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New AJCC guidance brings melanoma staging changes
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
“That’s good news. You have a whole year to become familiar with the changes,” Michael A. Marchetti, MD, observed at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
“That’s good news. You have a whole year to become familiar with the changes,” Michael A. Marchetti, MD, observed at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – The Eighth Edition of the American Joint Committee on Cancer Staging Manual includes significant changes in how melanoma is classified.
The manual has already been published and is available for purchase. However, its implementation will be delayed until Jan. 1, 2018, to give physicians, software vendors, and all other interested parties time to get up to speed. All cancers newly diagnosed through Dec. 31, 2017 should be staged in accord with the seventh edition, released in 2010.
“That’s good news. You have a whole year to become familiar with the changes,” Michael A. Marchetti, MD, observed at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The eighth edition breaks new ground, moving beyond TNM (Tumor, Node, Metastasis) anatomic staging to incorporate new evidence-based prognostic factors.
“There are some subtle differences here to be aware of. It can be a little bit tricky at first glance. You should become familiar with this,” advised Dr. Marchetti, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.
In addition to highlighting the changes in melanoma staging included in the new AJCC manual, he outlined key recommendations – some of them controversial – on the use of sentinel lymph node biopsy (SLNB) in melanoma patients incorporated in the 2017 National Comprehensive Cancer Network (NCCN) guidelines.
The biggest change for the dermatology community contained in the new edition of the AJCC staging manual is that the T1 classification of melanoma has changed. In the seventh edition, a melanoma was categorized as T1 if less than or equal to 1.0 mm thickness. The cancer was T1a if nonulcerated and had a mitosis rate of less than 1/mm2 and T1b if ulcerated or had at least 1 mitosis/mm2.
The eighth edition makes an evidence-based subcategorization of T1 based upon thickness in light of the prognostic implications of this distinction. A melanoma is defined as T1a if nonulcerated and less than 0.8 mm in thickness, and T1b if it is 0.8-1.0 mm thick or less than 0.8 mm with ulceration.
Of note, tumor mitotic rate has been dropped as a staging criterion for T1 tumors.
What this means is, for example, in 2017, a patient with a 0.9-mm nonulcerated melanoma with 1 mitosis/mm2 and a negative sentinel lymph node biopsy with wide local excision is T1bN0M0, pathologic Stage IB. Under the eighth edition of AJCC, the same patient is T1bN0M0, pathologic Stage IA, because that mitosis rate isn’t a factor.
Today, a patient with a 0.5-mm melanoma with 1 mitosis/mm2 with wide local excision is T1bN0M0, Pathologic Stage IB. Under the new system, the same tumor is downstaged to Pathologic Stage IA, Dr. Marchetti explained.
In the eighth edition, tumor thickness measurements are recorded with rounding to the nearest 0.1 mm, not to the nearest 0.01 mm as before. This change was prompted by the inherent lack of precision in measuring melanomas, especially thicker ones.
The T category definitions of primary tumors have been clarified in the eighth edition. A tumor should be classified as T0 only if there is no evidence of a primary tumor. T is utilized for melanoma in situ. TX is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained through curettage.
The N categorization of regional lymph node status has become much more complicated in the eighth edition, the dermatologist cautioned. Plus, the terminology for nodal disease has changed. The term micrometastasis has been replaced by “clinically occult disease” as detected by SLNB. Macrometastasis has been supplanted by “clinically detected disease.” And while in-transit or satellite node metastasis or microsatellite metastasis with satellite nodes was formerly listed simply as N3, in the new system there are subcategories for N3 based upon the number of metastatic nodes involved. For example, in the eighth edition, a melanoma is pathologic Stage N3a if there are four or more clinically occult regional lymph nodes and no in-transit, satellite, or matted nodes. Pathologic Stage N3b is shorthand for four or more tumor-involved regional lymph nodes, at least one of which was clinically detected, or any number of matted lymph nodes, with no in-transit or satellite nodal involvement. Stage N3c is reserved for melanomas with two or more clinically occult or clinically detected regional lymph nodes and/or any number of matted nodes, plus the presence of in-transit or satellite nodal metastasis.
As a result of the changes in the N classification, there are now four pathologic Stage III groups rather than three. Stages IIIA-C have been joined by pathologic Stage IIID, reserved for patients who are T4b, N3a, b, or c, and M0.
The M categorization of distant metastatic disease status has also become more elaborate. In the AJCC seventh edition, if serum lactate dehydrogenase (LDH) is elevated and a patient has any distant metastatic disease, that’s automatically category M1c. Not any longer, though.
Under the eighth edition, if a patient has distant metastasis to skin, soft tissue including muscle, and/or nonregional lymph nodes and the LDH is unspecified, the categorization is M1a. If serum LDH is not elevated, it’s M1a(0). If elevated, then M1a(1).
