Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial.

Grimaldi, C; Bleiberg, Harry; Messner, Matthias; Rougier, P; Kok, Tjebbe C.; Cirera, Lluís; Cervantes, A.; Grève, Jacques De; Paillot, B; Buset, M; Nitti, Donato; Sahmoud, Tarek; Duez, Nicole; Wils, J.

doi:10.1200/jco.1998.16.2.411

Cited by 124 publications

(77 citation statements)

References 18 publications

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“…Several treatments of unresectable HCC, such as immunotherapy with interferon, 78,80 antiandrogen therapy, 65 internal radiation, 55 and arterial 47,52 or systemic chemotherapy, 74,76 have also been evaluated in comparison with conservative management. However, none included a sufficient number of patients to guarantee a robust analysis.…”

Section: Discussionmentioning

confidence: 99%

Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival

2003

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There is no standard treatment for patients with unresectable hepatocellular carcinoma (HCC). Survival benefits derived from medical interventions are controversial. The aim of this systematic review was to assess the evidence of the impact of medical treatments on survival. Randomized controlled trials (RCTs) that were published as full papers assessing survival for primary treatments of HCC were included. MEDLINE, the Cochrane Library, CANCERLIT, and a manual search from 1978 to May 2002 were used. The primary end point was survival, and the secondary end point was response to treatment. Estimates of effect were calculated according to the random effects model. Sensitivity analysis included methodological quality. We identified 61 randomized trials, but only 14 met the criteria to perform a meta-analysis assessing arterial embolization (7 trials, 545 patients) or tamoxifen T he incidence of hepatocellular carcinoma (HCC) is increasing worldwide. 1 Liver cancer is the fifth most common cancer in the world and the third most common cause of cancer-related death. 2 Cohort studies and cost-efficiency modeling have suggested that surveillance of well-defined cirrhotic patients may decrease tumor-related mortality. However, only 30% of patients benefit from curative therapies such as resection, transplantation, or percutaneous ablation 3 and achieve 5-year survival rates of 50% to 75%. 4 Most patients with HCC are diagnosed at intermediate to advanced stages, and there is no standard treatment for these patients. 3,4 The most reliable method to show survival advantages is to perform large randomized controlled trials (RCTs) that include more than 1,000 patients comparing treatment versus no treatment in a well-defined strata of individuals. 5-10 These investigations are lacking in patients with HCC. On the contrary, several medical interventions have been tested in the setting of small RCTs. However, the reduced size of these studies may cause questions of their statistical power when detecting survival differences, which, as in many areas of health care and oncology, are unlikely to be large. This raises the need for a systematic meta-analysis assessment, with a major role to integrate valid information and provide estimates of treatment effects when RCTs themselves are not of sufficient size. 9,10 Two systematic reviews published years ago 11,12 suggested a potential benefit for at Abbreviations: HCC, hepatocellular carcinoma; RCT, randomized controlled trial; OR, odds ratio; CI, confidence interval.

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Section: Discussionmentioning

confidence: 99%

Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival

2003

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“…27 The hypothesis that androgen may play a role in the development of HCC is supported by the increased expression and activation of androgen receptors in HCC tumor cells and by the ability of antiandrogenic compounds and castration to inhibit tumor development in laboratory animals. 28,29 However, use of antiandrogenic compounds in clinical trials for HCC treatment has been disappointing, 30,31 arguing either that androgens do not play a role in HCC or that they act only early in the tumorigenic process. Chronic liver diseases cause an alteration in the sex hormone balance, which is more pronounced in men.…”

Section: Discussionmentioning

confidence: 99%

Relationship of hepatocellular carcinoma to soya food consumption: A cohort‐based, case‐control study in Japan

Sharp

Lagarde

Mizuno

et al. 2005

Intl Journal of Cancer

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To determine if the risk of hepatocellular carcinoma (HCC) is reduced by consumption of soya foods, we conducted a case-control study within a cohort of Japanese A-bomb survivors. We compared the prediagnosis consumption of isoflavone-rich miso soup and tofu to HCC risk, adjusting for hepatitis B (HBV) and C (HCV) viral infections, the major HCC risk factors in this population. The study included 176 pathologist-confirmed cases of HCC diagnosed in 1964-1988 and 560 controls who died of diseases other than liver cancer. We examined dietary information collected at least 2 years before diagnosis or death and tissue-based measures of viral hepatitis. Using logistic regression, crude ORs were 0.5 (95% CI 0.29-0.95) and 0.5 (95% CI 0.20-0.99) for high vs. low miso soup and tofu intake, respectively. Adjusting for year of birth, sex, HBV, HCV and other factors, the OR for miso soup was unchanged at 0.5 (95% CI 0.14-1.55), and miso results were similar when ORs were recalculated separately for earlier and later birth cohorts to assess consistency of results. The adjusted OR for tofu was 0.9 (95% CI 0.20-3.51). We also found a statistically significant (p < 0.0001) interaction between sex and HCV, with risk of HCC being substantially higher for women. We conclude that consumption of miso soup and other soya foods may reduce HCC risk. ' 2005 Wiley-Liss, Inc.

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“…Systemic chemotherapy with different agents is marginally effective against HCC but severely toxic and unassociated with increased survival Bruix and Sherman, 2005). Agents such as tamoxifen , antiandrogens (Grimaldi et al, 1998) and octreotide (Yuen et al, 2002) are completely ineffective.…”

Section: Current Treatmentmentioning

confidence: 99%

New aspects of diagnosis and therapy of hepatocellular carcinoma

et al. 2006

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Hepatocellular carcinoma is one of the major cancer killers. It affects patients with chronic liver disease who have established cirrhosis, and currently is the most frequent cause of death in these patients. The main risk factors for its development are hepatitis B and C virus infection, alcoholism and aflatoxin intake. If acquistion of risk factors is not prevented and cirrhosis is established, the sole option to improve survival is to detect the tumor at an early stage when effective therapy may be indicated. Early detection plans should be based on hepatic ultrasonography every 6 months, whereas determination of tumor markers is not efficient. Upon detection of a hepatic nodule, there is a need to establish unequivocal diagnosis, either through biopsy or through the application of non-invasive criteria based on the specific radiology appearance of the tumor: fast arterial uptake of contrast followed by venous washout. Effective treatment for liver cancer includes surgical resection, liver transplantation and percutaneous ablation. These options provide a high rate of complete responses and are assumed to improve survival that should exceed 50% at 5 years. If the tumor is diagnosed at an advanced stage, the sole option that improves survival is transarterial chemoembolization. Ongoing research should further advance the time at diagnosis and identify new and effective options targeting molecular pathways governing tumor progression.

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Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial.

Abstract: This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC.

Cited by 124 publications

References 18 publications

Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival

Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival

Relationship of hepatocellular carcinoma to soya food consumption: A cohort‐based, case‐control study in Japan

New aspects of diagnosis and therapy of hepatocellular carcinoma

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