Melanoma

NEW ORLEANS- National estimates of the incidence of malignant melanoma may be substantially off-base due to widespread underreporting of new cases to state cancer registries by dermatologists, results of a small survey suggest.

A survey of U.S. dermatologists indicates half are unaware of their legal obligation to report new cases of malignant melanoma to the cancer registries operative in all 50 states, Dr. Seema P. Kini reported at the annual meeting of the American Academy of Dermatology.

Leaving aside the issue of familiarity with the legal reporting requirement, the survey also showed that 58% of responding dermatologists don't report new cases of malignant melanoma to their state cancer registry and don't know of anyone else in their practice doing so, added Dr. Kini of Emory University in Atlanta.

She and her coinvestigators conducted the survey at the cutaneous oncology symposium held during last year's annual meeting of the AAD. Among the 424 dermatologists in attendance, 104 practicing in 30 states completed the survey.

Dermatologists in practice for less than 10 years were 3.3-fold more likely to be unaware of the existence of the legal mandate and the established reporting procedures in place in all 50 states than were more experienced practitioners.

Fifty-four percent of dermatologists indicated they had diagnosed nine or fewer new cases of melanoma during the previous year. They were 2.9-fold less likely to report new cases of melanoma to their state cancer registry and to be unaware of anybody in their practice who did so than were dermatologists who reported finding 10 or more melanomas in the prior year.

While conceding that the survey sample size is a limitation and a larger study investigating American dermatologists' melanoma reporting practices is in order, this initial survey clearly suggests the existence of a problem, and that educational efforts aimed at improving melanoma reporting practices might well target younger physicians who diagnose fewer than 10 new melanomas annually, Dr. Kini concluded.

Dr. Kini declared having no relevant financial disclosures.

NEW ORLEANS- National estimates of the incidence of malignant melanoma may be substantially off-base due to widespread underreporting of new cases to state cancer registries by dermatologists, results of a small survey suggest.

A survey of U.S. dermatologists indicates half are unaware of their legal obligation to report new cases of malignant melanoma to the cancer registries operative in all 50 states, Dr. Seema P. Kini reported at the annual meeting of the American Academy of Dermatology.

Leaving aside the issue of familiarity with the legal reporting requirement, the survey also showed that 58% of responding dermatologists don't report new cases of malignant melanoma to their state cancer registry and don't know of anyone else in their practice doing so, added Dr. Kini of Emory University in Atlanta.

She and her coinvestigators conducted the survey at the cutaneous oncology symposium held during last year's annual meeting of the AAD. Among the 424 dermatologists in attendance, 104 practicing in 30 states completed the survey.

Dermatologists in practice for less than 10 years were 3.3-fold more likely to be unaware of the existence of the legal mandate and the established reporting procedures in place in all 50 states than were more experienced practitioners.

Fifty-four percent of dermatologists indicated they had diagnosed nine or fewer new cases of melanoma during the previous year. They were 2.9-fold less likely to report new cases of melanoma to their state cancer registry and to be unaware of anybody in their practice who did so than were dermatologists who reported finding 10 or more melanomas in the prior year.

While conceding that the survey sample size is a limitation and a larger study investigating American dermatologists' melanoma reporting practices is in order, this initial survey clearly suggests the existence of a problem, and that educational efforts aimed at improving melanoma reporting practices might well target younger physicians who diagnose fewer than 10 new melanomas annually, Dr. Kini concluded.

Dr. Kini declared having no relevant financial disclosures.

NEW ORLEANS- National estimates of the incidence of malignant melanoma may be substantially off-base due to widespread underreporting of new cases to state cancer registries by dermatologists, results of a small survey suggest.

A survey of U.S. dermatologists indicates half are unaware of their legal obligation to report new cases of malignant melanoma to the cancer registries operative in all 50 states, Dr. Seema P. Kini reported at the annual meeting of the American Academy of Dermatology.

Leaving aside the issue of familiarity with the legal reporting requirement, the survey also showed that 58% of responding dermatologists don't report new cases of malignant melanoma to their state cancer registry and don't know of anyone else in their practice doing so, added Dr. Kini of Emory University in Atlanta.

She and her coinvestigators conducted the survey at the cutaneous oncology symposium held during last year's annual meeting of the AAD. Among the 424 dermatologists in attendance, 104 practicing in 30 states completed the survey.

Dermatologists in practice for less than 10 years were 3.3-fold more likely to be unaware of the existence of the legal mandate and the established reporting procedures in place in all 50 states than were more experienced practitioners.

Fifty-four percent of dermatologists indicated they had diagnosed nine or fewer new cases of melanoma during the previous year. They were 2.9-fold less likely to report new cases of melanoma to their state cancer registry and to be unaware of anybody in their practice who did so than were dermatologists who reported finding 10 or more melanomas in the prior year.

While conceding that the survey sample size is a limitation and a larger study investigating American dermatologists' melanoma reporting practices is in order, this initial survey clearly suggests the existence of a problem, and that educational efforts aimed at improving melanoma reporting practices might well target younger physicians who diagnose fewer than 10 new melanomas annually, Dr. Kini concluded.

Dr. Kini declared having no relevant financial disclosures.

The Skin Cancer Foundation's Road to Healthy Skin Tour made a stop outside the New Orleans convention center for the annual meeting of the American Academy of Dermatology. It's goal: to recruit volunteers.

The Foundation turned an RV into a mobile office. Since 2008, the tour bus and its volunteer dermatologists have held 249 screening events around the nation. Roughly 300 dermatologists have examined more than 10,000 patients and have identified more than 3,000 patients with suspected skin cancers.

To learn more about the tour, we spoke with Dr. Brent Schillinger, a volunteer and dermatologist from Palm Beach, Fla. He has been with the tour for 3 years.

-Naseem Miller

The Skin Cancer Foundation's Road to Healthy Skin Tour made a stop outside the New Orleans convention center for the annual meeting of the American Academy of Dermatology. It's goal: to recruit volunteers.

The Foundation turned an RV into a mobile office. Since 2008, the tour bus and its volunteer dermatologists have held 249 screening events around the nation. Roughly 300 dermatologists have examined more than 10,000 patients and have identified more than 3,000 patients with suspected skin cancers.

To learn more about the tour, we spoke with Dr. Brent Schillinger, a volunteer and dermatologist from Palm Beach, Fla. He has been with the tour for 3 years.

-Naseem Miller

The Skin Cancer Foundation's Road to Healthy Skin Tour made a stop outside the New Orleans convention center for the annual meeting of the American Academy of Dermatology. It's goal: to recruit volunteers.

The Foundation turned an RV into a mobile office. Since 2008, the tour bus and its volunteer dermatologists have held 249 screening events around the nation. Roughly 300 dermatologists have examined more than 10,000 patients and have identified more than 3,000 patients with suspected skin cancers.

To learn more about the tour, we spoke with Dr. Brent Schillinger, a volunteer and dermatologist from Palm Beach, Fla. He has been with the tour for 3 years.

-Naseem Miller

ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.

Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.

"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.

For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.

MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.

Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).

Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.

Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.

ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.

Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.

"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.

For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.

MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.

Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).

Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.

Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.

ORLANDO - Limiting treatment of actinic keratoses to cryosurgery is a disservice to patients, according to Dr. Neil A. Fenske.

Every patient with AKs deserves consideration for field therapy, he said at the Orlando Dermatology Aesthetic and Clinical Conference. Mutated cells occur not only within the visible AKs, but also in the surrounding, normal-looking skin.

"Most patients don't have one AK," said Dr. Fenske of the Moffitt Cancer Center at the University of South Florida in Tampa. Data based on mathematical models suggest that 6%-10% of typical patients with an average of eight AKs will develop at least one squamous cell carcinoma over a 10-year period.

For more complete treatment, following cryosurgery with field therapy a week later. Field therapy using methyl aminolevulinate (MAL) plus a red light–emitting diode (LED) is an up-and-coming option.

MAL has a higher relative porphyrin enrichment in AKs than in normal skin, and is able to penetrate deeply compared with 5-aminolevulinic acid, Dr. Fenske explained. In addition, the red LED at 630 nm requires a lower light dose than other light options, so there is less heating of the skin.

Dr. Fenske cited a study of MAL-PDT plus red LED at 630 nm in which 14 patients with a total of 223 AKs on the scalp and face underwent two treatments. The total number of AKs decreased by 55% after the first treatment and by 62% after the second treatment. Although global photodamage scores improved, pain was an issue (J. Dermatolog. Treat. 2010;21:252-7).

Dr. Fenske said he often uses aminolevulinic acid plus blue light, but to treat and kill bacteria deep in the sebaceous glands, "I would use red light and [MAL]," he said.

