Treatment Of Superficial Basal Cell Carcinoma Research Articles

Efficacy of photodynamic therapy using ALAHCl in gel with a lipid nanoemulsion and MALHCl in cream in superficial basal cell carcinoma.

Photodynamic therapy (PDT) is a therapeutic option for low-risk basal cell carcinoma (BCC). The aim of the study was to assess the efficacy of topical PDT in the treatment of superficial BCC (sBCC) using two different photosensitizers: aminolevulinic acid hydrochloride (ALA-HCl) in a gel formulation with a lipid nanoemulsion (ALA-HCl in gel) and ALA methyl ester hydrochloride (MAL-HCl) in a cream formulation (MAL-HCl in cream). 21 patients were treated twice with a one week interval between treatments. The formulations were applied onto lesions: 10 patients were treated with MAL-HCl in cream, and 11 with ALA-HCl in gel. After three hours of incubation and removing the preparations, fluorescence was assessed. The skin areas were then irradiated with red light 630 ± 5 nm. At the follow-up visit 12 weeks after the second treatment, complete clinical remission was found in 82% after ALA-HCl in gel and in 80% after MAL-HCl in cream. An excellent cosmetic result was found in 96% of patients after MALHCl in cream and in 100% after ALA-HCl in gel. Faster skin healing and less post-inflammatory hyperpigmentation during follow-up visits was observed after treatment with ALA-HCl in gel. Both formulations - ALA-HCl in gel and MAL-HCl in cream - were highly effective photosensitisers for PDT. The advantage of ALA-HCl in a gel formulation with a lipid nanoemulsion was faster skin healing, resulting in better cosmetic results.

PDT Brazil - Photodynamic Therapy based M-ALA for non melanoma skin cancer: Ecuador experiences

s / Photodiagnosis and Photodynamic Therapy 12 (2015) 325–375 373 PDT Brazil Photodynamic Therapy based M-ALA for non melanoma skin cancer: Ecuador experiences Romero Paulina1,2, Cabrera Franklin1,2, Tello Sonia1,2, Kurachi Cristina1,2, Ramirez Patricia1,2, Guaman Leonel1,2, Avalos Eduardo1,2, Bagnato Vanderlei1,2 1 Escuela Politecnica Nacional, Departamento de Materiales, Electrica y Fisica Quito-Ecuador. Hospital Carlos Andrade Marin, Servicio de Dermatologia e Histopatologia. Quito – Ecuador 2 Sao Carlos Institute of Physics, University of Sao Paulo, Brazil In Ecuador the National Tumor Registry (RNT) show in 2002 the non-melanoma skin cancer was the second most common cancer in men and women, but in 2005 it takes the first place for women. Experience: 11 patients with surface CBC, 47 with nodular CBC, 2 with CBC recurrences (depht middle dermis), 2 with CBC recurrences (neural invasion) and 3 with surface CEC, were treated with Photodynamic therapy based inMetil -ALA 20% and the LINCE light source with 100 W/cm2, 635nm wavelength. During treatment was used the dermatoscopy to monitor lesions. The results were evaluated by histopathological studies where the initial depth of the lesions was evident. These assessments allowed to find the depth at which treatment is efficient. Patients were treated between 2012 2014 in the “Carlos Andrade Marin” Hospital and “Gonzalo Gonzalez” Dermatological Hospital in QuitoEcuador. Results: After 2 therapy sessions for suface CBC (depht middle dermis) 90% of the patients have a complete response, for nodular CBC after 4 sessions 86% of the patients have a complete response, for the CBC recurrences (neural invasion) don’t show an effective response, and for surface CEC after 6 sessions 100% of the patients have a complete response. http://dx.doi.org/10.1016/j.pdpdt.2015.07.186 PDT Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months L.I.S. Mota, M.F.M. Brito, J.S. Belo Universidade Federal de Pernambuco Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months. Fundamentals: Basal-cell cancer is the most prevalent non-melanoma skin cancer in Brazil andworldwide. Photodynamic therapy (PDT) is a noninvasive technique with excellent cosmetic outcome and curative results. Maintaining cure rates remains an object of study due to the recent introduction of this therapy in dermatology. Objective: Evaluate the clinical response of photodynamic therapy in superficial basal-cell carcinoma after 12 months of treatment in patients with initial complete response at the end of the third month after treatment. Methods: After curettage and application of methyl aminolevulinate, the lesion was occluded for 3 hours. Then it was discovered and submitted a 635nm LED (37 J/cm2), positioned eight centimeters from the patient, for eight minutes. Two sessions were realized with intervals of 14 days. Pictures were performed before treatment, at 3 and 12 months after treatment. Results: The analyses involved 35 patients, that were submitted a MAL-PDT and presented complete response in the evaluation of three months. These cancers were checked with 12 months. A maintenance of complete clinical response was observed in 85% (30/35). Conclusion: PDT-MAL is a safe and effective therapeutic approach in the treatment of superficial BCC, with maintenance http://dx.doi.org/10.1016/j.pdpdt.2015.07.187 PDT Brazil A New Approach for Basal Cell Carcinoma Treatment Kate C. Blanco, Natalia M. Inada, Ana Paula da Silva, Pedro Russignoli, Dora P. Ramirez, Hilde H. Buzza, Mirian D. Stringasci, Lilian T. Moriyama, Clovis Grecco, Cristina Kurachi, Vanderlei S. Bagnato Sao Carlos Institute of Physics, University of Sao Paulo, Brazil Non-melanomaskin cancer (NMSC) is themostprevalent cancer type in Brazil andworldwide. According to the National Institute of Cancer (INCA) at the last year, it was estimated 182,130 new cases of NMSC in Brazil. Photodynamic Therapy (PDT) has proven to be effective with an excellent cosmetic outcome and reliable treatment option. A Brazilian programwas established to determine the efficacy of topicalMAL-PDTusing a Brazilian device (LINCE,MMOptics, Brazil) and medication (methyl aminolevulinate, PDTPharma, Brazil). During four years with financial support by BNDES (Brazilian Development Bank), we are reporting the treatment of 994 basal cell carcinoma (BCC), around all country and Latin America. Through these data it was analyzed the efficiency of the treatment 30 days after the second PDT session. Were compared the gender, age, skin type, location and size of the lesions. The conclusion of this extensive and important project has shown the efficacy PDT with 81.7% of clearance of superficial BCC and 75.1% for nodular BCC, and a small relapse rate of 1.22%. http://dx.doi.org/10.1016/j.pdpdt.2015.07.188 Prospective, double-blind, randomized placebo-controlled trial of the efficacy of lidocaine and tetracaine cream 7%/7% for pain control during PDT Ana Gabriela Salvio1, Pedro E Russignoli 2, Natalia Mayumi Inada2, Elisangela Ramos de Oliveira1, Cristina Kurachi2, Vanderlei Salvador Bagnato2 1 Skin Deppartment of Amaral Carvalho Hospital, Brazil 2 Sao Carlos Institute of Physics, University of Sao

