A new combination approach between topical 5-FU and hydrocortisone butyrate 0.1% lipocream.
Reducing Irritation While Effectively Treating AKs
Traditionally, 5-fluorouracil (5-FU) cream is one modality that has been effectively used as a treatment for widespread actinic keratoses.1 Several treatment regimens have been used with topical 5-FU in the treatment of AKs.2,3,4 The common manner of topical 5-FU use has been morning and night application for 2 to 4 weeks.5 However, the high degree of irritation associated with its use may lead to treatment failures due to noncompliance or inadequate duration of use. Topical emollients or topical corticosteroids6 can minimize this irritation allowing more tolerability and adequate 5-FU use. The results of a new pilot investigation show a concurrent role of hydrocortisone butyrate 0.1% lipocream in mitigating the irritation (erythema, itching, burning, pain, etc.) from 5-FU use without losing efficacy.
How the Study Was Conducted
For this pilot investigation, 20 patients who had at least five or more actinic keratoses on the scalp, forehead or chest were enrolled. Of these, 10 participants were randomly enrolled into monotherapy 5-FU cream use (Efudex) and the other 10 were randomly enrolled to the combination of 5-FU cream and subsequent use of hydrocortisone butyrate 0.1% lipocream (Locoid Lipocream). All enrolled subjects signed an informed consent and were encouraged to finish the full 4-week length of this study period. Exclusion criteria specified anyone who received treatment within the previous month with cryotherapy, imiqui-mod (Aldara), 5-FU, topical retinoids, chemical peel, diclofenac sodium (Solaraze), photodynamic therapy or laser resurfacing in the designated study area. The study subjects were asked to first apply the 5-FU to their affected areas morning and night. They continued this regimen until the first endpoint: redness, irritation, crusting or pain. The 5-FU monotherapy group was instructed to wait until this reaction cleared before starting their next application of 5-FU in the exact cosmetic unit. The hydrocortisone butyrate 0.1% lipocream/5-FU group was asked to start hydrocortisone butyrate 0.1% lipocream application once they reached their first endpoint. This treatment group then restarted therapy with only 5-FU in the same affected areas after the hydrocortisone butyrate 0.1% cream cleared their irritation. The second endpoint for both groups was at the end of the 4-week study period, regardless of which stage of application, for the final survey. At baseline, each subject was evaluated by the same observer to count the number of AKs in a designated 5-cm2 area on the scalp, forehead or chest. Then, digital pictures were taken. Participants were surveyed about the degree of irritation they experienced and the results were quantified. These steps were repeated at 2 weeks and again at 4 weeks of treatment.
A Look at the Results
Both the monotherapy (5-FU) and the combination (5-FU with hydrocortisone butyrate 0.1% cream) study groups showed a total reduction in the actinic keratosis count at the end of the 4-week study (see chart 1 below). Both study groups had at least one patient with limited use due to excessive irritation. The monotherapy 5-FU group reported 7 of 10 patients with excessive irritation while the 5-FU/ hydrocortisone butyrate 0.1% lipo-cream group reported 2 of 10 patients with similar excessive irritation. At the end of the 4-week treatment period, fewer patients showed irritation with hydrocortisone butyrate 0.1% lipocream use after initial 5-FU use than the patients in the 5-FU monotherapy group (see chart 2 below). Both groups showed similar degree of irritation to 5-FU at week 2, which may have been from lack of application with hydrocortisone butyrate 0.1% lipocream since patients had just reached the irritation point with the 5-FU.
An Effective Combination
In this study, the end reduction of total actinic keratosis count was significant in both groups, with a significant difference in the reduction in irritation between the two groups. Although the dropout rate was notably comparable in both groups, the small sample size in this pilot study may be responsible for such result. A larger sample size may be required to evaluate a statistically significant comparison. The end result was a noted distinction between irritation levels between the two treatment groups. The results of this open-label, single-site, 4-week pilot study showed both groups achieved the end point of AK treatment: a noted reduction in AK counts before and after therapy. Furthermore, a difference in irritation profile was noted between the monotherapy 5-FU cream and the combination therapy 5-FU cream with hydrocortisone butyrate 0.1% lipo-cream groups. This pilot study shows the ability of hydrocortisone butyrate 0.1% lipocream to decrease the excessive irritation associated with 5-FU treatment, which may lead to improved compliance and willingness of patients to use 5-FU. Hydrocortisone butyrate 0.1% lipo-cream decreased irritation associated with 5-FU treatment without losing its efficacy. However, the results are only initial, and further studies with larger sample sizes are needed.
Dr. Attica C. Chang is Director of the Boca Raton Skin & Laser Center in Boca Raton, FL. Dr. Chang is in private practice and performs Mohs micrographic surgery and general dermatology.
Article continues on page 2
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Treatment Regimens for AK Patients Q&A
Q: How Has Your Approach to Treating Patients Who Have Actinic Keratoses Changed Over the Last 5 Years?
Philip Werschler, MD: The basic answer is “combination therapy”. What I mean by that is that 10 years ago, dermatologists managed AKs almost exclusively with liquid nitrogen. Yes, we’ve had topical 5-fluorouracil (5-FU) as far back as the 1970s, but even as recently as 5 to 7 years ago, only a small amount of prescriptions were written for it by dermatologists. In addition, this therapy was largely concentrated in regional geographic pockets of dermatologists across the country, so its use was not evenly distributed. Overall, topical 5-FU was not a treatment protocol widely used in management of AK. Then, around the start of the new millennium, several new therapies were introduced for AKs. All of a sudden there was a lot of emphasis on topical therapies. Carac (a 5-FU) was introduced, 5-aminolevulinic acid (Levulan) and Blue-U light came out, along with diclofenac sodium (Solaraze). Also, over the last few years dermatologists have seen a significant increase in the frequency of AK diagnoses, driven in part by the aging of the population, and in part by renewed emphasis on early recognition and treatment.
