LAP07

Background

Phase III RCT (LAP07). N=442 LAPC controlled (no progression) after 4 months induction gemcitabine ± erlotinib. Two-step randomization: (1) gemcitabine ± erlotinib, then (2) chemoradiotherapy vs continued chemotherapy. Definitive prospective test of induction chemo → CRT strategy.

Interventions and follow up

Arm A: Induction gemcitabine ± erlotinib × 4 months, then CRT (capecitabine + 54 Gy RT) if no progression
Arm B: Induction gemcitabine ± erlotinib × 4 months, then continued chemotherapy
Primary endpoint: Overall survival
mFollow up: Median 36.7 months

Results

mOS (CRT vs continued chemo): 15.2 vs 16.5 months, HR 1.03, P=.83 — no difference
Erlotinib vs no erlotinib: no OS benefit (HR 1.09, P=.49)
Local progression-free survival: significantly improved with CRT (HR 0.57, P<.001)
Grade ≥3 toxicity (step 2): 36% (CRT) vs 27% (chemo)

Adverse events

CRT grade ≥3: nausea 11%, fatigue 9%
Erlotinib arms: higher toxicity overall
Grade 5: No grade 5 events attributed to treatment

Conclusions

CRT after induction gemcitabine in LAPC did not improve OS vs continued chemotherapy (15.2 vs 16.5 months, P=.83), despite significantly improving local PFS. Erlotinib added no benefit. LAP07 effectively ended routine consolidative CRT after induction chemo as OS-improving therapy in unselected LAPC.

Key Limitations

Older induction backbone (gemcitabine, not FOLFIRINOX); conventional 54 Gy RT, not SBRT/dose-escalated; only non-progressors randomized; local PFS a secondary endpoint.

Clinical Context

Practice-defining negative trial; ESMO regards consolidative CRT in LAPC as offering local control but no OS gain. Ongoing interest in SBRT and modern FOLFIRINOX-based induction for selected patients.

References