Dr. Fenske disclosed serving as a consultant and speaker for Graceway Pharmaceuticals, and serving as a speaker for Sanofi-Aventis.

NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

NEW ORLEANS - Skin conditions in cancer patients often are serious enough to result in a reduction or discontinuation of chemotherapy or radiation treatments, and yet only a small number of oncologists routinely refer their patients to dermatologists, said Dr. Mario E. Lacouture of Memorial Sloan-Kettering Cancer Center in New York.

Dr. Lacouture added that the skin conditions can severely impact patients' quality of life and even lead to a worsening of their disease. "In a sense, the skin becomes an innocent bystander to cancer, with far-reaching psychosocial, physical, and financial implications for patients," he said at a press briefing during the annual meeting of the American Academy of Dermatology.

About 1.5 million Americans are diagnosed with cancer each year, and there are some 10.5 million survivors. About 900,000 of those diagnosed will undergo chemotherapy and 700,000 will get radiation, said Dr. Lacouture. Before starting, some 45% have pre-existing skin conditions, such as skin infections, severe dry skin, or itchy skin, he said. Chemotherapy suppresses the immune system and prevents normal cell growth, which can aggravate these underlying conditions.

He estimated that half of patients will develop a treatable skin, nail, or hair condition. Among those most commonly seen are acneiform rash, mouth sores, nail changes, dry skin, itching, hair problems, and hand-foot syndrome.

And yet, only about 8% of oncologists refer their patients to a dermatologist, Dr. Lacouture said in an interview after the briefing.

These side effects are burdensome because they can make the cancer visible to others, which is upsetting to patients, said Dr. Lacouture. Treatments for the skin conditions can be expensive and might not be covered by insurance. And once the skin barrier is broken, it creates a greater susceptibility to infection. The skin conditions also can affect a patient's ability to sleep or function, thereby lessening quality of life.

Most importantly, oncologists might stop or decrease the chemotherapy dose, Dr. Lacouture said. A survey he and colleagues conducted a few years ago found that two-thirds of oncologists modify chemotherapy regimens and up to a third will stop because of certain dermatologic side effects, he said.

Patients also have been surveyed. In a study by Dr. Lacouture and his colleagues, 379 cancer patients were asked about side effects (Support. Care Cancer 2010;11:1461-8). Skin irritation and dry skin were listed as present by as many people as had difficulty with diarrhea, insomnia, and fatigue. Almost half the patients said that dry skin and skin irritation had a negative impact – more than for any other side effect.

Targeted therapies have not decreased the incidence of dermatologic conditions, said Dr. Lacouture. For instance, 70%-90% of patients taking cetuximab, erlotinib, and panitumumab experience an acneiform rash, he said.

Sloan-Kettering has begun an interdisciplinary program – the Skin and Eye Reactions to Inhibitors of EGFRs and Kinases Clinic – to treat these patients rapidly, as soon as the day or the day after they present with the side effects.

When cancer patients present with side effects, "they cannot wait for several weeks to be seen because it's imperative that they continue their treatment," said Dr. Lacouture.

But the goal now is to keep the patients from having to be referred. Many are given a prophylactic regimen of moisturizers, sunscreen, topical steroid cream, and doxycycline before they are started on a targeted therapy. The regimen was tested in the STEPP (Skin Toxicity Evaluation Protocol With Panitumumab) trial led by Dr. Lacouture (J. Clin. Oncol. 2010;28:1351-7).

Taxanes, used for breast, lung, head and neck, and prostate cancer, can cause inflammation, leading the nails to fall off. This affects up to 80% of patients taking the taxanes, he said. At Sloan-Kettering, patients are given cold pack gloves and slippers during infusion to prevent the side effect.

Many cancer institutions have adopted programs similar to those at Sloan-Kettering to reduce these dermatologic side effects, said Dr. Lacouture.

Dr. Lacouture reported that he has received honoraria from, or been a consultant or speaker with, Amgen, Bayer Pharmaceuticals, Bristol-Myers Squibb, Exelixis, Genentech, Hana Biosciences (now Talon Therapeutics), GlaxoSmithKline, ImClone, Lindi Skin, Onyx Pharmaceuticals, OSI Pharmaceuticals Inc., Pfizer, Roche, and Sanofi-Aventis.

ORLANDO – "The diameter of a single hair shaft is tens of thousands of nanometers," said Dr. Adam Friedman. Nanotechnology is the branch of technology related to dimensions and tolerances ranging from 0.1 to 100 nanometers.

"At this size, matter behaves somewhat differently," Dr. Friedman, of Albert Einstein College of Medicine in New York, said. As the size of material decreases, the surface area relative to volume decreases. There is more surface to interact with the environment.

"The three properties of matter – chemical, optical, and physical – can be manipulated and exploited at the nano scale," Dr. Friedman said. For example, something that is too bulky at the macro level to go into an aqueous vehicle can be distributed more easily in nano form. And "if something is smaller than the wavelength of visible light, guess what? It is going to be invisible," he said at the Orlando Dermatology Aesthetic and Clinical Conference.

By the year 2012, nanotechnology is predicted to be a $12 billion industry in the United States, and the cosmetic and cosmeceutical industries are leading the way, Dr. Friedman noted. He discussed several nanomaterials with diagnostic and therapeutic applications for dermatologists:

• Nanoparticles. The term nanoparticle is somewhat generic, Dr. Friedman said. The term refers to a small object that behaves as a whole unit in terms of its transport and properties. Nanoparticles can be derived from organic and nonorganic materials. For example, gold nanoparticles can be used to introduce an antibody or targeting molecule into the body to target tumors. Once the tumors are bound to the gold, they can be treated using selective photolysis, in which radiation is used to heat the gold enough to kill the tumor cells. In one study of mice, hollow gold nanoparticles were used to successfully treat melanoma, said Dr. Friedman. Silver nanoparticles are already in products ranging from clothing to plastic food storage containers, to take advantage of their antimicrobial properties, he said.

• Nanoemulsions. Nanoemulsions are already widely used in dermatology, in emollients, and as delivery vehicles for antiaging products. Nanoemulsions have an appealing nongreasy texture, are invisible, and penetrate the skin rapidly, Dr. Friedman said. Nanoemulsion products currently on the market include L’Oréal Plenitude Revitalift and Caudalie Vinosun Anti-Aging Suncare.

• Quantum dots. "These highly fluorescent nanoscale crystals absorb a broad range of wavelengths; however, they only re-emit one color," said Dr. Friedman. In dermatology, quantum dots are being used to identify sentinel lymph nodes in patients with melanoma and Merkel cell carcinoma.

• Nanomagnets. Nanosized magnetic materials "no longer exhibit a net magnetic force," Dr. Friedman said. These materials could be used to create magnetic field–directed imaging or therapy.

• Nanopigments. Many currently available sunblocks include nanoparticles of titanium or zinc oxide, such as SunVex Dailywear lotions and ZinClear Nano Zinc Oxide.

About safety: "From a purely theoretical standpoint, nanoparticles should be harmful," said Dr. Friedman. The same properties that make nanoparticles useful could come with side effects. Improved skin penetration can be beneficial for dermatology, but factors that determine the potential toxicity of nanoparticles include size, chemical purity, and the activity of the surface.

The current international stance on nanoparticle safety is that it is unlikely that significant amounts of the zinc or titanium used in sunblock products will result in local or systemic toxicity. However, "the safety of nanoscale zinc and titanium in sunscreen must be fully addressed," Dr. Friedman said. In 2009, the American Academy of Dermatology established a task force to study nanotechnology and educate the dermatology community, the public, and policy makers.

Dermatologists who are intrigued by the potential of nanotechnology can join the fledgling Nanodermatology Society, which had its first meeting for the 2011 AAD annual meeting in New Orleans. For more information, visit the society's Web site at www.nanodermsociety.org.

Dr. Friedman serves on the advisory board of Makefield Therapeutics.

ORLANDO – "The diameter of a single hair shaft is tens of thousands of nanometers," said Dr. Adam Friedman. Nanotechnology is the branch of technology related to dimensions and tolerances ranging from 0.1 to 100 nanometers.

"At this size, matter behaves somewhat differently," Dr. Friedman, of Albert Einstein College of Medicine in New York, said. As the size of material decreases, the surface area relative to volume decreases. There is more surface to interact with the environment.

"The three properties of matter – chemical, optical, and physical – can be manipulated and exploited at the nano scale," Dr. Friedman said. For example, something that is too bulky at the macro level to go into an aqueous vehicle can be distributed more easily in nano form. And "if something is smaller than the wavelength of visible light, guess what? It is going to be invisible," he said at the Orlando Dermatology Aesthetic and Clinical Conference.

