloan-Kettering Cancer Center (New York) melanoma disease management team, cautioned that U.S. policy makers will face several issues before adopting a similar program.

"We have begun to understand that no matter what you are screening for, you end up finding a lot of indolent disease, or what we now call overdiagnosis," Dr. Halpern said. In these cases, clinicians diagnose cancer or precancerous conditions "in patients who were never going to be hurt by their disease" but may incur harm from treatments or from the psychosocial stress of the diagnosis.

Courtesy of Memorial Sloan-Kettering Cancer Center

Melanoma is the only cancer for which mortality is increasing, despite simple and effective screening strategies, Dr. Halpern said. One problem is that only a proportion of those patients known to be at high risk for melanoma, such as those with a personal or family history of this disease, undergo regular surveillance. Despite a clear need for rigorous screening in high risk individuals, he suggested that "[dermatology] as a profession has not figured out how to do this consistently."

However, the program in Germany is not restricted to high-risk individuals. It was initiated after a screening program in Schleswig-Holstein, one of 16 German states, was credited with reducing melanoma mortality by 47% in women and 49% in men, based on rates 5 years after screening, compared with rates 4 years before screening (Cancer 2012;118:5395-402). Mortality rates in adjacent states over this period were unchanged.

In the German program, approximately 1,700 general practitioners were trained to provide whole body assessments for melanoma. Individuals aged 20 years and older were eligible, and more than 360,000 residents of Schleswig-Holstein were screened. Dr. Halpern said that the development of the program was largely because of the initiative of Dr. Eckhard W. Breitbart, a Schleswig-Holstein dermatologist who convinced public health authorities to provide funding.

The evidence of benefit was sufficient to generate a national program. So far, 13 million Germans have already been screened, Dr. Halpern said. Although the mortality reduction from the national program may not reach the magnitude seen at the regional level, any large reduction would provide "a huge endorsement for melanoma screening," Dr. Halpern noted.

Melanoma screening data are needed, Dr. Halpern added. The U.S. Preventive Services Task Force "specifically does not recommend melanoma screening for the population at large" because of lack of randomized, controlled trial evidence that it would provide an overall benefit, he said. Such trials have been proposed, and a pilot study was completed in Australia, Dr. Halpern said, but he said he does not believe a large scale trial is forthcoming. Rather, he said he believes that a study similar to the German study may be the best opportunity to show a benefit from screening.

Similar policy changes occurred after a Scandinavian initiative to screen cervical cancer demonstrated a large mortality benefit, according to Dr. Halpern, who called that experience the "poster child" for cancer screening initiatives. The mortality benefit data from the population-based program was so compelling that screening programs for cervical cancer are now broadly accepted worldwide, although a randomized controlled trial was never conducted. If the German data provide similar evidence of the benefits of melanoma screening, "this may be how we get to melanoma screening in this country," Dr. Halpern said.

Melanoma screening is "intuitively attractive," Dr. Halpern added, but he acknowledged the rationale for caution. While he said he believes there is a need to increase screening in high-risk populations, the risk of harm, including psychosocial harm, from population-based screening is not trivial. The German experience may provide the data to help determine whether population-based screening makes sense.

Dr. Halpern disclosed financial relationships with multiple companies including Canfield Scientific, DermTech International, Quintiles, Roche, and SciBase.

NEW YORK – A national, population-based melanoma screening program underway in Germany may provide the data to drive similar initiatives elsewhere, including the United States, but complex issues surround cancer screening programs of any kind, Dr. Allan C. Halpern said in a key address at the American Academy of Dermatology summer meeting.

Even if reduced mortality from the melanoma screening program in Germany equals the numbers seen in the regional initiative that prompted the national program, Dr. Halpern, chief of the dermatology service and co-leader of Memorial Sloan-Kettering Cancer Center (New York) melanoma disease management team, cautioned that U.S. policy makers will face several issues before adopting a similar program.

"We have begun to understand that no matter what you are screening for, you end up finding a lot of indolent disease, or what we now call overdiagnosis," Dr. Halpern said. In these cases, clinicians diagnose cancer or precancerous conditions "in patients who were never going to be hurt by their disease" but may incur harm from treatments or from the psychosocial stress of the diagnosis.

Courtesy of Memorial Sloan-Kettering Cancer Center

Melanoma is the only cancer for which mortality is increasing, despite simple and effective screening strategies, Dr. Halpern said. One problem is that only a proportion of those patients known to be at high risk for melanoma, such as those with a personal or family history of this disease, undergo regular surveillance. Despite a clear need for rigorous screening in high risk individuals, he suggested that "[dermatology] as a profession has not figured out how to do this consistently."

However, the program in Germany is not restricted to high-risk individuals. It was initiated after a screening program in Schleswig-Holstein, one of 16 German states, was credited with reducing melanoma mortality by 47% in women and 49% in men, based on rates 5 years after screening, compared with rates 4 years before screening (Cancer 2012;118:5395-402). Mortality rates in adjacent states over this period were unchanged.

In the German program, approximately 1,700 general practitioners were trained to provide whole body assessments for melanoma. Individuals aged 20 years and older were eligible, and more than 360,000 residents of Schleswig-Holstein were screened. Dr. Halpern said that the development of the program was largely because of the initiative of Dr. Eckhard W. Breitbart, a Schleswig-Holstein dermatologist who convinced public health authorities to provide funding.

