Day: 11/29/2010

Treatment of Intermediate/Advanced Hepatocellular Carcinoma in the Clinic: How Can Outcomes Be Improved?

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Hepatocellular carcinoma (HCC) is a complex condition associated with a poor prognosis. Treatment outcomes are affected by multiple variables, including liver function, performance status of the patient, and tumor stage, making a multidisciplinary approach to treatment essential for optimal patient management. Only ~30% of patients are eligible for curative therapies (surgery or ablation); palliative treatments include transcatheter arterial chemoembolization (TACE) and sorafenib. Treatment choice is guided by staging systems and treatment guidelines, although numerous systems exist and treatment guidelines vary by region. The current standard of care for patients unsuitable for potentially curative therapy is locoregional therapy with TACE. This treatment is associated with survival benefits, but there is no consensus regarding the optimum treatment/retreatment strategy. For patients with more advanced disease or who have failed locoregional therapy, sorafenib is the standard of care. Sorafenib is a targeted agent with proven survival benefits as monotherapy in these patients, and ongoing studies will clarify its role in combination with other agents and in patients with impaired liver function. Although other novel agents and therapeutic approaches are emerging, such as radioembolization and various targeted agents, further suitably designed randomized clinical trials (RCTs) comparing these agents with the standard of care are needed. In addition to RCTs, the collection of real-life data will also be important to allow physicians to make fully informed treatment decisions. The Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study is a global, noninterventional study of patients with unresectable HCC receiving sorafenib. The aim of that study is to compile a large robust database to evaluate local, regional, and global factors influencing the management of patients with HCC. It is hoped that findings from the GIDEON study along with phase III RCT data will lead to better outcomes for patients with intermediate–advanced HCC

source: the oncolologist

PPIs in First Trimester Not Associated with Birth Defects

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Proton-pump inhibitors taken by expectant mothers during the first trimester are not associated with major birth defects in the offspring, according to a New England Journal of Medicine study.

Researchers used Danish registries to identify roughly 5000 women who filled prescriptions for PPIs in the 4 weeks before conception through the first trimester of pregnancy. Omeprazole was the most commonly prescribed PPI.

PPI exposure during the first trimester was not associated with increased risk for major birth defects, compared with no exposure. However, PPI use in the 4 weeks before conception was associated with higher risk for major birth defects (adjusted odds ratio, 1.39). The authors and an editorialist say unmeasured confounding likely explains the latter result.

Given that the pre-conception risk was lowest with omeprazole, the editorialist suggests it may be “the PPI of choice” for women of childbearing potential.

source: NEJM