By the year 2012, nanotechnology is predicted to be a $12 billion industry in the United States, and the cosmetic and cosmeceutical industries are leading the way, Dr. Friedman noted. He discussed several nanomaterials with diagnostic and therapeutic applications for dermatologists:

• Nanoparticles. The term nanoparticle is somewhat generic, Dr. Friedman said. The term refers to a small object that behaves as a whole unit in terms of its transport and properties. Nanoparticles can be derived from organic and nonorganic materials. For example, gold nanoparticles can be used to introduce an antibody or targeting molecule into the body to target tumors. Once the tumors are bound to the gold, they can be treated using selective photolysis, in which radiation is used to heat the gold enough to kill the tumor cells. In one study of mice, hollow gold nanoparticles were used to successfully treat melanoma, said Dr. Friedman. Silver nanoparticles are already in products ranging from clothing to plastic food storage containers, to take advantage of their antimicrobial properties, he said.

• Nanoemulsions. Nanoemulsions are already widely used in dermatology, in emollients, and as delivery vehicles for antiaging products. Nanoemulsions have an appealing nongreasy texture, are invisible, and penetrate the skin rapidly, Dr. Friedman said. Nanoemulsion products currently on the market include L’Oréal Plenitude Revitalift and Caudalie Vinosun Anti-Aging Suncare.

• Quantum dots. "These highly fluorescent nanoscale crystals absorb a broad range of wavelengths; however, they only re-emit one color," said Dr. Friedman. In dermatology, quantum dots are being used to identify sentinel lymph nodes in patients with melanoma and Merkel cell carcinoma.

• Nanomagnets. Nanosized magnetic materials "no longer exhibit a net magnetic force," Dr. Friedman said. These materials could be used to create magnetic field–directed imaging or therapy.

• Nanopigments. Many currently available sunblocks include nanoparticles of titanium or zinc oxide, such as SunVex Dailywear lotions and ZinClear Nano Zinc Oxide.

About safety: "From a purely theoretical standpoint, nanoparticles should be harmful," said Dr. Friedman. The same properties that make nanoparticles useful could come with side effects. Improved skin penetration can be beneficial for dermatology, but factors that determine the potential toxicity of nanoparticles include size, chemical purity, and the activity of the surface.

The current international stance on nanoparticle safety is that it is unlikely that significant amounts of the zinc or titanium used in sunblock products will result in local or systemic toxicity. However, "the safety of nanoscale zinc and titanium in sunscreen must be fully addressed," Dr. Friedman said. In 2009, the American Academy of Dermatology established a task force to study nanotechnology and educate the dermatology community, the public, and policy makers.

Dermatologists who are intrigued by the potential of nanotechnology can join the fledgling Nanodermatology Society, which had its first meeting for the 2011 AAD annual meeting in New Orleans. For more information, visit the society's Web site at www.nanodermsociety.org.

Dr. Friedman serves on the advisory board of Makefield Therapeutics.

ORLANDO – "The diameter of a single hair shaft is tens of thousands of nanometers," said Dr. Adam Friedman. Nanotechnology is the branch of technology related to dimensions and tolerances ranging from 0.1 to 100 nanometers.

"At this size, matter behaves somewhat differently," Dr. Friedman, of Albert Einstein College of Medicine in New York, said. As the size of material decreases, the surface area relative to volume decreases. There is more surface to interact with the environment.

"The three properties of matter – chemical, optical, and physical – can be manipulated and exploited at the nano scale," Dr. Friedman said. For example, something that is too bulky at the macro level to go into an aqueous vehicle can be distributed more easily in nano form. And "if something is smaller than the wavelength of visible light, guess what? It is going to be invisible," he said at the Orlando Dermatology Aesthetic and Clinical Conference.

By the year 2012, nanotechnology is predicted to be a $12 billion industry in the United States, and the cosmetic and cosmeceutical industries are leading the way, Dr. Friedman noted. He discussed several nanomaterials with diagnostic and therapeutic applications for dermatologists:

• Nanoparticles. The term nanoparticle is somewhat generic, Dr. Friedman said. The term refers to a small object that behaves as a whole unit in terms of its transport and properties. Nanoparticles can be derived from organic and nonorganic materials. For example, gold nanoparticles can be used to introduce an antibody or targeting molecule into the body to target tumors. Once the tumors are bound to the gold, they can be treated using selective photolysis, in which radiation is used to heat the gold enough to kill the tumor cells. In one study of mice, hollow gold nanoparticles were used to successfully treat melanoma, said Dr. Friedman. Silver nanoparticles are already in products ranging from clothing to plastic food storage containers, to take advantage of their antimicrobial properties, he said.

• Nanoemulsions. Nanoemulsions are already widely used in dermatology, in emollients, and as delivery vehicles for antiaging products. Nanoemulsions have an appealing nongreasy texture, are invisible, and penetrate the skin rapidly, Dr. Friedman said. Nanoemulsion products currently on the market include L’Oréal Plenitude Revitalift and Caudalie Vinosun Anti-Aging Suncare.

• Quantum dots. "These highly fluorescent nanoscale crystals absorb a broad range of wavelengths; however, they only re-emit one color," said Dr. Friedman. In dermatology, quantum dots are being used to identify sentinel lymph nodes in patients with melanoma and Merkel cell carcinoma.

• Nanomagnets. Nanosized magnetic materials "no longer exhibit a net magnetic force," Dr. Friedman said. These materials could be used to create magnetic field–directed imaging or therapy.

• Nanopigments. Many currently available sunblocks include nanoparticles of titanium or zinc oxide, such as SunVex Dailywear lotions and ZinClear Nano Zinc Oxide.

About safety: "From a purely theoretical standpoint, nanoparticles should be harmful," said Dr. Friedman. The same properties that make nanoparticles useful could come with side effects. Improved skin penetration can be beneficial for dermatology, but factors that determine the potential toxicity of nanoparticles include size, chemical purity, and the activity of the surface.

The current international stance on nanoparticle safety is that it is unlikely that significant amounts of the zinc or titanium used in sunblock products will result in local or systemic toxicity. However, "the safety of nanoscale zinc and titanium in sunscreen must be fully addressed," Dr. Friedman said. In 2009, the American Academy of Dermatology established a task force to study nanotechnology and educate the dermatology community, the public, and policy makers.

Dermatologists who are intrigued by the potential of nanotechnology can join the fledgling Nanodermatology Society, which had its first meeting for the 2011 AAD annual meeting in New Orleans. For more information, visit the society's Web site at www.nanodermsociety.org.

Dr. Friedman serves on the advisory board of Makefield Therapeutics.

ORLANDO – The photodynamic therapy protocol that works best on the face is not necessarily the best protocol for the scalp, according to Dr. Amy Forman Taub of Northwestern University in Chicago.

The main indications for PDT are actinic keratoses, acne, and photorejuvenation, but other indications include psoriasis, vulvar neoplasia, methicillin-resistant Staphylococcus aureus, and onychomycosis.

"For long-term cosmesis, nothing stands up like PDT," said Dr. Taub at the Orlando Dermatology Aesthetic and Clinical Conference. She explained her protocols for using PDT for actinic keratoses on different parts of the body.

• Scalp. To treat actinic keratoses on the scalp, Dr. Taub recommended incubation for 60-90 minutes with 5-aminolevulinic acid (5-ALA), followed by exposure to blue light at 2-4 inches for 20 minutes. Next, prescribe emollients for morning use and fluticasone for nighttime use. Check the scalp at 4 weeks. Repeat the PDT protocol after 8 weeks. Check the patient again in 12-16 weeks and biopsy any residual lesions, Dr. Taub said.

• Face. For severe actinic keratoses on the face, Dr. Taub recommended incubation with 5-ALA for 1 hour, followed by exposure to blue light for 16 minutes. Next, instruct the patient to apply zinc oxide sunscreen on top of topical emollients in the morning, and to use topical emollients at night. If 20% or fewer lesions remain at a 4-week follow-up visit, use an alternate therapy. But if more than 20% of the lesions remain, repeat the PDT with 90 minutes of incubation and 1 minute of blue light, Dr. Taub advised.

• Arms and hands. Be sure to elevate the arms so they are 2-4 inches from the light source, Dr. Taub said. She recommended using the push-up handles sold at sporting goods stores to elevate a patient’s arms for more effective PDT. Her preferred protocol for treatment of the arms and hands is to incubate with 5-ALA for 2 hours using Saran Wrap and gloves for occlusion, followed by exposure to blue light for 20 minutes. Repeat the procedure in 4-8 weeks, then examine the patient 12 weeks later and biopsy any residual lesions.

