NAPOLI-1
After gemcitabine-based therapy for metastatic pancreatic cancer, does nanoliposomal irinotecan plus 5-FU/leucovorin improve survival?
Trial design and population
Key results
Median OS was 6.1 months with nanoliposomal irinotecan plus 5-FU/LV vs 4.2 months with 5-FU/LV alone (HR 0.67, 95% CI 0.49–0.92; P=.012). Median PFS was 3.1 vs 1.5 months.
Source-reported outcome visualization
Median overall survival · Median
Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.
Absolute Effect
Median OS difference 1.9 months is not an NNT; no fixed-time OS rate is used here.
NNT: Not calculated; median OS difference is not a valid NNT. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.
NNH: Not quantifiable. Grade 3–4 neutropenia occurred in about 27%, diarrhoea 13%, fatigue 14% and vomiting 11% with the combination. Monitor diarrhoea, dehydration, myelosuppression and nutritional status.
Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.
Safety and treatment burden
Grade 3–4 neutropenia occurred in about 27%, diarrhoea 13%, fatigue 14% and vomiting 11% with the combination. Monitor diarrhoea, dehydration, myelosuppression and nutritional status.
Follow-up, maturity and limitations
Follow-up: Primary report median follow-up approximately 9.2 months.
Applies after gemcitabine-based treatment; performance status and ability to tolerate combination chemotherapy are key.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.