Analyses of updated overall survival (OS) and prognostic effect of neutrophil-to-lymphocyte ratio (NLR) and CA 19-9 from the phase III MPACT study of nab-paclitaxel (nab-P) plus gemcitabine (Gem) versus Gem for patients (pts) with metastatic pancreatic cancer (PC).

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 , Teresa Macarulla , Luis Teixeira , Giampaolo Tortora , Jean Luc Van Laethem , Darryl Neil Penenberg , 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, Medical University of Vienna, Vienna, Austria, Ospedale Niguarda Ca' Granda Milano, Milan, Italy, Vall d'Hebron University Hospital, Barcelona, Spain, Breast Diseases Center and Oncology Department, Saint Louis Hospital, Paris, France, Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy, Erasme University Hospital, Brussels, Belgium, Celgene Corporation, Summit, NJ, Celgene International, Boudry, Switzerland, Clinical Trials, Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen, Scottsdale, AZ

Research Funding

Pharmaceutical/Biotech Company

Background: In the phase III MPACT trial, nab-P + Gem demonstrated superior OS vs Gem (primary endpoint; median 8.5 vs 6.7 months; HR 0.72; P< 0.001) with manageable toxicity in pts with metastatic PC. The primary analyses were based on a cutoff of Sep 17, 2012, at which time 80% of pts had died. Here, we report an updated OS analysis (post hoc) and an assessment of pts with elevated NLR or elevated CA 19-9 at baseline, 2 accepted markers of poor prognosis. Methods: 861 pts with metastatic PC and a Karnofsky performance status ≥ 70 were randomized at 151 community and academic centers 1:1 to receive nab-P 125 mg/m2 + Gem 1,000 mg/m2 on days 1, 8, and 15 of each 28-day cycle or Gem 1,000 mg/m2weekly for 7 wks followed by 1 wk of rest (cycle 1) and then days 1, 8, and 15 of each 28-day cycle (cycle ≥ 2). The data for the OS analysis were collected through May 9, 2013. Baseline NLR and CA19-9 were measured in blood samples collected before treatment. Results: As of the updated data cutoff, 380 of 431 pts (88%) in the nab-P + Gem arm and 394 of 430 pts (92%) in the Gem-alone arm had died. OS was superior for nab-P + Gem in the intent-to-treat (ITT) population, and longer follow-up identified > 3-yr survivors in the nab-P + Gem arm (Table). In a pooled–treatment-arm analysis, a NLR ≤ 5 was associated with longer OS vs a NLR > 5 (median 9.1 vs 5.0 months; HR 1.839; P < 0.001). Median OS was longer with nab-P + Gem vs Gem for pts with a NLR > 5 and pts with CA 19-9 > 59 × upper limit of normal (ULN; Table). Conclusions: Updated data confirmed the treatment effect favoring nab-P + Gem for OS. Additional follow-up has identified long-term survivors in the nab-P + Gem arm. The improved OS for pts treated with nab-P + Gem who have a NLR > 5 or an elevated CA 19-9 supports the relative benefit of the combination, even for pts with markers of poor prognosis. Clinical trial information: NCT00844649.

Updated OS (May 9, 2013).
nab-P+ Gem
n = 431
Gem
n = 430
HR P value
ITT population
Median OS, mo 8.7 6.6 0.72 < 0.001
OS rates by mo, %
6 66 55
12 35 22
24 10 5
36 4
40 3
42 3
Subsets with markers of poor prognosis
Median OS, mo
NLR > 5 (n = 309) 5.6 4.3 0.81 0.079
CA 19-9 ≥ 59 × ULN (n = 392) 8.4 5.7 0.61 < 0.001

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Highlights Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Pancreatic Cancer

Clinical Trial Registration Number

NCT00844649

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 4027^)

DOI

10.1200/jco.2014.32.15_suppl.4027

Abstract #

4027^

Poster Bd #

46

Abstract Disclosures