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.
Agha R, et al. J Clin Med. 2024;13(5835). doi:10.3390/jcm13195835
Large, retrospective cohort study (looking back at patients’ medical records) to determine the effect of risk factors (tumor location, tumor stage, and patient sex) on 2-, 4-, and 6-year freedom from recurrence rates in 19,988 NMSC lesions treated with Image-Guided SRT (IGSRT), including lesions with complete treatment courses.
Overall freedom from recurrence rates for lesions treated with Image-Guided SRT were 99.68% at 2 years, 99.54% at 4 years, and 99.54% at 6 years. Rates did not differ significantly by tumor location (head/neck versus other locations, p=0.9) or sex (male versus female, p=0.4). Although significant differences were seen by tumor stage (p=0.004), the freedom from recurrence rates exceeded 99% for patients with tumors of all stages.
These results suggest that IGSRT is a viable first-line therapeutic option for patients diagnosed with early-stage high- and low-risk NMSC.
Farber AS, et al. Geriatrics. 2024;9(5):114-127. doi:10.3390/geriatrics9050114
Retrospective cohort study (looking back at patients’ medical records) to determine the freedom from recurrence rates at year 2, 4, and 6 post-treatment in patients ≥65 years (16,911 lesions) vs <65 years (3158 lesions) with nonmelanoma skin cancers (NMSC) treated with guideline-directed image-guided superficial radiation therapy (IGSRT).
IGSRT demonstrated a freedom from recurrence rate >99.5% at 2, 4, and 6 years post-treatment, regardless of age or gender. Patients ≥65 years did demonstrate a difference in freedom from recurrence rates when stratified by stage at 2, 4, and 6 years, with slightly poorer outcomes seen in patients with stage 2 NMSC.
These findings demonstrate that IGSRT is a viable therapeutic option for patients with NMSC regardless of patient age, sex, or stage, and bolster previous findings that IGSRT demonstrates excellent local tumor control and absolute lesion control and superior recurrence rates in this cohort relative to traditional SRT and historical rates of MMS.
Stricker JB, et al. Dermato. 2024;4:86-96. doi:10.3390/dermato4030010
Retrospective chart review (looking ack at patients’ medical records) of 883 patients with 1507 NMSC treated at 7 dermatology practices with IG-SRT showed 92% of NMSC lesions had daily depth fluctuations, with nearly 40% of lesions requiring at least one change during treatment.
Full dermal visualizations via high-resolution dermal ultrasound imaging informs providers of when adaptive changes in energy (kV), time dose fractionation, and dose are needed to optimize efficacy and minimize toxicity.
Full dermal visualization of the constantly changing NMSC tumor depth throughout therapy allows the dermatologist and radiation therapist to make compensatory adjustments in real time…the first time in history that dermatologists and radiation therapists have been able to visualize the reactive changes that BCC and SCC undergo during radiation therapy.
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.
GentleCure / Image-Guided SRT is most commonly provided to people with various types of basal or squamous cell skin cancers that have not spread to other parts of the body. People with more advanced stages of skin cancer like stage 3 or 4 may not qualify for this type of treatment. To confirm you are a candidate, fill out our treatment questionnaire or visit a dermatologist that offers Image-Guided SRT.
Image-Guided SRT can treat several skin cancer lesions. For people with multiple skin cancers, this treatment may save them additional downtime from surgical scaring and surgical wound care healing.
GentleCure / Image-Guided SRT can be used to treat any skin area on the body. Areas that are more visible such as face, nose, ears, near eyes, and lips are more more likely to benefit from the cosmetic benefits of Image-Guided SRT treatment, instead of Mohs surgery. The procedure does not result in cutting, surgical scaring, or reconstructive therapy, or limit your physical activity.
Ultasound imaging is used to track treatment progress.
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