A prospective study of oxaliplatin and capecitabine (CapOx) in metastatic colorectal cancer (MCRC) with baseline stratification according to resectability status

Abstract

4024 Background: Consideration of metastasectomy is now standard practice in the management of selected patients (pts) with stage IV MCRC. As a result, modification to the current staging system has been suggested to more clearly define subgroups of stage IV pts. As yet, there are no prospective data comparing the outcomes of pts according to resectability status. This phase II study evaluates the outcomes of pts according to baseline resectability status, and examines the utility of CapOx chemotherapy as a neoadjuvant treatment strategy. Methods: Eligible pts had received no prior chemotherapy for MCRC. At study entry imaging review was undertaken and pts stratified into 3 groups according to resectability status; non-resectable (group 1), potentially resectable liver disease (group 2), resectable liver disease (group 3). All pts received identical chemotherapy; capecitabine 2,000mg/m2 d1–14 and oxaliplatin 130mg/m2 d 1 repeated every 3 weeks. Repeat imaging was undertaken every 4 cycles. For pts in groups 2 & 3, all imaging was reviewed by a specialist hepatic MDT, where feasible metastasectomy was undertaken following 4 or 8 cycles of chemotherapy. Planned enrolment was 130 pts, with study endpoints including; response rate, PFS & OS. Results: 129 pts are enrolled. Median age 62 (range 29–78). Median number of cycles delivered 8 (range 1–12). Grade III/IV toxicities; diarrhoea 14%, neutropenia 7.8%, peripheral neuropathy 2%. 60 day all cause mortality 3.1%. There have been no post operative deaths following liver resection. Median follow up is 19.3 months. Outcome data for each group is summarised below. Conclusion: CapOx chemotherapy is safe and well tolerated when used as a neoadjuvant treatment strategy. This prospective study clearly demonstrates the wide variation in outcomes according to baseline resectability status, and highlights the need for modification to the staging system to account for these patient subgroups in future studies. [Table: see text] [Table: see text]