The EPIC Study: A new era in non-surgical skin cancer treatment

Associate Professor Siddhartha (Sid) Baxi, Radiation Oncologist, Gold Coast

From 2021 to 2023, I had the privilege of participating in the EPIC clinical trial: a multi-centre phase four study evaluating the safety, efficacy, and patient experience of Rhenium-SCT® for treating non-melanoma skin cancers in Australian and international patients.

As we face rising rates of skin cancer and a growing ageing population, there is an increasing need for effective and innovative interventions that can reduce disease and treatment burden. Most non-melanoma skin cancer (NMSC) patients experience multiple lesions in their life, and additionally suffer from significant fatigue from invasive or ineffective therapies.

The EPIC-Skin study highlights the potential of Rhenium-SCT® as a non-invasive, durably effective and well-tolerated alternative. In this article, I share the findings and explore what this could mean for the future of skin cancer care.

The skin cancer burden & surgery fatigue

As many of you know, the burden of NMSCs in Australia is significant. NMSC costs our healthcare system over 1.7 billion dollars annually¹, and unfortunately, two in three Australians are diagnosed with skin cancer in their lifetime².

Surgery remains the mainstay of treatment – but over time, surgery can become difficult. Patients may experience surgical fatigue as they suffer with disfigurement, loss of function, pain, and other complications. There is a need for non-surgical treatments that will allow best cosmesis and functional outcomes for our patients without invasive intervention. 

And so, this is where Rhenium-SCT® is valuable as a treatment option.

Introducing Rhenium-SCT®

Rhenium-SCT®, a novel form of radiation therapy, is a topically administered paste utilising the beta emitting radioisotope of Rhenium-188. The resin or paste comes in a cartridge with an applicator, so you can accurately apply it on the skin cancer. Depending on how much paint you use, how big the lesion is, and how deep you want the treatment to penetrate, you calculate for how long it should be left on to deliver a therapeutic dose of radiation to the skin cancer – generally about 60 to 90 minutes.

The resin is then removed and disposed of, and patients experience a skin reaction similar to that of treatments like topical 5-Flurouracil that occurs between 2-6 weeks after the application. The beta emitted radiation produced by the Rhenium-188 radioisotope delivers a highly potent and effective dose, with 95% of the radiation delivered by 3mm. Importantly, as deeper tissues are spared from additional radiation toxicity, only one treatment is required to achieve a curative dose.

The benefits of Rhenium-SCT®

Rhenium-SCT® is a single-session treatment that is easy to plan, straightforward to apply, and precisely targets the affected area. It’s great for patients who are time-poor, or who live rurally and travel for medical care. It’s especially convenient for elderly patients who can't lie flat and still during conventional therapies. Its versatility means it can be applied in difficult-to-operate areas (e.g. conchal bowl) and where cosmesis is challenging (e.g. nose or lips).

Studies (including the EPIC clinical trial) show an efficacy of 95% and higher. The cosmetic outcomes show excellent to good outcomes in greater than 90% of all evaluations, and there are low complication rates.

A European study by Professor Julia Tietze asked patients, “If future circumstances demanded treatment, would you prefer to be treated with Rhenium-SCT® again or go back to surgery?” and 75% of patients said they would prefer Rhenium-SCT® if they had the option. 

In addition, Rhenium-SCT® can enhance efficiency within hospital systems by enabling faster treatment of more patients in shorter time frames, and with less capital and ongoing costs.

Rhenium-SCT® vs. Conventional radiotherapy

Rhenium-SCT® can be an alternative to conventional radiotherapy, which involves multiple (often daily) treatments over several weeks. While conventional radiotherapy is effective for skin cancers, the process is more involved and requires more complex planning with more hardware, software, and staff. 

Indications for treatment

Rhenium-SCT® is currently indicated for the treatment of basal cell carcinomas and squamous cell carcinomas less than 3mm deep and less than 8cm² in surface area, though larger regions can be considered depending on individual patient suitability.

While small and thin lesions like these have primarily been managed with surgery, now there is another tool in the toolbox for dermatologists, plastic surgeons, and skin cancer GPs, who can consider Rhenium-SCT® as an alternative where surgery is not ideal.