PDT Brazil - A New Approach for Basal Cell Carcinoma Treatment

s / Photodiagnosis and Photodynamic Therapy 12 (2015) 325–375 373 PDT Brazil Photodynamic Therapy based M-ALA for non melanoma skin cancer: Ecuador experiences Romero Paulina1,2, Cabrera Franklin1,2, Tello Sonia1,2, Kurachi Cristina1,2, Ramirez Patricia1,2, Guaman Leonel1,2, Avalos Eduardo1,2, Bagnato Vanderlei1,2 1 Escuela Politecnica Nacional, Departamento de Materiales, Electrica y Fisica Quito-Ecuador. Hospital Carlos Andrade Marin, Servicio de Dermatologia e Histopatologia. Quito – Ecuador 2 Sao Carlos Institute of Physics, University of Sao Paulo, Brazil In Ecuador the National Tumor Registry (RNT) show in 2002 the non-melanoma skin cancer was the second most common cancer in men and women, but in 2005 it takes the first place for women. Experience: 11 patients with surface CBC, 47 with nodular CBC, 2 with CBC recurrences (depht middle dermis), 2 with CBC recurrences (neural invasion) and 3 with surface CEC, were treated with Photodynamic therapy based inMetil -ALA 20% and the LINCE light source with 100 W/cm2, 635nm wavelength. During treatment was used the dermatoscopy to monitor lesions. The results were evaluated by histopathological studies where the initial depth of the lesions was evident. These assessments allowed to find the depth at which treatment is efficient. Patients were treated between 2012 2014 in the “Carlos Andrade Marin” Hospital and “Gonzalo Gonzalez” Dermatological Hospital in QuitoEcuador. Results: After 2 therapy sessions for suface CBC (depht middle dermis) 90% of the patients have a complete response, for nodular CBC after 4 sessions 86% of the patients have a complete response, for the CBC recurrences (neural invasion) don’t show an effective response, and for surface CEC after 6 sessions 100% of the patients have a complete response. http://dx.doi.org/10.1016/j.pdpdt.2015.07.186 PDT Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months L.I.S. Mota, M.F.M. Brito, J.S. Belo Universidade Federal de Pernambuco Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months. Fundamentals: Basal-cell cancer is the most prevalent non-melanoma skin cancer in Brazil andworldwide. Photodynamic therapy (PDT) is a noninvasive technique with excellent cosmetic outcome and curative results. Maintaining cure rates remains an object of study due to the recent introduction of this therapy in dermatology. Objective: Evaluate the clinical response of photodynamic therapy in superficial basal-cell carcinoma after 12 months of treatment in patients with initial complete response at the end of the third month after treatment. Methods: After curettage and application of methyl aminolevulinate, the lesion was occluded for 3 hours. Then it was discovered and submitted a 635nm LED (37 J/cm2), positioned eight centimeters from the patient, for eight minutes. Two sessions were realized with intervals of 14 days. Pictures were performed before treatment, at 3 and 12 months after treatment. Results: The analyses involved 35 patients, that were submitted a MAL-PDT and presented complete response in the evaluation of three months. These cancers were checked with 12 months. A maintenance of complete clinical response was observed in 85% (30/35). Conclusion: PDT-MAL is a safe and effective therapeutic approach in the treatment of superficial BCC, with maintenance http://dx.doi.org/10.1016/j.pdpdt.2015.07.187 PDT Brazil A New Approach for Basal Cell Carcinoma Treatment Kate C. Blanco, Natalia M. Inada, Ana Paula da Silva, Pedro Russignoli, Dora P. Ramirez, Hilde H. Buzza, Mirian D. Stringasci, Lilian T. Moriyama, Clovis Grecco, Cristina Kurachi, Vanderlei S. Bagnato Sao Carlos Institute of Physics, University of Sao Paulo, Brazil Non-melanomaskin cancer (NMSC) is themostprevalent cancer type in Brazil andworldwide. According to the National Institute of Cancer (INCA) at the last year, it was estimated 182,130 new cases of NMSC in Brazil. Photodynamic Therapy (PDT) has proven to be effective with an excellent cosmetic outcome and reliable treatment option. A Brazilian programwas established to determine the efficacy of topicalMAL-PDTusing a Brazilian device (LINCE,MMOptics, Brazil) and medication (methyl aminolevulinate, PDTPharma, Brazil). During four years with financial support by BNDES (Brazilian Development Bank), we are reporting the treatment of 994 basal cell carcinoma (BCC), around all country and Latin America. Through these data it was analyzed the efficiency of the treatment 30 days after the second PDT session. Were compared the gender, age, skin type, location and size of the lesions. The conclusion of this extensive and important project has shown the efficacy PDT with 81.7% of clearance of superficial BCC and 75.1% for nodular BCC, and a small relapse rate of 1.22%. http://dx.doi.org/10.1016/j.pdpdt.2015.07.188 Prospective, double-blind, randomized placebo-controlled trial of the efficacy of lidocaine and tetracaine cream 7%/7% for pain control during PDT Ana Gabriela Salvio1, Pedro E Russignoli 2, Natalia Mayumi Inada2, Elisangela Ramos de Oliveira1, Cristina Kurachi2, Vanderlei Salvador Bagnato2 1 Skin Deppartment of Amaral Carvalho Hospital, Brazil 2 Sao Carlos Institute of Physics, University of Sao

