Background
Retrospective pooled analysis (GERCOR). N=181 locally advanced pancreatic cancer (LAPC) from prospective GERCOR phase II/III studies. Compared sequential chemoradiation (CRT) after induction chemotherapy vs continued chemotherapy alone in non-progressors.
Interventions and follow up
Arm A: Induction chemotherapy followed by consolidative chemoradiation (CRT)
Arm B: Continued chemotherapy alone
Primary endpoint: Overall survival after consolidative CRT vs continued chemotherapy
mFollow up: Multi-year retrospective
Arm B: Continued chemotherapy alone
Primary endpoint: Overall survival after consolidative CRT vs continued chemotherapy
mFollow up: Multi-year retrospective
Results
mOS: 15.0 months (CRT) vs 11.7 months (continued chemo), P=.0009
mPFS: 10.8 months vs 7.4 months, P=.005
mPFS: 10.8 months vs 7.4 months, P=.005
Adverse events
Reporting: Not systematically reported (retrospective)
Tolerability: CRT generally tolerable per prospective protocol standards in this cohort
Tolerability: CRT generally tolerable per prospective protocol standards in this cohort
Conclusions
Sequential CRT after induction chemotherapy for LAPC was associated with significantly improved OS (15.0 vs 11.7 months) and PFS (10.8 vs 7.4 months) vs continued chemotherapy in non-progressors. This retrospective analysis provided the rationale for the LAP07 phase III trial.
Key Limitations
Retrospective, non-randomized comparison; selection bias (CRT favored fitter non-progressors after induction); pooled across trials; OS benefit not confirmed prospectively.
Clinical Context
Generated the induction-then-consolidative-CRT hypothesis for LAPC; directly motivated LAP07, which subsequently failed to confirm an OS benefit.