***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A r and omized controlled trial of tamoxifen ( 60 mg/die ) versus placebo was performed in patients with cirrhosis and advanced inoperable hepatocellular carcinoma . Twenty-two patients were matched and coupled for sex , age , Child-Pugh class and tumour mass and then r and omized to tamoxifen or placebo .  Median survival was 74 weeks in the tamoxifen group ( range 27 to 144 weeks ) and 52 weeks in the placebo group ( range 4 to 112 weeks ) . The survival of patients treated with tamoxifen improved significantly compared to the controls ( Logrank-test , p = 0.04 ) . These findings suggest that the effect of the antiestrogen tamoxifen is both statistically and clinical ly significant in increasing survival in patients with advanced hepatocellular carcinoma OBJECTIVES : A prospect i ve r and omized study was performed to test the hypothesis that tamoxifen might improve the survival of patients with advanced hepatocellular carcinoma ( HCC ) and to correlate the response of treatment with the expression of hormone receptors . METHODS : One hundred nineteen patients with advanced and otherwise untreatable HCC were included in a placebo-controlled , single-blind trial . The patients were r and omized to tamoxifen group ( 61 patients ) and control group ( 58 patients ) and were prescribed with a daily dose of 30 mg of tamoxifen and placebo , respectively . Immunohistochemical tests for estrogen and progesterone receptors were performed on the tumor tissues obtained from 66 patients . All patients were closely monitored and the survival outcome of the two groups of patients was compared and stratified according to the hormonal receptor status . RESULTS : There was no difference in the 1-month mortality rates ( 32.8 % vs 43.1 % , p = 0.246 ) and the median survival ( 44 days vs 41 days , p = 0.703 ) between the tamoxifen group and the control group . Furthermore , the expression of hormone receptors in the tumors did not affect the survival outcome of the patients treated with tamoxifen . None of the patients who survived longer than 3 months had tumor that had partial response to tamoxifen treatment on follow-up imaging study . CONCLUSIONS : Tamoxifen has no efficacy in the treatment of patients with advanced HCC and response to treatment was not affected by the expression of hormone receptors Clinical and experimental evidence indicates that estrogens are involved in the control of hepatocyte proliferation both in normal and in neoplastic conditions . Thirty-two cirrhotic patients with unresectable or otherwise untreatable hepatocellular carcinoma were allocated to receive either tamoxifen ( 30 mg/day ) or no treatment . The patients in the two groups were matched for age , male/female ratio , Child-Pugh class , approximate tumor volume ( US and CT scan ) , and etiology of the underlying cirrhosis . Survival of the tamoxifen-treated patients ( life-table , Wilcoxon-Breslow ) was significantly prolonged ( P=0.0038 ) , with 35 % ( vs 0 % ) survival at 12 months . No difference was observed between males and females or between alcoholic and nonalcoholic cirrhosis . In 40 % of tamoxifen-treated patients , the levels of α-fetoprotein declined . In conclusion , the antiestrogen tamoxifen appears to be effective in the palliative treatment of hepatocellular carcinoma . An initial decline in α-fetoprotein levels may represent an early favorable prognostic sign Thirty-six consecutive patients with advanced hepatocellular carcinoma and chronic liver disease were r and omly allocated to two groups : group I included 20 patients who were treated with 10 mg bid . tamoxifen  and group II with 16 non-treated patients . The two groups were homogeneous according to clinical and analytical data . Survival curves in the tamoxifen-treated patients improved significantly when compared with the non-treated group ( p = 0.01 ) . Cumulative survival at the end of the first year was 48.5 % in the treated patients and 9.1 % in controls . Median survival was 261 days in the treated group vs. 172 in the non-treated group ( p < 0.05 ) . Complications of cirrhosis and worsening of the performance status test occurred less in the treated patients than in the controls , but not significantly so . Tamoxifen was well tolerated and