ESPAC-5F

Background

ESPAC-5F. Phase II randomized trial enrolled 90 patients with borderline resectable pancreatic cancer comparing immediate surgery with neoadjuvant therapy (restaging at 4–6 weeks, then surgery if still resectable). Reported as an ASCO 2020 abstract.

Interventions and follow up

Arm A: Neoadjuvant gemcitabine + capecitabine (GEMCAP) x 2 cycles
Arm B: Neoadjuvant FOLFIRINOX x 4 cycles
Arm C: Neoadjuvant capecitabine-based chemoradiation (50.4 Gy in 28 fractions over 5½ weeks)
Arm D: Immediate surgery (control)
Primary endpoint: Recruitment rate and resection rate (R0/R1); secondary: OS and AEs
mFollow up: 12 mo

Results

R0 resection rate: 23% (immediate surgery) vs 15% (pooled neoadjuvant), P=.721
1-yr OS: 77% (neoadjuvant) vs 40% (immediate surgery); HR 0.27, 95%CI 0.13–0.55; P<.001
1-yr OS FOLFIRINOX arm: 84%

Adverse events

Chemotherapy-related: Detailed grade≥3 toxicity not reported in the abstract (NR); FOLFIRINOX expected to carry higher hematologic and GI toxicity than GEMCAP
Surgical: Postoperative complication rates not separately reported in the abstract (NR)

Conclusions

In borderline resectable pancreatic cancer, neoadjuvant therapy did not increase the resection rate but markedly improved 1-year survival versus immediate surgery, supporting a neoadjuvant approach.

Key Limitations

Preliminary phase II abstract; small per-arm numbers; short 12-month follow-up; not powered to compare neoadjuvant regimens against each other; full peer-reviewed publication and mature OS data awaited.

Clinical Context

Supports neoadjuvant chemotherapy for borderline resectable pancreatic cancer, consistent with ESMO/ASCO guidance favoring upfront systemic therapy in this setting; complements PREOPANC and Alliance A021501 data informing the neoadjuvant FOLFIRINOX standard.

References