User login
Young Children With Melanoma at Risk for SLN Metastases
BALTIMORE – Young children with melanoma are more likely to have sentinel lymph node metastases than older children and young adults, according to the results of a new study.
The study also found that thickness and ulceration were strong predictors of sentinel lymph node biopsy (SLNB) in children and young adults with melanoma (Cancer 2011 Oct. 5 [doi:10.1002/cncr.26578]).
Using the 2008 Surveillance, Epidemiology, and End Results (SEER) databases, Euphemia Mu, of Johns Hopkins University, Baltimore, and colleagues analyzed the medical records of 717 children (79 were aged less than 10 years and 638 were aged 10-19) and 1,368 young adults (aged 20-24) who were diagnosed with melanoma between 2003 and 2008.
The researchers gathered demographic and tumor data, and compared tests results from lymph node biopsies based on tumor size, tumor appearance, and age. Median follow-up for all patients was 34 months. Results offered information about:
• Demographics. Younger children with melanoma were more often male (47%) and nonwhite (9%), compared with adolescents (41% male, 2% nonwhite) and young adults (31% male, 1.4% nonwhite).
• Presentation. Melanoma in young children more frequently presented with distant metastases (6%), nodular morphology (10%), and more than 1 mm thickness (40%), compared with tumors in adolescents (1% metastatic, 5% nodular, and 28% more than 1 mm thick) and young adults (2% metastatic, 6% nodular, and 22% with thickness of 1 mm or higher). The proportion with ulceration did not differ significantly among these age groups.
• Likelihood of biopsy. In all, 40% of children and 31% of young adults who had localized disease on examination underwent SLN biopsy. Of those who met the recommendations for SLN biopsy (more than 1 mm in thickness or ulceration), 74% of children and 70% of young adults underwent SLN biopsy. In pediatric and young adult patients, ulceration, histology, thickness, sex, and primary site were correlated significantly with undergoing SLN biopsy.
• Metastases. A total of 25% of children and 14% of young adults who underwent biopsy had SLN metastases. Children whose melanomas were between 1.01 mm and 2.00 mm thick had SLN metastases more often than young adults (24% vs. 4%).
"This finding supports the idea that some melanomas in children may differ biologically from melanomas in adults and should encourage future efforts to investigate the biologic heterogeneity of melanoma," the researchers wrote.
Other characteristics associated with SLN metastases in patients included ulceration (62%) and nodular histology (43%). Overall, children were more likely than young adults to have SLN metastases for all analyzed characteristics (ulceration, histology, thickness, sex, and primary site).
• Prognosis. There was no statistically significant difference in survival between adults and children who tested positive on SLN biopsy. Four out of 64 children (6.3%) and 4 out of 54 young adults (7.4%) who tested positive died vs. 1 of 182 children (0.5%) and 3 of 322 young adults (0.9%) who tested negative.
• Completion lymph node dissection (CLND). Among patients who had negative SLN biopsies, 16% of pediatric and 12% of adult patients underwent CLND, compared with 78% of pediatric patients and 73% of young adult patients who had positive biopsies.
Findings of this study are "a powerful reminder that there’s much about pediatric melanoma that we don’t understand and that, just as is the case with other diseases, children are not small adults, but differ markedly in their response to disease," senior investigator Dr. John J. Strouse, a pediatric hematologist and oncologist at Johns Hopkins, said in a statement.
Study limitations included lack of a centralized review of diagnostic specimens, absence of information regarding mitotic rate, and lack of information about socioeconomic factors, the investigators noted.
Although this study was an important comparison for understanding age-related differences in melanoma characteristics, studies are needed that compare SLN biopsy use and results in pediatric cases with adult cases.
The study investigators made no disclosures.
BALTIMORE – Young children with melanoma are more likely to have sentinel lymph node metastases than older children and young adults, according to the results of a new study.
The study also found that thickness and ulceration were strong predictors of sentinel lymph node biopsy (SLNB) in children and young adults with melanoma (Cancer 2011 Oct. 5 [doi:10.1002/cncr.26578]).
Using the 2008 Surveillance, Epidemiology, and End Results (SEER) databases, Euphemia Mu, of Johns Hopkins University, Baltimore, and colleagues analyzed the medical records of 717 children (79 were aged less than 10 years and 638 were aged 10-19) and 1,368 young adults (aged 20-24) who were diagnosed with melanoma between 2003 and 2008.
The researchers gathered demographic and tumor data, and compared tests results from lymph node biopsies based on tumor size, tumor appearance, and age. Median follow-up for all patients was 34 months. Results offered information about:
• Demographics. Younger children with melanoma were more often male (47%) and nonwhite (9%), compared with adolescents (41% male, 2% nonwhite) and young adults (31% male, 1.4% nonwhite).
• Presentation. Melanoma in young children more frequently presented with distant metastases (6%), nodular morphology (10%), and more than 1 mm thickness (40%), compared with tumors in adolescents (1% metastatic, 5% nodular, and 28% more than 1 mm thick) and young adults (2% metastatic, 6% nodular, and 22% with thickness of 1 mm or higher). The proportion with ulceration did not differ significantly among these age groups.
• Likelihood of biopsy. In all, 40% of children and 31% of young adults who had localized disease on examination underwent SLN biopsy. Of those who met the recommendations for SLN biopsy (more than 1 mm in thickness or ulceration), 74% of children and 70% of young adults underwent SLN biopsy. In pediatric and young adult patients, ulceration, histology, thickness, sex, and primary site were correlated significantly with undergoing SLN biopsy.
• Metastases. A total of 25% of children and 14% of young adults who underwent biopsy had SLN metastases. Children whose melanomas were between 1.01 mm and 2.00 mm thick had SLN metastases more often than young adults (24% vs. 4%).
"This finding supports the idea that some melanomas in children may differ biologically from melanomas in adults and should encourage future efforts to investigate the biologic heterogeneity of melanoma," the researchers wrote.
Other characteristics associated with SLN metastases in patients included ulceration (62%) and nodular histology (43%). Overall, children were more likely than young adults to have SLN metastases for all analyzed characteristics (ulceration, histology, thickness, sex, and primary site).
• Prognosis. There was no statistically significant difference in survival between adults and children who tested positive on SLN biopsy. Four out of 64 children (6.3%) and 4 out of 54 young adults (7.4%) who tested positive died vs. 1 of 182 children (0.5%) and 3 of 322 young adults (0.9%) who tested negative.
• Completion lymph node dissection (CLND). Among patients who had negative SLN biopsies, 16% of pediatric and 12% of adult patients underwent CLND, compared with 78% of pediatric patients and 73% of young adult patients who had positive biopsies.
Findings of this study are "a powerful reminder that there’s much about pediatric melanoma that we don’t understand and that, just as is the case with other diseases, children are not small adults, but differ markedly in their response to disease," senior investigator Dr. John J. Strouse, a pediatric hematologist and oncologist at Johns Hopkins, said in a statement.
Study limitations included lack of a centralized review of diagnostic specimens, absence of information regarding mitotic rate, and lack of information about socioeconomic factors, the investigators noted.
Although this study was an important comparison for understanding age-related differences in melanoma characteristics, studies are needed that compare SLN biopsy use and results in pediatric cases with adult cases.
The study investigators made no disclosures.
BALTIMORE – Young children with melanoma are more likely to have sentinel lymph node metastases than older children and young adults, according to the results of a new study.
The study also found that thickness and ulceration were strong predictors of sentinel lymph node biopsy (SLNB) in children and young adults with melanoma (Cancer 2011 Oct. 5 [doi:10.1002/cncr.26578]).
Using the 2008 Surveillance, Epidemiology, and End Results (SEER) databases, Euphemia Mu, of Johns Hopkins University, Baltimore, and colleagues analyzed the medical records of 717 children (79 were aged less than 10 years and 638 were aged 10-19) and 1,368 young adults (aged 20-24) who were diagnosed with melanoma between 2003 and 2008.
The researchers gathered demographic and tumor data, and compared tests results from lymph node biopsies based on tumor size, tumor appearance, and age. Median follow-up for all patients was 34 months. Results offered information about:
• Demographics. Younger children with melanoma were more often male (47%) and nonwhite (9%), compared with adolescents (41% male, 2% nonwhite) and young adults (31% male, 1.4% nonwhite).
• Presentation. Melanoma in young children more frequently presented with distant metastases (6%), nodular morphology (10%), and more than 1 mm thickness (40%), compared with tumors in adolescents (1% metastatic, 5% nodular, and 28% more than 1 mm thick) and young adults (2% metastatic, 6% nodular, and 22% with thickness of 1 mm or higher). The proportion with ulceration did not differ significantly among these age groups.
• Likelihood of biopsy. In all, 40% of children and 31% of young adults who had localized disease on examination underwent SLN biopsy. Of those who met the recommendations for SLN biopsy (more than 1 mm in thickness or ulceration), 74% of children and 70% of young adults underwent SLN biopsy. In pediatric and young adult patients, ulceration, histology, thickness, sex, and primary site were correlated significantly with undergoing SLN biopsy.
• Metastases. A total of 25% of children and 14% of young adults who underwent biopsy had SLN metastases. Children whose melanomas were between 1.01 mm and 2.00 mm thick had SLN metastases more often than young adults (24% vs. 4%).
"This finding supports the idea that some melanomas in children may differ biologically from melanomas in adults and should encourage future efforts to investigate the biologic heterogeneity of melanoma," the researchers wrote.
Other characteristics associated with SLN metastases in patients included ulceration (62%) and nodular histology (43%). Overall, children were more likely than young adults to have SLN metastases for all analyzed characteristics (ulceration, histology, thickness, sex, and primary site).
• Prognosis. There was no statistically significant difference in survival between adults and children who tested positive on SLN biopsy. Four out of 64 children (6.3%) and 4 out of 54 young adults (7.4%) who tested positive died vs. 1 of 182 children (0.5%) and 3 of 322 young adults (0.9%) who tested negative.
• Completion lymph node dissection (CLND). Among patients who had negative SLN biopsies, 16% of pediatric and 12% of adult patients underwent CLND, compared with 78% of pediatric patients and 73% of young adult patients who had positive biopsies.
Findings of this study are "a powerful reminder that there’s much about pediatric melanoma that we don’t understand and that, just as is the case with other diseases, children are not small adults, but differ markedly in their response to disease," senior investigator Dr. John J. Strouse, a pediatric hematologist and oncologist at Johns Hopkins, said in a statement.
Study limitations included lack of a centralized review of diagnostic specimens, absence of information regarding mitotic rate, and lack of information about socioeconomic factors, the investigators noted.
Although this study was an important comparison for understanding age-related differences in melanoma characteristics, studies are needed that compare SLN biopsy use and results in pediatric cases with adult cases.
The study investigators made no disclosures.
FROM CANCER
Major Finding: Twenty-five percent of children and 14% of young adults who underwent biopsy had SLN metastases.
Data Source: Investigators used the 2008 SEER database to analyze the medical records of 717 children and 1,368 young adults who were diagnosed with melanoma between 2003 and 2008.
Disclosures: The study investigators made no disclosures.
Mini X-Ray Device Treats Nonmelanoma Skin Cancers
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
A physician who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
A physician who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
A physician who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: Approximately 93% of patients treated for nonmelanoma skin cancers with an electronic brachytherapy device had cosmetic results rated as excellent at 1 year, according to Radiation Therapy Oncology Group criteria.
Data Source: Retrospective case study of 102 patients with 120 basal cell, squamous cell, or other nonmelanoma cancers
Disclosures: The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
Mini X-Ray Device Treats Nonmelanoma Skin Cancers
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
Dr. Bhatnagar also launched a salvo in the turf battle between radiation oncologists and surgeons by urging his colleagues to take on more skin cancer cases. "Despite skin cancer being the most common malignancy in the world, it’s under-represented in our radiation oncology clinics. As radiation oncologists, we need to play a more prominent role in the treatment of nonmelanoma skin cancers," he said in his presentation.
A radiation oncologist who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
Dr. Bhatnagar also launched a salvo in the turf battle between radiation oncologists and surgeons by urging his colleagues to take on more skin cancer cases. "Despite skin cancer being the most common malignancy in the world, it’s under-represented in our radiation oncology clinics. As radiation oncologists, we need to play a more prominent role in the treatment of nonmelanoma skin cancers," he said in his presentation.
A radiation oncologist who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
MIAMI BEACH – An x-ray tube about the size of a sewing needle can safely deliver radiation to nonmelanoma skin tumors on the nose, scalp, or other highly visible areas of skin with good efficacy and good to excellent cosmetic results, an investigator reported at the annual meeting of the American Society for Radiation Oncology.
About 93% of patients treated with an electronic brachytherapy system from Xoft had cosmetic results judged to meet Radiation Therapy Oncology Group (RTOG) criteria for "excellent" at 1 year, said Dr. Ajay Bhatnagar of Cancer Treatment Services Arizona, Casa Grande.
"To date, the treatment of nonmelanoma skin cancer with electronic brachytherapy is comparable to traditional brachytherapy, with excellent cosmesis, acceptable acute toxicities, and no recurrences to date. Brachytherapy is an excellent modality for elderly patients with nonmelanoma skin cancers in cosmetically sensitive locations," he said.
The electronic brachytherapy system delivers a radiation dose to tumors equivalent to that of an iridium-192, high dose rate surface (Leipzig) applicator, but without the need for a radioisotope. The electronic device is a miniature, high dose rate, low-energy x-ray tube that produces x-rays with a maximum of 50 keV of energy.
Dr. Bhatnagar looked at data on 102 patients treated with the device for 120 nonmelanoma skin cancer lesions. All patients received 5 Gy in eight dose fractions for a total of 40 Gy delivered in two fractions per week for 4 weeks. The prescription depth, based on CT simulation, varied from 3 to 7 mm. The treatment goal was to achieve a minimum 5-mm treatment margin wherever possible.
The device was placed with the patient immobilized and wearing a flex shield that prevents excessive radiation exposure to the clinician. Skin care included application of petrolatum ointment during treatment and aloe vera gel for 1 month afterward.
Of the 120 lesions treated, 59% had basal cell histology, 36% were squamous cell, 2% were Merkel cell carcinomas, 3% were cutaneous T-cell lymphoma lesions, and 1% had a mixed basal-squamous histology.
About one-third of the lesions were on the nose, another third on the face, with the remainder on the ears, extremities, scalp, and torso.
Nearly all patients (91%) experienced an acute rash with treatment, and 25% had itching of the treatment site. The most frequent late adverse effect was hypopigmentation of the treated skin, which occurred in 11% of lesions from 3 to 6 months.
At 1 month post treatment, cosmesis was rated as excellent (no change to slight atrophy or pigment change; slight hair loss; or no changes to slight induration or loss of subcutaneous fat) in about 77% of 81 patients evaluated; the remainder had "good" cosmesis (patch atrophy, moderate telangiectasia, total hair loss; moderate fibrosis but asymptomatic, slight field contracture with less than 10% linear reduction).