Previously, AK was frequently thought of as a second-line diagnosis, then a medico-legal issue brought the lesions into the spotlight This was sparked by a much-publicized lawsuit in Florida involving Medicare. Basically, Medicare in Florida didn’t want to reimburse for the treatment of AK. Then, the American Academy of Dermatology swung into action. After a thorough scientific review, the Academy issued a white paper reporting that AK lesions were really a transitional lesion on the way to becoming squamous cell carcinoma in situ. They even shared the same p53 gene mutation that SCCs had; therefore, it was essential to treat these lesions as early as possible to prevent progression into invasive skin cancer. With this lawsuit receiving national attention and the increased emphasis on the nature of actinic keratosis, many dermatologists saw this disease in a new light. Then, our specialty went back and looked at the new treatment options. We looked at the effectiveness of topical therapy, especially for the subclinical or latent lesions. That brings us up to today. Now, the generally agreed upon consensus for optimum management is a combination of cryosurgery and topical therapies. Freezing when combined with topical therapy has been found to be a better way to treat AK lesions than freezing alone or topical treatment alone. The topical treatments now are very diverse: We have cytotoxic chemotherapeutics (the topical 5-FU therapies of Carac and Efudex), the immune-response modifier imiquimod (Aldara), the COX-2 inhibitor diclofenac sodium (Solaraze), and the photodynamic therapy that combines Levulan and BLU-U light. I use all of the topicals in combination. I use mostly 5-FU, but I also use a fair amount of imiquimod. It will be interesting to see what the next step in managing actinic keratosis will be. We can’t cure actinic keratosis; we can just remove clinically apparent and subclinical damage.
However, possibly we can borrow from the playbook of oncology and determine whether there is a role for sequential/ rotational therapy in treating AKs. Is there a better way to cycle through the different treatments to prevent the emergence of new AKs? Could or should we be using retinoids as long-term therapy? It will be interesting to see what the treatment protocols of the future will offer. One thing is for certain however, AKs as a diagnosis will continue to play a major role in our practices, as one of the most common lesions seen in dermatology for many years to come.
Dr Werschler is an Assistant Clinical Professor of Medicine and Dermatology at the University of Washington in Seattle. He is the Immediate Past President of the American Society of Cosmetic Dermatology and Aesthetic Surgery, and Founder and Medical Director of Aesthetic Image, a medical spa, in Spokane, WA. Disclosure: Dr. Werschler is a consultant, speaker, clinical investigator, and/or on the scientific advisory boards of Dermik, 3M and Valeant.
Q: How do you Assess Your Actinic Keratosis Patients for Treatment?
Wendy E. Roberts, MD: When assessing actinic keratosis patients, which treatment I use depends on the severity of lesions, the lifestyle of the patient and the age of the patient. In the last 5 years, topical treatments have played a much larger role. Imiquimod (Aldara), 5-fluorouracil (Carac, Efudex), and diclofenac sodium (Solaraze) have taken the place of treatments such as freezing the lesions with liquid nitrogen. I treat about 80 patients per week who have AK. This has increased in the last few years, and as baby boomers move into their fifth and sixth decades, the numbers will only increase. Dr Roberts runs the Desert Dermatology Medical Associates in Rancho Mirage, CA. Disclosure: Dr. Roberts serves as a medical consultant for Merck and 3M Pharmaceutical companies.
Q: How Has the Presentation of Actinic Keratosis Changed Over the Last 5 Years?
John Wolf, MD: Based on my observations in my practice, I’ve seen more people over the last few years with multiple actinic keratoses than ever before. Another alarming trend that I’m seeing is an increase in actinic keratosis in younger patients. I believe that I’ve seen more patients within the last 5 years who are younger than 50 and have AKs than at any other time in my practice. Now, I’m not sure exactly why these trends are occurring. Several factors may be converging to cause them. 1. For one thing, the increase in actinic keratosis might mean that our public health educational activities have not been effective. As dermatologists, we have spent so much time writing about and discussing ways for our patients to protect themselves from the sun. Maybe patients haven’t been listening. 2. Another possible explanation is that patients are more aware of skin cancer, and they’re coming to see us sooner and in larger numbers to seek treatment. Patients don’t really know what actinic keratosis is, but they are aware of the changes in the appearance of their skin, and that may be motivating them to schedule a visit. Actually, in my experience, many of my patients who present with multiple AKs also present with multiple seborrheic keratoses. Often, they’re more concerned about the appearance of the seborrheic keratoses, and they have no idea that the actinic keratoses are much more concerning. 3. The aging of the population may be contributing to the number of cases. We can see AKs at any age, but in patients over age 50 we’re seeing more patients with AKs than ever before. 4. Another reason could be that as dermatologists, we’ve had significant increased awareness in last 5 to 10 years of the serious nature of AKs among dermatologists. We’re even more keenly aware about identifying and treating these lesions earlier than ever before. We know that AK is a continuum that can end up as squamous cell carcinoma. We also know that among patients who have multiple AKs, 6% to 10% of their AKs may develop into squamous cell carcinomas within 10 years. 5. Lastly, I might be seeing an increase in actinic keratosis in my practice because my own focus on the disease has increased over the last 5 years. In that timeframe, I’ve done much clinical research on actinic keratosis, and this might have contributed to me having a higher level of suspicion and observation in detecting this disease. Fortunately, regardless of the reasons we’re seeing more patients and younger patients with actinic keratosis, we’ve had an influx of newer therapies within the last 5 years that have helped us treat these patients much more effectively. Dr Wolf is Professor and Chairman of the Department of Dermatology at Baylor College of Medicine in Houston. Disclosure: Dr. Wolf has been an investigator on two clinical studies for diclofenac sodium (Solaraze) and has served as a consultant and on speakers’ bureau for Doak Pharmaceuticals.
Q: What is Your First-Line Therapy for Actinic Keratosis?
Michael Gold, MD: In my office, if it looks like skin cancer, it’s removed by surgical procedure. If I want a histologic diagnosis, I use curettage. I feel we miss a lot of cancers when we don’t biopsy and get a histologic diagnosis. Once we have confirmed that there are no skin cancers, we then treat clinical AKs (those we see) and the subclinical AKs (those we don’t see) with photodynamic therapy (PDT). In the last year I’ve started using PDT almost as a prophylactic treatment for AKs. For most patients who only have AKs, I use PDT with 5-aminolevulinic acid (Levulan) in conjunction with blue light. For patients who also want to treat wrinkles (photorejuvenation) at the same time, I treat them with ALA/PDT in conjunction with intense pulsed light (IPL). We also use microlaser peels (Sciton Er:YAG laser peel), which treat clinical and subclinical AKs as well. On occasion an isolated AK is treated with liquid nitrogen/cryotherapy. I don’t typically use topicals as a treatment for AKs; however, I have seen some benefit to using imiquimod (Aldara). The volume of AK patients is up and it behooves us to be aggressive with treatment, with minimal downtime. Outside of acne, AKs are what I’m seeing most in my practice. As baby boomers age, especially those who didn’t use sunscreen, the number of AKs we’re seeing is epidemic. If I see 100 patients a day, about 25 of them have AKs. It’s a huge part of my practice. Dr Gold is the Director of the Gold Skin Care Center and the Tennessee Clinical Research Center in Nashville, TN. Disclosure: Dr. Gold is a consultant, performs research and owns stock in Dusa Pharmaceuticals, Inc.
