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P466 SQUAMOUS CELL CARCINOMA OF THE LIP AT WEST VIRGINIA UNIVERSITY SINCE 1980. Robert Wilson, West Virginia University School of Medicine, Morgantown, WV, United States, Jeffrey Jackson, MD, West Virginia University School of Medicine, Morgantown, WV, United States We have conducted a retrospective study concerning squamous cell carcinoma of the lip seen at West Virginia University Hospitals since 1980. The cases have been obtained through the tumor registry at West Virginia University. Data regarding the demographics of the patient, the initial presentation, risk factors, cancer staging, histopathological features of the cancer, treatments, and recurrences have been collected. Disclosure not available at press time. P467 POLYPOID SKIN METASTASES OF RENAL CELL CARCINOMA Viviana E Garcia, MD, San Cristobal MD. Fundation, Santiago, Chile, Sergio Gonzalez, MD, Dept. of Pathology, Catholic Univ. of Chile, Santiago, Chile A case of a 55-year-old male with a cutaneous polypoid mass in the left cheek is presented. 7 years before a right side nephrectomy for renal cell carcinoma was performed. One year after this surgery lung and bone metastases were identified. The patient rejected any type of treatment. The current cutaneous lesion was a reddish, slightly eroded, polypoid tumor mass of 3 cm in diameter. A biopsy was taken and the histological examination confirmed skin involvement by a clear cell carcinoma with abundant cytoplasmic glycogen and moderate cellular pleomorphism; necrotic foci and hemorrhages were also found. The findings were consistent with metastatic renal cell carcinoma. The patient died 6 months after the skin metatasis. Cutaneous metastases of carcinoma represent about 3% of all cases; renal cell carcinoma compromise about 3% of these cases. Skin metastases from renal cell carcinoma are rarely diagnosed during life with a mean survival after diagnosis of approximately 7 months. Disclosure not available at press time. P468 IMIQUIMOD 5% CREAM FOR THE TREATMENT OF CUTANEOUS EPITHELIAL NEO- PLASMS Ketty Peris, MD, Department of Dermatology, University of L’Aquila, L’Aquila, Italy, 67100 L’Aquila, Italy, Angela Ferrari, MD, Linda De Angelis, MD, Sergio Chimenti, MD, Department of Dermatology, University of Rome, Rome, Italy Imiquimod is a topical immunomodulatory agent that stimulates both innate and acquired immunity through induction of cytokines (IFN-a, TNF-a, IL-12), Langerhans’ cells activa- tion and migration, and T lymphocytes and natural killer cells activation. Recent data indicate that immune response modifiers act through the Toll-like receptor 7. Imiquimod has been shown to be an effective therapy for external genital warts and several reports indicate a favorable therapeutic activity in the treatment of epithelial skin neoplasms. We investigated the efficacy and safety of imiquimod cream in the treatment of 19 superficial basal cell carcinomas (BCCs), 3 squamous cell carcinomas (SCCs), 1 keratoacanthoma (KA) and multiple actinic keratoses (AK). The study population comprised 10 patients (3 men and 9 women), aged 64 to 85 years. One patient, affected by Gorlin syndrome, presented 9 BCCs. Treatment schedule consisted of once-daily application of imiquimod 5% cream, 3 times a week, for 4-12 weeks, followed by a follow-up period of 2-8 months. This study included patients with multiple or recurrent lesions and old patients in which surgery was contraindicated. Eighteen of 19 BCCs cleared whereas 1/19 showed partial remission; 2/3 SCCs presented a complete response and 1/3 a partial response. Further- more, all the AKs and the KA cleared with this treatment regimen. The most frequent local skin reactions to treatment were erythema and itching, however, all adverse events were mild to moderate and all patients completed the treatment period. Imiquimod 5% cream is an effective and well-tolerated treatment of cutaneous epithelial neoplasms and, in selected cases, might represent an alternative therapy to surgery. The authors have no financial interest. P469 LONG-TERM CLEARANCE OF MULTIPLE ACTINIC KERATOSES AFTER TOPICAL TREATMENT WITH IMIQUIMOD (5%) Eggert Stockfleth, MD, University of Berlin, Berlin, Germany, Bernd Benninghoff, PhD, University of Berlin, Berlin, Germany, Jan-Ole Busch, MD, University of Kiel, Kiel, Germany, Wolfram Sterry, MD, University of Berlin, Berlin, Germany Background: Actinic keratosis (AK) is characterized by lesions that frequently appear in areas of chronic sun exposure. Actinic keratosis has been identified as an important step (carcinoma in situ) in the formation of squamous cell carcinoma. Recent case studies have indicated that imiquimod cream (5%) is a safe and effective treatment for AK; however, the long-term effects of treatment are not yet known. This study examined the long-term (ie, up to 2 years) safety and efficacy of patients treated with imiquimod cream (5%) for AK. Methods: A randomized, double blind, vehicle-controlled study was conducted in patients with biopsy-proven AK (3 to 10 lesions/patient). Patients applied 5% imiquimod cream or vehicle 3 times/week for a maximum of 12 weeks. A rest period of up to 3 weeks followed by decreased application frequency (1 to 2 times/week) was permitted to manage adverse events. The number, size, and appearance of AK lesions were evaluated to determine complete or partial clearance. Follow-up examinations were conducted at 6, 12, 18, and 24 months. Results: Thirty-six patients, 25 in the treatment group and 11 in the vehicle-control group, completed the 12-week study. Complete clearance was observed in 21 of 25 (84%) patients and verified by histologic analysis 2 weeks following cessation of treatment. An additional 2 of 25 (8%) patients exhibited partial clearance based on a 50% to 75% reduction in AK lesion size. There were no reductions in the number or size of AK lesions in the control group. Imiquimod cream was well tolerated, with no discontinuations caused by adverse events. One of the imiquimod-treated patients who had cleared was lost to follow-up. None of the imiquimod-treated patients developed new lesions 6 months following treatment. The recurrence rates in the imiquimod-treated areas at 12, 18, and 24 months posttreatment were 8%, 13%, and 18%, respectively. Conclusions: Imiquimod cream (5%) is a safe and effective treatment for multiple AKs. There was a low incidence (18%) of AK recurrence 24 months posttreatment. This recurrence is lower than that reported for other treatments such as cryotherapy or 5-fluorouracil, suggesting that enhancement of immune memory may reduce the rate of new lesion formation. Dr Stockfleth is a consultant of 3M and Dr. Benninghoff is a employee of 3M Medica. Approximately 10% is supported by 3M Pharmaceuticals for poster production. P121 MARCH 2004 JAM ACAD DERMATOL

