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Bending the Curve Trial by Trial
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ABC-02

Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer

Phase 3N = 410NCT00262769

Population
Patients with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer or ampullary cancer
Design
Randomised phase 3 trial, extended from a randomised phase 2 study of 86 patients after an improvement in progression-free survival was seen. Patients with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer or ampullary cancer received cisplatin followed by gemcitabine, or gemcitabine alone, for up to 24 weeks. The primary end point was overall survival; the analysis was done after a median follow-up of 8.2 months and 327 deaths.
Primary endpoint
OS
Arms
  • Cisplatin plus gemcitabine (experimental, n = 204): Cisplatin 25 mg/m2 followed by gemcitabine 1000 mg/m2 on days 1 and 8, every 3 weeks for eight cycles
  • Gemcitabine alone (control, n = 206): Gemcitabine 1000 mg/m2 on days 1, 8 and 15, every 4 weeks for six cycles
People
Valle J
OSHR 0.64 (95% CI 0.52–0.80)Δ median OS+3.6 monthsΔ median PFS+3 months
Show the numbers
Results reported for ABC-02
EndpointAnalysisCisplatin plus gemcitabineGemcitabine aloneEffect
OSRandomly assigned patients (the abstract does not name the analysis population)primarymedian follow-up 8.2 monthsValle 2010median 11.7 monthsmedian 8.1 monthsHR 0.64 (95% CI 0.52–0.80)P<0.001The abstract gives no confidence intervals for the median values. Analysis after 327 deaths.
PFSRandomly assigned patients (the abstract does not name the analysis population)primaryValle 2010median 8 monthsmedian 5 monthsP<0.001The abstract gives no hazard ratio or confidence intervals for progression-free survival.
Results reported for ABC-02
EndpointAnalysisCisplatin plus gemcitabineGemcitabine aloneEffect
OSRandomly assigned patients (the abstract does not name the analysis population)primarymedian follow-up 8.2 monthsValle 2010median 11.7 monthsmedian 8.1 monthsHR 0.64 (95% CI 0.52–0.80)P<0.001The abstract gives no confidence intervals for the median values. Analysis after 327 deaths.
PFSRandomly assigned patients (the abstract does not name the analysis population)primaryValle 2010median 8 monthsmedian 5 monthsP<0.001The abstract gives no hazard ratio or confidence intervals for progression-free survival.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.640.52–0.8
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Cisplatin plus gemcitabine (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)
MonthsCisplatin plus gemcitabineGemcitabine alone
0100.0%100.0%
766.1%54.9%
1541.1%27.7%
2227.2%15.2%
2917.9%8.4%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Cisplatin plus gemcitabine (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)
MonthsCisplatin plus gemcitabineGemcitabine alone
0100.0%100.0%
564.8%50.0%
1042.0%25.0%
1527.3%12.5%
2017.7%6.3%
Primary publication: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273-81. PubMedDOI

Appears in

Sources

  1. Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273-81.

    PubMedDOI