Phase 3 REFLECT Trial in Patients with Unresectable Hepatocellular Carcinoma - Episode 2
Richard S. Finn, MD defines unresectable or advanced hepatocellular carcinoma by discussing venous invasion, extrahepatic spread, and progression after locoregional treatments.
Richard S. Finn, MD: What do we mean by advanced liver cancer? Well, unresectable liver cancer is a heterogeneous group of patients, because patients can be unresectable for physiology, for characteristics of their liver disease. And they can also be unresectable, because of characteristics of their tumor. And we know that patients who have tumors outside their liver or metastatic disease would be considered advanced. And we also know that patients who have tumors invading into the vasculature of their liver. Patients who have venous invasion are also considered advanced. And these are patients who should be considered, for systemic treatment. Now it's always been a challenge for us, to improve outcomes for patients who have more decompensated liver disease. In that case, a patient who presents with arthritis and elevated bilirubin low albumin. These are patients who have a high risk of passing from their underlying liver function, regardless of their tumor. And that treating their tumor, might not provide any survival benefit. Most of our clinical studies have focused on patients who have better-compensated diseases, such as trial QA, or some patients with Trial QB. Keep in mind, that as a patient's liver function declines, the ability for us to intervene and improve their survival from cancer, diminishes. And therefore, that is why it's very important that patients treating liver cancer, whether they be a medical oncologists or gastroenterologists and hepatologists, stay involved with the care of their patients, from the very beginning of their diagnosis. Certainly, local regional treatments, as I said, play a key role. But now that we have so many effective medical treatments, it really behooves us to know when to stop using local regional treatments, when patients are not candidates for those treatments. And that again would be patients who have vascular invasion, patient have extrahepatic spread or even those patients who get local regional treatments and progress on them. For example, a patient who has chemoembolization, to a lesion and follow-up shows that they have residual tumor. Maybe they have another chemoembolization, but still, repeated follow-up imaging shows that they still have residual tumor burden. Or tumor burden that's progressing, despite chemoembolization, this patient needs to be considered for systemic treatment. And systemic treatment has evolved over the years. Initially, we had, sorafenib approved around 2008. This drug improves survival, versus placebo. But did so, really by slowing progression without inducing objective responses. After the approval of sorafenib, we had numerous negative studies, until the REFLECT study.
This transcript has been edited for clarity.