Abstract
BackgroundThe prognosis of patients with unresectable or metastatic biliary tract cancer (BTC) is unacceptably low. This study aimed to determine the efficacy, safety and predictive biomarkers of the immune checkpoint...
Highlights
The prognosis of patients with unresectable or metastatic biliary tract cancer (BTC) is unacceptably low
At the time of data cut-o ff (September 31, 2019), all patients in cohort A and cohort B were eligible for safety analyses, of whom 6 in cohort A and 21 in cohort B were qualified for clinical activity analyses; 5 patients discontinued treatment within the first cycle due to rapidly deteriorating tumor-related complications (1 from cohort A and 3 from cohort B) or adverse events unrelated to study drugs (1 from cohort B)
We observed that the incidence of grade 3 or higher thrombocytopenia was much higher in this study than that currently reported for gemcitabine and cisplatin chemotherapy,[4 5 7] and whether the addition of nivolumab to chemotherapy affected thrombocytopenia remains unclear
Summary
The prognosis of patients with unresectable or metastatic biliary tract cancer (BTC) is unacceptably low. Maintenance treatment with gemcitabine plus nivolumab was administered to patients achieving disease control following the combination therapy. Of the six patients in cohort A who were resistant to gemcitabine-based or cisplatin-based chemotherapy, one achieved CR and one achieved partial response. Conclusions Nivolumab in combination with gemcitabine and cisplatin offers promising efficacy and a manageable safety profile for patients with advanced BTCs. Trial registration number NCT03311789. Biliary tract cancers (BTCs) represent a diverse group of highly invasive heterogeneous epithelial cancers arising from the biliary tract with poor prognosis. Recurrence is seen in >60% of patients within the first or the second year.[3] For patients with advanced unresectable or metastatic BTCs, gemcitabine plus cisplatin is the current standard first-line systemic therapy.[4] this combination regimen confers limited efficacy. Other regimens or strategies, such as gemcitabine and oxaliplatin with or without cetuximab,[5] capecitabine plus cisplatin,[6] nab-p aclitaxel and gemcitabine,[7] and small- molecule kinase inhibitors targeting FGFR, IDH, MET, mesothelin, BRCA and some mutated proteins, did not show significant improvements in efficacy and survival.[8 9]
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