TrialCurveKHBO1401-MITSUBA: reconstructed Kaplan–Meier curves
Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA). Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | J Hepatobiliary Pancreat Sci. 2022 Aug 9;30(1):102–10. doi: 10.1002/jhbp.1219 |
|---|---|
| DOI | 10.1002/jhbp.1219 |
| Registry | NCT02182778 |
| Phase | Phase 3 |
| Conditions | Biliary Tract Cancer |
| Interventions | Gemcitabine/Cisplatin, Gemcitabine/Cisplatin /S-1 |
| Sponsor | Kansai Hepatobiliary Oncology Group |
| Enrolment | 246 |
| Source licence | Figure published under CC BY 4.0 |
Overall survival
From figure panel · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Gemcitabine and cisplatin plus S-1 13.4 months; Gemcitabine and cisplatin 12.7 months. Survival at 12 months: Gemcitabine and cisplatin plus S-1 59%; Gemcitabine and cisplatin 53%. Hazard ratio Gemcitabine and cisplatin plus S-1 vs Gemcitabine and cisplatin 0.78 (95% CI 0.59–1.02).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Gemcitabine and cisplatin plus S-1 | 123 | 103 | 13.4 |
| Gemcitabine and cisplatin | 123 | 108 | 12.7 |
- Gemcitabine and cisplatin plus S-1 vs Gemcitabine and cisplatin: reconstructed HR 0.78 (95% CI 0.59–1.02)
Landmark survival (reconstructed)
| Time | Gemcitabine and cisplatin plus S-1 | Gemcitabine and cisplatin |
|---|---|---|
| 6 mo | 82.1% | 75.6% |
| 12 mo | 59.3% | 53.4% |
| 18 mo | 43.9% | 31.2% |
| 24 mo | 28.5% | 22.2% |
| 36 mo | 16.7% | 4.9% |
Checks against the published figure
- hazard ratio (direction inferred): printed 0.79, reconstructed 0.78 pass
Progression-free survival
From figure panel · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Gemcitabine and cisplatin plus S-1 7.4 months; Gemcitabine and cisplatin 5.5 months. Survival at 12 months: Gemcitabine and cisplatin plus S-1 25%; Gemcitabine and cisplatin 16%. Hazard ratio Gemcitabine and cisplatin plus S-1 vs Gemcitabine and cisplatin 0.75 (95% CI 0.58–0.97).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Gemcitabine and cisplatin plus S-1 | 123 | 116 | 7.4 |
| Gemcitabine and cisplatin | 123 | 120 | 5.5 |
- Gemcitabine and cisplatin plus S-1 vs Gemcitabine and cisplatin: reconstructed HR 0.75 (95% CI 0.58–0.97)
Landmark survival (reconstructed)
| Time | Gemcitabine and cisplatin plus S-1 | Gemcitabine and cisplatin |
|---|---|---|
| 6 mo | 60.2% | 47.2% |
| 12 mo | 25.2% | 16.3% |
| 18 mo | 15.4% | 8.1% |
| 24 mo | 8.1% | 3.3% |
| 36 mo | 5.7% | — |
Checks against the published figure
- hazard ratio (direction inferred): printed 0.75, reconstructed 0.753 pass
About these data
Pseudo-IPD reproduces the published curves and numbers at risk; the rows are not real patients. Cite the publication (DOI above) and TrialCurve. The source figure is © the authors (CC BY 4.0); the charts here are redrawn from the reconstruction.
Load these data in R or Python
# R
library(survival)
d <- read.csv("https://trialcurve.com/data/trials/khbo1401-mitsuba-1.csv")
survfit(Surv(time, event) ~ arm, data = d)
coxph(Surv(time, event) ~ arm, data = d)
# Python
import pandas as pd
from lifelines import KaplanMeierFitter
d = pd.read_csv("https://trialcurve.com/data/trials/khbo1401-mitsuba-1.csv")
for arm, g in d.groupby("arm"):
KaplanMeierFitter().fit(g.time, g.event, label=arm).plot_survival_function()
Suggested citation: J Hepatobiliary Pancreat Sci. 2022 Aug 9;30(1):102–10. doi: 10.1002/jhbp.1219 doi:10.1002/jhbp.1219. Reconstructed data: TrialCurve (2026), https://trialcurve.com/trials/khbo1401-mitsuba
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