Locally advanced pancreatic cancer: nab-paclitaxel+gemcitabine shows promise

  • Philip PA & al.
  • Lancet Gastroenterol Hepatol
  • 14 Jan 2020

  • curated by Jim Kling
  • Univadis Clinical Summaries
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

  • The median time to treatment failure for nab-paclitaxel plus gemcitabine exceeded the protocol-specified target in locally advanced pancreatic cancer.           

Why this matters

  • No prospective data are available for either nab-paclitaxel plus gemcitabine or FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) in locally advanced pancreatic cancer.

Study design

  • International, open-label phase 2 clinical trial (LAPACT, N=107).
  • Patients underwent 6 cycles of induction therapy with nab-paclitaxel plus gemcitabine, followed by the investigator’s choice of continued nab-paclitaxel plus gemcitabine, chemoradiation, or surgery.
  • Funding: Celgene.

Key results

  • 58% completed induction therapy, and 44% continued treatment after induction therapy (11% nab-paclitaxel plus gemcitabine, 17% chemoradiation, 16% surgery).
  • 17 patients underwent surgery: 7 had R0 resection status, 9 had R1.
  • Median time to treatment failure was 9.0 (90% CI, 7.3-10.1) months, exceeding the protocol-specified target of 6.6 months.
  • Median PFS: 10.9 (90% CI, 9.3-11.6) months.
  • Median OS: 18.8 (90% CI, 15.0-24.0) months.
  • Disease control rate during induction: 77.6% (90% CI, 70.3%-83.5%).
  • Overall response rate during induction: 33.6% (90% CI, 26.6%-41.5%).
  • Treatment-emergent adverse events during induction grade ≥3 included neutropenia (33%), anemia (11%), and fatigue (10%).
  • Treatment-emergent serious adverse events during induction included pneumonia (5%), pyrexia (5%), and febrile neutropenia (3%).

Limitations

  • Uncontrolled.
  • Open-label design.