NIFTY
A Korean randomised trial in which adding liposomal irinotecan to fluorouracil lengthened the time before second-line bile duct and gallbladder cancer grew; a later German trial did not reproduce the gain.
Overview
NIFTY randomised 174 analysed patients at five Korean centres (88 to liposomal irinotecan plus fluorouracil and leucovorin, 86 to fluorouracil and leucovorin) after progression on gemcitabine plus cisplatin. Median progression-free survival by blinded central review was 7.1 versus 1.4 months (hazard ratio 0.56, 95 percent CI 0.39 to 0.81). Grade 3 to 4 neutropenia was 24 versus 1 percent and serious adverse events 42 versus 24 percent. The German NALIRICC trial later found no benefit, so the regimen sits beside FOLFOX as an option rather than a standard.
- Median 7.1 vs 1.4 months with Liposomal irinotecan + 5-FU/LV compared with 5-FU/LV; about 5.7 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 44 percent lower chance of the event at any given time (hazard ratio 0.56, likely range 0.39 to 0.81).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 4.2 vs 1.7 months with Liposomal irinotecan + 5-FU/LV compared with 5-FU/LV; about 2.5 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 39 percent lower chance of the event at any given time (hazard ratio 0.61, likely range 0.44 to 0.86).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 24 vs 1 out of 100 reached this endpoint with Liposomal irinotecan + 5-FU/LV compared with 5-FU/LV; 23 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- 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: Metastatic biliary tract cancer after gemcitabine-cisplatin: liposomal irinotecan plus fluorouracil and leucovorin vs fluorouracil and leucovorin. 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.
178 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (blinded central review)primary | Liposomal irinotecan + 5-FU/LV | 88 | 7.1 months | 0.56 (0.39 to 0.81) | 0.0019 | link |
| 5-FU/LV | 86 | 1.4 months | ||||
| Progression-free survival by masked independent central review (updated, re-read) | Liposomal irinotecan + 5-FU/LV | 88 | 4.2 months | 0.61 (0.44 to 0.86) | 0.004 | link |
| 5-FU/LV | 86 | 1.7 months | ||||
| Grade 3-4 neutropenia | Liposomal irinotecan + 5-FU/LV | 88 | 24% | - | - | link |
| 5-FU/LV | 86 | 1% |
Notes
top- Key figures: 178 randomised (174 analysed, 88 versus 86); blinded central review progression-free survival 7.1 versus 1.4 months (hazard ratio 0.56, 0.39 to 0.81, p 0.0019) at the primary analysis and 4.2 versus 1.7 months (hazard ratio 0.61, 0.44 to 0.86, p 0.004) on the re-read with extended follow-up; grade 3 to 4 neutropenia 24 versus 1 percent; serious adverse events 42 versus 24 percent; no treatment-related deaths. Not reproduced by NALIRICC. Liposomal irinotecan is not commissioned for biliary cancer in the UK, where FOLFOX (ABC-06) is the second-line standard.
Similar pages
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