|The following article features coverage from the European Society for Medical Oncology (ESMO) Congress 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
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.
- 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.
- 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