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SWOG S1815

SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

Phase 3N = 452NCT03768414

Population
People with newly diagnosed locally advanced unresectable or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma)
Design
Randomised (2:1), open-label phase 3 trial of gemcitabine, cisplatin and nab-paclitaxel (GAP) versus gemcitabine and cisplatin in newly diagnosed locally advanced unresectable or metastatic biliary tract cancer. The primary end point was overall survival, analysed in all eligible participants (modified intention to treat). 452 participants were randomly assigned; 441 were eligible and analysable.
Primary endpoint
OS
Arms
  • Gemcitabine, cisplatin and nab-paclitaxel (experimental, n = 294): Gemcitabine 800 mg/m2, cisplatin 25 mg/m2 and nab-paclitaxel 100 mg/m2 intravenously on days 1 and 8 of a 21-day cycle
  • Gemcitabine and cisplatin (control, n = 147): Gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 intravenously on days 1 and 8 of a 21-day cycle
People
Shroff RT
OSHR 0.91 (95% CI 0.72–1.14)Δ median OS+0.4 monthsPFSHR 0.89 (95% CI 0.71–1.12)Δ median PFS+1.2 months
Show the numbers
Results reported for SWOG S1815
EndpointAnalysisGemcitabine, cisplatin and nab-paclitaxelGemcitabine and cisplatinEffect
OSEligible and analysable participants (441 of 452 randomly assigned)primaryShroff 2025median 14 months (12.4–16.1)median 13.6 months (9.7–16.6)HR 0.91 (95% CI 0.72–1.14)P=0.41The abstract states there was no significant difference in overall survival between the arms.
PFSEligible and analysable participants (441 of 452 randomly assigned)primaryShroff 2025median 7.5 months (6.4–8.5)median 6.3 months (4.4–8.2)HR 0.89 (95% CI 0.71–1.12)P=0.32Secondary end point; the abstract describes progression-free survival as similar between the groups.
Results reported for SWOG S1815
EndpointAnalysisGemcitabine, cisplatin and nab-paclitaxelGemcitabine and cisplatinEffect
OSEligible and analysable participants (441 of 452 randomly assigned)primaryShroff 2025median 14 months (12.4–16.1)median 13.6 months (9.7–16.6)HR 0.91 (95% CI 0.72–1.14)P=0.41The abstract states there was no significant difference in overall survival between the arms.
PFSEligible and analysable participants (441 of 452 randomly assigned)primaryShroff 2025median 7.5 months (6.4–8.5)median 6.3 months (4.4–8.2)HR 0.89 (95% CI 0.71–1.12)P=0.32Secondary end point; the abstract describes progression-free survival as similar between the groups.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.910.72–1.14
PFS0.890.71–1.12
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520253035Months (modelled)
  • Gemcitabine, cisplatin and nab-paclitaxel (experimental)
  • Gemcitabine and cisplatin (control)

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

Data table (modelled values)
MonthsGemcitabine, cisplatin and nab-paclitaxelGemcitabine and cisplatin
0100.0%100.0%
964.0%63.2%
1841.0%40.0%
2627.6%26.6%
3517.7%16.8%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Gemcitabine, cisplatin and nab-paclitaxel (experimental)
  • Gemcitabine and cisplatin (control)

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

Data table (modelled values)
MonthsGemcitabine, cisplatin and nab-paclitaxelGemcitabine and cisplatin
0100.0%100.0%
563.0%57.7%
943.5%37.1%
1427.4%21.4%
1917.3%12.4%
Primary publication: Shroff RT, King G, Colby S, Scott AJ, Borad MJ, Goff L, et al. SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers. J Clin Oncol. 2025;43(5):536-544. PubMedDOI

Appears in

Sources

  1. Shroff RT, King G, Colby S, Scott AJ, Borad MJ, Goff L, et al. SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers. J Clin Oncol. 2025;43(5):536-544.

    PubMedDOI