Efrat Dotan, MD, Fox Chase Cancer Center, Philadelphia, Pennsylvania, discussed results from the phase 2 GIANT study which compared gemcitabine and nab-paclitaxel to 5-fluorouracil, leucovorin, and liposomal irinotecan among older adults with treatment-naive metastatic pancreatic ductal adenocarcinoma. 

Dr Dotan stated “The bottom line from this trial is that we need to do a better job identifying patients that are candidates for therapy, that can benefit from therapy. We need to pay attention to their symptoms and their baseline quality of life measures and maybe support them better so they can tolerate and benefit more from treatment.” 

Transcript: 

I'm Efrat Dotan, I'm a medical oncologist from Fox Chase Cancer Center, and here at ASCO 2024 I will be presenting the results of the GIANT study (EA2186). This is a study that focused on older patients with metastatic pancreatic cancer who are vulnerable, and they had to comply with a screening geriatric assessment that identified these vulnerabilities. 

These vulnerable patients were randomized to 1 of 2 treatment arms: a dose-reduced gemcitabine and nab-paclitaxel and a dose-reduced 5-fluorouracil, leucovorin, and liposomal irinotecan. They were followed until disease progression, and we evaluated them for the primary end point of overall survival with additional secondary end points including quality of life, progression-free survival, and objective response rate. 

The results of the study showed that we were able to enroll a significant number of older adults. We had 176 patients enrolled with a median age of 77 with over 60% of them over the age of 75. When we looked at their vulnerability, many of them had vulnerabilities in multiple domains including functional status, comorbidities, and cognition. Patients, in terms of outcomes, had a similar overall survival between the 2 treatment regimens and a very similar toxicity profile, but what was interesting is that there was a significant percentage of patients that were unable to start therapy because their disease progressed so quickly, and they came off study very quickly. For those patients who were able to get treatment, these 2 regimens provided a median overall survival of about 8 months, which would be what we would expect for this patient population. We also did an initial analysis of some of their baseline factors like quality of life and nutrition and all of those correlated very strongly with how they did on their treatment.

The bottom line from this trial is that we need to do a better job identifying patients that are candidates for therapy, that can benefit from therapy. We need to pay attention to their symptoms and their baseline quality of life measures and maybe support them better so they can tolerate and benefit more from treatment.

Source: 

Dotan E. A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186. Presented at the ASCO Annual Meeting. May 31-June 4, 2024; Chicago, IL. Abstract #4003