CA19-9 decrease at 8 weeks as a predictor of overall survival (OS) in a randomized phase III trial (MPACT) of weekly nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients with metastatic pancreatic cancer (MPC).

Authors

E. Gabriela Chiorean

E. Gabriela Chiorean

University of Washington, Seattle, WA

E. Gabriela Chiorean , Daniel D. Von Hoff , Thomas J. Ervin , Francis P. Arena , Jeffrey R. Infante , Venu Gopal Bathini , Tina Evans Wood , Paul N. Mainwaring , Robert T. Muldoon , Philip R. Clingan , Volker Kunzmann , Ramesh K. Ramanathan , Josep Tabernero , David Goldstein , Amy Ko , Brian Lu

Organizations

University of Washington, Seattle, WA, Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare/TGen, Scottsdale, AZ, Florida Cancer Specialists, Englewood, FL, Arena Oncology Associates, Lake Success, NY, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN, Cancer Center of Excellence, University of Massachusetts Medical School, Worcester, MA, UAB Comprehensive Cancer Center, Birmingham, AL, Mater Private Centre for Haematology & Oncology, South Brisbane, Australia, Genesis Cancer Center, Hot Springs, AR, Southern Medical Day Care Centre, Wollongong, Australia, Medizinische Klinik und Poliklinik II, University of Wuerzburg, Würzburg, Germany, Vall d'Hebron University Hospital, Barcelona, Spain, Prince of Wales Hospital, Sydney, Australia, Celgene Corporation, Summit, NJ

Research Funding

Pharmaceutical/Biotech Company

Background: nab-P + G showed promising efficacy in a phase I/II study in MPC, and decreases in CA19-9 correlated with OS. In MPACT, patients (pts) who received nab-P + G vs G had improved median OS (8.5 vs 6.7 mo; HR 0.72; p = 0.000015), PFS (5.5 vs 3.7 mo; HR 0.69; p = 0.000024) and ORR (23% vs 7%; p = 1.1 × 10−10). Here we present a prespecified exploratory analysis of CA19-9 from the MPACT trial. Methods: 861 previously untreated pts with MPC were randomized 1:1 to receive nab-P 125 mg/m2 + G 1000 mg/m2 days 1, 8, and 15 every 4 weeks or G alone 1000 mg/m2 weekly for 7 weeks followed by a week of rest (cycle 1) and then days 1, 8, and 15 every 4 weeks (cycle ≥ 2). CA19-9 was evaluated at baseline and then every 8 weeks. OS comparisons at different CA19-9 criteria were performed by stratified Cox proportional hazards model (P by stratified log-rank test using randomization criteria). Results: 750 pts had an evaluable CA19-9 at baseline. More pts in the nab-P + G arm vs the G arm demonstrated a best CA19-9 decrease from baseline of ≥ 20% and ≥ 90% (61% vs 44% and 31% vs 14%, respectively; Table). At the first postbaseline assessment (week 8), greater proportions of pts in the nab-P + G arm vs the G arm had CA19-9 decreases of ≥ 20% and ≥ 90% (Table). At that time point, for pts with a decrease of ≥ 20% in CA19-9, nab-P + G demonstrated a significantly longer OS vs G. The risk reduction for pts with a ≥ 90% decrease was greater than in pts with a ≥ 20% decrease. In pts with an 8-week CA19-9 decrease < 20%, median OS for nab-P + G vs G was 8.3 vs 8.0 mo (HR 0.92; p = 0.705). The relationship of CA19-9 kinetics with OS will also be examined. Conclusions: Higher proportions of pts in the nab-P + G arm had CA 19-9 responses of ≥ 20% and ≥ 90% vs the G arm. Pts who achieved a CA19-9 decrease at 8 weeks of ≥ 20% or ≥ 90% had significantly longer OS with nab-P + G than with G. Clinical trial information: NCT00844649.

nab-P + G
n = 379
G
n = 371
Best CA19-9 decrease ≥ 20%, n (%) 230 (61) 162 (44)
8-week CA19-9 decrease ≥ 20%, n (%) 196 (52) 140 (38)
Median OS, mo 13.2 9.4
1-year OS, % 53 34
HR 0.59
p < 0.001
Best CA19-9 decrease ≥ 90%, n (%) 117 (31) 51 (14)
8-week CA19-9 decrease ≥ 90%, n (%) 59 (16) 33 (9)
Median OS, mo 13.4 9.4
1-year OS, % 57 20
HR 0.44
p 0.0022

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster 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 31, 2013 (suppl; abstr 4058^)

DOI

10.1200/jco.2013.31.15_suppl.4058

Abstract #

4058^

Poster Bd #

18D

Abstract Disclosures