• Legs and feet. When planning PDT for the legs, remove or biopsy any lesions 4 weeks before PDT, said Dr. Taub. She recommended dividing the legs into four quadrants that each take one stick of ALA: upper, lower, anterior, and posterior. Perform the PDT on each quadrant separately, she said. Incubate the area for 2-3 hours, ideally after 1 week of 5-fluorouracil treatment. Next, expose the quadrant to blue light for 20 minutes. Repeat the protocol 8 weeks later, and re-evaluate the patient 12 weeks after the second treatment, she said.

Tricky areas such as the arms, legs, and chest can respond especially well to intense pulsed light (IPL)-PDT, Dr. Taub noted. The cost to the patient is higher, but she has seen dramatic improvements. Another option is to do one IPL-PDT treatment and follow with a blue light treatment if necessary, she said.

Dr. Taub disclosed serving as a consultant and speaker for, and receiving research funding from, DUSA Pharmaceuticals and Syneron.

ORLANDO – The photodynamic therapy protocol that works best on the face is not necessarily the best protocol for the scalp, according to Dr. Amy Forman Taub of Northwestern University in Chicago.

The main indications for PDT are actinic keratoses, acne, and photorejuvenation, but other indications include psoriasis, vulvar neoplasia, methicillin-resistant Staphylococcus aureus, and onychomycosis.

"For long-term cosmesis, nothing stands up like PDT," said Dr. Taub at the Orlando Dermatology Aesthetic and Clinical Conference. She explained her protocols for using PDT for actinic keratoses on different parts of the body.

• Scalp. To treat actinic keratoses on the scalp, Dr. Taub recommended incubation for 60-90 minutes with 5-aminolevulinic acid (5-ALA), followed by exposure to blue light at 2-4 inches for 20 minutes. Next, prescribe emollients for morning use and fluticasone for nighttime use. Check the scalp at 4 weeks. Repeat the PDT protocol after 8 weeks. Check the patient again in 12-16 weeks and biopsy any residual lesions, Dr. Taub said.

• Face. For severe actinic keratoses on the face, Dr. Taub recommended incubation with 5-ALA for 1 hour, followed by exposure to blue light for 16 minutes. Next, instruct the patient to apply zinc oxide sunscreen on top of topical emollients in the morning, and to use topical emollients at night. If 20% or fewer lesions remain at a 4-week follow-up visit, use an alternate therapy. But if more than 20% of the lesions remain, repeat the PDT with 90 minutes of incubation and 1 minute of blue light, Dr. Taub advised.

• Arms and hands. Be sure to elevate the arms so they are 2-4 inches from the light source, Dr. Taub said. She recommended using the push-up handles sold at sporting goods stores to elevate a patient’s arms for more effective PDT. Her preferred protocol for treatment of the arms and hands is to incubate with 5-ALA for 2 hours using Saran Wrap and gloves for occlusion, followed by exposure to blue light for 20 minutes. Repeat the procedure in 4-8 weeks, then examine the patient 12 weeks later and biopsy any residual lesions.

• Legs and feet. When planning PDT for the legs, remove or biopsy any lesions 4 weeks before PDT, said Dr. Taub. She recommended dividing the legs into four quadrants that each take one stick of ALA: upper, lower, anterior, and posterior. Perform the PDT on each quadrant separately, she said. Incubate the area for 2-3 hours, ideally after 1 week of 5-fluorouracil treatment. Next, expose the quadrant to blue light for 20 minutes. Repeat the protocol 8 weeks later, and re-evaluate the patient 12 weeks after the second treatment, she said.

Tricky areas such as the arms, legs, and chest can respond especially well to intense pulsed light (IPL)-PDT, Dr. Taub noted. The cost to the patient is higher, but she has seen dramatic improvements. Another option is to do one IPL-PDT treatment and follow with a blue light treatment if necessary, she said.

Dr. Taub disclosed serving as a consultant and speaker for, and receiving research funding from, DUSA Pharmaceuticals and Syneron.

ORLANDO – The photodynamic therapy protocol that works best on the face is not necessarily the best protocol for the scalp, according to Dr. Amy Forman Taub of Northwestern University in Chicago.

The main indications for PDT are actinic keratoses, acne, and photorejuvenation, but other indications include psoriasis, vulvar neoplasia, methicillin-resistant Staphylococcus aureus, and onychomycosis.

"For long-term cosmesis, nothing stands up like PDT," said Dr. Taub at the Orlando Dermatology Aesthetic and Clinical Conference. She explained her protocols for using PDT for actinic keratoses on different parts of the body.

• Scalp. To treat actinic keratoses on the scalp, Dr. Taub recommended incubation for 60-90 minutes with 5-aminolevulinic acid (5-ALA), followed by exposure to blue light at 2-4 inches for 20 minutes. Next, prescribe emollients for morning use and fluticasone for nighttime use. Check the scalp at 4 weeks. Repeat the PDT protocol after 8 weeks. Check the patient again in 12-16 weeks and biopsy any residual lesions, Dr. Taub said.

• Face. For severe actinic keratoses on the face, Dr. Taub recommended incubation with 5-ALA for 1 hour, followed by exposure to blue light for 16 minutes. Next, instruct the patient to apply zinc oxide sunscreen on top of topical emollients in the morning, and to use topical emollients at night. If 20% or fewer lesions remain at a 4-week follow-up visit, use an alternate therapy. But if more than 20% of the lesions remain, repeat the PDT with 90 minutes of incubation and 1 minute of blue light, Dr. Taub advised.

• Arms and hands. Be sure to elevate the arms so they are 2-4 inches from the light source, Dr. Taub said. She recommended using the push-up handles sold at sporting goods stores to elevate a patient’s arms for more effective PDT. Her preferred protocol for treatment of the arms and hands is to incubate with 5-ALA for 2 hours using Saran Wrap and gloves for occlusion, followed by exposure to blue light for 20 minutes. Repeat the procedure in 4-8 weeks, then examine the patient 12 weeks later and biopsy any residual lesions.

• Legs and feet. When planning PDT for the legs, remove or biopsy any lesions 4 weeks before PDT, said Dr. Taub. She recommended dividing the legs into four quadrants that each take one stick of ALA: upper, lower, anterior, and posterior. Perform the PDT on each quadrant separately, she said. Incubate the area for 2-3 hours, ideally after 1 week of 5-fluorouracil treatment. Next, expose the quadrant to blue light for 20 minutes. Repeat the protocol 8 weeks later, and re-evaluate the patient 12 weeks after the second treatment, she said.

Tricky areas such as the arms, legs, and chest can respond especially well to intense pulsed light (IPL)-PDT, Dr. Taub noted. The cost to the patient is higher, but she has seen dramatic improvements. Another option is to do one IPL-PDT treatment and follow with a blue light treatment if necessary, she said.

Dr. Taub disclosed serving as a consultant and speaker for, and receiving research funding from, DUSA Pharmaceuticals and Syneron.

NEW ORLEANS - Even if you don't use lasers in your day-to-day practice of dermatology, it's helpful to know the options and their limitations to prevent unnecessary referrals, Dr. Harvey Lui said.

"For those of you who do not use lasers, hopefully you can learn which things those of us who do lasers can help you with and things we cannot," Dr. Lui said at the annual meeting of the American Academy of Dermatology.

If the question is whether to use laser treatment for pigmentation disorders, the answers vary from yes to maybe to no.

As a general guide, the depth of the dyspigmentation makes the difference with lasers, so Dr. Lui addressed their use for epidermal, mixed epidermal-dermal, or dermal disorders.

Epidermal Dyspigmentation. Lentigines are the prototype epidermal pigmentation disorder. "Lasers are highly effective, relatively simple, [and work in] one to two treatments," Dr. Lui said. Although lasers are not the only treatment option (for example, there is cryotherapy), "I get more precise effects in my practice for darker-skinned patients."

Lasers are also useful to treat a seborrheic keratosis. The advantage with lasers is an ability to target each spot to be cleared, Dr. Lui said.

In contrast, a Becker's nevus does not respond very well to laser treatment, "even though pigmentation is right there in the epidermis just begging to be removed," said Dr. Lui, medical director of the Skin Care Centre and head of the department of dermatology and skin science at the University of British Columbia, Vancouver. "There was some initial excitement using fractional photothermolysis, but I don't think that has panned out over time."

Lasers are not ideal for an epidermal nevus either, Dr. Lui said, due to a higher recurrence rate. However, he added, "in a highly motivated patient, I might do a test spot first."

A high recurrence rate and an unpredictable response are reasons to avoid laser treatment for café au lait macules, Dr. Lui said. Smaller lesions tend to respond the best. He advised caution, because there can be some paradoxical darkening in these patients.

