Canadian Cancer Trials Group Bulletins


Recent Publication

The authors compiled a database of cooperative group trials in metastatic pancreatic cancer to develop historical benchmarks for overall survival (OS) and progression free survival (PFS). Benchmarks are essential for evaluating new therapies in a single arm setting. Patients with untreated metastatic pancreatic cancer receiving regimens that included gemcitabine, between 1995 and 2005, were included. The article reports benchmark values for 6-month OS and PFS along with a method for using these values in future study design and analysis. The benchmarks can be used to enable single-arm phase II trials utilizing a Gemcitabine platform, especially under certain circumstances. Such circumstances might be when a randomized control arm is not practically feasible, an early signal of activity of an experimental agent is being explored such as in expansion cohorts of phase I studies, and in patients who are not candidates for combination cytotoxic therapy.

Philip PA, Chansky K, Rubinstein L, LeBlanc M, Seymour L, Ivy SP, Alberts SR, Catalano PJ, Crowley J. Historical Controls for Metastatic Pancreatic Cancer: Benchmarks for Planning and Analyzing Single Arm Phase II Trials (ONLINE). Clin Cancer Res 2014.