no marked side effects were observed . In this series , tamoxifen improved survival in patients with advanced hepatocellular carcinoma BACKGROUND / AIMS Lipiodol chemoembolization is a widely used method of treatment in patients with unresectable hepatocellular carcinoma , but its efficacy is still debated . The aim of our study was to assess the efficacy of lipiodol chemoembolization in patients with unresectable hepatocellular carcinoma . METHODS Seventy-three patients with unresectable hepatocellular carcinoma , but without severe liver disease or portal vein occlusion , were r and omly assigned to receive either repeated lipiodol chemoembolization ( lipiodol , cisplatin ( 2 mg/kg ) , lecithin , and gelatin sponge injected into the hepatic artery ) plus tamoxifen ( 40 mg ) or tamoxifen alone . The main end-point was survival . RESULTS The 37 patients in the lipiodol chemoembolization group received 104 courses ( median 3 per patient ) . By 1 September 1996 , 58 patients had died : 30 in the lipiodol chemoembolization group and 28 in the tamoxifen group . There was no difference in survival between the two groups ( p=0.77 ) . The relative risk of death in the lipiodol chemoembolization plus tamoxifen group as compared to the tamoxifen group was 0.92 ( 95 % confidence interval 0.55 to 1.56 ) . At 1 year , survival was 51 % and 55 % , respectively . An objective tumoral response was more frequently observed in the lipiodol chemoembolization group than in the tamoxifen group ( 24 versus 5.5 % , respectively , p=0.046 ) . Lipiodol chemoembolization caused two deaths and induced signs of liver failure in 51 % of the patients assigned to this treatment . CONCLUSION In our r and omized study , lipiodol chemoembolization did not improve the survival of patients with unresectable hepatocellular carcinoma treated with tamoxifen BACKGROUND Chemoembolization with lipiodol ( iodized oil ) is widely used to treat patients with unresectable hepatocellular carcinoma . Severe side effects have been reported , and improved survival has not been clearly demonstrated . METHODS Patients with unresectable hepatocellular carcinoma who did not have severe liver disease and who met additional entry criteria were r and omly assigned to receive either lipiodol chemoembolization ( 70 mg of cisplatin , 10 ml of lipiodol , and gelatin-sponge [ Gelfoam ] particles delivered through the hepatic artery ) or conservative management involving treatment of complications and pain . Courses of treatment were to be given every two months for a maximum of four courses . The main end point was survival . RESULTS The study was stopped in December , 1992 , after a sequential analysis showed the lack of the expected benefit from chemoembolization . As of October 1 , 1994 , 39 of the 50 patients assigned to chemoembolization and 40 of the 46 patients assigned to conservative management had died .  Twenty-six patients assigned to chemoembolization received all four courses of treatment . There was no significant difference in survival between the two groups , although there was a trend favoring the chemoembolization group ( estimated relative risk of death in the control group , 1.4 ; 95 percent confidence interval , 0.9 to 2.2 ; P = 0.13 ) . The comparison of survival between the two groups was not substantially changed by adjustments for differences in base-line and prognostic characteristics ( adjusted relative risk , 1.3 ; 95 percent confidence interval , 0.8 to 2.1 ; P = 0.31 ) . At one year , the estimated survival rates were 62 percent in the chemoembolization group ( 95 percent confidence interval , 48.6 to 75.4 percent ) and 43.5 percent in the conservative-management group ( 95 percent confidence interval , 29.2 to 57.8 percent ) . In the chemoembolization group , tumor growth , as assessed by tumor size and serum alpha-fetoprotein concentration , was reduced and the incidence of portal obstruction was lower than in the conservative-management group . Liver failure occurred after 47 courses of treatment in 30 patients assigned to chemoembolization . CONCLUSIONS In a group of patients with unresectable hepatocellular carcinoma but without severe liver disease , lipiodol chemoembolization reduced tumor growth , often caused acute liver failure , and did not significantly improve