The studies: What the evidence tells us

Rhenium-SCT® is not as new as you might think, as its first publication was in 2008. Seventeen years on, we now have publications out of Europe that are looking at effectiveness, cosmesis, and long-term local control of the cancer – and showing excellent outcomes at 2 to 3 years in various published studies.

The EPIC skin cancer study was designed to look at complete response, comfort of the treatment, quality of life, safety aspects, and cosmetic outcomes as assessed by the patient and the doctor.

In this single arm study, we enrolled 189 patients across 7 treatment centres on the Gold Coast and in Sydney, Perth, and Europe. We performed the treatment on these patients and then followed them up at 6 months, 12 months, and 24 months, and at each point we looked at the response of the tumour, the quality of life the patient reported, and the cosmetic outcomes. Recently we had the pleasure of having the 12-month outcomes published in Advances in Radiation Oncology, and I have included that paper down below.

Of the 189 participants enrolled, the median age was 71.5 years and 37 were from Australia. The study cohort included a mix of patients with basal cell carcinoma (80%), squamous cell carcinoma (18%), and approximately 2% with mixed basal and squamous cell skin cancers.

Majority of cancers were in the head and neck region (67%), which is a complex area for surgery and where Rhenium-SCT® is more likely to be useful as a non-surgical option. Cancers were also on the upper limbs (9%), lower limbs (11%), and the trunk (11%).

Looking at participants’ quality of life, we asked them about their emotional, social, and appearance subscales using a Skin Cancer Index, which is a validated patient-reported outcomes tool. Notably, there were significant and durable improvements across all subscales in the trial participants.

At 12 months, the overall response rate was 97.3% and a complete response rate (i.e. that the tumour has been cured) of ~95%. When we looked at the participants’ acceptability and cosmetic acceptability of the treatment (in a score from 0 – 10; 10 being the best or undetectable), ~80% of participants said 7 or above.

The side effects

• Majority of participants noticed radiation dermatitis in the first few weeks, as expected, however this resolved rapidly.
• At 12 months Grade 2 toxicity rates were mainly induration of 2%.
• At 12 months, Grade 1 telangiectasia was reported in 11.6% of patients, and hypopigmentation in 60.5%.
• Grade 2 induration and ulceration were each observed in 2.3% of patients.

Hypopigmentation is an expected side effect of conventional radiotherapy and Rhenium-SCT®. I advise my patients who are considering Rhenium-SCT® that they may see mild lightening of the skin.

The current state of Rhenium-SCT® in Australia

Rhenium-SCT® is currently available in clinics in Melbourne and on the Gold Coast, and there are further clinics looking to open in Sydney, Newcastle, and Perth. MSAC review is currently underway to consider funding for these treatments for patients, and select health insurers are reimbursing on a case-by-case basis, recognising its utility as a surgical alternative for suitable patients.

As Rhenium-SCT® is a radioactive treatment, it requires a doctor with a radiation license to use it – specifically, radiation oncologists and nuclear medicine physicians. GPs, dermatologists, and plastic surgeons who are interested in this treatment can partner with a local licensed physician (e.g. at your local radiotherapy or nuclear medicine department). This partnership allows skin clinicians to maintain ongoing management of their patient’s care, while still offering access to a new option.

The EPIC study adds to a growing body of evidence supporting Rhenium-SCT® as a safe, effective, and patient-friendly alternative to surgery or conventional radiation therapy for select non-melanoma skin cancers. With high response rates, excellent cosmetic outcomes, and strong patient satisfaction, this treatment offers new hope for those seeking non-invasive options, especially in complex or surgically challenging cases. As access expands and awareness grows, Rhenium-SCT® has the potential to become a valuable addition to the skin cancer treatment landscape in Australia.

Read the published paper in Advances in Radiation Oncology.

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References

1 Gordon LG, Shih S, Watts C, Goldsbury D, Green AC. The economics of skin cancer prevention with implications for Australia and New Zealand: where are we now? Public Health Res Pract. 2022;32(1):e31502119. First published 22 December 2021. Access: https://www.phrp.com.au/issues/march-2022-volume-32-issue-1/skin-cancer-economics/

2 Cancer Council: https://www.cancercouncil.com.au/skin-cancer/about-skin-cancer/#:~:text=About%202%20out%20of%203%20Australians%20will%20be%20diagnosed%20with,for%20non%2Dmelanoma%20skin%20cancers