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.

Authors

null

David Goldstein

Prince of Wales Hospital, Sydney, Australia

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

Organizations

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

Research Funding

Pharmaceutical/Biotech Company

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

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2014 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT00844649

Citation

J Clin Oncol 32, 2014 (suppl 3; abstr 178^)

DOI

10.1200/jco.2014.32.3_suppl.178

Abstract #

178^

Poster Bd #

A7

Abstract Disclosures