Melanoma

Chen et al (N Engl J Med. 2015;373:1618-1626) performed a multicenter, phase 3, double-blind, randomized, placebo-controlled trial. Results demonstrated that nicotinamide effectively decreased the rates of new nonmelanoma skin cancers (NMSCs) and actinic keratoses (AKs) in high-risk patients who had at least 2 histologically confirmed NMSCs in the last 5 years. In comparison to participants who received placebo, individuals who received nicotinamide 500 mg twice daily during the 12-month study (branded with a predictive acronym ONTRAC [oral nicotinamide to reduce actinic cancer]) had reduced rates of AKs of up to 20%, basal cell carcinomas of 20%, squamous cell carcinomas of 30%, and NMSCs of 23%. However, the effect of nicotinamide on NMSCs was not maintained at evaluation 6 months after discontinuation; the number of basal cell carcinomas was similar, and the number of squamous cell carcinomas was greater in participants who received nicotinamide in comparison to individuals who received placebo.

What’s the issue?

The risk for skin cancer is increased by UV radiation that damages DNA, suppresses cutaneous immunity, and inhibits DNA repair by depleting cellular adenosine triphosphate. Nicotinamide, an amide form of vitamin B₃, has been demonstrated to not only reduce UV radiation–induced immunosuppression but also to prevent UV radiation–induced adenosine triphosphate depletion and glycolic blockade. Nicotinamide, which is classified as a food additive, also has neuroprotective and antioxidant functions and reduces pigmentation, wrinkles, and sebum production. Although oral nicotinamide has been demonstrated to reduce NMSCs and AKs, topical application has been shown to improve many skin conditions such as acne, atopic dermatitis, isoniazid-induced pellagra, and rosacea.

In contrast to nicotinic acid (niacin), nicotinamide is not associated with headaches, hypotension, flushing, itching, or vasodilatation. At high oral doses, side effects of nicotinamide that have been hypothesized or observed in animals, humans, or both have included the development of Parkinson disease, insulin sensitivity and diabetes mellitus, and liver toxicity. Although there are no reports in humans of growth retardation, teratogenicity, or oncogenicity, Rolfe (J Cosmet Dermatol. 2014;13:324-328) discussed that fetal blood levels of nicotinamide are greater than corresponding maternal blood levels because it is able to cross the placenta. However, according to Chen et al, no clinically significant between-group differences were found with respect to the number or types of adverse events that occurred in the placebo participants and the individuals who received 1000 mg daily of nicotinamide. Chen et al implied that there were additional benefits in the recipients of nicotinamide with regards to cognitive function and transepidermal water loss.

Perhaps all patients with a history of AKs, basal cell carcinomas, or squamous cell carcinomas should receive lifelong nicotinamide. Also, it might be reasonable to consider that all individuals older than 18 years who are not pregnant or breastfeeding with increased sun exposure but no history of AKs or NMSC add nicotinamide to their daily diets as a proactive measure for chemoprevention. Would you suggest nicotinamide to your patients?

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

Chen et al (N Engl J Med. 2015;373:1618-1626) performed a multicenter, phase 3, double-blind, randomized, placebo-controlled trial. Results demonstrated that nicotinamide effectively decreased the rates of new nonmelanoma skin cancers (NMSCs) and actinic keratoses (AKs) in high-risk patients who had at least 2 histologically confirmed NMSCs in the last 5 years. In comparison to participants who received placebo, individuals who received nicotinamide 500 mg twice daily during the 12-month study (branded with a predictive acronym ONTRAC [oral nicotinamide to reduce actinic cancer]) had reduced rates of AKs of up to 20%, basal cell carcinomas of 20%, squamous cell carcinomas of 30%, and NMSCs of 23%. However, the effect of nicotinamide on NMSCs was not maintained at evaluation 6 months after discontinuation; the number of basal cell carcinomas was similar, and the number of squamous cell carcinomas was greater in participants who received nicotinamide in comparison to individuals who received placebo.

What’s the issue?

