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)

Autor:	Malcolm J. Moore, Jeffrey R. Infante, Werner Scheithauer, Sunil R. Hingorani, Xinyu Wei, E. Gabriela Chiorean, Thomas J. Ervin, Jeremy K. Hon, M. Biakhov, Daniel D. Von Hoff, Alfredo Romano, Ramesh K. Ramanathan, Colin D. Weekes, Josep Tabernero, Francis P. Arena, David Goldstein, Vinod Ganju
Rok vydání:	2013
Předmět:	Oncology Cancer Research medicine.medical_specialty Multivariate analysis business.industry Proportional hazards model Gemcitabine Surgery Increased risk Statistical significance Internal medicine Metastatic pancreatic cancer medicine In patient business medicine.drug Nab-paclitaxel
Zdroj:	Journal of Clinical Oncology. 31:4059-4059
ISSN:	1527-7755 0732-183X
Popis:	4059^ 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. [Table: see text]
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::ad6f545f7070f09b090538309a5d5513 https://doi.org/10.1200/jco.2013.31.15_suppl.4059 Zobrazit plný text záznamu