123211-143

Updated survival from a randomized phase III trial (MPACT) of nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients (pts) with metastatic adenocarcinoma of the pancreas.

Category: 
Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Type and Session Title: 
General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Oral Abstract Session: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract (eQ&A)
Abstract Number: 
178^
Citation: 
J Clin Oncol 32, 2014 (suppl 3; abstr 178^)
Author(s): 
David Goldstein, Robert Hassan El Maraghi, Pascal Hammel, Volker Heinemann, Volker Kunzmann, Javier Sastre, Werner Scheithauer, Salvatore Siena, Josep Tabernero, Luis Teixeira, Giampaolo Tortora, Jean-Luc Van Laethem, Rosemary Young, Xinyu Wei, Brian Lu, Alfredo Romano, Daniel D. Von Hoff; Prince of Wales Hospital, Sydney, Australia; Royal Victoria Regional Health Centre, Barrie, ON, Canada; Hôpital Beaujon, Clichy, France; Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany; Medizinische Klinik und Poliklinik II, University of Wuerzburg, Würzburg, Germany; Hospital Clínico San Carlos, Madrid, Spain; Medizinische Universität Wien, Wien, Austria; Azienda Ospedaleria Niguarda Ca' Granda, Milan, Italy; Vall d'Hebron University Hospital, Barcelona, Spain; Hôpital Saint-Antoine, Paris, France; Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy; Erasme University Hospital, Brussels, Belgium; Royal Hobart Hospital, Hobart, Australia; Celgene Corporation, Summit, NJ; Celgene International, Boudry, Switzerland; Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare/TGen, Scottsdale, AZ

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: In the phase III MPACT trial, nab-paclitaxel (nab-P) + gemcitabine (G) was tolerable and demonstrated superiority to G alone for all efficacy endpoints in pts with metastatic pancreatic cancer (MPC). nab-P + G vs G alone met the study’s primary endpoint by demonstrating a significant improvement in overall survival (OS; median 8.5 vs 6.7 months; HR 0.72; 95% CI, 0.617 - 0.835; P < 0.001) and the secondary endpoints of progression-free survival (PFS; median 5.5 vs 3.7 months; HR 0.69; 95% CI, 0.581 - 0.821; P < 0.001) and overall response rate (ORR; 23% vs 7%; P < 0.001). The 1-year survival rates for nab-P + G vs G alone were 35% vs 22%. The OS data reported above were based on a database cutoff of September 17, 2012, at which time 80% of pts had died. Here, we report an updated OS analysis (post hoc) from MPACT. Methods: 861 pts with MPC and a Karnofsky performance status (KPS) ≥ 70 were randomized at 151 community and academic centers 1:1 to receive nab-P 125 mg/m2 + G 1000 mg/m2 on days 1, 8, and 15 of a 28-day cycle or G alone 1000 mg/m2weekly for 7 weeks followed by 1 week of rest (cycle 1) and then days 1, 8, and 15 of a 28-day cycle (cycle ≥ 2). The data for this survival analysis were collected through April 1, 2013. Results: As of the updated data cutoff, 380/431 (88%) pts in the nab-P + G arm and 394/430 (92%) pts in the G alone arm had died. OS was superior for nab-P + G vs G alone in the intent-to-treat population, and the longer follow-up allowed an estimate of the 3-year survival rates (Table). The treatment effect was consistent across all pt subgroups examined. Conclusions: This updated survival analysis revealed a sustained difference in OS over time between the 2 arms. MPACT is the first phase III study in MPC to report 3-year survival rates. These data confirm and extend the previous report of the primary endpoint and support the superior efficacy of nab-P + G over G alone. These results may encourage efforts to build upon this well tolerated backbone to further extend survival. Clinical trial information: NCT00844649.

Updated survival.
nab-P + G
n=431
G
n=430
HR (95% CI) p value
Median OS, months 8.7 6.6 0.72
(0.620 - 0.825)
< 0.0001
1-year OS, % 35 22
2-year OS, % 10 5
3-year OS, % 4 0