Efficacy and Safety of First-Line Chemotherapy With Gemcitabine Plus Nab-Paclitaxel in Unresectable Gallbladder Cancer.
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PURPOSE: The purpose of this study is to evaluate the efficacy and safety of nab-paclitaxel combined with gemcitabine (AG regimen) as a first-line chemotherapy for patients with unresectable gallbladder cancer (GBC). MATERIALS AND METHODS: A retrospective analysis was conducted on patients diagnosed with GBC via histological examination. Inclusion criteria included locally advanced or metastatic gallbladder cancer deemed unresectable by multidisciplinary team (MDT) consensus; age 18-75 years; ECOG performance status ≤ 2; and AG as first-line chemotherapy. Treatment response was assessed using RECIST 1.1 criteria. Primary endpoints were overall response rate (ORR) and progression-free survival (PFS); secondary endpoints included disease control rate (DCR), overall survival (OS), and adverse events incidence. RESULTS: Thirty-one patients were enrolled. The ORR was 48.4%, and DCR was 90.3%. The median PFS was 8.4 months (95% CI, 5.0-11.8), and the median OS was 20.9 months (95% CI, 16.8-24.9). Among the 11 patients with locally advanced disease, 7 patients (63.6%) successfully converted to a resectable state and underwent surgery. Grade 3/4 treatment-related adverse events occurred in 11 patients (35.5%), predominantly hematologic toxicities, and no treatment-related deaths or treatment discontinuations due to adverse events were observed. CONCLUSION: First-line AG chemotherapy demonstrated promising efficacy and manageable safety for patients with unresectable GBC, with a substantial portion achieving disease control and some converting to resectable status.