Kari Oakes

LAS VEGAS – Tinea pedis plagues millions of patients yearly, and treatment is lengthy, cumbersome, and often ineffective.

But two potent new antifungals promise an easier treatment regimen and a higher rate of successful treatment outcomes, according to Dr. David M. Pariser, who shared data about luliconazole and a new formulation of naftifine as topical treatments for tinea infections, at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, pointed out that most antifungals currently approved for tinea pedis require at least daily – and sometimes twice daily – application for at least 4 weeks. Terbinafine and tolnaftate are the exceptions, with treatment periods ranging from 1-6 weeks for the two products, depending on clinical response.

A new formulation of naftifine hydrochloride 2%, (Naftin), a potent prescription topical allylamine antifungal available as a cream or a gel, has shown equivalent efficacy with just two weeks of treatment. Naftifine has lipophilic and keratinophilic properties; further, it has clinically significant anti-inflammatory and antibacterial effects, in addition to its potent fungicidal and fungistatic effects against dermatophytes, Dr. Pariser said at the meeting. The preparations are currently approved for topical treatment of tinea pedis, tinea cruris, and tinea corporis.

Notably, naftifine maintains a “clinically relevant therapeutic reservoir effect after treatment completion, with naftifine detected in the stratum corneum for up to 4 weeks posttreatment,” he said. This reservoir effect permits a significantly easier treatment regimen, with topical application of either formulation daily for just 2 weeks.

The clinical trials of naftifine HCl 2% with daily administration for 2 weeks showed equivalence with the 1% formulation administered for 4 weeks; the higher concentration was well tolerated and was effective in both the moccasin and interdigital distributions of tinea pedis involvement. Trials also showed the mycologic and clinical cure rates of naftifine 2% to be equivalent or superior to those of terbinafine, econazole, clotrimazole, miconazole, and tolnaftate.

Clinical trials showed treatment effectiveness – defined as 90% improvement over baseline and achieving “essentially normal skin” – in 52% of patients receiving naftifine 2%, compared with 20% of patients receiving vehicle only. Overall clinical success – defined as mycologic cure and either clinical cure of effective clinical treatment – was seen in 78% of the naftifine 2% patients, compared with 49% of the vehicle patients.

The second antifungal Dr. Pariser discussed is luliconazole (Luzu), a prescription topical imidazole that is available as a 1% cream. Luliconazole is also a broad-spectrum, potent antifungal with effects that persist several weeks after treatment. The preparation is at least as effective as bifonazole, terbinafine, and lanoconazole, both in vitro and in vivo, Dr. Pariser said.

In two parallel clinical trials comparing luliconazole 1% cream to its vehicle, treatment was effective (at least 90% clearing and with normal-appearing skin) in 48% and 33% of patients receiving luliconazole, compared with 10% and 15% of patients receiving vehicle alone.

An advantage of the topical agents is that there are generally no major systemic side effects, since there is minimal systemic absorption, Dr. Pariser noted. Allergic contact dermatitis may be a local reaction, but tends to be mild and transient, he said.

Clinicians should always be alert for tinea pedis when treating onychomycosis, said Dr. Pariser, and untreated tinea can contribute to recurrence of nail fungus. “If you don’t look for tinea, you might not find it, and you’ve missed a treatment opportunity,” he said.

Dr. Pariser disclosed that he is an investigator and consultant for Valeant and an investigator for Anacor Pharmaceuticals.

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

[email protected]

On Twitter @karioakes

LAS VEGAS – Tinea pedis plagues millions of patients yearly, and treatment is lengthy, cumbersome, and often ineffective.

But two potent new antifungals promise an easier treatment regimen and a higher rate of successful treatment outcomes, according to Dr. David M. Pariser, who shared data about luliconazole and a new formulation of naftifine as topical treatments for tinea infections, at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, pointed out that most antifungals currently approved for tinea pedis require at least daily – and sometimes twice daily – application for at least 4 weeks. Terbinafine and tolnaftate are the exceptions, with treatment periods ranging from 1-6 weeks for the two products, depending on clinical response.

A new formulation of naftifine hydrochloride 2%, (Naftin), a potent prescription topical allylamine antifungal available as a cream or a gel, has shown equivalent efficacy with just two weeks of treatment. Naftifine has lipophilic and keratinophilic properties; further, it has clinically significant anti-inflammatory and antibacterial effects, in addition to its potent fungicidal and fungistatic effects against dermatophytes, Dr. Pariser said at the meeting. The preparations are currently approved for topical treatment of tinea pedis, tinea cruris, and tinea corporis.

Notably, naftifine maintains a “clinically relevant therapeutic reservoir effect after treatment completion, with naftifine detected in the stratum corneum for up to 4 weeks posttreatment,” he said. This reservoir effect permits a significantly easier treatment regimen, with topical application of either formulation daily for just 2 weeks.

The clinical trials of naftifine HCl 2% with daily administration for 2 weeks showed equivalence with the 1% formulation administered for 4 weeks; the higher concentration was well tolerated and was effective in both the moccasin and interdigital distributions of tinea pedis involvement. Trials also showed the mycologic and clinical cure rates of naftifine 2% to be equivalent or superior to those of terbinafine, econazole, clotrimazole, miconazole, and tolnaftate.

Clinical trials showed treatment effectiveness – defined as 90% improvement over baseline and achieving “essentially normal skin” – in 52% of patients receiving naftifine 2%, compared with 20% of patients receiving vehicle only. Overall clinical success – defined as mycologic cure and either clinical cure of effective clinical treatment – was seen in 78% of the naftifine 2% patients, compared with 49% of the vehicle patients.

The second antifungal Dr. Pariser discussed is luliconazole (Luzu), a prescription topical imidazole that is available as a 1% cream. Luliconazole is also a broad-spectrum, potent antifungal with effects that persist several weeks after treatment. The preparation is at least as effective as bifonazole, terbinafine, and lanoconazole, both in vitro and in vivo, Dr. Pariser said.

In two parallel clinical trials comparing luliconazole 1% cream to its vehicle, treatment was effective (at least 90% clearing and with normal-appearing skin) in 48% and 33% of patients receiving luliconazole, compared with 10% and 15% of patients receiving vehicle alone.

An advantage of the topical agents is that there are generally no major systemic side effects, since there is minimal systemic absorption, Dr. Pariser noted. Allergic contact dermatitis may be a local reaction, but tends to be mild and transient, he said.

Clinicians should always be alert for tinea pedis when treating onychomycosis, said Dr. Pariser, and untreated tinea can contribute to recurrence of nail fungus. “If you don’t look for tinea, you might not find it, and you’ve missed a treatment opportunity,” he said.

Dr. Pariser disclosed that he is an investigator and consultant for Valeant and an investigator for Anacor Pharmaceuticals.

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

[email protected]

On Twitter @karioakes

LAS VEGAS – Tinea pedis plagues millions of patients yearly, and treatment is lengthy, cumbersome, and often ineffective.

But two potent new antifungals promise an easier treatment regimen and a higher rate of successful treatment outcomes, according to Dr. David M. Pariser, who shared data about luliconazole and a new formulation of naftifine as topical treatments for tinea infections, at the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar.

Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, pointed out that most antifungals currently approved for tinea pedis require at least daily – and sometimes twice daily – application for at least 4 weeks. Terbinafine and tolnaftate are the exceptions, with treatment periods ranging from 1-6 weeks for the two products, depending on clinical response.

A new formulation of naftifine hydrochloride 2%, (Naftin), a potent prescription topical allylamine antifungal available as a cream or a gel, has shown equivalent efficacy with just two weeks of treatment. Naftifine has lipophilic and keratinophilic properties; further, it has clinically significant anti-inflammatory and antibacterial effects, in addition to its potent fungicidal and fungistatic effects against dermatophytes, Dr. Pariser said at the meeting. The preparations are currently approved for topical treatment of tinea pedis, tinea cruris, and tinea corporis.

