Cabozantinib May Improve Survival Outcomes in Relapsed Hepatocellular Carcinoma

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Researchers randomly assigned 707 patients with advanced HCC to receive oral cabozantinib 60 mg once daily or placebo.
Researchers randomly assigned 707 patients with advanced HCC to receive oral cabozantinib 60 mg once daily or placebo.
The following article features coverage from the 2018 Gastrointestinal Cancers Symposium. Click here to read more of Cancer Therapy Advisor's conference coverage.

Patients with hepatocellular carcinoma (HCC) previously treated with sorafenib have significantly improved overall survival (OS) and progression-free survival (PFS) rates when treated with cabozantinib compared with placebo, according to data being presented at the 2018 Gastrointestinal Cancers Symposium in San Francisco, California.1

For the double-blind phase 3 CELESTIAL study (ClinicalTrials.gov Identifier: NCT01908426), researchers randomly assigned 707 patients with advanced HCC to receive oral cabozantinib 60 mg once daily or placebo; 470 and 237 patients were assigned to the cabozantinib and placebo arms, respectively. Eligible patients were previously treated with sorafenib, had disease progression after no more than 2 lines of systemic therapy, and were unamenable to curative therapy.

At time of data analysis, 484 of 707 (68.4%) enrolled patients had died (317 of 470 [67.4%] patients in the cabozantinib arm and 167 of 237 [70.4%] patients in the placebo arm).

Median OS was 10.2 months among patients in the cabozantinib arm vs 8.0 months for patients in the placebo arm (hazard ratio [HR], 0.76; 95% CI, 0.63-0.92; P = .0049), and median PFS was 5.2 months vs 1.9 months, respectively (HR, 0.44; 95% CI, 0.36-0.52; P < .001). The overall response rate was 4.0% in the cabozantinib arm vs 0.4% in the placebo arm (P = .0086).

The most frequently reported grade 3 to 4 adverse events — which occurred at a higher rate in the cabozantinib arm — included hand-foot-skin reactions, hypertension, elevated aspartate aminotransferase, fatigue, and diarrhea.

The authors concluded that “[cabozantinib] significantly improved OS and PFS vs [placebo] in previously treated pts with advanced HCC. Adverse events were consistent with the known safety profile of [cabozantinib].”

Read more of Cancer Therapy Advisor's coverage of the 2018 Gastrointestinal Cancers Symposium by visiting the conference page.

Reference

  1. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: Results from the randomized phase III CELESTIAL trial. Oral presentation at: 2018 Gastrointestinal Cancers Symposium; January 18-20, 2018; San Francisco, CA.

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