Is it the biggest dermatological challenge for Australians?
Is it the biggest dermatological challenge for Australians?
Despite advances in cutaneous oncology, skin cancer remains one of Australia’s biggest dermatological challenges – with nearly 1 in 3 Australians living with skin cancer1 and over 2 in 3 likely to be diagnosed with it before retirement age.2
Non-melanoma skin cancer (NMSC) – primarily basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is the most commonly diagnosed cancer in Australia.2,3 Most cancer registries do not include information on the incidence of BCC or SCC which means their real frequency remains largely unknown.2,4 Physicians, however, are very aware of high NMSC occurrence rates – with an estimated 86% of Australians presenting to their general practitioner (GP) each year5 and Medicare treatment services equating to over 3,000 treatments per day.2
Surgery is still the most commonly used treatment, but is invasive, with the potential for reconstructive surgery.6 While curing the patient is the ultimate goal, clinicians also need to consider the importance of retaining aesthetics, functionality and quality of life when deciding which treatment modality to use4 – and be aware of options that now offer patients tailored treatments with less anxiety.
To take care of patients and to enhance their quality of life, consider alternative options that are painless and offer excellent aesthetic results.
The NMSC patient
UV-radiation (UVR) plays a major role in the development of NMSCs, with exposure to solar UVR the major environmental risk factor for both BCC and SCC.7 Consequently, NMSCs are predominantly seen on skin areas most frequently exposed to the sun, such as the face, scalp, back and hands.4,6 Age is another leading risk factor and, given the increases in the ageing population, NMSC incidence rates are only likely to increase in the future.1
BCC rarely metastasises but frequently shows local invasion and tissue destruction.8
SCC is more aggressive and quickly metastasises to regional lymph nodes as compared to BCC.8
Treatment options
Determining the appropriate treatment option for each patient can be challenging and depends on a number of factors including size and site of the lesion, the number of lesions, patient history and co-morbidities – plus patient preferences.
Surgical removal
Surgery is currently considered the gold standard for treating NMSCs, with most being managed by simple surgical procedures.9 Other more complex techniques are used for high-risk or difficult-to-treat lesions. For example, Mohs micrographic surgery is considered a good option for primary NMSCs due to its favourable 5-year cure rate of over 95% with BCC and SCC.6
Surgical removal has the advantage of providing a complete sample for both histologic diagnosis and confirmation of adequate excision.9 However, it may have limited utility in cases where it can be technically difficult to obtain optimum results that do not affect functionality or aesthetics, such as large or multiple lesions in areas such as the face, genitalia or fingers.6
Non-surgical therapies
There are a range of non-surgical treatment options available for NMSCs, including:
- Topical therapies (such as 5% imiquimod and 5% fluorouracil) are usually considered in selected patients with low-risk BCCs or where surgery is declined or contraindicated (imiquimod),10 for the treatment of actinic keratosis (precursors to SCC) and in situ SCC (fluorouracil).5,11 Problems can arise as creams need to be applied regularly by patients over a period of weeks and can cause an intense inflammatory reaction.5
- Cryotherapy is considered an option for low-risk BCCs, or multiple BCCs on extra-facial areas, actinic keratosis or SCCs with well-defined edges in older or disabled patients.10,12,13 However, because of tissue destruction, no histologic margin assessment is possible.10
- Curettage and electrodesiccation are options for low-risk primary BCCs, superficial low-risk SCC and areas of in situ SCC.10,13 Like cryotherapy, this option does not permit histologic examination and it is not usually recommended for high-risk or recurrent tumours or lesions larger than 2cm in diameter.13
- Photodynamic therapy (PDT) utilising photosensitising agents such as methyl aminolevulinate can be considered in patients with non-aggressive, low-risk BCC where surgery is not suitable or contraindicated because of patient-related limitations, as well as recurrent small and large BCCs.10 PDT has been used as an adjunct therapy to curettage and surgery for invasive SCC in high-risk patients.12 PDT can be painful – with pain being the most frequent and limiting side effect of conventional PDT.14
- Radiation therapy is used when surgery is not feasible, contraindicated, or not preferred by the patient. Several different types of radiotherapy exist, including superficial radiation therapy, isotope-based brachytherapy (interstitial or topical contact) and external electron beam radiation.10,13 Multiple sessions are required with the totalradiation dose given in smaller doses or fractions (dependent on radiation modalities and lesion characteristics).10
Epidermal radioisotope therapy
The challenges for radioisotope therapy have been to find a way to:
- confine the radiation exposure to only the lesion – so surrounding tissues are not adversely affected, and
- perform the treatment in a single session – improving the patient experience and reducing hospital/clinic times for both the patient and clinician.
