Aesthetic Dermatology

GRAPEVINE, TEX. — A new ultrasound device was safe and effective for raising the brow line, smoothing facial wrinkles, and adding definition to the jowl line in a study with 33 evaluable patients.

"Ultrasound appears to be a safe, new modality for brow movement. The procedure appears to be extremely safe, and we expect to improve efficacy as the treatment is further refined," Dr. Murad Alam said at the annual meeting of the American Society for Laser Medicine and Surgery.

"This is a fascinating new technology with no side effects and no down time. The results were very impressive, with a dramatic improvement in elevation of the brow," commented Dr. Jeffrey S. Dover, a dermatologist in private practice in Chestnut Hill, Mass.

The device emits an ultrasound beam that was focused 4.5 mm below the skin surface. The goal is to produce thermal coagulation that tightens subepidermal tissue while leaving surface skin unchanged. The investigational device is made by Ulthera Inc. The company is in the process of collecting clinical data to submit to the Food and Drug Administration for device approval, said a company spokesman.

The study involved 35 people, aged 40–65 years, and mostly women, with mild-moderate facial laxity. After baseline photography and application of a topical anesthetic, treatment was done as a single pass, in linear arrays up to 25-mm long at 5-mm intervals over the entire face and neck. The ultrasound beam was set at 7.5 MHz at a power of 15–30 W, with exposure durations of 10–80 milliseconds on the temple, preauricular area, submental area, and neck. An ultrasound beam of 4.4 MHz at 30–40 W was applied for 10–80 milliseconds on the cheeks using a second type of probe. The total energy from each pulse delivered 0.4–1.2 J.

Ninety-day follow-up was available for 33 of the 35 treated patients. Clinically significant elevation of the eyebrow line occurred in 90%, with their brow line rising by 1.5–2.0 mm with an average rise of 1.7 mm. The result was that the eyes opened and the eyebrows appeared raised, said Dr. Alam, chief of cutaneous and aesthetic surgery at Northwestern University in Chicago.

Other common clinical effects were a reduction in forehead static lines, and in periorbital static lines (crow's feet). Also, the jowl line of most patients became better defined, and their neck lines became more recessed. These subjective assessments were made by blinded graders.

The pain of the procedure was graded as 2–8 (on a 10-point scale). The higher pain scores were rare and were given mostly by patients who had no prior history of a cosmetic procedure.

In no case did the pain lead to stopping treatment. About two-thirds of treated patients developed a mild-moderate erythema and edema that resolved within 1 day of treatment. No patients developed scars, erosions, infections, or muscle or neuron injury.

The study by Dr. Alam was funded by a grant by Ulthera to Northwestern University; Dr. Alam had no individual disclosures in his relationship with the company.

Clinically significant elevation of the eyebrow occurred in 90%, rising an average of 1.7 mm. DR. ALAM

GRAPEVINE, TEX. — A new ultrasound device was safe and effective for raising the brow line, smoothing facial wrinkles, and adding definition to the jowl line in a study with 33 evaluable patients.

"Ultrasound appears to be a safe, new modality for brow movement. The procedure appears to be extremely safe, and we expect to improve efficacy as the treatment is further refined," Dr. Murad Alam said at the annual meeting of the American Society for Laser Medicine and Surgery.

"This is a fascinating new technology with no side effects and no down time. The results were very impressive, with a dramatic improvement in elevation of the brow," commented Dr. Jeffrey S. Dover, a dermatologist in private practice in Chestnut Hill, Mass.

The device emits an ultrasound beam that was focused 4.5 mm below the skin surface. The goal is to produce thermal coagulation that tightens subepidermal tissue while leaving surface skin unchanged. The investigational device is made by Ulthera Inc. The company is in the process of collecting clinical data to submit to the Food and Drug Administration for device approval, said a company spokesman.

The study involved 35 people, aged 40–65 years, and mostly women, with mild-moderate facial laxity. After baseline photography and application of a topical anesthetic, treatment was done as a single pass, in linear arrays up to 25-mm long at 5-mm intervals over the entire face and neck. The ultrasound beam was set at 7.5 MHz at a power of 15–30 W, with exposure durations of 10–80 milliseconds on the temple, preauricular area, submental area, and neck. An ultrasound beam of 4.4 MHz at 30–40 W was applied for 10–80 milliseconds on the cheeks using a second type of probe. The total energy from each pulse delivered 0.4–1.2 J.

Ninety-day follow-up was available for 33 of the 35 treated patients. Clinically significant elevation of the eyebrow line occurred in 90%, with their brow line rising by 1.5–2.0 mm with an average rise of 1.7 mm. The result was that the eyes opened and the eyebrows appeared raised, said Dr. Alam, chief of cutaneous and aesthetic surgery at Northwestern University in Chicago.

Other common clinical effects were a reduction in forehead static lines, and in periorbital static lines (crow's feet). Also, the jowl line of most patients became better defined, and their neck lines became more recessed. These subjective assessments were made by blinded graders.

The pain of the procedure was graded as 2–8 (on a 10-point scale). The higher pain scores were rare and were given mostly by patients who had no prior history of a cosmetic procedure.

In no case did the pain lead to stopping treatment. About two-thirds of treated patients developed a mild-moderate erythema and edema that resolved within 1 day of treatment. No patients developed scars, erosions, infections, or muscle or neuron injury.

The study by Dr. Alam was funded by a grant by Ulthera to Northwestern University; Dr. Alam had no individual disclosures in his relationship with the company.

Clinically significant elevation of the eyebrow occurred in 90%, rising an average of 1.7 mm. DR. ALAM

GRAPEVINE, TEX. — A new ultrasound device was safe and effective for raising the brow line, smoothing facial wrinkles, and adding definition to the jowl line in a study with 33 evaluable patients.

"Ultrasound appears to be a safe, new modality for brow movement. The procedure appears to be extremely safe, and we expect to improve efficacy as the treatment is further refined," Dr. Murad Alam said at the annual meeting of the American Society for Laser Medicine and Surgery.

"This is a fascinating new technology with no side effects and no down time. The results were very impressive, with a dramatic improvement in elevation of the brow," commented Dr. Jeffrey S. Dover, a dermatologist in private practice in Chestnut Hill, Mass.

The device emits an ultrasound beam that was focused 4.5 mm below the skin surface. The goal is to produce thermal coagulation that tightens subepidermal tissue while leaving surface skin unchanged. The investigational device is made by Ulthera Inc. The company is in the process of collecting clinical data to submit to the Food and Drug Administration for device approval, said a company spokesman.

The study involved 35 people, aged 40–65 years, and mostly women, with mild-moderate facial laxity. After baseline photography and application of a topical anesthetic, treatment was done as a single pass, in linear arrays up to 25-mm long at 5-mm intervals over the entire face and neck. The ultrasound beam was set at 7.5 MHz at a power of 15–30 W, with exposure durations of 10–80 milliseconds on the temple, preauricular area, submental area, and neck. An ultrasound beam of 4.4 MHz at 30–40 W was applied for 10–80 milliseconds on the cheeks using a second type of probe. The total energy from each pulse delivered 0.4–1.2 J.

Ninety-day follow-up was available for 33 of the 35 treated patients. Clinically significant elevation of the eyebrow line occurred in 90%, with their brow line rising by 1.5–2.0 mm with an average rise of 1.7 mm. The result was that the eyes opened and the eyebrows appeared raised, said Dr. Alam, chief of cutaneous and aesthetic surgery at Northwestern University in Chicago.

Other common clinical effects were a reduction in forehead static lines, and in periorbital static lines (crow's feet). Also, the jowl line of most patients became better defined, and their neck lines became more recessed. These subjective assessments were made by blinded graders.

The pain of the procedure was graded as 2–8 (on a 10-point scale). The higher pain scores were rare and were given mostly by patients who had no prior history of a cosmetic procedure.

In no case did the pain lead to stopping treatment. About two-thirds of treated patients developed a mild-moderate erythema and edema that resolved within 1 day of treatment. No patients developed scars, erosions, infections, or muscle or neuron injury.

The study by Dr. Alam was funded by a grant by Ulthera to Northwestern University; Dr. Alam had no individual disclosures in his relationship with the company.

Clinically significant elevation of the eyebrow occurred in 90%, rising an average of 1.7 mm. DR. ALAM

GRAPEVINE, TEX. — A fractional, 1540-nm laser produced good responses in patients with treatment-resistant melasma of the face or neck in a pilot study with 12 patients.

These early findings suggest that this approach "is a useful, additional treatment modality," Dr. David B. Vasily said at the annual meeting of the American Society for Laser Medicine and Surgery.

"I wouldn't suggest that it produces a cure, but it was effective for resistant melasma, and we have not seen any recurrences during up to 6 months of follow-up in a small group of patients," said Dr. Vasily, a dermatologist in private practice in Bethlehem, Pa.

