A single arm phase II study of neoadjuvant transarterial regional therapy (TACE) using preloaded Irinotecan Beads in patients with resectable colorectal liver metastases (CRLM).

2015 
3588 Background: Perioperative chemotherapy confers 3-year progression free survival advantage following CRLM resection. Good pathologic response is associated with improved overall survival. Chemoembolisation using DEBIRI gives sustained delivery of drug directly to tumor, thereby maximising response and reducing systemic exposure. This study examined the safety and feasibility of neoadjuvant DEBIRI before CRLM resection and subsequent early disease free survival (DFS). Methods: Patients with resectable CRLM received segmental DEBIRI (median dose 100 mg Irinotecan, range 25-200) 1 month before surgery, with radiological endpoint of near stasis during the procedure. Primary study end-point: tumor resectability. Secondary end-points: safety; radiologic response (RECIST); pathologic tumor response; disease-free survival. Results: 40 patients received DEBIRI-TACE. All proceeded to surgery, 38 underwent hepatectomy (2 peritoneal disease, resectability rate 95%). 30-day post-operative mortality 5% (n = 2), nei...
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