In this international, multicenter, open-label, randomized, phase 3 study, we randomly assigned eligible patients, in a 1:1 ratio, to receive a 30-to-40–minute intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15, 29, 36, and 43, or to receive gemcitabine alone at a dose of 1000 mg per square meter weekly for 7 of 8 weeks (cycle 1). In subsequent cycles, all patients were administered treatment on days 1, 8, and 15 every 4 weeks.
Patients were stratified according to performance status, presence or absence of liver metastases, and geographic region. Treatment continued until disease progression or until there was an unacceptable level of adverse events. Per protocol, crossover was not allowed at any time after randomization.
Patients were stratified according to performance status, presence or absence of liver metastases, and geographic region. Treatment continued until disease progression or until there was an unacceptable level of adverse events. Per protocol, crossover was not allowed at any time after randomization.