Prospective, double-blind, randomized placebo-controlled trial of the efficacy of lidocaine and tetracaine cream 7%/7% for pain control during PDT

s / Photodiagnosis and Photodynamic Therapy 12 (2015) 325–375 373 PDT Brazil Photodynamic Therapy based M-ALA for non melanoma skin cancer: Ecuador experiences Romero Paulina1,2, Cabrera Franklin1,2, Tello Sonia1,2, Kurachi Cristina1,2, Ramirez Patricia1,2, Guaman Leonel1,2, Avalos Eduardo1,2, Bagnato Vanderlei1,2 1 Escuela Politecnica Nacional, Departamento de Materiales, Electrica y Fisica Quito-Ecuador. Hospital Carlos Andrade Marin, Servicio de Dermatologia e Histopatologia. Quito – Ecuador 2 Sao Carlos Institute of Physics, University of Sao Paulo, Brazil In Ecuador the National Tumor Registry (RNT) show in 2002 the non-melanoma skin cancer was the second most common cancer in men and women, but in 2005 it takes the first place for women. Experience: 11 patients with surface CBC, 47 with nodular CBC, 2 with CBC recurrences (depht middle dermis), 2 with CBC recurrences (neural invasion) and 3 with surface CEC, were treated with Photodynamic therapy based inMetil -ALA 20% and the LINCE light source with 100 W/cm2, 635nm wavelength. During treatment was used the dermatoscopy to monitor lesions. The results were evaluated by histopathological studies where the initial depth of the lesions was evident. These assessments allowed to find the depth at which treatment is efficient. Patients were treated between 2012 2014 in the “Carlos Andrade Marin” Hospital and “Gonzalo Gonzalez” Dermatological Hospital in QuitoEcuador. Results: After 2 therapy sessions for suface CBC (depht middle dermis) 90% of the patients have a complete response, for nodular CBC after 4 sessions 86% of the patients have a complete response, for the CBC recurrences (neural invasion) don’t show an effective response, and for surface CEC after 6 sessions 100% of the patients have a complete response. http://dx.doi.org/10.1016/j.pdpdt.2015.07.186 PDT Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months L.I.S. Mota, M.F.M. Brito, J.S. Belo Universidade Federal de Pernambuco Brazil Therapy in Superficial Basal Cell Carcinoma: follow-up for 12 months. Fundamentals: Basal-cell cancer is the most prevalent non-melanoma skin cancer in Brazil andworldwide. Photodynamic therapy (PDT) is a noninvasive technique with excellent cosmetic outcome and curative results. Maintaining cure rates remains an object of study due to the recent introduction of this therapy in dermatology. Objective: Evaluate the clinical response of photodynamic therapy in superficial basal-cell carcinoma after 12 months of treatment in patients with initial complete response at the end of the third month after treatment. Methods: After curettage and application of methyl aminolevulinate, the lesion was occluded for 3 hours. Then it was discovered and submitted a 635nm LED (37 J/cm2), positioned eight centimeters from the patient, for eight minutes. Two sessions were realized with intervals of 14 days. Pictures were performed before treatment, at 3 and 12 months after treatment. Results: The analyses involved 35 patients, that were submitted a MAL-PDT and presented complete response in the evaluation of three months. These cancers were checked with 12 months. A maintenance of complete clinical response was observed in 85% (30/35). Conclusion: PDT-MAL is a safe and effective therapeutic approach in the treatment of superficial BCC, with maintenance http://dx.doi.org/10.1016/j.pdpdt.2015.07.187 PDT Brazil A New Approach for Basal Cell Carcinoma Treatment Kate C. Blanco, Natalia M. Inada, Ana Paula da Silva, Pedro Russignoli, Dora P. Ramirez, Hilde H. Buzza, Mirian D. Stringasci, Lilian T. Moriyama, Clovis Grecco, Cristina Kurachi, Vanderlei S. Bagnato Sao Carlos Institute of Physics, University of Sao Paulo, Brazil Non-melanomaskin cancer (NMSC) is themostprevalent cancer type in Brazil andworldwide. According to the National Institute of Cancer (INCA) at the last year, it was estimated 182,130 new cases of NMSC in Brazil. Photodynamic Therapy (PDT) has proven to be effective with an excellent cosmetic outcome and reliable treatment option. A Brazilian programwas established to determine the efficacy of topicalMAL-PDTusing a Brazilian device (LINCE,MMOptics, Brazil) and medication (methyl aminolevulinate, PDTPharma, Brazil). During four years with financial support by BNDES (Brazilian