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PREOPANC-2 asked whether the strongest chemotherapy given entirely before surgery beats the Dutch standard of gemcitabine chemoradiotherapy before and gemcitabine after; survival was the same, about 22 months in both arms, so both remain reasonable ways to treat first, and the question of surgery first against treatment first moves to Alliance A021806 and PREOPANC-3.
PREOPANC-2 randomised 375 patients with resectable or borderline resectable pancreatic ductal adenocarcinoma and WHO performance status 0 or 1 to total neoadjuvant FOLFIRINOX (eight two-weekly cycles, surgery, no adjuvant treatment) or the PREOPANC-1 regimen of neoadjuvant gemcitabine-based chemoradiotherapy, surgery and adjuvant gemcitabine. After a median follow-up of 42.3 months, median overall survival was 21.9 months (95 percent confidence interval 17.7 to 27.0) with FOLFIRINOX against 21.3 months (16.8 to 25.5) with chemoradiotherapy (hazard ratio 0.88, 0.69 to 1.13; p 0.32). Grade 3 or 4 neutropenia was 25 against 22 percent, diarrhoea 23 against 1 percent and leucopenia 8 against 15 percent; serious adverse events 49 against 43 percent; three treatment-related deaths. The trial did not show a difference and the authors concluded that either neoadjuvant regimen may be used. Read with PREOPANC-1 (chemoradiotherapy first beat surgery first at five years) it supports treating before surgery in this Dutch population, while NORPACT-1 argues the opposite for clearly resectable tumours.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
375 randomised.
95% CI 17.7 to 27.0 · 95% CI 16.8 to 25.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (modified intention to treat)primary | Neoadjuvant FOLFIRINOX, surgery | 185 | 21.9 months | 0.88 (0.69 to 1.13) | 0.32 | link |
| Neoadjuvant gemcitabine chemoradiotherapy, surgery, adjuvant gemcitabine | 184 | 21.3 months |
Shares ESPAC-5, Hypofractionated radiotherapy, Pancreatic cancer: the failed and stopped programmes and why, FOLFIRINOX / mFOLFIRINOX.
Shares Marc G. Besselink, PREOPANC-1, Erasmus MC Cancer Institute, Borderline resectable pancreatic ductal adenocarcinoma.
Shares Marc G. Besselink, PREOPANC-1, Erasmus MC Cancer Institute, FOLFIRINOX / mFOLFIRINOX.
Shares PREOPANC-3, PREOPANC-1, FOLFIRINOX / mFOLFIRINOX, Neoadjuvant / adjuvant / perioperative.
Shares PREOPANC-1, FOLFIRINOX / mFOLFIRINOX, Chemoradiation (chemoradiotherapy, CRT), Borderline resectable pancreatic ductal adenocarcinoma.
Shares ESPAC-5, FOLFIRINOX / mFOLFIRINOX, Borderline resectable pancreatic ductal adenocarcinoma, Gemcitabine.
Shares PREOPANC-3, PREOPANC-1, Pancreatic cancer: the failed and stopped programmes and why, FOLFIRINOX / mFOLFIRINOX.
Shares ESPAC-5, PREOPANC-1, FOLFIRINOX / mFOLFIRINOX, Borderline resectable pancreatic ductal adenocarcinoma.