Similarly, for distant metastasis to the lung, the range of possibilities based upon LDH is M1b, M1b(0), and M1b(1). For distant metastasis to non-CNS visceral sites, the possibilities are M1c, M1c(0), and M1c(1).
M1d is a new classification, a clear departure from the seventh edition. It applies to patients with distant metastasis to the CNS. The classification is M1d if LDH isn’t recorded, M1d(0) if LDH isn’t elevated, and M1d(1) if it is.
Turning to the updated 2017 NCCN guidelines Version 1.2017 on the role of SLNB in melanoma, Dr. Marchetti noted that the procedure is not recommended in patients with melanoma in situ or Stage IA or IB disease 0.75 mm or less in thickness, regardless of features. Neither are routine imaging or lab tests. That’s because the pretest probability of a positive SLNB is so low, at around 3%.
For Clinicopathologic Stage IA disease, 0.76-1.0 mm in thickness with no ulceration and a mitotic rate of less than 1 per mm2, the guidelines recommend that physicians “discuss and consider” SLNB, which the available evidence suggests has roughly a 7% pretest probability of a positive result.
For Stage IB disease, 0.76-1.0 mm in thickness with ulceration or a mitotic rate of at least 1 per mm2, as well as for Stage IB or Stage II disease greater than 1.0 mm in thickness, with any feature, the language of the recommendation shifts to “discuss and offer” rather than “discuss and consider” SLNB, since various studies have reported pretest probabilities of a positive result as high as 35%.
“The rationale here for performing sentinel lymph node biopsy is primarily to acquire more staging information. Is it a perfect test? Absolutely not. But it’s the current standard of care in terms of providing additional information for staging,” according to Dr. Marchetti.
If the SLNB generates a positive result, by definition the patient now has Stage III melanoma. The NCCN guidelines recommend consideration of imaging to establish a baseline, and state further that the primary treatment is to discuss and offer complete lymph node dissection in order to control the regional nodal basin and because of a possible favorable impact on overall survival. But the question of a survival benefit has been controversial for many years, and it’s unlikely to be resolved soon, Dr. Marchetti predicted.
The final report from the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–1 (MSLT-1) concluded that patients with primary cutaneous melanomas 1.2 mm or more in thickness who were randomized to undergo SLNB and, if positive, immediate complete lymphadenectomy, fared significantly better in terms of 10-year disease-free survival, compared with those assigned to observation and lymphadenectomy in the event of nodal relapse (N Engl J Med. 2014 Feb 13;370[7]:599-609).
This conclusion has generated numerous letters to the editor from melanoma experts who took issue with the analysis and conclusion. To try to put the MSLT-1 results in perspective, Dr. Marchetti applied the results to a hypothetical cohort of 100 patients with intermediate-thickness melanomas of 1.2-3.5 mm undergoing SLNB.
Eighty of these patients would be true SLNB-negative for regional nodal disease. Five others would have a false-negative SLNB and would later develop clinically detectable nodal disease. Fifteen patients with a positive SLNB would undergo prompt complete lymph node dissection, of whom 12 or 13 would derive no mortality benefit at 10 years, assuming the MSLT-1 investigators are correct in their analysis.
“Two or three patients with a positive SLNB will derive mortality benefit at 10 years, but we have no way to identify who those people are from the original 100,” he said.
Since the MSLT-1 report, a phase III German multicenter randomized trial of 241 melanoma patients with a positive screening SLNB has reported results. The participants assigned to complete lymph node dissection didn’t differ in terms of 3-year overall survival, distant metastasis-free survival, or recurrence-free survival, compared with those assigned to observation and lymphadenectomy if nodal disease occurred (Lancet Oncol. 2016 Jun;17[6]:757-67). However, as the investigators noted, the study, known as DeCOG-SLT, was underpowered, and Dr. Marchetti’s view is that it can’t be considered definitive.
“Ultimately I don’t think we’ll have a definitive answer to this question until the final results of the MSLT-II trial in the fall of 2022,” he said.
The MSLT-II trial has the same design as DeCOG-SLT.
Dr. Marchetti reported having no financial conflicts of interest regarding his presentation.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
New topical agents for acne rolling out
WAILEA, HAWAII – The Food and Drug Administration’s approval of adapalene gel 0.1% as an over-the-counter treatment for acne is a potential game changer that could lead to revision of guideline-recommended treatment algorithms, Lawrence F. Eichenfield, MD, predicted at the Hawaii Dermatology Seminar.
