Multicenter phase 3 study of gemcitabine with or without paclitaxel for previously treated metastatic pancreatic ductal adenocarcinoma

The optimal second-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) after first-line 5-fluorouracil plus oxaliplatin and irinotecan is not known. The multicenter phase 3 GEMPAX study in France evaluated gemcitabine plus paclitaxel (GEMPAX) versus gemcitabine alone for these patients. The ORR was 17.1% with GEMPAX versus 4.2% with gemcitabine (p=0.008). GEMPAX versus gemcitabine was not associated with improved overall survival (primary end point) but was associated with improved progression-free survival. Treatment-related adverse events resulting in discontinuation were reported in 16.7% of patients with GEMPAX versus 2.9% with gemcitabine. Grade 3 or higher TRAEs occurred in 58.0% versus 27.1%, and grade 5 TRAE in one patient with GEMPAX. The authors conclude that among patients with previously treated mPDAC, addition of paclitaxel to second-line gemcitabine did not improve OS but did improve PFS and ORR.