693P - nab-paclitaxel (nab-P) plus gemcitabine (Gem) vs Gem alone for patients (pts) with metastatic pancreatic cancer (PC): Subgroup analyses of the MPAC...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Colin Weekes
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors C. Weekes1, F. Parnis2, J. Thaler3, H. Prenen4, R. Letourneau5, E. Raymond6, A. Santoro7, R. Garcia-Carbonero8, J. Weis9, A. Romano10, D. McGovern11, D. Penenberg10, D.D. von Hoff12
  • 1Medicine, Univ of Colorado Health Sci Ctr, 80045 - Aurora/US
  • 2Oncology, Ashford Cancer Centre, Ashford/AU
  • 3Oncology, Klinikum Wels-Grieskirchen GmbH, Wels/AT
  • 4Oncology, Hans.Prenen@med.kuleuven.be, Leuven/BE
  • 5Oncology, Centre Hospitalier Universite de Montreal, Montreal/CA
  • 6Oncology, Service de Cancerologie Hopital BEAUJON, 92110 - Clichy/FR
  • 7Oncology, Humanitas Cancer Center Istituto Clnico Humanitas IRCCS, IT-20089 - Milano/IT
  • 8Oncology, Hospital Universitario Virgen del Rocio, Instituto de Biomedicina de Sevella (IBIS), Sevilla/ES
  • 9Oncology, Huntsman Cancer Institute, Salt Lake City/US
  • 10Biostats, Celgene Corporation, Summit/US
  • 11Clinical Operations, Celgene Europe Ltd, Stockley Park/GB
  • 12Oncology, TGen/Virginia C Piper Cancer Center, Scottsdale/US

Abstract

Aim

Metastatic PC is associated with one of the worst prognoses among all the types of solid tumors. The presence of LMs and multiple sites of metastasis are factors associated with poorer prognosis. In the MPACT trial, nab-P + Gem demonstrated superior overall survival (OS, primary endpoint) vs Gem alone as first-line treatment for metastatic PC (Table). We report the efficacy and safety of nab-P + Gem vs Gem alone based on the presence of LMs and the number of metastatic sites.

Methods

Previously untreated pts (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 with respect to LMs and the number of metastatic sites: 84% of pts had LMs and 79% had 2 or 3 metastatic sites. In pts with LMs, median OS was significantly longer with nab-P + Gem vs Gem alone (Table). Similar trends were seen for PFS (5.4 vs 3.6 mo; HR 0.65; P < 0.001) and overall response. Median OS was longer with nab-P + Gem vs Gem alone regardless of the number of metastatic sites (Table). The rates of the most common grade ≥ 3 adverse events (neutropenia, peripheral neuropathy, and fatigue) in these patient subsets were similar to those in the intent-to-treat (ITT) population.

Patient Population n Median OS, mo
nab-P + Gem Gem nab-P + Gem Gem HR P Value
ITT 431 430 8.5 6.7 0.72 < 0.001
Subgroups
With LMs 365 360 8.3 5.9 0.69 < 0.001
No. of metastatic sites
1 33 21 13.5 9.0 0.41 0.021
2 202 206 8.3 7.1 0.75 0.015
3 136 140 8.0 5.9 0.79 0.093
> 3 60 63 8.6 5.0 0.50 0.001

Conclusions

In the MPACT trial, nab-P + Gem demonstrated longer OS vs Gem alone in the ITT population. The results for pts with LMs and in subgroups defined by the number of metastatic sites were consistent with the ITT findings. No new safety signals were observed.

Disclosure

C. Weekes: has received honoraria for advisory board participation in the past 3 years from Celgene F. Parnis: servied on the advisory board for Specialised Therapeutics; A. Santoro: is a consultant/advisor to Celgene; A. Romano, D. McGovern and D. Penenberg: is an employee of Celgene and owns stock; D.D. Von Hoff: is a consultant/advisory for Celgene and receives honoraria from them. He also receives research funding from TGen Clinical Research Service. All other authors have declared no conflicts of interest.