The study included patients with skin types I-III whose melasma of the face or neck had not responded well to conventional treatments. All patients received four treatments, at 3-week intervals, with the Lux1540 fractional laser handpiece made by Palomar.

Dr. Vasily has received research grants, equipment, and discounts from Palomar, and has stock in the company. The laser is approved by the Food and Drug Administration for soft-tissue coagulation and nonablative resurfacing; treatment of melasma is an off-label use.

Treatment was with a handpiece measuring 15 mm in diameter that produces at least 320 microbeams per pass. Each patient received four passes at a fluence of 10–15 mJ per microbeam and a 10-ms pulse duration. Topical anesthesia was not used; the average pain score was 4.4 on a scale of 0–10.

Erythema and edema did not appear after every treatment, and when it did occur it resolved within 72 hours.

Blinded assessments of before and after photographs showed an average 51% reduction in melasma at 3 months after the final treatment, with two patients having virtually complete clearance, said Dr. Vasily. The response was judged to be excellent (75%-100% resolution) in four patients, and good (50%-75% resolution) in another four patients.

All patients had some degree of pigmentation lightening that was maintained during follow-up, with no episodes of repigmentation or hyperpigmentation. Overall, these responses compare favorably with what is usually achieved with conventional treatments in patients who respond to those treatments, Dr. Vasily said.

He suggested that a better level of response might be seen in a study that enrolled all comers rather than one that focused entirely on the patients who had not responded to other treatments.

Before and after images of a patient in the pilot study showing the effect of four treatments of a 1,540-nm fractional laser for melasma at 3-week intervals. Photos courtesy Dr. David B. Vasily

GRAPEVINE, TEX. — A fractional, 1540-nm laser produced good responses in patients with treatment-resistant melasma of the face or neck in a pilot study with 12 patients.

These early findings suggest that this approach "is a useful, additional treatment modality," Dr. David B. Vasily said at the annual meeting of the American Society for Laser Medicine and Surgery.

"I wouldn't suggest that it produces a cure, but it was effective for resistant melasma, and we have not seen any recurrences during up to 6 months of follow-up in a small group of patients," said Dr. Vasily, a dermatologist in private practice in Bethlehem, Pa.

The study included patients with skin types I-III whose melasma of the face or neck had not responded well to conventional treatments. All patients received four treatments, at 3-week intervals, with the Lux1540 fractional laser handpiece made by Palomar.

Dr. Vasily has received research grants, equipment, and discounts from Palomar, and has stock in the company. The laser is approved by the Food and Drug Administration for soft-tissue coagulation and nonablative resurfacing; treatment of melasma is an off-label use.

Treatment was with a handpiece measuring 15 mm in diameter that produces at least 320 microbeams per pass. Each patient received four passes at a fluence of 10–15 mJ per microbeam and a 10-ms pulse duration. Topical anesthesia was not used; the average pain score was 4.4 on a scale of 0–10.

Erythema and edema did not appear after every treatment, and when it did occur it resolved within 72 hours.

Blinded assessments of before and after photographs showed an average 51% reduction in melasma at 3 months after the final treatment, with two patients having virtually complete clearance, said Dr. Vasily. The response was judged to be excellent (75%-100% resolution) in four patients, and good (50%-75% resolution) in another four patients.

All patients had some degree of pigmentation lightening that was maintained during follow-up, with no episodes of repigmentation or hyperpigmentation. Overall, these responses compare favorably with what is usually achieved with conventional treatments in patients who respond to those treatments, Dr. Vasily said.

He suggested that a better level of response might be seen in a study that enrolled all comers rather than one that focused entirely on the patients who had not responded to other treatments.

Before and after images of a patient in the pilot study showing the effect of four treatments of a 1,540-nm fractional laser for melasma at 3-week intervals. Photos courtesy Dr. David B. Vasily

GRAPEVINE, TEX. — A fractional, 1540-nm laser produced good responses in patients with treatment-resistant melasma of the face or neck in a pilot study with 12 patients.

These early findings suggest that this approach "is a useful, additional treatment modality," Dr. David B. Vasily said at the annual meeting of the American Society for Laser Medicine and Surgery.

"I wouldn't suggest that it produces a cure, but it was effective for resistant melasma, and we have not seen any recurrences during up to 6 months of follow-up in a small group of patients," said Dr. Vasily, a dermatologist in private practice in Bethlehem, Pa.

The study included patients with skin types I-III whose melasma of the face or neck had not responded well to conventional treatments. All patients received four treatments, at 3-week intervals, with the Lux1540 fractional laser handpiece made by Palomar.

Dr. Vasily has received research grants, equipment, and discounts from Palomar, and has stock in the company. The laser is approved by the Food and Drug Administration for soft-tissue coagulation and nonablative resurfacing; treatment of melasma is an off-label use.

Treatment was with a handpiece measuring 15 mm in diameter that produces at least 320 microbeams per pass. Each patient received four passes at a fluence of 10–15 mJ per microbeam and a 10-ms pulse duration. Topical anesthesia was not used; the average pain score was 4.4 on a scale of 0–10.

Erythema and edema did not appear after every treatment, and when it did occur it resolved within 72 hours.

Blinded assessments of before and after photographs showed an average 51% reduction in melasma at 3 months after the final treatment, with two patients having virtually complete clearance, said Dr. Vasily. The response was judged to be excellent (75%-100% resolution) in four patients, and good (50%-75% resolution) in another four patients.

All patients had some degree of pigmentation lightening that was maintained during follow-up, with no episodes of repigmentation or hyperpigmentation. Overall, these responses compare favorably with what is usually achieved with conventional treatments in patients who respond to those treatments, Dr. Vasily said.

He suggested that a better level of response might be seen in a study that enrolled all comers rather than one that focused entirely on the patients who had not responded to other treatments.

Before and after images of a patient in the pilot study showing the effect of four treatments of a 1,540-nm fractional laser for melasma at 3-week intervals. Photos courtesy Dr. David B. Vasily

MIAMI BEACH — Laser surgery with intravenous deep sedation can be performed safely in a pediatric procedure room rather than an operating room when treating congenital vascular stains, Dr. Elizabeth Alvarez Connelly said in a poster presentation at the annual Masters of Pediatrics conference sponsored by the University of Miami.

Pulsed dye lasers are considered the standard for the treatment of congenital vascular stains in young children, but one of the greatest challenges in their use is maintaining an adequate comfort level throughout the multiple treatment sessions needed.

Children are traditionally treated under gas anesthesia in the OR, but repeat sessions can be costly for all parties and stressful to the patient and family, said Dr. Connelly, a pediatric dermatologist at the University of Miami.

Laser surgery in pediatric procedure rooms does not require a sterile environment or a clearance visit by a pediatrician or anesthesiologist and allows clinicians to treat a large surface area during one laser session. The average time from start to patient release is about 2 hours, compared with 4–6 hours for OR-based treatments.

"For new parents, it's wonderful because they can come in to the procedure room and are there during the [intravenous line placement] and when they leave they can see that the child is asleep and comfortable," she said in an interview. "For the child, they don't even notice the parent was gone. It's just so much easier on everyone."

Dr. Connelly and colleagues presented a case series of 15 children with port-wine stains larger than 10 cm2 who received laser surgery in a pediatric procedure room separate from the main operating suite, with sedation provided by a nurse practitioner and pediatric intensivist. Ethyl chloride spray was used prior to intravenous line insertion and intravenous propofol (Diprivan)/fentanyl or ketamine was dosed based on weight.

The patients received an average of three to four treatments with a 595-nm pulsed dye laser (Candela VBeam) at a fluence of 7.5–9.5 J/cm2, pulse duration of 1.5 milliseconds, and 7-mm spot size.

Lightening of individual port wine stains was observed in all patients after each treatment. The only side effect, purpura, developed in all of the children treated and lasted for 10–14 days, which is the natural course following laser therapy, Dr. Connelly said.

There were no adverse reactions to the anesthesia. No intubations or overnight hospitalizations were required.

Without expensive OR costs, there was a 50%-70% cost savings per laser procedure, said Dr. Connelly, who acknowledged that a formal cost analysis was not performed.

When moving laser treatments from the OR to a pediatric procedure room, ensure that preoperative fluids are restricted based on age; properly sized safety equipment is readily available; and all patients are watched carefully for signs of nausea, vomiting, or fever prior to discharge, she said.

Dr. Connelly added that she has no relevant financial relationship with Candela Corp.

MIAMI BEACH — Laser surgery with intravenous deep sedation can be performed safely in a pediatric procedure room rather than an operating room when treating congenital vascular stains, Dr. Elizabeth Alvarez Connelly said in a poster presentation at the annual Masters of Pediatrics conference sponsored by the University of Miami.