The evidence of benefit was sufficient to generate a national program. So far, 13 million Germans have already been screened, Dr. Halpern said. Although the mortality reduction from the national program may not reach the magnitude seen at the regional level, any large reduction would provide "a huge endorsement for melanoma screening," Dr. Halpern noted.

Melanoma screening data are needed, Dr. Halpern added. The U.S. Preventive Services Task Force "specifically does not recommend melanoma screening for the population at large" because of lack of randomized, controlled trial evidence that it would provide an overall benefit, he said. Such trials have been proposed, and a pilot study was completed in Australia, Dr. Halpern said, but he said he does not believe a large scale trial is forthcoming. Rather, he said he believes that a study similar to the German study may be the best opportunity to show a benefit from screening.

Similar policy changes occurred after a Scandinavian initiative to screen cervical cancer demonstrated a large mortality benefit, according to Dr. Halpern, who called that experience the "poster child" for cancer screening initiatives. The mortality benefit data from the population-based program was so compelling that screening programs for cervical cancer are now broadly accepted worldwide, although a randomized controlled trial was never conducted. If the German data provide similar evidence of the benefits of melanoma screening, "this may be how we get to melanoma screening in this country," Dr. Halpern said.

Melanoma screening is "intuitively attractive," Dr. Halpern added, but he acknowledged the rationale for caution. While he said he believes there is a need to increase screening in high-risk populations, the risk of harm, including psychosocial harm, from population-based screening is not trivial. The German experience may provide the data to help determine whether population-based screening makes sense.

Dr. Halpern disclosed financial relationships with multiple companies including Canfield Scientific, DermTech International, Quintiles, Roche, and SciBase.

NEW YORK – A national, population-based melanoma screening program underway in Germany may provide the data to drive similar initiatives elsewhere, including the United States, but complex issues surround cancer screening programs of any kind, Dr. Allan C. Halpern said in a key address at the American Academy of Dermatology summer meeting.

Even if reduced mortality from the melanoma screening program in Germany equals the numbers seen in the regional initiative that prompted the national program, Dr. Halpern, chief of the dermatology service and co-leader of Memorial Sloan-Kettering Cancer Center (New York) melanoma disease management team, cautioned that U.S. policy makers will face several issues before adopting a similar program.

"We have begun to understand that no matter what you are screening for, you end up finding a lot of indolent disease, or what we now call overdiagnosis," Dr. Halpern said. In these cases, clinicians diagnose cancer or precancerous conditions "in patients who were never going to be hurt by their disease" but may incur harm from treatments or from the psychosocial stress of the diagnosis.

Courtesy of Memorial Sloan-Kettering Cancer Center

Melanoma is the only cancer for which mortality is increasing, despite simple and effective screening strategies, Dr. Halpern said. One problem is that only a proportion of those patients known to be at high risk for melanoma, such as those with a personal or family history of this disease, undergo regular surveillance. Despite a clear need for rigorous screening in high risk individuals, he suggested that "[dermatology] as a profession has not figured out how to do this consistently."

However, the program in Germany is not restricted to high-risk individuals. It was initiated after a screening program in Schleswig-Holstein, one of 16 German states, was credited with reducing melanoma mortality by 47% in women and 49% in men, based on rates 5 years after screening, compared with rates 4 years before screening (Cancer 2012;118:5395-402). Mortality rates in adjacent states over this period were unchanged.

In the German program, approximately 1,700 general practitioners were trained to provide whole body assessments for melanoma. Individuals aged 20 years and older were eligible, and more than 360,000 residents of Schleswig-Holstein were screened. Dr. Halpern said that the development of the program was largely because of the initiative of Dr. Eckhard W. Breitbart, a Schleswig-Holstein dermatologist who convinced public health authorities to provide funding.

The evidence of benefit was sufficient to generate a national program. So far, 13 million Germans have already been screened, Dr. Halpern said. Although the mortality reduction from the national program may not reach the magnitude seen at the regional level, any large reduction would provide "a huge endorsement for melanoma screening," Dr. Halpern noted.

Melanoma screening data are needed, Dr. Halpern added. The U.S. Preventive Services Task Force "specifically does not recommend melanoma screening for the population at large" because of lack of randomized, controlled trial evidence that it would provide an overall benefit, he said. Such trials have been proposed, and a pilot study was completed in Australia, Dr. Halpern said, but he said he does not believe a large scale trial is forthcoming. Rather, he said he believes that a study similar to the German study may be the best opportunity to show a benefit from screening.

Similar policy changes occurred after a Scandinavian initiative to screen cervical cancer demonstrated a large mortality benefit, according to Dr. Halpern, who called that experience the "poster child" for cancer screening initiatives. The mortality benefit data from the population-based program was so compelling that screening programs for cervical cancer are now broadly accepted worldwide, although a randomized controlled trial was never conducted. If the German data provide similar evidence of the benefits of melanoma screening, "this may be how we get to melanoma screening in this country," Dr. Halpern said.