Mixed Epidermal-Dermal Dyspigmentation. Expect a variable response to lasers for melanocytic nevi. "The best response is with small, junctional nevi." Use the highest fluence possible, Dr. Lui advised. An unknown long-term risk and incomplete pigment removal that can lead to problematic lesions are considerations. "Tell the patient that if the pigment does not completely clear, we are going to cut it out. You don't want to leave them with a lesion that meets one of the ABCD criteria [that could develop into melanoma someday]," Dr. Lui said.

Congenital melanocytic nevi may respond to a normal-mode ruby laser, but again, the long-term risk is unknown.

Dr. Lui generally does not recommend lasers for melasma. "The bottom line is that melasma will reliably darken with lasers. You can bet on it." Initial excitement about fractional lasers did not pan out, he added.

Dr. Lui also cautioned against lasers for postinflammatory hyperpigmentation. "A laser usually generates more postinflammatory hyperpigmentation. It's just a vicious circle, so the bottom line is 'Don't go there.' " Instead, convince your patient to be patient. "The best treatment is often time, and it's the cheapest, too."

Dermal Dyspigmentation. Nevus of Ota and nevus of Ito, which are more common in Asian patients, feature an excellent responsiveness to laser treatment, Dr. Lui said. "These are life-transforming types of procedures you can do for patients. This is why I became a doctor."

Lasers also are appropriate for treatment of Hori's macules. These often look like lentigines, Dr. Lui said. To distinguish between the two types of lesions, look for a blue-gray color (as opposed to a brown color with lentigines) and lesions that appear smudgy rather than well delineated.

Lasers can be used to treat blue nevi, but caution is advised, Dr. Lui said.

Dr. Lui said that he had no relevant financial disclosures.

NEW ORLEANS - Even if you don't use lasers in your day-to-day practice of dermatology, it's helpful to know the options and their limitations to prevent unnecessary referrals, Dr. Harvey Lui said.

"For those of you who do not use lasers, hopefully you can learn which things those of us who do lasers can help you with and things we cannot," Dr. Lui said at the annual meeting of the American Academy of Dermatology.

If the question is whether to use laser treatment for pigmentation disorders, the answers vary from yes to maybe to no.

As a general guide, the depth of the dyspigmentation makes the difference with lasers, so Dr. Lui addressed their use for epidermal, mixed epidermal-dermal, or dermal disorders.

Epidermal Dyspigmentation. Lentigines are the prototype epidermal pigmentation disorder. "Lasers are highly effective, relatively simple, [and work in] one to two treatments," Dr. Lui said. Although lasers are not the only treatment option (for example, there is cryotherapy), "I get more precise effects in my practice for darker-skinned patients."

Lasers are also useful to treat a seborrheic keratosis. The advantage with lasers is an ability to target each spot to be cleared, Dr. Lui said.

In contrast, a Becker's nevus does not respond very well to laser treatment, "even though pigmentation is right there in the epidermis just begging to be removed," said Dr. Lui, medical director of the Skin Care Centre and head of the department of dermatology and skin science at the University of British Columbia, Vancouver. "There was some initial excitement using fractional photothermolysis, but I don't think that has panned out over time."

Lasers are not ideal for an epidermal nevus either, Dr. Lui said, due to a higher recurrence rate. However, he added, "in a highly motivated patient, I might do a test spot first."

A high recurrence rate and an unpredictable response are reasons to avoid laser treatment for café au lait macules, Dr. Lui said. Smaller lesions tend to respond the best. He advised caution, because there can be some paradoxical darkening in these patients.

Mixed Epidermal-Dermal Dyspigmentation. Expect a variable response to lasers for melanocytic nevi. "The best response is with small, junctional nevi." Use the highest fluence possible, Dr. Lui advised. An unknown long-term risk and incomplete pigment removal that can lead to problematic lesions are considerations. "Tell the patient that if the pigment does not completely clear, we are going to cut it out. You don't want to leave them with a lesion that meets one of the ABCD criteria [that could develop into melanoma someday]," Dr. Lui said.

Congenital melanocytic nevi may respond to a normal-mode ruby laser, but again, the long-term risk is unknown.

Dr. Lui generally does not recommend lasers for melasma. "The bottom line is that melasma will reliably darken with lasers. You can bet on it." Initial excitement about fractional lasers did not pan out, he added.

Dr. Lui also cautioned against lasers for postinflammatory hyperpigmentation. "A laser usually generates more postinflammatory hyperpigmentation. It's just a vicious circle, so the bottom line is 'Don't go there.' " Instead, convince your patient to be patient. "The best treatment is often time, and it's the cheapest, too."

Dermal Dyspigmentation. Nevus of Ota and nevus of Ito, which are more common in Asian patients, feature an excellent responsiveness to laser treatment, Dr. Lui said. "These are life-transforming types of procedures you can do for patients. This is why I became a doctor."

Lasers also are appropriate for treatment of Hori's macules. These often look like lentigines, Dr. Lui said. To distinguish between the two types of lesions, look for a blue-gray color (as opposed to a brown color with lentigines) and lesions that appear smudgy rather than well delineated.

Lasers can be used to treat blue nevi, but caution is advised, Dr. Lui said.

Dr. Lui said that he had no relevant financial disclosures.

NEW ORLEANS - Even if you don't use lasers in your day-to-day practice of dermatology, it's helpful to know the options and their limitations to prevent unnecessary referrals, Dr. Harvey Lui said.

"For those of you who do not use lasers, hopefully you can learn which things those of us who do lasers can help you with and things we cannot," Dr. Lui said at the annual meeting of the American Academy of Dermatology.

If the question is whether to use laser treatment for pigmentation disorders, the answers vary from yes to maybe to no.

As a general guide, the depth of the dyspigmentation makes the difference with lasers, so Dr. Lui addressed their use for epidermal, mixed epidermal-dermal, or dermal disorders.

Epidermal Dyspigmentation. Lentigines are the prototype epidermal pigmentation disorder. "Lasers are highly effective, relatively simple, [and work in] one to two treatments," Dr. Lui said. Although lasers are not the only treatment option (for example, there is cryotherapy), "I get more precise effects in my practice for darker-skinned patients."

Lasers are also useful to treat a seborrheic keratosis. The advantage with lasers is an ability to target each spot to be cleared, Dr. Lui said.

In contrast, a Becker's nevus does not respond very well to laser treatment, "even though pigmentation is right there in the epidermis just begging to be removed," said Dr. Lui, medical director of the Skin Care Centre and head of the department of dermatology and skin science at the University of British Columbia, Vancouver. "There was some initial excitement using fractional photothermolysis, but I don't think that has panned out over time."

Lasers are not ideal for an epidermal nevus either, Dr. Lui said, due to a higher recurrence rate. However, he added, "in a highly motivated patient, I might do a test spot first."

A high recurrence rate and an unpredictable response are reasons to avoid laser treatment for café au lait macules, Dr. Lui said. Smaller lesions tend to respond the best. He advised caution, because there can be some paradoxical darkening in these patients.

Mixed Epidermal-Dermal Dyspigmentation. Expect a variable response to lasers for melanocytic nevi. "The best response is with small, junctional nevi." Use the highest fluence possible, Dr. Lui advised. An unknown long-term risk and incomplete pigment removal that can lead to problematic lesions are considerations. "Tell the patient that if the pigment does not completely clear, we are going to cut it out. You don't want to leave them with a lesion that meets one of the ABCD criteria [that could develop into melanoma someday]," Dr. Lui said.

Congenital melanocytic nevi may respond to a normal-mode ruby laser, but again, the long-term risk is unknown.

Dr. Lui generally does not recommend lasers for melasma. "The bottom line is that melasma will reliably darken with lasers. You can bet on it." Initial excitement about fractional lasers did not pan out, he added.

Dr. Lui also cautioned against lasers for postinflammatory hyperpigmentation. "A laser usually generates more postinflammatory hyperpigmentation. It's just a vicious circle, so the bottom line is 'Don't go there.' " Instead, convince your patient to be patient. "The best treatment is often time, and it's the cheapest, too."

Dermal Dyspigmentation. Nevus of Ota and nevus of Ito, which are more common in Asian patients, feature an excellent responsiveness to laser treatment, Dr. Lui said. "These are life-transforming types of procedures you can do for patients. This is why I became a doctor."

Lasers also are appropriate for treatment of Hori's macules. These often look like lentigines, Dr. Lui said. To distinguish between the two types of lesions, look for a blue-gray color (as opposed to a brown color with lentigines) and lesions that appear smudgy rather than well delineated.

Lasers can be used to treat blue nevi, but caution is advised, Dr. Lui said.

Dr. Lui said that he had no relevant financial disclosures.

