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Multiple Melanomas in the Same Patient a Real Phenomenon

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SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)

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SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)

SAN DIEGO - The chances of a patient developing multiple primary melanomas over a lifetime is a real phenomenon, with an incidence ranging from 2% to 8% among patients who have had a first melanoma, or an average of about 5%.

"That's significantly higher than if we apply the risk of melanoma to all fair-skinned people in the country," Dr. William M. Burrows said at a melanoma update sponsored by the Scripps Clinic.

Of patients who develop additional melanomas, about 80% develop one in addition to the original, 15% develop two, and the remainder develop three or more. "In my practice I have about four people I follow who have had five or six primary melanomas," said Dr. Burrows, who has practiced dermatology for nearly 40 years and is currently with the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego. "We've become the primary care physicians for patients with melanoma."

He went on to note that the risk of multiple primary melanomas is twofold higher among men, and that the majority of subsequent primary melanomas (70%) occur on a different anatomical site, while 30% occur on the same site.

"They have the same distribution as melanomas in general," he said.

The majority of subsequent primary melanomas occur after 2 months, while 30% occur within 2 months or less.

Depth of invasion is similar to national statistics for all primary melanomas. "But the second primary melanoma tends to be thinner than the first one, which makes sense," Dr. Burrows commented. "After the first primary melanoma we raise our index of suspicion on lesions that are irregular. In addition, the patient has a significant level of worry."

Recognized risk factors for multiple melanomas include presence of atypical/dysplastic nevi, family history, and early age of onset.

According to a retrospective review of 1,258 melanoma patients treated at the Scripps Clinic between 1990 and 2000, 149 (12%) developed multiple primary lesions, which is more than double the national incidence. "This could be due to one of two things," Dr. Burrows said. "One is the criteria that are used in making the diagnosis of melanoma in situ. I wonder if we [at Scripps] diagnose melanoma in situ more often, as opposed to others who might sign it out as atypical melanocytic hyperplasia or another worrisome diagnosis."

The other possibility is that incidence of melanoma is rising. "We know that we are making the diagnosis of primary melanomas at a younger age than we did 20 years ago," Dr. Burrows said.

In the Scripps series, 75% of patients had two primary melanomas, 15% had three, and the remainder had four or more. The average age at initial primary melanoma diagnosis was 64 among men and 56 among women.

Nearly half of the patients (49%) developed subsequent melanomas less than 3 years after their initial primary melanoma diagnoses.

At this point, Dr. Burrows does not recommend testing for the CDKN2A and CDK4 gene mutations in most patients. "It's not a good screening tool for the general population or fair-skinned population with multiple nevi, but it has potential use in screening patients with a family history of melanoma," he said.

"You want to know if they have a 75%-100% risk of developing melanoma. But in my opinion, this test is not helpful in people who have had one primary melanoma. It doesn't pick out the people at risk of getting a second primary melanoma."

As for managing patients with multiple melanomas, a full skin exam during initial workup and follow-up intervals is essential, he said. "Follow-up should be lifelong."

Dr. Burrows had no conflicts to disclose.

(Image above is of Dr. William M. Burrows/Photo credit: Doug Brunk)

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Expert Recommends Snapping Photos of Every Lesion Biopsied

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SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

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SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

SAN DIEGO — The way Dr. Charles H. Miller sees it, dermatologists should have a digital camera at the ready to take photos of every lesion they biopsy.

"You should jump in and start doing this as part of your daily practice, because the future of dermatology is going to be significantly impacted by how we use digital images," Dr. Miller, chief of dermatology at Kaiser Permanente, San Diego, said at a melanoma update sponsored by the Scripps Clinic.

He and his associates routinely send along digital images of relevant lesions when they refer their patients to other specialists. "Anytime we send a patient for Mohs surgery, head and neck surgery, general surgery, or plastic surgery, we'll upload photos," he explained. "The surgeons love it because they can get an idea of what to expect before they see the patient. They're well prepared for what's to come, oftentimes saving a preop appointment."

He emphasized the importance of choosing a digital camera that fits you and your style of practice. Some can be had for less than $200, but the most important characteristic of a camera is not price. It's "that it's one you'll use often," Dr. Miller said.

"Some people wear white coats; others don't. Some people see 60-80 patients a day; other people see 20 a day. If you're seeing a lot more than 30 patients a day, make sure you have the camera with you at all times or else you're just not going to take the time to snap a picture."