Melanoma screening is "intuitively attractive," Dr. Halpern added, but he acknowledged the rationale for caution. While he said he believes there is a need to increase screening in high-risk populations, the risk of harm, including psychosocial harm, from population-based screening is not trivial. The German experience may provide the data to help determine whether population-based screening makes sense.

Dr. Halpern disclosed financial relationships with multiple companies including Canfield Scientific, DermTech International, Quintiles, Roche, and SciBase.

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

[email protected] On Twitter @aliciaault

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

[email protected] On Twitter @aliciaault

The Internal Revenue Service has issued the final regulation on collecting a 10% tax on tanning salon receipts as called for by the Affordable Care Act.

The tax first went into effect in July 2010 under temporary regulations while the IRS collected comments on the proposal. Updated regulations were issued and opened for comments in 2012.

Tanning salons have widely complained about the tax, which they said would help drive many of them out of business.

It’s not clear whether that has come to pass, Dr. Jack Resneck Jr., a member of the American Academy of Dermatology board of directors, said in a statement.

"It’s too early to assess the full impact of the tanning tax, but we know it has provided countless opportunities to raise awareness about the dangers of indoor tanning," said Dr. Resneck, vice-chair of clinical dermatology at the University of California, San Francisco.

In 2011, the Indoor Tanning Association was able to rally Republicans in the House and Senate to sponsor a bill to repeal the tax. The campaign did not gain much ground.

"Efforts by the tanning industry to fight this important public health measure have only furthered our efforts to communicate through the media about the overwhelming evidence on the risks of indoor UV tanning," Dr. Resneck said.

"Combined with the FDA’s recent proposal to reclassify tanning beds, as well as efforts in numerous states to restrict minors’ access to indoor tanning, I am optimistic that we are witnessing a real turning point in public awareness and sentiment," he added.

The final rule exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax, as was proposed in 2010.

Phototherapy performed by, and on the premises of, a licensed medical professional also is exempted.

[email protected] On Twitter @aliciaault

CHICAGO – Selumetinib, an investigational MEK 1/2 inhibitor, shrank uveal melanomas in half of all treated patients, with a duration of disease control that was more than twice that achieved with the comparator therapy temozolomide, based on the final analysis of data from 98 patients in a phase II crossover study.

This is the first clinical trial to identify a drug that improves clinical outcome in patients with advanced melanoma of the eye, said Dr. Richard D. Carvajal, who presented the data at the annual meeting of the American Society of Clinical Oncology.

"Selumetinib is a new standard of therapy for uveal metastatic melanoma," he said at a press conference announcing the results. Before this study, there was no evidence that any systemic therapy was truly effective in this disease. In eight different clinical trials conducted in the last decade, 2 of 157 patients have responded to potential new therapies, including chemotherapy, targeted therapy, and immunotherapy.

“Right now, there are no plans for an official compassionate use program; however, we are reopening up our trial without the randomization such that additional patients can receive selumetinib through this mechanism,” he said in an interview after the meeting.

With about 2,000 cases diagnosed each year in the United States, uveal melanoma is an orphan disease that is biologically distinct from cutaneous melanoma. Treatment consists of surgery to remove the tumor or eye, as well as radiation therapy or chemotherapy. About half of cases metastasize, and survival for these patients is 9-12 months.

In this study, 98 patients with metastatic melanoma of the eye were randomly assigned to receive selumetinib or temozolomide (Temodar), with 48 receiving selumetinib and 50 receiving temozolomide. Based on imaging studies using RECIST (Response Evaluation Criteria in Solid Tumors), patients whose disease worsened on temozolomide were permitted to cross over to selumetinib.

Looking at the response patterns, tumors regressed in 11% (RECIST response, 0%) of 46 evaluable patients in the temozolomide arm and in 50% (RECIST response, 15%) of 46 evaluable patients in the selumetinib arm, for a highly significant hazard ratio of 0.46, reported Dr. Carvajal of Memorial Sloan-Kettering Cancer Center in New York.

Progression-free survival was improved to nearly 16 weeks for selumetinib as compared with 7 weeks for temozolomide. Overall survival was 10.8 months for selumetinib and 9.4 months with temozolomide.

More than 90% of patients in both arms of the study had metastatic liver disease and more than 50% had an elevated lactate dehydrogenase, Dr. Carvajal noted. Further, the study allowed for crossover to selumetinib by temozolomide-treated patients with no evidence of response at 4 weeks; 80% of patients in the temozolomide arm crossed over to selumetinib.

Selumetinib blocks the MEK protein, a key component of the MAPK pathway, which is activated by Gnaq and Gna11 gene mutations, found in 84% of the uveal melanoma patients in the study. Selumetinib also is being investigated for the treatment of cancers of the thyroid and lung, and trials are underway with selumetinib in combination with other drugs.

Dr. Carvajal noted that another MEK inhibitor, trametinib (Mekinist, GlaxoSmithKline), recently became the first MEK inhibitor to be approved by the Food and Drug Administration. Trametinib was approved in May 2013 as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations.

AstraZeneca is developing selumetinib under a licensing agreement with Array Biopharma.

