NAPOLI 3
The first head-to-head trial of the two chemotherapy backbones, won narrowly by the four-drug regimen.
770 patients. OS 11.1 vs 9.2 months (HR 0.84, p=0.04); PFS 7.4 vs 5.6 months (HR 0.69). Led to FDA approval of NALIRIFOX (February 2024). Critics note the absence of a mFOLFIRINOX arm.
- Median 11.1 vs 9.2 months with NALIRIFOX compared with Gemcitabine + nab-paclitaxel; about 1.9 months longer 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 17 percent lower chance of the event at any given time (hazard ratio 0.83, likely range 0.7 to 0.99).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: First-line metastatic PDAC: NALIRIFOX vs gemcitabine + nab-paclitaxel. 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.
770 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | NALIRIFOX | 383 | 11.1 months | 0.83 (0.7–0.99) | 0.036 | link |
| Gemcitabine + nab-paclitaxel | 387 | 9.2 months |
Pages like this
not linked directly; found by shared links- TrialPRODIGE 24 / CCTG PA6
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Shares Cold tumours and the immunosuppressive microenvironment, Pancreatic ductal adenocarcinoma.
- CompanyIpsen
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- InstitutionSalk Institute Cancer Center
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Shares Cold tumours and the immunosuppressive microenvironment, Pancreatic ductal adenocarcinoma.