An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer
| Autor: | Arjun Takhar, Brian J. Rowlands, Ian J. Beckingham, Istvan Pulay, Paul Broome, Andrew D. Gilliam, Eskender G. Topuzov, Anne Whitehead, Avgust M. Garin, Jane Humphreys |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Endocrinology Diabetes and Metabolism Population Kaplan-Meier Estimate Placebo Cancer Vaccines law.invention Placebos Endocrinology Life Expectancy Randomized controlled trial Double-Blind Method law Internal medicine Gastrins Internal Medicine Clinical endpoint medicine Humans Prospective Studies Karnofsky Performance Status education Aged Proportional Hazards Models Aged 80 and over education.field_of_study Hepatology Proportional hazards model business.industry Hazard ratio Middle Aged Interim analysis Surgery Europe Pancreatic Neoplasms Treatment Outcome Tolerability Female business |
| Zdroj: | Pancreas. 41(3) |
| ISSN: | 1536-4828 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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