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

Autor: David W. Markby, Rajesh Kaldate, Robin Kate Kelley, Joong-Won Park, Ghassan K. Abou-Alfa, Vincent C. Tam, Anthony B. El-Khoueiry, Philippe Merle, Thomas Yau, Stephen L. Chan, Ann-Lii Cheng, Lorenza Rimassa, Vincenzo Dadduzio, Jean-Frédéric Blanc, Tim Meyer, Albert Tran
Rok vydání: 2019
Předmět:
Male
Cancer Research
Pyridines
Serum alpha-fetoprotein
Gastroenterology
Placebos
chemistry.chemical_compound
0302 clinical medicine
Reference Values
80 and over
Anilides
Cancer
Aged
80 and over
digestive
oral
and skin physiology
Liver Neoplasms
Middle Aged
Prognosis
Progression-Free Survival
Oncology
030220 oncology & carcinogenesis
Hepatocellular carcinoma
6.1 Pharmaceuticals
embryonic structures
030211 gastroenterology & hepatology
Female
alpha-Fetoproteins
Adult
medicine.medical_specialty
Optimal cutoff
Carcinoma
Hepatocellular
Cabozantinib
Clinical Trials and Supportive Activities
Oncology and Carcinogenesis
Placebo
Article
03 medical and health sciences
Young Adult
Clinical Research
Internal medicine
medicine
Humans
In patient
Oncology & Carcinogenesis
neoplasms
Protein Kinase Inhibitors
Aged
Neoplasm Staging
business.industry
Carcinoma
Evaluation of treatments and therapeutic interventions
Hepatocellular
medicine.disease
Confidence interval
digestive system diseases
chemistry
Previously treated
business
Zdroj: Clin Cancer Res
Clinical cancer research : an official journal of the American Association for Cancer Research, vol 26, iss 18
ISSN: 1557-3265
Popis: 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 Conclusions: Cabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.
Databáze: OpenAIRE
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