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


Johnson, C.D., Puntis, M., Davidson, N., Todd, S. and Bryce, R. (2001) Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma British Journal of Surgery, 88, (5), pp. 662-668. (doi:10.1046/j.0007-1323.2001.01770.x).

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Description/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.

Item Type: Article
Digital Object Identifier (DOI): doi:10.1046/j.0007-1323.2001.01770.x
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ePrint ID: 26400
Date :
Date Event
1 May 2001Published
Date Deposited: 24 Apr 2006
Last Modified: 16 Apr 2017 22:33
Further Information:Google Scholar
URI: http://eprints.soton.ac.uk/id/eprint/26400

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