Cell-free DNA and chemoembolization in patients with liver metastases from colorectal cancer.

Transarterial chemoembolization with irinotecan loaded beads (DEBIRI-TACE) represents an investigative treatment option for patients with metastatic colorectal cancer (mCRC). The present study examined DEBIRI-TACE with concomitant mFOLOFX6-bevacizumab as a first-line treatment for mCRC and explored the clinical value of circulating cell-free DNA (cfDNA). Patients with limited mCRC of the liver who had not been treated with chemotherapy received up to 4 biweekly DEBIRI-TACE treatments. The endpoints examined included the response rate, survival, toxicity and translational analysis. Due to toxicity and lack of feasibility, the study closed prematurely. Total cfDNA was measured with a direct fluorescent assay. Between December 2012 and February 2014, 14 patients underwent a total of 49 DEBIRI-TACE treatments. With a median follow-up of 1.7 years, the median progression free survival and overall survival (OS) were 240 days [95% confidence interval (CI): 161-357] and 522 days (95% CI: 174-1,054), respectively. The response rate was 50%. Twelve patients experienced grade 3 toxicity or above. Dynamics of cfDNA showed biological variations in relation to therapy. To conclude, the present results indicated a response rate of 50% and median OS of 522 days for 14 patients with mCRC undergoing DEBIRI-TACE, but unacceptable toxicity and lack of feasibility with the applied schedule. The findings suggest that the level of cfDNA may be associated with the disease course, response to treatment and outcome. TRIAL REGISTRATION: The European Clinical Trials database (EudraCT no. 2012-000987-11) at 05-14-2012.