LAP07

NCT00634725 📎

Regimen

Experimental
R1: gemcitabine 1000 mg/m2 + erlotinib 100 mg/day vs gemcitabine alone, x 4 months. R2 (if no progression): chemoRT 54 Gy + capecitabine vs continued gemcitabine-based chemo x 2 mo.
Control
R1: gem alone (vs gem+erlotinib). R2: continued chemo (vs chemoRT).

Population

Locally advanced, unresectable PDAC, ECOG 0-2, French/European multicenter, 2 sequential randomizations.

Key finding

LAP07 showed neither consolidative chemoradiation (after 4 months of stable disease on induction chemo) nor added erlotinib improves OS in locally advanced PDAC. Consolidative chemoRT did improve local control without translating to survival benefit. The trial refocused LA-PDAC practice on systemic therapy intensification.

Source: PMID 27139057

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.7)