Article continues on page 3
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The Benefit of Combination AK Therapy 5-FU plus cryosurgery is effective in reducing AKs.
Results from a 12-month clinical trial showed that a 1-week treatment with topical 0.5% fluorouracil cream (Carac) before cryosurgery is significantly more effective in reducing actinic keratosis lesions than cryosurgery alone. For this prospective, randomized, double-blind, vehicle-controlled study, 142 patients were randomly assigned to apply topical 0.5% fluorouracil or placebo once daily for 7 days to the face plus one or more investigator-designated areas, including the scalp, ears, neck and/or lips. Residual AKs were treated with liquid nitrogen cryosurgery after 4 weeks and patient evaluations were made 6 and 12 months later. The researchers found greater reductions in AK lesions on the face and overall occurred after one, two and three cycles of a 1-week course of 0.5% fluorouracil before cryosurgery than with cryosurgery alone. After 4 weeks of treatment, the mean AK lesion count was reduced by 62.4% in the 5-FU group compared to 28.8% in the placebo group (p<0.001), with complete clearing in 16.7% of patients in the 5-FU group versus 0% in the placebo group. At 6 months following cryosurgery, the mean lesion count of residual AKs was reduced by 67% in the 5-FU plus cryosurgery group versus 45.6% of the placebo plus cryosurgery group (p=0.011), with 30% versus 7.7% achieving complete clearance, respectively. Total clearance was not maintained at 12 months after the initial treatment. The most common adverse effects were eye irritation and application site reactions, with adverse effects occurring more frequently in the 5-FU group (37.5%) versus the placebo group. Researchers concluded that the results demonstrate the need to evaluate patients 6 and 12 months after treatment for AKs, especially if cryosurgery alone is used.
Poster Authors: J. Jorizzo, M.D., J. Weiss, M.D., and T.J. Poirot, M.D.
Taking a New Look at Non-Melanoma Skin Cancers
A recent study investigates the differences between basal cell and squamous cell carcinomas. Research presented at last month’s American Society for Dermatologic Surgery annual meeting may change the way many dermatologists think about basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). James Spencer, M.D., led a study, which will be published in the December issue of the Journal of Drugs in Dermatology, to explore patterns of expression among patients with BCC and SCC. Dr. Spencer said that skin cancers tend to be categorized into melanoma and non-melanoma and that, therefore, BCCs and SCCs tend to get lumped together in the non-melanoma category. He explained that the commonly held assumption now is that if a patient produces non-melanoma skin cancer, then he or she is at risk for producing more — meaning patients who produce BCCs are just as likely to produce more BCCs as they are to produce SCCs. This study examined the validity of this assumption. The case-controlled study, conducted at the Mount Sinai School of Medicine in New York, involved patients who had had more than three (showing a history of multiple cancers) and fewer than 10 (excluding patients with a cancer predisposing condition) basal or squamous cell carcinomas in a 10-year period. Researchers at Mount Sinai reviewed all biopsies submitted to the dermatopathology service at the Mount Sinai School of Medicine that had the diagnosis of either BCC or SCC during the month of May 2004. There were 792 biopsies that showed non-melanoma skin cancers. Researchers then went back through the center’s records to determine who in this group fit their inclusion criteria of having had more than three and less than 10 previous BCCs or SCCs. There were 151 patients identified who made greater than 3 and less than 10 non-melanoma skin cancers during the period from March 1994 to May 2004. Patients who were identified with a BCC had a BCC:SCC ratio of 2.6:1. Patients who were identified with a SCC had a BCC:SCC ratio of 0.3:1. Dr. Spencer explained that this suggests patients who make BCC are more likely to make another BCC, and patients who make SCC are more likely to make another SCC, which suggests the etiology, susceptible populations or risk factors are not the same for the two tumor types. According to Dr. Spencer, this means that dermatologists need to start thinking of these two types of non-melanoma skin cancers differently. He suggested that BCCs are caused by childhood sunburns and that SCCs are likely the result of prolonged sun exposure, as is the case with people who work outside.
Study authors: James M. Spencer, MD, MS, Sivan Shemesh, BS, and Robert Phelps, MD
A new combination approach between topical 5-FU and hydrocortisone butyrate 0.1% lipocream.
Reducing Irritation While Effectively Treating AKs
Traditionally, 5-fluorouracil (5-FU) cream is one modality that has been effectively used as a treatment for widespread actinic keratoses.1 Several treatment regimens have been used with topical 5-FU in the treatment of AKs.2,3,4 The common manner of topical 5-FU use has been morning and night application for 2 to 4 weeks.5 However, the high degree of irritation associated with its use may lead to treatment failures due to noncompliance or inadequate duration of use. Topical emollients or topical corticosteroids6 can minimize this irritation allowing more tolerability and adequate 5-FU use. The results of a new pilot investigation show a concurrent role of hydrocortisone butyrate 0.1% lipocream in mitigating the irritation (erythema, itching, burning, pain, etc.) from 5-FU use without losing efficacy.
How the Study Was Conducted
For this pilot investigation, 20 patients who had at least five or more actinic keratoses on the scalp, forehead or chest were enrolled. Of these, 10 participants were randomly enrolled into monotherapy 5-FU cream use (Efudex) and the other 10 were randomly enrolled to the combination of 5-FU cream and subsequent use of hydrocortisone butyrate 0.1% lipocream (Locoid Lipocream). All enrolled subjects signed an informed consent and were encouraged to finish the full 4-week length of this study period. Exclusion criteria specified anyone who received treatment within the previous month with cryotherapy, imiqui-mod (Aldara), 5-FU, topical retinoids, chemical peel, diclofenac sodium (Solaraze), photodynamic therapy or laser resurfacing in the designated study area. The study subjects were asked to first apply the 5-FU to their affected areas morning and night. They continued this regimen until the first endpoint: redness, irritation, crusting or pain. The 5-FU monotherapy group was instructed to wait until this reaction cleared before starting their next application of 5-FU in the exact cosmetic unit. The hydrocortisone butyrate 0.1% lipocream/5-FU group was asked to start hydrocortisone butyrate 0.1% lipocream application once they reached their first endpoint. This treatment group then restarted therapy with only 5-FU in the same affected areas after the hydrocortisone butyrate 0.1% cream cleared their irritation. The second endpoint for both groups was at the end of the 4-week study period, regardless of which stage of application, for the final survey. At baseline, each subject was evaluated by the same observer to count the number of AKs in a designated 5-cm2 area on the scalp, forehead or chest. Then, digital pictures were taken. Participants were surveyed about the degree of irritation they experienced and the results were quantified. These steps were repeated at 2 weeks and again at 4 weeks of treatment.