Pulsed dye lasers are considered the standard for the treatment of congenital vascular stains in young children, but one of the greatest challenges in their use is maintaining an adequate comfort level throughout the multiple treatment sessions needed.

Children are traditionally treated under gas anesthesia in the OR, but repeat sessions can be costly for all parties and stressful to the patient and family, said Dr. Connelly, a pediatric dermatologist at the University of Miami.

Laser surgery in pediatric procedure rooms does not require a sterile environment or a clearance visit by a pediatrician or anesthesiologist and allows clinicians to treat a large surface area during one laser session. The average time from start to patient release is about 2 hours, compared with 4–6 hours for OR-based treatments.

"For new parents, it's wonderful because they can come in to the procedure room and are there during the [intravenous line placement] and when they leave they can see that the child is asleep and comfortable," she said in an interview. "For the child, they don't even notice the parent was gone. It's just so much easier on everyone."

Dr. Connelly and colleagues presented a case series of 15 children with port-wine stains larger than 10 cm2 who received laser surgery in a pediatric procedure room separate from the main operating suite, with sedation provided by a nurse practitioner and pediatric intensivist. Ethyl chloride spray was used prior to intravenous line insertion and intravenous propofol (Diprivan)/fentanyl or ketamine was dosed based on weight.

The patients received an average of three to four treatments with a 595-nm pulsed dye laser (Candela VBeam) at a fluence of 7.5–9.5 J/cm2, pulse duration of 1.5 milliseconds, and 7-mm spot size.

Lightening of individual port wine stains was observed in all patients after each treatment. The only side effect, purpura, developed in all of the children treated and lasted for 10–14 days, which is the natural course following laser therapy, Dr. Connelly said.

There were no adverse reactions to the anesthesia. No intubations or overnight hospitalizations were required.

Without expensive OR costs, there was a 50%-70% cost savings per laser procedure, said Dr. Connelly, who acknowledged that a formal cost analysis was not performed.

When moving laser treatments from the OR to a pediatric procedure room, ensure that preoperative fluids are restricted based on age; properly sized safety equipment is readily available; and all patients are watched carefully for signs of nausea, vomiting, or fever prior to discharge, she said.

Dr. Connelly added that she has no relevant financial relationship with Candela Corp.

MIAMI BEACH — Laser surgery with intravenous deep sedation can be performed safely in a pediatric procedure room rather than an operating room when treating congenital vascular stains, Dr. Elizabeth Alvarez Connelly said in a poster presentation at the annual Masters of Pediatrics conference sponsored by the University of Miami.

Pulsed dye lasers are considered the standard for the treatment of congenital vascular stains in young children, but one of the greatest challenges in their use is maintaining an adequate comfort level throughout the multiple treatment sessions needed.

Children are traditionally treated under gas anesthesia in the OR, but repeat sessions can be costly for all parties and stressful to the patient and family, said Dr. Connelly, a pediatric dermatologist at the University of Miami.

Laser surgery in pediatric procedure rooms does not require a sterile environment or a clearance visit by a pediatrician or anesthesiologist and allows clinicians to treat a large surface area during one laser session. The average time from start to patient release is about 2 hours, compared with 4–6 hours for OR-based treatments.

"For new parents, it's wonderful because they can come in to the procedure room and are there during the [intravenous line placement] and when they leave they can see that the child is asleep and comfortable," she said in an interview. "For the child, they don't even notice the parent was gone. It's just so much easier on everyone."

Dr. Connelly and colleagues presented a case series of 15 children with port-wine stains larger than 10 cm2 who received laser surgery in a pediatric procedure room separate from the main operating suite, with sedation provided by a nurse practitioner and pediatric intensivist. Ethyl chloride spray was used prior to intravenous line insertion and intravenous propofol (Diprivan)/fentanyl or ketamine was dosed based on weight.

The patients received an average of three to four treatments with a 595-nm pulsed dye laser (Candela VBeam) at a fluence of 7.5–9.5 J/cm2, pulse duration of 1.5 milliseconds, and 7-mm spot size.

Lightening of individual port wine stains was observed in all patients after each treatment. The only side effect, purpura, developed in all of the children treated and lasted for 10–14 days, which is the natural course following laser therapy, Dr. Connelly said.

There were no adverse reactions to the anesthesia. No intubations or overnight hospitalizations were required.

Without expensive OR costs, there was a 50%-70% cost savings per laser procedure, said Dr. Connelly, who acknowledged that a formal cost analysis was not performed.

When moving laser treatments from the OR to a pediatric procedure room, ensure that preoperative fluids are restricted based on age; properly sized safety equipment is readily available; and all patients are watched carefully for signs of nausea, vomiting, or fever prior to discharge, she said.

Dr. Connelly added that she has no relevant financial relationship with Candela Corp.

MAUI, HAWAII — Now that sentinel lymph node biopsy has become the standard-of-care staging procedure in intermediate-thickness melanoma, the focus has expanded to include identification of patients with thin melanomas who have novel high-risk features that also warrant sentinel node biopsy, Dr. Merrick Ross said at the annual Hawaii Dermatology seminar sponsored by Skin Disease Education Foundation.

Although the prognosis of thin melanomas is generally quite favorable, there is considerable heterogeneity. Buried within the very large population of patients with melanomas not more than 1.0 mm thick are subgroups with biologically aggressive disease, he noted.

"The thin melanoma population is important. Everyone says they have such a good prognosis. Why even bother with sentinel node biopsy? Because they represent a very high percentage of newly diagnosed invasive melanoma patients. Although only a small percentage of them go on to develop stage IV disease and die, that small percentage represents a relatively large percentage of stage IV patients. So it's very important not to lump them all together as good performers," explained Dr. Ross, professor of surgery and chief of the melanoma section at M.D. Anderson Cancer Center and the University of Texas, Houston.

It is clear that performing sentinel lymph node (SLN) biopsy in all patients with thin melanoma wouldn't be cost effective. Surgeons at Ohio State University, Columbus, reviewed their prospective melanoma database and found a 1.4% prevalence of SLN positivity in 138 unselected thin-melanoma patients. They estimated the cost to identify a single patient with a positive SLN at $700,000 to $1 million (Surgery 2003;134:542–7).

"That's clearly not a cost-effective maneuver. But what if you could increase that positivity rate by 10-fold and make it 14%? Obviously the cost of finding a positive SLN goes way down," he observed.

Among the promising biologically based prognostic factors for enriching the yield of SLN biopsy in patients with thin melanomas are mitotic rate, vertical growth phase, and the presence of tumor-infiltrating lymphocytes. Add these biologic risk factors to other predictors—ulceration, evidence of tumor regression, male gender, younger age, and/or location on the trunk or a lower extremity—and the prospects for risk stratification look quite good, Dr. Ross said.

In a recent series of 882 patients with thin melanomas dating back to the pre-SLN era, surgeons at the University of Pennsylvania, Philadelphia, found that those whose tumors were in the vertical growth phase and had a mitotic rate greater than zero had an 11.9% prevalence of regional nodal disease (Ann. Surg. Oncol. 2006;13:533–41).

While this and other studies of novel biologic risk factors for SLN positivity are promising, they need to be validated in other thin-melanoma databases before gaining acceptance in routine clinical practice.

For now, the practice at M.D. Anderson and the other major cancer centers is to recommend SLN biopsy for stage IB-IIC melanoma based upon the positive results of the landmark 1,269-patient Multicenter Selective Lymphadenectomy Trial (N. Engl. J. Med. 2006; 355:1307–17), and to selectively biopsy in stage IA patients with high-risk features, according to Dr. Ross.

He noted there has been concern that wide excision of the primary tumor might disrupt the local lymphatic system and render SLN biopsy inaccurate. A review of the M.D. Anderson experience showed that surgeons were still able to identify the SLN following wide excision, but it required examination of a greater number of lymphatic basins.

"We still ultimately identified the right node, but we had to do more surgery to identify the sentinel node after wide excision," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

MAUI, HAWAII — Now that sentinel lymph node biopsy has become the standard-of-care staging procedure in intermediate-thickness melanoma, the focus has expanded to include identification of patients with thin melanomas who have novel high-risk features that also warrant sentinel node biopsy, Dr. Merrick Ross said at the annual Hawaii Dermatology seminar sponsored by Skin Disease Education Foundation.

Although the prognosis of thin melanomas is generally quite favorable, there is considerable heterogeneity. Buried within the very large population of patients with melanomas not more than 1.0 mm thick are subgroups with biologically aggressive disease, he noted.

"The thin melanoma population is important. Everyone says they have such a good prognosis. Why even bother with sentinel node biopsy? Because they represent a very high percentage of newly diagnosed invasive melanoma patients. Although only a small percentage of them go on to develop stage IV disease and die, that small percentage represents a relatively large percentage of stage IV patients. So it's very important not to lump them all together as good performers," explained Dr. Ross, professor of surgery and chief of the melanoma section at M.D. Anderson Cancer Center and the University of Texas, Houston.

