Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma

Robin Kate Kelley, Tim Meyer, Lorenza Rimassa, Philippe Merle, Joong-Won Park, Thomas Yau, Stephen L Chan, Jean-Frederic Blanc, Vincent C Tam, Albert Tran, Vincenzo Dadduzio, David W Markby, Rajesh Kaldate, Ann-Lii Cheng, Anthony B El-Khoueiry, Ghassan K Abou-Alfa

Research output: Contribution to journalArticlepeer-review

Abstract

PURPOSE: The phase III CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes.PATIENTS AND METHODS: Serum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics.RESULTS: Median OS for cabozantinib versus placebo was 13.9 versus 10.3 months [HR, 0.81; 95% confidence interval (CI), 0.62-1.04] for patients with baseline AFP
Original languageEnglish
Pages (from-to)4795-4804
Number of pages10
JournalClin. Cancer Res.
Volume26
Issue number18
DOIs
Publication statusPublished - Sep 15 2020

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