Uveal melanoma is the most common primary intraocular malignancy in adults. Despite
successful control of the primary tumor, metastatic disease will ultimately develop in
approximately 50% of the patients. The liver is the most common site for metastases, and
about 50% of the patients will have isolated liver metastases. These metastases are
generally refractory to systemic chemotherapy and the median survival for patients with
liver metastases is about 6 months. Regardless of treatment, the mortality rate is
approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.
Isolated hepatic perfusion (IHP) is a regional treatment that was first performed more than
40 years ago (Aust and Ausman 1960). During IHP, the liver is completely isolated from the
systemic circulation, allowing a high concentration of chemotherapy to be perfused through
the liver with minimal systemic exposure. In a previous study from our institution, IHP was
analysed based on improvements in the procedure and the results showed an improved outcome
together with minimized morbidity and mortality over time.
A phase II follow-up study confirms that IHP is a promising technique with tolerable
morbidity. There are yet no randomized trials comparing overall survival in IHP, but in an
attempt to answer this question the investigators did a register study showing a 14 months
increased survival when comparing the patients treated with IHP with the longest surviving
patients in Sweden during the same time period.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
OS defined as the frequency of individuals alive at 24 months
Roger Olofsson, Dr
Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Sweden: Regional Ethical Review Board