P-273 Hepatectomy followed by adjuvant chemotherapy with capecitabine plus oxaliplatin for three months for liver metastases from colorectal cancer: a multicenter phase 2 study

Abstract

Introduction: Hepatic resection is one of the treatment strategies for resectable liver metastases from colorectal cancer. The role of neoadjuvant and adjuvant chemotherapy in the management of initially resectable colorectal liver metastases is still unclear. A randomized controlled trial is now underway in Japan to compare hepatectomy alone with hepatectomy followed by adjuvant FOLFOX as treatment in patients with curatively resected liver metastases from colorectal cancer to improve survival; however, the results are as yet undecided. Adjuvant chemotherapy consisting of capecitabine plus oxaliplatin (CapeOx) appears to be equivalent to FOLFOX in patients with stage III colon cancer. Furthermore, some studies suggest that adjuvant chemotherapy for three months after curative resection for stage II/III colorectal cancer has equivalent efficacy to adjuvant chemotherapy for 6 months.We initiated a multi‐institutional, single‐arm, open label, phase II trial to confirm the feasibility of adjuvant CapeOx for three months for post curative resection of liver metastasis from colorectal cancer. Methods: Eligibility criteria included histologically proven colorectal cancer, curatively resected metastatic liver tumors from colorectal cancer, no extrahepatic sites of disease, within 90 days after liver resection, age > 20, and ECOG performance status 0 to 1. No prior chemotherapy or radiotherapy for the liver was allowed. Adequate organ function and written informed consent were required. Patients received one course of capecitabine followed by four courses of CapeOx for a total five courses (15 weeks) as adjuvant chemotherapy after curative resection of colorectal liver metastases. CapeOx consisted of a 2‐hour intravenous infusion of oxaliplatin 130 mg/m2 on day 1 plus oral capecitabine 1,000 mg/m2 twice daily for 2 weeks in a 3‐week cycle. The primary endpoint was completion rate of adjuvant chemotherapy. The key secondary endpoints included overall survival, progression‐free survival, dose intensity, recurrence and adverse events.We set a threshold completion rate of protocol treatment of 45% and an expected completion rate of 70%. Given a one‐sided a of 0.1 and statistical power of 80%, a minimum of 25 patients was required. A total of twenty‐eight patients were accrued between May 2013 and November 2015 from six Japanese institutions. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000011164. Results: Conclusion:.