APACT

NCT01964430 📎

Regimen

Experimental
Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 d1, 8, 15 q4w x 6 cycles.
Control
Gemcitabine 1000 mg/m2 d1, 8, 15 q4w x 6 cycles.

Population

Resected PDAC (R0/R1), post-surgery within 12 weeks, ECOG PS 0-1, global multicenter.

Key finding

APACT missed its DFS primary endpoint on blinded-independent review, although investigator-assessed DFS (HR 0.82, p=0.02) and OS (HR 0.82, p=0.045) favored the combination. The trial is widely cited as a cautionary tale on endpoint-assessment method; not adopted as new adjuvant standard.

Source: PMID 36521097

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.141)