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

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Abstract
Background: Chemotherapy for pancreatic cancer offers small survival benefits and considerable side-effects. Unsaturated fatty acids have an antitumour effect in experimental studies; in phase II studies few side-effects were seen. Methods: In this group-sequential, open-label, randomized study, 278 patients with a diagnosis of inoperable pancreatic cancer were treated with either 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 survival 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 infusion, was associated with a median survival time of 249 days in the low-dose intravenous group. Conclusion: Oral or low-dose intravenous LiGLA led to survival times similar 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 treatment with LiGLA cannot be recommended for the treatment of pancreatic cancer.