Latest study demonstrates high efficacy in curing invasive non-melanoma skin cancer
Published: Tietze JK, et al. Clin Nucl Med. 2023;48(10):869–876.
By: OncoBeta GmbH
NMSCs are the most common cancers seen in the European population and their incidence are rising all over the world,2,3 with 7.7 million cases reported globally in 2017.4 In Australia, 2 in 3 people will be diagnosed with skin cancer in their lifetime and this is likely to increase as the population ages.5
Typically, treatment options for NMSCs include surgery, radiation, and cryotherapy. Surgical intervention is currently the most common treatment for invasive tumors, but it can lead to unfavorable cosmetic outcomes for some presentations.6
A team of researchers in Germany, led by dermatologist Professor Julia Tietze, and funded by OncoBeta® GmbH, Germany, investigated the efficacy and safety of topical rhenium-188 ionizing radiation therapy for the treatment of invasive NMSC.
Research lead, Professor Tietze from the University Medical Center, Rostock says, "The study found rhenium skin cancer therapy to be a highly effective treatment for NMSCs, in particular, the cosmetic outcomes on the head and face. The overall conclusion is, while surgery is the gold standard therapy for NMSCs, rhenium skin cancer therapy may be suitable for large tumors, and tumors located on sensitive areas such as nose, ear, or lips; or where surgery would be challenging."
The study involved 22 patients with 40 histologically confirmed NMSCs (57.5% basal cell carcinomas (BCCs), 12.5% cutaneous squamous cell carcinomas (cSCCs), 30% Bowen's disease lesions). Following the rhenium-188 single-session treatment, the response rate, adverse events, and cosmetic outcomes were assessed at 14 days, 4 months, and 12 months.
The key findings included:
"Surgery for the removal of NMCSs has a high clearance rate of 95% after 5 years, however depending on the size and localization of the lesion, treatment may be painful and it may also lead to disfigurement. This study shows the efficacy of rhenium skin cancer therapy demonstrating a 97.5% response rate with 37 of the 39 lesions showing complete response at 12 months," adds Professor Tietze.
The full report and results of the study have been published in the Journal Clinical Nuclear Medicine – available to healthcare professionals via this link: https://bit.ly/
Study Design and Ethics Approval
Patients were eligible if they had a histologically confirmed BCC or cSCC with an area of <5 cm2 and thickness <3 mm, they were least 18 years of age and were not suitable or not willing to undergo surgery due to comorbidities, specific anatomic location or unsuccessful previous surgical procedures. Exclusion criteria included known primary melanoma near the treatment area, they were undergoing treatment for non-resectable or metastatic melanoma (including BRAF- or MEK-Kinase inhibition), they had significant impaired blood circulation in the treatment area or if they were pregnant. Patients were treated once with 188Re resin with a targeted dose of 50 Gy. The response rate (RR), adverse events (AEs) and cosmetic outcome were assessed at 14 days, 4- and 12-months post-treatment.
All procedures performed in this study were in accordance with the 1964 Helsinki declaration and its later amendments. The study was approved by the local Ethical Committee (A2020-0178)
About the Rhenium-SCT®
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.3 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.7
The Rhenium-SCT is a painless*, single session†, non-invasive‡ therapy that provides aesthetic results, even in cases otherwise considered difficult to treat8-10 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs. The Rhenium-SCT is a precise, personalised8,11 therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient's skin and the application is safe and simple for the applying physician. Most cases of NMSCs (basal cell carcinoma, squamous cell carcinoma, Bowen's disease, and Queyrate Erythroplasia)
OncoBeta® with its headquarters located in Garching near Munich, Germany, is a privately held medical device company, specializing in the development and commercialization of state-of-the-
Find out more about the Rhenium-SCT®
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This announcement includes forward-looking statements that involve risks, uncertainties, and other factors, many of which are outside of OncoBeta's control, and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OncoBeta's plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OncoBeta® undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
*No pain reported during procedure.8,10
†Complete tumor regression in 98.5% of lesions treated.9
‡A procedure is considered non-invasive when no break or cut in the skin is created.11