Development Bank), we are reporting the treatment of 994 basal cell carcinoma (BCC), around all country and Latin America. Through these data it was analyzed the efficiency of the treatment 30 days after the second PDT session. Were compared the gender, age, skin type, location and size of the lesions. The conclusion of this extensive and important project has shown the efficacy PDT with 81.7% of clearance of superficial BCC and 75.1% for nodular BCC, and a small relapse rate of 1.22%. http://dx.doi.org/10.1016/j.pdpdt.2015.07.188 Prospective, double-blind, randomized placebo-controlled trial of the efficacy of lidocaine and tetracaine cream 7%/7% for pain control during PDT Ana Gabriela Salvio1, Pedro E Russignoli 2, Natalia Mayumi Inada2, Elisangela Ramos de Oliveira1, Cristina Kurachi2, Vanderlei Salvador Bagnato2 1 Skin Deppartment of Amaral Carvalho Hospital, Brazil 2 Sao Carlos Institute of Physics, University of Sao

Parameter study of myocardial cell damage with photosensitization reaction under extracellular talaporfin sodium existence

s / Photodiagnosis and Photodynamic Therapy 12 (2015) 325–375 333 Conduction block recovery by photosensitization reaction under extracellular talaporfin sodium existence in a cardiomyocyte electrical conduction wire Mariko Kurotsu, Emiyu Ogawa, Tsunenori Arai Graduate School of Science and Technology, Keio University, Japan Westudied theelectrical conduction (EC)block recoverybyphotosensitization reaction (PR) under extracellular talaporfin sodium existence in a novel cardiomyocyte EC wire in vitro. Tachyarrhythmia can be cured by permanent block of abnormal EC. The EC block recovery sometimes occurs in the case of weak damage on myocardium. The pattern cultivation cover glass, which had 60 m width cultivation areas, was used to form the wires. The PR was operated to the wires for 600 s varying 3–120mW/cm2 in 663nm laser irradianceswith 20 g/ml talaporfin sodium. The cardiomyocyte ECwas evaluated by the cross correlation function of a fluorescence brightness of intracellular Ca2+ probe in a wire. In 30 and 60mW/cm2, the EC of 15min after the PR was blocked significantly faster than the reported cardiomyocyte necrosis occurrence timing of the same PR conditions. Despite the EC block probabilities of 15min and 2h after the PR were almost 90% in 60mW/cm2, those in 30mW/cm2 were approximately 90 and 60%, respectively. We think this temporary EC block might be caused by gap junction closure induced by intracellular Ca2+ increase. http://dx.doi.org/10.1016/j.pdpdt.2015.07.036 Light fractionation improves the response to BF-200 ALA-PDT in hairless mouse skin Henriette S. de Bruijn1, Sander Brooks2, Angelique van der Ploeg-van den Heuvel1, Ellen R.M. de Haas2, Dominic J. Robinson1 1 The Centre for Optical Diagnostics and Therapy, Department of Otolaryngology and Head & Neck Surgery, The Netherlands 2 Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands Fractionated illumination significantly enhances the effectiveness of 5-aminolevulinic-acid based photodynamic therapy (ALAPDT) but not of Methyl-AminoLevulinate (MAL). BF-200 ALA is a recently approved novel formulation of 10% ALA in a lecithin-based nanoemulsion. Here we compare the fluorescence kinetics, distribution and PDT induced response in hairless mice using BF-200 ALA, MAL and ALA. Comparable fluorescence kinetics was determined forMAL, ALAandBF-200ALA. Cryo-sectionswere stained for CD31 and co-localization with PpIX fluorescence was significantly stronger after ALA and BF-200 ALA compared to MAL (p<0.01). Intra-vital confocalmicroscopy showed no difference betweenALA and BF-200 ALA at depth in skin. Vascular responses were not different as determined in the skin-fold chamber immediately after PDT or at day 1 in cryosections. Visual skin damage scored up to 14 days post PDT showed an significantly increased response to light fractionation for bothALAandBF-200ALA. BF-200ALAbehaves like ALA in normal mouse skin. While light fractionated ALA-PDT was successfully translated to a treatment modality for human lesions our results suggest that ALA can be replaced by BF-200 ALA, marketed as Ameluz® in Europe, for the treatment of superficial BasalCell-Carcinoma and other skin lesions using light fractionation. http://dx.doi.org/10.1016/j.pdpdt.2015.07.037 Parameter study of myocardial cell damage with photosensitization reaction under extracellular talaporfin sodium existence

