Long-acting octreotide versus placebo for treatment of advanced HCC: A randomized controlled double-blind study

Abstract

Although numerous treatment modalities have been explored in patients with advanced HCC, the therapeutic options are still limited. Somatostatin has been shown to have antimitotic activity in endocrine as well as in a variety of nonendocrine tumors. Expression of somatostatin receptors is found in HCCs, but the efficacy of the somatostatin analogue octreotide remains controversial. Therefore, a randomized double-blind placebo-controlled multicenter trial was performed to assess the efficacy of long-acting octreotide for the treatment of advanced HCC. One hundred twenty untreated patients with histologically confirmed HCC were randomized to receive either long-acting octreotide (Sandostation LAR 30 mg) intramuscularly every 4 weeks or placebo. The study groups were comparable with respect to clinical characteristics. There was no difference in the cumulative survival. The median survival time was 4.7 months in the octreotide group compared with 5.3 months in the control group. Six-month survival rates were 41% for octreotide patients and 42% for control patients, respectively. The unadjusted relative risk for mortality in the octreotide group compared with patients in the control group was 1.11 (95% CI 0.76-1.63; P ‫؍‬ 0.59). When adjusted for Okuda, CTP, and Cancer of the Liver Italian Program (CLIP) scores, the relative risk for octreotide did not change markedly and was 1.05 (95% CI 0.71-1.55; P ‫؍‬ 0.83). The CLIP score seems to predict survival better than both Okuda and CTP score. Conclusion:The randomized controlled double-blind HECTOR trial showed no survival benefit for HCC patients treated with long-acting octreotide compared with placebo.

Hepatocellular carcinoma (HCC): beyond sorafenib—chemotherapy

“…Initial early phase studied demonstrated modest clinical activity of these agents. However, subsequent randomized trials failed to show antitumor activity of hormonal therapy (53)(54)(55)(56)(57)(58)(59). Based on in vitro data demonstrating tamoxifen can reverse multidrug resistance in human cancer cells (60), the combination of tamoxifen and chemotherapy such as doxorubicin was investigated in patients with advanced HCC which highly expresses multidrug resistance gene, MDR-1.…”

Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study

“…Octreotide was previously used in HCC patients with conflicting results (14)(15)(16)(17)(18)(19)(20)(21). We showed, in a previous study, that combination of octreotide and radiofrequency ablation 6 produced about 80.0% of disease control and interesting mean overall survival (31.4 months) in a series of advanced HCC patients (22).…”

Inhibition of early preneoplastic events in the rat liver by the somatostatin analog lanreotide

“…They have shown antitumoral effects in liver cancer cell lines in vitro (18)(19)(20)(21) and in in vivo animal models (22) but showed conflicting results in clinical trials on humans with advanced cancer. (23)(24)(25)(26)(27) Lanreotide has not been tested in a prophylactic setting.In this study, we aimed to evaluate the effects of lanreotide on the early carcinogenic events induced by a two-stage initiation/ promotion model of hepatocarcinogenesis in rats. We studied its effects after initiation by DEN, and after initiation/promotion induced by DEN and AAF, on the formation of preneoplastic foci both in terms of number and size.…”