Efrat Dotan, MD, on Pancreatic Cancer in Older Adults: Defining the Optimal Treatment Approach

Well, I am going to be presenting the GIANT study results. This is EA2186. It's a study that focused on older patients with metastatic pancreatic cancer, but we specifically looked at patients that were vulnerable. We developed a novel screening geriatric assessment that really helped us identify those patients who were vulnerable, looking at three main areas of cognition, comorbidities, and function. And those vulnerable patients were randomized to one of two treatment arms. Both were dose-adjusted, so a little bit of a lower dose or attenuated dose, of gemcitabine and nab-paclitaxel versus 5FU and liposomal irinotecan. We followed patients until disease progression, and the primary endpoint was overall survival. And we also looked at a lot of other secondary endpoints like progression-free survival, overall response rate, and quality of life. The study was able to accrue 176 patients at the time of study discontinuation. And despite multiple obstacles on the way, we were able to accrue these very vulnerable and sick patient population. The reason for the trial was really the fact that we just don't know how to care for these patients, because the data that we have focuses on much younger patients. And what we see in clinic are older adults dealing with a lot of issues outside of just metastatic pancreas cancer. What the results of this trial show is that overall the two treatment arms performed about the same, with survival that were a little bit lower than what we would expect. However, given the vulnerability of this population, that may not be a surprise. We also noticed that the percentage of patients that were not able to actually start therapy or get more than two cycles were so low that when we conducted an analysis just on patients that received four or more cycles of therapy, we found that their survival was about the same as what we would expect for this patient population. This really led us to think that there are factors that we're not identifying and we're not using to select the patient that could benefit and could get some long response from their chemotherapy. We're conducting now an analysis also looking at the geriatric factors and the quality of life measurements at baseline, and what we can see from our initial analysis is that there is a very strong correlation between those factors and how patients do on these chemotherapies. So our hope is that this study with additional analysis will help us to understand what factors really define outcomes in this patient population. How can we have better tools to select patients for therapy to be able to personalize their care, maybe help them with supportive care measures to allow them to benefit from this treatment, and also have discussions with the patients about their prognosis and help them, with shared decision-making, understand the benefit they can derive from their treatment? This study really is the first study that has been able to be completed for older adults that are vulnerable with metastatic pancreas cancer. I think it shows that these studies are feasible and are really important for providing evidence-based data to guide how we care for this important patient population.