Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer
Prognostic Factors of Survival in a Randomized Phase III Trial (MPACT) of Weekly nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Pancreatic Cancer
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DOI：
10.1634/theoncologist.2014-0394
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发表时间：
2015-02-01
期刊：
影响因子：
5.8
通讯作者：
Von Hoff, Daniel D.
中科院分区：
文献类型：
--
作者：
Tabernero, Josep;Chiorean, E. Gabriela;Von Hoff, Daniel D.
背景基于在III期MPACT试验中证明的优于吉西他滨的优势，nab-Paclitazone联合吉西他滨已成为转移性胰腺癌（MPC）患者的新治疗选择。以前，Karnofsky体能状态（KPS）评分和肝转移的存在被证明是预测生存与白蛋白结合型紫杉醇加吉西他滨治疗。该分析旨在进一步探讨MPACT试验中临床特征与生存率之间的关系，并确定MPC患者总生存率和无进展生存率的潜在预测因素。采用考克斯回归模型校正分层因素，并对预先设定的基线预后因素进行逐步多变量分析。治疗效果与生存率显著相关，与先前报告的主要分析相比，死亡风险降低幅度相似。在大多数预先规定的因素中，治疗效果始终有利于白蛋白结合型紫杉醇+吉西他滨。除了KPS评分和肝转移外，年龄和转移部位数量是影响总生存期和无进展生存期的独立预后因素。基线糖链抗原19-9未被发现是生存的独立预后因素。该分析的结果证实了白蛋白结合型紫杉醇加吉西他滨用于治疗MPC的广泛效用。此外，这些研究结果表明，KPS评分，肝转移的存在，年龄和转移部位的数量是生存的重要预测因素，在制定治疗决策和设计未来的临床试验时可能是有用的。
Background. nab-Paclitaxel in combination with gemcitabine has emerged as a new treatment option for patients with metastatic pancreatic cancer (MPC), based on superiority over gemcitabine demonstrated in the phase III MPACT trial. Previously, Karnofsky performance status (KPS) score and the presence of liver metastases were shown to be predictive of survival with nab-paclitaxel plus gemcitabine treatment. This analysis sought to further explore the relationship between clinical characteristics and survival in the MPACT trial and to identify potential predictors of overall survival and progression-free survival in patients with MPC.Materials and Methods. Cox regression models adjusted for stratification factors and a stepwise multivariate analysis of prespecified baseline prognostic factors were performed.Results. Treatment effect was significantly associated with survival, with a similar magnitude of reduction in risk of death compared with the previously reported primary analysis. Treatment effect consistently favored nab-paclitaxel plus gemcitabine across the majority of the prespecified factors. In addition to KPS score and presence of liver metastases, age and number of metastatic sites were independent prognostic factors of overall and progressionfree survival. Baseline carbohydrate antigen 19-9 was not found to be an independent prognostic factor of survival in this analysis.Conclusion. The results of this analysis confirm broad utility of nab-paclitaxel plus gemcitabine for the treatment of MPC. In addition, these findings suggest that KPS score, presence of liver metastases, age, and number of metastatic sites are important predictors of survival that may be useful when making treatment decisions and designing future clinical trials.