Multicenter randomized phase 2 trial of dose-reduction stategy of gemcitabine plus nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma

A standardized dose-reduction strategy has not been established for the widely used gemcitabine plus nab-paclitaxel regimen in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The multicenter randomized phase 2 ALPACA trial in Germany compared this standard regimen versus alternating cycles of gemcitabine-nab-paclitaxel and gemcitabine alone for these patients. After three cycles of induction treatment with standard gemcitabine-nab-paclitaxel, patients with at least stable disease were randomized to continuation of this treatment (n=85; 79 started treatment) or alternating cycles of standard treatment and gemcitabine alone (n=89; 88 started treatment). Median overall survival was similar between the groups (10.4 months with standard treatment versus 10.5 months with alternating treatment; p=0.56), while tolerability was improved with alternating treatment. The authors conclude that a dose-reduced regimen with alternating cycles of nab-paclitaxel-gemcitabine and gemcitabine alone after three standard induction cycles had an improved benefit/harm ratio compared to standard treatment.