NORPACT-1
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.
Overview
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.
- 60 vs 73 out of 100 reached this endpoint at 18 months with Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy compared with Upfront surgery, adjuvant chemotherapy; 13 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.032) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- Median 25.1 vs 38.5 months with Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy compared with Upfront surgery, adjuvant chemotherapy; about 13.4 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 52 percent higher chance of the event at any given time (hazard ratio 1.52, likely range 1 to 2.33).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 82 vs 89 out of 100 reached this endpoint with Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy compared with Upfront surgery, adjuvant chemotherapy; 7 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.24) means the difference could plausibly be due to chance.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 58 vs 40 out of 100 reached this endpoint with Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy compared with Upfront surgery, adjuvant chemotherapy; 18 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Resectable pancreatic head cancer in Norway, Sweden, Denmark and Finland: four cycles of neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy, against upfront surgery and adjuvant chemotherapy, with overall survival at 18 months as the primary endpoint. People in a different situation may not see the same effect.
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% |
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