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.
RCT Entities:
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.
Authors: Emil Ter Veer; L Bengt van Rijssen; Marc G Besselink; Rosa M A Mali; Jordan D Berlin; Stefan Boeck; Franck Bonnetain; Ian Chau; Thierry Conroy; Eric Van Cutsem; Gael Deplanque; Helmut Friess; Bengt Glimelius; David Goldstein; Richard Herrmann; Roberto Labianca; Jean-Luc Van Laethem; Teresa Macarulla; Jonathan H M van der Meer; John P Neoptolemos; Takuji Okusaka; Eileen M O'Reilly; Uwe Pelzer; Philip A Philip; Marcel J van der Poel; Michele Reni; Werner Scheithauer; Jens T Siveke; Chris Verslype; Olivier R Busch; Johanna W Wilmink; Martijn G H van Oijen; Hanneke W M van Laarhoven Journal: Lancet Oncol Date: 2018-03 Impact factor: 41.316
Authors: K C H Fearon; M F Von Meyenfeldt; A G W Moses; R Van Geenen; A Roy; D J Gouma; A Giacosa; A Van Gossum; J Bauer; M D Barber; N K Aaronson; A C Voss; M J Tisdale Journal: Gut Date: 2003-10 Impact factor: 23.059
Authors: Irina N Gaisina; Franck Gallier; Andrei V Ougolkov; Ki H Kim; Toru Kurome; Songpo Guo; Denise Holzle; Doris N Luchini; Sylvie Y Blond; Daniel D Billadeau; Alan P Kozikowski Journal: J Med Chem Date: 2009-04-09 Impact factor: 7.446
Authors: D D Stocken; A B Hassan; D G Altman; L J Billingham; S R Bramhall; P J Johnson; N Freemantle Journal: Br J Cancer Date: 2008-09-16 Impact factor: 7.640