Nab-Paclitaxel (Nab-P) Plus Gemcitabine (Gem) Vs Gem Alone As Adjuvant Treatment For Resected Pancreatic Cancer (Pc) In A Phase Iii Trial (Apact).

TPS4153 Background: Adjuvant chemotherapy for resected PC has been shown to decrease recurrence and increase survival. Gem alone is a standard adjuvant therapy option. nab-P + Gem was superior to Gem alone as first-line treatment in a phase III trial in patients (pts) with metastatic PC, including the primary endpoint of overall survival (median, 8.5 vs 6.7 months; HR 0.72; P u003c 0.001). Toxicities were manageable. Based on these findings in the metastatic setting, the APACT trial will compare nab-P + Gem vs Gem alone in the adjuvant setting. Methods: Pts with histologically confirmed PC who underwent macroscopic complete resection (R0 or R1) within 12 weeks of randomization, with no evidence of metastasis at screening, are eligible for enrollment. Other eligibility criteria include staging of T1-3, N0-1, M0; Eastern Cooperative Oncology Group performance status of 0 or 1; acceptable hematologic function; CA19-9 u003c 100 U/mL prior to randomization; and no prior neoadjuvant therapy or radiation for PC. Pts wit...