Phase III APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P + Gem) versus gemcitabine (Gem) alone for patients with resected pancreatic cancer (PC): Outcomes by geographic region

4515 Background: The APACT trial was one of the largest and most geographically diverse trials of adjuvant chemotherapy for resected PC, allowing for comparison of outcomes by geographic region. In this analysis, we report updated overall survival (OS) results for the intent-to-treat (ITT) population and examine outcomes by geographic region. Methods: Treatment-naive patients with histologically confirmed PC, macroscopic complete resection, Eastern Cooperative Oncology Group performance status 0 or 1, and carbohydrate antigen 19-9 < 100 U/mL were eligible. Stratification factors were resection status (R0/R1) and lymph node status (positive/negative). Treatment was initiated ≤ 12 weeks postsurgery. Patients received nab-P 125 mg/m2 + Gem 1000 mg/m2 or Gem 1000 mg/m2 on days 1, 8, and 15 of six 28-day cycles. The primary endpoint was disease-free survival by independent review. Secondary endpoints were OS and safety. Results: The updated OS analysis (data cutoff date, January 2020) revealed a median OS of 41.8 months with nab-P + Gem compared with 37.7 months with Gem alone (hazard ratio [HR] 0.81; 95% CI, 0.68 - 0.97; nominal P = 0.047; Table). In each geographic region, the median OS with nab-P + Gem was numerically longer than with Gem alone. Conclusions: The updated OS analysis of the ITT population supports the previously reported trend favoring nab-P + Gem. The geographic regional analyses reveal numerically longer OS with nab-P + Gem vs Gem alone and variable outcomes by region; however, the differences do not support the trend observed in the ITT population, potentially due to limited sample sizes. Registration: EudraCT (2013-003398-91). Clinical trial information: NCT01964430 . [Table: see text]