The triplet regimen of nab-paclitaxel plus gemcitabine plus cisplatin (GCN) did not improve the health outcomes in untreated patients with advanced biliary tract cancer (BTC), the first-ever phase 3 trial in this population demonstrated.

Prof. Rachna Shroff (University of Arizona Cancer Center) and co-investigators designed the first phase 3 trial in patients with untreated, advanced cholangiocarcinoma or gallbladder cancer (N=441).1 Patients were randomized 2:1 to GCN or to standard-of-care gemcitabine plus cisplatin. Overall survival (OS) was the primary endpoint of the study.

Patients receiving the triplet regimen did not show a significantly improved OS compared with patients receiving standard-of-care treatment (median OS, 14.0 months vs 12.7; P=0.65). Progression-free survival data of the 2 study groups confirmed this result (8.2 months vs 6.4; P=0.43). Prof. Shroff added that grade 3 or 4 hematologic toxicities were more common in the GCN arm than in the control arm.

The first randomized phase 3 trial in patients with these rare types of cancer did not deliver results that support the addition of nab-paclitaxel to gemcitabine and cisplatin.

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