It is clear that performing sentinel lymph node (SLN) biopsy in all patients with thin melanoma wouldn't be cost effective. Surgeons at Ohio State University, Columbus, reviewed their prospective melanoma database and found a 1.4% prevalence of SLN positivity in 138 unselected thin-melanoma patients. They estimated the cost to identify a single patient with a positive SLN at $700,000 to $1 million (Surgery 2003;134:542–7).

"That's clearly not a cost-effective maneuver. But what if you could increase that positivity rate by 10-fold and make it 14%? Obviously the cost of finding a positive SLN goes way down," he observed.

Among the promising biologically based prognostic factors for enriching the yield of SLN biopsy in patients with thin melanomas are mitotic rate, vertical growth phase, and the presence of tumor-infiltrating lymphocytes. Add these biologic risk factors to other predictors—ulceration, evidence of tumor regression, male gender, younger age, and/or location on the trunk or a lower extremity—and the prospects for risk stratification look quite good, Dr. Ross said.

In a recent series of 882 patients with thin melanomas dating back to the pre-SLN era, surgeons at the University of Pennsylvania, Philadelphia, found that those whose tumors were in the vertical growth phase and had a mitotic rate greater than zero had an 11.9% prevalence of regional nodal disease (Ann. Surg. Oncol. 2006;13:533–41).

While this and other studies of novel biologic risk factors for SLN positivity are promising, they need to be validated in other thin-melanoma databases before gaining acceptance in routine clinical practice.

For now, the practice at M.D. Anderson and the other major cancer centers is to recommend SLN biopsy for stage IB-IIC melanoma based upon the positive results of the landmark 1,269-patient Multicenter Selective Lymphadenectomy Trial (N. Engl. J. Med. 2006; 355:1307–17), and to selectively biopsy in stage IA patients with high-risk features, according to Dr. Ross.

He noted there has been concern that wide excision of the primary tumor might disrupt the local lymphatic system and render SLN biopsy inaccurate. A review of the M.D. Anderson experience showed that surgeons were still able to identify the SLN following wide excision, but it required examination of a greater number of lymphatic basins.

"We still ultimately identified the right node, but we had to do more surgery to identify the sentinel node after wide excision," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

MAUI, HAWAII — Now that sentinel lymph node biopsy has become the standard-of-care staging procedure in intermediate-thickness melanoma, the focus has expanded to include identification of patients with thin melanomas who have novel high-risk features that also warrant sentinel node biopsy, Dr. Merrick Ross said at the annual Hawaii Dermatology seminar sponsored by Skin Disease Education Foundation.

Although the prognosis of thin melanomas is generally quite favorable, there is considerable heterogeneity. Buried within the very large population of patients with melanomas not more than 1.0 mm thick are subgroups with biologically aggressive disease, he noted.

"The thin melanoma population is important. Everyone says they have such a good prognosis. Why even bother with sentinel node biopsy? Because they represent a very high percentage of newly diagnosed invasive melanoma patients. Although only a small percentage of them go on to develop stage IV disease and die, that small percentage represents a relatively large percentage of stage IV patients. So it's very important not to lump them all together as good performers," explained Dr. Ross, professor of surgery and chief of the melanoma section at M.D. Anderson Cancer Center and the University of Texas, Houston.

It is clear that performing sentinel lymph node (SLN) biopsy in all patients with thin melanoma wouldn't be cost effective. Surgeons at Ohio State University, Columbus, reviewed their prospective melanoma database and found a 1.4% prevalence of SLN positivity in 138 unselected thin-melanoma patients. They estimated the cost to identify a single patient with a positive SLN at $700,000 to $1 million (Surgery 2003;134:542–7).

"That's clearly not a cost-effective maneuver. But what if you could increase that positivity rate by 10-fold and make it 14%? Obviously the cost of finding a positive SLN goes way down," he observed.

Among the promising biologically based prognostic factors for enriching the yield of SLN biopsy in patients with thin melanomas are mitotic rate, vertical growth phase, and the presence of tumor-infiltrating lymphocytes. Add these biologic risk factors to other predictors—ulceration, evidence of tumor regression, male gender, younger age, and/or location on the trunk or a lower extremity—and the prospects for risk stratification look quite good, Dr. Ross said.

In a recent series of 882 patients with thin melanomas dating back to the pre-SLN era, surgeons at the University of Pennsylvania, Philadelphia, found that those whose tumors were in the vertical growth phase and had a mitotic rate greater than zero had an 11.9% prevalence of regional nodal disease (Ann. Surg. Oncol. 2006;13:533–41).

While this and other studies of novel biologic risk factors for SLN positivity are promising, they need to be validated in other thin-melanoma databases before gaining acceptance in routine clinical practice.

For now, the practice at M.D. Anderson and the other major cancer centers is to recommend SLN biopsy for stage IB-IIC melanoma based upon the positive results of the landmark 1,269-patient Multicenter Selective Lymphadenectomy Trial (N. Engl. J. Med. 2006; 355:1307–17), and to selectively biopsy in stage IA patients with high-risk features, according to Dr. Ross.

He noted there has been concern that wide excision of the primary tumor might disrupt the local lymphatic system and render SLN biopsy inaccurate. A review of the M.D. Anderson experience showed that surgeons were still able to identify the SLN following wide excision, but it required examination of a greater number of lymphatic basins.

"We still ultimately identified the right node, but we had to do more surgery to identify the sentinel node after wide excision," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

ELSEVIER GLOBAL MEDICAL NEWS

ELSEVIER GLOBAL MEDICAL NEWS

ELSEVIER GLOBAL MEDICAL NEWS

MAUI, HAWAII — "If you do Botox, you can certainly do fillers," Dr. Howard K. Steinman said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Dr. Steinman stressed the importance of developing skills with injectable fillers, noting their ease of use, minimal risk and downtime, efficacy, and high patient and clinician satisfaction. "They're rapidly becoming the 'go to' treatment for lots of types of facial rejuvenation," he said.

Honing skills using temporary fillers, he suggested, is a good way to learn. "I would start with temporary fillers, before you [use] semipermanent fillers, and certainly before you go to permanent fillers," said Dr. Steinman of the University of California, San Diego.

He acknowledged that temporary fillers present a conundrum. For the patient, the problem with temporary fillers is that they're temporary. "They only last 3–6 or 9 months. My patients don't like it [because] they have to keep coming back," Dr. Steinman noted. But for those who are learning to use them, the advantage of temporary fillers is that they're temporary.

"If you're thinking of doing lips, I would suggest first learning with a temporary filler before you mess up somebody's lips permanently," he cautioned.

More important, if a woman has never had her lips or nasolabial folds face enlarged and she's not sure that she wants it, do not give her a semipermanent or permanent filler since she may not like the results, he said.

A "cool thing" about the temporary filler hyaluronic acid, Dr. Steinman noted, is that it is dissolved by hyaluronidase, which is readily available. In one situation in which a lump had appeared when he was using a hyaluronic acid filler, he was able to eliminate the lump by injecting hyaluronidase.

While learning on temporary fillers, treat forgiving areas first. The easiest way to do that is to treat patients after botulinum toxin type A injections. "They already trust you to stick needles in their face," he explained, "and many of them have wrinkles that won't completely go away."

Dr. Steinman recalled a patient whom he had told, "Your glabellar rhytid is not going to completely resolve with the Botox." As he predicted, she had a good result with Botox but still had a rhytid. "That's a great place to learn," he said.

"There's a synergy between the places I inject Botox and the places where you can learn to inject hyaluronic acid." (See box.) For instance, he said, "Nasolabial folds are an excellent location—and glabellar lines."

Using fillers after Botox is a highly effective, versatile, nonablative, low-risk treatment option that can be useful for resistant resting rhytids.

Use the filler after waiting for maximal botulinum effect. Fillers often last longer when placed after botulinum, said Dr. Steinman, who stated that he had no conflicts of interest.

After learning on more forgiving areas, move on to other areas. He started treating lip patients once he had developed his skills.

"The last place I would suggest you learn is the teardrop of the eyelid," he said. Above all, he urged, "use common sense."

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

ELSEVIER GLOBAL MEDICAL NEWS

MAUI, HAWAII — "If you do Botox, you can certainly do fillers," Dr. Howard K. Steinman said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Dr. Steinman stressed the importance of developing skills with injectable fillers, noting their ease of use, minimal risk and downtime, efficacy, and high patient and clinician satisfaction. "They're rapidly becoming the 'go to' treatment for lots of types of facial rejuvenation," he said.

Honing skills using temporary fillers, he suggested, is a good way to learn. "I would start with temporary fillers, before you [use] semipermanent fillers, and certainly before you go to permanent fillers," said Dr. Steinman of the University of California, San Diego.

