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A Korean trial found that adding liposomal irinotecan to fluorouracil as second-line chemotherapy for bile duct and gallbladder cancer delayed progression, from about six weeks to four months on the re-read scans, at the cost of more neutropenia. A German trial of the same idea was negative, so it is an option rather than a standard, and it is not commissioned in the UK.
NIFTY (NCT03524508) randomised 178 patients (174 in the full analysis set: 88 to liposomal irinotecan 70 mg/m² plus leucovorin 400 mg/m² and fluorouracil 2,400 mg/m² every two weeks, 86 to fluorouracil and leucovorin alone) with metastatic biliary tract cancer that had progressed on first-line gemcitabine and cisplatin, stratified by primary tumour site. At the primary analysis (median follow-up 11.8 months) blinded independent central review progression-free survival was 7.1 versus 1.4 months (hazard ratio 0.56, 95 percent confidence interval 0.39 to 0.81, p 0.0019). With extended follow-up and a re-performed masked central review by three new radiologists, the medians fell to 4.2 versus 1.7 months (hazard ratio 0.61, 0.44 to 0.86, p 0.004), a discordance the authors attributed to reader variation. Grade 3 to 4 neutropenia occurred in 24 versus 1 percent and serious adverse events in 42 versus 24 percent, with no treatment-related deaths. The German NALIRICC trial did not reproduce the benefit, though a pooled analysis modestly favoured the combination. NCCN lists the regimen as a second-line option; in the UK FOLFOX from ABC-06 is the commissioned second-line regimen and liposomal irinotecan is licensed only for pancreatic cancer.
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 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% |
Shares Liposomal irinotecan, Leucovorin (folinic acid), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Liposomal irinotecan, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Fluorouracil (5-FU).
Shares Liposomal irinotecan, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Fluorouracil (5-FU).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Fluorouracil (5-FU).
Shares Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Fluorouracil (5-FU), Biliary tract cancer (cholangiocarcinoma).
Shares Leucovorin (folinic acid), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Fluorouracil (5-FU).