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An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer
Andrew D Gilliam1, Paul Broome, Eskender G Topuzov
1Division of GI Surgery, University Hospital, Nottingham, UK.
Objectives:
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.
Insights
This study evaluated G17DT for advanced pancreatic cancer, showing improved survival in patients who developed antibodies. G17DT was well-tolerated, offering a potential new treatment option.
Area of Science:
- Oncology
- Immunotherapy
- Gastroenterology
Background:
- Pancreatic cancer remains a significant challenge with limited treatment options.
- Gastrin-17 plays a role in tumor growth, making it a target for therapeutic intervention.
Purpose of the Study:
- To assess the efficacy and tolerability of G17DT, an immunogen targeting gastrin-17, in patients with advanced pancreatic cancer.
- To evaluate the impact of G17DT on patient survival and performance status.
Main Methods:
- A randomized, double-blind, placebo-controlled, multicenter trial involving 154 patients with advanced pancreatic cancer.
- Patients received G17DT or placebo emulsion over a defined schedule.
- Primary endpoint was survival; secondary endpoints included tolerability and Karnofsky performance score.
Main Results:
- Conventional analysis showed median survival of 151 days for G17DT versus 82 days for placebo (P = 0.03).
- Patients developing anti-G17DT antibodies (73.8%) had significantly longer median survival (176 days) compared to non-responders or placebo (63-83 days; P = 0.003).
- G17DT demonstrated good tolerability.
Conclusions:
- G17DT immunotherapy shows promise in improving survival for advanced pancreatic cancer patients.
- The development of anti-G17DT antibodies correlates with enhanced patient survival.
- G17DT is a well-tolerated treatment option for pancreatic cancer.
