OBJECTIVE: To evaluate the effect of tamoxifen (TAM) combined with a somatostatin analogue, octretide (OCT) on advanced liver cancer and whether tamoxifen combined with OCT is superior to regular chemotherapeutic agents 5-Fu and mitomycin C (MMC). METHODS:Thirty-nine patients with inoperable liver cancer were randomly subdivided into TAM+OCT group (n=24) and regular chemotherapeutic group (n=15). They received treatment for three months respectively. Blood cell count, liver function, immunologic function, blood alpha-FP was regularly measured. Liver lump and extrahepatic metastasis were examined by CT. The patients were followed up after treatment and conducted survival analysis. RESULTS: In the TAM+OCT group, complete response is 4 patients, partial response is 7 patients, no change is 9 patients and progressive disease is 4 patients; blood level of ALT and AST had no noticeable change, IgE and IgG increased (P<0.01), and alpha-FP lowered (P<0.05). In regular chemotherapeutic group, no change is 4 patients and progressive disease is 11 patients. There was conspicuous statistical difference in the two groups. The accumulative survival rates of 6 months, 1 year and 2 years were 95.7% vs 41.2% (P<0.01), 63.7% vs 21.1% (P<0.01), 25.4% vs 0 (P<0.01), respectively. Medium survival time was 12.8 months in TAM+OCT group and 5.5 months in chemotherapeutic group. CONCLUSIONS:TAM+OCT excerts reliable therapeutic effect on patients with inoperable ER(+) hepatocellular cancer. It is superior to 5-Fu and MMC in increasing the survival rate, prolonging survival time, and reducing side-effects.
RCT Entities:
OBJECTIVE: To evaluate the effect of tamoxifen (TAM) combined with a somatostatin analogue, octretide (OCT) on advanced liver cancer and whether tamoxifen combined with OCT is superior to regular chemotherapeutic agents 5-Fu and mitomycin C (MMC). METHODS: Thirty-nine patients with inoperable liver cancer were randomly subdivided into TAM+OCT group (n=24) and regular chemotherapeutic group (n=15). They received treatment for three months respectively. Blood cell count, liver function, immunologic function, blood alpha-FP was regularly measured. Liver lump and extrahepatic metastasis were examined by CT. The patients were followed up after treatment and conducted survival analysis. RESULTS: In the TAM+OCT group, complete response is 4 patients, partial response is 7 patients, no change is 9 patients and progressive disease is 4 patients; blood level of ALT and AST had no noticeable change, IgE and IgG increased (P<0.01), and alpha-FP lowered (P<0.05). In regular chemotherapeutic group, no change is 4 patients and progressive disease is 11 patients. There was conspicuous statistical difference in the two groups. The accumulative survival rates of 6 months, 1 year and 2 years were 95.7% vs 41.2% (P<0.01), 63.7% vs 21.1% (P<0.01), 25.4% vs 0 (P<0.01), respectively. Medium survival time was 12.8 months in TAM+OCT group and 5.5 months in chemotherapeutic group. CONCLUSIONS:TAM+OCT excerts reliable therapeutic effect on patients with inoperable ER(+) hepatocellular cancer. It is superior to 5-Fu and MMC in increasing the survival rate, prolonging survival time, and reducing side-effects.