Notably, naftifine maintains a “clinically relevant therapeutic reservoir effect after treatment completion, with naftifine detected in the stratum corneum for up to 4 weeks posttreatment,” he said. This reservoir effect permits a significantly easier treatment regimen, with topical application of either formulation daily for just 2 weeks.

The clinical trials of naftifine HCl 2% with daily administration for 2 weeks showed equivalence with the 1% formulation administered for 4 weeks; the higher concentration was well tolerated and was effective in both the moccasin and interdigital distributions of tinea pedis involvement. Trials also showed the mycologic and clinical cure rates of naftifine 2% to be equivalent or superior to those of terbinafine, econazole, clotrimazole, miconazole, and tolnaftate.

Clinical trials showed treatment effectiveness – defined as 90% improvement over baseline and achieving “essentially normal skin” – in 52% of patients receiving naftifine 2%, compared with 20% of patients receiving vehicle only. Overall clinical success – defined as mycologic cure and either clinical cure of effective clinical treatment – was seen in 78% of the naftifine 2% patients, compared with 49% of the vehicle patients.

The second antifungal Dr. Pariser discussed is luliconazole (Luzu), a prescription topical imidazole that is available as a 1% cream. Luliconazole is also a broad-spectrum, potent antifungal with effects that persist several weeks after treatment. The preparation is at least as effective as bifonazole, terbinafine, and lanoconazole, both in vitro and in vivo, Dr. Pariser said.

In two parallel clinical trials comparing luliconazole 1% cream to its vehicle, treatment was effective (at least 90% clearing and with normal-appearing skin) in 48% and 33% of patients receiving luliconazole, compared with 10% and 15% of patients receiving vehicle alone.

An advantage of the topical agents is that there are generally no major systemic side effects, since there is minimal systemic absorption, Dr. Pariser noted. Allergic contact dermatitis may be a local reaction, but tends to be mild and transient, he said.

Clinicians should always be alert for tinea pedis when treating onychomycosis, said Dr. Pariser, and untreated tinea can contribute to recurrence of nail fungus. “If you don’t look for tinea, you might not find it, and you’ve missed a treatment opportunity,” he said.

Dr. Pariser disclosed that he is an investigator and consultant for Valeant and an investigator for Anacor Pharmaceuticals.

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

[email protected]

On Twitter @karioakes

LAS VEGAS – Better penetration through the nail is a key driver behind the increased efficacy of newer topical treatments for onychomycosis, affording a better chance for a clinical and mycologic cure without the potential for toxicity that comes with systemic treatments, according to Dr. David M. Pariser.

At the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar, Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, reviewed clinical trial data for 10% topical efinaconazole solution and 5% tavaborole topical solution, newer treatment options for the old problem of nail fungus. “New topical antifungals have improved the challenge of nail penetration,” which had been a key obstacle to efficacy with earlier topical treatments, he said.

Though topical treatments for onychomycosis avoid the risk of systemic side effects and the need for periodic blood tests to check liver function, historically, these treatments have not been very effective, he commented.

Ciclopirox (Penlac), one of the more efficacious treatments, achieves a cure rate of 5.5%-8.5%, and the buildup of the lacquer vehicle requires frequent nail debridement. Because of real or perceived risks, patients may be reluctant to take oral antifungals for onychomycosis, he said, noting that in addition to the potential for liver injury, use of these medications may also be limited by multiple drug-drug interactions.

The two new topical formulations he reviewed have a low molecular weight to allow better penetration through the dense, keratin-rich nail plate, Dr. Pariser said.

One of the topicals, 10% topical efinaconazole solution (Jublia), uses a formulation with low surface tension for good penetration with no surface buildup of vehicle material, achieving better nail penetration than do lacquer-based products, he noted.

A key efinaconazole study assessed clinical improvement in nail appearance in combination with mycologic cure, defined as negative findings on KOH prep exam and negative fungal culture. A complete cure was defined as a “totally clear target toenail and negative KOH/negative fungal culture,” and an “almost complete cure” was defined as mycologic cure, combined with no more than 5% clinically apparent involvement of the target toenail.

©Metin Cengiz Bar/Thinkstock

After double-blinded randomization into two parallel studies, patients applied either efinaconazole or the vehicle alone once daily at bedtime to the target toenail for 48 weeks. In the studies, 18% and 15% of those in the efinaconazole arm had achieved complete cure 52 weeks after beginning treatment, compared with 3% and 6% of the vehicle arm patients, respectively. However, for a pooled intent-to-treat population, the treatment arm saw a 28% cured or almost-cured rate, compared with 7% of the pooled vehicle-treated patients (P less than .001). Mycologic cure was achieved by 55% and 53% of the patients in the two efinaconazole arms, compared with 17% of the vehicle-only patients in each arm, according to Dr. Pariser.

Adverse events, similar between treatment arms, were mostly mild to moderate and localized, with dermatitis, vesicles, pain, and ingrown toenails the most commonly reported effects.

Tavaborole topical solution, 5% (Kerydin), is a boron-based compound that is highly water soluble, with broad antifungal activity that persists in the presence of keratin. As with efinaconazole, there is no product buildup, so nail debridement is not needed during treatment, Dr. Pariser said.

Two multicenter tavaborole trials compared the active tavaborole solution with a vehicle-only arm in a randomized, double-blind fashion, with product application daily for 48 weeks. The primary efficacy outcome for the trials was complete cure of the target great toenail at week 52. Secondary endpoints were a completely clear or almost clear (10% or less involvement of the target nail) target great toenail, as well as mycologic cure of the nail. Safety was measured by tracking adverse events, and local tolerability, as well as monitoring labs and ECG parameters.

A complete cure for the tavaborole trials required a completely clear nail on clinical exam, as well as negative mycology (negative KOH and negative fungal culture). At 52 weeks, 6.5% and 9.1% of the tavaborole-treated patients saw a complete cure, compared with 0.5% and 1.5% of vehicle-only patients in the two studies. Of those treated with tavaborole, 31.1% and 35.9% achieved mycologic cure, compared with 7.2% and 12.2% of those in the vehicle arm.

The rates of complete or almost complete clearing of the target great toenail for those in the tavaborole arms were 26.1% and 27.5%, compared with 9.3% and 14.6% in the vehicle arms. Predefined treatment success – a combination of mycologic cure and clear or almost clear target great toenail – was seen in 15.3% and 17.9% of the tavaborole-treated patients, compared with 1.5% and 3.9% of the vehicle-only patients (P less than or equal to .001 for all endpoints in both studies).

Treatment-related adverse events were generally mild and similar between the vehicle and treatment arms, with application site exfoliation, erythema, dermatitis, as well as ingrown toenails, the most commonly reported events for both arms.

Dr. Pariser noted that comparing efficacy of the newer agents directly is difficult, since the pivotal clinical trials for each had different designs, entry criteria, clinical assessments, and endpoints.

He disclosed that he is an investigator and consultant for Valeant, which manufactures the 10% topical efinaconazole solution, and an investigator for Anacor Pharmaceuticals, which markets tavaborole.

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

[email protected]

On Twitter @karioakes

LAS VEGAS – Better penetration through the nail is a key driver behind the increased efficacy of newer topical treatments for onychomycosis, affording a better chance for a clinical and mycologic cure without the potential for toxicity that comes with systemic treatments, according to Dr. David M. Pariser.

