***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 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 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 B ) the same protocol of anti-cancer drugs administration , without the hormonal agents , was given . At least three courses of the treatments were carried out . Twelve patients in group A and 14 in group B were evaluated .  Partial response of the hepatic tumor to the treatments was observed in 33.3 % of group A patients and 21.4 % of group B patients , a difference that was not statistically significant . The 1-year survival rate was 44.5 % in group A and 33.0 % in group B. The performance status of 25 % of the patients in group A was significantly improved compared with 14.3 % in group B ( p < 0.05 ) . TAM- and MPA-combined chemotherapy may not prolong the survival of patients with HCC , although it improves their quality of life We tested the hypothesis that a combination of sex hormone suppression and inhibition of their target receptors might improve survival for patients with hepatocellular carcinoma ( HCC ) . Eighty‐five consequent , previously untreated HCC patients with inoperable disease , were r and omized to receive the luteinizing hormone‐releasing hormone (LR‐RH)‐analogue triptorelin and the antiestrogen tamoxifen ( 33 patients ) or triptorelin plus the anti and rogen flutamide ( 23 patients ) , or only placebo ( 29 patients ) in a double blind fashion . All groups were comparable as to age , sex , tumor extension , underlying cirrhosis and biochemical parameters . The tamoxifen ( TMX ) group had a significantly longer survival ( 282 days ) compared with flutamide ( 112 days ) and with placebo ( 127 days ) groups ( P = 0.0238 , log rank test ) . The upper quartile of patients in the TMX group lived 384 days or longer , and most of them ( 57.1 % ) were women ( P < 0.0005 ) , in contrast to the upper quartile of the placebo ( 170 days , 16.7 % women ) and the flutamide group ( 134 days , 33.3 % women ) . The calculated tumor volume doubling time ( TVDT ) was significantly higher in the TMX group ( 296 days ) than in the other two groups ( 99 and 101 days for placebo and flutamide groups , respectively , P = 0.023 ) . In a Cox proportional hazards model , the TMX treatment , along with the baseline Okuda 's HCC stage , the hepatitis B surface antigen , the portal vein diameter , the carcino embryonic antigen ( CEA ) and a self‐ assessment score of quality of life , were covariates predicting survival . Although the degree of serum sex hormone suppression was not a significant predictor of survival , the interaction of female sex and TMX treatment , it was ( P = 0.0052 ) . We conclude that TMX treatment significantly prolongs survival and the TVDT in unresectable HCC . The effect is most pronounced in female patients and is unrelated to sex hormone suppression BACKGROUND In 1998 , when data of a meta- analysis on tamoxifen in the treatment of hepatocellular carcinoma ( HCC ) had suggested a little advantage for this treatment , we published the results of a multicenter r and omised controlled trial , that showed no survival benefit for tamoxifen vs. control . Here we report an up date d analysis of the study results 4.5 years after the closure of enrollment . METHODS The study had a planned sample size of 480 patients . Patients with any stage HCC were eligible , irrespective of locoregional treatment .  Tamoxifen was given orally , 40 mg/die , from r and omisation until death . RESULTS 496 patients were r and omised by 30 Institutions from January 1995 to January 1997 . Information was available for 477 patients . As of July 2001 , 374 deaths ( 78 % ) were recorded , and median survival times were 16 and 15 months ( p=0.54 ) , in the control and tamoxifen arm . 
    Output:
    
Tamoxifen was associated with adverse effects .
REVIEW ERS ' CONCLUSIONS These data do not support the use of tamoxifen for patients with hepatocellular carcinoma .