Conduction block recovery by photosensitization reaction under extracellular talaporfin sodium existence in a cardiomyocyte electrical conduction wire

s / Photodiagnosis and Photodynamic Therapy 12 (2015) 325–375 333 Conduction block recovery by photosensitization reaction under extracellular talaporfin sodium existence in a cardiomyocyte electrical conduction wire Mariko Kurotsu, Emiyu Ogawa, Tsunenori Arai Graduate School of Science and Technology, Keio University, Japan Westudied theelectrical conduction (EC)block recoverybyphotosensitization reaction (PR) under extracellular talaporfin sodium existence in a novel cardiomyocyte EC wire in vitro. Tachyarrhythmia can be cured by permanent block of abnormal EC. The EC block recovery sometimes occurs in the case of weak damage on myocardium. The pattern cultivation cover glass, which had 60 m width cultivation areas, was used to form the wires. The PR was operated to the wires for 600 s varying 3–120mW/cm2 in 663nm laser irradianceswith 20 g/ml talaporfin sodium. The cardiomyocyte ECwas evaluated by the cross correlation function of a fluorescence brightness of intracellular Ca2+ probe in a wire. In 30 and 60mW/cm2, the EC of 15min after the PR was blocked significantly faster than the reported cardiomyocyte necrosis occurrence timing of the same PR conditions. Despite the EC block probabilities of 15min and 2h after the PR were almost 90% in 60mW/cm2, those in 30mW/cm2 were approximately 90 and 60%, respectively. We think this temporary EC block might be caused by gap junction closure induced by intracellular Ca2+ increase. http://dx.doi.org/10.1016/j.pdpdt.2015.07.036 Light fractionation improves the response to BF-200 ALA-PDT in hairless mouse skin Henriette S. de Bruijn1, Sander Brooks2, Angelique van der Ploeg-van den Heuvel1, Ellen R.M. de Haas2, Dominic J. Robinson1 1 The Centre for Optical Diagnostics and Therapy, Department of Otolaryngology and Head & Neck Surgery, The Netherlands 2 Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands Fractionated illumination significantly enhances the effectiveness of 5-aminolevulinic-acid based photodynamic therapy (ALAPDT) but not of Methyl-AminoLevulinate (MAL). BF-200 ALA is a recently approved novel formulation of 10% ALA in a lecithin-based nanoemulsion. Here we compare the fluorescence kinetics, distribution and PDT induced response in hairless mice using BF-200 ALA, MAL and ALA. Comparable fluorescence kinetics was determined forMAL, ALAandBF-200ALA. Cryo-sectionswere stained for CD31 and co-localization with PpIX fluorescence was significantly stronger after ALA and BF-200 ALA compared to MAL (p<0.01). Intra-vital confocalmicroscopy showed no difference betweenALA and BF-200 ALA at depth in skin. Vascular responses were not different as determined in the skin-fold chamber immediately after PDT or at day 1 in cryosections. Visual skin damage scored up to 14 days post PDT showed an significantly increased response to light fractionation for bothALAandBF-200ALA. BF-200ALAbehaves like ALA in normal mouse skin. While light fractionated ALA-PDT was successfully translated to a treatment modality for human lesions our results suggest that ALA can be replaced by BF-200 ALA, marketed as Ameluz® in Europe, for the treatment of superficial BasalCell-Carcinoma and other skin lesions using light fractionation. http://dx.doi.org/10.1016/j.pdpdt.2015.07.037 Parameter study of myocardial cell damage with photosensitization reaction under extracellular talaporfin sodium existence

Commentary on 'Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial'.

Commentary on 'Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial'.