At the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar, Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, reviewed clinical trial data for 10% topical efinaconazole solution and 5% tavaborole topical solution, newer treatment options for the old problem of nail fungus. “New topical antifungals have improved the challenge of nail penetration,” which had been a key obstacle to efficacy with earlier topical treatments, he said.

Though topical treatments for onychomycosis avoid the risk of systemic side effects and the need for periodic blood tests to check liver function, historically, these treatments have not been very effective, he commented.

Ciclopirox (Penlac), one of the more efficacious treatments, achieves a cure rate of 5.5%-8.5%, and the buildup of the lacquer vehicle requires frequent nail debridement. Because of real or perceived risks, patients may be reluctant to take oral antifungals for onychomycosis, he said, noting that in addition to the potential for liver injury, use of these medications may also be limited by multiple drug-drug interactions.

The two new topical formulations he reviewed have a low molecular weight to allow better penetration through the dense, keratin-rich nail plate, Dr. Pariser said.

One of the topicals, 10% topical efinaconazole solution (Jublia), uses a formulation with low surface tension for good penetration with no surface buildup of vehicle material, achieving better nail penetration than do lacquer-based products, he noted.

A key efinaconazole study assessed clinical improvement in nail appearance in combination with mycologic cure, defined as negative findings on KOH prep exam and negative fungal culture. A complete cure was defined as a “totally clear target toenail and negative KOH/negative fungal culture,” and an “almost complete cure” was defined as mycologic cure, combined with no more than 5% clinically apparent involvement of the target toenail.

©Metin Cengiz Bar/Thinkstock

After double-blinded randomization into two parallel studies, patients applied either efinaconazole or the vehicle alone once daily at bedtime to the target toenail for 48 weeks. In the studies, 18% and 15% of those in the efinaconazole arm had achieved complete cure 52 weeks after beginning treatment, compared with 3% and 6% of the vehicle arm patients, respectively. However, for a pooled intent-to-treat population, the treatment arm saw a 28% cured or almost-cured rate, compared with 7% of the pooled vehicle-treated patients (P less than .001). Mycologic cure was achieved by 55% and 53% of the patients in the two efinaconazole arms, compared with 17% of the vehicle-only patients in each arm, according to Dr. Pariser.

Adverse events, similar between treatment arms, were mostly mild to moderate and localized, with dermatitis, vesicles, pain, and ingrown toenails the most commonly reported effects.

Tavaborole topical solution, 5% (Kerydin), is a boron-based compound that is highly water soluble, with broad antifungal activity that persists in the presence of keratin. As with efinaconazole, there is no product buildup, so nail debridement is not needed during treatment, Dr. Pariser said.

Two multicenter tavaborole trials compared the active tavaborole solution with a vehicle-only arm in a randomized, double-blind fashion, with product application daily for 48 weeks. The primary efficacy outcome for the trials was complete cure of the target great toenail at week 52. Secondary endpoints were a completely clear or almost clear (10% or less involvement of the target nail) target great toenail, as well as mycologic cure of the nail. Safety was measured by tracking adverse events, and local tolerability, as well as monitoring labs and ECG parameters.

A complete cure for the tavaborole trials required a completely clear nail on clinical exam, as well as negative mycology (negative KOH and negative fungal culture). At 52 weeks, 6.5% and 9.1% of the tavaborole-treated patients saw a complete cure, compared with 0.5% and 1.5% of vehicle-only patients in the two studies. Of those treated with tavaborole, 31.1% and 35.9% achieved mycologic cure, compared with 7.2% and 12.2% of those in the vehicle arm.

The rates of complete or almost complete clearing of the target great toenail for those in the tavaborole arms were 26.1% and 27.5%, compared with 9.3% and 14.6% in the vehicle arms. Predefined treatment success – a combination of mycologic cure and clear or almost clear target great toenail – was seen in 15.3% and 17.9% of the tavaborole-treated patients, compared with 1.5% and 3.9% of the vehicle-only patients (P less than or equal to .001 for all endpoints in both studies).

Treatment-related adverse events were generally mild and similar between the vehicle and treatment arms, with application site exfoliation, erythema, dermatitis, as well as ingrown toenails, the most commonly reported events for both arms.

Dr. Pariser noted that comparing efficacy of the newer agents directly is difficult, since the pivotal clinical trials for each had different designs, entry criteria, clinical assessments, and endpoints.

He disclosed that he is an investigator and consultant for Valeant, which manufactures the 10% topical efinaconazole solution, and an investigator for Anacor Pharmaceuticals, which markets tavaborole.

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

[email protected]

On Twitter @karioakes

LAS VEGAS – Better penetration through the nail is a key driver behind the increased efficacy of newer topical treatments for onychomycosis, affording a better chance for a clinical and mycologic cure without the potential for toxicity that comes with systemic treatments, according to Dr. David M. Pariser.

At the Skin Disease Education Foundation’s annual Las Vegas dermatology seminar, Dr. Pariser, professor in the department of dermatology at Eastern Virginia Medical School, Norfolk, reviewed clinical trial data for 10% topical efinaconazole solution and 5% tavaborole topical solution, newer treatment options for the old problem of nail fungus. “New topical antifungals have improved the challenge of nail penetration,” which had been a key obstacle to efficacy with earlier topical treatments, he said.

Though topical treatments for onychomycosis avoid the risk of systemic side effects and the need for periodic blood tests to check liver function, historically, these treatments have not been very effective, he commented.

Ciclopirox (Penlac), one of the more efficacious treatments, achieves a cure rate of 5.5%-8.5%, and the buildup of the lacquer vehicle requires frequent nail debridement. Because of real or perceived risks, patients may be reluctant to take oral antifungals for onychomycosis, he said, noting that in addition to the potential for liver injury, use of these medications may also be limited by multiple drug-drug interactions.

The two new topical formulations he reviewed have a low molecular weight to allow better penetration through the dense, keratin-rich nail plate, Dr. Pariser said.

One of the topicals, 10% topical efinaconazole solution (Jublia), uses a formulation with low surface tension for good penetration with no surface buildup of vehicle material, achieving better nail penetration than do lacquer-based products, he noted.

A key efinaconazole study assessed clinical improvement in nail appearance in combination with mycologic cure, defined as negative findings on KOH prep exam and negative fungal culture. A complete cure was defined as a “totally clear target toenail and negative KOH/negative fungal culture,” and an “almost complete cure” was defined as mycologic cure, combined with no more than 5% clinically apparent involvement of the target toenail.

©Metin Cengiz Bar/Thinkstock

After double-blinded randomization into two parallel studies, patients applied either efinaconazole or the vehicle alone once daily at bedtime to the target toenail for 48 weeks. In the studies, 18% and 15% of those in the efinaconazole arm had achieved complete cure 52 weeks after beginning treatment, compared with 3% and 6% of the vehicle arm patients, respectively. However, for a pooled intent-to-treat population, the treatment arm saw a 28% cured or almost-cured rate, compared with 7% of the pooled vehicle-treated patients (P less than .001). Mycologic cure was achieved by 55% and 53% of the patients in the two efinaconazole arms, compared with 17% of the vehicle-only patients in each arm, according to Dr. Pariser.

Adverse events, similar between treatment arms, were mostly mild to moderate and localized, with dermatitis, vesicles, pain, and ingrown toenails the most commonly reported effects.

Tavaborole topical solution, 5% (Kerydin), is a boron-based compound that is highly water soluble, with broad antifungal activity that persists in the presence of keratin. As with efinaconazole, there is no product buildup, so nail debridement is not needed during treatment, Dr. Pariser said.

