A Multicenter Prospective Trial of Electronic Skin Surface Brachytherapy for Keratinocyte Carcinoma: Early Cosmesis, Quality of Life, and Adverse Events

Abstract

Purpose: Keratinocyte carcinomas are amenable to many treatments, including radiation therapy (RT). Electronic skin surface brachytherapy (ESSB) enables the precise delivery of radiation without radioisotopes. In this prospective multicenter clinical trial, we characterized early outcomes of ESSB prospectively through both patient- and clinician-reported measures. To corroborate the cosmesis observations, we also assessed patient-reported quality of life (QoL) and adverse events.

Methods and materials: Patients ≥60 years old with stage T₁N₀M₀ keratinocyte carcinoma were treated with ESSB. At 2-, 6-, and 12-weeks post-treatment, cosmesis from ESSB was assessed by both the patient and a clinician study investigator as either "good," "fair," or "bad." The Skindex-16 and the Skin Cancer Index (SCI) were used to assess patient QoL before and after treatment. Adverse events were assessed using the Common Toxicity Criteria for Adverse Events, version 4.0.

Results: Cosmesis and QoL were collected at 97% (99/102) of possible patient follow-up times. By 12 weeks post-treatment, 93.9% (31/33) of patient-reported and 96.9% (31/32) of clinician-reported cosmesis outcomes were "good." Compared with baseline, total Skindex-16 score significantly deteriorated at 2 weeks post-treatment (10.5 vs 24.5, P <.001), but significantly improved at 6 weeks (10.5 vs 4.7, P = .014) and 12 weeks (10.5 vs 2.1, P = .001) post-treatment. The total SCI score significantly improved from baseline to 6 weeks (78.4 vs 89.0, P = .001) post-treatment. The most frequent adverse events were radiation dermatitis, skin pain, and pruritus. All adverse events resolved to Grade ≤1 by 12 weeks post-treatment.

Conclusions: This prospective, multicenter study demonstrated that ESSB is associated with a high rate of "good" early patient-reported cosmesis and increasing QoL and satisfaction with time. Validated assessments demonstrated a significant improvement in quality of life and resolution of moderate early adverse events by 6 to 12 weeks after treatment and corroborate the observation of favorable cosmesis.

Figure 1.

A patient treated with ESSB at pre-treatment and 2, 6, and 12 weeks post-treatment.

Figure 2.

Patient and clinician assessed cosmesis over time.

Figure 3.

Plots of adverse events graded using CTCAE, version 4.0, over time. No skin atrophy was reported at any time point.

Figure 4.

Patient satisfaction over time.