Mary F. Mulcahy, MD, professor of medicine (hematology and oncology), radiology, and surgery (organ transplantation), Department of Medicine, Division of Hematology/Oncology, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, discusses the design of the phase 3 EPOCH trial (NCT01483027) in patients with metastatic colorectal cancer (mCRC) and liver metastases.

The EPOCH trial was designed to evaluate TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres as a second-line therapy for patients with mCRC and liver metastases after patients had progressed on first-line therapy for mCRC, Mulcahy says. The patient population evaluated was selected because they had liver-only disease to ensure they could receive subsequent active chemotherapy, Mulcahy explains. This was taken into consideration given the unknown long-term toxicities of radiation to the liver, Mulcahy adds.

Moreover, patients received TheraSphere in place of cycles 2 of standard second-line chemotherapy, Mulcahy continues. Patients were randomized 1:1 to receive standard of care systemic chemotherapy vs standard chemotherapy plus TheraSphere, Mulcahy concludes.

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Mary F. Mulcahy, MD, discusses the design of the phase 3 EPOCH trial in patients with metastatic colorectal cancer and liver metastases. 


Dr. Mulcahy on the Design of the EPOCH Trial in mCRC With Liver Metastases 

Mary F. Mulcahy, MD, Department of Medicine, Division of Hematology/Oncology, Northwestern University, Lurie Comprehensive Cancer Center, discusses the key takeaways from the ongoing EPOCH trial (NCT01483027) in patients with colorectal cancer (CRC) and liver metastases. 

Multiple prespecified subgroups were investigated on the study to determine which patients would benefit most from the addition of TheraSphere™ Yttrium-90 (Y-90) Glass Microspheres to systemic therapy, according to Mulcahy. Y-90 resulted in promising responses in patients whose tumors harbored 

 mutations. Because limited treatments are available for this population, further exploration with this modality is warranted, Mulcahy says.

Additionally, patients with intermediate hepatic tumor burden, defined as greater than 10% but less than 25%, as well as those who had fewer than 3 liver lesions and those who had left-sided primary disease were found to derive benefit from the treatment, Mulcahy adds.

During the second line of therapy, it was encouraged that patients receive standard-of-care treatment; however, only 40% of patients who had 

 wild-type disease received a biologic agent with their second line of treatment, Mulcahy notes. It is possible that if more patients received a biologic agent, there would have been even better outcomes, Mulcahy concludes.

Mary F. Mulcahy, MD, discusses the key takeaways from the ongoing EPOCH trial in patients with colorectal cancer and liver metastases. 

Mary F. Mulcahy, MD

Articles

Dr. Mulcahy on the Design of the EPOCH Trial in mCRC With Liver Metastases

Dr. Mulcahy on Key Takeaways from the EPOCH Trial With TheraSphere Y-90 in CRC