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Gemcitabine, Cisplatin, and Nab-Paclitaxel vs Gemcitabine and Cisplatin for Newly Diagnosed Advanced Biliary Tract Cancers
TAKE-HOME MESSAGE
- The SWOG S1815 trial compared gemcitabine, cisplatin, and nab-paclitaxel (GAP) with gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers. No significant improvement in overall and progression-free survival was observed with GAP versus GC, with the median overall survival at 14.0 months with GAP and 13.6 months with GC. Exploratory analyses suggested potential benefits of GAP in patients with gallbladder cancer and locally advanced disease; however, these were not statistically significant. GAP was associated with higher toxicity.
- The trial concluded that adding nab-paclitaxel to the GC regimen does not improve outcomes in patients with biliary tract cancers, emphasizing the need for further research into targeted and immunotherapy-based treatments.
abstract
This abstract is available on the publisher's site.
Access this abstract nowPURPOSE
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/m2, cisplatin 25 mg/m2, and nab-paclitaxel 100 mg/m2 intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 intravenously once per day on days 1 and 8 of a 21-day cycle).
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); P = .41. Median progression-free survival (PFS) was similar between groups with median PFS for GAP being 7.5 months (95% CI, 6.4 to 8.5) versus 6.3 months for GC (95% CI, 4.4 to 8.2); HR, 0.89 (95% CI, 0.71 to 1.12); P = .32. In exploratory subset analyses, the OS and PFS benefits of GAP versus GC treatment were greater in locally advanced disease compared with metastatic disease, although not statistically significant (interaction P = .14 for OS and P = .17 for PFS). Moreover, GAP versus GC showed greater improvement in PFS among participants with GBC than those with ICC or ECC (interaction P = .01), but not OS (interaction P = .28).
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.
Additional Info
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 2024 Dec 13;[EPub Ahead of Print], RT Shroff, G King, S Colby, AJ Scott, MJ Borad, L Goff, K Matin, A Mahipal, A Kalyan, MM Javle, I El Dika, B Tan, P Cheema, A Patel, R Iyer, RK Kelley, J Thumar, A El-Khoueiry, KA Guthrie, EG Chiorean, H Hochster, PA PhilipFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.