Abstract
ABSTRACT Introduction Patients (pts) with ≥3 CTCs/7.5ml blood at baseline, enumerated by the CellSearch® (Veridex) system, have poor overall survival (OS)1. CTC guided treatment strategies may improve pt outcomes. This study investigated the efficacy of combining 4 active agents and evaluated CTC numbers for prognostic and pharmacodynamic utility. Methods Pts with previously untreated, inoperable, ACRC and wtKRAS were eligible. Chemotherapy was administered every 28 days with Cetuximab 400 mg/m2 D1 & D15 and UFT 250 mg/m2 with calcium folinate 30mg TDS D1-21. UFT dose was reduced by 1 caps/day for grade 2/3 diarrhoea. Irinotecan 180 mg/m2 D1 and oxaliplatin 100 mg/m2 D15 alternated to reduce long-term toxicity of each drug. Treatment was continued until disease progression. The primary end-point was response rate (RR) and secondary endpoints included progression free survival (PFS), OS, toxicity and CTC number. Blood samples (7.5ml) for CTC analysis were drawn at baseline and D15. CTCs were enumerated using the CellSearch® system. Results: Forty-eight pts were recruited; 46 were evaluable for response and 42 for CTC enumeration. A 67% RR was achieved with disease control in 91% - CR 2 pts (4%), PR 29 (63%) & SD in 11pts (24%). Two pts with inoperable colonic tumours had curative resections after chemotherapy; no patients had liver only disease. Grade 3 toxicities included diarrhoea (21%), lethargy (17%), neutropenia (8%), parasthesia (17% G2, no G3) and alopecia (4% G2). Only 14 pts have died so OS is expected to increase with longer review. At baseline 50% pts had ≥3 CTCs suggesting this cohort comprised a poor prognostic group; median PFS/OS of these pts was 8.5/18.8 months(m), considerably better than expected (cf 6.1/11.6m in Cohen1). Pts with Disclosure All authors have declared no conflicts of interest.
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