Dr. Bhatnagar also launched a salvo in the turf battle between radiation oncologists and surgeons by urging his colleagues to take on more skin cancer cases. "Despite skin cancer being the most common malignancy in the world, it’s under-represented in our radiation oncology clinics. As radiation oncologists, we need to play a more prominent role in the treatment of nonmelanoma skin cancers," he said in his presentation.
A radiation oncologist who was not involved in the study commented that radiation therapy offers certain advantages over surgery when tumors are located in prominent locations, such as the face.
"We’ve been treating these lesions for close to 100 years now, and radiation does very well," said Dr. Keith A. Cengel, of the University of Pennsylvania School of Medicine in Philadelphia. "The one drawback – and I tell this to my patients when I treat with radiation – is that [subsequent] surgery can be more difficult and have a higher complication rate if you have a recurrence."
Mohs surgery, the most common form of treatment for basal or squamous cell skin cancers, may itself leave a comparatively deep and wide wound that may not heal as smoothly as a radiation-treated lesion, he added.
Dr. Cengel comoderated the session in which the electronic brachytherapy data were presented.
The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR RADIATION ONCOLOGY
Major Finding: Approximately 93% of patients treated for nonmelanoma skin cancers with an electronic brachytherapy device had cosmetic results rated as excellent at 1 year, according to Radiation Therapy Oncology Group criteria.
Data Source: Retrospective case study of 102 patients with 120 basal cell, squamous cell, or other nonmelanoma cancers
Disclosures: The study was sponsored by Xoft, manufacturer of the brachytherapy device. Dr. Bhatnagar receives funding for serving as principal investigator of a prospective multicenter study of the device.
Hair Stylists Report Looking for Suspicious Lesions
Hair stylists are on the lookout for suspicious lesions on their customers’ scalps, necks, and faces, and are "very" interested in receiving formal skin cancer education, according to a study published Oct. 17 in the Archives of Dermatology.
Although only 28% of hair professionals have received any formal skin cancer education, many reported routinely looking for problematic spots or changing moles, according to Dr. Elizabeth E. Bailey of the department of medicine at Brigham and Women’s Hospital in Boston.
Dr. Bailey and her colleagues received 203 completed surveys from hair professionals in January 2010 on skin cancer practice and knowledge. The hair professionals were from a chain of 17 salons in the greater Houston area.
Hair stylists who frequently talked with their customers about health issues, including personal skin protection practices, were more likely to scan for suspicious lesions. However, it didn’t seem to matter whether or not the stylists had basic skin cancer knowledge, possibly because most already knew the basics, the investigators reported (Arch. Dermatol. 2011;147:1159-65).
According to the study, about 90% agreed or strongly agreed that a customer should see a health professional for a mole that is changing in size or frequently bleeds. A total of 89% said customers should see a health professional if they have a mole that is changing in color, and 78% said moles that itch frequently should be checked out.
A total of 37% of the hair professionals surveyed had scanned more than half of their customers’ scalps, 29% had scanned more than half of their customers’ necks, and 15% had scanned more than half of their customers’ faces for suspicious lesions in the past month.
Survey participants who knew the ABCD rule for melanoma were more likely to look at customers’ skin, and "understanding the difference between melanoma and ordinary skin growths and disagreeing that skin cancer was more difficult to detect than other types of cancer was also associated with a higher likelihood of customer observation," the investigators wrote.
Hair stylists who were confident looking at their own moles also tended to look at their customers’ skin, and stylists who had a personal history of skin cancer or experience with a friend or family member’s skin cancer also looked for potential problem spots on customers’ skin more often, the study found.
About half (49%) of survey participants said they were "very" or "extremely" interested in participating in a skin cancer education program, indicating that dermatologists should consider investigating hair stylists’ potential role in skin cancer prevention and detection.
"Hair professionals are currently acting as lay health advisors for skin cancer detection and prevention and are willing to become more involved in skin cancer education in the salon," said the investigators. "As professionals who have a natural view of difficult-to-see areas and who develop a close rapport with their customers, hair professionals are ideally suited to this role."
Melanoma of the scalp and neck accounted for 6% of all melanoma and for 10% of melanoma deaths in the United States between 1973 and 2003, likely because it’s difficult to find suspicious lesions in these locations during self-examinations by patients and routine exams by physicians, the investigators noted.
Therefore, hair stylists – who typically see areas of the head and scalp that patients and physicians might miss – are in a unique position to detect skin cancers that might otherwise go unnoticed.
"Through the many active professional education venues within the hair industry, the infrastructure exists to educate them," wrote Dr. Bailey and her colleagues. "Future research should focus on creating a program that provides hair professionals with expert training and effective health communication tools to become confident and skilled lay skin cancer educators."
The investigators did not report having any conflicts of interest.
Hair stylists are on the lookout for suspicious lesions on their customers’ scalps, necks, and faces, and are "very" interested in receiving formal skin cancer education, according to a study published Oct. 17 in the Archives of Dermatology.
Although only 28% of hair professionals have received any formal skin cancer education, many reported routinely looking for problematic spots or changing moles, according to Dr. Elizabeth E. Bailey of the department of medicine at Brigham and Women’s Hospital in Boston.
Dr. Bailey and her colleagues received 203 completed surveys from hair professionals in January 2010 on skin cancer practice and knowledge. The hair professionals were from a chain of 17 salons in the greater Houston area.
Hair stylists who frequently talked with their customers about health issues, including personal skin protection practices, were more likely to scan for suspicious lesions. However, it didn’t seem to matter whether or not the stylists had basic skin cancer knowledge, possibly because most already knew the basics, the investigators reported (Arch. Dermatol. 2011;147:1159-65).
According to the study, about 90% agreed or strongly agreed that a customer should see a health professional for a mole that is changing in size or frequently bleeds. A total of 89% said customers should see a health professional if they have a mole that is changing in color, and 78% said moles that itch frequently should be checked out.
A total of 37% of the hair professionals surveyed had scanned more than half of their customers’ scalps, 29% had scanned more than half of their customers’ necks, and 15% had scanned more than half of their customers’ faces for suspicious lesions in the past month.
Survey participants who knew the ABCD rule for melanoma were more likely to look at customers’ skin, and "understanding the difference between melanoma and ordinary skin growths and disagreeing that skin cancer was more difficult to detect than other types of cancer was also associated with a higher likelihood of customer observation," the investigators wrote.
Hair stylists who were confident looking at their own moles also tended to look at their customers’ skin, and stylists who had a personal history of skin cancer or experience with a friend or family member’s skin cancer also looked for potential problem spots on customers’ skin more often, the study found.
About half (49%) of survey participants said they were "very" or "extremely" interested in participating in a skin cancer education program, indicating that dermatologists should consider investigating hair stylists’ potential role in skin cancer prevention and detection.
"Hair professionals are currently acting as lay health advisors for skin cancer detection and prevention and are willing to become more involved in skin cancer education in the salon," said the investigators. "As professionals who have a natural view of difficult-to-see areas and who develop a close rapport with their customers, hair professionals are ideally suited to this role."
Melanoma of the scalp and neck accounted for 6% of all melanoma and for 10% of melanoma deaths in the United States between 1973 and 2003, likely because it’s difficult to find suspicious lesions in these locations during self-examinations by patients and routine exams by physicians, the investigators noted.
Therefore, hair stylists – who typically see areas of the head and scalp that patients and physicians might miss – are in a unique position to detect skin cancers that might otherwise go unnoticed.
"Through the many active professional education venues within the hair industry, the infrastructure exists to educate them," wrote Dr. Bailey and her colleagues. "Future research should focus on creating a program that provides hair professionals with expert training and effective health communication tools to become confident and skilled lay skin cancer educators."
The investigators did not report having any conflicts of interest.
