Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial

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

• Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. (Mulcahy MF, et al. J Clin Oncol. 2021 Sep 20: JCO2101839)
• EPOCH is the first positive phase 3 global study of Y-90 [Yttrium 90] TARE [Transarterial radioembolization] and chemotherapy in the second-line treatment of patients with colorectal liver metastases.
• This study examined safety and efficacy in patients with unresectable unilobar or bilobar colorectal metastases who were able to receive second-line irinotecan- or oxaliplatin-based chemotherapy.
• Patients were randomized 1:1 to receive Y-90 glass TARE and standard-of-care chemotherapy with or without targeted therapy (n=215) or standard of care chemotherapy with or without targeted therapy (n=213). Follow-up occurred every 8 weeks until disease progression or hepatic disease progression or death.
• Primary end points were PFS [progression-free survival] and hPFS [hepatic PFS] adjudicated by BICR [blinded independent central review]. Secondary end points were OS [overall survival], ORR [overall response rate] by BICR, DCR [disease control rate] by BICR, TTSP [time to symptomatic progression], and TTDQoL [time to deterioration quality of life].
• Safety/Efficacy Results:
  • The addition of Y-90 TARE to chemotherapy increased PFS from 7.2 to 8.0 months and increased hPFS from 7.2 to 9.1 months; these increases were statistically significant, and the study success criteria were met (PFS: HR 0.69; 1-sided P = .0013; hPFS: HR 0.59; 1-sided P < 0.0001).
  • No significant differences were found in OS.
  • Overall response rate in the TARE-chemotherapy group was nominally better than the chemotherapy alone group.
  • Chemotherapy-related adverse events were comparable between the groups.
  • No new, unexpected safety signals.
  • Y-90 did not compromise ability to receive additional chemotherapy.