In addition to discussing the implications of the FDA’s unprecedented approval of a full prescription–strength topical retinoid for OTC use, he highlighted other developments in topical therapy for acne, including the 2016 approval of dapsone 7.5% gel, as well as several agents with novel mechanisms of action now wending their way through the developmental pipeline.
In announcing approval of adapalene gel 0.1% as an OTC product, the FDA cited as a major factor in the regulatory decision the opportunity to afford acne patients greater access to retinoid therapy. The drug is now on pharmacy and supermarket shelves, marketed by Galderma Laboratories under the brand name Differin Gel 0.1% for once-daily application by patients aged 12 years and older at a cost of $20-$28 for 45 g.
“This development could be very interesting from an access standpoint and in terms of how physicians write prescriptions for retinoids, in light of the copays for other agents,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego.
“We know that with other retinoids, access is an issue. In Southern California, for example, we have strong pharmacy benefits’ managers for the insurance companies, and they’re very restrictive. It seems like every 3 months, they change the tiering of the different retinoids. It’s something we have to work on to get our patients a fair price,” he explained.
Dapsone 7.5% gel, marketed as Aczone Gel, 7.5% by Allergan, is a once-daily reformulation of the older 5% product administered twice daily. It received FDA approval for use in patients aged 12 years and older based on two 12-week, double-blind, placebo-controlled, randomized trials totaling more than 4,300 acne patients. The studies showed the stronger once-daily product was extremely well tolerated, with application site dryness and itching rates similar to placebo. In terms of efficacy, a Global Acne Assessment Score of 0 or 1 with at least a 2-grade improvement was achieved in 30% of patients assigned to dapsone 7.5% gel, compared with 21% of vehicle-treated controls.
Dr. Eichenfield was lead investigator in a recently published positive phase IIb, randomized, vehicle-controlled study of a topical nitric oxide-releasing agent for acne known for now as SB204 (J Drugs Dermatol. 2016 Dec 1;15[12]:1496-502). The product has both antimicrobial and anti-inflammatory properties, bacteria don’t develop resistance to it, and there is no significant systemic absorption.
He noted, however, that in a recent press release the product’s developer, Novan, reported mixed results in two parallel pivotal phase III clinical trials totaling more than 2,600 patients aged 9 years and older with moderate to severe acne. One of the studies was positive for all three coprimary endpoints, but the other trial showed a statistically significant benefit on only one of the three endpoints.
“I haven’t seen the data yet. We’ll have to wait and see whether this agent continues to go forward,” Dr. Eichenfield said at the meeting, sponsored by the Global Academy for Medical Education/Skin Disease Research Foundation.
In its press release, Novan stated that the company believes “its cash on hand is sufficient to fund operations at least through the end of 2017, of which the allocation of capital will be dependent upon further assessment of the SB204 phase III trial results.”
DRM01 is a novel topical inhibitor of acetyl coenzyme-A carboxylase, an enzyme involved in synthesis of the fatty acids that are an essential component of sebum. A phase IIb randomized trial in 420 adult acne patients yielded positive results, according to Dermira, which is developing DRM01. The company plans to begin a pivotal phase III trial in the first half of 2017.
Another investigational topical acne therapy to keep an eye on is cortexolone. This peripherally selective antiandrogenic agent is under development by Cassiopea* Pharmaceuticals.
Dr. Eichenfield’s financial disclosures included serving as an investigator for Novan, Regeneron, Galderma, and Astellas Pharma US; and as a consultant for Galderma, Genentech, Janssen, Lilly, Otsuka, and TopMD.
SDEF and this news organization are owned by the same parent company.
[email protected]
*An earlier version of this article misstated the company that developed the peripherally selective antiandrogenic agent.
WAILEA, HAWAII – The Food and Drug Administration’s approval of adapalene gel 0.1% as an over-the-counter treatment for acne is a potential game changer that could lead to revision of guideline-recommended treatment algorithms, Lawrence F. Eichenfield, MD, predicted at the Hawaii Dermatology Seminar.
In addition to discussing the implications of the FDA’s unprecedented approval of a full prescription–strength topical retinoid for OTC use, he highlighted other developments in topical therapy for acne, including the 2016 approval of dapsone 7.5% gel, as well as several agents with novel mechanisms of action now wending their way through the developmental pipeline.
In announcing approval of adapalene gel 0.1% as an OTC product, the FDA cited as a major factor in the regulatory decision the opportunity to afford acne patients greater access to retinoid therapy. The drug is now on pharmacy and supermarket shelves, marketed by Galderma Laboratories under the brand name Differin Gel 0.1% for once-daily application by patients aged 12 years and older at a cost of $20-$28 for 45 g.
“This development could be very interesting from an access standpoint and in terms of how physicians write prescriptions for retinoids, in light of the copays for other agents,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego.
