Does Adding Nab-Paclitaxel to First-Line Chemotherapy in Biliary Cancer Improve Survival?

The combination of gemcitabine and cisplatin (GC) is standard chemotherapy for advanced biliary cancer and is usually taken together with durvalumab or pembrolizumab for first-line therapy. In 2019, a phase II study demonstrated positive results with the addition of nab-paclitaxel to first-line GC in advanced biliary cancer. Now, the Southwest Oncology Group has completed a randomized, open-label, phase 3 trial of this regimen, with overall survival (OS) as the primary endpoint. Patients received standard GC either alone or in combination with nab-paclitaxel (100 mg/m² on days 1 and 8 of a 21-day cycle). Of 441 patients, 55% were female, 67% had intrahepatic cholangiocarcinoma, and 73% had metastatic disease.

Patients receiving nab-paclitaxel had a higher overall response rate than those receiving GC alone (31% vs. 21%), but no significant differences were seen in OS (median, 14 vs. 13.6 months; hazard ratio, 0.91) or progression-free survival (7.5 vs. 6.3 months; HR, 0.89). The addition of nab-paclitaxel was associated with higher rates of treatment-related grade 3/4 adverse events, both hematologic (60% vs. 45%) and nonhematologic. Treatment-related grade 5 events were much more common with the addition of nab-paclitaxel (7 patients) than with GC alone (1 patient).