The selumetinib study was supported in part by a Conquer Cancer Foundation of ASCO Career Development Award, the National Institutes of Health, Cycle for Survival, and the Fund for Ophthalmic Knowledge. Dr. Carvajal had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

CHICAGO – Selumetinib, an investigational MEK 1/2 inhibitor, shrank uveal melanomas in half of all treated patients, with a duration of disease control that was more than twice that achieved with the comparator therapy temozolomide, based on the final analysis of data from 98 patients in a phase II crossover study.

This is the first clinical trial to identify a drug that improves clinical outcome in patients with advanced melanoma of the eye, said Dr. Richard D. Carvajal, who presented the data at the annual meeting of the American Society of Clinical Oncology.

"Selumetinib is a new standard of therapy for uveal metastatic melanoma," he said at a press conference announcing the results. Before this study, there was no evidence that any systemic therapy was truly effective in this disease. In eight different clinical trials conducted in the last decade, 2 of 157 patients have responded to potential new therapies, including chemotherapy, targeted therapy, and immunotherapy.

“Right now, there are no plans for an official compassionate use program; however, we are reopening up our trial without the randomization such that additional patients can receive selumetinib through this mechanism,” he said in an interview after the meeting.

With about 2,000 cases diagnosed each year in the United States, uveal melanoma is an orphan disease that is biologically distinct from cutaneous melanoma. Treatment consists of surgery to remove the tumor or eye, as well as radiation therapy or chemotherapy. About half of cases metastasize, and survival for these patients is 9-12 months.

In this study, 98 patients with metastatic melanoma of the eye were randomly assigned to receive selumetinib or temozolomide (Temodar), with 48 receiving selumetinib and 50 receiving temozolomide. Based on imaging studies using RECIST (Response Evaluation Criteria in Solid Tumors), patients whose disease worsened on temozolomide were permitted to cross over to selumetinib.

Looking at the response patterns, tumors regressed in 11% (RECIST response, 0%) of 46 evaluable patients in the temozolomide arm and in 50% (RECIST response, 15%) of 46 evaluable patients in the selumetinib arm, for a highly significant hazard ratio of 0.46, reported Dr. Carvajal of Memorial Sloan-Kettering Cancer Center in New York.

Progression-free survival was improved to nearly 16 weeks for selumetinib as compared with 7 weeks for temozolomide. Overall survival was 10.8 months for selumetinib and 9.4 months with temozolomide.

More than 90% of patients in both arms of the study had metastatic liver disease and more than 50% had an elevated lactate dehydrogenase, Dr. Carvajal noted. Further, the study allowed for crossover to selumetinib by temozolomide-treated patients with no evidence of response at 4 weeks; 80% of patients in the temozolomide arm crossed over to selumetinib.

Selumetinib blocks the MEK protein, a key component of the MAPK pathway, which is activated by Gnaq and Gna11 gene mutations, found in 84% of the uveal melanoma patients in the study. Selumetinib also is being investigated for the treatment of cancers of the thyroid and lung, and trials are underway with selumetinib in combination with other drugs.

Dr. Carvajal noted that another MEK inhibitor, trametinib (Mekinist, GlaxoSmithKline), recently became the first MEK inhibitor to be approved by the Food and Drug Administration. Trametinib was approved in May 2013 as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations.

AstraZeneca is developing selumetinib under a licensing agreement with Array Biopharma.

The selumetinib study was supported in part by a Conquer Cancer Foundation of ASCO Career Development Award, the National Institutes of Health, Cycle for Survival, and the Fund for Ophthalmic Knowledge. Dr. Carvajal had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

CHICAGO – Selumetinib, an investigational MEK 1/2 inhibitor, shrank uveal melanomas in half of all treated patients, with a duration of disease control that was more than twice that achieved with the comparator therapy temozolomide, based on the final analysis of data from 98 patients in a phase II crossover study.

This is the first clinical trial to identify a drug that improves clinical outcome in patients with advanced melanoma of the eye, said Dr. Richard D. Carvajal, who presented the data at the annual meeting of the American Society of Clinical Oncology.

"Selumetinib is a new standard of therapy for uveal metastatic melanoma," he said at a press conference announcing the results. Before this study, there was no evidence that any systemic therapy was truly effective in this disease. In eight different clinical trials conducted in the last decade, 2 of 157 patients have responded to potential new therapies, including chemotherapy, targeted therapy, and immunotherapy.

“Right now, there are no plans for an official compassionate use program; however, we are reopening up our trial without the randomization such that additional patients can receive selumetinib through this mechanism,” he said in an interview after the meeting.

With about 2,000 cases diagnosed each year in the United States, uveal melanoma is an orphan disease that is biologically distinct from cutaneous melanoma. Treatment consists of surgery to remove the tumor or eye, as well as radiation therapy or chemotherapy. About half of cases metastasize, and survival for these patients is 9-12 months.

In this study, 98 patients with metastatic melanoma of the eye were randomly assigned to receive selumetinib or temozolomide (Temodar), with 48 receiving selumetinib and 50 receiving temozolomide. Based on imaging studies using RECIST (Response Evaluation Criteria in Solid Tumors), patients whose disease worsened on temozolomide were permitted to cross over to selumetinib.