In general, digital cameras with a resolution of at least 11 megapixels (MP) take pictures that are just as clear as those taken with the old 35-mm Kodachrome film technology. And when viewed on computer monitors, photos of much lower resolutions are acceptable. He divided his favorite cameras currently on the market into one of three groups based on size: "shirt pocket," "pants pocket," and "white-coat pocket" cameras "The actual measurements won't vary much," just an inch or so, "but it's enough" to make a difference, Dr. Miller said. Prices are approximate.

His recommended shirt-pocket cameras, which are "usually no bigger than a deck of cards," include the Canon SD790 (8 MP, $225), the Nikon S210 (8 MP, $150), the Sony T700 (10 MP, $350), and the Panasonic FX37 (10 MP, $270).
His recommended pants-pocket cameras include the Fujifilm 200EXR (12 MP, $360), the Canon A470 (8 MP, $145), the Canon S90 (10 MP, $399), the Canon SD780 IS (12 MP, $250), the Panasonic FX150 (15 MP, $300), and the Sony W300 (14 MP, $300).

Dr. Miller's recommended white coat-pocket cameras include the Panasonic LX3 (10 MP, $425), the Nikon P6000 (14 MP, $450), and the Canon G11 (10 MP, $459).

For even higher resolution, consider digital single lens reflex (DSLR) cameras, which accept macro lenses that are more optically correct and have less distortion than lenses in the smaller cameras listed above. Dr. Miller's suggested cameras in this category include the Nikon D40x (10 MP, $499), the Canon EOS Rebel T1i (15 MP, $720), the Nikon D90 (12 MP, $900), and the Nikon D700 (12 MP, $2,450).

"A lot of these cameras now include video capability as well," he noted. "That's something that dermatologists will start to consider in the future. It may be easier to take a quick video of a patient if it's at high-enough resolution, as opposed to taking single pictures. But that's something that needs to be more thoroughly evaluated."

Dr. Miller also advises dermatologists to think of digital cameras as disposable items that they'll want to replace every 3-5 years. "Once you get into that mind-set, it's not nearly as hard to jump in, because you realize that every few years you're going to grant yourself the benefit of upgrading," he said. He is on his sixth digital camera in 13 years.

Disclosures: Dr. Miller had no relevant conflicts to disclose.

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Presidential Conspiracy Alert!

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New book claims malignant melanoma killed FDR, not a stroke.

Malignant melanoma killed FDR! That is the working theory powering a book out this year entitled “FDR’s Deadly Secret” (New York: PublicAffairs, 2010), by Dr. Steven Lomazow and Eric Fettmann.   

Personally, this news comes as a shock. There never seemed to be any reason to question the stroke that was listed as Franklin Delano Roosevelt’s official cause of death. After all, the man was rarely photographed without a lit cigarette propped in a holder clenched between his teeth at a jaunty angle.

His heavy drinking was legion. Only British Prime Minister Winston Churchill seemed able to drink him under the table. And it would take more than the laps he swam in the White House pool and at his “Little White House” retreat in Warm Springs, Ga., to make up for how sedentary his life became after he was diagnosed with polio.

And let’s not even talk about his diet, which was a recipe for cerebrovascular disease. But, according to the authors, his weight loss and generally increasingly frail appearance in the final months of his life was not because of a combination of the stress induced by years of world war and poor lifestyle choices. Rather, if one accepts the book’s premises, FDR’s rapid decline was due to the metastasis of a melanoma from over his left eye brow to his brain and bowel.

The putative melanoma first appeared in photos in the 1920s, grew in size throughout the 1930s, and disappeared from view in 1940, by which time it was large enough to not look out of place over Aaron Neville’s eyebrow.

What’s the basis for this call to rewrite medical history? It’s not FDR’s medical records, which disappeared decades ago. And his personal physician never spoke of his patient’s rapid decline. Dr. Lomazow, a neurologist, and Mr. Fettmann, an editor at the New York Post, based their diagnosis on diary notes of people who worked in the White House.

Whatever the truth may be, never has this blog—“The Mole” —been more aptly named.

Sally Kubetin
Senior Editor

Photo courtesy Center for the Study of Intelligence, Central Intelligence Agency

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New book claims malignant melanoma killed FDR, not a stroke.
New book claims malignant melanoma killed FDR, not a stroke.

Malignant melanoma killed FDR! That is the working theory powering a book out this year entitled “FDR’s Deadly Secret” (New York: PublicAffairs, 2010), by Dr. Steven Lomazow and Eric Fettmann.   