NEW ORLEANS - Serial screening of patients at high risk for melanoma is effective for detecting lesions, and appears to have prevented the development of aggressive advanced nodular melanoma.

For the past 19 years, Dr. Ronald N. Shore has been conducting serial screening on patients at high risk for melanoma, as many as 1,100 patients per year. He reported finding no metastases, recurrences, or deaths during this time period.

In addition, only one of his patients developed nodular melanoma, a phenomenon that Dr. Shore, who is in private practice in Rockville, Md., attributes to serial screening. The one patient who developed nodular melanoma failed to return for screening for 27 months.

Dr. Shore said that he believes the total absence of nodular melanoma for the first 17 years of his program is best explained by the program's detection of previously unrecognized early melanomas that he suspects have the potential to become nodular lesions.

He presented his most recent findings at the annual meeting of the American Academy of Dermatology.

He described finding what he termed "papular erythematous melanomas," which are distinct, amelanotic, red or pink, symmetrical lesions that closely resemble some of the recently described early nodular melanomas. The lesions were distinguished by their smaller size, lack of rapid growth, and radial growth phase histopathology.

The absence of classic ABCDE features may be another reason why the lesions had not been recognized, he said.

These findings raise the possibility that these lesions are recognizable precursors of nodular melanoma, he said. If the theory proves correct, "it reveals a way we can prevent development of nodular melanoma and by doing so, save lives," he added.

Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel, a professor of dermatology and dermatologic surgery at New York University Medical Center (Cancer 1989;63:386-9), and another more recent study led by Dr. Stephen Wang of the Memorial Sloan-Kettering Cancer Center in New York (J. Am. Acad. Dermatol. 2004;50:15-20). Dr. Shore pointed out that the studies share two common features: the use of serial screening, and performance of thorough examinations by dermatologists.

Analysis of 5 years of study data showed that 10 new cases of melanoma were detected in serially screened patients. The greatest Breslow depth was 0.15 mm; the lesions were all in radial growth phase; 70% were in men aged older than 50 years; and only 10% of the lesions were detected by patients.

The latter finding is one that Dr. Shore emphasized.

"Neither random screenings nor patient self-examinations can provide anywhere near the efficacy provided by serial professional examinations in the office setting," Dr. Shore said.

"Patients are very symptom oriented," he said, but early melanomas are mostly asymptomatic. In addition, "our records clearly show that some patients – especially men over 50 – are very poor at self-examination."

The study classified high-risk patients as those with significant past sun exposure and damage, especially multiple or severe sunburns; numerous or dysplastic nevi; actinic keratoses; any skin cancer; and family history of melanoma, especially in multiple blood relatives.

His practice has implemented a recall system, in which high-risk patients get reminders for their 6-month visit and continued follow-up reminders if they do not schedule an appointment.

Dr. Shore's findings are scheduled to appear in an upcoming issue of the Journal of Drugs in Dermatology.

He said that he had no financial interests relevant to his study.

NEW ORLEANS - Serial screening of patients at high risk for melanoma is effective for detecting lesions, and appears to have prevented the development of aggressive advanced nodular melanoma.

For the past 19 years, Dr. Ronald N. Shore has been conducting serial screening on patients at high risk for melanoma, as many as 1,100 patients per year. He reported finding no metastases, recurrences, or deaths during this time period.

In addition, only one of his patients developed nodular melanoma, a phenomenon that Dr. Shore, who is in private practice in Rockville, Md., attributes to serial screening. The one patient who developed nodular melanoma failed to return for screening for 27 months.

Dr. Shore said that he believes the total absence of nodular melanoma for the first 17 years of his program is best explained by the program's detection of previously unrecognized early melanomas that he suspects have the potential to become nodular lesions.

He presented his most recent findings at the annual meeting of the American Academy of Dermatology.

He described finding what he termed "papular erythematous melanomas," which are distinct, amelanotic, red or pink, symmetrical lesions that closely resemble some of the recently described early nodular melanomas. The lesions were distinguished by their smaller size, lack of rapid growth, and radial growth phase histopathology.

The absence of classic ABCDE features may be another reason why the lesions had not been recognized, he said.

These findings raise the possibility that these lesions are recognizable precursors of nodular melanoma, he said. If the theory proves correct, "it reveals a way we can prevent development of nodular melanoma and by doing so, save lives," he added.

Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel, a professor of dermatology and dermatologic surgery at New York University Medical Center (Cancer 1989;63:386-9), and another more recent study led by Dr. Stephen Wang of the Memorial Sloan-Kettering Cancer Center in New York (J. Am. Acad. Dermatol. 2004;50:15-20). Dr. Shore pointed out that the studies share two common features: the use of serial screening, and performance of thorough examinations by dermatologists.

Analysis of 5 years of study data showed that 10 new cases of melanoma were detected in serially screened patients. The greatest Breslow depth was 0.15 mm; the lesions were all in radial growth phase; 70% were in men aged older than 50 years; and only 10% of the lesions were detected by patients.

The latter finding is one that Dr. Shore emphasized.

"Neither random screenings nor patient self-examinations can provide anywhere near the efficacy provided by serial professional examinations in the office setting," Dr. Shore said.

"Patients are very symptom oriented," he said, but early melanomas are mostly asymptomatic. In addition, "our records clearly show that some patients – especially men over 50 – are very poor at self-examination."

The study classified high-risk patients as those with significant past sun exposure and damage, especially multiple or severe sunburns; numerous or dysplastic nevi; actinic keratoses; any skin cancer; and family history of melanoma, especially in multiple blood relatives.

His practice has implemented a recall system, in which high-risk patients get reminders for their 6-month visit and continued follow-up reminders if they do not schedule an appointment.

Dr. Shore's findings are scheduled to appear in an upcoming issue of the Journal of Drugs in Dermatology.

He said that he had no financial interests relevant to his study.

NEW ORLEANS - Serial screening of patients at high risk for melanoma is effective for detecting lesions, and appears to have prevented the development of aggressive advanced nodular melanoma.

For the past 19 years, Dr. Ronald N. Shore has been conducting serial screening on patients at high risk for melanoma, as many as 1,100 patients per year. He reported finding no metastases, recurrences, or deaths during this time period.

In addition, only one of his patients developed nodular melanoma, a phenomenon that Dr. Shore, who is in private practice in Rockville, Md., attributes to serial screening. The one patient who developed nodular melanoma failed to return for screening for 27 months.

Dr. Shore said that he believes the total absence of nodular melanoma for the first 17 years of his program is best explained by the program's detection of previously unrecognized early melanomas that he suspects have the potential to become nodular lesions.

He presented his most recent findings at the annual meeting of the American Academy of Dermatology.

He described finding what he termed "papular erythematous melanomas," which are distinct, amelanotic, red or pink, symmetrical lesions that closely resemble some of the recently described early nodular melanomas. The lesions were distinguished by their smaller size, lack of rapid growth, and radial growth phase histopathology.

The absence of classic ABCDE features may be another reason why the lesions had not been recognized, he said.

These findings raise the possibility that these lesions are recognizable precursors of nodular melanoma, he said. If the theory proves correct, "it reveals a way we can prevent development of nodular melanoma and by doing so, save lives," he added.

Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel, a professor of dermatology and dermatologic surgery at New York University Medical Center (Cancer 1989;63:386-9), and another more recent study led by Dr. Stephen Wang of the Memorial Sloan-Kettering Cancer Center in New York (J. Am. Acad. Dermatol. 2004;50:15-20). Dr. Shore pointed out that the studies share two common features: the use of serial screening, and performance of thorough examinations by dermatologists.

Analysis of 5 years of study data showed that 10 new cases of melanoma were detected in serially screened patients. The greatest Breslow depth was 0.15 mm; the lesions were all in radial growth phase; 70% were in men aged older than 50 years; and only 10% of the lesions were detected by patients.

The latter finding is one that Dr. Shore emphasized.

"Neither random screenings nor patient self-examinations can provide anywhere near the efficacy provided by serial professional examinations in the office setting," Dr. Shore said.

"Patients are very symptom oriented," he said, but early melanomas are mostly asymptomatic. In addition, "our records clearly show that some patients – especially men over 50 – are very poor at self-examination."

The study classified high-risk patients as those with significant past sun exposure and damage, especially multiple or severe sunburns; numerous or dysplastic nevi; actinic keratoses; any skin cancer; and family history of melanoma, especially in multiple blood relatives.

His practice has implemented a recall system, in which high-risk patients get reminders for their 6-month visit and continued follow-up reminders if they do not schedule an appointment.

Dr. Shore's findings are scheduled to appear in an upcoming issue of the Journal of Drugs in Dermatology.

He said that he had no financial interests relevant to his study.