“We know that with other retinoids, access is an issue. In Southern California, for example, we have strong pharmacy benefits’ managers for the insurance companies, and they’re very restrictive. It seems like every 3 months, they change the tiering of the different retinoids. It’s something we have to work on to get our patients a fair price,” he explained.
Dapsone 7.5% gel, marketed as Aczone Gel, 7.5% by Allergan, is a once-daily reformulation of the older 5% product administered twice daily. It received FDA approval for use in patients aged 12 years and older based on two 12-week, double-blind, placebo-controlled, randomized trials totaling more than 4,300 acne patients. The studies showed the stronger once-daily product was extremely well tolerated, with application site dryness and itching rates similar to placebo. In terms of efficacy, a Global Acne Assessment Score of 0 or 1 with at least a 2-grade improvement was achieved in 30% of patients assigned to dapsone 7.5% gel, compared with 21% of vehicle-treated controls.
Dr. Eichenfield was lead investigator in a recently published positive phase IIb, randomized, vehicle-controlled study of a topical nitric oxide-releasing agent for acne known for now as SB204 (J Drugs Dermatol. 2016 Dec 1;15[12]:1496-502). The product has both antimicrobial and anti-inflammatory properties, bacteria don’t develop resistance to it, and there is no significant systemic absorption.
He noted, however, that in a recent press release the product’s developer, Novan, reported mixed results in two parallel pivotal phase III clinical trials totaling more than 2,600 patients aged 9 years and older with moderate to severe acne. One of the studies was positive for all three coprimary endpoints, but the other trial showed a statistically significant benefit on only one of the three endpoints.
“I haven’t seen the data yet. We’ll have to wait and see whether this agent continues to go forward,” Dr. Eichenfield said at the meeting, sponsored by the Global Academy for Medical Education/Skin Disease Research Foundation.
In its press release, Novan stated that the company believes “its cash on hand is sufficient to fund operations at least through the end of 2017, of which the allocation of capital will be dependent upon further assessment of the SB204 phase III trial results.”
DRM01 is a novel topical inhibitor of acetyl coenzyme-A carboxylase, an enzyme involved in synthesis of the fatty acids that are an essential component of sebum. A phase IIb randomized trial in 420 adult acne patients yielded positive results, according to Dermira, which is developing DRM01. The company plans to begin a pivotal phase III trial in the first half of 2017.
Another investigational topical acne therapy to keep an eye on is cortexolone. This peripherally selective antiandrogenic agent is under development by Cassiopea* Pharmaceuticals.
Dr. Eichenfield’s financial disclosures included serving as an investigator for Novan, Regeneron, Galderma, and Astellas Pharma US; and as a consultant for Galderma, Genentech, Janssen, Lilly, Otsuka, and TopMD.
SDEF and this news organization are owned by the same parent company.
[email protected]
*An earlier version of this article misstated the company that developed the peripherally selective antiandrogenic agent.
WAILEA, HAWAII – The Food and Drug Administration’s approval of adapalene gel 0.1% as an over-the-counter treatment for acne is a potential game changer that could lead to revision of guideline-recommended treatment algorithms, Lawrence F. Eichenfield, MD, predicted at the Hawaii Dermatology Seminar.
In addition to discussing the implications of the FDA’s unprecedented approval of a full prescription–strength topical retinoid for OTC use, he highlighted other developments in topical therapy for acne, including the 2016 approval of dapsone 7.5% gel, as well as several agents with novel mechanisms of action now wending their way through the developmental pipeline.
In announcing approval of adapalene gel 0.1% as an OTC product, the FDA cited as a major factor in the regulatory decision the opportunity to afford acne patients greater access to retinoid therapy. The drug is now on pharmacy and supermarket shelves, marketed by Galderma Laboratories under the brand name Differin Gel 0.1% for once-daily application by patients aged 12 years and older at a cost of $20-$28 for 45 g.
“This development could be very interesting from an access standpoint and in terms of how physicians write prescriptions for retinoids, in light of the copays for other agents,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego.
“We know that with other retinoids, access is an issue. In Southern California, for example, we have strong pharmacy benefits’ managers for the insurance companies, and they’re very restrictive. It seems like every 3 months, they change the tiering of the different retinoids. It’s something we have to work on to get our patients a fair price,” he explained.
Dapsone 7.5% gel, marketed as Aczone Gel, 7.5% by Allergan, is a once-daily reformulation of the older 5% product administered twice daily. It received FDA approval for use in patients aged 12 years and older based on two 12-week, double-blind, placebo-controlled, randomized trials totaling more than 4,300 acne patients. The studies showed the stronger once-daily product was extremely well tolerated, with application site dryness and itching rates similar to placebo. In terms of efficacy, a Global Acne Assessment Score of 0 or 1 with at least a 2-grade improvement was achieved in 30% of patients assigned to dapsone 7.5% gel, compared with 21% of vehicle-treated controls.