Hair stylists are on the lookout for suspicious lesions on their customers’ scalps, necks, and faces, and are "very" interested in receiving formal skin cancer education, according to a study published Oct. 17 in the Archives of Dermatology.
Although only 28% of hair professionals have received any formal skin cancer education, many reported routinely looking for problematic spots or changing moles, according to Dr. Elizabeth E. Bailey of the department of medicine at Brigham and Women’s Hospital in Boston.
Dr. Bailey and her colleagues received 203 completed surveys from hair professionals in January 2010 on skin cancer practice and knowledge. The hair professionals were from a chain of 17 salons in the greater Houston area.
Hair stylists who frequently talked with their customers about health issues, including personal skin protection practices, were more likely to scan for suspicious lesions. However, it didn’t seem to matter whether or not the stylists had basic skin cancer knowledge, possibly because most already knew the basics, the investigators reported (Arch. Dermatol. 2011;147:1159-65).
According to the study, about 90% agreed or strongly agreed that a customer should see a health professional for a mole that is changing in size or frequently bleeds. A total of 89% said customers should see a health professional if they have a mole that is changing in color, and 78% said moles that itch frequently should be checked out.
A total of 37% of the hair professionals surveyed had scanned more than half of their customers’ scalps, 29% had scanned more than half of their customers’ necks, and 15% had scanned more than half of their customers’ faces for suspicious lesions in the past month.
Survey participants who knew the ABCD rule for melanoma were more likely to look at customers’ skin, and "understanding the difference between melanoma and ordinary skin growths and disagreeing that skin cancer was more difficult to detect than other types of cancer was also associated with a higher likelihood of customer observation," the investigators wrote.
Hair stylists who were confident looking at their own moles also tended to look at their customers’ skin, and stylists who had a personal history of skin cancer or experience with a friend or family member’s skin cancer also looked for potential problem spots on customers’ skin more often, the study found.
About half (49%) of survey participants said they were "very" or "extremely" interested in participating in a skin cancer education program, indicating that dermatologists should consider investigating hair stylists’ potential role in skin cancer prevention and detection.
"Hair professionals are currently acting as lay health advisors for skin cancer detection and prevention and are willing to become more involved in skin cancer education in the salon," said the investigators. "As professionals who have a natural view of difficult-to-see areas and who develop a close rapport with their customers, hair professionals are ideally suited to this role."
Melanoma of the scalp and neck accounted for 6% of all melanoma and for 10% of melanoma deaths in the United States between 1973 and 2003, likely because it’s difficult to find suspicious lesions in these locations during self-examinations by patients and routine exams by physicians, the investigators noted.
Therefore, hair stylists – who typically see areas of the head and scalp that patients and physicians might miss – are in a unique position to detect skin cancers that might otherwise go unnoticed.
"Through the many active professional education venues within the hair industry, the infrastructure exists to educate them," wrote Dr. Bailey and her colleagues. "Future research should focus on creating a program that provides hair professionals with expert training and effective health communication tools to become confident and skilled lay skin cancer educators."
The investigators did not report having any conflicts of interest.
FROM ARCHIVES OF DERMATOLOGY
Major Finding: A total of 37% of the hair professionals surveyed had scanned more than half of their customers’ scalps, 29% had scanned more than half of their customers’ necks, and 15% had scanned more than half of their customers’ faces for suspicious lesions in the past month.
Data Source: Survey of hair professionals (n = 203) from a chain of 17 salons in the greater Houston area, conducted in January 2010.
Disclosures: The investigators did not report having any conflicts of interest.
NICE Rejects Ipilimumab
A drug considered a breakthrough treatment for advanced melanoma has been turned down by England’s clinical and cost-effectiveness agency.
In first draft guidance issued Oct. 14, the National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy).
The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab (n = 676). The drug, a monoclonal antibody, was shown to significantly improve overall survival in previously treated patients with unresectable stage II or IV melanomas (J. Clin. Oncol. 28:18s, 2010 [suppl; abstr 4]).
Subjects who received ipilimumab alone or with a peptide vaccine saw a median survival of about 10 months, compared with 6.4 months for those receiving only the vaccine. At 1 year follow up, between 44% and 46% of subjects in the ipilimumab arms had survived, compared with 25% in the vaccine-only arm, and at 2 years, between 22% and 24% in the ipilimumab arms had survived, compared with 14% in the vaccine-only arm.
"Ipilimumab is not a cost-effective use of NHS resources."
On the strength of these results, in patient groups for whom few effective treatments exist, the Food and Drug Administration fast-tracked its review of ipilimumab, approving it in March; the European Medicines Agency recommended it in May, and it has been available Europe-wide since July.
But NICE chief executive Andrew Dillon criticized the same results in a news release, saying that ipilimumab had not been compared to the drugs currently used to treat stage III or IV melanoma. (In U.K. practice, this is carboplatin-based chemotherapy, dacarbazine, or supportive care.)
Although the results, Mr. Dillon continued, "did show the drug could potentially be very effective for a small percentage of patients," the follow up from the trial "was too short to determine how long this effect would last."
Clinical specialists have advised NICE that about 30% of people treated with ipilimumab would have improved survival, with an estimated 10% potentially experiencing long-term benefits.
Currently no biomarkers have been established to identify patients who will benefit, Mr. Dillon said, and "ipilimumab currently costs around £80k per patient whether the treatment is effective for them or not." On the basis of evidence submitted so far, he said, "ipilimumab is not a cost-effective use of NHS resources."
NICE’s decision on ipilimumab is likely to be met with fierce criticism and appeals in the United Kingdom, where about 10,000 new cases of malignant melanoma are registered each year, a fifth of them in young adults between the ages of 15 and 39. Some 400-500 Britons with advanced melanoma have disease that has progressed on second-line treatment, NICE said. The 5-year survival rates are between 40% and 50% for stage III disease and 5%-15% for stage IV disease, where median survival is 6-9 months.
Ipilimumab is administered intravenously. It works by blocking the activity of CTLA-4, boosting and prolonging the body’s T-cell response against cancer cells. At £20k per dose, and four doses per course of treatment, NICE estimates the incremental cost effectiveness ratio for ipilimumab at between £54,000 and £70,000 per quality-adjusted life-year gained, based on current evidence.
NICE’s draft guidance on ipilimumab is open for comment until Nov. 4.
A drug considered a breakthrough treatment for advanced melanoma has been turned down by England’s clinical and cost-effectiveness agency.
In first draft guidance issued Oct. 14, the National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy).
The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab (n = 676). The drug, a monoclonal antibody, was shown to significantly improve overall survival in previously treated patients with unresectable stage II or IV melanomas (J. Clin. Oncol. 28:18s, 2010 [suppl; abstr 4]).
Subjects who received ipilimumab alone or with a peptide vaccine saw a median survival of about 10 months, compared with 6.4 months for those receiving only the vaccine. At 1 year follow up, between 44% and 46% of subjects in the ipilimumab arms had survived, compared with 25% in the vaccine-only arm, and at 2 years, between 22% and 24% in the ipilimumab arms had survived, compared with 14% in the vaccine-only arm.
"Ipilimumab is not a cost-effective use of NHS resources."
On the strength of these results, in patient groups for whom few effective treatments exist, the Food and Drug Administration fast-tracked its review of ipilimumab, approving it in March; the European Medicines Agency recommended it in May, and it has been available Europe-wide since July.
But NICE chief executive Andrew Dillon criticized the same results in a news release, saying that ipilimumab had not been compared to the drugs currently used to treat stage III or IV melanoma. (In U.K. practice, this is carboplatin-based chemotherapy, dacarbazine, or supportive care.)