Looking at the response patterns, tumors regressed in 11% (RECIST response, 0%) of 46 evaluable patients in the temozolomide arm and in 50% (RECIST response, 15%) of 46 evaluable patients in the selumetinib arm, for a highly significant hazard ratio of 0.46, reported Dr. Carvajal of Memorial Sloan-Kettering Cancer Center in New York.

Progression-free survival was improved to nearly 16 weeks for selumetinib as compared with 7 weeks for temozolomide. Overall survival was 10.8 months for selumetinib and 9.4 months with temozolomide.

More than 90% of patients in both arms of the study had metastatic liver disease and more than 50% had an elevated lactate dehydrogenase, Dr. Carvajal noted. Further, the study allowed for crossover to selumetinib by temozolomide-treated patients with no evidence of response at 4 weeks; 80% of patients in the temozolomide arm crossed over to selumetinib.

Selumetinib blocks the MEK protein, a key component of the MAPK pathway, which is activated by Gnaq and Gna11 gene mutations, found in 84% of the uveal melanoma patients in the study. Selumetinib also is being investigated for the treatment of cancers of the thyroid and lung, and trials are underway with selumetinib in combination with other drugs.

Dr. Carvajal noted that another MEK inhibitor, trametinib (Mekinist, GlaxoSmithKline), recently became the first MEK inhibitor to be approved by the Food and Drug Administration. Trametinib was approved in May 2013 as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations.

AstraZeneca is developing selumetinib under a licensing agreement with Array Biopharma.

The selumetinib study was supported in part by a Conquer Cancer Foundation of ASCO Career Development Award, the National Institutes of Health, Cycle for Survival, and the Fund for Ophthalmic Knowledge. Dr. Carvajal had no relevant financial disclosures.

[email protected]

On Twitter @maryjodales

Daily sunscreen users were significantly less likely than discretionary sunscreen users to show signs of skin aging after 4.5 years, according to a study of young and middle-aged adults.

However, beta-carotene supplements appeared to have no effect on skin aging.

©Thinkstockphotos.com

The findings from the randomized controlled trial were published online June 3 in Annals of Internal Medicine (2013;158:781-90).

"No known randomized studies in humans have evaluated the effect of sunscreen on surface changes associated with skin aging," wrote Maria Celia B. Hughes, MMedSci., of the Queensland Institute of Medical Research, Australia, and her colleagues.

The investigators used data from the Nambour (Australia) Skin Cancer Prevention Trial, in which 1,621 adults were studied from 1992 to 1996 to test the effect of sunscreen use or dietary supplements on skin cancer risk, photoaging, and actinic keratosis development.

To determine whether consistent, daily sunscreen use could prevent progression of skin aging, researchers randomized Nambour study participants under age 55 into four groups: daily use of broad-spectrum sunscreen plus 30 mg of beta-carotene; daily sunscreen use plus a placebo supplement; discretionary sunscreen use plus 30 mg of beta-carotene; and discretionary sunscreen use plus a placebo supplement.

The investigators focused on 903 adults younger than 55 to exclude the potential effects of growing old on participants’ skin aging.

Skin aging was assessed by comparing skin microtopography based on impressions taken of the backs of participants’ hands at baseline in 1992 and 4.5 years later in 1996. Assessors were blinded to the treatment groups.

"Most of the study participants were fair skinned, and more than 90% burned on acute sun exposure," the researchers noted. The groups were similar in terms of phenotype, sun exposure, and pretrial sunscreen use. All groups reported similar amounts of sun exposure during the study period; 78% of daily sunscreen users and 76% of discretionary sunscreen users reported being outdoors for less than 50% of their weekend time. In addition, the use of other sun protection measures, including seeking shade and wearing a hat, was similar among the groups.

By the end of the study, 77% of the daily sunscreen users applied sunscreen at least 3-4 days per week, vs. 33% of the discretionary users.

Overall, 58% of the participants in the current study met criteria for moderate photoaging at baseline in 1992, and 49% met those criteria in 1996. However, at the end of the 4.5-year period, daily sunscreen users were 24% less likely to show signs of skin aging than were discretionary users, a statistically significant difference.

When the odds of having a higher microtopography grade in 1996 than in 1992 were adjusted for sunburns and photoaging of the neck, the researchers noted, "only the daily sunscreen intervention group showed no detectable increase in microtopography grade."

No significant differences in skin aging were seen in participants randomized to beta-carotene vs. placebo.

The study was limited by several factors, including limited outcome data, which reduced the power to detect moderate treatment effects. In addition, the data were insufficient to rule out an effect of beta carotene on skin aging, the researchers noted.

However, "these results have important clinical implications," the researchers said. "A unit increase in microtopography significantly correlates with risk for actinic keratoses and skin cancer." Thus, the cosmetic benefits of reducing skin changes in middle age also may reduce cancer risk.

The National Health and Medical Research Council of Australia funded the study.

[email protected]

Daily sunscreen users were significantly less likely than discretionary sunscreen users to show signs of skin aging after 4.5 years, according to a study of young and middle-aged adults.

However, beta-carotene supplements appeared to have no effect on skin aging.

©Thinkstockphotos.com

The findings from the randomized controlled trial were published online June 3 in Annals of Internal Medicine (2013;158:781-90).

