As of today, clinicaltrials.gov shows that there are 64 Phase II clinical trials for metastatic pancreatic adenocarcinoma that are actively recruiting. These studies aim to identify a signal of clinical efficacy. But what is the appropriate historical control to use for comparison? In 2011, a Phase II study (LINK) in the 1L metastatic setting reported that Gemcitabine (G) + Nab-paclitaxel (A) produced a response rate of 48% with a 1 year survival of 48%. Two years later in 2013, a Phase III study (LINK) was reported which showed that the same treatment regimen in the 1L metastatic setting produced a response rate of 23% and a 1-yr survival of 35%. These are remarkable differences in outcomes reported with the same regimen which likely reflects issues in patient selection bias that inevitably occur between Phase II and Phase III studies. As we here more results of ongoing Phase II studies using GA or FOLFIRINOX backbones in the 1L metastatic setting for pancreatic cancer, we need to mindful of whether the appropriate historical controls are being selected for comparison.
The Beatty Laboratory is part of the Perelman School of Medicine at the University of Pennsylvania.
