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NORPACT-1 asked whether giving FOLFIRINOX chemotherapy before surgery helps people whose pancreatic cancer can be removed straight away; it did not, and patients who went straight to surgery were if anything more likely to be alive at 18 months, so upfront surgery remains the standard for clearly resectable disease.
NORPACT-1 was a Nordic multicentre randomised phase 2 trial in 140 patients with resectable pancreatic head cancer, assigned to four cycles of neoadjuvant FOLFIRINOX then surgery and adjuvant chemotherapy (77) or upfront surgery and adjuvant chemotherapy (63). The primary endpoint was the proportion alive at 18 months by intention to treat.
At 18 months 60 percent of the neoadjuvant group were alive against 73 percent of the upfront surgery group, and median overall survival was 25.1 against 38.5 months (hazard ratio 1.52); resection rates were similar (82 against 89 percent) and grade 3 or worse adverse events were more frequent with neoadjuvant treatment. With PREOPANC on the other side of the argument, NORPACT-1 is the evidence the corpus's resectable pancreatic cancer page cites against routine neoadjuvant chemotherapy 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.
140 enrolled.
95% CI 49 to 71 · 95% CI 62 to 84
Source95% CI 17.2 to 34.9 · 95% CI 27.6 to not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Alive at 18 months (intention to treat)primary | Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy | 77 | 60% | - | 0.032 | link |
| Upfront surgery, adjuvant chemotherapy | 63 | 73% | ||||
| Overall survival (intention to treat) | Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy | 77 | 25.1 months | 1.52 (1 to 2.33) | 0.050 | link |
| Upfront surgery, adjuvant chemotherapy | 63 | 38.5 months | ||||
| Resection rate | Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy | 77 | 82% | - | 0.24 | link |
| Upfront surgery, adjuvant chemotherapy | 63 | 89% | ||||
| Patients with at least one grade 3 or worse adverse event (safety population) | Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy | 73 | 58% | - | - | link |
| Upfront surgery, adjuvant chemotherapy | 47 | 40% |
Shares Oxaliplatin, Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Fluorouracil (5-FU), Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Pancreatic cancer: the failed and stopped programmes and why, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares FOLFIRINOX / mFOLFIRINOX, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Oxaliplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.