nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial

Abstract

Purpose: The global Phase III MPACT trial demonstrated superior efficacy of nab-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.

Patients and methods: Patients received nab-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 with nab-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 with nab-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%).

Conclusion: 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 with nab-paclitaxel plus gemcitabine in patients treated in Western Europe with metastatic pancreatic cancer.

Keywords: MPACT; Western Europe; gemcitabine; metastatic pancreatic cancer; nab-paclitaxel.

Conflict of interest statement

Disclosure Josep Tabernero: consultant or advisory role, Amgen, Boehringer, BMS, Celgene, Genentech, Imclone, Lilly, Merck KGaA, Millennium, Novartis, Onyx, Pfizer, Roche, Sanofi; honoraria, Amgen, Merck KGaA, Novartis, Roche, Sanofi. Volker Kunzmann: consultant or advisory role and research funding, Celgene. Werner Scheithauer: consultant or advisory role and honoraria, Celgene. Michele Reni: consultant or advisory role, honoraria, research funding, Celgene. Jack Shiansong Li, Stefano Ferrara, Kamel Djazouli: employment, stock ownership, Celgene. The authors report no other conflicts of interest in this work.

Figures

Figure 1

Overall survival in the Western European cohort. Abbreviations: CI, confidence interval; Gem, gemcitabine; HR, hazard ratio; mo, month; nab-P, nab-paclitaxel.