Adding Doxorubicin to Sorafenib Not Effective for Hepatocellular Carcinoma

Share this content:
The addition of doxorubicin to sorafenib led to higher toxicity and did not improve survival in patients with advanced hepatocellular carcinoma.
The addition of doxorubicin to sorafenib led to higher toxicity and did not improve survival in patients with advanced hepatocellular carcinoma.

The addition of doxorubicin to sorafenib led to higher toxicity and did not improve overall or progression-free survival in patients with advanced hepatocellular carcinoma (HCC), a study presented at the 2016 Gastrointestinal Cancers Symposium in San Francisco, CA, has shown.1

Because an exploratory analysis of a randomized phase 2 study in patients with HCC comparing doxorubicin alone to doxorubicin plus sorafenib demonstrated a significant improve in overall survival with doxorubicin and sorafenib, researchers sought to conduct a pivotal sorafenib trial to assess if doxorubicin plus sorafenib improved survival compared with the tyrosine kinase inhibitor (TKI) alone.

For the study, researchers enrolled 346 patients with histologically proven advanced HCC who had no prior systemic therapy and were Child-Pugh A.

Participants were randomly assigned to receive doxorubicin 60 mg/m2 intravenously every 21 days plus sorafenib 400 mg orally twice daily or sorafenib alone. Patients could receive up to 360 mg/m2 and those with a bilirubin level 1.3 times normal or higher received half doses of doxorubicin and sorafenib.

Results showed that median overall survival was 9.3 months (95% CI, 7.1 - 12.9) for the combination compared with 10.5 months (95% CI, 7.3 - 14.3) for sorafenib alone (HR, 1.06; 95% CI, 0.8 - 1.4). The median overall survival with sorafenib alone is consistent with previous reports.

Researchers found that median progression-free survival was 3.6 months (95% CI, 2.8 - 4.6) and 3.2 months (95% CI, 2.3 - 4.1), respectively (HR, 0.90; 95% CI, 0.72 - 1.2).

In regard to safety, there were 18 deaths in the combination arm and 20 deaths in the sorafenib alone arm, of which 8 and 3, respectively, were at least possibly related to treatment.

RELATED: For Hepatocellular Carcinoma, Axitinib May Improve Survival, Time to Progression

A total of 37.8% of patients receiving doxorubicin plus sorafenib experienced grade 3 or 4 hematologic adverse events compared with 8.1% of those receiving sorafenib; however, the rate of non-hematologic adverse events were similar between the 2 arms (63.6% vs 61.5%, respectively).

Reference

  1. Abou-Alfa GK, Niedzwieski D, Knox JJ, et al. Phase III randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC): CALGB 80802 (Alliance). J Clin Oncol. 2016;34(suppl 4S; abstr 192).

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters