Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification

  • No advanced disease, as defined by any of the following:

    • Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:

      • Vascular invasion, including segmental portal obstruction
      • Extrahepatic spread
      • Cancer-related symptoms (PST of 1-2)

    • BCLC class D disease, as defined by the following:

      • Okuda stage III disease
      • WHO performance status 3 or 4
    • Diffuse HCC, defined as massive ill-defined tumor involvement
    • Child-Pugh Class C
• Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)

• No significant liver decompensation

  • Preserved liver function (Child-Pugh class A-B)

    • No ascites (trace ascites allowed)
• No other active primary tumor
• Arteries supplying the lesion must be large enough to accept GelSpheres™ beads

PATIENT CHARACTERISTICS:

• Bilirubin ≤ 3 mg/dL
• Albumin > 2.0 g/dL
• AST and ALT ≤ 5 times the upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
• No active gastrointestinal bleeding
• No encephalopathy

• No contraindication to hepatic embolization procedures, as indicated by any of the following:

  • Porto-systemic shunt
  • Hepatofugal blood flow
  • Platelet count < 50,000/mm^3
  • INR ≥ 1.8
  • PTT ≥ 39 seconds
  • Renal failure
  • Severe atheromatosis

• No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:

  • Bilirubin > 5 mg/dL
  • WBC < 1,500/mm^3
  • Ejection fraction < 50% by isotopic ventriculography or echocardiography
• Not pregnant
• No known allergy to contrast media
• No intolerance to occlusion procedures

• No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:

  • Active or risk of hemorrhage
  • Patent extra-to-intracranial anastomoses or shunts
  • End arteries leading directly to the cranial nerves
  • Feeding arteries smaller than distal branches from which they emerge
  • Collateral vessel pathways that would potentially endanger normal territories during embolization

PRIOR CONCURRENT THERAPY:

• No prior anticancer therapy for HCC