Effect of baseline geriatric and quality of life assessments on treatment outcomes in ECOG-ACRIN EA2186 (GIANT): 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.

• DOI: 10.1200/jco.2025.43.4_suppl.676
• Publication Date: 2025-01-27T14:37:03Z
• Authors: Efrat Dotan; Paul J. Catalano; Leon Lenchik; Robert Boutin; Xin Yao; James Ohr; Kian-Huat Lim; George A. Fisher; Namrata Vijayvergia; Sreenivasa R Chan...; Aparna Kalyan; Richard Francis D...; David Bing Zhen; Daneng Li; Kim Anna Reiss; Melissa A. Simon; Jordan Berlin; Lynne I. Wagner; Peter J. O'Dwyer
• Keywords: Clinical endpoint; Nab-paclitaxel

676 Background: Data is lacking to guide the care of vulnerable older adults (OA) with newly diagnosed metastatic pancreatic adenocarcinoma (mPDAC). EA2186 trial demonstrated poor outcomes among OA mPDAC treated dose-reduced chemotherapy. To understand factors driving treatment in this patient population, we analyzed correlation between baseline geriatric and quality life (QOL) assessments outcomes. Methods: Vulnerable ≥70 yo mPDAC, ECOG PS 0-2 were enrolled. Vulnerability was defined by screening assessment (GA) demonstrating mild abnormalities function, comorbidities, cognition, or age≥80y. Pts randomized Arm A: Gemcitabine (1000mg/m2) + Nab-Paclitaxel (125mg/m2) q14 days B: 5-Fluorouracil (2400mg/m2 46hr) Leucovorin (400mg/m2) Liposomal Irinotecan (50mg/m2) days. GA QOL evaluations completed at 3 time points. Secondary endpoints study included evaluating GA, Regression models used evaluate associations factors, survival grade higher toxicity, 80% power detect doubling toxicity for GA/QOL measures. Results: 176 pts (88 per arm) enrolled median age 77 (range 70-90), 24% ECOG-0, 64% ECOG-1 12% ECOG-2. deemed cognition (46%), (36%) comorbidities (31.4%), 35% meeting vulnerability criteria ≥2 domains. No significant difference seen OS (4.7 vs. 4.4 months; p=0.72) ≥grade rate (45.6% 58.7%; p=0.10) arms A B, respectively. Strong found instrumental activities daily living score (HR 0.84; p=0.02), nutritional scores 0.82; p<0.0001), depression 1.07; all measures 0.98; p<0.0001). comorbidity, Activities Daily Living scores. After adjustment PS, only WBC level (OR=0.35; p=0.0054), (OR=1.20 unit; p=0.021) a lesser extent FACT-G (OR=0.98 p=0.061) correlate rates toxicity. Conclusions: Baseline strongly tolerance. Supportive address these may favorably affect population. Clinical information: NCT04233866 .