Sorafenib Plus Hepatic Arterial Infusion Chemo Improves OS in HCC With Portal Vein Invasion

Using sorafenib plus hepatic arterial infusion chemotherapy (HAIC) in the first-line setting improved survival in patients with hepatocellular carcinoma (HCC) and portal vein invasion compared with sorafenib alone (JAMA Oncol. 2019 May 9. Epub ahead of print).

“Sorafenib is the first-line treatment for hepatocellular carcinoma with portal vein invasion; however, it has shown unsatisfactory survival benefit. Sorafenib plus…HAIC…of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) has shown promising results for these patients in a previous phase 2 study,” explained lead investigator MinKe He, MD, Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

Seeking to assess the safety and efficacy of using sorafenib plus HAIC versus sorafenib monotherapy in patients with HCC and portal vein invasion, Dr He and colleagues conducted an open-label clinical trial of 247 (median age, 49 years; 223 men and 24 women) patients with the disease. Patients were enrolled from 5 hospitals across China between April 1, 2016, and October 10, 2017, and followed-up with for 10 months.

These patients were randomized in a 1:1 ratio to receive sorafenib 400 mg twice daily with or without HAIC (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil infusion 2400 mg/m2 for 46 hours, every 3 weeks).

The primary end point was overall survival (OS) via an intention-to-treat evaluation, and safety was assessed in those receiving ≥1 study treatment dose.

Results showed a median OS of 13.37 months (95% CI, 10.27-16.46) in the combination arm versus 7.13 months (95% CI, 6.28-7.98) in the sorafenib-alone arm (hazard ratio [HR], 0.35; 95% CI, 0.26-0.48; P <.001).

A higher response rate was observed with the combination than with sorafenib alone (40.8% vs 2.46%, respectively; P <.001), as was a longer median progression-free survival (7.03 months; 95% CI, 6.05-8.02 vs 2.6 months; 95% CI, 2.15-3.05; P <.001).

Grade 3/4 adverse events occurred more frequently with the combination than with sorafenib alone, including neutropenia (9.68% vs 2.48%, respectively), thrombocytopenia (12.9% vs 4.96%), and vomiting (6.45% vs 0.83%).

“Sorafenib plus HAIC of FOLFOX improved overall survival and had acceptable toxic effects compared with sorafenib in patients with hepatocellular carcinoma and portal vein invasion,” Dr He et al concluded.—Hina Khaliq