Although the results, Mr. Dillon continued, "did show the drug could potentially be very effective for a small percentage of patients," the follow up from the trial "was too short to determine how long this effect would last."
Clinical specialists have advised NICE that about 30% of people treated with ipilimumab would have improved survival, with an estimated 10% potentially experiencing long-term benefits.
Currently no biomarkers have been established to identify patients who will benefit, Mr. Dillon said, and "ipilimumab currently costs around £80k per patient whether the treatment is effective for them or not." On the basis of evidence submitted so far, he said, "ipilimumab is not a cost-effective use of NHS resources."
NICE’s decision on ipilimumab is likely to be met with fierce criticism and appeals in the United Kingdom, where about 10,000 new cases of malignant melanoma are registered each year, a fifth of them in young adults between the ages of 15 and 39. Some 400-500 Britons with advanced melanoma have disease that has progressed on second-line treatment, NICE said. The 5-year survival rates are between 40% and 50% for stage III disease and 5%-15% for stage IV disease, where median survival is 6-9 months.
Ipilimumab is administered intravenously. It works by blocking the activity of CTLA-4, boosting and prolonging the body’s T-cell response against cancer cells. At £20k per dose, and four doses per course of treatment, NICE estimates the incremental cost effectiveness ratio for ipilimumab at between £54,000 and £70,000 per quality-adjusted life-year gained, based on current evidence.
NICE’s draft guidance on ipilimumab is open for comment until Nov. 4.
A drug considered a breakthrough treatment for advanced melanoma has been turned down by England’s clinical and cost-effectiveness agency.
In first draft guidance issued Oct. 14, the National Institute for Health and Clinical Excellence, which makes recommendations to the National Health Service in England and Wales, said that it was not likely to recommend ipilimumab (Bristol-Myers Squibb’s Yervoy).
The agency cited cost concerns and what it called insufficient follow-up results from a manufacturer-sponsored, phase III, randomized, placebo-controlled trial of ipilimumab (n = 676). The drug, a monoclonal antibody, was shown to significantly improve overall survival in previously treated patients with unresectable stage II or IV melanomas (J. Clin. Oncol. 28:18s, 2010 [suppl; abstr 4]).
Subjects who received ipilimumab alone or with a peptide vaccine saw a median survival of about 10 months, compared with 6.4 months for those receiving only the vaccine. At 1 year follow up, between 44% and 46% of subjects in the ipilimumab arms had survived, compared with 25% in the vaccine-only arm, and at 2 years, between 22% and 24% in the ipilimumab arms had survived, compared with 14% in the vaccine-only arm.
"Ipilimumab is not a cost-effective use of NHS resources."
On the strength of these results, in patient groups for whom few effective treatments exist, the Food and Drug Administration fast-tracked its review of ipilimumab, approving it in March; the European Medicines Agency recommended it in May, and it has been available Europe-wide since July.
But NICE chief executive Andrew Dillon criticized the same results in a news release, saying that ipilimumab had not been compared to the drugs currently used to treat stage III or IV melanoma. (In U.K. practice, this is carboplatin-based chemotherapy, dacarbazine, or supportive care.)
Although the results, Mr. Dillon continued, "did show the drug could potentially be very effective for a small percentage of patients," the follow up from the trial "was too short to determine how long this effect would last."
Clinical specialists have advised NICE that about 30% of people treated with ipilimumab would have improved survival, with an estimated 10% potentially experiencing long-term benefits.
Currently no biomarkers have been established to identify patients who will benefit, Mr. Dillon said, and "ipilimumab currently costs around £80k per patient whether the treatment is effective for them or not." On the basis of evidence submitted so far, he said, "ipilimumab is not a cost-effective use of NHS resources."
NICE’s decision on ipilimumab is likely to be met with fierce criticism and appeals in the United Kingdom, where about 10,000 new cases of malignant melanoma are registered each year, a fifth of them in young adults between the ages of 15 and 39. Some 400-500 Britons with advanced melanoma have disease that has progressed on second-line treatment, NICE said. The 5-year survival rates are between 40% and 50% for stage III disease and 5%-15% for stage IV disease, where median survival is 6-9 months.
Ipilimumab is administered intravenously. It works by blocking the activity of CTLA-4, boosting and prolonging the body’s T-cell response against cancer cells. At £20k per dose, and four doses per course of treatment, NICE estimates the incremental cost effectiveness ratio for ipilimumab at between £54,000 and £70,000 per quality-adjusted life-year gained, based on current evidence.
NICE’s draft guidance on ipilimumab is open for comment until Nov. 4.
California Teen Tanning Ban Signed Into Law
On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.
California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.
The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.
"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."
According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.
"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S."
Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.
Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."
The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.
The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.
On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.
California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.
The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.
"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."
According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.
"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S."
Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.
Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."
The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.
The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.
On Oct. 9, California became the first state in the nation to enact a comprehensive ban on the use of indoor tanning beds by minors.
California Gov. Jerry Brown signed a bill sponsored by state Sen. Ted W. Lieu, a democrat. The bill, SB 746, was brought to fruition by the California Society of Dermatology and Dermatologic Surgery and the Aim at Melanoma Foundation, and is supported by the American Academy of Dermatology, the California Medical Association, Anthem Blue Cross, Kaiser Permanente, and the American Academy of Pediatrics, among other groups.
The law, which goes into effect on Jan. 1, 2012, prohibits tanning bed use by anyone under the age of 18, but makes an exception for physicians to prescribe use of the devices for phototherapy.
"Indoor tanning is especially harmful because of the intense and dangerous type of UV rays emitted from the tanning beds," said Sen. Lieu in a statement. "Moreover the skin damage is cumulative, so the more exposure one gets younger in life, the worse the harmful effects will be."
According to the American Academy of Dermatology, exposure to ultraviolet radiation from indoor tanning is associated with an increased risk of melanoma and nonmelanoma skin cancer. There are more than 3.5 million skin cancers in more than 2 million Americans diagnosed annually.
"In 2011, California is expected to have 8,250 new cases of melanoma, which is approximately 12% of the national number of new cases, which is 70,230," said Dr. Ann F. Haas, past president of the California Society of Dermatology and Dermatologic Surgery in a statement. "Melanoma incidence rates have been increasing for the last 30 years, with the most rapid increases occurring among young, white women, 3% per year since 1992 in those ages 15 to 39," she added. "We pushed for this legislation in the hopes of stemming that rise and encouraging other states to follow California’s lead and prohibit the use of tanning devices by minors to reduce the incidence of skin cancer in the U.S."
Dr. Ronald Moy, president of the American Academy of Dermatology, said that the organization supported the legislation and was pleased that it had been made into law. "We commend Gov. Brown, Sen. Ted Lieu, and the other members of the California legislature for their efforts to help reduce the future incidence of skin cancer by protecting youth from the dangers of indoor tanning," said Dr. Moy, in a statement.
Valerie Guild, president and founder of Aim at Melanoma, called the law a "major victory in the fight against melanoma." Added, Ms. Guild: "It is alarming that so many young women are unnecessarily developing melanoma because of a recreational activity. We hope other states will follow California’s lead."
The Indoor Tanning Association issued a statement saying that it was "disappointed" by the Governor’s decision to sign the bill into law. "In making this decision, they ignored the fact that there is no consensus among researchers that normal non-burning exposure to ultraviolet light, whether from the sun or a sun bed, has any effect on the development of melanoma skin cancer," said the association.
The group also said that the law will probably cause more tanning salons to close, reporting that 25% of the state’s salons have shut down since 2009. And, said the Indoor Tanning Association, teens would likely continue to tan outdoors without supervision.
The Skinny Vodcast: Episode 2
Skin & Allergy News editor Amy Pfeiffer and reporter Naseem Miller review hot news in dermatology with the experts. And, guest dermatologist Lily Talakoub tackles the sea of cleansers.
Skin & Allergy News editor Amy Pfeiffer and reporter Naseem Miller review hot news in dermatology with the experts. And, guest dermatologist Lily Talakoub tackles the sea of cleansers.
Skin & Allergy News editor Amy Pfeiffer and reporter Naseem Miller review hot news in dermatology with the experts. And, guest dermatologist Lily Talakoub tackles the sea of cleansers.
Vismodegib Shrinks Advanced Basal Cell Carcinoma
STOCKHOLM – The experimental oral drug vismodegib provided a "substantial clinical benefit" for patients with locally advanced and metastatic basal cell carcinoma in a phase II trial involving 104 patients.
"Nearly all patients did have some tumor shrinkage," Dr. Luc Dirix said at the European Multidisciplinary Cancer Congress. The overall majority of those with locally advanced disease "had huge responses, with major decreases in tumor size."
The primary end point of overall response rate by independent review was reached in 43% of patients with locally advanced basal cell carcinoma (P less than .0001) and in 30% of those with metastatic disease (P = .0011). Response rates per investigator reached 60% and 45.5%, respectively.
Only a small minority of basal cell carcinomas (BCCs) become locally advanced or metastatic, but the consequences can be disfiguring and ultimately life threatening. For these patients, there is no clear standard of care, and thus this is an unmet medical need, explained Dr. Dirix of the Iridium Kankernetwerk at Sint-Augustinus Hospital in Wilrijk, Belgium.
Vismodegib is a first-in-class small-molecule inhibitor of the hedgehog signaling pathway, which is activated in more than 90% of BCC. Genentech, a member of the Roche group, is studying the drug in a variety of cancers. Based on the current phase II data, it filed a New Drug Application, announced on Sept. 12, 2011, with the Food and Drug Administration for vismodegib in the treatment of advanced, inoperable BCC.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma, but I think that long-term tolerance is really an issue," the invited discussant, Dr. Caroline Robert, said at the meeting, which was a joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).
"It’s not a very serious adverse event, but [rather] the chronic effect [of] fatigue, loss of appetite, muscular pain that will impact the patients," said Dr. Robert, chief of dermatology at the Institut Cancérologie Gustave Roussy in Villejuif, France.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma."
Adverse events occurring in more than 30% of patients were muscle spasms, alopecia, taste loss, weight loss, and fatigue, but they were mainly grade 1 and 2, Dr. Dirix said.
Serious adverse events were reported in 26 patients (25%), of which four were possibly related to vismodegib. They included cholestasis; dehydration with syncope; pneumonia and cardiac failure; and pulmonary embolism. No fatal events were linked to the drug, he said.
The efficacy analysis was based on 63 patients who had locally advanced BCC that was inoperable or for whom surgery would be significantly disfiguring, and 33 patients with histologically confirmed, RECIST (Response Evaluation Criteria in Solid Tumors)–measurable metastatic BCC.
Patients received 150-mg oral vismodegib daily until disease progression or intolerable toxicity. Their mean age was 61 years.
Three-fourths of patients in both cohorts had a clinical benefit (defined as a response at any time plus stable disease), Dr. Dirix said. The response often occurred before week 8, and lasted a median of 7.6 months in both cohorts, based on independent review.
Median progression-free survival by independent review was 9.5 months in both cohorts.
The current phase II trial, called ERIVANCE BCC, was prompted by a phase I trial reporting a 55% response rate in 33 patients with advanced BCC, including 2 complete responses and 16 partial responses (N. Engl. J. Med. 2009;361:1164-72). Only one patient withdrew because of adverse events.
In a recent unpublished phase II study, however, 28% of 41 patients taking vismodegib for Gorlin's syndrome dropped out because of an adverse event, Dr. Robert said during the presidential session. She called for other treatment modalities for advanced BCC, and suggested that vismodegib may be optimal at lower doses, when used sequentially, or as a 3-month course prior to surgery.
"This is very important, I think, because it may lead us to the use of this drug in the neoadjuvant setting, where we can do surgery after the tumor has already shrunk," she added.
Genentech supported the trial. Dr. Dirix reported that a coauthor is a Genentech employee.
STOCKHOLM – The experimental oral drug vismodegib provided a "substantial clinical benefit" for patients with locally advanced and metastatic basal cell carcinoma in a phase II trial involving 104 patients.
"Nearly all patients did have some tumor shrinkage," Dr. Luc Dirix said at the European Multidisciplinary Cancer Congress. The overall majority of those with locally advanced disease "had huge responses, with major decreases in tumor size."
The primary end point of overall response rate by independent review was reached in 43% of patients with locally advanced basal cell carcinoma (P less than .0001) and in 30% of those with metastatic disease (P = .0011). Response rates per investigator reached 60% and 45.5%, respectively.
Only a small minority of basal cell carcinomas (BCCs) become locally advanced or metastatic, but the consequences can be disfiguring and ultimately life threatening. For these patients, there is no clear standard of care, and thus this is an unmet medical need, explained Dr. Dirix of the Iridium Kankernetwerk at Sint-Augustinus Hospital in Wilrijk, Belgium.
Vismodegib is a first-in-class small-molecule inhibitor of the hedgehog signaling pathway, which is activated in more than 90% of BCC. Genentech, a member of the Roche group, is studying the drug in a variety of cancers. Based on the current phase II data, it filed a New Drug Application, announced on Sept. 12, 2011, with the Food and Drug Administration for vismodegib in the treatment of advanced, inoperable BCC.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma, but I think that long-term tolerance is really an issue," the invited discussant, Dr. Caroline Robert, said at the meeting, which was a joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).
"It’s not a very serious adverse event, but [rather] the chronic effect [of] fatigue, loss of appetite, muscular pain that will impact the patients," said Dr. Robert, chief of dermatology at the Institut Cancérologie Gustave Roussy in Villejuif, France.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma."
Adverse events occurring in more than 30% of patients were muscle spasms, alopecia, taste loss, weight loss, and fatigue, but they were mainly grade 1 and 2, Dr. Dirix said.
Serious adverse events were reported in 26 patients (25%), of which four were possibly related to vismodegib. They included cholestasis; dehydration with syncope; pneumonia and cardiac failure; and pulmonary embolism. No fatal events were linked to the drug, he said.
The efficacy analysis was based on 63 patients who had locally advanced BCC that was inoperable or for whom surgery would be significantly disfiguring, and 33 patients with histologically confirmed, RECIST (Response Evaluation Criteria in Solid Tumors)–measurable metastatic BCC.
Patients received 150-mg oral vismodegib daily until disease progression or intolerable toxicity. Their mean age was 61 years.
Three-fourths of patients in both cohorts had a clinical benefit (defined as a response at any time plus stable disease), Dr. Dirix said. The response often occurred before week 8, and lasted a median of 7.6 months in both cohorts, based on independent review.
Median progression-free survival by independent review was 9.5 months in both cohorts.
The current phase II trial, called ERIVANCE BCC, was prompted by a phase I trial reporting a 55% response rate in 33 patients with advanced BCC, including 2 complete responses and 16 partial responses (N. Engl. J. Med. 2009;361:1164-72). Only one patient withdrew because of adverse events.
In a recent unpublished phase II study, however, 28% of 41 patients taking vismodegib for Gorlin's syndrome dropped out because of an adverse event, Dr. Robert said during the presidential session. She called for other treatment modalities for advanced BCC, and suggested that vismodegib may be optimal at lower doses, when used sequentially, or as a 3-month course prior to surgery.