A Look at the Results
Both the monotherapy (5-FU) and the combination (5-FU with hydrocortisone butyrate 0.1% cream) study groups showed a total reduction in the actinic keratosis count at the end of the 4-week study (see chart 1 below). Both study groups had at least one patient with limited use due to excessive irritation. The monotherapy 5-FU group reported 7 of 10 patients with excessive irritation while the 5-FU/ hydrocortisone butyrate 0.1% lipo-cream group reported 2 of 10 patients with similar excessive irritation. At the end of the 4-week treatment period, fewer patients showed irritation with hydrocortisone butyrate 0.1% lipocream use after initial 5-FU use than the patients in the 5-FU monotherapy group (see chart 2 below). Both groups showed similar degree of irritation to 5-FU at week 2, which may have been from lack of application with hydrocortisone butyrate 0.1% lipocream since patients had just reached the irritation point with the 5-FU.
An Effective Combination
In this study, the end reduction of total actinic keratosis count was significant in both groups, with a significant difference in the reduction in irritation between the two groups. Although the dropout rate was notably comparable in both groups, the small sample size in this pilot study may be responsible for such result. A larger sample size may be required to evaluate a statistically significant comparison. The end result was a noted distinction between irritation levels between the two treatment groups. The results of this open-label, single-site, 4-week pilot study showed both groups achieved the end point of AK treatment: a noted reduction in AK counts before and after therapy. Furthermore, a difference in irritation profile was noted between the monotherapy 5-FU cream and the combination therapy 5-FU cream with hydrocortisone butyrate 0.1% lipo-cream groups. This pilot study shows the ability of hydrocortisone butyrate 0.1% lipocream to decrease the excessive irritation associated with 5-FU treatment, which may lead to improved compliance and willingness of patients to use 5-FU. Hydrocortisone butyrate 0.1% lipo-cream decreased irritation associated with 5-FU treatment without losing its efficacy. However, the results are only initial, and further studies with larger sample sizes are needed.
Dr. Attica C. Chang is Director of the Boca Raton Skin & Laser Center in Boca Raton, FL. Dr. Chang is in private practice and performs Mohs micrographic surgery and general dermatology.
Article continues on page 2
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Treatment Regimens for AK Patients Q&A
Q: How Has Your Approach to Treating Patients Who Have Actinic Keratoses Changed Over the Last 5 Years?
Philip Werschler, MD: The basic answer is “combination therapy”. What I mean by that is that 10 years ago, dermatologists managed AKs almost exclusively with liquid nitrogen. Yes, we’ve had topical 5-fluorouracil (5-FU) as far back as the 1970s, but even as recently as 5 to 7 years ago, only a small amount of prescriptions were written for it by dermatologists. In addition, this therapy was largely concentrated in regional geographic pockets of dermatologists across the country, so its use was not evenly distributed. Overall, topical 5-FU was not a treatment protocol widely used in management of AK. Then, around the start of the new millennium, several new therapies were introduced for AKs. All of a sudden there was a lot of emphasis on topical therapies. Carac (a 5-FU) was introduced, 5-aminolevulinic acid (Levulan) and Blue-U light came out, along with diclofenac sodium (Solaraze). Also, over the last few years dermatologists have seen a significant increase in the frequency of AK diagnoses, driven in part by the aging of the population, and in part by renewed emphasis on early recognition and treatment.
Previously, AK was frequently thought of as a second-line diagnosis, then a medico-legal issue brought the lesions into the spotlight This was sparked by a much-publicized lawsuit in Florida involving Medicare. Basically, Medicare in Florida didn’t want to reimburse for the treatment of AK. Then, the American Academy of Dermatology swung into action. After a thorough scientific review, the Academy issued a white paper reporting that AK lesions were really a transitional lesion on the way to becoming squamous cell carcinoma in situ. They even shared the same p53 gene mutation that SCCs had; therefore, it was essential to treat these lesions as early as possible to prevent progression into invasive skin cancer. With this lawsuit receiving national attention and the increased emphasis on the nature of actinic keratosis, many dermatologists saw this disease in a new light. Then, our specialty went back and looked at the new treatment options. We looked at the effectiveness of topical therapy, especially for the subclinical or latent lesions. That brings us up to today. Now, the generally agreed upon consensus for optimum management is a combination of cryosurgery and topical therapies. Freezing when combined with topical therapy has been found to be a better way to treat AK lesions than freezing alone or topical treatment alone. The topical treatments now are very diverse: We have cytotoxic chemotherapeutics (the topical 5-FU therapies of Carac and Efudex), the immune-response modifier imiquimod (Aldara), the COX-2 inhibitor diclofenac sodium (Solaraze), and the photodynamic therapy that combines Levulan and BLU-U light. I use all of the topicals in combination. I use mostly 5-FU, but I also use a fair amount of imiquimod. It will be interesting to see what the next step in managing actinic keratosis will be. We can’t cure actinic keratosis; we can just remove clinically apparent and subclinical damage.
However, possibly we can borrow from the playbook of oncology and determine whether there is a role for sequential/ rotational therapy in treating AKs. Is there a better way to cycle through the different treatments to prevent the emergence of new AKs? Could or should we be using retinoids as long-term therapy? It will be interesting to see what the treatment protocols of the future will offer. One thing is for certain however, AKs as a diagnosis will continue to play a major role in our practices, as one of the most common lesions seen in dermatology for many years to come.
Dr Werschler is an Assistant Clinical Professor of Medicine and Dermatology at the University of Washington in Seattle. He is the Immediate Past President of the American Society of Cosmetic Dermatology and Aesthetic Surgery, and Founder and Medical Director of Aesthetic Image, a medical spa, in Spokane, WA. Disclosure: Dr. Werschler is a consultant, speaker, clinical investigator, and/or on the scientific advisory boards of Dermik, 3M and Valeant.
Q: How do you Assess Your Actinic Keratosis Patients for Treatment?