He acknowledged that temporary fillers present a conundrum. For the patient, the problem with temporary fillers is that they're temporary. "They only last 3–6 or 9 months. My patients don't like it [because] they have to keep coming back," Dr. Steinman noted. But for those who are learning to use them, the advantage of temporary fillers is that they're temporary.

"If you're thinking of doing lips, I would suggest first learning with a temporary filler before you mess up somebody's lips permanently," he cautioned.

More important, if a woman has never had her lips or nasolabial folds face enlarged and she's not sure that she wants it, do not give her a semipermanent or permanent filler since she may not like the results, he said.

A "cool thing" about the temporary filler hyaluronic acid, Dr. Steinman noted, is that it is dissolved by hyaluronidase, which is readily available. In one situation in which a lump had appeared when he was using a hyaluronic acid filler, he was able to eliminate the lump by injecting hyaluronidase.

While learning on temporary fillers, treat forgiving areas first. The easiest way to do that is to treat patients after botulinum toxin type A injections. "They already trust you to stick needles in their face," he explained, "and many of them have wrinkles that won't completely go away."

Dr. Steinman recalled a patient whom he had told, "Your glabellar rhytid is not going to completely resolve with the Botox." As he predicted, she had a good result with Botox but still had a rhytid. "That's a great place to learn," he said.

"There's a synergy between the places I inject Botox and the places where you can learn to inject hyaluronic acid." (See box.) For instance, he said, "Nasolabial folds are an excellent location—and glabellar lines."

Using fillers after Botox is a highly effective, versatile, nonablative, low-risk treatment option that can be useful for resistant resting rhytids.

Use the filler after waiting for maximal botulinum effect. Fillers often last longer when placed after botulinum, said Dr. Steinman, who stated that he had no conflicts of interest.

After learning on more forgiving areas, move on to other areas. He started treating lip patients once he had developed his skills.

"The last place I would suggest you learn is the teardrop of the eyelid," he said. Above all, he urged, "use common sense."

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

ELSEVIER GLOBAL MEDICAL NEWS

MAUI, HAWAII — "If you do Botox, you can certainly do fillers," Dr. Howard K. Steinman said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

Dr. Steinman stressed the importance of developing skills with injectable fillers, noting their ease of use, minimal risk and downtime, efficacy, and high patient and clinician satisfaction. "They're rapidly becoming the 'go to' treatment for lots of types of facial rejuvenation," he said.

Honing skills using temporary fillers, he suggested, is a good way to learn. "I would start with temporary fillers, before you [use] semipermanent fillers, and certainly before you go to permanent fillers," said Dr. Steinman of the University of California, San Diego.

He acknowledged that temporary fillers present a conundrum. For the patient, the problem with temporary fillers is that they're temporary. "They only last 3–6 or 9 months. My patients don't like it [because] they have to keep coming back," Dr. Steinman noted. But for those who are learning to use them, the advantage of temporary fillers is that they're temporary.

"If you're thinking of doing lips, I would suggest first learning with a temporary filler before you mess up somebody's lips permanently," he cautioned.

More important, if a woman has never had her lips or nasolabial folds face enlarged and she's not sure that she wants it, do not give her a semipermanent or permanent filler since she may not like the results, he said.

A "cool thing" about the temporary filler hyaluronic acid, Dr. Steinman noted, is that it is dissolved by hyaluronidase, which is readily available. In one situation in which a lump had appeared when he was using a hyaluronic acid filler, he was able to eliminate the lump by injecting hyaluronidase.

While learning on temporary fillers, treat forgiving areas first. The easiest way to do that is to treat patients after botulinum toxin type A injections. "They already trust you to stick needles in their face," he explained, "and many of them have wrinkles that won't completely go away."

Dr. Steinman recalled a patient whom he had told, "Your glabellar rhytid is not going to completely resolve with the Botox." As he predicted, she had a good result with Botox but still had a rhytid. "That's a great place to learn," he said.

"There's a synergy between the places I inject Botox and the places where you can learn to inject hyaluronic acid." (See box.) For instance, he said, "Nasolabial folds are an excellent location—and glabellar lines."

Using fillers after Botox is a highly effective, versatile, nonablative, low-risk treatment option that can be useful for resistant resting rhytids.

Use the filler after waiting for maximal botulinum effect. Fillers often last longer when placed after botulinum, said Dr. Steinman, who stated that he had no conflicts of interest.

After learning on more forgiving areas, move on to other areas. He started treating lip patients once he had developed his skills.

"The last place I would suggest you learn is the teardrop of the eyelid," he said. Above all, he urged, "use common sense."

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

ELSEVIER GLOBAL MEDICAL NEWS

GRAPEVINE, TEX. — Brief exposure of arm skin to infrared radiation appeared to protect against subsequent ultraviolet B exposure in a pilot study of 13 subjects, Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery.

Results from this proof-of-concept study suggest that infrared pretreatment of skin with a light-emitting diode (LED) device may protect against ultraviolet B exposure as well as sunscreen, but in a way that's unaffected by moisture or perspiration, environmental factors, allergy, or compliance. The infrared-treatment protocols appeared to protect skin as well as a sunscreen with SPF 15, said Dr. Barolet, a dermatologist at McGill University in Montreal.

The investigators tested an infrared, LED device that delivered 660-nm radiation at a power density of 50 mW/cm2 and a fluence of 4.5 J/cm2. Each treatment session lasted 3 minutes.

The LumiPhase-R device used in the study to produce infrared protection was made by Opusmed, a company based in Montreal. Dr. Barolet founded the company and is a stockholder.

The study tested several different treatment regimens, ranging from 6 treatment sessions over 3 weeks to 10 sessions during 1 week. Thirteen people (seven women and six men) completed the study. Their age range was 19–50 years, with a mean age of 41.

The subjects received their prespecified infrared regimen on the skin of their right arms, with their left arms remaining untreated and acting as controls. A patch on both arms was also treated with an SPF-15 sunscreen. Following pretreatment, both arms received a series of escalating ultraviolet B doses, and patients were followed for at least 1 month. Each arm received ultraviolet radiation on a treated and a control skin patch that corresponded to one minimal erythema dose (MED1), and also to a series of higher MEDs, up to MED4.

All of the treatment regimens studies showed some ultraviolet B protection, with the most consistent protection coming against the effects of exposure to MED1 and MED2. The level of protection seemed to be dose dependent, with the best protection provided by a regimen of 10 infrared treatments in 1 week, said Dr. Barolet.

The right arms of patients received three doses of infrared light over 6 days prior to indicated dosages of ultraviolet B exposure. Infrared pretreatment reduced both acute erythema and long-term, postinflammatory hyperpigmentation (PIH). Photos courtesy Dr. Daniel Barolet

GRAPEVINE, TEX. — Brief exposure of arm skin to infrared radiation appeared to protect against subsequent ultraviolet B exposure in a pilot study of 13 subjects, Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery.

Results from this proof-of-concept study suggest that infrared pretreatment of skin with a light-emitting diode (LED) device may protect against ultraviolet B exposure as well as sunscreen, but in a way that's unaffected by moisture or perspiration, environmental factors, allergy, or compliance. The infrared-treatment protocols appeared to protect skin as well as a sunscreen with SPF 15, said Dr. Barolet, a dermatologist at McGill University in Montreal.

The investigators tested an infrared, LED device that delivered 660-nm radiation at a power density of 50 mW/cm2 and a fluence of 4.5 J/cm2. Each treatment session lasted 3 minutes.

The LumiPhase-R device used in the study to produce infrared protection was made by Opusmed, a company based in Montreal. Dr. Barolet founded the company and is a stockholder.

The study tested several different treatment regimens, ranging from 6 treatment sessions over 3 weeks to 10 sessions during 1 week. Thirteen people (seven women and six men) completed the study. Their age range was 19–50 years, with a mean age of 41.

The subjects received their prespecified infrared regimen on the skin of their right arms, with their left arms remaining untreated and acting as controls. A patch on both arms was also treated with an SPF-15 sunscreen. Following pretreatment, both arms received a series of escalating ultraviolet B doses, and patients were followed for at least 1 month. Each arm received ultraviolet radiation on a treated and a control skin patch that corresponded to one minimal erythema dose (MED1), and also to a series of higher MEDs, up to MED4.

All of the treatment regimens studies showed some ultraviolet B protection, with the most consistent protection coming against the effects of exposure to MED1 and MED2. The level of protection seemed to be dose dependent, with the best protection provided by a regimen of 10 infrared treatments in 1 week, said Dr. Barolet.

