TARE Prolongs PFS, Not OS, in Colorectal Cancer With Liver Metastases

Adding glass-based transarterial radioembolization (TARE) to chemotherapy as second-line treatment for colorectal cancer (CRC) with liver metastases prolonged progression-free survival (PFS), but not overall survival (OS), in a phase 3 trial.

“TARE with Yttrium-90 glass microspheres provides selective internal radiotherapy with beta-emitting particles delivered through the hepatic vasculature into tumor-feeding arteries,” explained Mary F. Mulcahy, MD, of Northwestern University in Chicago.

Dr Mulcahy presented results with glass-based TARE, from the phase 3 EPOCH trial (ClinicalTrials.gov Identifier: NCT01483027), at the European Society for Medical Oncology (ESMO) Congress 2021.¹ The results were published simultaneously in the Journal of Clinical Oncology.²

The EPOCH trial included 428 patients with CRC and liver metastases whose disease had progressed on first-line therapy. The patients were randomly assigned to receive chemotherapy with TARE (215 patients) or chemotherapy alone (213 patients).

TARE prolonged both PFS and hepatic PFS (hPFS), the study’s co-primary endpoints.

The median PFS was 8.0 months with TARE and 7.2 months with chemotherapy alone (hazard ratio [HR], 0.69; 95% CI, 0.54-0.88; P =.0013). The 12-month PFS rate was 25.8% with TARE and 13.2% with chemotherapy alone. The 18-month PFS rates were 16.7% and 1.8%, respectively.

The median hPFS was 9.1 months with TARE and 7.2 months with chemotherapy alone (HR, 0.59; 95% CI, 0.46-0.77; P <.0001). The 12-month hPFS rate was 29.8% with TARE and 13.5% with chemotherapy. The 18-month hPFS rates were 19.8% and 1.9%, respectively.

The overall response rate was 34.0% with TARE and 21.1% with chemotherapy alone. The complete response rates were 0.9% and 1.4%, respectively.

OS was similar between the treatment arms. The median OS was 14.0 months with TARE and 14.4 months with chemotherapy alone (HR, 1.07; 95% CI, 0.86-1.32; P =.7229). The 12-month OS rate was 56.3% with TARE and 62.4% with chemotherapy. The 18-month OS rates were 36.4% and 34.3%, respectively.

Grade 3 or higher treatment-emergent adverse events (AEs) were more common in the TARE arm than in the chemotherapy-alone arm — 68.4% and 49.3%, respectively. Serious AEs occurred in 37.4% and 20.8% of patients, respectively.

Chemotherapy-related AEs occurred in 92.0% of patients in the TARE arm and 91.3% of those in the chemotherapy-alone arm. Device-related AEs occurred in 55.1% of patients in the TARE arm. Dr Mulcahy noted that TARE did not compromise the ability to receive additional chemotherapy. “This is the first arterial radiotherapy device study to demonstrate a statistically significant delay in progression of metastatic CRC isolated to the liver,” she concluded.

Disclosures: This research was supported by Boston Scientific Corporation. The study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Mulcahy MF, Salem R, Mahvash A, et al. Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial (EPOCH study). Presented at: European Society for Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract LBA21.
2. Mulcahy MF, Mahvash A, Pracht M, et al. Radioembolization with chemotherapy for colorectal liver metastases: A randomized, open-label, international, multicenter, phase III trial. J Clin Oncol. Published online September 20, 2021. doi:10.1200/JCO.21.01839

This article originally appeared on Cancer Therapy Advisor