"This is very important, I think, because it may lead us to the use of this drug in the neoadjuvant setting, where we can do surgery after the tumor has already shrunk," she added.
Genentech supported the trial. Dr. Dirix reported that a coauthor is a Genentech employee.
STOCKHOLM – The experimental oral drug vismodegib provided a "substantial clinical benefit" for patients with locally advanced and metastatic basal cell carcinoma in a phase II trial involving 104 patients.
"Nearly all patients did have some tumor shrinkage," Dr. Luc Dirix said at the European Multidisciplinary Cancer Congress. The overall majority of those with locally advanced disease "had huge responses, with major decreases in tumor size."
The primary end point of overall response rate by independent review was reached in 43% of patients with locally advanced basal cell carcinoma (P less than .0001) and in 30% of those with metastatic disease (P = .0011). Response rates per investigator reached 60% and 45.5%, respectively.
Only a small minority of basal cell carcinomas (BCCs) become locally advanced or metastatic, but the consequences can be disfiguring and ultimately life threatening. For these patients, there is no clear standard of care, and thus this is an unmet medical need, explained Dr. Dirix of the Iridium Kankernetwerk at Sint-Augustinus Hospital in Wilrijk, Belgium.
Vismodegib is a first-in-class small-molecule inhibitor of the hedgehog signaling pathway, which is activated in more than 90% of BCC. Genentech, a member of the Roche group, is studying the drug in a variety of cancers. Based on the current phase II data, it filed a New Drug Application, announced on Sept. 12, 2011, with the Food and Drug Administration for vismodegib in the treatment of advanced, inoperable BCC.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma, but I think that long-term tolerance is really an issue," the invited discussant, Dr. Caroline Robert, said at the meeting, which was a joint congress of the European Cancer Organization (ECCO), the European Society for Medical Oncology (ESMO), and the European Society for Radiotherapy and Oncology (ESTRO).
"It’s not a very serious adverse event, but [rather] the chronic effect [of] fatigue, loss of appetite, muscular pain that will impact the patients," said Dr. Robert, chief of dermatology at the Institut Cancérologie Gustave Roussy in Villejuif, France.
"Vismodegib is really a breakthrough for the treatment of advanced basal cell carcinoma."
Adverse events occurring in more than 30% of patients were muscle spasms, alopecia, taste loss, weight loss, and fatigue, but they were mainly grade 1 and 2, Dr. Dirix said.
Serious adverse events were reported in 26 patients (25%), of which four were possibly related to vismodegib. They included cholestasis; dehydration with syncope; pneumonia and cardiac failure; and pulmonary embolism. No fatal events were linked to the drug, he said.
The efficacy analysis was based on 63 patients who had locally advanced BCC that was inoperable or for whom surgery would be significantly disfiguring, and 33 patients with histologically confirmed, RECIST (Response Evaluation Criteria in Solid Tumors)–measurable metastatic BCC.
Patients received 150-mg oral vismodegib daily until disease progression or intolerable toxicity. Their mean age was 61 years.
Three-fourths of patients in both cohorts had a clinical benefit (defined as a response at any time plus stable disease), Dr. Dirix said. The response often occurred before week 8, and lasted a median of 7.6 months in both cohorts, based on independent review.
Median progression-free survival by independent review was 9.5 months in both cohorts.
The current phase II trial, called ERIVANCE BCC, was prompted by a phase I trial reporting a 55% response rate in 33 patients with advanced BCC, including 2 complete responses and 16 partial responses (N. Engl. J. Med. 2009;361:1164-72). Only one patient withdrew because of adverse events.
In a recent unpublished phase II study, however, 28% of 41 patients taking vismodegib for Gorlin's syndrome dropped out because of an adverse event, Dr. Robert said during the presidential session. She called for other treatment modalities for advanced BCC, and suggested that vismodegib may be optimal at lower doses, when used sequentially, or as a 3-month course prior to surgery.
"This is very important, I think, because it may lead us to the use of this drug in the neoadjuvant setting, where we can do surgery after the tumor has already shrunk," she added.
Genentech supported the trial. Dr. Dirix reported that a coauthor is a Genentech employee.
FROM THE EUROPEAN MULTIDISCIPLINARY CANCER CONGRESS
Major Finding: The overall response rate by independent review was 43% for locally advanced BCC (P less than .0001) and 30% for metastatic BCC (P = .0011).
Data Source: Phase II multicenter trial in 104 patients with locally advanced or metastatic BCC.
Disclosures: Genentech supported the trial. Dr. Dirix reported that a coauthor is a Genentech employee.
Unopened Scotch and Genital Warts: The Skinny Podcast
In this month's podcast, we catch up with Dr. Darrel S. Rigel to discuss the spike in melanoma in women in their 20s and 30s.
Contributor Gina Henderson discusses news stats on how dermatology practices are faring in today's tough economy.
And, in "Hats on for Albinism," reporter Naseem Miller interviews the secretary general of the International League of Dermatological Societies, Dr. David McLean, who is leading the effort to help albinos in Tanzania.
In this month's Cosmetic Counter segment, Dr. Lily Talakoub offers tips on how to navigate the overwhelming sea of moisturizers.
And last but not least, Dr. Alan Rockoff relays the story of a how an unopened bottle of scotch eased the nerves of a man facing cryosurgery for his genital warts.
Don't miss another episode of The Skinny Podcast; subscribe on iTunes!
In this month's podcast, we catch up with Dr. Darrel S. Rigel to discuss the spike in melanoma in women in their 20s and 30s.
Contributor Gina Henderson discusses news stats on how dermatology practices are faring in today's tough economy.
And, in "Hats on for Albinism," reporter Naseem Miller interviews the secretary general of the International League of Dermatological Societies, Dr. David McLean, who is leading the effort to help albinos in Tanzania.
In this month's Cosmetic Counter segment, Dr. Lily Talakoub offers tips on how to navigate the overwhelming sea of moisturizers.
And last but not least, Dr. Alan Rockoff relays the story of a how an unopened bottle of scotch eased the nerves of a man facing cryosurgery for his genital warts.
Don't miss another episode of The Skinny Podcast; subscribe on iTunes!
In this month's podcast, we catch up with Dr. Darrel S. Rigel to discuss the spike in melanoma in women in their 20s and 30s.
Contributor Gina Henderson discusses news stats on how dermatology practices are faring in today's tough economy.
And, in "Hats on for Albinism," reporter Naseem Miller interviews the secretary general of the International League of Dermatological Societies, Dr. David McLean, who is leading the effort to help albinos in Tanzania.
In this month's Cosmetic Counter segment, Dr. Lily Talakoub offers tips on how to navigate the overwhelming sea of moisturizers.
And last but not least, Dr. Alan Rockoff relays the story of a how an unopened bottle of scotch eased the nerves of a man facing cryosurgery for his genital warts.
Don't miss another episode of The Skinny Podcast; subscribe on iTunes!
Expert: Risk of AK Progression to SCC Hard to Predict
NAPA, CALIF. – Because actinic keratoses are the most common lesions with premalignant potential in the skin, knowing how to predict their malignancy can be life saving, according to Dr. Miriam S. Bettencourt.
Most AKs do not progress to squamous cell carcinoma (SCC), but most invasive SCCs have evidence of preexisting AK, she said. Of the AKs that progress, 10% will metastasize, giving patients a 5-year survival rate, Dr. Bettencourt of the University of Nevada, Las Vegas.
"Major risk factors for AK malignancy include induration and inflammation, a diameter of over 1 cm, rapid enlargement, bleeding, erythema, and ulceration. Minor risk factors include pigmentation changes, palpability, pain, pruritus, and hyperkeratosis.
