P-0028 - Subgroup analyses based on liver metastases and the number of metastatic sites from the MPACT phase III trial of nab-paclitaxel plus gemcitabine vs...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Colin Weekes
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors C. Weekes1, J. Weis2, A. Romano3, D. McGovern4, D. Penenberg5, D. Von Hoff6, F. Parnis7, J. Thaler8, H. Prenen9, R. Letourneau10, E. Raymond11, A. Santoro12, R. Garcia-Carbonero13
  • 1University Colorado Cancer Center, Aurora/US
  • 2Huntsman Cancer Center, Salt Lake City/US
  • 3Celgene Corporation, Summit/US
  • 4Celgene, Stockley Park/UK
  • 5Celgene, Summit/US
  • 6Scottsdale Healthcare/TGen, Scottsdale/US
  • 7Adelaide Cancer Centre (T/A Ashford Cancer Ctr), Kurralta Park/AU
  • 8Klinikum Wels-Grieskirchen GmbH, Wels, Austria, /
  • 9University Hospital Gasthuisberg, Leuven/BE
  • 10Centre Hospitalier Universite de Montreal, Montréal/CA
  • 11Hopital Beaujon, Clichy/FR
  • 12Humanitas Cancer Center, Istituto Clinico Humanitas IRCCS, Milano/IT
  • 13Hospital Universitario Virgen del Rocío Instituto de Biomedicina de Sevilla (IBIS), Sevilla/ES

Abstract

Introduction

Among all types of solid tumors, metastatic PC is associated with one of the worst prognoses. A poorer prognosis is associated with the presence of liver metastases (LMs) and multiple sites of metastasis. In the MPACT trial, nab-paclitaxel (nab-P) + gemcitabine (Gem) demonstrated superior overall survival (OS; primary endpoint) vs Gem alone as first-line treatment for patients with metastatic PC (Table). Here we report subgroup analyses evaluating efficacy and safety outcomes with nab-P + Gem vs Gem alone based on the presence of LMs and the number of metastatic sites.

Methods

Previously untreated patients (N = 861) with metastatic PC were randomized 1:1 (stratified by performance status, region, and the presence of LMs) to receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle or Gem alone 1000 mg/m2 weekly for 7 weeks followed by 1 week of rest (cycle 1) and then days 1, 8, and 15 of each 28-day cycle (cycle ≥ 2).

Results

Treatment arms were well balanced in terms of LMs and metastatic site number; 84% of patients had LMs and 79% had 2 or 3 metastatic sites. Median OS and progression-free survival (PFS) were significantly longer for nab-P + Gem vs Gem alone in patients with LMs (Table), and similar trends were seen for overall response rate. Median OS was longer with nab-P + Gem vs Gem alone regardless of the number of metastatic sites (Table). This subgroup analysis revealed that the rates of the most common grade ≥ 3 adverse events of neutropenia, peripheral neuropathy, and fatigue were similar among these patient subsets and the intent-to-treat (ITT) population.

Conclusion

In the MPACT trial, nab-P + Gem demonstrated longer OS and PFS vs Gem alone in the ITT population. Results for patients with LMs and in subgroups based on metastatic site number were consistent with the ITT findings. There were no new safety signals.