Dr. Eichenfield was lead investigator in a recently published positive phase IIb, randomized, vehicle-controlled study of a topical nitric oxide-releasing agent for acne known for now as SB204 (J Drugs Dermatol. 2016 Dec 1;15[12]:1496-502). The product has both antimicrobial and anti-inflammatory properties, bacteria don’t develop resistance to it, and there is no significant systemic absorption.
He noted, however, that in a recent press release the product’s developer, Novan, reported mixed results in two parallel pivotal phase III clinical trials totaling more than 2,600 patients aged 9 years and older with moderate to severe acne. One of the studies was positive for all three coprimary endpoints, but the other trial showed a statistically significant benefit on only one of the three endpoints.
“I haven’t seen the data yet. We’ll have to wait and see whether this agent continues to go forward,” Dr. Eichenfield said at the meeting, sponsored by the Global Academy for Medical Education/Skin Disease Research Foundation.
In its press release, Novan stated that the company believes “its cash on hand is sufficient to fund operations at least through the end of 2017, of which the allocation of capital will be dependent upon further assessment of the SB204 phase III trial results.”
DRM01 is a novel topical inhibitor of acetyl coenzyme-A carboxylase, an enzyme involved in synthesis of the fatty acids that are an essential component of sebum. A phase IIb randomized trial in 420 adult acne patients yielded positive results, according to Dermira, which is developing DRM01. The company plans to begin a pivotal phase III trial in the first half of 2017.
Another investigational topical acne therapy to keep an eye on is cortexolone. This peripherally selective antiandrogenic agent is under development by Cassiopea* Pharmaceuticals.
Dr. Eichenfield’s financial disclosures included serving as an investigator for Novan, Regeneron, Galderma, and Astellas Pharma US; and as a consultant for Galderma, Genentech, Janssen, Lilly, Otsuka, and TopMD.
SDEF and this news organization are owned by the same parent company.
[email protected]
*An earlier version of this article misstated the company that developed the peripherally selective antiandrogenic agent.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Coffee break at the Hawaii Dermatology Seminar
WAILEA, HAWAII – A few attendees at the Hawaii Dermatology Seminar discussed some of the highlights of the presentations during a coffee break at the meeting.
New treatment protocols for psoriasis, details about skin disease in children, managing medication side effects, and promising data about biologics are discussed in this video, as are updates on the latest tips for treating atopic dermatitis.
The interviewees had no conflicts to disclose.
The meeting is provided by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – A few attendees at the Hawaii Dermatology Seminar discussed some of the highlights of the presentations during a coffee break at the meeting.
New treatment protocols for psoriasis, details about skin disease in children, managing medication side effects, and promising data about biologics are discussed in this video, as are updates on the latest tips for treating atopic dermatitis.
The interviewees had no conflicts to disclose.
The meeting is provided by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – A few attendees at the Hawaii Dermatology Seminar discussed some of the highlights of the presentations during a coffee break at the meeting.
New treatment protocols for psoriasis, details about skin disease in children, managing medication side effects, and promising data about biologics are discussed in this video, as are updates on the latest tips for treating atopic dermatitis.
The interviewees had no conflicts to disclose.
The meeting is provided by Global Academy for Medical Education/Skin Disease Education Foundation. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Distinctive features define pediatric psoriasis
WAILEA, HAWAII – Plaque type psoriasis continues to be the most common type of psoriasis in children, but there are other presentations that should be considered, said Wynnis Tom, MD, a pediatric dermatologist at the University of California, San Diego, and Rady Children’s Hospital, San Diego.
“We certainly see a form of what some people would call napkin dermatitis,” or “diaper psoriasis,” affecting the diaper area in young infants, Dr. Tom said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
So when a child has a more refractory diaper rash, “look around to see if there are other lesions in the surrounding area that might be more typical for psoriasis,” she noted.
“We also see a lot more guttate disease” in children with psoriasis, which is more likely to be related to infections and triggers, Dr. Tom said. The face and scalp are often affected in children, and it is important to attend to these areas early to help avoid social stigma, she added.
Dr. Tom disclosed financial relationships with companies including Celgene, Janssen, and Promius. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Plaque type psoriasis continues to be the most common type of psoriasis in children, but there are other presentations that should be considered, said Wynnis Tom, MD, a pediatric dermatologist at the University of California, San Diego, and Rady Children’s Hospital, San Diego.
“We certainly see a form of what some people would call napkin dermatitis,” or “diaper psoriasis,” affecting the diaper area in young infants, Dr. Tom said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
So when a child has a more refractory diaper rash, “look around to see if there are other lesions in the surrounding area that might be more typical for psoriasis,” she noted.