Companies seeking accelerated approval for oncology drugs should avoid the temptation of single-arm trials and conduct randomized trials, except for indications with small patient populations or when drug activity is high, a Food and Drug Administration advisory panel concluded Feb. 8.

A single-arm trial, which is easier and faster to conduct, should be reserved for rare circumstances, Dr. Gary Lyman of Duke University, Durham, N.C., noted during an Oncologic Drugs Advisory Committee meeting. For Dr. Silvana Martino of the Angeles Clinic and Research Institute in Santa Monica, Calif., that would be when "patients are few and the activity of the drug is considerable."

Modest effects in a single-arm trial are insufficient to justify approval, agreed Dr. Malcolm Smith of the National Cancer Institute, Rockville, Md.

The committee’s preference for randomized trials confirms the direction in which the FDA is already moving. Dr. Richard Pazdur, director of the FDA’s office of oncology drug products in Silver Spring, Md., noted that the agency is encouraging sponsors to think randomization before conducting a single-arm trial.

Marginal response rates found in single-arm trials in a refractory setting make it difficult to judge whether they are predictive of clinical benefit, he pointed out.

It’s not that a single-arm study will never be acceptable, Dr. Pazdur said, but drugs are often submitted with very small response rates and sometimes the true benefit is not known until a randomized trial assesses survival.

Committee members also supported requiring drug sponsors to conduct two postapproval confirmatory trials instead of one, and they agreed that these trials should be ongoing or at least in the final stages of development at the time of accelerated approval.

The FDA sought support for those requirements to ensure that confirmation of accelerated approval can be provided in a timely fashion. If a single trial fails to show efficacy and then a second trial is conducted, it takes too long to determine whether a drug is, in fact, beneficial, Dr. Pazdur said.

This news organization and "The Pink Sheet" are owned by Elsevier.

Companies seeking accelerated approval for oncology drugs should avoid the temptation of single-arm trials and conduct randomized trials, except for indications with small patient populations or when drug activity is high, a Food and Drug Administration advisory panel concluded Feb. 8.

A single-arm trial, which is easier and faster to conduct, should be reserved for rare circumstances, Dr. Gary Lyman of Duke University, Durham, N.C., noted during an Oncologic Drugs Advisory Committee meeting. For Dr. Silvana Martino of the Angeles Clinic and Research Institute in Santa Monica, Calif., that would be when "patients are few and the activity of the drug is considerable."

Modest effects in a single-arm trial are insufficient to justify approval, agreed Dr. Malcolm Smith of the National Cancer Institute, Rockville, Md.

The committee’s preference for randomized trials confirms the direction in which the FDA is already moving. Dr. Richard Pazdur, director of the FDA’s office of oncology drug products in Silver Spring, Md., noted that the agency is encouraging sponsors to think randomization before conducting a single-arm trial.

Marginal response rates found in single-arm trials in a refractory setting make it difficult to judge whether they are predictive of clinical benefit, he pointed out.

It’s not that a single-arm study will never be acceptable, Dr. Pazdur said, but drugs are often submitted with very small response rates and sometimes the true benefit is not known until a randomized trial assesses survival.

Committee members also supported requiring drug sponsors to conduct two postapproval confirmatory trials instead of one, and they agreed that these trials should be ongoing or at least in the final stages of development at the time of accelerated approval.

The FDA sought support for those requirements to ensure that confirmation of accelerated approval can be provided in a timely fashion. If a single trial fails to show efficacy and then a second trial is conducted, it takes too long to determine whether a drug is, in fact, beneficial, Dr. Pazdur said.

This news organization and "The Pink Sheet" are owned by Elsevier.

Companies seeking accelerated approval for oncology drugs should avoid the temptation of single-arm trials and conduct randomized trials, except for indications with small patient populations or when drug activity is high, a Food and Drug Administration advisory panel concluded Feb. 8.

A single-arm trial, which is easier and faster to conduct, should be reserved for rare circumstances, Dr. Gary Lyman of Duke University, Durham, N.C., noted during an Oncologic Drugs Advisory Committee meeting. For Dr. Silvana Martino of the Angeles Clinic and Research Institute in Santa Monica, Calif., that would be when "patients are few and the activity of the drug is considerable."

Modest effects in a single-arm trial are insufficient to justify approval, agreed Dr. Malcolm Smith of the National Cancer Institute, Rockville, Md.

The committee’s preference for randomized trials confirms the direction in which the FDA is already moving. Dr. Richard Pazdur, director of the FDA’s office of oncology drug products in Silver Spring, Md., noted that the agency is encouraging sponsors to think randomization before conducting a single-arm trial.

Marginal response rates found in single-arm trials in a refractory setting make it difficult to judge whether they are predictive of clinical benefit, he pointed out.

It’s not that a single-arm study will never be acceptable, Dr. Pazdur said, but drugs are often submitted with very small response rates and sometimes the true benefit is not known until a randomized trial assesses survival.

Committee members also supported requiring drug sponsors to conduct two postapproval confirmatory trials instead of one, and they agreed that these trials should be ongoing or at least in the final stages of development at the time of accelerated approval.

The FDA sought support for those requirements to ensure that confirmation of accelerated approval can be provided in a timely fashion. If a single trial fails to show efficacy and then a second trial is conducted, it takes too long to determine whether a drug is, in fact, beneficial, Dr. Pazdur said.

This news organization and "The Pink Sheet" are owned by Elsevier.

NEW ORLEANS - An oral inhibitor of the hedgehog pathway proved effective for the treatment and prevention of basal cell carcinomas in patients with basal cell nevus syndrome in a phase II study.

The randomized double-blind trial was halted early for ethical reasons because patients assigned to vismodegib, formerly known as GDC-0449, demonstrated a 25-fold reduction in the rate of new basal cell carcinomas (BCCs), compared with placebo-treated controls, Dr. Jean Y. Tang reported at the annual meeting of the American Academy of Dermatology.

"We're really excited by these results as dermatologists because we're sick of just chopping up these poor patients' skin, and we're excited to offer something better," said Dr. Tang of Stanford (Calif.) University.

Basal cell carcinomas are most commonly treated by surgical excision. That's a traumatic therapy for patients with the genetic disease known as basal cell nevus syndrome (BCNS) because they experience many hundreds of BCCs during their lifetime.

The phase II study involved 41 patients at three medical centers who were randomized 2:1 to vismodegib at 150 mg once daily or placebo for a planned 18 months.

At baseline, the participants collectively had 2,000 existing BCCs. During a median 8 months of follow-up before halt of the study, the patients developed 694 new BCCs. The incidence of new BCCs was 0.07 cancers per month in the vismodegib arm, compared with 1.74 per month in controls.

In addition to preventing new skin cancers, treatment with vismodegib typically began shrinking existing tumors within the first month or two. Sixty percent of biopsied tumors that appeared clinically clear showed histologic clearance.

A side benefit seen after several months of vismodegib therapy was the "remarkable" clearance of the palmar and plantar pits which are a characteristic part of BCNS, Dr. Tang observed.

"Our patients are really struck by this. They've lived with this condition all their lives and now they can comfortably shake the hands of strangers," she explained.

Side effects were mild to moderate but sufficiently frequent that the investigators believe 18 months of daily therapy is unlikely to be tolerable. As patients from the placebo arm of the halted phase II study are crossed over to vismodegib, they are being dosed on an intermittent regimen consisting of repeated cycles of 3 months on daily therapy, then 2 months off, with the aim of minimizing side effects.

Eighty-three percent of patients on vismodegib experienced taste loss, typically starting in the first month. Seventy percent reported muscle cramping, again beginning in the first month or two. Half of treated patients experienced significant hair loss which occurred months later than the other side effects. Thirty percent of vismodegib-treated subjects dropped out of the study, because of adverse events. All side effects were completely reversed 1 month after stopping therapy.

Thus far, no tumor resistance has been seen. Patients who stopped the drug after a few months have not experienced a return of tumors to baseline size or number during the next 6 months.

Vismodegib is an oral small molecule antagonist of the smoothened receptor. In binding to smoothened, the drug turns off the hedgehog-signaling pathway, which is inappropriately activated in patients with BCNS, leading to tumor cell growth and proliferation.

Dr. Tang and coworkers became interested in evaluating vismodegib in patients with BCNS after other investigators reported the drug to be effective in a study involving 33 non-BCNS patients with locally aggressive or metastatic BCCs (N. Engl. J. Med. 2009;361:1164-72).

Remaining questions involving treatment of BCNS patients include the best vismodegib dosing regimen, and whether the tumors will eventually come back after the drug is stopped, she noted.

Dr. Tang is considering conducting a study of vismodegib in non-BCNS patients with a large BCC burden. One audience member suggested including patients with post–radiation therapy BCCs. "I have postradiation patients with 400 BCCs," he said.