Response to 'Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal'.

Response to 'Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal'.

Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal.

Arits etal. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior to methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma. This single-blind, noninferiority, randomized controlled trial was conducted at one coordinating academic hospital and six peripheral dermatological departments in the Netherlands between March 2008 and August 2010. Patients with a superficial basal cell carcinoma were randomly assigned to be treated with PDT (two treatments); or imiquimod 5% cream, once daily five times a week for 6weeks; or fluorouracil 5% cream twice daily for 4weeks. Follow-up visits were planned after 3months and 1year. The primary outcome was defined as the probability that a patient was free of tumour reoccurrence at both 3 and 12months' follow-up. Secondary outcomes were aesthetic outcome of the treated area, compliance and adverse reactions. In total 911 patients were assessed for eligibility, of whom 601 were randomized: 202 to receive MAL-PDT, 198 to receive imiquimod cream and 201 to receive fluorouracil cream. The proportions (95% confidence intervals) of patients tumour free at both 3 and 12months were 72·8% (66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream and 80·1% (74·7-85·9) for fluorouracil cream. For patients treated with MAL-PDT, moderate-to-severe pain and burning sensation were reported most often during the treatment itself. For the creams, moderate-to-severe local swelling, erosion, crust formation and itching of the skin were mentioned most often. Arits etal. conclude that topical fluorouracil was noninferior and imiquimod was superior to MAL-PDT for treatment of superficial basal cell carcinoma. Imiquimod cream is suggested as the preferred treatment.

Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial

Superficial basal-cell carcinoma is most commonly treated with topical non-surgical treatments, such as photodynamic therapy or topical creams. Photodynamic therapy is considered the preferable treatment, although this has not been previously tested in a randomised control trial. We assessed the effectiveness of photodynamic therapy compared with imiquimod or fluorouracil in patients with superficial basal-cell carcinoma. In this single blind, non-inferiority, randomised controlled multicentre trial, we enrolled patients with a histologically proven superficial basal-cell carcinoma at seven hospitals in the Netherlands. Patients were randomly assigned to receive treatment with methylaminolevulinate photodynamic therapy (MAL-PDT; two sessions with an interval of 1 week), imiquimod cream (once daily, five times a week for 6 weeks), or fluorouracil cream (twice daily for 4 weeks). Follow-up was at 3 and 12 months post-treatment. Data were collected by one observer who was blinded to the assigned treatment. The primary outcome was the proportion of patients free of tumour at both 3 and 12 month follow up. A pre-specified non-inferiority margin of 10% was used and modified intention-to-treat analyses were done. This trial is registered as an International Standard Randomised controlled trial (ISRCTN 79701845). 601 patients were randomised: 202 to receive MAL-PDT, 198 to receive imiquimod, and 201 to receive fluorouracil. A year after treatment, 52 of 196 patients treated with MAL-PDT, 31 of 189 treated with imiquimod, and 39 of 198 treated with fluorouracil had tumour residue or recurrence. The proportion of patients tumour-free at both 3 and 12 month follow-up was 72.8% (95% CI 66.8-79.4) for MAL-PDT, 83.4% (78.2-88.9) for imiquimod cream, and 80.1% (74.7-85.9) for fluorouracil cream. The difference between imiquimod and MAL-PDT was 10.6% (95% CI 1.5-19.5; p=0.021) and 7.3% (-1.9 to 16.5; p=0.120) between fluorouracil and MAL-PDT, and between fluorouracil and imiquimod was -3.3% (-11.6 to 5.0; p=0.435. For patients treated with MAL-PDT, moderate to severe pain and burning sensation were reported most often during the actual MAL-PDT session. For other local adverse reactions, local skin redness was most often reported as moderate or severe in all treatment groups. Patients treated with creams more often reported moderate to severe local swelling, erosion, crust formation, and itching of the skin than patients treated with MAL-PDT. In the MAL-PDT group no serious adverse events were reported. One patient treated with imiquimod and two patients treated with fluorouracil developed a local wound infection and needed additional treatment in the outpatient setting. Topical fluorouracil was non-inferior and imiquimod was superior to MAL-PDT for treatment of superficial basal-cell carcinoma. On the basis of these findings, imiquimod can be considered the preferred treatment, but all aspects affecting treatment choice should be weighted to select the best treatment for patients. Grant of the Netherlands Organization for Scientific Research ZONMW (08-82310-98-08626).

What Lies Beneath? A Lesson for the Clinician. Intraoperative Frozen Section Appearance of Persistent Basal Cell Carcinoma after Apparent Cure with Imiquimod 5% Cream

The Food and Drug Administration (FDA) has approved imiquimod 5% cream for the treatment of nonfacial superficial basal cell carcinoma (BCC), and it has increased in popularity as a nonsurgical approach for the treatment of BCC. Its use for the treatment of superficial BCCs on the trunk, neck, and extremities has been documented in the dermatology and family physician literature. Studies of imiquimod for nodular BCC, on the other hand, have demonstrated suboptimal cure rates according to both clinical and histologic criteria, but little is known about the efficacy of imiquimod cream in the treatment of more extensive lesions, more aggressive BCC subtypes, or treatment in higher risk locations like the face, although the off-label practice of treating facial BCCs with imiquimod is not rare.

