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A RANDOMISED PHASE II STUDY OF SUNITINIB VERSUS DACARBAZINE IN THE TREATMENT OF PATIENTS WITH METASTATIC UVEAL MELANOMA

SUAVE

A RANDOMISED PHASE II STUDY OF SUNITINIB VERSUS DACARBAZINE IN THE TREATMENT OF PATIENTS WITH METASTATIC UVEAL MELANOMA
Funding CRUK & Pfizer
Portfolio Cancer
Interventions Medicine
Randomised Yes
Status Closed
Start Date 04-Oct-2010

Uveal melanoma is the most common primary malignancy involving the eye, but remains rare, with an annual age-adjusted incidence of around 7 per million of the population. Uveal melanoma is characterised by an unpredictable clinical course and a tendency to metastasise late. Even so, overall prognosis is significantly worse than for cutaneous melanoma, with 5 and 15 year survival rates of 72% and 53% respectively. Local control can be achieved using various radiotherapy techniques or enucleation of the affected eye. However once local control is lost, the disease is incurable. No adjuvant therapy has demonstrated any survival benefit. Approximately 5% of patients present with metastatic disease. A further 30-50% develop metastatic disease, usually within 3 years of primary treatment. In metastatic patients, the median survival varies from 2-6 months with only 15% of patients surviving more than a year.
There is no effective systemic therapy for metastatic uveal melanoma. Furthermore, few clinical trials have been conducted and those which have often involve small numbers of patients. The lack of activity noted to date point to an urgent need to investigate novel therapies in this disease.