Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - An international multicentre randomized controlled trial of G17DT in patients with pancreatic cancer
AU - Gilliam, Andrew
AU - Broome, Paul
AU - Topuzov, Eskender
AU - Garin, Avgust
AU - Pulay, Istvan
AU - Humphreys, Jane
AU - Whitehead, Anne
AU - Takhar, Arjun
AU - Rowlands, Brian
AU - Beckingham, Ian
PY - 2012/4
Y1 - 2012/4
N2 - Objectives: This study aimed to investigate G17DT, an immunogen producing neutralising antibodies against the tumour growth factors amidated and glycine-extended forms of gastrin17, in the treatment of pancreatic cancer. Methods: A randomised, double blind, placebo-controlled, group-sequential multicentre trial of G17DT in patients with advanced pancreatic cancer unsuitable for or unwilling to take chemotherapy. Inclusion criteria were a Karnofsky performance score of 60 or higher and a life expectancy of more than 2 months. Patients received G17DT or placebo emulsion at weeks 0, 1, 3, 24 and 52. The primary end point was survival, and the secondary end points were tolerability, Karnofsky performance. Results: A total of 154 patients were recruited: 79 G17DT and 75 placebo. A final analysis of the intention-to-treat population, using a proportional hazards model, stratifying by disease stage and adjusting for interim analysis, gave a hazard ratio for mortality of 0.75 (95% confidence interval, 0.51-1.10, P=0.138; G17DT/placebo). A conventional analysis without adjustment for disease stage or interim analysis, censoring for chemotherapy and excluding protocol violators, gave median survival periods of 151 days (G17DT) and 82 days (placebo) (log-rank test, P = 0.03). Patients developing anti-G17DT responses (73.8%) survived longer than nonresponders or those on placebo(median survival, 176 vs 63 vs 83; log-rank test, P=0.003). G17DT was well tolerated.
AB - Objectives: This study aimed to investigate G17DT, an immunogen producing neutralising antibodies against the tumour growth factors amidated and glycine-extended forms of gastrin17, in the treatment of pancreatic cancer. Methods: A randomised, double blind, placebo-controlled, group-sequential multicentre trial of G17DT in patients with advanced pancreatic cancer unsuitable for or unwilling to take chemotherapy. Inclusion criteria were a Karnofsky performance score of 60 or higher and a life expectancy of more than 2 months. Patients received G17DT or placebo emulsion at weeks 0, 1, 3, 24 and 52. The primary end point was survival, and the secondary end points were tolerability, Karnofsky performance. Results: A total of 154 patients were recruited: 79 G17DT and 75 placebo. A final analysis of the intention-to-treat population, using a proportional hazards model, stratifying by disease stage and adjusting for interim analysis, gave a hazard ratio for mortality of 0.75 (95% confidence interval, 0.51-1.10, P=0.138; G17DT/placebo). A conventional analysis without adjustment for disease stage or interim analysis, censoring for chemotherapy and excluding protocol violators, gave median survival periods of 151 days (G17DT) and 82 days (placebo) (log-rank test, P = 0.03). Patients developing anti-G17DT responses (73.8%) survived longer than nonresponders or those on placebo(median survival, 176 vs 63 vs 83; log-rank test, P=0.003). G17DT was well tolerated.
KW - gastrin
KW - pancreatic cancer
KW - placebo
U2 - 10.1097/MPA.0b013e31822ade7e
DO - 10.1097/MPA.0b013e31822ade7e
M3 - Journal article
VL - 41
SP - 374
EP - 379
JO - Pancreas
JF - Pancreas
SN - 0885-3177
IS - 3
ER -