ABC-06
After progression on cisplatin–gemcitabine, does second-line FOLFOX plus active symptom control improve survival over active symptom control alone?
Trial design and population
Key results
Median OS 6.2 months with FOLFOX+ASC vs 5.3 months with ASC alone (adjusted HR 0.69; 95% CI 0.50–0.97; p=0.031). Six-month OS 50.6% vs 35.5%; 12-month OS 25.9% vs 11.4%.
Source-reported outcome visualization
12-month overall survival · 12 months
Bars display source-reported values for the named endpoint; where the endpoint is a median, bars compare medians and do not represent probabilities. No unreported rates are inferred.
Absolute Effect
14.5 percentage-point increase in 12-month OS; source-reported estimate.
NNT: 7 (approximate reciprocal of 14.5%; 12-month OS endpoint). No NNT is derived from median survival/PFS differences.
NNH / harm: Grade 3–5 adverse events occurred in 69% with FOLFOX+ASC vs 52% with ASC alone; three chemotherapy-related deaths were reported in the FOLFOX arm.
NNT/NNH are only displayed where the endpoint and time horizon support a defensible absolute-risk calculation. Otherwise, the source-reported outcome is visualized.
Safety and treatment burden
Grade 3–5 adverse events occurred in 69% with FOLFOX+ASC vs 52% with ASC alone; three chemotherapy-related deaths were reported in the FOLFOX arm.
Follow-up, maturity and limitations
Open-label trial with modest median OS gain and meaningful treatment toxicity. Patients were fit enough for second-line chemotherapy; weigh performance status, goals and biliary complications.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates original trial findings from contemporary treatment context. Confirm current disease-specific guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent current standard practice; subgroup findings and immature endpoints should not be generalized.