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Bending the Curve Trial by Trial
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BT22

Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan

Phase 2N = 84NCT00380588

Population
Chemotherapy-naive patients with locally advanced or metastatic biliary tract cancer
Design
Multicentre randomised phase 2 trial in Japan in chemotherapy-naive patients with locally advanced or metastatic biliary tract cancer. Patients received cisplatin followed by gemcitabine on days 1 and 8 of a 21-day cycle, or gemcitabine alone on days 1, 8 and 15 of a 28-day cycle, for at least 12 weeks and up to a maximum of 48 weeks. The primary objective was to compare the 1-year survival rate; 84 patients were randomised and 83 were included in the analysis.
Primary endpoint
Overall survival at 12 months
Arms
  • Gemcitabine plus cisplatin (experimental, n = 41): Cisplatin 25 mg/m2 followed by gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle
  • Gemcitabine alone (control, n = 42): Gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle
People
Okusaka T
OSHR 0.69 (95% CI 0.42–1.13)Δ median OS+3.5 monthsΔ 12-month OS+8 pointsPFSHR 0.66 (95% CI 0.41–1.05)Δ median PFS+2.1 months
Show the numbers
Results reported for BT22
EndpointAnalysisGemcitabine plus cisplatinGemcitabine aloneEffect
OSPatients included in the analysis (83 of 84 randomised)primaryOkusaka 2010median 11.2 months (9.1–12.5); 39% at 12 mo (23.7–54.4%)median 7.7 months (6.1–11.0); 31% at 12 mo (17.0–44.9%)HR 0.69 (95% CI 0.42–1.13)P=0.139The 1-year survival rate was the primary outcome; Table 2 of the open full text lists no P value against the 1-year rates. The P value shown is for the hazard ratio. Medians and 1-year rates also appear in the abstract; confidence intervals and the hazard ratio are from the open full text (Table 2).
PFSPatients included in the analysis (83 of 84 randomised)primaryOkusaka 2010median 5.8 months (4.1–8.2)median 3.7 months (2.1–5.3)HR 0.66 (95% CI 0.41–1.05)P=0.077Secondary endpoint. The P value shown is for the hazard ratio. Medians also appear in the abstract; confidence intervals and the hazard ratio are from the open full text (Table 2).
Results reported for BT22
EndpointAnalysisGemcitabine plus cisplatinGemcitabine aloneEffect
OSPatients included in the analysis (83 of 84 randomised)primaryOkusaka 2010median 11.2 months (9.1–12.5); 39% at 12 mo (23.7–54.4%)median 7.7 months (6.1–11.0); 31% at 12 mo (17.0–44.9%)HR 0.69 (95% CI 0.42–1.13)P=0.139The 1-year survival rate was the primary outcome; Table 2 of the open full text lists no P value against the 1-year rates. The P value shown is for the hazard ratio. Medians and 1-year rates also appear in the abstract; confidence intervals and the hazard ratio are from the open full text (Table 2).
PFSPatients included in the analysis (83 of 84 randomised)primaryOkusaka 2010median 5.8 months (4.1–8.2)median 3.7 months (2.1–5.3)HR 0.66 (95% CI 0.41–1.05)P=0.077Secondary endpoint. The P value shown is for the hazard ratio. Medians also appear in the abstract; confidence intervals and the hazard ratio are from the open full text (Table 2).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.690.42–1.13
PFS0.660.41–1.05
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Gemcitabine plus cisplatin (experimental)
  • Gemcitabine alone (control)

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

Data table (modelled values)
MonthsGemcitabine plus cisplatinGemcitabine alone
0100.0%100.0%
764.8%53.3%
1442.0%28.4%
2127.3%15.1%
2817.7%8.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Gemcitabine plus cisplatin (experimental)
  • Gemcitabine alone (control)

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

Data table (modelled values)
MonthsGemcitabine plus cisplatinGemcitabine alone
0100.0%100.0%
462.0%47.3%
743.3%26.9%
1126.9%12.7%
1516.7%6.0%
Primary publication: Okusaka T, Nakachi K, Fukutomi A, Mizuno N, Ohkawa S, Funakoshi A, et al. Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer. 2010;103(4):469-74. PubMedDOI

Appears in

Sources

  1. Okusaka T, Nakachi K, Fukutomi A, Mizuno N, Ohkawa S, Funakoshi A, et al. Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer. 2010;103(4):469-74.

    PubMedDOI