Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly nab -Paclitaxel Plus Gemcitabine vs Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer. Abstract #4059. nab -P + Gem. Gem.
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Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly nab-Paclitaxel Plus Gemcitabine vs Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer
nab-P + Gem
Malcolm J. Moore,1 Daniel D. Von Hoff,2 Thomas J. Ervin,3 Francis P. Arena,4 E. Gabriela Chiorean,5Jeffrey R. Infante,6 Jeremy K. Hon,7 Mikhail Yu Biakhov,8 Sunil R. Hingorani,9Vinod Ganju,10 Colin D. Weekes,11 Werner Scheithauer,12 Ramesh K. Ramanathan,2JosepTabernero,13 David Goldstein,14Xinyu Wei,15 Alfred Romano15
1 Princess Margaret Hospital, Toronto, ON, Canada; 2 Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare/TGen, Scottsdale, AZ; 3 Florida Cancer Specialists, Englewood, FL; 4 Arena Oncology Associates, Lake Success, NY;5University of Washington, Seattle, WA; 6 Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN; 7Clearview Cancer Institute, Huntsville, AL; 8Semashko Central Clinical Hospital, Moscow, Russia; 9 Fred Hutchinson Cancer Research Center, Seattle, WA; 10 Peninsula Oncology Centre, Frankston, VIC, Australia; 11 University of Colorado Cancer Center, Aurora, CO; 12MedizinischeUniversität Wien, Wien, Austria; 13Valld'Hebron University Hospital, Barcelona, Spain; 14 Prince of Wales Hospital, Sydney, Australia; 15CelgeneCorporation, Summit, NJ
Table 3. OS in Subgroups
Figure 2. OS in the ITT Population
Primary Tumor Location: Head
Primary Tumor Location: Other
No Liver Metastases
1 Metastatic Site
2 Metastatic Sites
3 Metastatic Sites
> 3 Metastatic Sites
Table 2. Stepwise Multivariate Analysis for Predictors of OS and PFS
CA19-9 ULN to < 59 × ULN
CA19-9 ≥ 59 × ULN
HR = 0.72
95% CI (0.617 - 0.835)
Proportion of Survival
Patients at Risk
nab-P + Gem:
nab® is a registered trademark of Celgene Corporation.
Table 1. Baseline Characteristics
Figure 1. Planned Trial Design
nab-P125 mg/m2IV qw 3/4
Gem 1000 mg/m2 IV qw 3/4
Figure 3. OS - Prespecified Subgroups
Age < 65 Years
Age ≥ 65 Years
The authors acknowledge the financial support for this study from Celgene Corporation and the production support from MediTech Media, Ltd.
Gem 1000 mg/m2 IV qw 7/8, then qw 3/4
MJM: consultant or advisory role and research funding, Celgene Corp.; DDVH: consultant or advisory role, honoraria, and research funding, Celgene Corp.; TJE: Research funding, Celgene Corp.; FPA: research funding, Clinical Research Alliance and CelgeneCorp.; EGC: research funding, CelgeneCorp.; JRI: nothing to disclose; JKH: nothing to disclose; MYB: research funding, Celgene Corp.; SRH: nothing to disclose; VG: nothing to disclose; CDW: consultant or advisory role and honoraria, Celgene Corp.; WS: consultant or advisory role, honoraria, and research funding, Celgene Corp.; RKR: consultant or advisory role, honoraria, and research funding, CelgeneCorp.; JT: Consultant or advisory role and honoraria, CelgeneCorp.; DG: Consultant or advisory role and research funding, CelgeneCorp.; XW: employment or leadership position and stock ownership, CelgeneCorp.; AR: employment or leadership position and stock ownership, CelgeneCorp.
Favors nab-P + Gem
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KPS, Karnofskyperformance status; qw 3/4, first 3 of 4 weeks; qw 7/8, first 7 of 8 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; ULN, upper limit of normal.