Two multicenter tavaborole trials compared the active tavaborole solution with a vehicle-only arm in a randomized, double-blind fashion, with product application daily for 48 weeks. The primary efficacy outcome for the trials was complete cure of the target great toenail at week 52. Secondary endpoints were a completely clear or almost clear (10% or less involvement of the target nail) target great toenail, as well as mycologic cure of the nail. Safety was measured by tracking adverse events, and local tolerability, as well as monitoring labs and ECG parameters.

A complete cure for the tavaborole trials required a completely clear nail on clinical exam, as well as negative mycology (negative KOH and negative fungal culture). At 52 weeks, 6.5% and 9.1% of the tavaborole-treated patients saw a complete cure, compared with 0.5% and 1.5% of vehicle-only patients in the two studies. Of those treated with tavaborole, 31.1% and 35.9% achieved mycologic cure, compared with 7.2% and 12.2% of those in the vehicle arm.

The rates of complete or almost complete clearing of the target great toenail for those in the tavaborole arms were 26.1% and 27.5%, compared with 9.3% and 14.6% in the vehicle arms. Predefined treatment success – a combination of mycologic cure and clear or almost clear target great toenail – was seen in 15.3% and 17.9% of the tavaborole-treated patients, compared with 1.5% and 3.9% of the vehicle-only patients (P less than or equal to .001 for all endpoints in both studies).

Treatment-related adverse events were generally mild and similar between the vehicle and treatment arms, with application site exfoliation, erythema, dermatitis, as well as ingrown toenails, the most commonly reported events for both arms.

Dr. Pariser noted that comparing efficacy of the newer agents directly is difficult, since the pivotal clinical trials for each had different designs, entry criteria, clinical assessments, and endpoints.

He disclosed that he is an investigator and consultant for Valeant, which manufactures the 10% topical efinaconazole solution, and an investigator for Anacor Pharmaceuticals, which markets tavaborole.

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

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Patients with low thyroid function may experience a “double whammy” of hypothyroidism and metabolic syndrome.

Even subclinical hypothyroidism affects many metabolic pathways that can contribute to deranged glucose and lipid metabolism, raising the risk of metabolic syndrome, according to Dr. Gabriela Brenta of the department of endocrinology at the Dr. Cesar Milstein Hospital in Buenos Aires. Though some mechanisms are incompletely understood, the association is clear enough to warrant screening all metabolic syndrome patients for hypothyroidism, she said.

Dr. Brenta described the recent work she and others have completed in the field. Basic science work revealed some early clues. For example, those who studied the effects of acute thyroid hormone withdrawal on patients with no thyroid gland found that these patients saw a rapid rise in insulin resistance. It’s known that even subclinical insulin resistance can lead to impaired glucose metabolism, making it logical to follow both normal and deranged metabolic pathways to help sort out the relationship between thyroid dysfunction and impaired glucose metabolism, she reported at the International Thyroid Congress.

Hypothyroidism can affect glucose homeostasis through multiple mechanisms, said Dr. Brenta. Firstly, hypothyroidism can lead to decreased hepatic gluconeogenesis and glycogenolysis. Hypothyroidism also can lead to reduced baseline plasma insulin levels and increased postglucose insulin secretion. In the peripheral tissues, hypothyroidism can interfere with glucose metabolism and disposal. All of these mechanisms can decrease hepatic glucose metabolism and lead to a postabsorptive hyperglycemia state, said Dr. Brenta, noting: “Insulin resistance is in some way the backbone of metabolic syndrome.”

Lipid metabolism is also affected by subclinical hypothyroidism, which can decrease expression of mRNA for LDL-C receptors, leading to LDL-C receptor down-regulation. With fewer receptors available, serum levels of LDL-C increase, with resultant increased susceptibility to oxidative effects and increased foam cell generation.

Dr. Brenta cited her earlier work showing that “triglyceride enrichment of LDL particles correlates with lower hepatic lipase activity” for individuals with subclinical hypothyroidism, with significantly lower hepatic lipase activity and a higher LDL-C to triglyceride ratio for those patients than for controls (Thyroid. 2007 May;17[5]:453-60). Overall, in hypothyroidism, “LDL particles are exposed to more substances that make them more atherogenic with decreased degradation and increased half-life,” said Dr. Brenta.

The increased risk for hypertension in both subclinical and overt hypothyroidism may be related, in part, to the fact that triiodothyronine deficiency can contribute to endothelial dysfunction. The relationship between subclinical hypothyroidism and hypertension was confirmed in a 2011 meta-analysis, said Dr. Brenta (Hypertens Res. 2011 Oct;34[10]:1098-105).

Though many factors contribute to obesity and thyroid function alone does not regulate body weight, a large population-based Danish study found that “even mild elevations of TSH are important for body weight,” said Dr. Brenta. The relationship is complex and bidirectional – a classic “chicken and egg” story – since obesity also may modulate TSH, she said; “however, we must not forget the ample literature on low levels of thyroid hormones reducing resting energy expenditure” (J Clin Endocrinol Metab. 2005 Jul;90[7]:4019-24).

Even though TSH tends to rise naturally through the lifespan, the association between elevated TSH and increased risk of metabolic syndrome held true even for older patients in one study, with “each one unit increase in TSH predicting a 3% increase in the odds of metabolic syndrome,” even after adjustment for age, BMI, and HOMA-IR status, among other variables, said Dr. Brenta (Clin Endocrinol [Oxf]. 2012 Jun;76[6]:911-8).

Advocating for universal screening for hypothyroidism among patients with metabolic syndrome, Dr. Brenta said that “hypothyroid disturbances are associated with an adverse metabolic profile, and even low normal TSH levels are associated with the metabolic traits of metabolic syndrome.”

The meeting was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society. Dr. Brenta did not identify any conflicts of interest.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Patients with low thyroid function may experience a “double whammy” of hypothyroidism and metabolic syndrome.

Even subclinical hypothyroidism affects many metabolic pathways that can contribute to deranged glucose and lipid metabolism, raising the risk of metabolic syndrome, according to Dr. Gabriela Brenta of the department of endocrinology at the Dr. Cesar Milstein Hospital in Buenos Aires. Though some mechanisms are incompletely understood, the association is clear enough to warrant screening all metabolic syndrome patients for hypothyroidism, she said.

Dr. Brenta described the recent work she and others have completed in the field. Basic science work revealed some early clues. For example, those who studied the effects of acute thyroid hormone withdrawal on patients with no thyroid gland found that these patients saw a rapid rise in insulin resistance. It’s known that even subclinical insulin resistance can lead to impaired glucose metabolism, making it logical to follow both normal and deranged metabolic pathways to help sort out the relationship between thyroid dysfunction and impaired glucose metabolism, she reported at the International Thyroid Congress.

Hypothyroidism can affect glucose homeostasis through multiple mechanisms, said Dr. Brenta. Firstly, hypothyroidism can lead to decreased hepatic gluconeogenesis and glycogenolysis. Hypothyroidism also can lead to reduced baseline plasma insulin levels and increased postglucose insulin secretion. In the peripheral tissues, hypothyroidism can interfere with glucose metabolism and disposal. All of these mechanisms can decrease hepatic glucose metabolism and lead to a postabsorptive hyperglycemia state, said Dr. Brenta, noting: “Insulin resistance is in some way the backbone of metabolic syndrome.”

Lipid metabolism is also affected by subclinical hypothyroidism, which can decrease expression of mRNA for LDL-C receptors, leading to LDL-C receptor down-regulation. With fewer receptors available, serum levels of LDL-C increase, with resultant increased susceptibility to oxidative effects and increased foam cell generation.

Dr. Brenta cited her earlier work showing that “triglyceride enrichment of LDL particles correlates with lower hepatic lipase activity” for individuals with subclinical hypothyroidism, with significantly lower hepatic lipase activity and a higher LDL-C to triglyceride ratio for those patients than for controls (Thyroid. 2007 May;17[5]:453-60). Overall, in hypothyroidism, “LDL particles are exposed to more substances that make them more atherogenic with decreased degradation and increased half-life,” said Dr. Brenta.