Epidermal radioisotope therapy has emerged as a flexible, personalised approach to NMSC treatment. It uses a paste form of radioactive β particles for the targeted treatment of superficial skin cancers – using the localised and direct cell-killing effect of β-radiation to trigger the death of cancer cells.15
Rhenium-SCT® (Skin Cancer Therapy), by OncoBeta, is a new tailored epidermal radioisotope treatment option that brings the radioactivity as close as possible to the surface of the lesion independent of its three dimensional shape and size.6
Treating NMSC with Rhenium-SCT®
Rhenium-SCT® is the only therapy that targets NMSC lesions with non-invasive high-dose rhenium-188 radioisotope. For patients with BCC or SCC, Rhenium-SCT® offers a painless (no reported pain), single-session and non-invasive alternative with optimal aesthetic outcomes.6,15,16
- Rhenium-SCT® uses a custom applicator to apply a paste containing rhenium-188 to the surface area of the NMSC lesion, which has been covered with a sterile foil, conforming to the unique shape and dimensions of each lesion, and avoiding direct contact with the skin.6,15
- The therapy delivers conformal radiotherapy tailored to the shape of the tumour, while sparing the surrounding normal tissue.17 The β-radiation of rhenium-188 penetrates up to 3 mm, allowing underlying tissues to be spared15 – making it ideal for treating mucous tissues, sparing ear cartilage and avoiding irradiation of the eyelids.18,19
Rhenium-SCT®: preparing the patient, cleansing and defining treatment area.
Rhenium-SCT®: applying paste containing the rhenium-188 to the treatment area.
Rhenium-SCT®: removal of foil post-treatment.
To date, six studies have investigated Rhenium-SCT® for the treatment of BCC, SCC, extramammary Paget’s disease (EMPD), Bowen’s disease, and SCC of the penis (SCCP) – providing clinical evidence that it is an effective, rapid, safe, painless treatment mostly performed in a single therapeutic session, regardless of the shape complexity, anatomical site and number of lesions.6,15,16,18-21
- Treatment is non-invasive and does not require hospitalisation.6,15
- Multiple lesions may be treated in a single session.15,21
- One session typically takes between 45 to 180 minutes and most patients only require one treatment session to achieve remission.6,15
- To date, there are no long-term side effects.6,15,21 Post-treatment side effects (including radiation wound) were quickly resolved and, where needed, easily managed with topical treatments.6,15,18,21 All side effects have resolved within weeks of treatment.6,21
BCC prior to treatment.
25 days after a single Rhenium-SCT® treatment session.
Rhenium-SCT® is considered an effective, rapid, painless treatment mostly performed in a single therapeutic session, regardless of the shape complexity, anatomical site and number of lesions.15
Rhenium-SCT® international phase IV clinical study
Australian patients were the first to be treated with Rhenium-SCT® as part of the global phase IV EPIC-Skin study (Efficacy of Personalised Irradiation with Rhenium-SCT – for the treatment of non-melanoma skin cancer).
This international study was conducted through centres located in Australia, Austria, Germany, the United Kingdom and South Africa, with patient progress followed over a 24-month period. Australia hosted multiple study centres in selected capital cities, with trial patients being treated at Gold Coast’s John Flynn Private Hospital, Perth’s Hollywood Private Hospital and Sydney’s Royal North Shore Hospital.
The aim of the study is to further evaluate the efficacy of Rhenium-SCT® as well as important patient reported outcome measures such as quality of life, treatment comfort and cosmetic outcomes. Patients in the study utilised a specifically developed clinical study app, which provided a simple and streamlined way to record their experiences.
International Registry for NMSC
OncoBeta® has also launched the International Registry for NMSC (via specialist health solutions partner, Avion Medical) that enables real-world patient data to be collected and reviewed in order to ascertain optimal methods of treating NMSC and for these to be applied internationally.
The registry is not just for Rhenium-SCT® patients – it is an observational, multicentre, international, non-interventional program that registers patients diagnosed with NMSC treated with surgery, radiotherapy or Rhenium-SCT® to monitor treatment outcomes and patterns of care at international hospitals.
