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S0205

Gemcitabine plus cetuximab versus gemcitabine in advanced pancreatic adenocarcinoma (Southwest Oncology Group-directed intergroup trial S0205)

Phase 3N = 745NCT00075686

Population
Unresectable locally advanced or metastatic pancreatic adenocarcinoma
Design
Randomised phase 3 trial of gemcitabine alone versus gemcitabine plus cetuximab in unresectable locally advanced or metastatic pancreatic adenocarcinoma. Primary end point overall survival.
Primary endpoint
OS
Arms
  • Gemcitabine plus cetuximab (experimental): Gemcitabine plus cetuximab
  • Gemcitabine (control): Gemcitabine alone
People
Philip PA
OSHR 1.06 (95% CI 0.91–1.23)Δ median OS+0.4 months
Show the numbers
Results reported for S0205
EndpointAnalysisGemcitabine plus cetuximabGemcitabineEffect
OSEligible patients accrued (745)primaryPhilip 2010median 6.3 monthsmedian 5.9 monthsHR 1.06 (95% CI 0.91–1.23)P=.23, one-sided
Results reported for S0205
EndpointAnalysisGemcitabine plus cetuximabGemcitabineEffect
OSEligible patients accrued (745)primaryPhilip 2010median 6.3 monthsmedian 5.9 monthsHR 1.06 (95% CI 0.91–1.23)P=.23, one-sided
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.060.91–1.23
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Gemcitabine plus cetuximab (experimental)
  • Gemcitabine (control)

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

Data table (modelled values)
MonthsGemcitabine plus cetuximabGemcitabine
0100.0%100.0%
464.4%62.5%
841.5%39.1%
1226.7%24.4%
1617.2%15.3%
Primary publication: Philip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, et al. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol. 2010;28(22):3605-10. PubMedDOI

Appears in

Sources

  1. Philip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, et al. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol. 2010;28(22):3605-10.

    PubMedDOI