564 Lithium gammolinolenate (LiGLA)- a novel outpatient treatment for nonresectable pancreatic carcinoma (PC)

LiGLA, a lithium salt of an essential fatty acid, has cytotoxicity in vitro and in vivo against a number of tumour types; a phase II trial has shown median survival of 410 days in patients (pts) with advanced, non-metastatic PC. As part of an ongoing multi-centre randomised phase III study, we have assessed, in a cohort of 6 pts, the feasibility of a short outpatient daily infusion, as compared to the usual inpatient continuous infusion for 10–14 days. All pts had histologically proven non-resectable PC. Karnofsky score >70%, assessable for toxicity & response, & no previous chemotherapy. The maximum period of infusion, via an indwelling. CVC, was 6 hours. Dose escalation was limited by short-lived macroscopic haemoglobinuria (due to an osmotic effect of LiGLA on erythrocytes), which developed at a dose level above 7 g/day. Total dose for each pt (determined by body weight) was 26–84 g. Days of infusion varied from 6 to 16. One pt experienced grade II anaemia. No other toxicities were seen (in particular no renal or Lithium toxicity). This method has a similar toxicity profile to the inpatient infusion. No meaningful comment can be made on efficacy equivalence. Short term infusion should be considered in future trials of this interesting, novel agent. The future development of an ambulatory pump protocol offers a potential home based treatment.