Another audience member, a dermatologist involved in the BCNS Network, commented that the buzz circulating among members of the patient support group is focused mainly on the improvement in quality of life resulting from vismodegib therapy.

Dr. Tang agreed. "The patients say that this medication has completely changed their lives," she said. "These patients have terrible phobias after undergoing tons and tons of biopsies and surgeries, so they're really incredibly grateful for this drug. Obviously there are some side effects, but I think the positive effects of this drug on quality of life cannot be adequately quantitated."

The investigator-initiated phase II study was sponsored by Genentech. Dr. Tang reporting having no commercial financial relationships.

NEW ORLEANS - An oral inhibitor of the hedgehog pathway proved effective for the treatment and prevention of basal cell carcinomas in patients with basal cell nevus syndrome in a phase II study.

The randomized double-blind trial was halted early for ethical reasons because patients assigned to vismodegib, formerly known as GDC-0449, demonstrated a 25-fold reduction in the rate of new basal cell carcinomas (BCCs), compared with placebo-treated controls, Dr. Jean Y. Tang reported at the annual meeting of the American Academy of Dermatology.

"We're really excited by these results as dermatologists because we're sick of just chopping up these poor patients' skin, and we're excited to offer something better," said Dr. Tang of Stanford (Calif.) University.

Basal cell carcinomas are most commonly treated by surgical excision. That's a traumatic therapy for patients with the genetic disease known as basal cell nevus syndrome (BCNS) because they experience many hundreds of BCCs during their lifetime.

The phase II study involved 41 patients at three medical centers who were randomized 2:1 to vismodegib at 150 mg once daily or placebo for a planned 18 months.

At baseline, the participants collectively had 2,000 existing BCCs. During a median 8 months of follow-up before halt of the study, the patients developed 694 new BCCs. The incidence of new BCCs was 0.07 cancers per month in the vismodegib arm, compared with 1.74 per month in controls.

In addition to preventing new skin cancers, treatment with vismodegib typically began shrinking existing tumors within the first month or two. Sixty percent of biopsied tumors that appeared clinically clear showed histologic clearance.

A side benefit seen after several months of vismodegib therapy was the "remarkable" clearance of the palmar and plantar pits which are a characteristic part of BCNS, Dr. Tang observed.

"Our patients are really struck by this. They've lived with this condition all their lives and now they can comfortably shake the hands of strangers," she explained.

Side effects were mild to moderate but sufficiently frequent that the investigators believe 18 months of daily therapy is unlikely to be tolerable. As patients from the placebo arm of the halted phase II study are crossed over to vismodegib, they are being dosed on an intermittent regimen consisting of repeated cycles of 3 months on daily therapy, then 2 months off, with the aim of minimizing side effects.

Eighty-three percent of patients on vismodegib experienced taste loss, typically starting in the first month. Seventy percent reported muscle cramping, again beginning in the first month or two. Half of treated patients experienced significant hair loss which occurred months later than the other side effects. Thirty percent of vismodegib-treated subjects dropped out of the study, because of adverse events. All side effects were completely reversed 1 month after stopping therapy.

Thus far, no tumor resistance has been seen. Patients who stopped the drug after a few months have not experienced a return of tumors to baseline size or number during the next 6 months.

Vismodegib is an oral small molecule antagonist of the smoothened receptor. In binding to smoothened, the drug turns off the hedgehog-signaling pathway, which is inappropriately activated in patients with BCNS, leading to tumor cell growth and proliferation.

Dr. Tang and coworkers became interested in evaluating vismodegib in patients with BCNS after other investigators reported the drug to be effective in a study involving 33 non-BCNS patients with locally aggressive or metastatic BCCs (N. Engl. J. Med. 2009;361:1164-72).

Remaining questions involving treatment of BCNS patients include the best vismodegib dosing regimen, and whether the tumors will eventually come back after the drug is stopped, she noted.

Dr. Tang is considering conducting a study of vismodegib in non-BCNS patients with a large BCC burden. One audience member suggested including patients with post–radiation therapy BCCs. "I have postradiation patients with 400 BCCs," he said.

Another audience member, a dermatologist involved in the BCNS Network, commented that the buzz circulating among members of the patient support group is focused mainly on the improvement in quality of life resulting from vismodegib therapy.

Dr. Tang agreed. "The patients say that this medication has completely changed their lives," she said. "These patients have terrible phobias after undergoing tons and tons of biopsies and surgeries, so they're really incredibly grateful for this drug. Obviously there are some side effects, but I think the positive effects of this drug on quality of life cannot be adequately quantitated."

The investigator-initiated phase II study was sponsored by Genentech. Dr. Tang reporting having no commercial financial relationships.

NEW ORLEANS - An oral inhibitor of the hedgehog pathway proved effective for the treatment and prevention of basal cell carcinomas in patients with basal cell nevus syndrome in a phase II study.

The randomized double-blind trial was halted early for ethical reasons because patients assigned to vismodegib, formerly known as GDC-0449, demonstrated a 25-fold reduction in the rate of new basal cell carcinomas (BCCs), compared with placebo-treated controls, Dr. Jean Y. Tang reported at the annual meeting of the American Academy of Dermatology.

"We're really excited by these results as dermatologists because we're sick of just chopping up these poor patients' skin, and we're excited to offer something better," said Dr. Tang of Stanford (Calif.) University.

Basal cell carcinomas are most commonly treated by surgical excision. That's a traumatic therapy for patients with the genetic disease known as basal cell nevus syndrome (BCNS) because they experience many hundreds of BCCs during their lifetime.

The phase II study involved 41 patients at three medical centers who were randomized 2:1 to vismodegib at 150 mg once daily or placebo for a planned 18 months.

At baseline, the participants collectively had 2,000 existing BCCs. During a median 8 months of follow-up before halt of the study, the patients developed 694 new BCCs. The incidence of new BCCs was 0.07 cancers per month in the vismodegib arm, compared with 1.74 per month in controls.

In addition to preventing new skin cancers, treatment with vismodegib typically began shrinking existing tumors within the first month or two. Sixty percent of biopsied tumors that appeared clinically clear showed histologic clearance.

A side benefit seen after several months of vismodegib therapy was the "remarkable" clearance of the palmar and plantar pits which are a characteristic part of BCNS, Dr. Tang observed.

"Our patients are really struck by this. They've lived with this condition all their lives and now they can comfortably shake the hands of strangers," she explained.

Side effects were mild to moderate but sufficiently frequent that the investigators believe 18 months of daily therapy is unlikely to be tolerable. As patients from the placebo arm of the halted phase II study are crossed over to vismodegib, they are being dosed on an intermittent regimen consisting of repeated cycles of 3 months on daily therapy, then 2 months off, with the aim of minimizing side effects.

Eighty-three percent of patients on vismodegib experienced taste loss, typically starting in the first month. Seventy percent reported muscle cramping, again beginning in the first month or two. Half of treated patients experienced significant hair loss which occurred months later than the other side effects. Thirty percent of vismodegib-treated subjects dropped out of the study, because of adverse events. All side effects were completely reversed 1 month after stopping therapy.

Thus far, no tumor resistance has been seen. Patients who stopped the drug after a few months have not experienced a return of tumors to baseline size or number during the next 6 months.

Vismodegib is an oral small molecule antagonist of the smoothened receptor. In binding to smoothened, the drug turns off the hedgehog-signaling pathway, which is inappropriately activated in patients with BCNS, leading to tumor cell growth and proliferation.

Dr. Tang and coworkers became interested in evaluating vismodegib in patients with BCNS after other investigators reported the drug to be effective in a study involving 33 non-BCNS patients with locally aggressive or metastatic BCCs (N. Engl. J. Med. 2009;361:1164-72).

Remaining questions involving treatment of BCNS patients include the best vismodegib dosing regimen, and whether the tumors will eventually come back after the drug is stopped, she noted.

Dr. Tang is considering conducting a study of vismodegib in non-BCNS patients with a large BCC burden. One audience member suggested including patients with post–radiation therapy BCCs. "I have postradiation patients with 400 BCCs," he said.

Another audience member, a dermatologist involved in the BCNS Network, commented that the buzz circulating among members of the patient support group is focused mainly on the improvement in quality of life resulting from vismodegib therapy.

Dr. Tang agreed. "The patients say that this medication has completely changed their lives," she said. "These patients have terrible phobias after undergoing tons and tons of biopsies and surgeries, so they're really incredibly grateful for this drug. Obviously there are some side effects, but I think the positive effects of this drug on quality of life cannot be adequately quantitated."

The investigator-initiated phase II study was sponsored by Genentech. Dr. Tang reporting having no commercial financial relationships.