Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma
Randomized, dose-finding phase III study of lithium gamolenate in patients with advanced pancreatic adenocarcinoma
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.
662-668
Johnson, C.D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Puntis, M.
719d5fa4-9433-4b28-830a-7ccb06b30626
Davidson, N.
23afd02c-9db0-47cc-8f11-5bd70eb3267e
Todd, S.
f19e1751-823c-45ae-9301-4a2256a96431
Bryce, R.
1db2507e-e9b2-4acc-8643-b52539d4e53e
1 May 2001
Johnson, C.D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Puntis, M.
719d5fa4-9433-4b28-830a-7ccb06b30626
Davidson, N.
23afd02c-9db0-47cc-8f11-5bd70eb3267e
Todd, S.
f19e1751-823c-45ae-9301-4a2256a96431
Bryce, R.
1db2507e-e9b2-4acc-8643-b52539d4e53e
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), .
(doi:10.1046/j.0007-1323.2001.01770.x).
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.
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Published date: 1 May 2001
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Local EPrints ID: 26400
URI: http://eprints.soton.ac.uk/id/eprint/26400
PURE UUID: 6cab6cb0-3547-4349-aea7-f2d7bb364d61
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Date deposited: 24 Apr 2006
Last modified: 15 Mar 2024 07:10
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Author:
M. Puntis
Author:
N. Davidson
Author:
S. Todd
Author:
R. Bryce
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