研究目的
To confirm the clinical efficacy, toxicity and cosmesis of a new EBT system, namely Esteya? in the treatment of nodular and superficial basal cell carcinoma (BCC).
研究成果
For nodular and superficial BCC, EBT with Esteya? is an effective, simple, safe, and comfortable treatment associated with excellent cosmesis. It is a good treatment alternative for elderly patients, patients who do not want surgery, patients with multiple cancerous lesions, patients with contraindications for surgery (due to comorbidities or anticoagulant drugs) or patients where surgery would result in a more disfiguring outcome. A longer follow-up and more studies are needed to confirm these preliminary results.
研究不足
Only a limited number of patients have been included. As it was a phase II study to assess safety and efficacy, the technique was not compared with other treatments. The short follow up is insufficient to assess efficacy.
1：Experimental Design and Method Selection:
A prospective single-center, non-randomized pilot study to assess the efficacy and safety of EBT in nodular and superficial BCC using the Esteya? system.
2：Sample Selection and Data Sources:
Twenty patients with 23 lesions were included. The study was conducted from June 2014 to February
3：List of Experimental Equipment and Materials:
20 Esteya? EBT system with a
4：5 kV X-ray source and aluminum flattening filter, applicators of different diameters (10 mm, 15 mm, 20 mm, 25 mm, and 30 mm). Experimental Procedures and Operational Workflow:
Treatment was delivered twice weekly with at least 48 hours between each fraction, total dose was 42 Gy divided in 6 fractions of 7 Gy.
5：Data Analysis Methods:
Data are reported as mean ± standard deviation. Categorical variables are presented as proportions. Differences between groups were determined using the Fisher exact test. Statistical analysis was performed with SPSS Statistics 18?.
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