Clinical Trials in Skin Cancer at the CRCTU

Dr Joshua Savage (@joshsavage)

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About 115,000 people are diagnosed with skin cancer every year in the UK. The majority of these cases are the non-melanoma types of disease, such as basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), although there are rarer sub-types of the disease. Despite being very common, non-melanomas are less life threatening and are often successfully treated if caught early, which is more achievable compared to other cancers due to the visibility and palpable nature of skin cancer.

Around 13,000 patients have the more serious, and often more aggressive, malignant melanoma which results in over 2000 deaths per year. In the last 30 years, the rate of malignant melanoma has risen faster than any of the other 10 most common cancers, and its incidence is disproportionately higher in younger people compared to other cancers, with a 1/3 of cases being in people under 55. As with all cancers, there are many risk factors involved in the development of the disease but sun exposure is thought to be the main cause, with most lesions occurring on sun exposed areas of skin. Genetics, namely skin colour, and a history of sunburn and the use of sunbeds also increase the risk of the disease.

There have been great improvements in the treatment of malignant melanoma in the last 30 years, with 5 year survival now at 84% for men and 92% for women. These patients are usually treated with surgery then a combination of radiotherapy and chemotherapy. Earlier this month, very promising results were presented at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago and widely covered in the media, for a “ground-breaking” new immunotherapy by pharmaceutical company Merck, called MK-3475, or more commonly known as pembrolizumab. This drug works by targeting PD-1, or Programmed Death receptor, a protein used by cancer cells to avoid detection by the immune system. This is one of several drugs in a new class of treatments called ‘immune checkpoint blockers’, that ‘modulate’ the immune system allowing the body’s own defences to combat the disease in a more targeted manner than conventional chemotherapy that non-discriminately kills rapidly dividing cells. Currently, 1 year survival for advanced melanoma is 10% for men and 35% for women; encouragingly, 70% of patients on pembrolizumab were still alive after 1 year. These exciting developments are welcome news that will hopefully result in new treatments and a change in standard care for this group of patients who previously had a very poor prognosis.

At the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham, we have a growing portfolio of skin cancer trials. UKMCC-01, is a phase II study using pazopanib to treat patients with metastatic merkel cell carcinoma (MCC), a very rare (400 patients per year in UK) and aggressive form of non-melanoma cancer with a poor prognosis after first line treatment. Pazopanib is currently licensed in the UK to treat advanced renal cell carcinoma and works by targeting platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) receptors, amongst other targets, both which have been shown to be mutated or over-expressed in MCC tumours.

We will also soon be opening another phase II trial called SPOT; Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments. SPOT aims to prevent the development of cutaneous SCC from actinic keratoses, asymptomatic red scaly lesions on sun exposed areas of the skin, which are generally regarded as precursors to cSCC. This feasibility study will examine how patients cope with two different topical treatments, 5-fluorouracil and imiquimod versus standard care (sunscreen). SPOT will observe this in a sub-set of patients who have received organ transplants and are taking immunosuppressive medication to prevent organ rejection. These patients have previously been shown to have a much higher incidence of cSCC and other cancers, which once again demonstrates the vital role that the immune system plays in combatting cancer.

Researchers at the CRCTU are working with colleagues across the science and research community to maximise on developments and ensure they reach patients rapidly and change the course of this devastating disease. Novel treatments along with early diagnosis and prevention are key to changing the course of this cancer, Justine a survivor of skin cancer reminds us why we must continue with this plight.

Dr Joshua Savage is a Trial Coordinator at Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham. Follow Dr Savage on Twitter @joshsavage

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