"No known randomized studies in humans have evaluated the effect of sunscreen on surface changes associated with skin aging," wrote Maria Celia B. Hughes, MMedSci., of the Queensland Institute of Medical Research, Australia, and her colleagues.

The investigators used data from the Nambour (Australia) Skin Cancer Prevention Trial, in which 1,621 adults were studied from 1992 to 1996 to test the effect of sunscreen use or dietary supplements on skin cancer risk, photoaging, and actinic keratosis development.

To determine whether consistent, daily sunscreen use could prevent progression of skin aging, researchers randomized Nambour study participants under age 55 into four groups: daily use of broad-spectrum sunscreen plus 30 mg of beta-carotene; daily sunscreen use plus a placebo supplement; discretionary sunscreen use plus 30 mg of beta-carotene; and discretionary sunscreen use plus a placebo supplement.

The investigators focused on 903 adults younger than 55 to exclude the potential effects of growing old on participants’ skin aging.

Skin aging was assessed by comparing skin microtopography based on impressions taken of the backs of participants’ hands at baseline in 1992 and 4.5 years later in 1996. Assessors were blinded to the treatment groups.

"Most of the study participants were fair skinned, and more than 90% burned on acute sun exposure," the researchers noted. The groups were similar in terms of phenotype, sun exposure, and pretrial sunscreen use. All groups reported similar amounts of sun exposure during the study period; 78% of daily sunscreen users and 76% of discretionary sunscreen users reported being outdoors for less than 50% of their weekend time. In addition, the use of other sun protection measures, including seeking shade and wearing a hat, was similar among the groups.

By the end of the study, 77% of the daily sunscreen users applied sunscreen at least 3-4 days per week, vs. 33% of the discretionary users.

Overall, 58% of the participants in the current study met criteria for moderate photoaging at baseline in 1992, and 49% met those criteria in 1996. However, at the end of the 4.5-year period, daily sunscreen users were 24% less likely to show signs of skin aging than were discretionary users, a statistically significant difference.

When the odds of having a higher microtopography grade in 1996 than in 1992 were adjusted for sunburns and photoaging of the neck, the researchers noted, "only the daily sunscreen intervention group showed no detectable increase in microtopography grade."

No significant differences in skin aging were seen in participants randomized to beta-carotene vs. placebo.

The study was limited by several factors, including limited outcome data, which reduced the power to detect moderate treatment effects. In addition, the data were insufficient to rule out an effect of beta carotene on skin aging, the researchers noted.

However, "these results have important clinical implications," the researchers said. "A unit increase in microtopography significantly correlates with risk for actinic keratoses and skin cancer." Thus, the cosmetic benefits of reducing skin changes in middle age also may reduce cancer risk.

The National Health and Medical Research Council of Australia funded the study.

[email protected]

Daily sunscreen users were significantly less likely than discretionary sunscreen users to show signs of skin aging after 4.5 years, according to a study of young and middle-aged adults.

However, beta-carotene supplements appeared to have no effect on skin aging.

©Thinkstockphotos.com

The findings from the randomized controlled trial were published online June 3 in Annals of Internal Medicine (2013;158:781-90).

"No known randomized studies in humans have evaluated the effect of sunscreen on surface changes associated with skin aging," wrote Maria Celia B. Hughes, MMedSci., of the Queensland Institute of Medical Research, Australia, and her colleagues.

The investigators used data from the Nambour (Australia) Skin Cancer Prevention Trial, in which 1,621 adults were studied from 1992 to 1996 to test the effect of sunscreen use or dietary supplements on skin cancer risk, photoaging, and actinic keratosis development.

To determine whether consistent, daily sunscreen use could prevent progression of skin aging, researchers randomized Nambour study participants under age 55 into four groups: daily use of broad-spectrum sunscreen plus 30 mg of beta-carotene; daily sunscreen use plus a placebo supplement; discretionary sunscreen use plus 30 mg of beta-carotene; and discretionary sunscreen use plus a placebo supplement.

The investigators focused on 903 adults younger than 55 to exclude the potential effects of growing old on participants’ skin aging.

Skin aging was assessed by comparing skin microtopography based on impressions taken of the backs of participants’ hands at baseline in 1992 and 4.5 years later in 1996. Assessors were blinded to the treatment groups.

"Most of the study participants were fair skinned, and more than 90% burned on acute sun exposure," the researchers noted. The groups were similar in terms of phenotype, sun exposure, and pretrial sunscreen use. All groups reported similar amounts of sun exposure during the study period; 78% of daily sunscreen users and 76% of discretionary sunscreen users reported being outdoors for less than 50% of their weekend time. In addition, the use of other sun protection measures, including seeking shade and wearing a hat, was similar among the groups.

By the end of the study, 77% of the daily sunscreen users applied sunscreen at least 3-4 days per week, vs. 33% of the discretionary users.

Overall, 58% of the participants in the current study met criteria for moderate photoaging at baseline in 1992, and 49% met those criteria in 1996. However, at the end of the 4.5-year period, daily sunscreen users were 24% less likely to show signs of skin aging than were discretionary users, a statistically significant difference.

When the odds of having a higher microtopography grade in 1996 than in 1992 were adjusted for sunburns and photoaging of the neck, the researchers noted, "only the daily sunscreen intervention group showed no detectable increase in microtopography grade."