The right arms of patients received three doses of infrared light over 6 days prior to indicated dosages of ultraviolet B exposure. Infrared pretreatment reduced both acute erythema and long-term, postinflammatory hyperpigmentation (PIH). Photos courtesy Dr. Daniel Barolet

GRAPEVINE, TEX. — Brief exposure of arm skin to infrared radiation appeared to protect against subsequent ultraviolet B exposure in a pilot study of 13 subjects, Dr. Daniel Barolet said at the annual meeting of the American Society for Laser Medicine and Surgery.

Results from this proof-of-concept study suggest that infrared pretreatment of skin with a light-emitting diode (LED) device may protect against ultraviolet B exposure as well as sunscreen, but in a way that's unaffected by moisture or perspiration, environmental factors, allergy, or compliance. The infrared-treatment protocols appeared to protect skin as well as a sunscreen with SPF 15, said Dr. Barolet, a dermatologist at McGill University in Montreal.

The investigators tested an infrared, LED device that delivered 660-nm radiation at a power density of 50 mW/cm2 and a fluence of 4.5 J/cm2. Each treatment session lasted 3 minutes.

The LumiPhase-R device used in the study to produce infrared protection was made by Opusmed, a company based in Montreal. Dr. Barolet founded the company and is a stockholder.

The study tested several different treatment regimens, ranging from 6 treatment sessions over 3 weeks to 10 sessions during 1 week. Thirteen people (seven women and six men) completed the study. Their age range was 19–50 years, with a mean age of 41.

The subjects received their prespecified infrared regimen on the skin of their right arms, with their left arms remaining untreated and acting as controls. A patch on both arms was also treated with an SPF-15 sunscreen. Following pretreatment, both arms received a series of escalating ultraviolet B doses, and patients were followed for at least 1 month. Each arm received ultraviolet radiation on a treated and a control skin patch that corresponded to one minimal erythema dose (MED1), and also to a series of higher MEDs, up to MED4.

All of the treatment regimens studies showed some ultraviolet B protection, with the most consistent protection coming against the effects of exposure to MED1 and MED2. The level of protection seemed to be dose dependent, with the best protection provided by a regimen of 10 infrared treatments in 1 week, said Dr. Barolet.

The right arms of patients received three doses of infrared light over 6 days prior to indicated dosages of ultraviolet B exposure. Infrared pretreatment reduced both acute erythema and long-term, postinflammatory hyperpigmentation (PIH). Photos courtesy Dr. Daniel Barolet

MAUI, HAWAII — Evidence from randomized clinical trials indicates that excision margins of 2 cm are optimal for primary melanomas greater than 2 mm thick, Dr. Merrick Ross said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

That's good news for patients, because 90% of surgical defects resulting from a 2-cm-wide excision margin on the trunk or a proximal extremity can be closed primarily without grafts, noted Dr. Ross, Charles McBride Professor of Surgery and chief of the melanoma section at the University of Texas M.D. Anderson Cancer Center, Houston.

"The take-home message is we probably don't need wider margins than 2 cm for any melanoma. But we shouldn't be cavalier about our margins of excision because very narrow margins—particularly 1 cm for the thicker melanomas—may not be adequate and will have a negative impact on the natural history," he said.

Empirically based 5-cm excision margins were standard for most of the 20th century. Beginning in about 1970, however, surgeons began to adopt narrower margins for thinner melanomas with good clinical results.

The contemporary era of evidence-based excision margins rests upon five prospective randomized trials that attempted to define the margins, optimizing the chance for durable local control while minimizing surgical morbidity and cost.

These trials established 1-cm margins as the standard for thin melanomas, defined as those with a Breslow's depth of invasion of less than 1 mm. For tumors measuring 1–2 mm in thickness, the trials suggested margins of 1–2 cm.

The 2-cm margins for melanomas thicker than 2 mm favored by Dr. Ross and other surgical oncologists were arrived at by examining the results of two complementary randomized trials. One was an as-yet-unpublished study by the Swedish Melanoma Study Group that randomized 644 patients with such melanomas to wide excision with either 2- or 4-cm margins. Rates of locoregional recurrence or death from melanoma proved no different in the two groups (SKIN & ALLERGY NEWS, December 2005, p. 36).

The other relevant trial was conducted by the United Kingdom Melanoma Study Group. In that trial, 900 patients with melanoma measuring at least 2 mm in thickness were randomized to 1- or 3-cm excision margins. The 1-cm group had a 26% increased relative risk of locoregional recurrence during a median 60 months of follow-up (N. Engl. J. Med. 2004;350:757–66).

"For lesions thicker than 2 mm, a 3-cm margin is better than 1 cm based on the U.K. trial in terms of locoregional events," he said. But based on the Swedish trial, if a 4-cm margin is not better than a 2-cm margin, then a 3-cm margin can't be better than a 2-cm margin. "So by default, our standard is a 2-cm margin," Dr. Ross explained.

The standard margin for melanoma in situ is 5 mm. Unlike the recommendations for true melanoma, the standard for melanoma in situ is not based upon prospective randomized trial data. It's simply accepted practice based upon extensive clinical observation and experience indicating that the risk for local recurrence is extremely low with 5-mm margins. This sets a precedent that may be relevant to the future status of Mohs surgery for melanoma, he continued.

Critics of Mohs for melanoma argue it is not the standard of care and is unlikely to offer a cost advantage over standard excision, so therefore it should be evaluated in a randomized trial before gaining acceptance.

"I'm not convinced that's true," Dr. Ross said. "First of all, that trial is never going to be done. Second, we didn't use randomized clinical trials to set standards for melanoma in situ. Once we get a body of literature that's very robust and shows very good outcomes for Mohs surgery, it may become a standard of care."

He predicted that Mohs will be a niche procedure in melanoma. It is most likely to prove advantageous for thin melanomas in anatomically difficult locations, such as the head and neck, as well as for lentigo maligna melanoma, in which subclinical disease is often present at a considerable distance from the primary tumor.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

'The take-home message is we probably don't need wider margins than 2 cm for any melanoma.' DR. ROSS

MAUI, HAWAII — Evidence from randomized clinical trials indicates that excision margins of 2 cm are optimal for primary melanomas greater than 2 mm thick, Dr. Merrick Ross said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

That's good news for patients, because 90% of surgical defects resulting from a 2-cm-wide excision margin on the trunk or a proximal extremity can be closed primarily without grafts, noted Dr. Ross, Charles McBride Professor of Surgery and chief of the melanoma section at the University of Texas M.D. Anderson Cancer Center, Houston.

"The take-home message is we probably don't need wider margins than 2 cm for any melanoma. But we shouldn't be cavalier about our margins of excision because very narrow margins—particularly 1 cm for the thicker melanomas—may not be adequate and will have a negative impact on the natural history," he said.

Empirically based 5-cm excision margins were standard for most of the 20th century. Beginning in about 1970, however, surgeons began to adopt narrower margins for thinner melanomas with good clinical results.

The contemporary era of evidence-based excision margins rests upon five prospective randomized trials that attempted to define the margins, optimizing the chance for durable local control while minimizing surgical morbidity and cost.

These trials established 1-cm margins as the standard for thin melanomas, defined as those with a Breslow's depth of invasion of less than 1 mm. For tumors measuring 1–2 mm in thickness, the trials suggested margins of 1–2 cm.

The 2-cm margins for melanomas thicker than 2 mm favored by Dr. Ross and other surgical oncologists were arrived at by examining the results of two complementary randomized trials. One was an as-yet-unpublished study by the Swedish Melanoma Study Group that randomized 644 patients with such melanomas to wide excision with either 2- or 4-cm margins. Rates of locoregional recurrence or death from melanoma proved no different in the two groups (SKIN & ALLERGY NEWS, December 2005, p. 36).

The other relevant trial was conducted by the United Kingdom Melanoma Study Group. In that trial, 900 patients with melanoma measuring at least 2 mm in thickness were randomized to 1- or 3-cm excision margins. The 1-cm group had a 26% increased relative risk of locoregional recurrence during a median 60 months of follow-up (N. Engl. J. Med. 2004;350:757–66).

"For lesions thicker than 2 mm, a 3-cm margin is better than 1 cm based on the U.K. trial in terms of locoregional events," he said. But based on the Swedish trial, if a 4-cm margin is not better than a 2-cm margin, then a 3-cm margin can't be better than a 2-cm margin. "So by default, our standard is a 2-cm margin," Dr. Ross explained.

The standard margin for melanoma in situ is 5 mm. Unlike the recommendations for true melanoma, the standard for melanoma in situ is not based upon prospective randomized trial data. It's simply accepted practice based upon extensive clinical observation and experience indicating that the risk for local recurrence is extremely low with 5-mm margins. This sets a precedent that may be relevant to the future status of Mohs surgery for melanoma, he continued.

Critics of Mohs for melanoma argue it is not the standard of care and is unlikely to offer a cost advantage over standard excision, so therefore it should be evaluated in a randomized trial before gaining acceptance.

