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.

Author:

Goldstein David1,El Maraghi Robert Hassan2,Hammel Pascal3,Heinemann Volker4,Kunzmann Volker5,Sastre Javier6,Scheithauer Werner7,Siena Salvatore8,Tabernero Josep9,Teixeira Luis10,Tortora Giampaolo11,Van Laethem Jean-Luc12,Young Rosemary13,Wei Xinyu14,Lu Brian14,Romano Alfredo15,Von Hoff Daniel D.16

Affiliation:

1. Prince of Wales Hospital, Sydney, Australia

2. Royal Victoria Regional Health Centre, Barrie, ON, Canada

3. Hôpital Beaujon, Clichy, France

4. Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany

5. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Würzburg, Germany

6. Hospital Clínico San Carlos, Madrid, Spain

7. Medizinische Universität Wien, Wien, Austria

8. Azienda Ospedaleria Niguarda Ca' Granda, Milan, Italy

9. Vall d'Hebron University Hospital, Barcelona, Spain

10. Hôpital Saint-Antoine, Paris, France

11. Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy

12. Erasme University Hospital, Brussels, Belgium

13. Royal Hobart Hospital, Hobart, Australia

14. Celgene Corporation, Summit, NJ

15. Celgene International, Boudry, Switzerland

16. Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare/TGen, Scottsdale, AZ

Abstract

178^ 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. [Table: see text]

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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