No significant differences in skin aging were seen in participants randomized to beta-carotene vs. placebo.

The study was limited by several factors, including limited outcome data, which reduced the power to detect moderate treatment effects. In addition, the data were insufficient to rule out an effect of beta carotene on skin aging, the researchers noted.

However, "these results have important clinical implications," the researchers said. "A unit increase in microtopography significantly correlates with risk for actinic keratoses and skin cancer." Thus, the cosmetic benefits of reducing skin changes in middle age also may reduce cancer risk.

The National Health and Medical Research Council of Australia funded the study.

[email protected]

JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”

What’s the issue?

A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?

We want to know your views! Tell us what you think.

JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”

What’s the issue?

A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?

We want to know your views! Tell us what you think.

JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”

What’s the issue?

A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?

We want to know your views! Tell us what you think.

CHICAGO – Nivolumab, an investigational PD-1 inhibitor, shrank tumors by at least 30% in 33 of 107 pretreated patients with metastatic melanoma, based on results from an expanded phase I trial reported at the annual meeting of the American Society of Clinical Oncology.

An additional 11% of patients had prolonged stable disease or non-conventional, immune-related response profiles.

The findings build on favorable initial results reported at last year’s annual meeting for nivolumab in melanoma, renal cell carcinoma, and nonsmall cell lung cancer. The latest results in melanoma patients at follow-ups as long as 2 years indicate no new safety signals with nivolumab, which was associated with a 21% rate of grade 3-4 events. The rate of severe immune-related adverse events was 5%, and there were no cases of grade 3 or higher pneumonitis.

© ASCO/Scott Morgan

Median overall survival was nearly 17 months with nivolumab, with a 2-year survival rate of 43%. Median overall survival with vemurafenib (Zelboraf) is 16 months and with ipilimumab (Yervoy) is 10 months, with 2-year survival rates of 24% to 33% with ipilimumab, according to Dr. Mario Sznol, who presented the results from the phase I trial.

"We’re very excited that there is potential for even more activity [with nivolumab] in combination with other drugs," said Dr. Sznol, professor of medicine (medical oncology) at the Yale Cancer Center in New Haven, Conn.

Responses were seen at all five dose levels tested (0.1, 0.3, 1, 3, and 10 mg/kg), with a 41% objective response rate at the 3 mg/kg dose, which has been selected for evaluation in phase III studies.

Median overall survival across all doses of nivolumab was 16.8 months. It reached 20.3 months for the 3 mg/kg dose. The 1-year survival rate was 62% and the 2-year survival rate, 43%.

Patients in the nivolumab trial were representative of typical patients with advanced melanoma, Dr. Sznol said. All patients in the study had disease that worsened despite prior standard systemic therapies, 25% of them had three or more prior therapies and 63% had two or more prior therapies.

All had ECOG performance standards of 0 or 1. Patients received up to 12 cycles of treatment, with four doses of nivolumab per cycle, until discontinuation criteria were met.

Response has persisted after stopping treatment in 17 of 33 patients, with 12 of the 17 continuing to respond for at least 4 months, Dr. Sznol said.

The overall objective response rate included partial and complete responses. Dr. Sznol acknowledged that just one patient had a verified complete response to nivolumab and four others had near complete responses at 2 years. Historical response rates to immunotherapy drugs are 5%-10% in advanced melanoma, he noted, which is lower than the 30% response seen in these pretreated patients.

"I have seen a few relapses after 2 years of response, but some patients continue to do well at 4 years. One patient who has been off nivolumab for 2 years continues to do well at over 4 years," Dr. Sznol commented during a question and answer session.

To define the best candidates for nivolumab, molecular markers need to be identified to predict probable response, he added. As nivolumab is a PD-1 inhibitor, one potential marker is the protein PD-L1 on the surface of tumor cells, which is being studied in several other clinical trials.

The research was supported by Bristol-Myers Squibb. Dr. Sznol disclosed that he serves in a consultant or advisory role with Bristol-Myers Squibb.

CHICAGO – Nivolumab, an investigational PD-1 inhibitor, shrank tumors by at least 30% in 33 of 107 pretreated patients with metastatic melanoma, based on results from an expanded phase I trial reported at the annual meeting of the American Society of Clinical Oncology.

An additional 11% of patients had prolonged stable disease or non-conventional, immune-related response profiles.

The findings build on favorable initial results reported at last year’s annual meeting for nivolumab in melanoma, renal cell carcinoma, and nonsmall cell lung cancer. The latest results in melanoma patients at follow-ups as long as 2 years indicate no new safety signals with nivolumab, which was associated with a 21% rate of grade 3-4 events. The rate of severe immune-related adverse events was 5%, and there were no cases of grade 3 or higher pneumonitis.

© ASCO/Scott Morgan

Median overall survival was nearly 17 months with nivolumab, with a 2-year survival rate of 43%. Median overall survival with vemurafenib (Zelboraf) is 16 months and with ipilimumab (Yervoy) is 10 months, with 2-year survival rates of 24% to 33% with ipilimumab, according to Dr. Mario Sznol, who presented the results from the phase I trial.

