- 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.
- 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.
- 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%).
- Open-label design.