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Laura Goff, MD, discusses how to consider clinical trial information to inform treatment decisions in patients with hepatocellular carcinoma.
Laura Goff, MD, associate professor of Medicine, Hematology/Oncology, executive medical director, Vanderbilt-Ingram Cancer Center Patient Care Center, co-chair, Data and Safety Monitoring Committee, Vanderbilt-Ingram Cancer Center, discusses how to consider clinical trial information to inform treatment decisions in patients with hepatocellular carcinoma (HCC).
Safety is a key aspect when considering clinical trial inclusion criteria and how they will relate to real-world treatment decisions in this population, Goff says. Checking to see whether a platelet count threshold was included or whether patients were screened for varices can be important, especially if the trial was evaluating a VEGF-targeted agent, Goff adds.
However, other factors allow for more flexibility, such as Child-Pugh score for cirrhosis. It is important to evaluate individual factors that may contribute to a patient’s ability to tolerate a specific treatment, Goff explains. For example, Goff shares that she would still consider to use all or part of a regimen in an otherwise functional patient with Child-Pugh B cirrhosis if there is no clear indicator that they may experience excessive toxicity with the regimen—even though these patients may not have been included in clinical trials. Additionally, it is known that patients with severe cirrhosis can have significant functional impairment, either to the liver or their performance status, limiting their ability to derive benefit from treatment, Goff explains.
It is important to practice caution when making cross-trial comparisons of overall survival (OS) data reported with different regimens in HCC, Goff says. Progress has been made with extending OS in this population, as has been demonstrated with different agents and trials, according to Goff. Investigators continue to evaluate which patients go on to receive subsequent treatment and how much that relates to outcomes, Goff says. Newer agents in different lines of treatment can affect the ability to use OS as a single marker to demonstrate the benefit of a specific regimen, Goff concludes.