Interventions for basal cell carcinoma of the skin

Basal cell carcinoma (BCC) is the commonest skin cancer. BCCs are slow-growing, locally invasive, epidermal skin tumours which mainly affect white skinned people. The first line treatment is usually surgical excision, but numerous alternatives are available. To assess the effects of treatments for basal cell carcinoma. We searched the Cochrane Skin Group Specialised Register (January 2006), the Cochrane Central Register of Controlled Trials (The Cochrane LIbrary Issue 1, 2006), the Cochrane Database of Systematic Reviews (The Cochrane Library Issue 1, 2006), MEDLINE (2004 to January 2006), EMBASE (2005 to January 2006), the metaRegister of Controlled Trials (February 2006). Cited references of all trials identified and key review articles were searched. Pharmaceutical companies were contacted where appropriate for reviews or unpublished trials. Inclusion criteria were adults with one or more histologically proven, primary basal cell carcinoma. The primary outcome measure was recurrence at three to five years, measured clinically. The secondary outcome included early treatment failure within six months, measured histologically. Adverse treatment effects included aesthetic appearance and pain during and after treatment. Two authors independantly carried out study selection and assessment of methodological quality. Twenty seven studies were identified. Only one RCT of surgery versus radiotherapy had primary outcome data at four years, showing significantly more persistent tumours and recurrences in the radiotherapy group as compared to the surgery group, (RR 0.09, 95%CI, 0.01 to 0.69). One study found no significant difference for recurrence at 30 months when Moh's micrographic surgery was compared to surgery for high risk facial BCCs, (RR 0.64, 95%CI 0.16,2.64). One study of methylaminolevulinate photodynamic therapy (MAL PDT) versus cryotherapy found no significant difference in recurrences in the MAL PDT group when compared to cryotherapy at one year (RR 0.50, 95% CI 0.22,1.12). Cryotherapy showed no significant difference in recurrences at one year when compared to surgery on one small study. When radiotherapy was compared to cryotherapy there were significantly fewer recurrences at one year in the radiotherapy group compared to the cryotherapy group.Short-term studies suggest a success rate of 87 to 88% for imiquimod in the treatment of superficial BCC using a once-daily regimen for 6 weeks and a 76% treatment response when treating nodular BCC for 12 weeks, when measured histologically. Overall there has been very little good quality research on treatments for BCC. Most trials have only evaluated BCCs in low risk locations. Surgery and radiotherapy appear to be the most effective treatments with surgery showing the lowest failure rates. Although cosmetic outcomes appear good with PDT, long term follow up data are needed. Other treatments might have some use but few have been compared to surgery. An ongoing study comparing imiquimod to surgery should clarify whether imiquimod is a useful option.

Imiquimod Treatment of Superficial and Nodular Basal Cell Carcinoma: 12-Week Open-Label Trial

Imiquimod is an immune response modifier shown to be effective in basal cell carcinoma (BCC). To evaluate the efficacy, tolerability, and response durability of imiquimod 5% cream in selected patients with superficial and/or nodular BCCs. Seventy-five superficial and 19 nodular BCCs in 49 patients were treated with imiquimod once daily three times a week for up to 12 weeks. Of the 49 enrolled patients, 1 discontinued the study and 1 was lost to follow-up. After 12 weeks of treatment, a complete response occurred in 70 of 75 (93.3%) superficial BCCs and a partial response in 4 of 75 (5.3%) superficial BCCs. Ten of 19 (52.6%) nodular BCCs cleared after 12 weeks, whereas 7 (36.8%) showed partial remission. Adverse side effects were limited to local skin reactions. Recurrence was observed in 2 of 70 (2.9%) successfully treated superficial BCCs 6 and 8 months after treatment discontinuation. No recurrence was detected in 68 of 70 (97.1%) superficial BCCs and in 10 successfully treated nodular BCCs after 12 to 34 months of follow-up (mean 23 months). In our patient population, treatment of superficial BCCs with topical imiquimod for 12 weeks produced an excellent clinical response overall, with complete remission maintained after a mean of 23 months.

Imiquimod Treatment of Superficial and Nodular Basal Cell Carcinoma

Background Imiquimod is an immune response modifier shown to be effective in basal cell carcinoma (BCC). Objective To evaluate the efficacy, tolerability, and response durability of imiquimod 5% cream in selected patients with superficial and/or nodular BCCs. Methods Seventy-five superficial and 19 nodular BCCs in 49 patients were treated with imiquimod once daily three times a week for up to 12 weeks. Results Of the 49 enrolled patients, 1 discontinued the study and 1 was lost to follow-up. After 12 weeks of treatment, a complete response occurred in 70 of 75 (93.3%) superficial BCCs and a partial response in 4 of 75 (5.3%) superficial BCCs. Ten of 19 (52.6%) nodular BCCs cleared after 12 weeks, whereas 7 (36.8%) showed partial remission. Adverse side effects were limited to local skin reactions. Recurrence was observed in 2 of 70 (2.9%) successfully treated superficial BCCs 6 and 8 months after treatment discontinuation. No recurrence was detected in 68 of 70 (97.1%) superficial BCCs and in 10 successfully treated nodular BCCs after 12 to 34 months of follow-up (mean 23 months). Conclusions In our patient population, treatment of superficial BCCs with topical imiquimod for 12 weeks produced an excellent clinical response overall, with complete remission maintained after a mean of 23 months.