The risk for skin cancer is increased by UV radiation that damages DNA, suppresses cutaneous immunity, and inhibits DNA repair by depleting cellular adenosine triphosphate. Nicotinamide, an amide form of vitamin B₃, has been demonstrated to not only reduce UV radiation–induced immunosuppression but also to prevent UV radiation–induced adenosine triphosphate depletion and glycolic blockade. Nicotinamide, which is classified as a food additive, also has neuroprotective and antioxidant functions and reduces pigmentation, wrinkles, and sebum production. Although oral nicotinamide has been demonstrated to reduce NMSCs and AKs, topical application has been shown to improve many skin conditions such as acne, atopic dermatitis, isoniazid-induced pellagra, and rosacea.

In contrast to nicotinic acid (niacin), nicotinamide is not associated with headaches, hypotension, flushing, itching, or vasodilatation. At high oral doses, side effects of nicotinamide that have been hypothesized or observed in animals, humans, or both have included the development of Parkinson disease, insulin sensitivity and diabetes mellitus, and liver toxicity. Although there are no reports in humans of growth retardation, teratogenicity, or oncogenicity, Rolfe (J Cosmet Dermatol. 2014;13:324-328) discussed that fetal blood levels of nicotinamide are greater than corresponding maternal blood levels because it is able to cross the placenta. However, according to Chen et al, no clinically significant between-group differences were found with respect to the number or types of adverse events that occurred in the placebo participants and the individuals who received 1000 mg daily of nicotinamide. Chen et al implied that there were additional benefits in the recipients of nicotinamide with regards to cognitive function and transepidermal water loss.

Perhaps all patients with a history of AKs, basal cell carcinomas, or squamous cell carcinomas should receive lifelong nicotinamide. Also, it might be reasonable to consider that all individuals older than 18 years who are not pregnant or breastfeeding with increased sun exposure but no history of AKs or NMSC add nicotinamide to their daily diets as a proactive measure for chemoprevention. Would you suggest nicotinamide to your patients?

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

Chen et al (N Engl J Med. 2015;373:1618-1626) performed a multicenter, phase 3, double-blind, randomized, placebo-controlled trial. Results demonstrated that nicotinamide effectively decreased the rates of new nonmelanoma skin cancers (NMSCs) and actinic keratoses (AKs) in high-risk patients who had at least 2 histologically confirmed NMSCs in the last 5 years. In comparison to participants who received placebo, individuals who received nicotinamide 500 mg twice daily during the 12-month study (branded with a predictive acronym ONTRAC [oral nicotinamide to reduce actinic cancer]) had reduced rates of AKs of up to 20%, basal cell carcinomas of 20%, squamous cell carcinomas of 30%, and NMSCs of 23%. However, the effect of nicotinamide on NMSCs was not maintained at evaluation 6 months after discontinuation; the number of basal cell carcinomas was similar, and the number of squamous cell carcinomas was greater in participants who received nicotinamide in comparison to individuals who received placebo.

What’s the issue?

The risk for skin cancer is increased by UV radiation that damages DNA, suppresses cutaneous immunity, and inhibits DNA repair by depleting cellular adenosine triphosphate. Nicotinamide, an amide form of vitamin B₃, has been demonstrated to not only reduce UV radiation–induced immunosuppression but also to prevent UV radiation–induced adenosine triphosphate depletion and glycolic blockade. Nicotinamide, which is classified as a food additive, also has neuroprotective and antioxidant functions and reduces pigmentation, wrinkles, and sebum production. Although oral nicotinamide has been demonstrated to reduce NMSCs and AKs, topical application has been shown to improve many skin conditions such as acne, atopic dermatitis, isoniazid-induced pellagra, and rosacea.

In contrast to nicotinic acid (niacin), nicotinamide is not associated with headaches, hypotension, flushing, itching, or vasodilatation. At high oral doses, side effects of nicotinamide that have been hypothesized or observed in animals, humans, or both have included the development of Parkinson disease, insulin sensitivity and diabetes mellitus, and liver toxicity. Although there are no reports in humans of growth retardation, teratogenicity, or oncogenicity, Rolfe (J Cosmet Dermatol. 2014;13:324-328) discussed that fetal blood levels of nicotinamide are greater than corresponding maternal blood levels because it is able to cross the placenta. However, according to Chen et al, no clinically significant between-group differences were found with respect to the number or types of adverse events that occurred in the placebo participants and the individuals who received 1000 mg daily of nicotinamide. Chen et al implied that there were additional benefits in the recipients of nicotinamide with regards to cognitive function and transepidermal water loss.

Perhaps all patients with a history of AKs, basal cell carcinomas, or squamous cell carcinomas should receive lifelong nicotinamide. Also, it might be reasonable to consider that all individuals older than 18 years who are not pregnant or breastfeeding with increased sun exposure but no history of AKs or NMSC add nicotinamide to their daily diets as a proactive measure for chemoprevention. Would you suggest nicotinamide to your patients?

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

The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

WAIKOLOA, HAWAII – The familiar oral triazole antifungal agent itraconazole (Sporanox) is under active investigation for an unexpected use: as adjunctive therapy in patients with locally advanced or metastatic basal cell carcinoma.

“The promise of this drug is that the use of itraconazole with vismodegib or sonidegib may actually enhance the effectiveness of those drugs and also reduce the frequency of grade 2 toxicities by perhaps allowing a lower dose of vismodegib or sonidegib,” Dr. David L. Swanson said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

“Be looking for this drug that we use to treat toenail fungus as a potential drug for locally advanced or metastatic basal cell carcinoma,” advised Dr. Swanson, a dermatologist at the Mayo Clinic in Scottsdale, Ariz.

Vismodegib (Erivedge) has been a game changer for patients with inoperable locally advanced or metastatic breast cancer. “The response to this drug was amazing,” Dr. Swanson said of the landmark study which led to its approval in 2012 (N Engl J Med. 2012; 366[23]:2171-9).

Sonidegib (Odomzo), which like vismodegib inhibits the essential Hedgehog signaling pathway component known as Smoothened, was approved by the Food and Drug Administration in 2015 as the second oral drug in this novel class.

While the clinical benefits of these two drugs in patients with the most horrific basal cell carcinomas are extremely impressive, vismodegib and sonidegib have two major drawbacks: The tumors eventually develop resistance and commence growing again, and onerous grade 2 side effects requiring dose reduction are extremely common. The most frequent of these limiting side effects are a disturbed sense of taste, muscle spasms, alopecia, and weight loss.

The hope is that itraconazole may be of help with both issues, according to Dr. Swanson. It turns out that the antifungal agent is also an inhibitor of the Hedgehog pathway, and via a different mechanism than that of vismodegib and sonidegib.

He pointed to an international open-label exploratory phase II study led by Dr. Jean Y. Tang of Stanford (Calif.) University. The investigators treated 19 patients with a total of 90 basal cell carcinomas with oral itraconazole at 200 mg twice a day for 1 month or 100 mg twice a day for an average of 2.3 months.

The treatment reduced Hedgehog signaling pathway activity by 65%, Ki67 tumor cell proliferation by 45%, and tumor area by 24% (J Clin Oncol. 2014 Mar 10;32[8]:745-51).

These results aren’t as dramatic as what’s achieved using vismodegib or sonidegib. As stand-alone therapy, itraconazole doesn’t compare with those agents. However, the hope is that when itraconazole is prescribed in conjunction with vismodegib or sonidegib it will permit the latter drugs to be used at lower doses with no drop-off in efficacy, which would mean less grade 2 toxicity. Moreover, since itraconazole inhibits Hedgehog signaling through a mechanism that is different from that of the more potent agents, combination therapy might delay onset of tumor resistance, Dr. Swanson explained.

He reported having no financial conflicts of interest regarding his presentation.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The familiar oral triazole antifungal agent itraconazole (Sporanox) is under active investigation for an unexpected use: as adjunctive therapy in patients with locally advanced or metastatic basal cell carcinoma.

“The promise of this drug is that the use of itraconazole with vismodegib or sonidegib may actually enhance the effectiveness of those drugs and also reduce the frequency of grade 2 toxicities by perhaps allowing a lower dose of vismodegib or sonidegib,” Dr. David L. Swanson said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

“Be looking for this drug that we use to treat toenail fungus as a potential drug for locally advanced or metastatic basal cell carcinoma,” advised Dr. Swanson, a dermatologist at the Mayo Clinic in Scottsdale, Ariz.

Vismodegib (Erivedge) has been a game changer for patients with inoperable locally advanced or metastatic breast cancer. “The response to this drug was amazing,” Dr. Swanson said of the landmark study which led to its approval in 2012 (N Engl J Med. 2012; 366[23]:2171-9).

Sonidegib (Odomzo), which like vismodegib inhibits the essential Hedgehog signaling pathway component known as Smoothened, was approved by the Food and Drug Administration in 2015 as the second oral drug in this novel class.

While the clinical benefits of these two drugs in patients with the most horrific basal cell carcinomas are extremely impressive, vismodegib and sonidegib have two major drawbacks: The tumors eventually develop resistance and commence growing again, and onerous grade 2 side effects requiring dose reduction are extremely common. The most frequent of these limiting side effects are a disturbed sense of taste, muscle spasms, alopecia, and weight loss.

The hope is that itraconazole may be of help with both issues, according to Dr. Swanson. It turns out that the antifungal agent is also an inhibitor of the Hedgehog pathway, and via a different mechanism than that of vismodegib and sonidegib.

He pointed to an international open-label exploratory phase II study led by Dr. Jean Y. Tang of Stanford (Calif.) University. The investigators treated 19 patients with a total of 90 basal cell carcinomas with oral itraconazole at 200 mg twice a day for 1 month or 100 mg twice a day for an average of 2.3 months.

The treatment reduced Hedgehog signaling pathway activity by 65%, Ki67 tumor cell proliferation by 45%, and tumor area by 24% (J Clin Oncol. 2014 Mar 10;32[8]:745-51).

These results aren’t as dramatic as what’s achieved using vismodegib or sonidegib. As stand-alone therapy, itraconazole doesn’t compare with those agents. However, the hope is that when itraconazole is prescribed in conjunction with vismodegib or sonidegib it will permit the latter drugs to be used at lower doses with no drop-off in efficacy, which would mean less grade 2 toxicity. Moreover, since itraconazole inhibits Hedgehog signaling through a mechanism that is different from that of the more potent agents, combination therapy might delay onset of tumor resistance, Dr. Swanson explained.

He reported having no financial conflicts of interest regarding his presentation.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The familiar oral triazole antifungal agent itraconazole (Sporanox) is under active investigation for an unexpected use: as adjunctive therapy in patients with locally advanced or metastatic basal cell carcinoma.

“The promise of this drug is that the use of itraconazole with vismodegib or sonidegib may actually enhance the effectiveness of those drugs and also reduce the frequency of grade 2 toxicities by perhaps allowing a lower dose of vismodegib or sonidegib,” Dr. David L. Swanson said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

“Be looking for this drug that we use to treat toenail fungus as a potential drug for locally advanced or metastatic basal cell carcinoma,” advised Dr. Swanson, a dermatologist at the Mayo Clinic in Scottsdale, Ariz.

Vismodegib (Erivedge) has been a game changer for patients with inoperable locally advanced or metastatic breast cancer. “The response to this drug was amazing,” Dr. Swanson said of the landmark study which led to its approval in 2012 (N Engl J Med. 2012; 366[23]:2171-9).

Sonidegib (Odomzo), which like vismodegib inhibits the essential Hedgehog signaling pathway component known as Smoothened, was approved by the Food and Drug Administration in 2015 as the second oral drug in this novel class.

While the clinical benefits of these two drugs in patients with the most horrific basal cell carcinomas are extremely impressive, vismodegib and sonidegib have two major drawbacks: The tumors eventually develop resistance and commence growing again, and onerous grade 2 side effects requiring dose reduction are extremely common. The most frequent of these limiting side effects are a disturbed sense of taste, muscle spasms, alopecia, and weight loss.