Polypoid skin metastases of renal cell carcinoma

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P466SQUAMOUS CELL CARCINOMA OF THE LIP AT WEST VIRGINIA UNIVERSITYSINCE 1980.Robert Wilson, West Virginia University School of Medicine, Morgantown, WV, UnitedStates, Jeffrey Jackson, MD, West Virginia University School of Medicine, Morgantown,WV, United States

We have conducted a retrospective study concerning squamous cell carcinoma of the lipseen at West Virginia University Hospitals since 1980. The cases have been obtainedthrough the tumor registry at West Virginia University. Data regarding the demographicsof the patient, the initial presentation, risk factors, cancer staging, histopathologicalfeatures of the cancer, treatments, and recurrences have been collected.

Disclosure not available at press time.

P467POLYPOID SKIN METASTASES OF RENAL CELL CARCINOMAViviana E Garcia, MD, San Cristobal MD. Fundation, Santiago, Chile, Sergio Gonzalez, MD,Dept. of Pathology, Catholic Univ. of Chile, Santiago, Chile

A case of a 55-year-old male with a cutaneous polypoid mass in the left cheek is presented.7 years before a right side nephrectomy for renal cell carcinoma was performed. One yearafter this surgery lung and bone metastases were identified. The patient rejected any typeof treatment. The current cutaneous lesion was a reddish, slightly eroded, polypoid tumormass of 3 cm in diameter. A biopsy was taken and the histological examination confirmedskin involvement by a clear cell carcinoma with abundant cytoplasmic glycogen andmoderate cellular pleomorphism; necrotic foci and hemorrhages were also found. Thefindings were consistent with metastatic renal cell carcinoma. The patient died 6 monthsafter the skin metatasis. Cutaneous metastases of carcinoma represent about 3% of allcases; renal cell carcinoma compromise about 3% of these cases. Skin metastases fromrenal cell carcinoma are rarely diagnosed during life with a mean survival after diagnosisof approximately 7 months.

Disclosure not available at press time.

