691P - Regional subanalysis of the phase III MPACT trial: nab-paclitaxel (nab-P) plus gemcitabine (Gem) vs gem alone for patients (pts) with metastatic pa...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Pancreatic Cancer
Therapy
Biological therapy
Presenter Salvatore Siena
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors S. Siena1, L. Lipton2, R. Letourneau3, S.A. Tjulandin4, C. Guillen Ponce5, M. Schwarz6, R. Ramanathan7, T. Macarulla8, D. Goldstein9, A. Romano10, S. Ferrara11, D. Penenberg10, D.D. von Hoff7
  • 1Oncology, Ospedale Niguarda Ca, 20162 - Granada/IT
  • 2Footscray Walter And Eliza Hall Institute, Royal Melbourne Western Hopital, Victoria/AU
  • 3Oncology, Cemtre Hospitalier de L'Universite de Montreal St Luc, Montreal/CA
  • 4Clinical Pharmacology And Chemotherapy, Blokhin Russian Cancer Research Center, RU-115478 - Moscow/RU
  • 5Oncology, Hospital Universitario Ramon y Cajal, Madrid/ES
  • 6Oncololgy, VA Cancer Institute, Richmond/US
  • 7Onocology, TGen/Virginia C. Piper Cancer Center, Scottsdale/US
  • 8Oncology, Vall d´Hebron University Hospital, Barcelona/ES
  • 9Oncology, Prince of Wales Hospital, Sydney/AU
  • 10Biostats, Celgene Corporation, Summit/US
  • 11Medical Affairs, Celgene, Boudry/CH

Abstract

Aim

nab-P + Gem demonstrated superior efficacy over Gem alone in the MPACT trial of patients with metastatic PC. An updated analysis confirmed the superior OS (primary endpoint) of nab-P + Gem vs Gem alone (8.7 vs 6.6 mo; HR 0.72; P < 0.001). This analysis examined efficacy outcomes by geographic region.

Methods

Previously untreated pts with metastatic PC were randomized 1:1—stratified by performance status, region (Australia [AU], Eastern Europe [EE], Western Europe [WE], or North America [NA]), and the presence of liver metastases—to receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on d 1, 8, and 15 of each 28-day cycle or Gem 1000 mg/m2 weekly for 7 weeks followed by 1 week of rest (cycle 1) and then d 1, 8, and 15 of each 28-day cycle (cycle ≥ 2).

Results

The analysis included 861 pts. An updated OS analysis (data cutoff 9 May 2013) revealed that OS was longer for nab-P + Gem vs Gem alone in each region, although the difference was not statistically significant in all cases (table). Similar trends were observed for PFS and ORR. White blood cell growth factors were used at the following rates (nab-P + Gem vs Gem): NA, 28% vs 16%; EE, 16% vs 13%; AU, 16% vs 12%; WE, 37% vs 11%. The safety profile of each treatment arm was similar across the regions. Differences in the proportion of pts receiving post-progression therapies were noted for some regions (nab-P + Gem vs Gem): NA, 40% vs 42%; EE, 20% vs 31%; AU, 39% vs 41%; WE, 45% vs 55%. The rates of use were different across regions for 5-FU/capecitabine-based therapies (NA, 26% vs 31%; EE, 17% vs 26%; AU, 26% vs 22%; WE, 42% vs 47%) and FOLFIRINOX (NA, 6% vs 7%; EE, 0 vs 2%; AU, 2% vs 2%; WE, 3% vs 8%).

nab-P + Gem Gem HR (95% CI) P Value
n Median OS, mo n Median OS, mo
North America 268 8.8 271 6.6 0.69 (0.57-0.82) < 0.001
Eastern Europe 64 7.7 62 5.9 0.84 (0.58-1.23) 0.372
Australia 61 9.4 59 6.7 0.59 (0.40-0.88) 0.010
Western Europe 38 10.7 38 6.9 0.82 (0.48-1.40) 0.471

Conclusions

nab-P + Gem was associated with improved survival compared with Gem alone in pts with metastatic PC, regardless of region. Variations in postprogression therapy use were noted across regions.

Disclosure

R.K. Ramanathan: a consultant/advisor to Celgene, receives honoraria and research funding from them as well; D. Goldstein: is a consultant/advisor for Celgene and receives research funding from them; A. Romano: is a Celgene employee and owns stock; D. Penenberg: is a an employee of Celgene and owns stock; D.D. Von Hoff: is a consultant/advisor for Celgene and receives honoraria from them. He also receives research funding from TG Clinical Research. All other authors have declared no conflicts of interest.