%0 Journal Article
%T A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases
%A Oliver F Bathe
%A Scott Ernst
%A Francis R Sutherland
%A Elijah Dixon
%A Charles Butts
%A David Bigam
%A David Holland
%A Geoffrey A Porter
%A Jennifer Koppel
%A Scot Dowden
%J BMC Cancer
%D 2009
%I BioMed Central
%R 10.1186/1471-2407-9-156
%X A phase II trial was initiated in which patients with resectable CLM received CPT-11, 5-FU and LV for 12 weeks. Metastasectomy was performed unless extrahepatic disease appeared. Postoperatively, patients with stable or responsive disease received the same regimen for 12 weeks. Patients with progressive disease received either second-line chemotherapy or best supportive care. The primary endpoint was disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety.35 patients were accrued. During preoperative chemotherapy, 16 patients (46%) had grade 3/4 toxicities. Resection was not possible in 5 patients. One patient died of arrhythmia following surgery, and 1 patient had transient liver failure. During the postoperative treatment phase, 12 patients (55%) had grade 3/4 toxicities. Deep venous thrombosis (DVT) occurred in 11 patients (34%) at various times during treatment. Of those who underwent resection, median DFS was 23.0 mo. and median OS has not been reached. The overall survival from time of diagnosis of liver metastases was 51.6 mo for the entire cohort.A short course of chemotherapy prior to hepatic metastasectomy may serve to select candidates best suited for resection and it may also direct postoperative systemic treatment. Given the significant incidence of DVT, alternative systemic neoadjuvant regimens should be investigated, particularly those that avoid the use of a central venous line.ClinicalTrials.gov NCT00168155.The liver is the most common site of metastasis for colorectal cancer. Resection is the only hope for long-term survival for CLM. The median survival in such patients prior to recent advances in chemotherapy ranged from 19 ¨C 30 mo, with five year survivals of 30¨C39% [1-3]. Recent studies have reported even better survivals [1,2,4,5]. This may be due to improved chemotherapy, administered during various times of the patient's illness. Typically, response rates for first line chemotherapy are 39¨C60% [6-9]. While i
%U http://www.biomedcentral.com/1471-2407/9/156