Personally, this news comes as a shock. There never seemed to be any reason to question the stroke that was listed as Franklin Delano Roosevelt’s official cause of death. After all, the man was rarely photographed without a lit cigarette propped in a holder clenched between his teeth at a jaunty angle.

His heavy drinking was legion. Only British Prime Minister Winston Churchill seemed able to drink him under the table. And it would take more than the laps he swam in the White House pool and at his “Little White House” retreat in Warm Springs, Ga., to make up for how sedentary his life became after he was diagnosed with polio.

And let’s not even talk about his diet, which was a recipe for cerebrovascular disease. But, according to the authors, his weight loss and generally increasingly frail appearance in the final months of his life was not because of a combination of the stress induced by years of world war and poor lifestyle choices. Rather, if one accepts the book’s premises, FDR’s rapid decline was due to the metastasis of a melanoma from over his left eye brow to his brain and bowel.

The putative melanoma first appeared in photos in the 1920s, grew in size throughout the 1930s, and disappeared from view in 1940, by which time it was large enough to not look out of place over Aaron Neville’s eyebrow.

What’s the basis for this call to rewrite medical history? It’s not FDR’s medical records, which disappeared decades ago. And his personal physician never spoke of his patient’s rapid decline. Dr. Lomazow, a neurologist, and Mr. Fettmann, an editor at the New York Post, based their diagnosis on diary notes of people who worked in the White House.

Whatever the truth may be, never has this blog—“The Mole” —been more aptly named.

Sally Kubetin
Senior Editor

Photo courtesy Center for the Study of Intelligence, Central Intelligence Agency

Malignant melanoma killed FDR! That is the working theory powering a book out this year entitled “FDR’s Deadly Secret” (New York: PublicAffairs, 2010), by Dr. Steven Lomazow and Eric Fettmann.   

Personally, this news comes as a shock. There never seemed to be any reason to question the stroke that was listed as Franklin Delano Roosevelt’s official cause of death. After all, the man was rarely photographed without a lit cigarette propped in a holder clenched between his teeth at a jaunty angle.

His heavy drinking was legion. Only British Prime Minister Winston Churchill seemed able to drink him under the table. And it would take more than the laps he swam in the White House pool and at his “Little White House” retreat in Warm Springs, Ga., to make up for how sedentary his life became after he was diagnosed with polio.

And let’s not even talk about his diet, which was a recipe for cerebrovascular disease. But, according to the authors, his weight loss and generally increasingly frail appearance in the final months of his life was not because of a combination of the stress induced by years of world war and poor lifestyle choices. Rather, if one accepts the book’s premises, FDR’s rapid decline was due to the metastasis of a melanoma from over his left eye brow to his brain and bowel.

The putative melanoma first appeared in photos in the 1920s, grew in size throughout the 1930s, and disappeared from view in 1940, by which time it was large enough to not look out of place over Aaron Neville’s eyebrow.

What’s the basis for this call to rewrite medical history? It’s not FDR’s medical records, which disappeared decades ago. And his personal physician never spoke of his patient’s rapid decline. Dr. Lomazow, a neurologist, and Mr. Fettmann, an editor at the New York Post, based their diagnosis on diary notes of people who worked in the White House.

Whatever the truth may be, never has this blog—“The Mole” —been more aptly named.

Sally Kubetin
Senior Editor

Photo courtesy Center for the Study of Intelligence, Central Intelligence Agency

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Facial Skin Damage from Sun Exposure and an Unsuccessful Cosmetic Procedure

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Facial Skin Damage from Sun Exposure and an Unsuccessful Cosmetic Procedure
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What Is Your Diagnosis? Metastatic Adenocarcinoma

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Indoor Tanning: Just Say No [editorial]

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Architectural Features Help Establish Melanoma Diagnosis

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SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

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SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

SAN DIEGO — Many times the most important feature in establishing the correct diagnosis of melanoma is evaluating the lesion's overall growth pattern, referred to as its architecture or silhouette, said Dr. David J. Barnette Jr.

"These architectural features include size, symmetry, and circumscription," Dr. Barnette, said at a melanoma update sponsored by the Scripps Clinic. "Accurate prognosis relies on assessing tumor depth, whereas making the correct diagnosis may require evaluation of the lateral aspects of the lesion."

After you perform a biopsy and send it to a pathologist, the results should fall under one of three categories: "benign"-  a nevus or one of its variants; "malignant"- a melanoma; or "not sure"-  either the diagnosis or biologic behavior of the lesion is unknown, said Dr. Barnette, a dermatopathologist and dermatologist at the Scripps Clinic, La Jolla, Calif. A pathology report may convey the latter diagnosis with terms such as atypical nevus, atypical melanocytic lesion, atypical melanocytosis, atypical melanocytic hyperplasia (AMH), or melanocytic tumor of uncertain malignant potential.