"I'm not convinced that's true," Dr. Ross said. "First of all, that trial is never going to be done. Second, we didn't use randomized clinical trials to set standards for melanoma in situ. Once we get a body of literature that's very robust and shows very good outcomes for Mohs surgery, it may become a standard of care."

He predicted that Mohs will be a niche procedure in melanoma. It is most likely to prove advantageous for thin melanomas in anatomically difficult locations, such as the head and neck, as well as for lentigo maligna melanoma, in which subclinical disease is often present at a considerable distance from the primary tumor.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

'The take-home message is we probably don't need wider margins than 2 cm for any melanoma.' DR. ROSS

MAUI, HAWAII — Evidence from randomized clinical trials indicates that excision margins of 2 cm are optimal for primary melanomas greater than 2 mm thick, Dr. Merrick Ross said at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

That's good news for patients, because 90% of surgical defects resulting from a 2-cm-wide excision margin on the trunk or a proximal extremity can be closed primarily without grafts, noted Dr. Ross, Charles McBride Professor of Surgery and chief of the melanoma section at the University of Texas M.D. Anderson Cancer Center, Houston.

"The take-home message is we probably don't need wider margins than 2 cm for any melanoma. But we shouldn't be cavalier about our margins of excision because very narrow margins—particularly 1 cm for the thicker melanomas—may not be adequate and will have a negative impact on the natural history," he said.

Empirically based 5-cm excision margins were standard for most of the 20th century. Beginning in about 1970, however, surgeons began to adopt narrower margins for thinner melanomas with good clinical results.

The contemporary era of evidence-based excision margins rests upon five prospective randomized trials that attempted to define the margins, optimizing the chance for durable local control while minimizing surgical morbidity and cost.

These trials established 1-cm margins as the standard for thin melanomas, defined as those with a Breslow's depth of invasion of less than 1 mm. For tumors measuring 1–2 mm in thickness, the trials suggested margins of 1–2 cm.

The 2-cm margins for melanomas thicker than 2 mm favored by Dr. Ross and other surgical oncologists were arrived at by examining the results of two complementary randomized trials. One was an as-yet-unpublished study by the Swedish Melanoma Study Group that randomized 644 patients with such melanomas to wide excision with either 2- or 4-cm margins. Rates of locoregional recurrence or death from melanoma proved no different in the two groups (SKIN & ALLERGY NEWS, December 2005, p. 36).

The other relevant trial was conducted by the United Kingdom Melanoma Study Group. In that trial, 900 patients with melanoma measuring at least 2 mm in thickness were randomized to 1- or 3-cm excision margins. The 1-cm group had a 26% increased relative risk of locoregional recurrence during a median 60 months of follow-up (N. Engl. J. Med. 2004;350:757–66).

"For lesions thicker than 2 mm, a 3-cm margin is better than 1 cm based on the U.K. trial in terms of locoregional events," he said. But based on the Swedish trial, if a 4-cm margin is not better than a 2-cm margin, then a 3-cm margin can't be better than a 2-cm margin. "So by default, our standard is a 2-cm margin," Dr. Ross explained.

The standard margin for melanoma in situ is 5 mm. Unlike the recommendations for true melanoma, the standard for melanoma in situ is not based upon prospective randomized trial data. It's simply accepted practice based upon extensive clinical observation and experience indicating that the risk for local recurrence is extremely low with 5-mm margins. This sets a precedent that may be relevant to the future status of Mohs surgery for melanoma, he continued.

Critics of Mohs for melanoma argue it is not the standard of care and is unlikely to offer a cost advantage over standard excision, so therefore it should be evaluated in a randomized trial before gaining acceptance.

"I'm not convinced that's true," Dr. Ross said. "First of all, that trial is never going to be done. Second, we didn't use randomized clinical trials to set standards for melanoma in situ. Once we get a body of literature that's very robust and shows very good outcomes for Mohs surgery, it may become a standard of care."

He predicted that Mohs will be a niche procedure in melanoma. It is most likely to prove advantageous for thin melanomas in anatomically difficult locations, such as the head and neck, as well as for lentigo maligna melanoma, in which subclinical disease is often present at a considerable distance from the primary tumor.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

'The take-home message is we probably don't need wider margins than 2 cm for any melanoma.' DR. ROSS

PHOENIX — Although cutting through a melanoma during a shave biopsy may make reaching an accurate prognosis more difficult, it probably will not harm the patient, Dr. Darrell Rigel said at a clinical dermatology conference sponsored by Medicis.

Dr. Rigel, who is with New York University Medical Center, New York, said that two recently published studies addressed the concern that cutting through certain cancers during a biopsy can disperse tumor cells and worsen prognosis. It probably is not harmful in melanoma patients, he said.

The studies he cited compared excisional with incisional biopsies.

In the first study, investigators from Carolinas Medical Center in Charlotte, N.C., reported that 22% of shave biopsies had positive deep margins (Ann. Surg. Oncol. 2007;14:893–98). In the second study, investigators from the Free University Hospital, Amsterdam, found that use of incisional biopsies did not have a negative impact on survival (Ann. Surg. Oncol. 2007;14:1424–30).

"So at least if you accidentally shave through a melanoma, you [probably] haven't harmed the patient," Dr. Rigel said. "However, you may have harmed your ability to get the right prognosis for the patient." Thinner melanomas have a better prognosis, he noted, but tumor thickness is harder to determine in patients with deep positive margins.

In the first study, Dr. Richard L. White Jr. and his colleagues analyzed pathology reports from Jan. 1, 2004, through June 30, 2005, for 223 cases of primary melanoma.

Although the National Comprehensive Cancer Network and the American Academy of Dermatology have each designated excisional biopsies with narrow margins as the preferred method for diagnosing primary cutaneous melanoma, more than half the biopsies were done with the easier, faster shave technique. The sample comprised 51 excisional biopsies, 44 punch biopsies, and 128 shave biopsies. Three-fourths (167) of the specimens analyzed were from thin melanomas (1 mm or less).

Only 16% of excisional biopsies had positive margins. Just 2% were positive deep margins, and none were found in specimens from the thin melanomas.

Punch biopsy specimens also had no positive deep margins in the thinner melanomas. Positive margins were more common overall (68%), but were mostly wide margins attributable to the punch technique. Only 7% of all punch biopsies had positive deep margins.

Half of all shave biopsies produced positive margins, including the 22% that had positive deep margins. The analysis revealed positive deep margins for 17% of the thinner melanomas sampled by the shave technique.

Shave biopsy was most commonly done for thinner melanomas. It also produced samples that were significantly thinner. A review of 56 specimens showed the average biopsy thickness to be 1.41 mm with the shave technique, 3.58 mm with the punch method, and 3.19 mm for excisional biopsies.

"Based on these data," the authors concluded, "we encourage the use of an excisional biopsy technique for all skin lesions where melanoma is in the differential diagnosis when excision is feasible."

In the second study, Dr. Paul A.M. van Leeuwen and his colleagues in the Netherlands prospectively studied 471 patients who were diagnosed with stage I or II melanoma after partial removal of a skin lesion. Most of the patients had a superficial spreading melanoma (65%) or a nodular melanoma (26.7%). Average follow-up was 5 years or more.

The investigators divided the population by biopsy type: wide excision biopsy (279 patients), narrow excision biopsy (109), excision biopsy with positive margins (52), and incision biopsy (31). Biopsy type did not prove to be significant in univariate or multivariate analyses of disease-free survival or overall survival. The presence of residual tumor cells in reexcision specimens for 41 patients also was not significant.

"Incisional biopsies are not recommended, but there is no cause for concern when an excision biopsy turns out to have positive margins," the authors concluded.

In a telephone interview, Dr. Randall K. Roenigk agreed that both studies make good points, but he said that they are not likely to dissuade physicians from doing shave biopsies.

"If you do a shave and miss the depth of the specimen, you miss a key bit of information—the thickness of the melanoma. Your decision-making tree could be compromised," said Dr. Roenigk, professor of dermatology and chair of the department of dermatology at Mayo Medical School, Rochester, Minn.

"On the flip side, it is easier to do a shave biopsy," he continued, citing the time required for an excisional biopsy, the delay in diagnosis until an excisional biopsy can be scheduled, and the reality that some patients won't come back for the procedure.

He suggested that, as a result, doing more shave biopsies can mean more melanoma diagnoses, even though excisional biopsies are more comprehensive. From Dr. Roenigk's perspective, the studies demonstrate the importance of doing deep biopsies even when the suspected melanoma appears to be thin.

"You shouldn't be shy about taking extra tissue when you are thinking about a melanoma. It should be a thick, deep shave," he said. "If you are thinking about melanoma, you shouldn't worry about the scar."

PHOENIX — Although cutting through a melanoma during a shave biopsy may make reaching an accurate prognosis more difficult, it probably will not harm the patient, Dr. Darrell Rigel said at a clinical dermatology conference sponsored by Medicis.

