Intra-arterial FOLFOX+sorafenib ups survival in HCC with portal vein invasion

  • He M & al.
  • JAMA Oncol
  • 9 May 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Adding hepatic arterial infusion chemotherapy (HAIC) to sorafenib nearly doubled OS in hepatocellular carcinoma (HCC) with portal vein invasion.

Why this matters

  • Prognosis remains poor with frontline sorafenib; add-on HAIC had previously shown benefit in a phase 2 study.

Study design

  • Open-label, phase 3 randomized trial (n=247) of patients receiving frontline sorafenib with or without oxaliplatin, fluorouracil, and leucovorin (FOLFOX) HAIC.
  • Funding: Nonindustry sources.

Key results

  • Compared with sorafenib alone, adding FOLFOX significantly improved:
    • Response rate (40.8% vs 2.46%; P<.001>
    • Median OS in the combination group (13.37 vs 7.13 months; HR, 0.35; P<.001>
    • Median PFS (7.03 vs 2.6 months; HR, 0.33; P<.001>
    • Median intrahepatic PFS (8.07 vs 3.1 months; HR, 0.28; P<.001>
    • OS, based on RECIST criteria (40.8% vs 2.46%; P<.001>
  • Median OS was higher among 35 patients who crossed over to combination therapy vs those continuing to receive sorafenib alone (9.47 vs 5.53 months).
  • Rate of treatment-related adverse events was similar between groups.
  • Combination therapy was associated with higher rates of grade 3/4 neutropenia (9.68% vs 2.48%), thrombocytopenia (12.9% vs 4.96%), and vomiting (6.45% vs 0.83%).

Limitations

  • Open-label.
  • Chinese population.

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