title: nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial.
abstract: OBJECTIVE
  The global Phase III MPACT trial demonstrated superior efficacy ofnab-paclitaxel plus gemcitabine over gemcitabine alone as first-line treatment for metastatic pancreatic cancer. Region was a randomization stratification factor in the MPACT trial. This subgroup analysis of MPACT examined efficacy and safety of patients treated in Western Europe.
  
  
  METHODS
  Patients receivednab-paclitaxel plus gemcitabine or gemcitabine alone as first-line treatment for metastatic pancreatic cancer as previously described. A total of 76 patients were included in this analysis (n=38 for each arm).
  
  
  RESULTS
  Differences between the overall Western European cohort and the intention-to-treat population included lower percentages of male patients (46% and 58%, respectively) and patients with biliary stents (8% and 17%), and higher percentages of patients with Karnofsky performance status of 90-100 (78% and 60%) and primary tumors in the body of the pancreas (48% and 31%). The median overall survival was 10.7 months withnab-paclitaxel plus gemcitabine vs 6.9 months with gemcitabine alone (hazard ratio [HR]: 0.82 [95% confidence interval (CI): 0.48-1.40];P=0.471). Median progression-free survival was 5.3 vs 3.7 months, respectively (HR: 0.70 [95% CI: 0.37-1.33];P=0.277). The independently assessed overall response rate was 18% vs 5% (response rate ratio, 3.50 [95% CI: 0.78-15.78];P=0.076). The most common grade ≥3 adverse events withnab-paclitaxel plus gemcitabine and gemcitabine alone were neutropenia (46% vs 33%, respectively), leukopenia (35% vs 19%), anemia (22% vs 0%), asthenia (21% vs 6%), thrombocytopenia (14% vs 3%), and peripheral neuropathy (13% vs 3%).
  
  
  CONCLUSIONS
  Although a statistically significant difference between the treatment arms was not reached for efficacy endpoints, this study does report treatment benefit and a manageable safety profile associated withnab-paclitaxel plus gemcitabine in patients treated in Western Europe with metastatic pancreatic cancer.
authors.affiliation: Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Tabernero
authors.affiliation: Medizinische Klinik und Poliklinik II, University of Würzburg, Würzburg, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Kunzmann
authors.affiliation: Medizinische Universität Wien, Wien, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Scheithauer
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Reni
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Jack
authors.initials: J
authors.lastname: Shiansong Li
authors.affiliation: Celgene Corporation, Boudry, Switzerland.
authors.forename: Stefano
authors.initials: S
authors.lastname: Ferrara
authors.affiliation: Celgene Corporation, Paris, France.
authors.forename: Kamel
authors.initials: K
authors.lastname: Djazouli
keywords: MPACT; Western Europe; gemcitabine; metastatic pancreatic cancer; nab-paclitaxel