The increased risk for hypertension in both subclinical and overt hypothyroidism may be related, in part, to the fact that triiodothyronine deficiency can contribute to endothelial dysfunction. The relationship between subclinical hypothyroidism and hypertension was confirmed in a 2011 meta-analysis, said Dr. Brenta (Hypertens Res. 2011 Oct;34[10]:1098-105).

Though many factors contribute to obesity and thyroid function alone does not regulate body weight, a large population-based Danish study found that “even mild elevations of TSH are important for body weight,” said Dr. Brenta. The relationship is complex and bidirectional – a classic “chicken and egg” story – since obesity also may modulate TSH, she said; “however, we must not forget the ample literature on low levels of thyroid hormones reducing resting energy expenditure” (J Clin Endocrinol Metab. 2005 Jul;90[7]:4019-24).

Even though TSH tends to rise naturally through the lifespan, the association between elevated TSH and increased risk of metabolic syndrome held true even for older patients in one study, with “each one unit increase in TSH predicting a 3% increase in the odds of metabolic syndrome,” even after adjustment for age, BMI, and HOMA-IR status, among other variables, said Dr. Brenta (Clin Endocrinol [Oxf]. 2012 Jun;76[6]:911-8).

Advocating for universal screening for hypothyroidism among patients with metabolic syndrome, Dr. Brenta said that “hypothyroid disturbances are associated with an adverse metabolic profile, and even low normal TSH levels are associated with the metabolic traits of metabolic syndrome.”

The meeting was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society. Dr. Brenta did not identify any conflicts of interest.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Patients with low thyroid function may experience a “double whammy” of hypothyroidism and metabolic syndrome.

Even subclinical hypothyroidism affects many metabolic pathways that can contribute to deranged glucose and lipid metabolism, raising the risk of metabolic syndrome, according to Dr. Gabriela Brenta of the department of endocrinology at the Dr. Cesar Milstein Hospital in Buenos Aires. Though some mechanisms are incompletely understood, the association is clear enough to warrant screening all metabolic syndrome patients for hypothyroidism, she said.

Dr. Brenta described the recent work she and others have completed in the field. Basic science work revealed some early clues. For example, those who studied the effects of acute thyroid hormone withdrawal on patients with no thyroid gland found that these patients saw a rapid rise in insulin resistance. It’s known that even subclinical insulin resistance can lead to impaired glucose metabolism, making it logical to follow both normal and deranged metabolic pathways to help sort out the relationship between thyroid dysfunction and impaired glucose metabolism, she reported at the International Thyroid Congress.

Hypothyroidism can affect glucose homeostasis through multiple mechanisms, said Dr. Brenta. Firstly, hypothyroidism can lead to decreased hepatic gluconeogenesis and glycogenolysis. Hypothyroidism also can lead to reduced baseline plasma insulin levels and increased postglucose insulin secretion. In the peripheral tissues, hypothyroidism can interfere with glucose metabolism and disposal. All of these mechanisms can decrease hepatic glucose metabolism and lead to a postabsorptive hyperglycemia state, said Dr. Brenta, noting: “Insulin resistance is in some way the backbone of metabolic syndrome.”

Lipid metabolism is also affected by subclinical hypothyroidism, which can decrease expression of mRNA for LDL-C receptors, leading to LDL-C receptor down-regulation. With fewer receptors available, serum levels of LDL-C increase, with resultant increased susceptibility to oxidative effects and increased foam cell generation.

Dr. Brenta cited her earlier work showing that “triglyceride enrichment of LDL particles correlates with lower hepatic lipase activity” for individuals with subclinical hypothyroidism, with significantly lower hepatic lipase activity and a higher LDL-C to triglyceride ratio for those patients than for controls (Thyroid. 2007 May;17[5]:453-60). Overall, in hypothyroidism, “LDL particles are exposed to more substances that make them more atherogenic with decreased degradation and increased half-life,” said Dr. Brenta.

The increased risk for hypertension in both subclinical and overt hypothyroidism may be related, in part, to the fact that triiodothyronine deficiency can contribute to endothelial dysfunction. The relationship between subclinical hypothyroidism and hypertension was confirmed in a 2011 meta-analysis, said Dr. Brenta (Hypertens Res. 2011 Oct;34[10]:1098-105).

Though many factors contribute to obesity and thyroid function alone does not regulate body weight, a large population-based Danish study found that “even mild elevations of TSH are important for body weight,” said Dr. Brenta. The relationship is complex and bidirectional – a classic “chicken and egg” story – since obesity also may modulate TSH, she said; “however, we must not forget the ample literature on low levels of thyroid hormones reducing resting energy expenditure” (J Clin Endocrinol Metab. 2005 Jul;90[7]:4019-24).

Even though TSH tends to rise naturally through the lifespan, the association between elevated TSH and increased risk of metabolic syndrome held true even for older patients in one study, with “each one unit increase in TSH predicting a 3% increase in the odds of metabolic syndrome,” even after adjustment for age, BMI, and HOMA-IR status, among other variables, said Dr. Brenta (Clin Endocrinol [Oxf]. 2012 Jun;76[6]:911-8).

Advocating for universal screening for hypothyroidism among patients with metabolic syndrome, Dr. Brenta said that “hypothyroid disturbances are associated with an adverse metabolic profile, and even low normal TSH levels are associated with the metabolic traits of metabolic syndrome.”

The meeting was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society. Dr. Brenta did not identify any conflicts of interest.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – More cases of thyroid cancer are being seen in Japanese youth after the Fukushima Daiichi nuclear power plant accident, but the increased incidence may be an artifact of heightened surveillance.

“The thyroid cancers appear to have already occurred prior to radiation exposure,” said Dr. Shinichi Suzuki of the department of thyroid and endocrinology at Fukushima (Japan) Medical University. Radiation-induced thyroid cancers take about 5 years to become detectable, so physicians should just now be seeing the earliest cases of thyroid cancer related to Fukushima radiation exposure, according to Dr. Suzuki. He presented interim results of Japan’s universal screening protocol for children potentially affected by the Fukushima incident at the International Thyroid Conference.

The protocol, designed to screen everyone residing in the Fukushima prefecture and aged 19 years or younger at the time of the 2011 incident, has been highly successful, with over 80% of those eligible receiving a baseline screening that included a thyroid ultrasound exam.

Screening consisted of an initial thyroid ultrasound exam performed with a portable ultrasound device. If no cyst or nodule was found, then the patient would be seen at the next scheduled thyroid ultrasound exam, 2 years later. Patients with cysts 20 mm or less in greatest diameter or nodules 5 mm or smaller also were deferred to the next scheduled examination. Patients with cysts larger than 20 mm or nodules larger than 5 mm received confirmatory examination by detailed ultrasound examination, blood work, and fine-needle aspiration.

Of the 300,476 patients who received the preliminary baseline survey, 2,294 (0.8%) had an abnormality that warranted confirmatory examination and 91.9% of patients went on to have the confirmatory exams. Of these, 113 were assessed as malignant or suspicious for malignancy. Ninety-nine patients had surgery, with findings of 98 cases of thyroid cancer and one benign tumor.

Patients examined after April 2014 were part of an expanded protocol. Under this protocol, 169,455 patients (44.7% participation) were examined and 1,223 patients (0.8%) had suspicious findings on thyroid ultrasound exam. Participation rate for confirmatory testing for this group was 62.7%, with 25 patients’ thyroids having malignant or potentially malignant findings. Six of these patients had surgery, and thyroid cancer was found in all six cases.

