Rapid Readouts: A Global Study of Advanced Dosimetry in the Treatment of HCC With Y 90 Glass Microspheres

Riad Salem, MD, discusses data from the following presentation:

• Primary study objective:To establish relationships between absorbed dose, adverse events, and objective response in patients with HCC treated with yttrium-90 glass microspheres

• Methods used in the study
  • Primary and secondary end points
    • Primary: Relationship between greater than or equal to Grade 3 hyperbilirubinemia without disease progression and normal tissue-absorbed dose
    • Secondary: Relationship between objective response and tumor-absorbed dose, overall survival, tumor-absorbed dose, and probability of tumor marker
      (α-fetoprotein [AFP]) response and tumor-absorbed dose

• Baseline and primary resultsgreater than or equal to Grade 3 hyperbilirubinemia and normal tissue-absorbed dose
• Responders had a significantly higher tumor-absorbed dose (225.5 Gy: 95% CI=201.0 Gy, 253.0 Gy) compared with nonresponders (188.3 Gy: 95% CI=164.6 Gy, 215.3 Gy; P<.05)
• Overall survival hazard ratio (corresponding to every 100 Gy change in tumor-absorbed dose) = 0.826 (95% CI=0.71, 0.95; P=.009)
• Increase in tumor-absorbed dose independently associated with increased overall survival

• Probability of AFP response 90 days post treatment
  • 38.0% (27/71) of patients with AFP greater than or equal to 200 ng/mL at baseline had a response at 90 days post treatment.
  • 38.3% (41/107) of patients with AFP greater than or equal to 20 ng/mL at baseline had a response at 90 days post treatment.
  • Absorbed dose to total perfused tumor was significantly associated with AFP response at 90 days post treatment (P<.05).
    • In summary, no relationship was found between greater than or equal to Grade 3 hyperbilirubinemia and normal tissue-absorbed dose as well as safety.
    • Tumor-absorbed dose independently associated with overall survival.
    • No relationship was found between greater than or equal to Grade 3 hyperbilirubinemia and normal tissue-absorbed dose.
    • Concluding a relationship between greater than or equal to Grade 3 hyperbilirubinemia and normal tissue-absorbed dose was not found.
    • Global real-world data confirmed a significant association between tumor-absorbed dose and objective response and between tumor-absorbed dose and overall survival in patients with HCC treated with yttrium-90 glass microspheres.