Background
Phase II single-arm trial (LAPACT). 107 patients with previously untreated locally advanced pancreatic cancer (LAPC) at 35 sites in 5 countries. Evaluated nab-paclitaxel + gemcitabine as induction therapy, with continued treatment per investigator's choice (continued nab-P + gem, chemoradiotherapy, or surgery) after 6 induction cycles.
Interventions and follow up
Arm A: nab-Paclitaxel 125 mg/m² + gemcitabine 1,000 mg/m² days 1, 8, 15 every 28 days ×6 cycles → continued nab-P+gem, chemoradiotherapy, or surgery (investigator's choice)
Primary endpoint: Time to treatment failure (TTF)
Median follow-up: NR
Primary endpoint: Time to treatment failure (TTF)
Median follow-up: NR
Results
mTTF: 9.0 months (90% CI 7.3–10.1)
mPFS: 10.9 months (90% CI 9.3–11.6)
mOS: 18.8 months (90% CI 15.0–24.0)
Disease control rate: 77.6%
ORR: 33.6%
Resection rate: 16% (17 patients — 7 R0, 9 R1)
mPFS: 10.9 months (90% CI 9.3–11.6)
mOS: 18.8 months (90% CI 15.0–24.0)
Disease control rate: 77.6%
ORR: 33.6%
Resection rate: 16% (17 patients — 7 R0, 9 R1)
Adverse events
Hematologic: Grade ≥3 neutropenia 33%, anemia 11%.
Non-hematologic: Grade ≥3 fatigue 10%; treatment discontinuation for AEs 21%; no treatment-related deaths during induction.
Non-hematologic: Grade ≥3 fatigue 10%; treatment discontinuation for AEs 21%; no treatment-related deaths during induction.
Conclusions
nab-Paclitaxel + gemcitabine demonstrated activity in LAPC with a disease control rate of 77.6%, mPFS of 10.9 months, and mOS of 18.8 months. 16% of patients achieved surgical resection including 7 R0 resections. The regimen is feasible and active, comparable to FOLFIRINOX in historical comparison.
Key Limitations
Single-arm phase 2 study with no randomized comparator. Relatively small (n=107). Response-based outcomes and resection rates depend on institutional expertise and selection criteria. The primary endpoint (TTF) is non-standard and less informative than PFS/OS. FOLFIRINOX remains the more established induction regimen (per ACCORD 11 extrapolation and Suker meta-analysis). No head-to-head comparison with FOLFIRINOX in LAPC exists.
Clinical Context
LAPACT supports nab-paclitaxel + gemcitabine as a reasonable alternative induction regimen for LAPC, particularly in patients unable to tolerate FOLFIRINOX. The 16% surgical conversion rate and 18.8-month mOS are clinically meaningful. ESMO guidance supports either FOLFIRINOX or nab-paclitaxel + gemcitabine for LAPC induction in fit patients.
References