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JCOG1113/FUGA-BT

Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial

Phase 3N = 354

Population
Chemotherapy-naive patients with recurrent or unresectable biliary tract cancer
Design
Randomised phase 3 non-inferiority trial in 33 institutions in Japan of gemcitabine plus S-1 (GS) versus gemcitabine plus cisplatin (GC) in chemotherapy-naive patients with recurrent or unresectable biliary tract cancer and ECOG performance status 0 or 1. The primary end point was overall survival; the calculated sample size was 350 (one-sided alpha 5%, power 80%, non-inferiority margin for the hazard ratio 1.155). 354 patients were enrolled between May 2013 and March 2016.
Primary endpoint
OS
Arms
  • Gemcitabine plus S-1 (experimental): Gemcitabine plus S-1 (doses not stated in the abstract)
  • Gemcitabine plus cisplatin (control): Gemcitabine plus cisplatin (doses not stated in the abstract)
People
Morizane C
OSHR 0.945Δ median OS+1.7 monthsPFSHR 0.86 (95% CI 0.70–1.07)Δ median PFS+1 months
Show the numbers
Results reported for JCOG1113/FUGA-BT
EndpointAnalysisGemcitabine plus S-1Gemcitabine plus cisplatinEffect
OSEnrolled patients (the abstract does not name the analysis population)primaryMorizane 2019median 15.1 monthsmedian 13.4 monthsHR 0.945P=0.046 (for non-inferiority)The confidence interval of the hazard ratio is a 90% interval, 0.78 to 1.15, not a 95% interval. The P value is for non-inferiority of gemcitabine plus S-1; this was a non-inferiority design, not a superiority test. The abstract gives no confidence intervals for the medians.
PFSEnrolled patients (the abstract does not name the analysis population)primaryMorizane 2019median 6.8 monthsmedian 5.8 monthsHR 0.86 (95% CI 0.70–1.07)Secondary end point; the abstract gives no P value.
Results reported for JCOG1113/FUGA-BT
EndpointAnalysisGemcitabine plus S-1Gemcitabine plus cisplatinEffect
OSEnrolled patients (the abstract does not name the analysis population)primaryMorizane 2019median 15.1 monthsmedian 13.4 monthsHR 0.945P=0.046 (for non-inferiority)The confidence interval of the hazard ratio is a 90% interval, 0.78 to 1.15, not a 95% interval. The P value is for non-inferiority of gemcitabine plus S-1; this was a non-inferiority design, not a superiority test. The abstract gives no confidence intervals for the medians.
PFSEnrolled patients (the abstract does not name the analysis population)primaryMorizane 2019median 6.8 monthsmedian 5.8 monthsHR 0.86 (95% CI 0.70–1.07)Secondary end point; the abstract gives no P value.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.860.7–1.07
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Gemcitabine plus S-1 (experimental)
  • Gemcitabine plus cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsGemcitabine plus S-1Gemcitabine plus cisplatin
0100.0%100.0%
966.2%62.8%
1941.8%37.4%
2827.7%23.5%
3817.5%14.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Gemcitabine plus S-1 (experimental)
  • Gemcitabine plus cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsGemcitabine plus S-1Gemcitabine plus cisplatin
0100.0%100.0%
466.5%62.0%
940.0%34.1%
1326.6%21.1%
1717.7%13.1%
Primary publication: Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019;30(12):1950-1958. PubMedDOI

Appears in

Sources

  1. Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, et al. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019;30(12):1950-1958.

    PubMedDOI