An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer.
OBJECTIVE
This study aimed to investigate G17DT, an immunogen producing neutralizing antibodies against the tumor growth factors amidated and glycine-extended forms of gastrin-17, in the treatment of pancreatic cancer.


METHODS
A randomized, double-blind, placebo-controlled, group-sequential multicenter 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 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 (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.
Division of GI Surgery, University Hospital, Nottingham, UK.
Andrew D
AD
Gilliam
Paul
P
Broome
Eskender G
EG
Topuzov
Avgust M
AM
Garin
Istvan
I
Pulay
Jane
J
Humphreys
Anne
A
Whitehead
Arjun
A
Takhar
Brian J
BJ
Rowlands
Ian J
IJ
Beckingham
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005755:Gastrins / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008017:Life Expectancy; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000276:immunology / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D010919:Placebos; D016016:Proportional Hazards Models; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
D019496:Cancer Vaccines; D005755:Gastrins; D010919:Placebos; C482698:gastrin immunogen; C013550:gastrin 17