Japanese BT22
In advanced biliary tract cancer, does gemcitabine plus cisplatin improve outcomes over gemcitabine alone in a Japanese phase II study?
Trial design and population
Key results
Median OS was approximately 11.2 months with gemcitabine–cisplatin vs 7.7 months with gemcitabine alone; phase II study and estimates are imprecise. The study helped support subsequent confirmatory testing, including ABC-02.
Source-reported outcome visualization
Median overall survival · Median, 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
Median OS difference 3.5 months; not a fixed-time absolute risk difference.
NNT: Not quantifiable from median OS difference. No NNT is derived from median survival/PFS differences.
NNH / harm: Cisplatin adds myelosuppression, nausea/vomiting, nephrotoxicity and electrolyte loss; use the original trial report for exact arm-specific grade ≥3 toxicity.
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
Cisplatin adds myelosuppression, nausea/vomiting, nephrotoxicity and electrolyte loss; use the original trial report for exact arm-specific grade ≥3 toxicity.
Follow-up, maturity and limitations
Small phase II Japanese study; do not treat as equivalent in precision to the larger phase III ABC-02 trial.
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 Historical comparators may no longer represent current standard practice; subgroup findings and immature endpoints should not be generalized.