Pooling data from the 138 malignant or suspicious cases from the two groups, 105 patients in total have had surgery, 13 patients with small, noninvasive masses are being watched, and a further 20 are awaiting surgery, Dr. Suzuki said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Of the 97 patients with thyroid cancer who were treated at Fukushima University, 61 were female. The mean patient age at the time of the disaster was 14.8 ± 2.7 years (range, 6-18 years), while the mean age at diagnosis was 17.4 ± 2.8 years (range, 9-22 years). All patients were asymptomatic.

Tumors were unilateral in all but two patients. Mean tumor size was 15.1 ± 0.8 mm (range, 5-53 mm). Nearly all of the tumors (94/97) were papillary thyroid carcinoma, with 86 of those being classical-type papillary thyroid carcinoma. Three patients had poorly differentiated thyroid carcinoma. Fifty-eight patients (60%) had some intraglandular spread, while 71 (73%) had calcifications.

Dr. Suzuki and his collaborators compared these 97 cases with 37 cases of pediatric thyroid cancer in an historical Japanese cohort and to the 26 cases seen in a cohort from Belarus following the Chernobyl disaster. The Fukushima patients were significantly older than either comparison group, with mean age of 11.9 years for the historical Japanese cohort and 10.6 years for the children from Belarus. Tumor size was smaller than the historical Japanese cohort’s mean of 4.1 cm but about the same as that seen in Belarus (1.4 cm). Pulmonary metastases were more common in the historical Japanese cohort (19% vs. 4% in Belarus and 2% in Fukushima).

To have reference data that use similar techniques on a similar population, Japanese researchers are conducting thyroid ultrasound examsaccording to the Fukushima protocol concurrently in three other Japanese prefectures. This is especially important, Dr. Suzuki said, because rapid technological advances in ultrasound imaging mean that screening is much more likely to detect small abnormalities in the thyroid than would have been the case even a few years ago. For this reason, and also because much more radiation was released at the site of the Chernobyl nuclear disaster, only limited comparisons can be made between pediatric thyroid cancer rates from the two nuclear accidents.

Thyroid ultrasound exam “has the ability to detect a lot of thyroid cancers,” he said, so care must be taken to avoid overdiagnosis and overtreatment in this group of young people. Information to date from the Fukushima surveillance project does not yet “give us the clear view about the influence of radiation exposure after the accident on thyroid cancer occurrence,” he said.

Dr. Suzuki reported no relevant disclosures.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – More cases of thyroid cancer are being seen in Japanese youth after the Fukushima Daiichi nuclear power plant accident, but the increased incidence may be an artifact of heightened surveillance.

“The thyroid cancers appear to have already occurred prior to radiation exposure,” said Dr. Shinichi Suzuki of the department of thyroid and endocrinology at Fukushima (Japan) Medical University. Radiation-induced thyroid cancers take about 5 years to become detectable, so physicians should just now be seeing the earliest cases of thyroid cancer related to Fukushima radiation exposure, according to Dr. Suzuki. He presented interim results of Japan’s universal screening protocol for children potentially affected by the Fukushima incident at the International Thyroid Conference.

The protocol, designed to screen everyone residing in the Fukushima prefecture and aged 19 years or younger at the time of the 2011 incident, has been highly successful, with over 80% of those eligible receiving a baseline screening that included a thyroid ultrasound exam.

Screening consisted of an initial thyroid ultrasound exam performed with a portable ultrasound device. If no cyst or nodule was found, then the patient would be seen at the next scheduled thyroid ultrasound exam, 2 years later. Patients with cysts 20 mm or less in greatest diameter or nodules 5 mm or smaller also were deferred to the next scheduled examination. Patients with cysts larger than 20 mm or nodules larger than 5 mm received confirmatory examination by detailed ultrasound examination, blood work, and fine-needle aspiration.

Of the 300,476 patients who received the preliminary baseline survey, 2,294 (0.8%) had an abnormality that warranted confirmatory examination and 91.9% of patients went on to have the confirmatory exams. Of these, 113 were assessed as malignant or suspicious for malignancy. Ninety-nine patients had surgery, with findings of 98 cases of thyroid cancer and one benign tumor.

Patients examined after April 2014 were part of an expanded protocol. Under this protocol, 169,455 patients (44.7% participation) were examined and 1,223 patients (0.8%) had suspicious findings on thyroid ultrasound exam. Participation rate for confirmatory testing for this group was 62.7%, with 25 patients’ thyroids having malignant or potentially malignant findings. Six of these patients had surgery, and thyroid cancer was found in all six cases.

Pooling data from the 138 malignant or suspicious cases from the two groups, 105 patients in total have had surgery, 13 patients with small, noninvasive masses are being watched, and a further 20 are awaiting surgery, Dr. Suzuki said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Of the 97 patients with thyroid cancer who were treated at Fukushima University, 61 were female. The mean patient age at the time of the disaster was 14.8 ± 2.7 years (range, 6-18 years), while the mean age at diagnosis was 17.4 ± 2.8 years (range, 9-22 years). All patients were asymptomatic.

Tumors were unilateral in all but two patients. Mean tumor size was 15.1 ± 0.8 mm (range, 5-53 mm). Nearly all of the tumors (94/97) were papillary thyroid carcinoma, with 86 of those being classical-type papillary thyroid carcinoma. Three patients had poorly differentiated thyroid carcinoma. Fifty-eight patients (60%) had some intraglandular spread, while 71 (73%) had calcifications.

Dr. Suzuki and his collaborators compared these 97 cases with 37 cases of pediatric thyroid cancer in an historical Japanese cohort and to the 26 cases seen in a cohort from Belarus following the Chernobyl disaster. The Fukushima patients were significantly older than either comparison group, with mean age of 11.9 years for the historical Japanese cohort and 10.6 years for the children from Belarus. Tumor size was smaller than the historical Japanese cohort’s mean of 4.1 cm but about the same as that seen in Belarus (1.4 cm). Pulmonary metastases were more common in the historical Japanese cohort (19% vs. 4% in Belarus and 2% in Fukushima).

To have reference data that use similar techniques on a similar population, Japanese researchers are conducting thyroid ultrasound examsaccording to the Fukushima protocol concurrently in three other Japanese prefectures. This is especially important, Dr. Suzuki said, because rapid technological advances in ultrasound imaging mean that screening is much more likely to detect small abnormalities in the thyroid than would have been the case even a few years ago. For this reason, and also because much more radiation was released at the site of the Chernobyl nuclear disaster, only limited comparisons can be made between pediatric thyroid cancer rates from the two nuclear accidents.

Thyroid ultrasound exam “has the ability to detect a lot of thyroid cancers,” he said, so care must be taken to avoid overdiagnosis and overtreatment in this group of young people. Information to date from the Fukushima surveillance project does not yet “give us the clear view about the influence of radiation exposure after the accident on thyroid cancer occurrence,” he said.

Dr. Suzuki reported no relevant disclosures.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – More cases of thyroid cancer are being seen in Japanese youth after the Fukushima Daiichi nuclear power plant accident, but the increased incidence may be an artifact of heightened surveillance.

“The thyroid cancers appear to have already occurred prior to radiation exposure,” said Dr. Shinichi Suzuki of the department of thyroid and endocrinology at Fukushima (Japan) Medical University. Radiation-induced thyroid cancers take about 5 years to become detectable, so physicians should just now be seeing the earliest cases of thyroid cancer related to Fukushima radiation exposure, according to Dr. Suzuki. He presented interim results of Japan’s universal screening protocol for children potentially affected by the Fukushima incident at the International Thyroid Conference.

