Octreotide alone or in combination with rofecoxib as palliative treatment for advanced hepatocellular cancer.

BACKGROUND

Median survival for advanced hepatocellular carcinoma (HCC) is around 3 months. Previous octreotide-based treatment studies revealed conflicting results.

AIMS AND METHODS

To determine whether palliative treatment for HCC is beneficial in terms of survival and quality of life (primary outcome measures). Patients were prospectively randomised to receive open-label octreotide 30 mg monthly alone (n = 39) or in combination with rofecoxib (up to 50 mg bid daily, n = 32) for a minimum of six months, or until death occurred.

RESULTS

Median overall survival (154 days) and time to progression (94 days) were similar for both treatments and within the range of published trials for octreotide, while adding rofecoxib to octreotide did not alter overall survival (149 vs. 155 days, p = 0.849). Treatment-associated clinical benefit was seen in 16/71 patients (3 patients with partial remissions and 13 with stable disease). Delay in tumor progression was associated with prolonged median survival (p < 0.0001) and a better quality of life (p < 0.05). Moreover, survival outcome was associated with a CLIP score < 3, extent of portal vein infiltration, well-differentiated tumor histology, prothrombin time, alkaline phosphatase, bilirubin, serum ferritin, and gamma-glutamyltransferase (p < 0.01 each).

DISCUSSION

Rofecoxib added to octreotide treatment did not improve survival over octreotide treatment alone. Octreotide treatment, although without major side effects, cannot be recommended in general as monotherapy, unless the few patients responding can better be characterised. There may still be a role for combining octreotide with other emerging targeted therapies because of potentially synergistic modes of action.