Hyperkeratotic AKs greater than 1 cm on the hands, wrists, or forearms have a 50% or greater risk for malignancy, she noted.
Other risk factors include age at diagnosis, human papillomavirus status, skin type, sunburns during childhood, proximity to the Equator, amount of outdoor activity, and a history of skin cancer.
Organ-transplant recipients have a 250-fold greater risk for developing AKs, and a 100-fold risk for SCC; 40% of organ-transplant patients with an AK will show progression to SCC, compared with 10% of the average population, she said.
However, the wide range of rates for the risk of AK progression to SCC found in the literature highlights the difficulty of putting risk into perspective, she noted.
In one study, of 169 patients with AKs, 65% developed an SCC from an AK; 97% of the patients had a contiguous AK near the site of the SCC (Dermatol. Surg. 1995;21:184). But a review of 875 studies of AKs found a much lower rate; 11 studies were identified that predicted the risk of malignancy. The review found the rate to be 0.025% to 10% per lesion, per year (Eur. J. Dermatol. 2006;16:335-9).
In another study, 10% of AKs were found to transform into SCC in 2 years (Dermatol. Surg. 2007;33:1099-101).
A more recent report suggests that AKs also may progress to basal cell carcinomas (BCCs), she reported. In a study of 7,784 lesions on the face and ears of 169 patients, 65% of SCCs and 36% of BCCs arose in lesions that were previously diagnosed as AKs (Cancer 2009;115:2523-30). The study also found the risk of progression of AK to SCC to be 0.6% at year 1 and 2.6% at year 4.
It is important to remember that risk applies to each individual AK and that the fate of any one AK is impossible to predict, said Dr. Bettencourt. "Although the risk [of progression] is small, since most [patients] have multiple AKs, the risk of transformation is much greater than the risk of any individual lesion."
She recommended treating all AKs because some may be difficult to distinguish from SCC and lentigo maligna.
Dr. Bettencourt reported being on the speakers bureaus of PharmaDerm and Graceway, and conducting clinical trials for 3M Pharmaceuticals.
NAPA, CALIF. – Because actinic keratoses are the most common lesions with premalignant potential in the skin, knowing how to predict their malignancy can be life saving, according to Dr. Miriam S. Bettencourt.
Most AKs do not progress to squamous cell carcinoma (SCC), but most invasive SCCs have evidence of preexisting AK, she said. Of the AKs that progress, 10% will metastasize, giving patients a 5-year survival rate, Dr. Bettencourt of the University of Nevada, Las Vegas.
"Major risk factors for AK malignancy include induration and inflammation, a diameter of over 1 cm, rapid enlargement, bleeding, erythema, and ulceration. Minor risk factors include pigmentation changes, palpability, pain, pruritus, and hyperkeratosis.
Hyperkeratotic AKs greater than 1 cm on the hands, wrists, or forearms have a 50% or greater risk for malignancy, she noted.
Other risk factors include age at diagnosis, human papillomavirus status, skin type, sunburns during childhood, proximity to the Equator, amount of outdoor activity, and a history of skin cancer.
Organ-transplant recipients have a 250-fold greater risk for developing AKs, and a 100-fold risk for SCC; 40% of organ-transplant patients with an AK will show progression to SCC, compared with 10% of the average population, she said.
However, the wide range of rates for the risk of AK progression to SCC found in the literature highlights the difficulty of putting risk into perspective, she noted.
In one study, of 169 patients with AKs, 65% developed an SCC from an AK; 97% of the patients had a contiguous AK near the site of the SCC (Dermatol. Surg. 1995;21:184). But a review of 875 studies of AKs found a much lower rate; 11 studies were identified that predicted the risk of malignancy. The review found the rate to be 0.025% to 10% per lesion, per year (Eur. J. Dermatol. 2006;16:335-9).
In another study, 10% of AKs were found to transform into SCC in 2 years (Dermatol. Surg. 2007;33:1099-101).
A more recent report suggests that AKs also may progress to basal cell carcinomas (BCCs), she reported. In a study of 7,784 lesions on the face and ears of 169 patients, 65% of SCCs and 36% of BCCs arose in lesions that were previously diagnosed as AKs (Cancer 2009;115:2523-30). The study also found the risk of progression of AK to SCC to be 0.6% at year 1 and 2.6% at year 4.
It is important to remember that risk applies to each individual AK and that the fate of any one AK is impossible to predict, said Dr. Bettencourt. "Although the risk [of progression] is small, since most [patients] have multiple AKs, the risk of transformation is much greater than the risk of any individual lesion."
She recommended treating all AKs because some may be difficult to distinguish from SCC and lentigo maligna.
Dr. Bettencourt reported being on the speakers bureaus of PharmaDerm and Graceway, and conducting clinical trials for 3M Pharmaceuticals.
NAPA, CALIF. – Because actinic keratoses are the most common lesions with premalignant potential in the skin, knowing how to predict their malignancy can be life saving, according to Dr. Miriam S. Bettencourt.
Most AKs do not progress to squamous cell carcinoma (SCC), but most invasive SCCs have evidence of preexisting AK, she said. Of the AKs that progress, 10% will metastasize, giving patients a 5-year survival rate, Dr. Bettencourt of the University of Nevada, Las Vegas.
"Major risk factors for AK malignancy include induration and inflammation, a diameter of over 1 cm, rapid enlargement, bleeding, erythema, and ulceration. Minor risk factors include pigmentation changes, palpability, pain, pruritus, and hyperkeratosis.
Hyperkeratotic AKs greater than 1 cm on the hands, wrists, or forearms have a 50% or greater risk for malignancy, she noted.
Other risk factors include age at diagnosis, human papillomavirus status, skin type, sunburns during childhood, proximity to the Equator, amount of outdoor activity, and a history of skin cancer.
Organ-transplant recipients have a 250-fold greater risk for developing AKs, and a 100-fold risk for SCC; 40% of organ-transplant patients with an AK will show progression to SCC, compared with 10% of the average population, she said.
However, the wide range of rates for the risk of AK progression to SCC found in the literature highlights the difficulty of putting risk into perspective, she noted.
In one study, of 169 patients with AKs, 65% developed an SCC from an AK; 97% of the patients had a contiguous AK near the site of the SCC (Dermatol. Surg. 1995;21:184). But a review of 875 studies of AKs found a much lower rate; 11 studies were identified that predicted the risk of malignancy. The review found the rate to be 0.025% to 10% per lesion, per year (Eur. J. Dermatol. 2006;16:335-9).
In another study, 10% of AKs were found to transform into SCC in 2 years (Dermatol. Surg. 2007;33:1099-101).
A more recent report suggests that AKs also may progress to basal cell carcinomas (BCCs), she reported. In a study of 7,784 lesions on the face and ears of 169 patients, 65% of SCCs and 36% of BCCs arose in lesions that were previously diagnosed as AKs (Cancer 2009;115:2523-30). The study also found the risk of progression of AK to SCC to be 0.6% at year 1 and 2.6% at year 4.
It is important to remember that risk applies to each individual AK and that the fate of any one AK is impossible to predict, said Dr. Bettencourt. "Although the risk [of progression] is small, since most [patients] have multiple AKs, the risk of transformation is much greater than the risk of any individual lesion."
She recommended treating all AKs because some may be difficult to distinguish from SCC and lentigo maligna.
Dr. Bettencourt reported being on the speakers bureaus of PharmaDerm and Graceway, and conducting clinical trials for 3M Pharmaceuticals.
EXPERT ANALYSIS FROM THE COASTAL DERMATOLOGY SYMPOSISUM