Wendy E. Roberts, MD: When assessing actinic keratosis patients, which treatment I use depends on the severity of lesions, the lifestyle of the patient and the age of the patient. In the last 5 years, topical treatments have played a much larger role. Imiquimod (Aldara), 5-fluorouracil (Carac, Efudex), and diclofenac sodium (Solaraze) have taken the place of treatments such as freezing the lesions with liquid nitrogen. I treat about 80 patients per week who have AK. This has increased in the last few years, and as baby boomers move into their fifth and sixth decades, the numbers will only increase. Dr Roberts runs the Desert Dermatology Medical Associates in Rancho Mirage, CA. Disclosure: Dr. Roberts serves as a medical consultant for Merck and 3M Pharmaceutical companies.
Q: How Has the Presentation of Actinic Keratosis Changed Over the Last 5 Years?
John Wolf, MD: Based on my observations in my practice, I’ve seen more people over the last few years with multiple actinic keratoses than ever before. Another alarming trend that I’m seeing is an increase in actinic keratosis in younger patients. I believe that I’ve seen more patients within the last 5 years who are younger than 50 and have AKs than at any other time in my practice. Now, I’m not sure exactly why these trends are occurring. Several factors may be converging to cause them. 1. For one thing, the increase in actinic keratosis might mean that our public health educational activities have not been effective. As dermatologists, we have spent so much time writing about and discussing ways for our patients to protect themselves from the sun. Maybe patients haven’t been listening. 2. Another possible explanation is that patients are more aware of skin cancer, and they’re coming to see us sooner and in larger numbers to seek treatment. Patients don’t really know what actinic keratosis is, but they are aware of the changes in the appearance of their skin, and that may be motivating them to schedule a visit. Actually, in my experience, many of my patients who present with multiple AKs also present with multiple seborrheic keratoses. Often, they’re more concerned about the appearance of the seborrheic keratoses, and they have no idea that the actinic keratoses are much more concerning. 3. The aging of the population may be contributing to the number of cases. We can see AKs at any age, but in patients over age 50 we’re seeing more patients with AKs than ever before. 4. Another reason could be that as dermatologists, we’ve had significant increased awareness in last 5 to 10 years of the serious nature of AKs among dermatologists. We’re even more keenly aware about identifying and treating these lesions earlier than ever before. We know that AK is a continuum that can end up as squamous cell carcinoma. We also know that among patients who have multiple AKs, 6% to 10% of their AKs may develop into squamous cell carcinomas within 10 years. 5. Lastly, I might be seeing an increase in actinic keratosis in my practice because my own focus on the disease has increased over the last 5 years. In that timeframe, I’ve done much clinical research on actinic keratosis, and this might have contributed to me having a higher level of suspicion and observation in detecting this disease. Fortunately, regardless of the reasons we’re seeing more patients and younger patients with actinic keratosis, we’ve had an influx of newer therapies within the last 5 years that have helped us treat these patients much more effectively. Dr Wolf is Professor and Chairman of the Department of Dermatology at Baylor College of Medicine in Houston. Disclosure: Dr. Wolf has been an investigator on two clinical studies for diclofenac sodium (Solaraze) and has served as a consultant and on speakers’ bureau for Doak Pharmaceuticals.
Q: What is Your First-Line Therapy for Actinic Keratosis?
Michael Gold, MD: In my office, if it looks like skin cancer, it’s removed by surgical procedure. If I want a histologic diagnosis, I use curettage. I feel we miss a lot of cancers when we don’t biopsy and get a histologic diagnosis. Once we have confirmed that there are no skin cancers, we then treat clinical AKs (those we see) and the subclinical AKs (those we don’t see) with photodynamic therapy (PDT). In the last year I’ve started using PDT almost as a prophylactic treatment for AKs. For most patients who only have AKs, I use PDT with 5-aminolevulinic acid (Levulan) in conjunction with blue light. For patients who also want to treat wrinkles (photorejuvenation) at the same time, I treat them with ALA/PDT in conjunction with intense pulsed light (IPL). We also use microlaser peels (Sciton Er:YAG laser peel), which treat clinical and subclinical AKs as well. On occasion an isolated AK is treated with liquid nitrogen/cryotherapy. I don’t typically use topicals as a treatment for AKs; however, I have seen some benefit to using imiquimod (Aldara). The volume of AK patients is up and it behooves us to be aggressive with treatment, with minimal downtime. Outside of acne, AKs are what I’m seeing most in my practice. As baby boomers age, especially those who didn’t use sunscreen, the number of AKs we’re seeing is epidemic. If I see 100 patients a day, about 25 of them have AKs. It’s a huge part of my practice. Dr Gold is the Director of the Gold Skin Care Center and the Tennessee Clinical Research Center in Nashville, TN. Disclosure: Dr. Gold is a consultant, performs research and owns stock in Dusa Pharmaceuticals, Inc.
Article continues on page 3
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The Benefit of Combination AK Therapy 5-FU plus cryosurgery is effective in reducing AKs.
Results from a 12-month clinical trial showed that a 1-week treatment with topical 0.5% fluorouracil cream (Carac) before cryosurgery is significantly more effective in reducing actinic keratosis lesions than cryosurgery alone. For this prospective, randomized, double-blind, vehicle-controlled study, 142 patients were randomly assigned to apply topical 0.5% fluorouracil or placebo once daily for 7 days to the face plus one or more investigator-designated areas, including the scalp, ears, neck and/or lips. Residual AKs were treated with liquid nitrogen cryosurgery after 4 weeks and patient evaluations were made 6 and 12 months later. The researchers found greater reductions in AK lesions on the face and overall occurred after one, two and three cycles of a 1-week course of 0.5% fluorouracil before cryosurgery than with cryosurgery alone. After 4 weeks of treatment, the mean AK lesion count was reduced by 62.4% in the 5-FU group compared to 28.8% in the placebo group (p<0.001), with complete clearing in 16.7% of patients in the 5-FU group versus 0% in the placebo group. At 6 months following cryosurgery, the mean lesion count of residual AKs was reduced by 67% in the 5-FU plus cryosurgery group versus 45.6% of the placebo plus cryosurgery group (p=0.011), with 30% versus 7.7% achieving complete clearance, respectively. Total clearance was not maintained at 12 months after the initial treatment. The most common adverse effects were eye irritation and application site reactions, with adverse effects occurring more frequently in the 5-FU group (37.5%) versus the placebo group. Researchers concluded that the results demonstrate the need to evaluate patients 6 and 12 months after treatment for AKs, especially if cryosurgery alone is used.
Poster Authors: J. Jorizzo, M.D., J. Weiss, M.D., and T.J. Poirot, M.D.