Carcinoma basocelular múltiple tratado con imiquimod

Superficial basal cell carcinoma (BCC) account for 15% of all BCC. Treatment of superficial BCC with surgery, cryosurgery and electrodessication often produce anaesthetic scars. We present a case of a 58 year-old male, with multiple superficial BCC, who was treated with imiquimod 5% cream, in a schedule of one application daily three times per week, with a very good response after 12 applications. Imiquimod is an immune response modifier which induces cytokines and interferon, and is effective for the treatment of different types of BCC.

Interventions for basal cell carcinoma of the skin.

Basal cell carcinoma (BCC) is the most common skin malignancy in humans. BCCs are defined as slow-growing, locally invasive, malignant (but not life threatening), epidermal skin tumours which mainly affect white skinned people. The first line treatment is usually surgical excision, but numerous alternatives are available. To assess the effects of treatments for basal cell carcinoma. We searched the Cochrane Database of Systematic Reviews (2002 issue 1) and Cochrane Controlled Trials Register (2002 issue 1), the Cochrane Skin Group Specialised Register (January 2002), MEDLINE (from 1966-2002), EMBASE (from 1980-2002), the Mega Register of Controlled trials and the National Research Register (2002 issue 1). In addition the cited references of all trials identified and key review articles were searched. Pharmaceutical companies were contacted where appropriate for reviews or unpublished trials. Inclusion criteria were adults with one or more histologically proven, primary basal cell carcinoma. The primary outcome measure was recurrence at 3- 5 years, measured clinically. The secondary outcome included early treatment failure within 6 months, measured histologically. Adverse effect of treatment was evaluated by reviewing aesthetic appearance (to patient and blinded observer) and pain during and after treatment. Study selection and assessment of methodological quality were carried out by two independent reviewers. 19 studies (13 published and 6 abstracts) were identified which include 7 broad therapeutic categories. Only one RCT of surgery versus radiotherapy had primary outcome data at four years, which showed that there were significantly more persistent tumours and recurrences, measured histologically, in the radiotherapy group as compared to the surgery group, which translates to an odds ratio of 0.09 (95%CI, 0.01 to 0.67) in favour of surgery. Cryotherapy, although convenient and less expensive than surgery, showed no significant difference in recurrences at one year, measured clinically, when compared to surgery, OR 0.23 (0.01 to 6.78). However when radiotherapy was compared to cryotherapy there were significantly more recurrences at one year, measured histologically, in the cryotherapy group, this translates to an odds ratio of 14.80 (95%CI, 3.17 to 69) in favour of radiotherapy. Preliminary studies suggest a high success rate (87-88%) for imiquimod in the treatment of superficial BCC using a once-daily regimen for 6 weeks and a useful (76%) treatment response when treating nodular BCC for 12 weeks, when measured histologically. However this cream has not been compared to surgery. There has been very little good quality research on efficacy of the treatment modalities used. Most of the trials have looked only at BCCs in low risk areas. Surgery and radiotherapy appear to be the most effective treatments with surgery showing the lowest failure rates. Other treatments might have some use but few have been compared to surgery. Imiquimod emerged as a possible new treatment although it has not been compared to surgery or any other modality.

Topical Fluorouracil Therapy for Precancers and Cancers of the Skin

Topical fluorouracil (FU) is an extremely effective agent for treating multiple actinic keratoses. It is also of value in the treatment of Bowen's disease, actinic cheilitis, arsenical keratoses, radiodermatitis, X-ray-induced keratoses, leukoplakia, and the erythroplasia of Queyrat. Topical FU may be successful in the treatment of superficial basal-cell carcinomas, but should not be used for nodular carcinomas of the face or neck except under unusual circumstances and with mandatory histologic follow-up evaluation. The usual method of treatment is twice daily application of a 1 percent FU solution in propylene glycol. Several modifications of various types of commonly employed preparations and the manner in which each is used are described, along with the respective indications. The considerable discomfort associated with the use of topical FU can be lessened by the stepwise approach outlined--a method extraordinarily valuable for older patients. Occasional complications are primary irritant dermatitis and allergic contact dermatitis; these must be recognized promptly and treated, as must other less frequent side effects. Topical FU appears to be of great value in the destruction of existing precancerous skin lesions. When used repeatedly, it may postpone indefinitely the development of significant precancerous and cancerous skin lesions.