“We also see a lot more guttate disease” in children with psoriasis, which is more likely to be related to infections and triggers, Dr. Tom said. The face and scalp are often affected in children, and it is important to attend to these areas early to help avoid social stigma, she added.
Dr. Tom disclosed financial relationships with companies including Celgene, Janssen, and Promius. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Plaque type psoriasis continues to be the most common type of psoriasis in children, but there are other presentations that should be considered, said Wynnis Tom, MD, a pediatric dermatologist at the University of California, San Diego, and Rady Children’s Hospital, San Diego.
“We certainly see a form of what some people would call napkin dermatitis,” or “diaper psoriasis,” affecting the diaper area in young infants, Dr. Tom said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
So when a child has a more refractory diaper rash, “look around to see if there are other lesions in the surrounding area that might be more typical for psoriasis,” she noted.
“We also see a lot more guttate disease” in children with psoriasis, which is more likely to be related to infections and triggers, Dr. Tom said. The face and scalp are often affected in children, and it is important to attend to these areas early to help avoid social stigma, she added.
Dr. Tom disclosed financial relationships with companies including Celgene, Janssen, and Promius. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Pediatric psoriasis patients prepare for biologics
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Nonsteroidal topical expands options for pediatric AD
WAILEA, HAWAII – In an interview, pediatric dermatologist Lawrence F. Eichenfield, MD, discusses a recently approved topical therapy for atopic dermatitis, which provides a nonsteroidal option for treating the disease in young patients.
“We’re really excited to have a new topical agent” for AD, Dr. Eichenfield said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The product, crisaborole (Eucrisa), is a phosphodiesterase 4 (PDE-4) inhibitor, a new type of chemical entity “based on a different pathway of decreasing inflammation,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego. Crisaborole, the first new chemical entity to become available for treating AD since 2001, blocks PDE-4 and decreases cytokines, thereby reducing the inflammation in AD, he explained.
In the United States, the product is approved for the topical treatment of mild to moderate AD for patients aged 2 years and older. No serious adverse events attributed to crisaborole have been reported so far, in phase II and III studies and in a 1-year study, he said.
Dr. Eichenfield disclosed relationships with companies including Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka. Crisaborole is manufactured by Anacor. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – In an interview, pediatric dermatologist Lawrence F. Eichenfield, MD, discusses a recently approved topical therapy for atopic dermatitis, which provides a nonsteroidal option for treating the disease in young patients.
“We’re really excited to have a new topical agent” for AD, Dr. Eichenfield said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The product, crisaborole (Eucrisa), is a phosphodiesterase 4 (PDE-4) inhibitor, a new type of chemical entity “based on a different pathway of decreasing inflammation,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego. Crisaborole, the first new chemical entity to become available for treating AD since 2001, blocks PDE-4 and decreases cytokines, thereby reducing the inflammation in AD, he explained.
In the United States, the product is approved for the topical treatment of mild to moderate AD for patients aged 2 years and older. No serious adverse events attributed to crisaborole have been reported so far, in phase II and III studies and in a 1-year study, he said.
Dr. Eichenfield disclosed relationships with companies including Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka. Crisaborole is manufactured by Anacor. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – In an interview, pediatric dermatologist Lawrence F. Eichenfield, MD, discusses a recently approved topical therapy for atopic dermatitis, which provides a nonsteroidal option for treating the disease in young patients.
“We’re really excited to have a new topical agent” for AD, Dr. Eichenfield said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The product, crisaborole (Eucrisa), is a phosphodiesterase 4 (PDE-4) inhibitor, a new type of chemical entity “based on a different pathway of decreasing inflammation,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego. Crisaborole, the first new chemical entity to become available for treating AD since 2001, blocks PDE-4 and decreases cytokines, thereby reducing the inflammation in AD, he explained.
In the United States, the product is approved for the topical treatment of mild to moderate AD for patients aged 2 years and older. No serious adverse events attributed to crisaborole have been reported so far, in phase II and III studies and in a 1-year study, he said.
Dr. Eichenfield disclosed relationships with companies including Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka. Crisaborole is manufactured by Anacor. SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VIDEO: Dosing an important consideration when using neuromodulators in men
WAILEA, HAWAII – Using larger doses and avoiding overarching of the brows are among the considerations to keep in mind when using neuromodulators in men, advised Canadian dermatologist Katie Beleznay, MD.
In general, men have a very different anatomy with a different brow position, and have needs different from those of women, said Dr. Beleznay of the University of British Columbia, Vancouver.