The hope is that itraconazole may be of help with both issues, according to Dr. Swanson. It turns out that the antifungal agent is also an inhibitor of the Hedgehog pathway, and via a different mechanism than that of vismodegib and sonidegib.

He pointed to an international open-label exploratory phase II study led by Dr. Jean Y. Tang of Stanford (Calif.) University. The investigators treated 19 patients with a total of 90 basal cell carcinomas with oral itraconazole at 200 mg twice a day for 1 month or 100 mg twice a day for an average of 2.3 months.

The treatment reduced Hedgehog signaling pathway activity by 65%, Ki67 tumor cell proliferation by 45%, and tumor area by 24% (J Clin Oncol. 2014 Mar 10;32[8]:745-51).

These results aren’t as dramatic as what’s achieved using vismodegib or sonidegib. As stand-alone therapy, itraconazole doesn’t compare with those agents. However, the hope is that when itraconazole is prescribed in conjunction with vismodegib or sonidegib it will permit the latter drugs to be used at lower doses with no drop-off in efficacy, which would mean less grade 2 toxicity. Moreover, since itraconazole inhibits Hedgehog signaling through a mechanism that is different from that of the more potent agents, combination therapy might delay onset of tumor resistance, Dr. Swanson explained.

He reported having no financial conflicts of interest regarding his presentation.

SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

emechcatie@frontlinemedcom.com

Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.

Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.

Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.

Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.

Courtesy Wikimedia Commons/Nephron/Creative Commons

Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).

Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.

The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.

The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.

Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.

Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.

Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.

Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.

Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.

Courtesy Wikimedia Commons/Nephron/Creative Commons

Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).

Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.

The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.

The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.

Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.

Progression-free survival was significantly better when patients with relapsed or refractory mantle-cell lymphoma were treated with oral ibrutinib than with intravenous temsirolimus, based on results from 280 patients in an international, randomized, open-label phase III trial.

Study subjects had undergone one or more previous rituximab-containing chemotherapy regimens to receive intravenous temsirolimus or oral ibrutinib at a daily dose of 560 mg.

Compared with temsirolimus, ibrutinib resulted in a 57% reduction in the risk of disease progression or death at a median follow-up of 20 months. Median progression-free survival – the trial’s primary endpoint – was 14.6 months for the ibrutinib group and 6.2 months for the temsirolimus group.

Ibrutinib was also better tolerated, with 68% of patients having grade 3 or higher treatment-emergent adverse events as compared to 87% of patients in the temsirolimus group, despite a median 4-fold longer treatment duration for the ibrutinib group than the temsirolimus group. Additionally, 6% of patients discontinued ibrutinib because of adverse events versus 26% in the temsirolimus group, reported Dr. Martin Dreyling of Klinikum der Universität in Munich, Germany, and his associates.

Courtesy Wikimedia Commons/Nephron/Creative Commons

Based on results of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, ibrutinib was associated with greater and more rapid improvements, and also with less worsening in lymphoma symptoms, as measured by the lymphoma subscale of the FACT-Lym (Lancet. 2016;387:770-78).

Ibrutinib, a first-in-class oral inhibitor of Bruton’s tyrosine kinase, is approved in the United States and the European Union at a dose of 560 mg per day for patients with mantle cell lymphoma who have received at least one previous line of therapy.

The mammalian target of rapamycin (mTOR) inhibitor temsirolimus is approved in the European Union for relapsed or refractory mantle-cell lymphoma, but does not have FDA approval for this indication.

The study, funded by Janssen, is ongoing. Future research, the investigators say, should examine ibrutinib-based combination approaches for patients with relapsed or refractory mantle-cell lymphoma and in front-line therapy.

Dr. Dreyling reported grants and personal fees from Janssen and Pfizer outside of the study. Several other authors reported grants from Janssen during the study and financial ties to the company.

Cosentyx

Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.

Emverm

Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.

Opdivo + Yervoy Regimen

The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.

TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion

Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.

Cosentyx

Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.

Emverm

Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.

Opdivo + Yervoy Regimen

The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.

TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion

Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.

Cosentyx

Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.

Emverm

Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.

Keytruda

Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.

Opdivo + Yervoy Regimen

The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.

TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion

Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.

If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.