- The registry gives the patient the opportunity to contribute feedback and record experiences via the WeBe mobile app.
- The registry allows the international physician community to be part of a credible project and a robust platform to share useful long-term data.
Together, the EPIC-Skin study and the International Registry for NMSC presents an important opportunity for the international medical community to better understand NMSC treatment, and to further evaluate this new non-invasive epidermal radioisotope therapy.
For more information about Rhenium-SCT® contact OncoBeta via email: info@oncobeta.com or visit the website: www.oncobeta.com
This information is intended for Health Professionals use only.
References:
1. Cancer Council Australia. Skin Cancer Statistics and Issues. Skin cancer incidence and mortality [online]. Last updated 17 May 2022. Available at: https://wiki.cancer.org.au/skincancerstats_mw/index.php?title=Skin_cancer_incidence_and_mortality&oldid=797 (accessed June 2022).
2. Staples MP, et al. Non-melanoma skin cancer in Australia: the 2002 national survey and trends since 1985. Med J Aust. 2006;184(1):6-10.
3. International Agency for Research on Cancer. Data source: GLOBOCAN 2020. Graph production: Global Cancer Observatory. https://gco.iarc.fr/ (accessed June 2022).
4. Khong J, Gorayski P, Roos D. Non-melanoma skin cancer in general practice: Radiotherapy is an effective treatment option. Aust J Gen Pract. 2020;49(8):496-9.
5. Clarke P. Nonmelanoma skin cancers Treatment options. Aus Fam Phys. 2012;41(7):476-80.
6. Castellucci P, et al. High dose brachytherapy with non sealed 188Re (rhenium) resin in patients with non-melanoma skin cancers (NMSCs): single center preliminary results. Eur J Nucl Med Mol Imaging. 2021;48(5):1511-21.
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8. Khan NH, et al. Skin cancer biology and barriers to treatment: Recent applications of polymeric micro/nanostructures. J Adv Res. 2021;36:223-47.
9. Callan P, et al. Clinical practice guidelines for keratinocyte carcinoma: Surgical treatment. Cancer Council Australia. Last modified 25 November 2019. Available from: https://wiki.cancer.org.au/australia/Guidelines:Keratinocyte_carcinoma/Surgical_treatment (accessed July 2022).
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11. Cancer Council Australia. Clinical Guidelines. 10.1 The role of topical treatments in the treatment keratinocyte cancer [online]. Last updated 25 November 2019. Available at: https://wiki.cancer.org.au/australia/Clinical_question:Topical_treatments (accessed August 2022).
12. Work Group; Invited Reviewers, Kim JYS, et al. Guidelines of care for the management of cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2018;78(3):560-78.
13. Potenza C, et al. A Review of the Literature of Surgical and Nonsurgical Treatments of Invasive Squamous Cells Carcinoma. Biomed Res Int. 2018;2018:9489163.
14. Borgia F, et al. Early and Late Onset Side Effects of Photodynamic Therapy. Biomedicines. 2018;6(1):12.
15. Cipriani C, et al. Personalized irradiation therapy for NMSC by rhenium-188 skin cancer therapy: a long-term retrospective study. J Dermatolog Treat. 2020;33(2):969-75.
16. Cipriani C, et al. Epidermal Radionuclide Therapy – Dermatological High-Dose-Rate. Brachytherapy for the Treatment of Basal and Squamous Cell Carcinoma. In: Therapeutic Nuclear Medicine, editor Baum RP; New York: Springer, 2014.
17. Kemikler G. History of Brachytherapy. Turk J. Oncol. 2019;34(Supp 1):1-10.
18. Carrozzo AM, et al. Dermo Beta Brachytherapy with 188Re in extramammary Paget’s disease. G Ital Dermatol Venereol. 2014;149(1):115-21.
19. Carrozzo AM, et al. Dermo beta brachytherapy with 188-Re in squamous cell carcinoma of the penis: a new therapy. Eur J Dermatol. 2013;23(2):183-8.
20. Sedda AF, et al. Dermatological high-dose-rate brachytherapy for the treatment of basal and squamous cell carcinoma. Clin Exp Dermatol. 2008;33(6):745-9.
21. Cipriani C, et al. Personalized High-Dose-Rate Brachytherapy with Non-Sealed Rhenium-188 in Non-Melanoma Skin Cancer. Int J Nuclear Med. 2017;July:114-12.