Dr. Rigel, who is with New York University Medical Center, New York, said that two recently published studies addressed the concern that cutting through certain cancers during a biopsy can disperse tumor cells and worsen prognosis. It probably is not harmful in melanoma patients, he said.

The studies he cited compared excisional with incisional biopsies.

In the first study, investigators from Carolinas Medical Center in Charlotte, N.C., reported that 22% of shave biopsies had positive deep margins (Ann. Surg. Oncol. 2007;14:893–98). In the second study, investigators from the Free University Hospital, Amsterdam, found that use of incisional biopsies did not have a negative impact on survival (Ann. Surg. Oncol. 2007;14:1424–30).

"So at least if you accidentally shave through a melanoma, you [probably] haven't harmed the patient," Dr. Rigel said. "However, you may have harmed your ability to get the right prognosis for the patient." Thinner melanomas have a better prognosis, he noted, but tumor thickness is harder to determine in patients with deep positive margins.

In the first study, Dr. Richard L. White Jr. and his colleagues analyzed pathology reports from Jan. 1, 2004, through June 30, 2005, for 223 cases of primary melanoma.

Although the National Comprehensive Cancer Network and the American Academy of Dermatology have each designated excisional biopsies with narrow margins as the preferred method for diagnosing primary cutaneous melanoma, more than half the biopsies were done with the easier, faster shave technique. The sample comprised 51 excisional biopsies, 44 punch biopsies, and 128 shave biopsies. Three-fourths (167) of the specimens analyzed were from thin melanomas (1 mm or less).

Only 16% of excisional biopsies had positive margins. Just 2% were positive deep margins, and none were found in specimens from the thin melanomas.

Punch biopsy specimens also had no positive deep margins in the thinner melanomas. Positive margins were more common overall (68%), but were mostly wide margins attributable to the punch technique. Only 7% of all punch biopsies had positive deep margins.

Half of all shave biopsies produced positive margins, including the 22% that had positive deep margins. The analysis revealed positive deep margins for 17% of the thinner melanomas sampled by the shave technique.

Shave biopsy was most commonly done for thinner melanomas. It also produced samples that were significantly thinner. A review of 56 specimens showed the average biopsy thickness to be 1.41 mm with the shave technique, 3.58 mm with the punch method, and 3.19 mm for excisional biopsies.

"Based on these data," the authors concluded, "we encourage the use of an excisional biopsy technique for all skin lesions where melanoma is in the differential diagnosis when excision is feasible."

In the second study, Dr. Paul A.M. van Leeuwen and his colleagues in the Netherlands prospectively studied 471 patients who were diagnosed with stage I or II melanoma after partial removal of a skin lesion. Most of the patients had a superficial spreading melanoma (65%) or a nodular melanoma (26.7%). Average follow-up was 5 years or more.

The investigators divided the population by biopsy type: wide excision biopsy (279 patients), narrow excision biopsy (109), excision biopsy with positive margins (52), and incision biopsy (31). Biopsy type did not prove to be significant in univariate or multivariate analyses of disease-free survival or overall survival. The presence of residual tumor cells in reexcision specimens for 41 patients also was not significant.

"Incisional biopsies are not recommended, but there is no cause for concern when an excision biopsy turns out to have positive margins," the authors concluded.

In a telephone interview, Dr. Randall K. Roenigk agreed that both studies make good points, but he said that they are not likely to dissuade physicians from doing shave biopsies.

"If you do a shave and miss the depth of the specimen, you miss a key bit of information—the thickness of the melanoma. Your decision-making tree could be compromised," said Dr. Roenigk, professor of dermatology and chair of the department of dermatology at Mayo Medical School, Rochester, Minn.

"On the flip side, it is easier to do a shave biopsy," he continued, citing the time required for an excisional biopsy, the delay in diagnosis until an excisional biopsy can be scheduled, and the reality that some patients won't come back for the procedure.

He suggested that, as a result, doing more shave biopsies can mean more melanoma diagnoses, even though excisional biopsies are more comprehensive. From Dr. Roenigk's perspective, the studies demonstrate the importance of doing deep biopsies even when the suspected melanoma appears to be thin.

"You shouldn't be shy about taking extra tissue when you are thinking about a melanoma. It should be a thick, deep shave," he said. "If you are thinking about melanoma, you shouldn't worry about the scar."

PHOENIX — Although cutting through a melanoma during a shave biopsy may make reaching an accurate prognosis more difficult, it probably will not harm the patient, Dr. Darrell Rigel said at a clinical dermatology conference sponsored by Medicis.

Dr. Rigel, who is with New York University Medical Center, New York, said that two recently published studies addressed the concern that cutting through certain cancers during a biopsy can disperse tumor cells and worsen prognosis. It probably is not harmful in melanoma patients, he said.

The studies he cited compared excisional with incisional biopsies.

In the first study, investigators from Carolinas Medical Center in Charlotte, N.C., reported that 22% of shave biopsies had positive deep margins (Ann. Surg. Oncol. 2007;14:893–98). In the second study, investigators from the Free University Hospital, Amsterdam, found that use of incisional biopsies did not have a negative impact on survival (Ann. Surg. Oncol. 2007;14:1424–30).

"So at least if you accidentally shave through a melanoma, you [probably] haven't harmed the patient," Dr. Rigel said. "However, you may have harmed your ability to get the right prognosis for the patient." Thinner melanomas have a better prognosis, he noted, but tumor thickness is harder to determine in patients with deep positive margins.

In the first study, Dr. Richard L. White Jr. and his colleagues analyzed pathology reports from Jan. 1, 2004, through June 30, 2005, for 223 cases of primary melanoma.

Although the National Comprehensive Cancer Network and the American Academy of Dermatology have each designated excisional biopsies with narrow margins as the preferred method for diagnosing primary cutaneous melanoma, more than half the biopsies were done with the easier, faster shave technique. The sample comprised 51 excisional biopsies, 44 punch biopsies, and 128 shave biopsies. Three-fourths (167) of the specimens analyzed were from thin melanomas (1 mm or less).

Only 16% of excisional biopsies had positive margins. Just 2% were positive deep margins, and none were found in specimens from the thin melanomas.

Punch biopsy specimens also had no positive deep margins in the thinner melanomas. Positive margins were more common overall (68%), but were mostly wide margins attributable to the punch technique. Only 7% of all punch biopsies had positive deep margins.

Half of all shave biopsies produced positive margins, including the 22% that had positive deep margins. The analysis revealed positive deep margins for 17% of the thinner melanomas sampled by the shave technique.

Shave biopsy was most commonly done for thinner melanomas. It also produced samples that were significantly thinner. A review of 56 specimens showed the average biopsy thickness to be 1.41 mm with the shave technique, 3.58 mm with the punch method, and 3.19 mm for excisional biopsies.

"Based on these data," the authors concluded, "we encourage the use of an excisional biopsy technique for all skin lesions where melanoma is in the differential diagnosis when excision is feasible."

In the second study, Dr. Paul A.M. van Leeuwen and his colleagues in the Netherlands prospectively studied 471 patients who were diagnosed with stage I or II melanoma after partial removal of a skin lesion. Most of the patients had a superficial spreading melanoma (65%) or a nodular melanoma (26.7%). Average follow-up was 5 years or more.

The investigators divided the population by biopsy type: wide excision biopsy (279 patients), narrow excision biopsy (109), excision biopsy with positive margins (52), and incision biopsy (31). Biopsy type did not prove to be significant in univariate or multivariate analyses of disease-free survival or overall survival. The presence of residual tumor cells in reexcision specimens for 41 patients also was not significant.

"Incisional biopsies are not recommended, but there is no cause for concern when an excision biopsy turns out to have positive margins," the authors concluded.

In a telephone interview, Dr. Randall K. Roenigk agreed that both studies make good points, but he said that they are not likely to dissuade physicians from doing shave biopsies.

"If you do a shave and miss the depth of the specimen, you miss a key bit of information—the thickness of the melanoma. Your decision-making tree could be compromised," said Dr. Roenigk, professor of dermatology and chair of the department of dermatology at Mayo Medical School, Rochester, Minn.

"On the flip side, it is easier to do a shave biopsy," he continued, citing the time required for an excisional biopsy, the delay in diagnosis until an excisional biopsy can be scheduled, and the reality that some patients won't come back for the procedure.

He suggested that, as a result, doing more shave biopsies can mean more melanoma diagnoses, even though excisional biopsies are more comprehensive. From Dr. Roenigk's perspective, the studies demonstrate the importance of doing deep biopsies even when the suspected melanoma appears to be thin.

"You shouldn't be shy about taking extra tissue when you are thinking about a melanoma. It should be a thick, deep shave," he said. "If you are thinking about melanoma, you shouldn't worry about the scar."