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

• Tác giả: Mitesh J Borad, Puneet Cheema, E Gabriela Chiorean, Sarah Colby, Imane El Dika, Anthony El-Khoueiry, Laura Goff, Katherine A Guthrie, Howard Hochster, Renuka Iyer, Milind M Javle, Aparna Kalyan, R Katie Kelley, Gentry King, Amit Mahipal, Khalid Matin, Anuj Patel, Philip A Philip, Aaron J Scott, Rachna T Shroff, Benjamin Tan, Jaykumar Thumar
• Ngôn ngữ: eng
• Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025
• Bộ sưu tập: NCBI
• ID: 700275

Tóm tắt

 PURPOSE: SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs). METHODS: Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m RESULTS: Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC. There was no significant difference in overall survival (OS) between GAP versus GC. Median OS with GAP was 14.0 months (95% CI, 12.4 to 16.1) and 13.6 months with GC (95% CI, 9.7 to 16.6)
  hazard ratio (HR), 0.91 (95% CI, 0.72 to 1.14)
  CONCLUSION: The addition of a taxane in the GAP regimen to the standard gemcitabine-cisplatin regimen did not improve OS in newly diagnosed BTC. More toxicity was encountered with GAP versus GC.