"We’re very excited that there is potential for even more activity [with nivolumab] in combination with other drugs," said Dr. Sznol, professor of medicine (medical oncology) at the Yale Cancer Center in New Haven, Conn.

Responses were seen at all five dose levels tested (0.1, 0.3, 1, 3, and 10 mg/kg), with a 41% objective response rate at the 3 mg/kg dose, which has been selected for evaluation in phase III studies.

Median overall survival across all doses of nivolumab was 16.8 months. It reached 20.3 months for the 3 mg/kg dose. The 1-year survival rate was 62% and the 2-year survival rate, 43%.

Patients in the nivolumab trial were representative of typical patients with advanced melanoma, Dr. Sznol said. All patients in the study had disease that worsened despite prior standard systemic therapies, 25% of them had three or more prior therapies and 63% had two or more prior therapies.

All had ECOG performance standards of 0 or 1. Patients received up to 12 cycles of treatment, with four doses of nivolumab per cycle, until discontinuation criteria were met.

Response has persisted after stopping treatment in 17 of 33 patients, with 12 of the 17 continuing to respond for at least 4 months, Dr. Sznol said.

The overall objective response rate included partial and complete responses. Dr. Sznol acknowledged that just one patient had a verified complete response to nivolumab and four others had near complete responses at 2 years. Historical response rates to immunotherapy drugs are 5%-10% in advanced melanoma, he noted, which is lower than the 30% response seen in these pretreated patients.

"I have seen a few relapses after 2 years of response, but some patients continue to do well at 4 years. One patient who has been off nivolumab for 2 years continues to do well at over 4 years," Dr. Sznol commented during a question and answer session.

To define the best candidates for nivolumab, molecular markers need to be identified to predict probable response, he added. As nivolumab is a PD-1 inhibitor, one potential marker is the protein PD-L1 on the surface of tumor cells, which is being studied in several other clinical trials.

The research was supported by Bristol-Myers Squibb. Dr. Sznol disclosed that he serves in a consultant or advisory role with Bristol-Myers Squibb.

CHICAGO – Nivolumab, an investigational PD-1 inhibitor, shrank tumors by at least 30% in 33 of 107 pretreated patients with metastatic melanoma, based on results from an expanded phase I trial reported at the annual meeting of the American Society of Clinical Oncology.

An additional 11% of patients had prolonged stable disease or non-conventional, immune-related response profiles.

The findings build on favorable initial results reported at last year’s annual meeting for nivolumab in melanoma, renal cell carcinoma, and nonsmall cell lung cancer. The latest results in melanoma patients at follow-ups as long as 2 years indicate no new safety signals with nivolumab, which was associated with a 21% rate of grade 3-4 events. The rate of severe immune-related adverse events was 5%, and there were no cases of grade 3 or higher pneumonitis.

© ASCO/Scott Morgan

Median overall survival was nearly 17 months with nivolumab, with a 2-year survival rate of 43%. Median overall survival with vemurafenib (Zelboraf) is 16 months and with ipilimumab (Yervoy) is 10 months, with 2-year survival rates of 24% to 33% with ipilimumab, according to Dr. Mario Sznol, who presented the results from the phase I trial.

"We’re very excited that there is potential for even more activity [with nivolumab] in combination with other drugs," said Dr. Sznol, professor of medicine (medical oncology) at the Yale Cancer Center in New Haven, Conn.

Responses were seen at all five dose levels tested (0.1, 0.3, 1, 3, and 10 mg/kg), with a 41% objective response rate at the 3 mg/kg dose, which has been selected for evaluation in phase III studies.

Median overall survival across all doses of nivolumab was 16.8 months. It reached 20.3 months for the 3 mg/kg dose. The 1-year survival rate was 62% and the 2-year survival rate, 43%.

Patients in the nivolumab trial were representative of typical patients with advanced melanoma, Dr. Sznol said. All patients in the study had disease that worsened despite prior standard systemic therapies, 25% of them had three or more prior therapies and 63% had two or more prior therapies.

All had ECOG performance standards of 0 or 1. Patients received up to 12 cycles of treatment, with four doses of nivolumab per cycle, until discontinuation criteria were met.

Response has persisted after stopping treatment in 17 of 33 patients, with 12 of the 17 continuing to respond for at least 4 months, Dr. Sznol said.

The overall objective response rate included partial and complete responses. Dr. Sznol acknowledged that just one patient had a verified complete response to nivolumab and four others had near complete responses at 2 years. Historical response rates to immunotherapy drugs are 5%-10% in advanced melanoma, he noted, which is lower than the 30% response seen in these pretreated patients.

"I have seen a few relapses after 2 years of response, but some patients continue to do well at 4 years. One patient who has been off nivolumab for 2 years continues to do well at over 4 years," Dr. Sznol commented during a question and answer session.

To define the best candidates for nivolumab, molecular markers need to be identified to predict probable response, he added. As nivolumab is a PD-1 inhibitor, one potential marker is the protein PD-L1 on the surface of tumor cells, which is being studied in several other clinical trials.

The research was supported by Bristol-Myers Squibb. Dr. Sznol disclosed that he serves in a consultant or advisory role with Bristol-Myers Squibb.