Clinical Study Overview
Published Research on the Use of Image-Guided Superficial Radiation Therapy (Image-Guided SRT) in the Treatment of Nonmelanoma Skin Cancer (NMSC)
See the clinical research supporting the safety and efficacy of surgery-free GentleCure (Image-Guided SRT) in the treatment of basal cell and squamous cell skin cancers.
McClure E, et al. Adv Radiat Oncol. 2024.
Retrospective cohort study (looking back at patients’ medical records) to determine the 2-year freedom from recurrence rate of 2880 NMSCs (basal cell, squamous cell, and squamous cell in situ) that were treated with Image-Guided SRT, and comparing it to recurrence rates in pooled data from 2 studies in which 5615 NMSCs were treated with non-image-guided SRT
NMSCs treated with Image-Guided SRT had a 99.2% 2-year freedom from recurrence rate, which was shown to be significantly better than the 2-year recurrence rate for NMSCs treated with non-image-guided SRT (0.7% vs 5.8%, respectively; p<.001)
IGSRT offers statistically significantly improved outcomes compared to standard SRT, and a more desirable toxicity profile to surgical options…IGSRT is associated with remarkably low recurrence rates…in line with modern outcomes for Mohs micrographic surgery.
McClure E, et al. Clin Transl Radiat Oncol. 2023;43:1-5.
A retrospective cohort study (looking back at patients’ medical records) to see the likelihood of the skin cancer returning within 2 years after treatment with Image-Guided SRT (2286 early stage skin cancers treated) or Mohs surgery (5391 early stage skin cancers treated)
Results showed that people treated with Image-Guided SRT had significantly lower rates of skin cancer recurrence compared to those treated with Mohs surgery.
There is a statistically significant improvement in 2-year recurrence probabilities of NMSCs when treated primarily with IG-SRT compared to MMS. This suggests that IG-SRT should become a first-line recommendation for patients with early stage NMSCs like BCCs, and SCCs…
Tran A, et al. J Cancer Res Clin Oncol. 2023.
Retrospective chart review (looking back at patients’ medical records) was conducted to evaluate the cure rates of 1243 people with 1899 stage 0-II NMSC (basal cell, squamous cell, and squamous cell in situ) who received treatment with Image-Guided SRT energies ranging from 50 to 100 kV, for a mean of 20.2 fractions, and treatment dose of 5364.4 cGy
After an average of 7.5 weeks of treatment with Image-Guided SRT, 99.7% of people showed no signs of skin cancer in the treated area, and 95% of people continued to show no signs of skin cancer at the 5-year follow-up visit.
Image-Guided SRT has a high safety profile, can achieve superior cosmesis and should be considered first-line for treating early-stage NMSC tumors as cure rates have been shown to be effective in all NMSC on early follow-up…making it a safe, and potentially cost-effective, option for NMSC treatment compared to surgery.
Yu L, et all. BMC Cancer. 2023;23(1):98.
Logistic regression analysis (a way to understand and predict how different treatments might influence a result or outcome) that compared the cure rates by skin cancer subtype (basal cell, squamous cell, and squamous cell in situ) from 4 studies of people treated with non-image-guided radiotherapies to 1 study of people treated with Image-Guided SRT
When the studies were compared individually and all together, Image-Guided SRT was shown to deliver statistically superior cure rates across basal cell, squamous cell, and squamous cell in situ skin cancers compared with traditional, non-image-guided radiotherapies.
Image guidance with high resolution dermal ultrasound in the form of US-SRT [Image-Guided SRT] is shown to confer a statistically significant advantage in lesion local control over non–image-guided forms of SRT or XRT [electron beam therapy and superficial radiation therapy] in all subtypes of cutaneous epithelial NMSC and should be considered the preferred standard of non-surgical treatment for early-stage cutaneous BCC, SCC, and SCCIS.
Tran A, Yu L. J Dermaol Skin Sci. 2022;4(4):6-8.
Review of the evidence supporting the potential for IG-SRT to improve access to skin cancer treatment in poor and rural communities
- Skin cancer is the most common cancer in the United States, with incidence rates of melanoma and NMSC on the rise
- Reduced access to cancer treatment and long travel times may contribute to poor outcomes for patients in non-metropolitan counties
- Collaboration across care providers can address disparities in access to oncodermatologic care (dermatologists, surgeons, otolaryngologists, radiation oncologists, and radiation therapists)
- With favorable clinical and cosmetic outcomes, tolerable side effects, and flexibility in treatment administration locations, IG-SRT may help improve access to skin cancer treatment in poor and rural communities
The use of modern superficial radiation therapy might address disparities in dermatologic care.
Yu L, et al. Discov Oncol. 2022;13(1):129.
Meta analysis (combining information from different studies to find a common pattern) that compared the cure rates from 2 studies of people with NMSC who were treated with Image-Guided SRT with the cure rates from 4 studies of people who were treated with non-image-guided radiotherapies, including electron beam radiation and superficial radiation therapy
Cure rates for people treated with Image-Guided SRT were shown to be statistically superior to the cure rates for those treated with non-image-guided radiotherapies when the studies were compared individually and all together.
US-SRT [Image-Guided SRT] is statistically superior to non–image-guided radiotherapies for NMSC treatment. This modality may represent the future standard of non-surgical treatment for early-stage NMSC.
Yu L, et al. Oncol Ther. 2021;9(1):153-166.
Retrospective chart review (looking back at patients’ medical records) that evaluated the cure rates of 1632 people with 2917 stage 0-II skin cancers who were treated with GentleCure (Image-Guided SRT)
Results showed that GentleCure (Image-Guided SRT) delivered a 99.3% cure rate and should be considered a first-line treatment option for basal cell and squamous cell skin cancers.
Cure rates observed in this initial period of follow-up are similar, and potentially superior with further follow-up, to traditional SRT and surgical options.
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