ASCO 2019 — Adjuvant nab-paclitaxel fails phase 3 trial for pancreatic cancer


  • Hao Cheng, MD
  • Oncology Conference reports
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%.

Limitations

  • OS data are yet to be finalized.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit