Tamoxifen combined with octreotide or regular chemotherapeutic agents in treatment of primary liver cancer: a randomized controlled trial.
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.
Department of General Surgery, Zhongnan Hospital, Wuhan University, Wuhan 430071, China. pdydoctor@hotmail.com
Ding-Yu
DY
Pan
Jian-Guo
JG
Qiao
Ji-Wei
JW
Chen
Yin-Cheng
YC
Huo
Ya-Kui
YK
Zhou
Hai-An
HA
Shi
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008099:Liver / Q000502:physiology; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D015282:Octreotide / Q000008:administration & dosage* / Q000009:adverse effects; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects; D000509:alpha-Fetoproteins / Q000378:metabolism
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D000509:alpha-Fetoproteins; D013629:Tamoxifen; D016685:Mitomycin; D015282:Octreotide; D005472:Fluorouracil