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
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 | ||
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 Disclosures
2022 ASCO Annual Meeting
First Author: Shukui Qin
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Kazuki Watabe
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Koen Zwart
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Felix Keil