Real-world retrospective evidence from Korean patients with advanced biliary tract cancer indicates that efficacy and safety with nab-paclitaxel plus gemcitabine/cisplatin combination were consistent with those previously reported in clinical trials.
A multicenter, retrospective, noncomparative, observational study (ClinicalTrials.gov Identifier: NCT02392637) evaluated the efficacy and safety of nab-paclitaxel plus gemcitabine/cisplatin (GemCis/nab-P) in Korean patients with advanced biliary tract cancers (BTCs). Results of this trial were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
This retrospective analysis identified patients with advanced BTC who received GemCis/nab-P at 3 institutes in Korea between September 2019 and September 2020. Key eligibility criteria included histologically confirmed BTC (intrahepatic cholangiocarcinoma [iCCA], extrahepatic cholangiocarcinoma [eCCA], gallbladder cancer [GBC]); metastatic or locally advanced unresectable stage disease; and ≥1 response evaluations after initiation of GemCis/nab-P.
A total of 104 patients were included in this analysis. The median age of the study population was 64 years. The majority of the participants were male (57.7%) and had metastatic or recurrent disease (74.6%). The primary tumor site was iCCA in 44.5% of patients and eCCA in 33.5% of patients. The majority of patients had received gemcitabine/cisplatin as a starting regimen (n = 60, 57.7%); 16 patients (15.4%) had received gemcitabine/cisplatin plus an immune checkpoint inhibitor.
The objective response rate was 38.7% in the overall cohort, including 1 complete response and 66 partial responses. These responses were similar in other subgroups: 43.4% in the initial GemCis/nab-P cohort, 30.0% after the addition of nab-P, 35.1% in the iCCA cohort, and 44.8% in the eCCA cohort. The disease control rate was 84.4% overall, 89.4% in the initial GemCis/nab-P cohort, 75.0% in the add-on nab-P group, 79.2% in the iCCA cohort, and 96.6% in the eCCA cohort. At a median follow-up of 4.0 months, median overall survival was not reached and median progression-free survival was 9.3 months (95% confidence interval, 7.7-10.8).
Nearly all patients experienced any-grade treatment-emergent adverse events (TEAEs; 96.5%). The most common TEAEs occurring in >30% of patients were alopecia, anorexia, nausea, fatigue, sensory neuropathy, decreased white cell count, anemia, thrombocytopenia, neutropenia, and increased aspartate aminotransferase level. Grade 3/4 adverse events occurred in 64.0% of patients.
The most common grade 3/4 toxicities were neutropenia (n = 36, 34.6%), anemia (n = 17, 16.4%), thrombocytopenia (n = 10, 9.6%), and febrile neutropenia (n = 9, 8.1%). In patients with locally advanced BTC (n = 22), 5 individuals (22.7%) were converted to resectable disease and underwent surgery. Dose reductions were needed in 50.9% of patients and treatment discontinuation in 2.9% of patients.
Among Korean patients with advanced BTC treated in a real-world setting, efficacy and safety outcomes with a GemCis/nab-P combination regimen were consistent with those previously reported in clinical trials.
Source: Cheon J, Lee CK, Sang Y, et al. Efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin (GemCis/nab-P) in Korean patients with advanced biliary tract cancers (aBTC): multicenter retrospective analysis. J Clin Oncol. 2021;39(suppl_3):274-274.
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