New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study.

BACKGROUND: Topical photodynamic therapy (PDT) is an approved and widely used treatment for low-risk basal cell carcinoma (BCC), comprising two sessions with an interval of 1 week. Simplification of the treatment course can be cost-effective, easier to organize, and cause less discomfort for the patients. METHODS AND FINDINGS: We performed an investigator-initiated, single-blind, non-inferiority, randomized controlled multicentre study with the objective of investigating whether a simpler and more flexible PDT regimen was not >10% less effective than the standard double PDT in the treatment of primary, superficial, and nodular ≤2 mm-thick BCC and evaluate the cosmetic outcome. With a non-inferiority margin of 0.1 and an expected probability complete response of 0.85, 190 tumours were required in each group. Histologically verified BCCs from seven centres in Norway were randomly assigned (1:1) to either receive a new regimen of single PDT with one possible re-treatment of non-complete responding tumours, or the standard regimen. The primary endpoint was the number of tumours with complete response or treatment failure at 36 months of follow-up, assessed by investigators blinded to the treatment regimen. Intention-to-treat and per-protocol analyses were performed. The cosmetic outcome was recorded. The study was registered with ClinicalTrials.gov, NCT-01482104, and EudraCT, 2011-004797-28. A total of 402 BCCs in 246 patients were included; 209 tumours assigned to the new and 193 to the standard regimen. After 36 months, there were 61 treatment failures with the new and 34 failures with the standard regimen. Complete response rate was 69.5% in the new and 81.1% in the standard treatment group. The difference was 11.6% (upper 97.5% CI 20.3), i.e. > than the non-inferiority margin of 10%. Cosmetic outcomes were excellent or good in 92% and 89% following the new and standard regimens, respectively. CONCLUSIONS: Single PDT with possible re-treatment of primary, superficial, and nodular ≤ 2-mm-thick BCC was significantly less effective than the approved standard double treatment. The cosmetic outcome was favorable and comparable between the two treatment groups.

Basosquamous Basal Cell Carcinoma with Bone Marrow Metastasis.

Basal cell carcinoma (BCC) is the most common cancer in Caucasians. It is slow growing and rarely metastasizes. If left untreated over time, invasive growth can occur. We present a patient case with a primary BCC located in the right sub-mammary area, with extensive metastases to the skeleton and bone marrow. Histopathological examination of the tumour showed BCC with a diverse growth pattern. There were no signs of local metastases. Surgery was successfully performed. Three months post-surgery the patient developed normocytic anaemia and elevated inflammation markers. [18F]FDG PET/CT showed extensive FDG uptake in the entire skeleton and bone marrow. Biopsy confirmed the infiltration of BCC with similar histopathological features as the primary tumour. Prognosis of metastasized BCC is poor and, therefore, long-term follow-up of patients with risk factors is of importance.

Tumor necrosis is a prognostic factor in thick cutaneous melanoma.

The significance of tumor necrosis in cutaneous melanoma has not been well elucidated. The purpose of this study was to explore the prognostic impact of necrosis in comparison with other known clinicopathologic factors in these tumors. Initially, 457 consecutive cases of nodular cutaneous melanoma (1981 to 2008) were included in this series. Tumor necrosis was assessed on hematoxylin and eosin-stained sections and was recorded as significant when an area of at least a quarter of a high-power field (×400; 0.07 mm) was occupied by necrotic cells and as sparse when clusters of at least 5 necrotic cells were observed. Tumor necrosis (26% of the cases) was associated with increased tumor thickness, high mitotic count, presence of tumor ulceration, and decreased survival. Stratified analyses (univariate and multivariate) with standard microscopic variables indicated the strongest prognostic influence of necrosis in tumors thicker than 4 mm. Notably, in the stratum of pT4 tumors, presence of necrosis was a stronger prognostic predictor than was ulceration. Tumor necrosis was a significant prognostic indicator providing additional information to established predictors of patient outcome in this series of nodular cutaneous melanoma, predominantly among thick tumors (>4 mm). Presence of necrosis was a stronger indicator for worse outcome compared with ulceration in pT4 tumors.