Prognostic factors (PFs) of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients (pts) with metastatic pancreatic cancer (MPC).

Authors

null

Malcolm J. Moore

Princess Margaret Hospital, Toronto, ON, Canada

Malcolm J. Moore , Daniel D. Von Hoff , Thomas J. Ervin , Francis P. Arena , E. Gabriela Chiorean , Jeffrey R. Infante , Jeremy K. Hon , Mikhail Yu Biakhov , Sunil R. Hingorani , Vinod Ganju , Colin D. Weekes , Werner Scheithauer , Ramesh K. Ramanathan , Josep Tabernero , David Goldstein , Xinyu Wei , Alfredo Romano

Organizations

Princess Margaret Hospital, Toronto, ON, Canada, Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen, Scottsdale, AZ, Florida Cancer Specialists, Fort Myers, FL, Arena Oncology Associates, Lake Success, NY, University of Washington, Seattle, WA, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN, Clearview Cancer Institute, Huntsville, AL, Semashko Central Clinical Hospital, Moscow, Russia, Fred Hutchinson Cancer Research Center, Seattle, WA, Peninsula Oncology Centre, Frankston, Australia, University of Colorado Cancer Center, Aurora, CO, Medizinische Universität Wien, Wien, Austria, Vall d'Hebron University Hospital, Barcelona, Spain, Prince of Wales Hospital, Sydney, Australia, Celgene Corporation, Summit, NJ

Research Funding

Pharmaceutical/Biotech Company

Background: In MPACT, pts who received nab-P + G vs G had improved overall survival (OS; median 8.5 vs 6.7 mo; HR 0.72; p= 0.000015). Here we assessed potential PFs of OS. Methods: 861 pts with MPC were randomized 1:1, stratified by region, presence of liver metastases, and Karnofsky performance status (KPS), to nab-P + G or G. OS was described in subgroups. A step-wise multivariate analysis (with significance level for entry of 0.20 and for stay of 0.10) was performed to evaluate the treatment effect and identify possible predictors of OS. Results: Pts with poorer PFs had a shorter median OS, consistent with the literature, and OS consistently favored nab-P + G in pts with these PFs (Table). Region of Eastern Europe, age ≥ 65 years, poorer KPS, presence of liver metastases, and number of metastatic sites all predicted OS (increased risk of death). The treatment effect remained significant (HR 0.72; 95% CI, 0.605 - 0.849; p < 0.0001, Cox proportional hazards [CPH] model). In another multivariate analysis in which baseline CA19-9 was added to the final model described above, the treatment effect HR was 0.67 (95% CI, 0.573 - 0.794; p < 0.0001, CPH model). Baseline CA19-9, a predictor of OS by univariate analysis, was not predictive after correction for the above factors. Conclusions: In MPACT, the most important predictors of OS were KPS, age, presence of liver metastases, number of metastatic sites, and region. After correcting for these factors, assignment to nab-P + G was an independent significant predictor of improved survival. Clinical trial information: NCT00844649.

Factors predictive of OS HR P value
Treatment (nab-P + G vs G) 0.72 0.0001
Region (E Europe vs N America) 1.22 0.0765
Age (< 65 vs ≥ 65 years) 0.81 0.0190
KPS (70 - 80 vs 90 - 100) 1.60 < 0.0001
Liver metastases (yes vs no) 1.81 < 0.0001
No. of metastatic sites (1, 2, 3, > 3) 1.08 0.0864
Pt subgroups
nab-P + G G
n Median OS, mo n Median OS, mo
Region
N America 268 8.7 271 6.8
E Europe 64 7.7 62 5.9
Age
< 65 254 9.2 242 6.8
≥ 65 years 177 7.8 188 6.6
KPS
70 30 3.9 33 2.8
80 149 8.1 128 5.6
90 179 8.9 199 7.1
100 69 12.6 69 10.9
Liver metastases
Yes 365 8.3 360 5.9
No 66 11.0 70 10.7
No. of metastatic sites
1 33 13.5 21 9.0
2 202 8.3 206 7.1
3 136 8.0 140 5.9
> 3 60 8.6 63 5.0

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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 4059^)

DOI

10.1200/jco.2013.31.15_suppl.4059

Abstract #

4059^

Poster Bd #

18E

Abstract Disclosures