The FDA based its approval on data from the REFLECT phase 3 study in which investigators enrolled 954 previously untreated patients with metastatic or unresectable hepatocellular carcinoma.
Twenty-three systemic therapy-naive patients with advanced hepatocellular carcinoma received atezolizumab plus bevacizumab every 3 weeks.
Previous studies have demonstrated tivantinib prolonged progression-free survival and overall survival in hepatocellular carcinoma.
Patients were enrolled regardless of portal vein thrombosis status and were unable to tolerate other curative therapies.
Researchers evaluated whether the PD-1 inhibitor would improve outcomes among patients with HCC who progressed after sorafenib treatment.
Researchers randomly assigned 707 patients with advanced HCC to receive oral cabozantinib 60 mg once daily or placebo.
Researchers randomly assigned 459 patients to receive SIRT with 90Y-loaded resin microspheres for 2 to 5 weeks or oral sorafenib 400 mg twice daily continuously.
A previous study demonstrated that TACE plus orantinib insignificantly prolonged progression-free survival, though it did not improve OS.
Patients had similar HRQOL scores by all measures at baseline, but experienced significant changes in scores for the HRQOL domains of Body Image, Diarrhea, Nutrition, Pain, and Role Function.
The combination of axitinib and TACE is safe and potentially efficacious for patients with inoperable hepatocellular carcinoma.
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