Randomized, dose-finding phase III study of lithium gamolenate in patientswith advanced pancreatic adenocarcinoma

Background: Chemotherapy for pancreatic cancer offers small survival benefi ts and considerable side-effects. Unsaturated fatty acids have an antitumou r effect in experimental studies; in phase II studies few side-effects were seen. Methods: In this group-sequential, open-label, randomized study, 278 patien ts with a diagnosis of inoperable pancreatic cancer were treated with eithe r oral (700 mg daily for 15 days), low-dose (0.28 g/kg) or high-dose (0.84 g/kg) intravenous lithium gamolenate (LiGLA). The primary endpoint was surv ival time from randomization using Kaplan-Meier estimates. Results: Median survival after oral and low-dose intravenous treatment was 129 and 121 days respectively. Median survival after high-dose intravenous treatment was 94 days. A good Karnofsky score and the absence of metastases were associated with increased survival. Haemolysis, a marker of rapid inf usion, was associated with a median survival time of 249 days in the low-do se intravenous group. Conclusion: Oral or low-dose intravenous LiGLA led to survival times simila r to those of other treatments for pancreatic cancer although one subgroup (low-dose intravenous LiGLA with haemolysis) had longer survival. High-dose intravenous treatment appeared to have an adverse effect. Systemic treatme nt with LiGLA cannot be recommended for the treatment of pancreatic cancer.