Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study / Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico

Background Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. Objective To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. Methods We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. Results A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. Conclusion Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice (AU)

Antecedentes El carcinoma de células basales (CBC) es el cáncer más prevalente. Una minoría de CBC tiene un comportamiento agresivo (laBCC) y puede requerir inhibidores de la vía del erizo, como sonidegib como tratamiento. Objetivo Describir el uso de sonidegib en un gran número de pacientes y aportar más datos sobre su perfil de eficacia y seguridad en la vida real. Métodos Realizamos un estudio retrospectivo y multicéntrico que incluyó pacientes tratados con sonidegib. Se recogieron datos epidemiológicos, de eficacia y de seguridad. Resultados Se incluyeron un total de 82 pacientes con una edad media de 73,9 años. Diez pacientes tenían síndrome de Gorlin. La mediana de duración del tratamiento fue de 6 meses. La mediana de duración del seguimiento fue de 34,2 meses. Globalmente, el 81,7% de los pacientes mostró mejoría clínica (52,4% respuesta parcial y 29,3% respuesta completa), el 12,2% estabilidad clínica y el 6,1% progresión de la enfermedad. No hubo diferencias estadísticamente significativas en la mejoría clínica entre la posología de sonidegib de 24horas y de 48horas. Después de 6 meses de tratamiento, el 48,8% de los pacientes suspendió sonidegib. El tratamiento previo con vismodegib y el CBC primario recurrente se asociaron con una peor respuesta a sonidegib. A los 6 meses de tratamiento el 68,3% de los pacientes experimentó al menos un efecto adverso. Conclusión Sonidegib muestra un perfil de eficacia y seguridad mejor de lo esperado en la práctica clínica habitual (AU)

[Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico / Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study

Antecedentes El carcinoma de células basales (CBC) es el cáncer más prevalente. Una minoría de CBC tiene un comportamiento agresivo (laBCC) y puede requerir inhibidores de la vía del erizo, como sonidegib como tratamiento. Objetivo Describir el uso de sonidegib en un gran número de pacientes y aportar más datos sobre su perfil de eficacia y seguridad en la vida real. Métodos Realizamos un estudio retrospectivo y multicéntrico que incluyó pacientes tratados con sonidegib. Se recogieron datos epidemiológicos, de eficacia y de seguridad. Resultados Se incluyeron un total de 82 pacientes con una edad media de 73,9 años. Diez pacientes tenían síndrome de Gorlin. La mediana de duración del tratamiento fue de 6 meses. La mediana de duración del seguimiento fue de 34,2 meses. Globalmente, el 81,7% de los pacientes mostró mejoría clínica (52,4% respuesta parcial y 29,3% respuesta completa), el 12,2% estabilidad clínica y el 6,1% progresión de la enfermedad. No hubo diferencias estadísticamente significativas en la mejoría clínica entre la posología de sonidegib de 24horas y de 48horas. Después de 6 meses de tratamiento, el 48,8% de los pacientes suspendió sonidegib. El tratamiento previo con vismodegib y el CBC primario recurrente se asociaron con una peor respuesta a sonidegib. A los 6 meses de tratamiento el 68,3% de los pacientes experimentó al menos un efecto adverso. Conclusión Sonidegib muestra un perfil de eficacia y seguridad mejor de lo esperado en la práctica clínica habitual (AU)

Background Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. Objective To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. Methods We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. Results A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. Conclusion Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice (AU)

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study. / [Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24 h and 48 h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

High-dose-rate plesiotherapy with customized molds in non-melanoma skin cancer: efficacy and safety at 10 years—single institution experience

PurposeOur center adopted high-dose-rate brachytherapy with surface applicators (plesiotherapy) in 2008, creating custom molds to treat irregular areas. This study describes the efficacy and safety outcomes after extensive follow-up in the patients.Methods/patientsWe planned the treatment using two computed tomography (CT) scans: the first to delineate the lesion and the second after placing the thermoplastic mold. Fusing the two CT images enables planning of the target volume and pinpointing, where the catheters are in the mold.ResultsSeventy patients received plesiotherapy, either exclusively or following excision in patients with risk factors for recurrence. Those receiving plesiotherapy alone showed a complete response rate of 95.8%, and recurrences occurred in 5.7% at a mean follow-up of 96.2 months. Chronic toxicity appeared in 26.6% of patients, but severity was limited to grade 1 or 2.ConclusionsHigh-dose-rate brachytherapy with customized molds yields a high rate of complete response, with long-term recurrence rates in line with similar studies and an acceptable toxicity rate.