One secret for successful injections of toxins in male patients: Dose matters. Men have stronger muscles in the face and need larger doses to overcome their muscular strength, Dr. Beleznay said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
On average, “if you use 20-30 units in a female glabella, maybe you’d use 40-50, maybe even 60 units in a male patient,” she said. However, the volume depends on the strength of the muscles in the area, and some men may need less to avoid a frozen look. “You can always treat less and bring them back in a couple of weeks and add more,” especially with patients who are new to treatment, Dr. Beleznay noted.
She disclosed financial relationships with Allergan, Revance, Evolus, Galderma, and Zeltiq.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Using larger doses and avoiding overarching of the brows are among the considerations to keep in mind when using neuromodulators in men, advised Canadian dermatologist Katie Beleznay, MD.
In general, men have a very different anatomy with a different brow position, and have needs different from those of women, said Dr. Beleznay of the University of British Columbia, Vancouver.
One secret for successful injections of toxins in male patients: Dose matters. Men have stronger muscles in the face and need larger doses to overcome their muscular strength, Dr. Beleznay said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
On average, “if you use 20-30 units in a female glabella, maybe you’d use 40-50, maybe even 60 units in a male patient,” she said. However, the volume depends on the strength of the muscles in the area, and some men may need less to avoid a frozen look. “You can always treat less and bring them back in a couple of weeks and add more,” especially with patients who are new to treatment, Dr. Beleznay noted.
She disclosed financial relationships with Allergan, Revance, Evolus, Galderma, and Zeltiq.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Using larger doses and avoiding overarching of the brows are among the considerations to keep in mind when using neuromodulators in men, advised Canadian dermatologist Katie Beleznay, MD.
In general, men have a very different anatomy with a different brow position, and have needs different from those of women, said Dr. Beleznay of the University of British Columbia, Vancouver.
One secret for successful injections of toxins in male patients: Dose matters. Men have stronger muscles in the face and need larger doses to overcome their muscular strength, Dr. Beleznay said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
On average, “if you use 20-30 units in a female glabella, maybe you’d use 40-50, maybe even 60 units in a male patient,” she said. However, the volume depends on the strength of the muscles in the area, and some men may need less to avoid a frozen look. “You can always treat less and bring them back in a couple of weeks and add more,” especially with patients who are new to treatment, Dr. Beleznay noted.
She disclosed financial relationships with Allergan, Revance, Evolus, Galderma, and Zeltiq.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Patient survey data yield useful information on acne and different contraceptives
WAILEA, HAWAII – A study that used patient-reported outcomes to assess the impact of different contraceptive methods on acne provided “fascinating results,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“Progestins are present in birth control for the birth control, but they’re not usually good for the acne,” Dr. Eichenfield said in a video interview at the meeting.
Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and his colleagues reviewed patient reports from an Internet-based survey of more than 2,000 adolescent and young adult acne patients asking whether they were on any contraceptive, and if so, how they thought the contraceptive method affected their acne.
Overall, hormonal progestin-only IUDs and some progestin-only implants correlated with worse acne. Of the combined oral contraceptives, those on the OCs containing drospirenone performed best, he said. Also of interest, the triphasic OCs, with the progestin in three phases, had a better impact on the acne than did the dual ones, he added.
The review of patient-reported outcomes can not only inform clinicians on how they should prescribe hormonal therapy, but also raises awareness of the impact of contraceptives on acne in general, Dr. Eichenfield said.
The results were published last year (J Drugs Dermatol. 2016 Jun 1;15[6]:670-4).
Dr. Eichenfield disclosed relationships with Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – A study that used patient-reported outcomes to assess the impact of different contraceptive methods on acne provided “fascinating results,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“Progestins are present in birth control for the birth control, but they’re not usually good for the acne,” Dr. Eichenfield said in a video interview at the meeting.
Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and his colleagues reviewed patient reports from an Internet-based survey of more than 2,000 adolescent and young adult acne patients asking whether they were on any contraceptive, and if so, how they thought the contraceptive method affected their acne.
Overall, hormonal progestin-only IUDs and some progestin-only implants correlated with worse acne. Of the combined oral contraceptives, those on the OCs containing drospirenone performed best, he said. Also of interest, the triphasic OCs, with the progestin in three phases, had a better impact on the acne than did the dual ones, he added.
The review of patient-reported outcomes can not only inform clinicians on how they should prescribe hormonal therapy, but also raises awareness of the impact of contraceptives on acne in general, Dr. Eichenfield said.
The results were published last year (J Drugs Dermatol. 2016 Jun 1;15[6]:670-4).
Dr. Eichenfield disclosed relationships with Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – A study that used patient-reported outcomes to assess the impact of different contraceptive methods on acne provided “fascinating results,” Lawrence F. Eichenfield, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“Progestins are present in birth control for the birth control, but they’re not usually good for the acne,” Dr. Eichenfield said in a video interview at the meeting.
Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and his colleagues reviewed patient reports from an Internet-based survey of more than 2,000 adolescent and young adult acne patients asking whether they were on any contraceptive, and if so, how they thought the contraceptive method affected their acne.
Overall, hormonal progestin-only IUDs and some progestin-only implants correlated with worse acne. Of the combined oral contraceptives, those on the OCs containing drospirenone performed best, he said. Also of interest, the triphasic OCs, with the progestin in three phases, had a better impact on the acne than did the dual ones, he added.
The review of patient-reported outcomes can not only inform clinicians on how they should prescribe hormonal therapy, but also raises awareness of the impact of contraceptives on acne in general, Dr. Eichenfield said.
The results were published last year (J Drugs Dermatol. 2016 Jun 1;15[6]:670-4).
Dr. Eichenfield disclosed relationships with Anacor/Pfizer, Genentech, Lilly, Regeneron/Sanofi, Medimetriks, and Otsuka.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Office-based survey characterizes seborrheic keratosis lesions in adults
WAILEA, HAWAII – More than half of the patients with seborrheic keratosis had more than 16 lesions, in a prospective study of 406 adults at 10 dermatology practices.
The results were presented in a poster at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The study population was 62% female, with an average age of 58 years. Patients were seen at 10 community dermatology clinics across the United States, where they completed questionnaires about their seborrheic keratosis.
Of those surveyed, 54% had more than 16 lesions, while 18% had 5 or fewer; another 18% had 6-10 lesions, and 10% had 11-15 lesions. The mean number of lesions by location ranged from 3.6 on the face to 26 on the upper body. Approximately 31% of patients reported picking at their lesions to cause them to fall off.
Most of those surveyed said they were either interested or somewhat interested in an office-based treatment. Female patients and patients with lesions on the head and neck were more likely to report interest in an office-based treatment.
The findings were limited by the inclusion only of patients who presented to private dermatology clinics and therefore may not generalize to the overall population of seborrheic keratosis patients.
The author of the study was James Del Rosso, MD, of Touro University, Nevada.
The study was supported by Aclaris Therapeutics. Dr. Del Rosso has received consulting fees from Aclaris.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – More than half of the patients with seborrheic keratosis had more than 16 lesions, in a prospective study of 406 adults at 10 dermatology practices.
The results were presented in a poster at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The study population was 62% female, with an average age of 58 years. Patients were seen at 10 community dermatology clinics across the United States, where they completed questionnaires about their seborrheic keratosis.
Of those surveyed, 54% had more than 16 lesions, while 18% had 5 or fewer; another 18% had 6-10 lesions, and 10% had 11-15 lesions. The mean number of lesions by location ranged from 3.6 on the face to 26 on the upper body. Approximately 31% of patients reported picking at their lesions to cause them to fall off.
Most of those surveyed said they were either interested or somewhat interested in an office-based treatment. Female patients and patients with lesions on the head and neck were more likely to report interest in an office-based treatment.
The findings were limited by the inclusion only of patients who presented to private dermatology clinics and therefore may not generalize to the overall population of seborrheic keratosis patients.
The author of the study was James Del Rosso, MD, of Touro University, Nevada.
The study was supported by Aclaris Therapeutics. Dr. Del Rosso has received consulting fees from Aclaris.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – More than half of the patients with seborrheic keratosis had more than 16 lesions, in a prospective study of 406 adults at 10 dermatology practices.
The results were presented in a poster at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The study population was 62% female, with an average age of 58 years. Patients were seen at 10 community dermatology clinics across the United States, where they completed questionnaires about their seborrheic keratosis.
Of those surveyed, 54% had more than 16 lesions, while 18% had 5 or fewer; another 18% had 6-10 lesions, and 10% had 11-15 lesions. The mean number of lesions by location ranged from 3.6 on the face to 26 on the upper body. Approximately 31% of patients reported picking at their lesions to cause them to fall off.
Most of those surveyed said they were either interested or somewhat interested in an office-based treatment. Female patients and patients with lesions on the head and neck were more likely to report interest in an office-based treatment.
The findings were limited by the inclusion only of patients who presented to private dermatology clinics and therefore may not generalize to the overall population of seborrheic keratosis patients.
The author of the study was James Del Rosso, MD, of Touro University, Nevada.
The study was supported by Aclaris Therapeutics. Dr. Del Rosso has received consulting fees from Aclaris.
SDEF and this news organization are owned by the same parent company.
AT SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: New dermal fillers add flexibility
WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.
The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.
In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.
He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.
The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.
In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.
He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.
The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.
In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.
He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR