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An international multicentre randomized controlled trial of G17DT in patients with pancreatic cancer

Research output: Contribution to journalJournal article

Published

  • Andrew Gilliam
  • Paul Broome
  • Eskender Topuzov
  • Avgust Garin
  • Istvan Pulay
  • Jane Humphreys
  • Anne Whitehead
  • Arjun Takhar
  • Brian Rowlands
  • Ian Beckingham
Journal publication date04/2012
JournalPancreas
Journal number3
Volume41
Number of pages6
Pages374-379
Original languageEnglish

Abstract

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.