survival UNLABELLED Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma ( HCC ) and a contraindication for chemoembolization . Intra-arterial injection of 131I-iodized oil which does not modify arterial flow , is feasible in this condition . The aim of this prospect i ve r and omized controlled trial was to compare the efficacy of treatment with radiolabeled oil ( treated group ) versus medical support ( control group ) in patients with stage I or II HCC ( classification of Okuda ) with portal vein thrombosis . METHODS Twenty-seven HCC patients ( 26 males , 1 female ) , aged 53 - 79 yr , with portal vein thrombosis were r and omly assigned to Lipiocis group ( n = 14 ) or Control group ( n = 13 ) . Additional injections of radiolabeled oil were given 2 , 5 , 8 and 12 mo after initial therapy . Medical support treatment consisted of : tamoxifen ( n = 5 ) , 5 FU intravenously ( n = 1 ) , NSAIDs or corticosteroids ( n = 5 ) . Efficacy was evaluated according to survival rate ( Kaplan-Meier method ; log rank test ) , AFP serum values ( measured at 2 , 5 , 8 and 12 mo ) and angiography . RESULTS The two groups were comparable ( Child 's classification , Okuda 's classification , liver function tests , location of the thrombus ) . Tolerance was excellent in the Treated group . The actuarial survival curves were significantly different ( p < 0.01 ) between the two groups , the survival rates ( Cl 95 % ) at 3 , 6 and 9 mo being 71 % ( 48%-95 % ) , 48 % ( 12%-55 % ) , 7 % ( 1%-31 % ) for the Treated group ; and 10 % ( 1%-33 % ) , 0 % and 0 % for the Control group . CONCLUSION Intra-arterial hepatic injection of 131I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis The liver is an estrogen responsive organ . Clinical ly , estrogens may play a role in the induction of liver tumors and , experimentally , estrogens are involved in the control of hepatocyte proliferation . The results of a prospect i ve controlled clinical trial using an anti-estrogen , tamoxifen , in patients with unresectable hepatocellular carcinoma ( HCC ) are presented below . Thirty-eight consecutive cirrhotics with HCC were allocated to either 30 mg/day tamoxifen or no treatment . The two groups of patients were matched for mean age , male/female ratio , Child-Pugh risk group , approximate tumor volume ( US and /or CT scan ) and etiology of the underlying cirrhosis . The drug appeared to have no side effects . Survival was significantly prolonged in tamoxifen-treated patients with 22 % ( vs. 5 % ) survival at 12 months . No differences were observed between males and females or alcoholic and non-alcoholic cirrhosis . In 53 % of tamoxifen-treated patients the levels of alpha-fetoprotein dropped and , in this subgroup , survival was further prolonged . Tumor volume , lactate dehydrogenase ( LDH ) and alkaline phosphatase slowly increased , suggesting a slower , but continuous , progression of the disease . In conclusion , anti-estrogen treatment appears effective in the palliation of unresectable or otherwise untreatable HCC . A reduction in alpha-fetoprotein levels appears to be a favorable prognostic index This article reports a prospect i ve r and omized controlled study to investigate the effect of sex hormone therapy combined with intra-arterial chemotherapy for hepatocellular carcinoma ( HCC ) . Thirty patients with unresectable HCC were r and omly divided into two groups . A catheter was inserted into the hepatic artery of all patients . The first group ( group A ) was administered 60 mg/m2 of cisplatin ( CDDP ) on day 15 and 13 mg/m2 of Adriamycin ( ADM ) on day 1 and 8 post-operatively via the hepatic artery cannula ; in addition , a daily dose of 150 mg 5-fluorouracil ( 5-FU ) was administered orally . Tamoxifen ( TAM ) 25 mg/m2 daily and medroxyprogesterone acetate ( MPA ) 400 mg/m2 daily were also administered orally . TAM and MPA administration were alternated every 4 weeks . For the second group ( group 
    Output:
    
The findings were stable in sensitivity analyses and were not affected by publication bias or inclusion of low- quality studies or studies reported in abstract form only .
Few adverse events or withdrawals were noted .
There was no support for the therapeutic use of tamoxifen in advanced HCC , nor for its use as a control arm in future clinical trials