P468IMIQUIMOD 5% CREAM FOR THE TREATMENT OF CUTANEOUS EPITHELIAL NEO-PLASMSKetty Peris, MD, Department of Dermatology, University of L’Aquila, L’Aquila, Italy,67100 L’Aquila, Italy, Angela Ferrari, MD, Linda De Angelis, MD, Sergio Chimenti, MD,Department of Dermatology, University of Rome, Rome, Italy

Imiquimod is a topical immunomodulatory agent that stimulates both innate and acquiredimmunity through induction of cytokines (IFN-a, TNF-a, IL-12), Langerhans’ cells activa-tion and migration, and T lymphocytes and natural killer cells activation. Recent dataindicate that immune response modifiers act through the Toll-like receptor 7. Imiquimodhas been shown to be an effective therapy for external genital warts and several reportsindicate a favorable therapeutic activity in the treatment of epithelial skin neoplasms. Weinvestigated the efficacy and safety of imiquimod cream in the treatment of 19 superficialbasal cell carcinomas (BCCs), 3 squamous cell carcinomas (SCCs), 1 keratoacanthoma(KA) and multiple actinic keratoses (AK). The study population comprised 10 patients (3men and 9 women), aged 64 to 85 years. One patient, affected by Gorlin syndrome,presented 9 BCCs. Treatment schedule consisted of once-daily application of imiquimod5% cream, 3 times a week, for 4-12 weeks, followed by a follow-up period of 2-8 months.This study included patients with multiple or recurrent lesions and old patients in whichsurgery was contraindicated. Eighteen of 19 BCCs cleared whereas 1/19 showed partialremission; 2/3 SCCs presented a complete response and 1/3 a partial response. Further-more, all the AKs and the KA cleared with this treatment regimen. The most frequentlocal skin reactions to treatment were erythema and itching, however, all adverse eventswere mild to moderate and all patients completed the treatment period. Imiquimod 5%cream is an effective and well-tolerated treatment of cutaneous epithelial neoplasms and,in selected cases, might represent an alternative therapy to surgery.

The authors have no financial interest.

P469LONG-TERM CLEARANCE OF MULTIPLE ACTINIC KERATOSES AFTER TOPICALTREATMENT WITH IMIQUIMOD (5%)Eggert Stockfleth, MD, University of Berlin, Berlin, Germany, Bernd Benninghoff, PhD,University of Berlin, Berlin, Germany, Jan-Ole Busch, MD, University of Kiel, Kiel,Germany, Wolfram Sterry, MD, University of Berlin, Berlin, Germany

Background: Actinic keratosis (AK) is characterized by lesions that frequently appear inareas of chronic sun exposure. Actinic keratosis has been identified as an important step(carcinoma in situ) in the formation of squamous cell carcinoma. Recent case studies haveindicated that imiquimod cream (5%) is a safe and effective treatment for AK; however,the long-term effects of treatment are not yet known. This study examined the long-term(ie, up to 2 years) safety and efficacy of patients treated with imiquimod cream (5%) forAK.

Methods: A randomized, double blind, vehicle-controlled study was conducted in patientswith biopsy-proven AK (3 to 10 lesions/patient). Patients applied 5% imiquimod cream orvehicle 3 times/week for a maximum of 12 weeks. A rest period of up to 3 weeksfollowed by decreased application frequency (1 to 2 times/week) was permitted tomanage adverse events. The number, size, and appearance of AK lesions were evaluatedto determine complete or partial clearance. Follow-up examinations were conducted at6, 12, 18, and 24 months.

Results: Thirty-six patients, 25 in the treatment group and 11 in the vehicle-control group,completed the 12-week study. Complete clearance was observed in 21 of 25 (84%)patients and verified by histologic analysis 2 weeks following cessation of treatment. Anadditional 2 of 25 (8%) patients exhibited partial clearance based on a 50% to 75%reduction in AK lesion size. There were no reductions in the number or size of AK lesionsin the control group. Imiquimod cream was well tolerated, with no discontinuationscaused by adverse events. One of the imiquimod-treated patients who had cleared waslost to follow-up. None of the imiquimod-treated patients developed new lesions 6months following treatment. The recurrence rates in the imiquimod-treated areas at 12,18, and 24 months posttreatment were 8%, 13%, and 18%, respectively.

Conclusions: Imiquimod cream (5%) is a safe and effective treatment for multiple AKs.There was a low incidence (18%) of AK recurrence 24 months posttreatment. Thisrecurrence is lower than that reported for other treatments such as cryotherapy or5-fluorouracil, suggesting that enhancement of immune memory may reduce the rate ofnew lesion formation.

Dr Stockfleth is a consultant of 3M and Dr. Benninghoff is a employee of 3M Medica.

Approximately 10% is supported by 3M Pharmaceuticals for poster production.

P121MARCH 2004 J AM ACAD DERMATOL