- Adding nab-paclitaxel to adjuvant gemcitabine failed to improve DFS in a phase 3 trial of patients with resected pancreatic adenocarcinoma.
- However, interim data did show an OS advantage along with expected treatment-emergent adverse events (TEAEs).
Why this matters
- A prior phase 3 trial (MPACT) demonstrated significantly longer OS with nab-P/G vs G in metastatic PC.
- APACT multicenter, international, open-label trial of 866 patients with resected T1-3, N0-1 pancreatic adenocarcinoma, randomly assigned to receive adjuvant gemcitabine with or without nab-paclitaxel.
- Primary endpoint: independently assessed DFS.
- Secondary endpoints: OS, safety.
- Overall, 69% of patients completed 6 treatment cycles.
- The primary endpoint was not met: independently assessed DFS failed to significantly differ between the 2 groups (P=.1824).
- Interim OS was significantly longer with nab-paclitaxel+gemcitabine vs gemcitabine alone (40.5 vs 36.2 months; P=.045).
- Add-on nab-paclitaxel increased TEAEs vs gemcitabine alone:
- ≥1 grade ≥3 TEAE: nab-P/G 86%, G 68%.
- ≥1 serious TEAE: nab-P/G 41%, G 23%.
- OS data are yet to be finalized.