A Non-Interventional Study on Vismodegib for Basal Cell Carcinoma in Swedish Patients.

INTRODUCTION: Real-life data on vismodegib in advanced basal cell carcinoma (aBCC) are limited. Optimal treatment duration is left to the discretion of the physician. OBJECTIVES: To assess the effectiveness, safety and treatment pattern for vismodegib in aBCC in clinical practice. METHODS: In this multicenter, non-interventional, prospective study, 49 Swedish patients planned for vismodegib treatment were included. The treatment pattern observed was treatment until remission, allowing unlimited discontinuations/pauses. RESULTS: The majority of patients (93.8%), discontinued at least once during the study. Compared to earlier studies there was a decrease of more than 2 months with actual drug intake, reducing the patients burden and costs, at the same time as a high number of responses were seen (87.8%). Median progression-free-survival was 16.7 months, and 90% of the patients were alive at 13.3 months. Ten patients were re-challenged with vismodegib at recurrence or progression, resulting in five partial remissions and three complete remissions. CONCLUSIONS: Clinical response rates with vismodegib for aBCC were comparable to those of similar trials despite a shorter and more intermittent treatment duration. The majority of re-challenges lead to partial or complete remissions.

Sun protection behaviour in organ transplant recipients and non-transplant patients attending a dermatology outpatient clinic in Sweden: A questionnaire survey.

BACKGROUND/PURPOSE: Organ transplant recipients (OTRs) are at high risk of developing skin cancer and are therefore advised to protect their skin against ultraviolet radiation from the sun. Specialized OTR clinics with dermatological follow-up may improve sun habits among OTRs. In this study, we compared self-reported sun exposure and sun protection behaviour between OTRs and non-transplant patients (non-TPs) and between OTRs with and without special dermatological follow-up. METHODS: Patients from Sahlgrenska University Hospital, Gothenburg, Sweden, completed a sun exposure questionnaire. Between 2011 and 2015, 282 OTRs transplanted in the period 1976-2014 and 414 non-TPs were recruited among dermatological outpatients. Participants were stratified into five groups by their status as OTRs or non-TPs and by attendance to dermatological follow-up. RESULTS: More non-TPs than OTRs reported one or more sunburns in the past year, 46% vs. 20%, P < .0001). More OTRs with than OTRs without dermatological follow-up reported frequent use of sunscreens (63% vs 44%, P = .006). More OTRs with follow-up used one or more sun protection measure such as covering clothes, than other OTRs (54% vs 34%, P = .016). CONCLUSION: In this study, OTRs reported less sun exposure than non-TPs. Specialized dermatological follow-up seems to improve sun protection behaviour among OTRs. We suggest that specialized OTR clinics should be more broadly implemented.

Patients' experiences of pain and pain relief during photodynamic therapy on actinic keratoses: an interview study.

Photodynamic therapy (PDT) is a well-known, effective method for treating extensive areas of multiple actinic keratoses in the face and scalp. The main side-effect of PDT is the pain experienced during treatment. The objective of this study was to explore and describe patients' experiences of PDT. The study used individual interviews, and analysis was carried out using phenomenography. The patients had all been treated with PDT for actinic keratoses on the face and scalp, and experienced PDT with and without nerve blocks. The results are presented in 3 themes and 10 categories. Most patients reported that the nerve blocks given prior to PDT altered their experience of pain. Alternative options are needed to reduce pain during PDT based on patients' needs and body site. This study adds a patient perspective highlight-ing patients' own voices as a qualitative complement to statistical analysis using the visual analogue scale.

Predictors of pain associated with photodynamic therapy: a retrospective study of 658 treatments.

Pain is the most common side-effect of photodynamic therapy (PDT). Our main objective was to identify pain predictors in PDT. In total, we performed 658 treatments on 377 patients at our department during 2004. Larger sized treatment areas were the strongest pain predictor, and actinic keratoses were more painful to treat than basal cell carcinomas and Bowen's disease. The most sensitive areas to treat were the face and scalp. Gender and age did not influence pain. Although treatment outcome was not our primary objective, 62% of 95 superficial basal cell carcinomas that were followed for 3 years showed complete clearance. Also, perforation of nodular basal cell carcinomas did not lead to better clinical results. In conclusion, the size of the treatment area, the diagnosis and the lesion location influence pain during PDT. Nevertheless, there is a large variance in visual analogue scale assessment within each group, thereby limiting the ability to predict pain.

Fluorescence diagnostics of basal cell carcinomas comparing methyl-aminolaevulinate and aminolaevulinic acid and correlation with visual clinical tumour size.

Fluorescence diagnostics based on aminolaevulinic acid (ALA) fluorescence has been suggested as an in vivo pre-surgical tool for tumour demarcation. We performed fluorescence diagnostics of 35 basal cell carcinomas (BCCs) undergoing photodynamic therapy (PDT) using methyl-aminolaevulinate (MAL). In addition, a semi-automated thresholding algorithm was implemented to detect the potential tumour region. The mean tumour fluorescence contrast was found to be 1.65 ± 0.06 during the first MAL-PDT session, and increased to 1.84 ± 0.07 at the second treatment (p < 0.01). This could imply that disruption of the skin barrier and inflammatory responses after the first session of PDT led to higher accumulation of proto-porphyrin IX during the second session of PDT. The tumour areas detected based on fluorescence in small BCCs (< 1 cm(2)) were in general (n = 18/23) larger than the visual clinical tumour size. In addition, the fluorescence contrast using MAL (1.65 ± 0.06) was found to be significantly higher (p<10(-4)) than the contrast (data from previous study) after application of ALA (1.20 ± 0.06). Thus, MAL generally provides higher tumour contrast than ALA in BCCs, and should be preferred for use in fluorescence diagnostics. Correlation between fluorescence, lack of treatment response and/or pain was not observed.

Single low-dose red light is as efficacious as methyl-aminolevulinate--photodynamic therapy for treatment of acne: clinical assessment and fluorescence monitoring.

This controlled study investigated single low-dose red light photodynamic therapy and methyl-aminolevulinate (MAL) for treatment of moderate to severe facial acne in 19 patients. The right cheek was treated with MAL (160 mg/g) for 3 h prior to illumination. The left cheek received red light only. Both cheeks were illuminated with narrow-band red light (635 nm) at a light dose of 15 J/cm2. The global severity of acne was assessed at baseline and at follow-up, 10 and 20 weeks after treatment. Fluorescence images, clinical photographs and skin surface biopsies were obtained. Both MAL-photodynamic therapy and control areas showed a significant decrease in acne score at follow-up; no significant difference was found compared with control. MAL-photodynamic therapy was associated with adverse effects such as erythema and stinging. Fluorescence images revealed poor selectivity of MAL-induced fluorescence to the acne lesions, suggesting a general photoablating mechanism rather than selective destruction of sebaceous glands. No significant reduction in Propionibacterium acnes or sebum excretion was found.