"These terms are not problematic if the clinician and pathologist are on the same page as to what they mean and how to best treat the patient," Dr. Barnette said, noting that he and his associates use the term AMH when the diagnosis is unclear.

"If the lesion is not completely excised, we include a recommendation for re-excision," he said. "This is appropriate treatment for either an atypical nevus or an evolving melanoma in situ. Communication between the pathologist and clinician and good clinicopathologic correlation are critical in preventing over- and under-treatment."

A biopsy report for an established diagnosis of melanoma should include a comment regarding its Breslow tumor depth, mitotic rate, presence or ulceration if applicable, and an assessment of the surgical margins, especially if an excisional biopsy was performed. Other elements to consider including in a biopsy report include site of lesion, type of biopsy, presence of angiolymphatic invasion (if present), margin status, melanoma subtype, regression (if present), and host response, including plasma cells and tumor-infiltrating lymphocytes (if present).

In November 2003, the Association of Directors of Anatomic and Surgical Pathology established a diagnostic checklist for skin melanoma.

Dr. Barnette disclosed no conflicts of interests.

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Confocal Microscopy Promising for Melanoma Management

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SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

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SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

SAN DIEGO — Confocal microscopy is a promising technology to improve the management of skin lesions, but it's not quite ready for prime time, according to Dr. Lawrence T. Wang.

"At this time, the technology is very expensive, costing several tens of thousand of dollars," said Dr. Wang of the division of dermatology at Scripps Clinic Rancho Bernardo in San Diego, Calif. "It is time consuming, requiring 5-10 minutes to thoroughly evaluate a single lesion. The process is labor intensive and would likely require a trained clinician to interpret the images."

Confocal microscopy is a high-resolution, painless imaging technique that reveals epidermal structures including cells, connective tissue, and blood vessels to a maximum depth of about 300 microns. The illumination source is typically a laser.

"Only one point in the tissue is acquired at a time, so two-dimensional or even three-dimensional images are generated by scanning the tissue," Dr. Wang said at a melanoma update sponsored by the Scripps Clinic.

Findings from two recent studies suggest confocal microscopy may be useful in helping to improve the diagnosis of melanoma in the clinical setting. In one study, researchers from Italy and Australia evaluated 351 melanocytic lesions that were suspicious for melanoma based on clinical history, sequential digital photography, or dermoscopy (J. Invest. Dermatol. 2007;127:2759-65). They evaluated each lesion with confocal microscopy prior to biopsy and classified the lesions as either benign or malignant according to an algorithm based on major and minor criteria. They found that confocal microscopy showed a sensitivity of 96% and a specificity of 52%.

In the second study, Canadian researchers evaluated 125 suspicious pigmented lesions by dermoscopy followed by confocal microscopy (Dermatology 2007;215:365-72). The lesions were selected based on a history of change or clinical appearance. They found that confocal microscopy showed a sensitivity of 97% and specificity of 83%. The higher specificity "is likely due to the study design," Dr. Wang commented. "The authors' dermoscopic evaluation influenced their subsequent confocal evaluation. The study was designed this way to mimic a realistic clinical application of confocal microscopy."

Larger clinical trials of the technology are currently under way.
In Dr. Wang's opinion, current benefits of confocal microscopy include the fact that it provides immediate, real time, in vivo images prior to biopsy, removing the need for tissue preservation, sectioning, or staining. "This type of technology can significantly minimize sampling error when incisional biopsies are done of large pigmented lesions," he said. "The images are microscopic, giving single cell resolution."

However, the in vivo imaging falls short of conventional histology, he said, noting that nuclear features such as chromatin patterns, nuclear contours, and nucleoli "cannot be evaluated by confocal microscopy."

He also pointed out that since the depth of confocal microscopy is limited to the reticular dermis, subsequent biopsy of suspicious lesions "will always be needed to obtain a Breslow depth for melanoma lesions."

At this point in time, one of the best clinical applications of the technology is for managing large, atypical pigmented lesions. "Lesions in cosmetically sensitive areas such as the face are prone to sampling errors when partial biopsies are done," Dr. Wang explained. "Confocal microscopy could be used to scan entire lesions and direct appropriate sampling biopsies."

Dr. Wang disclosed having no relevant conflicts of interest.