Taking a New Look at Non-Melanoma Skin Cancers
A recent study investigates the differences between basal cell and squamous cell carcinomas. Research presented at last month’s American Society for Dermatologic Surgery annual meeting may change the way many dermatologists think about basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). James Spencer, M.D., led a study, which will be published in the December issue of the Journal of Drugs in Dermatology, to explore patterns of expression among patients with BCC and SCC. Dr. Spencer said that skin cancers tend to be categorized into melanoma and non-melanoma and that, therefore, BCCs and SCCs tend to get lumped together in the non-melanoma category. He explained that the commonly held assumption now is that if a patient produces non-melanoma skin cancer, then he or she is at risk for producing more — meaning patients who produce BCCs are just as likely to produce more BCCs as they are to produce SCCs. This study examined the validity of this assumption. The case-controlled study, conducted at the Mount Sinai School of Medicine in New York, involved patients who had had more than three (showing a history of multiple cancers) and fewer than 10 (excluding patients with a cancer predisposing condition) basal or squamous cell carcinomas in a 10-year period. Researchers at Mount Sinai reviewed all biopsies submitted to the dermatopathology service at the Mount Sinai School of Medicine that had the diagnosis of either BCC or SCC during the month of May 2004. There were 792 biopsies that showed non-melanoma skin cancers. Researchers then went back through the center’s records to determine who in this group fit their inclusion criteria of having had more than three and less than 10 previous BCCs or SCCs. There were 151 patients identified who made greater than 3 and less than 10 non-melanoma skin cancers during the period from March 1994 to May 2004. Patients who were identified with a BCC had a BCC:SCC ratio of 2.6:1. Patients who were identified with a SCC had a BCC:SCC ratio of 0.3:1. Dr. Spencer explained that this suggests patients who make BCC are more likely to make another BCC, and patients who make SCC are more likely to make another SCC, which suggests the etiology, susceptible populations or risk factors are not the same for the two tumor types. According to Dr. Spencer, this means that dermatologists need to start thinking of these two types of non-melanoma skin cancers differently. He suggested that BCCs are caused by childhood sunburns and that SCCs are likely the result of prolonged sun exposure, as is the case with people who work outside.
Study authors: James M. Spencer, MD, MS, Sivan Shemesh, BS, and Robert Phelps, MD
A new combination approach between topical 5-FU and hydrocortisone butyrate 0.1% lipocream.
Reducing Irritation While Effectively Treating AKs
Traditionally, 5-fluorouracil (5-FU) cream is one modality that has been effectively used as a treatment for widespread actinic keratoses.1 Several treatment regimens have been used with topical 5-FU in the treatment of AKs.2,3,4 The common manner of topical 5-FU use has been morning and night application for 2 to 4 weeks.5 However, the high degree of irritation associated with its use may lead to treatment failures due to noncompliance or inadequate duration of use. Topical emollients or topical corticosteroids6 can minimize this irritation allowing more tolerability and adequate 5-FU use. The results of a new pilot investigation show a concurrent role of hydrocortisone butyrate 0.1% lipocream in mitigating the irritation (erythema, itching, burning, pain, etc.) from 5-FU use without losing efficacy.
How the Study Was Conducted
For this pilot investigation, 20 patients who had at least five or more actinic keratoses on the scalp, forehead or chest were enrolled. Of these, 10 participants were randomly enrolled into monotherapy 5-FU cream use (Efudex) and the other 10 were randomly enrolled to the combination of 5-FU cream and subsequent use of hydrocortisone butyrate 0.1% lipocream (Locoid Lipocream). All enrolled subjects signed an informed consent and were encouraged to finish the full 4-week length of this study period. Exclusion criteria specified anyone who received treatment within the previous month with cryotherapy, imiqui-mod (Aldara), 5-FU, topical retinoids, chemical peel, diclofenac sodium (Solaraze), photodynamic therapy or laser resurfacing in the designated study area. The study subjects were asked to first apply the 5-FU to their affected areas morning and night. They continued this regimen until the first endpoint: redness, irritation, crusting or pain. The 5-FU monotherapy group was instructed to wait until this reaction cleared before starting their next application of 5-FU in the exact cosmetic unit. The hydrocortisone butyrate 0.1% lipocream/5-FU group was asked to start hydrocortisone butyrate 0.1% lipocream application once they reached their first endpoint. This treatment group then restarted therapy with only 5-FU in the same affected areas after the hydrocortisone butyrate 0.1% cream cleared their irritation. The second endpoint for both groups was at the end of the 4-week study period, regardless of which stage of application, for the final survey. At baseline, each subject was evaluated by the same observer to count the number of AKs in a designated 5-cm2 area on the scalp, forehead or chest. Then, digital pictures were taken. Participants were surveyed about the degree of irritation they experienced and the results were quantified. These steps were repeated at 2 weeks and again at 4 weeks of treatment.
A Look at the Results
Both the monotherapy (5-FU) and the combination (5-FU with hydrocortisone butyrate 0.1% cream) study groups showed a total reduction in the actinic keratosis count at the end of the 4-week study (see chart 1 below). Both study groups had at least one patient with limited use due to excessive irritation. The monotherapy 5-FU group reported 7 of 10 patients with excessive irritation while the 5-FU/ hydrocortisone butyrate 0.1% lipo-cream group reported 2 of 10 patients with similar excessive irritation. At the end of the 4-week treatment period, fewer patients showed irritation with hydrocortisone butyrate 0.1% lipocream use after initial 5-FU use than the patients in the 5-FU monotherapy group (see chart 2 below). Both groups showed similar degree of irritation to 5-FU at week 2, which may have been from lack of application with hydrocortisone butyrate 0.1% lipocream since patients had just reached the irritation point with the 5-FU.
An Effective Combination
In this study, the end reduction of total actinic keratosis count was significant in both groups, with a significant difference in the reduction in irritation between the two groups. Although the dropout rate was notably comparable in both groups, the small sample size in this pilot study may be responsible for such result. A larger sample size may be required to evaluate a statistically significant comparison. The end result was a noted distinction between irritation levels between the two treatment groups. The results of this open-label, single-site, 4-week pilot study showed both groups achieved the end point of AK treatment: a noted reduction in AK counts before and after therapy. Furthermore, a difference in irritation profile was noted between the monotherapy 5-FU cream and the combination therapy 5-FU cream with hydrocortisone butyrate 0.1% lipo-cream groups. This pilot study shows the ability of hydrocortisone butyrate 0.1% lipocream to decrease the excessive irritation associated with 5-FU treatment, which may lead to improved compliance and willingness of patients to use 5-FU. Hydrocortisone butyrate 0.1% lipo-cream decreased irritation associated with 5-FU treatment without losing its efficacy. However, the results are only initial, and further studies with larger sample sizes are needed.