The protocol, designed to screen everyone residing in the Fukushima prefecture and aged 19 years or younger at the time of the 2011 incident, has been highly successful, with over 80% of those eligible receiving a baseline screening that included a thyroid ultrasound exam.

Screening consisted of an initial thyroid ultrasound exam performed with a portable ultrasound device. If no cyst or nodule was found, then the patient would be seen at the next scheduled thyroid ultrasound exam, 2 years later. Patients with cysts 20 mm or less in greatest diameter or nodules 5 mm or smaller also were deferred to the next scheduled examination. Patients with cysts larger than 20 mm or nodules larger than 5 mm received confirmatory examination by detailed ultrasound examination, blood work, and fine-needle aspiration.

Of the 300,476 patients who received the preliminary baseline survey, 2,294 (0.8%) had an abnormality that warranted confirmatory examination and 91.9% of patients went on to have the confirmatory exams. Of these, 113 were assessed as malignant or suspicious for malignancy. Ninety-nine patients had surgery, with findings of 98 cases of thyroid cancer and one benign tumor.

Patients examined after April 2014 were part of an expanded protocol. Under this protocol, 169,455 patients (44.7% participation) were examined and 1,223 patients (0.8%) had suspicious findings on thyroid ultrasound exam. Participation rate for confirmatory testing for this group was 62.7%, with 25 patients’ thyroids having malignant or potentially malignant findings. Six of these patients had surgery, and thyroid cancer was found in all six cases.

Pooling data from the 138 malignant or suspicious cases from the two groups, 105 patients in total have had surgery, 13 patients with small, noninvasive masses are being watched, and a further 20 are awaiting surgery, Dr. Suzuki said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Of the 97 patients with thyroid cancer who were treated at Fukushima University, 61 were female. The mean patient age at the time of the disaster was 14.8 ± 2.7 years (range, 6-18 years), while the mean age at diagnosis was 17.4 ± 2.8 years (range, 9-22 years). All patients were asymptomatic.

Tumors were unilateral in all but two patients. Mean tumor size was 15.1 ± 0.8 mm (range, 5-53 mm). Nearly all of the tumors (94/97) were papillary thyroid carcinoma, with 86 of those being classical-type papillary thyroid carcinoma. Three patients had poorly differentiated thyroid carcinoma. Fifty-eight patients (60%) had some intraglandular spread, while 71 (73%) had calcifications.

Dr. Suzuki and his collaborators compared these 97 cases with 37 cases of pediatric thyroid cancer in an historical Japanese cohort and to the 26 cases seen in a cohort from Belarus following the Chernobyl disaster. The Fukushima patients were significantly older than either comparison group, with mean age of 11.9 years for the historical Japanese cohort and 10.6 years for the children from Belarus. Tumor size was smaller than the historical Japanese cohort’s mean of 4.1 cm but about the same as that seen in Belarus (1.4 cm). Pulmonary metastases were more common in the historical Japanese cohort (19% vs. 4% in Belarus and 2% in Fukushima).

To have reference data that use similar techniques on a similar population, Japanese researchers are conducting thyroid ultrasound examsaccording to the Fukushima protocol concurrently in three other Japanese prefectures. This is especially important, Dr. Suzuki said, because rapid technological advances in ultrasound imaging mean that screening is much more likely to detect small abnormalities in the thyroid than would have been the case even a few years ago. For this reason, and also because much more radiation was released at the site of the Chernobyl nuclear disaster, only limited comparisons can be made between pediatric thyroid cancer rates from the two nuclear accidents.

Thyroid ultrasound exam “has the ability to detect a lot of thyroid cancers,” he said, so care must be taken to avoid overdiagnosis and overtreatment in this group of young people. Information to date from the Fukushima surveillance project does not yet “give us the clear view about the influence of radiation exposure after the accident on thyroid cancer occurrence,” he said.

Dr. Suzuki reported no relevant disclosures.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – An outpatient procedure may represent an efficacious and safe alternative to surgery for those patients with small papillary thyroid cancers who prefer definitive treatment over the “wait and watch” approach. Further, at one institution, the cost-effective alternative to surgery saved almost $40,000 per patient.

Ultrasound-guided percutaneous ethanol injection (UPEA) of small (cT1N0) intrathyroidal papillary thyroid cancer (SIPC) successfully reduced tumor volume by a median of 92%, eliminated tumor blood flow, and was very well tolerated by a series of 13 patients who received UPEA at the Mayo Clinic, Rochester, Minn.

Dr. Ian D. Hay, a consultant in Mayo’s division of endocrinology, diabetes, metabolism, and nutrition, presented the findings during a poster session at the International Thyroid Congress.

Dr. Hay and his colleagues treated 13 patients with a total of 15 tumors with injections of percutaneous ethanol. The first patient received just one injection; the remaining patients received one injection to each tumor site on each of 2 consecutive days. Five of the tumor foci had less than a 50% reduction in tumor volume at the first follow-up visit, so those tumors were injected a third time.

Patients in the series ranged from 38 to 86 years old (median 45), and five patients had significant comorbidities: one had congestive heart failure and the other four had concomitant unrelated cancers. Tumors were a median 8 mm in size, with volumes ranging from 25 to 676 mm³ (median 140 mm³).

All of the injections were performed under ultrasound guidance, and a median of 0.9 cc of ethanol was injected into each tumor. Ultrasound examination was performed at each follow-up visit to evaluate tumor volume and blood flow. Dr. Hay reported that the procedure was well tolerated: Local neck tenderness resolved within a day or two, and there were no reports of hoarseness or laryngeal nerve palsy.

Patients were followed for a mean 2.0 years (range, 0.4-5.7 years), with a median tumor reduction of 92% (range 46%-100%). For the nine tumors that were still identifiable on ultrasound at the time of reporting, the mean volume had decreased by 73%. Six tumor foci had completely disappeared, and no tumor had detectable blood flow on Doppler exam. Tumor thyroglobulin levels remained stable in all patients, and no nodal metastases were identified, Dr. Hay reported at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Internationally, the approach to managing SIPC varies from lobectomy to near-total thyroidectomy to active surveillance. For patients who prefer definitive management of their tumors but are reluctant to have surgery or who may have significant comorbidities, UPEA may represent a safe alternative, and at significant cost savings compared to surgery: Dr. Hay and his colleagues reported that they estimated the average cost savings at their institution to be over $38,000 per patient. “If prospective trials of observation vs. surgery for SIPC are to occur in the USA, perhaps it could be included as a ‘third arm’ in such trials,” Dr. Hay and his colleagues said.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – An outpatient procedure may represent an efficacious and safe alternative to surgery for those patients with small papillary thyroid cancers who prefer definitive treatment over the “wait and watch” approach. Further, at one institution, the cost-effective alternative to surgery saved almost $40,000 per patient.

Ultrasound-guided percutaneous ethanol injection (UPEA) of small (cT1N0) intrathyroidal papillary thyroid cancer (SIPC) successfully reduced tumor volume by a median of 92%, eliminated tumor blood flow, and was very well tolerated by a series of 13 patients who received UPEA at the Mayo Clinic, Rochester, Minn.

Dr. Ian D. Hay, a consultant in Mayo’s division of endocrinology, diabetes, metabolism, and nutrition, presented the findings during a poster session at the International Thyroid Congress.

Dr. Hay and his colleagues treated 13 patients with a total of 15 tumors with injections of percutaneous ethanol. The first patient received just one injection; the remaining patients received one injection to each tumor site on each of 2 consecutive days. Five of the tumor foci had less than a 50% reduction in tumor volume at the first follow-up visit, so those tumors were injected a third time.