High-dose-rate plesiotherapy with customized molds in non-melanoma skin cancer: efficacy and safety at 10 years-single institution experience.

PURPOSE: Our center adopted high-dose-rate brachytherapy with surface applicators (plesiotherapy) in 2008, creating custom molds to treat irregular areas. This study describes the efficacy and safety outcomes after extensive follow-up in the patients. METHODS/PATIENTS: We planned the treatment using two computed tomography (CT) scans: the first to delineate the lesion and the second after placing the thermoplastic mold. Fusing the two CT images enables planning of the target volume and pinpointing, where the catheters are in the mold. RESULTS: Seventy patients received plesiotherapy, either exclusively or following excision in patients with risk factors for recurrence. Those receiving plesiotherapy alone showed a complete response rate of 95.8%, and recurrences occurred in 5.7% at a mean follow-up of 96.2 months. Chronic toxicity appeared in 26.6% of patients, but severity was limited to grade 1 or 2. CONCLUSIONS: High-dose-rate brachytherapy with customized molds yields a high rate of complete response, with long-term recurrence rates in line with similar studies and an acceptable toxicity rate.

Initial results of ixekizumab efficacy and safety in real-world plaque psoriasis patients: a multicentre retrospective study.

BACKGROUND: Ixekizumab (anti-IL17A) is effective as treatment for moderate-to-severe plaque psoriasis, but real-life data on effectiveness and safety are currently very limited. OBJECTIVE: To evaluate the efficacy and safety of ixekizumab in a cohort of real-life plaque psoriasis patients. METHODS: Retrospective chart review of 100 patients with moderate-to-severe plaque psoriasis treated with ixekizumab at seven Spanish dermatological centres. RESULTS: According to the as observed analysis, the percentage of patients achieving a 75% and 90% of reduction from the baseline score of Psoriasis Area and Severity Index (PASI) was 87.5%-50.0% at week 12-16; 88.3%-58.4% at week 24 and 82.9%-58.5% at week 52, respectively. The mean ± standard deviation (SD) score of PASI at baseline was 12.9 ± 9.2, and it declined rapidly after ixekizumab administration to 1.9 ± 4.0 (P < 0.001) at week 12-16 and was maintained at 1.7 ± 4.1 and 1.8 ± 2.9 at week 24 and 52, respectively. Ixekizumab response was not affected by clinical variables like body mass index, disease duration or the presence of psoriatic arthritis. However, the bio-naive group showed significantly higher PASI 75 response rate at week 12-16 compared to patients previously exposed to biologic agents (P = 0.037). Twenty-six (26%) patients experienced adverse events (AEs) during the follow-up period, being most of them of mild-to-moderate intensity. The most common AE was local reaction at the site of injection (14/26; 53.8%). At the end of the observational period, 15 (15%) patients discontinued ixekizumab treatment due to limited clinical improvement (n = 11), adverse events (n = 3) or lost to follow-up (n = 1) within a mean ± SD time of 6.0 ± 3.9 months. CONCLUSION: The present study illustrates the initial experience with ixekizumab in real-world clinical practice confirming its usefulness and safety in the management of plaque psoriasis patients.

Contact allergy to preservatives: ESSCA* results with the baseline series, 2009-2012.

BACKGROUND: Allergic contact dermatitis caused by biocides is common and causes significant patient morbidity. OBJECTIVE: To describe the current frequency and pattern of patch test reactivity to biocide allergens included in the baseline series of most European countries. METHODS: Data collected by the European Surveillance System on Contact Allergies (ESSCA) network between 2009 and 2012 from 12 European countries were analysed. RESULTS: Methylisothiazolinone 0.2% aq. produced the highest prevalence of sensitization during the study period, with an overall prevalence of 4.5%. The mixture methylchloroisothiazolinone /methylisothiazolinone tested at 0.02% aq. followed closely, with 4.1% of positive reactions. Other preservatives with lower rates of sensitization, but still over 1%, include methyldibromo glutaronitrile (MDBGN) 0.5% pet. and iodopropynyl butylcarbamate (IPBC) 0.2% pet. Formaldehyde releasers and parabens yielded less than 1% positive reactions during the study period. Some regional differences in the prevalence of contact allergy to biocides among European countries were observed. CONCLUSIONS: Contact allergy to biocides is common throughout Europe, and regional differences could be explained by differences in exposure or characteristics of the population tested. Timely regulatory action for isothiazolinones is required. Although MDBGN is banned from cosmetics products since 2005, sensitization prevalence has not appeared to plateau. IPBC is an emerging allergen with an increasing prevalence over the last few years, and its inclusion in the European baseline series may be appropriate.