Dr. Attica C. Chang is Director of the Boca Raton Skin & Laser Center in Boca Raton, FL. Dr. Chang is in private practice and performs Mohs micrographic surgery and general dermatology.
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Treatment Regimens for AK Patients Q&A
Q: How Has Your Approach to Treating Patients Who Have Actinic Keratoses Changed Over the Last 5 Years?
Philip Werschler, MD: The basic answer is “combination therapy”. What I mean by that is that 10 years ago, dermatologists managed AKs almost exclusively with liquid nitrogen. Yes, we’ve had topical 5-fluorouracil (5-FU) as far back as the 1970s, but even as recently as 5 to 7 years ago, only a small amount of prescriptions were written for it by dermatologists. In addition, this therapy was largely concentrated in regional geographic pockets of dermatologists across the country, so its use was not evenly distributed. Overall, topical 5-FU was not a treatment protocol widely used in management of AK. Then, around the start of the new millennium, several new therapies were introduced for AKs. All of a sudden there was a lot of emphasis on topical therapies. Carac (a 5-FU) was introduced, 5-aminolevulinic acid (Levulan) and Blue-U light came out, along with diclofenac sodium (Solaraze). Also, over the last few years dermatologists have seen a significant increase in the frequency of AK diagnoses, driven in part by the aging of the population, and in part by renewed emphasis on early recognition and treatment.
Previously, AK was frequently thought of as a second-line diagnosis, then a medico-legal issue brought the lesions into the spotlight This was sparked by a much-publicized lawsuit in Florida involving Medicare. Basically, Medicare in Florida didn’t want to reimburse for the treatment of AK. Then, the American Academy of Dermatology swung into action. After a thorough scientific review, the Academy issued a white paper reporting that AK lesions were really a transitional lesion on the way to becoming squamous cell carcinoma in situ. They even shared the same p53 gene mutation that SCCs had; therefore, it was essential to treat these lesions as early as possible to prevent progression into invasive skin cancer. With this lawsuit receiving national attention and the increased emphasis on the nature of actinic keratosis, many dermatologists saw this disease in a new light. Then, our specialty went back and looked at the new treatment options. We looked at the effectiveness of topical therapy, especially for the subclinical or latent lesions. That brings us up to today. Now, the generally agreed upon consensus for optimum management is a combination of cryosurgery and topical therapies. Freezing when combined with topical therapy has been found to be a better way to treat AK lesions than freezing alone or topical treatment alone. The topical treatments now are very diverse: We have cytotoxic chemotherapeutics (the topical 5-FU therapies of Carac and Efudex), the immune-response modifier imiquimod (Aldara), the COX-2 inhibitor diclofenac sodium (Solaraze), and the photodynamic therapy that combines Levulan and BLU-U light. I use all of the topicals in combination. I use mostly 5-FU, but I also use a fair amount of imiquimod. It will be interesting to see what the next step in managing actinic keratosis will be. We can’t cure actinic keratosis; we can just remove clinically apparent and subclinical damage.
However, possibly we can borrow from the playbook of oncology and determine whether there is a role for sequential/ rotational therapy in treating AKs. Is there a better way to cycle through the different treatments to prevent the emergence of new AKs? Could or should we be using retinoids as long-term therapy? It will be interesting to see what the treatment protocols of the future will offer. One thing is for certain however, AKs as a diagnosis will continue to play a major role in our practices, as one of the most common lesions seen in dermatology for many years to come.
Dr Werschler is an Assistant Clinical Professor of Medicine and Dermatology at the University of Washington in Seattle. He is the Immediate Past President of the American Society of Cosmetic Dermatology and Aesthetic Surgery, and Founder and Medical Director of Aesthetic Image, a medical spa, in Spokane, WA. Disclosure: Dr. Werschler is a consultant, speaker, clinical investigator, and/or on the scientific advisory boards of Dermik, 3M and Valeant.
Q: How do you Assess Your Actinic Keratosis Patients for Treatment?
Wendy E. Roberts, MD: When assessing actinic keratosis patients, which treatment I use depends on the severity of lesions, the lifestyle of the patient and the age of the patient. In the last 5 years, topical treatments have played a much larger role. Imiquimod (Aldara), 5-fluorouracil (Carac, Efudex), and diclofenac sodium (Solaraze) have taken the place of treatments such as freezing the lesions with liquid nitrogen. I treat about 80 patients per week who have AK. This has increased in the last few years, and as baby boomers move into their fifth and sixth decades, the numbers will only increase. Dr Roberts runs the Desert Dermatology Medical Associates in Rancho Mirage, CA. Disclosure: Dr. Roberts serves as a medical consultant for Merck and 3M Pharmaceutical companies.
Q: How Has the Presentation of Actinic Keratosis Changed Over the Last 5 Years?
John Wolf, MD: Based on my observations in my practice, I’ve seen more people over the last few years with multiple actinic keratoses than ever before. Another alarming trend that I’m seeing is an increase in actinic keratosis in younger patients. I believe that I’ve seen more patients within the last 5 years who are younger than 50 and have AKs than at any other time in my practice. Now, I’m not sure exactly why these trends are occurring. Several factors may be converging to cause them. 1. For one thing, the increase in actinic keratosis might mean that our public health educational activities have not been effective. As dermatologists, we have spent so much time writing about and discussing ways for our patients to protect themselves from the sun. Maybe patients haven’t been listening. 2. Another possible explanation is that patients are more aware of skin cancer, and they’re coming to see us sooner and in larger numbers to seek treatment. Patients don’t really know what actinic keratosis is, but they are aware of the changes in the appearance of their skin, and that may be motivating them to schedule a visit. Actually, in my experience, many of my patients who present with multiple AKs also present with multiple seborrheic keratoses. Often, they’re more concerned about the appearance of the seborrheic keratoses, and they have no idea that the actinic keratoses are much more concerning. 3. The aging of the population may be contributing to the number of cases. We can see AKs at any age, but in patients over age 50 we’re seeing more patients with AKs than ever before. 4. Another reason could be that as dermatologists, we’ve had significant increased awareness in last 5 to 10 years of the serious nature of AKs among dermatologists. We’re even more keenly aware about identifying and treating these lesions earlier than ever before. We know that AK is a continuum that can end up as squamous cell carcinoma. We also know that among patients who have multiple AKs, 6% to 10% of their AKs may develop into squamous cell carcinomas within 10 years. 5. Lastly, I might be seeing an increase in actinic keratosis in my practice because my own focus on the disease has increased over the last 5 years. In that timeframe, I’ve done much clinical research on actinic keratosis, and this might have contributed to me having a higher level of suspicion and observation in detecting this disease. Fortunately, regardless of the reasons we’re seeing more patients and younger patients with actinic keratosis, we’ve had an influx of newer therapies within the last 5 years that have helped us treat these patients much more effectively. Dr Wolf is Professor and Chairman of the Department of Dermatology at Baylor College of Medicine in Houston. Disclosure: Dr. Wolf has been an investigator on two clinical studies for diclofenac sodium (Solaraze) and has served as a consultant and on speakers’ bureau for Doak Pharmaceuticals.