Patients in the series ranged from 38 to 86 years old (median 45), and five patients had significant comorbidities: one had congestive heart failure and the other four had concomitant unrelated cancers. Tumors were a median 8 mm in size, with volumes ranging from 25 to 676 mm³ (median 140 mm³).

All of the injections were performed under ultrasound guidance, and a median of 0.9 cc of ethanol was injected into each tumor. Ultrasound examination was performed at each follow-up visit to evaluate tumor volume and blood flow. Dr. Hay reported that the procedure was well tolerated: Local neck tenderness resolved within a day or two, and there were no reports of hoarseness or laryngeal nerve palsy.

Patients were followed for a mean 2.0 years (range, 0.4-5.7 years), with a median tumor reduction of 92% (range 46%-100%). For the nine tumors that were still identifiable on ultrasound at the time of reporting, the mean volume had decreased by 73%. Six tumor foci had completely disappeared, and no tumor had detectable blood flow on Doppler exam. Tumor thyroglobulin levels remained stable in all patients, and no nodal metastases were identified, Dr. Hay reported at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Internationally, the approach to managing SIPC varies from lobectomy to near-total thyroidectomy to active surveillance. For patients who prefer definitive management of their tumors but are reluctant to have surgery or who may have significant comorbidities, UPEA may represent a safe alternative, and at significant cost savings compared to surgery: Dr. Hay and his colleagues reported that they estimated the average cost savings at their institution to be over $38,000 per patient. “If prospective trials of observation vs. surgery for SIPC are to occur in the USA, perhaps it could be included as a ‘third arm’ in such trials,” Dr. Hay and his colleagues said.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – An outpatient procedure may represent an efficacious and safe alternative to surgery for those patients with small papillary thyroid cancers who prefer definitive treatment over the “wait and watch” approach. Further, at one institution, the cost-effective alternative to surgery saved almost $40,000 per patient.

Ultrasound-guided percutaneous ethanol injection (UPEA) of small (cT1N0) intrathyroidal papillary thyroid cancer (SIPC) successfully reduced tumor volume by a median of 92%, eliminated tumor blood flow, and was very well tolerated by a series of 13 patients who received UPEA at the Mayo Clinic, Rochester, Minn.

Dr. Ian D. Hay, a consultant in Mayo’s division of endocrinology, diabetes, metabolism, and nutrition, presented the findings during a poster session at the International Thyroid Congress.

Dr. Hay and his colleagues treated 13 patients with a total of 15 tumors with injections of percutaneous ethanol. The first patient received just one injection; the remaining patients received one injection to each tumor site on each of 2 consecutive days. Five of the tumor foci had less than a 50% reduction in tumor volume at the first follow-up visit, so those tumors were injected a third time.

Patients in the series ranged from 38 to 86 years old (median 45), and five patients had significant comorbidities: one had congestive heart failure and the other four had concomitant unrelated cancers. Tumors were a median 8 mm in size, with volumes ranging from 25 to 676 mm³ (median 140 mm³).

All of the injections were performed under ultrasound guidance, and a median of 0.9 cc of ethanol was injected into each tumor. Ultrasound examination was performed at each follow-up visit to evaluate tumor volume and blood flow. Dr. Hay reported that the procedure was well tolerated: Local neck tenderness resolved within a day or two, and there were no reports of hoarseness or laryngeal nerve palsy.

Patients were followed for a mean 2.0 years (range, 0.4-5.7 years), with a median tumor reduction of 92% (range 46%-100%). For the nine tumors that were still identifiable on ultrasound at the time of reporting, the mean volume had decreased by 73%. Six tumor foci had completely disappeared, and no tumor had detectable blood flow on Doppler exam. Tumor thyroglobulin levels remained stable in all patients, and no nodal metastases were identified, Dr. Hay reported at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Internationally, the approach to managing SIPC varies from lobectomy to near-total thyroidectomy to active surveillance. For patients who prefer definitive management of their tumors but are reluctant to have surgery or who may have significant comorbidities, UPEA may represent a safe alternative, and at significant cost savings compared to surgery: Dr. Hay and his colleagues reported that they estimated the average cost savings at their institution to be over $38,000 per patient. “If prospective trials of observation vs. surgery for SIPC are to occur in the USA, perhaps it could be included as a ‘third arm’ in such trials,” Dr. Hay and his colleagues said.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes

LAKE BUENA VISTA, FLA. – Most patients with differentiated thyroid cancer who had shown progression on previous courses of targeted chemotherapy either maintained stable disease or responded to the oral multikinase inhibitor cabozantinib (Cometriq), according to a small multicenter phase II trial presented at the International Thyroid Congress.

This is important, according to Dr. Manisha H. Shah, because there has been no standard of care for patients with differentiated thyroid cancer whose cancer progresses on first- or second-line vascular endothelial growth factor receptor (VEGFR) inhibitors.

Nine of the 25 enrolled patients (36%; 95% confidence interval, 18%-57%) showed confirmed partial response, 12 patients (48%) had stable disease, and one patient had disease progression, according to Dr. Shah, director of the neuroendocrine tumor program at Ohio State University’s Wexner Medical Center. The trial enrolled patients with radioiodine–refractory differentiated thyroid cancer who had progression of their disease after one or two previous VEGFR agents.

©SciePro/Science Source

Cabozantinib targets VEGFR and MET and is approved as first-line treatment for medullary thyroid cancer. The majority of the response to cabozantinib occurs in the first several months of treatment, so the study used a Simon minimax two-stage design, enrolling an initial 16 patients, then opening enrollment to an additional 9 when at least 2 of the initial cohort showed partial or complete response within the first 6 months.

The primary outcome measure was the number of patients showing objective response (partial or complete response) within the first 6 months of therapy.

Median patient age was 64 years, and 64% of patients were male. Just over half of the patients previously had been treated with sorafenib, and just over a quarter had received pazopanib. Five patients had received two previous VEGFR-targeted therapies, while the remaining 20 had received one.

Nine patients (36%) had papillary thyroid cancer, seven (28%) had poorly differentiated thyroid cancer, five (20%) had Hurthle cell cancer, and four (16%) had follicular thyroid cancer. The most common metastasis sites were lymph node, bone, and lung.

Patients received continuous treatment until they showed disease progression, had an unacceptable adverse event or an illness precluding further treatment, or withdrew consent.

Disease progression was measured by serum tumor markers and CT or MRI scan every 8 weeks while in the study; patients also received bone scans and ¹⁸F-FDG and ¹⁸F-fluoride PET scans before the study and while in the study.

Side effects were common and generally mild, with two instances each of grade 3 events related to fatigue, hand-foot skin reactions, and diarrhea. One death occurred and was adjudicated as possibly study related; there were no grade 4 events, and no grade 3 bleeding events.

Dr. Shah noted that the starting cabozantinib dose of 60 mg/day was considerably lower than that used in previous trials for thyroid cancer. With time, investigators have learned that the sometimes debilitating side effects of cabozantinib are somewhat dose dependent, she noted. The study design permitted dose escalation to 80 mg for nonresponders to the lower dose, and permitted a decrease to 40 or 20 mg/day as needed to manage side effects. Investigators were able to tell the patients what to expect, and to be proactive in anticipating side effects. “We have learned to manage these drugs much better with time,” she said.

“Cabozantinib was effective in inducing a durable partial response,” said Dr. Shah. Future directions, in addition to phase III clinical trials, may include combining cabozantinib with immune checkpoint–targeted therapies such as lenvatinib, a strategy that has been effective for other cancers, she said at the meeting, which was held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The multisite study was sponsored by the National Cancer Institute with participation by eight International Thyroid Oncology Group centers. Dr. Shah reported being on the advisory board for Exelixis and Eisai, and receiving research funding from those two organizations and Bayer.

[email protected]

On Twitter @karioakes