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Indoor Tanning Business Burned by the FTC

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The Indoor Tanning Association (ITA) is really feeling the heat these days.

The Food and Drug Administration (FDA) said it would finally act on congressional orders to take a closer look at tanning bed labels (see my earlier post), and now the Federal Trade Commission (FTC) said it has exacted a settlement from the ITA to cease and desist "false health and safety claims about indoor tanning."

The FTC said, "Contrary to claims in the association’s advertising, indoor tanning increases the risk of squamous cell and melanoma skin cancers."

The agency’s complaint followed a widely reviled March 2008 ITA advertising campaign that set out to dispel what it called myths about melanoma and skin cancer. Among other claims in that campaign, according to the FTC, the ITA claimed that indoor tanning is approved by the government, and that a National Academy of Sciences study showed the risk of not getting enough ultraviolet light outweighed the "hypothetical" risk of skin cancer.

So what does the ITA have to do to make amends?

Deceptive advertisements are barred. Health benefit claims for indoor tanning have to be substantiated. And advertisements have to carry the following boldfaced warning: "NOTICE: Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

Although all four members of the FTC agreed that this settlement is proper, it is still subject to a 30-day comment period. That means indoor tanning enthusiasts have until Feb. 26 to try to change the agency’s mind. After that, the settlement is final.

--- Alicia Ault (on Twitter @aliciaault)

Image Courtesy Flickr user jasonippolito, Creative Commons attribution license

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The Indoor Tanning Association (ITA) is really feeling the heat these days.

The Food and Drug Administration (FDA) said it would finally act on congressional orders to take a closer look at tanning bed labels (see my earlier post), and now the Federal Trade Commission (FTC) said it has exacted a settlement from the ITA to cease and desist "false health and safety claims about indoor tanning."

The FTC said, "Contrary to claims in the association’s advertising, indoor tanning increases the risk of squamous cell and melanoma skin cancers."

The agency’s complaint followed a widely reviled March 2008 ITA advertising campaign that set out to dispel what it called myths about melanoma and skin cancer. Among other claims in that campaign, according to the FTC, the ITA claimed that indoor tanning is approved by the government, and that a National Academy of Sciences study showed the risk of not getting enough ultraviolet light outweighed the "hypothetical" risk of skin cancer.

So what does the ITA have to do to make amends?

Deceptive advertisements are barred. Health benefit claims for indoor tanning have to be substantiated. And advertisements have to carry the following boldfaced warning: "NOTICE: Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

Although all four members of the FTC agreed that this settlement is proper, it is still subject to a 30-day comment period. That means indoor tanning enthusiasts have until Feb. 26 to try to change the agency’s mind. After that, the settlement is final.

--- Alicia Ault (on Twitter @aliciaault)

Image Courtesy Flickr user jasonippolito, Creative Commons attribution license

The Indoor Tanning Association (ITA) is really feeling the heat these days.

The Food and Drug Administration (FDA) said it would finally act on congressional orders to take a closer look at tanning bed labels (see my earlier post), and now the Federal Trade Commission (FTC) said it has exacted a settlement from the ITA to cease and desist "false health and safety claims about indoor tanning."

The FTC said, "Contrary to claims in the association’s advertising, indoor tanning increases the risk of squamous cell and melanoma skin cancers."

The agency’s complaint followed a widely reviled March 2008 ITA advertising campaign that set out to dispel what it called myths about melanoma and skin cancer. Among other claims in that campaign, according to the FTC, the ITA claimed that indoor tanning is approved by the government, and that a National Academy of Sciences study showed the risk of not getting enough ultraviolet light outweighed the "hypothetical" risk of skin cancer.

So what does the ITA have to do to make amends?

Deceptive advertisements are barred. Health benefit claims for indoor tanning have to be substantiated. And advertisements have to carry the following boldfaced warning: "NOTICE: Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

Although all four members of the FTC agreed that this settlement is proper, it is still subject to a 30-day comment period. That means indoor tanning enthusiasts have until Feb. 26 to try to change the agency’s mind. After that, the settlement is final.

--- Alicia Ault (on Twitter @aliciaault)

Image Courtesy Flickr user jasonippolito, Creative Commons attribution license

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Short Course of Imiquimod 3.75% Improves Actinic Keratoses on Face

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ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

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ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

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Short Course of Imiquimod 3.75% Improves Actinic Keratoses on Face
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Short Course of Imiquimod 3.75% Improves Actinic Keratoses on Face
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AK, Actinic Keratoses, Imiquimod, Hanke
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AK, Actinic Keratoses, Imiquimod, Hanke
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