Q: What is Your First-Line Therapy for Actinic Keratosis?
Michael Gold, MD: In my office, if it looks like skin cancer, it’s removed by surgical procedure. If I want a histologic diagnosis, I use curettage. I feel we miss a lot of cancers when we don’t biopsy and get a histologic diagnosis. Once we have confirmed that there are no skin cancers, we then treat clinical AKs (those we see) and the subclinical AKs (those we don’t see) with photodynamic therapy (PDT). In the last year I’ve started using PDT almost as a prophylactic treatment for AKs. For most patients who only have AKs, I use PDT with 5-aminolevulinic acid (Levulan) in conjunction with blue light. For patients who also want to treat wrinkles (photorejuvenation) at the same time, I treat them with ALA/PDT in conjunction with intense pulsed light (IPL). We also use microlaser peels (Sciton Er:YAG laser peel), which treat clinical and subclinical AKs as well. On occasion an isolated AK is treated with liquid nitrogen/cryotherapy. I don’t typically use topicals as a treatment for AKs; however, I have seen some benefit to using imiquimod (Aldara). The volume of AK patients is up and it behooves us to be aggressive with treatment, with minimal downtime. Outside of acne, AKs are what I’m seeing most in my practice. As baby boomers age, especially those who didn’t use sunscreen, the number of AKs we’re seeing is epidemic. If I see 100 patients a day, about 25 of them have AKs. It’s a huge part of my practice. Dr Gold is the Director of the Gold Skin Care Center and the Tennessee Clinical Research Center in Nashville, TN. Disclosure: Dr. Gold is a consultant, performs research and owns stock in Dusa Pharmaceuticals, Inc.
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The Benefit of Combination AK Therapy 5-FU plus cryosurgery is effective in reducing AKs.
Results from a 12-month clinical trial showed that a 1-week treatment with topical 0.5% fluorouracil cream (Carac) before cryosurgery is significantly more effective in reducing actinic keratosis lesions than cryosurgery alone. For this prospective, randomized, double-blind, vehicle-controlled study, 142 patients were randomly assigned to apply topical 0.5% fluorouracil or placebo once daily for 7 days to the face plus one or more investigator-designated areas, including the scalp, ears, neck and/or lips. Residual AKs were treated with liquid nitrogen cryosurgery after 4 weeks and patient evaluations were made 6 and 12 months later. The researchers found greater reductions in AK lesions on the face and overall occurred after one, two and three cycles of a 1-week course of 0.5% fluorouracil before cryosurgery than with cryosurgery alone. After 4 weeks of treatment, the mean AK lesion count was reduced by 62.4% in the 5-FU group compared to 28.8% in the placebo group (p<0.001), with complete clearing in 16.7% of patients in the 5-FU group versus 0% in the placebo group. At 6 months following cryosurgery, the mean lesion count of residual AKs was reduced by 67% in the 5-FU plus cryosurgery group versus 45.6% of the placebo plus cryosurgery group (p=0.011), with 30% versus 7.7% achieving complete clearance, respectively. Total clearance was not maintained at 12 months after the initial treatment. The most common adverse effects were eye irritation and application site reactions, with adverse effects occurring more frequently in the 5-FU group (37.5%) versus the placebo group. Researchers concluded that the results demonstrate the need to evaluate patients 6 and 12 months after treatment for AKs, especially if cryosurgery alone is used.
Poster Authors: J. Jorizzo, M.D., J. Weiss, M.D., and T.J. Poirot, M.D.
Taking a New Look at Non-Melanoma Skin Cancers
A recent study investigates the differences between basal cell and squamous cell carcinomas. Research presented at last month’s American Society for Dermatologic Surgery annual meeting may change the way many dermatologists think about basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). James Spencer, M.D., led a study, which will be published in the December issue of the Journal of Drugs in Dermatology, to explore patterns of expression among patients with BCC and SCC. Dr. Spencer said that skin cancers tend to be categorized into melanoma and non-melanoma and that, therefore, BCCs and SCCs tend to get lumped together in the non-melanoma category. He explained that the commonly held assumption now is that if a patient produces non-melanoma skin cancer, then he or she is at risk for producing more — meaning patients who produce BCCs are just as likely to produce more BCCs as they are to produce SCCs. This study examined the validity of this assumption. The case-controlled study, conducted at the Mount Sinai School of Medicine in New York, involved patients who had had more than three (showing a history of multiple cancers) and fewer than 10 (excluding patients with a cancer predisposing condition) basal or squamous cell carcinomas in a 10-year period. Researchers at Mount Sinai reviewed all biopsies submitted to the dermatopathology service at the Mount Sinai School of Medicine that had the diagnosis of either BCC or SCC during the month of May 2004. There were 792 biopsies that showed non-melanoma skin cancers. Researchers then went back through the center’s records to determine who in this group fit their inclusion criteria of having had more than three and less than 10 previous BCCs or SCCs. There were 151 patients identified who made greater than 3 and less than 10 non-melanoma skin cancers during the period from March 1994 to May 2004. Patients who were identified with a BCC had a BCC:SCC ratio of 2.6:1. Patients who were identified with a SCC had a BCC:SCC ratio of 0.3:1. Dr. Spencer explained that this suggests patients who make BCC are more likely to make another BCC, and patients who make SCC are more likely to make another SCC, which suggests the etiology, susceptible populations or risk factors are not the same for the two tumor types. According to Dr. Spencer, this means that dermatologists need to start thinking of these two types of non-melanoma skin cancers differently. He suggested that BCCs are caused by childhood sunburns and that SCCs are likely the result of prolonged sun exposure, as is the case with people who work outside.
Study authors: James M. Spencer, MD, MS, Sivan Shemesh, BS, and Robert Phelps, MD
