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纳米白蛋白结合型紫杉醇/吉西他滨治疗局部晚期或转移性胰腺腺癌的有效性和安全性

Effectiveness and safety of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma.

作者信息

Nebot-Villacampa María-José, Zafra-Morales Ricardo, Alfaro-Olea Ascensión, Marín-Gorricho Raquel, Casajús-Navasal Andrea, Uriarte-Pinto Moisés

机构信息

Pharmacy Department, San Pedro Hospital, Logroño, Spain.

Pharmacy Department, Miguel Servet University Hospital, Zaragoza, Spain.

出版信息

J Oncol Pharm Pract. 2020 Apr;26(3):603-611. doi: 10.1177/1078155219862035. Epub 2019 Jul 18.

DOI:10.1177/1078155219862035
PMID:31315550
Abstract

BACKGROUND

Treatment based on nab-paclitaxel plus gemcitabine is one of the standard treatments for locally advanced or metastatic pancreatic adenocarcinoma. Not much information is available about its use in clinical practice. Looking for prognostic markers may aid in improving treatment plans for patients.

OBJECTIVE

To describe the effectiveness and safety profile of nab-paclitaxel/gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma. We also tried to evaluate prognostic markers of response to treatment.

SETTING

Retrospective descriptive study carried out in a tertiary hospital of Spain.

METHOD

Patients with locally advanced or metastatic pancreatic adenocarcinoma treated with nab-paclitaxel/gemcitabina between January 2014 and December 2017 were included in the analyses.

MAIN OUTCOME MEASURE

Effectiveness was measured in terms of overall survival, progression-free survival and response rate. To evaluate the safety profile, every adverse event from the start of the treatment and up to 10 days after its completion was registered.

RESULTS

Fifty patients were included. Thirty-three (66%) had metastatic disease. Median overall survival was 8.8 months (95%CI: 5.1-12.5) and the median progression-free survival was 5.6 months (95%CI: 4.3-6.9). Relevance of carbohydrate antigen 19-9 baseline levels as prognostic response marker was confirmed, while neutrophil-to-lymphocyte ratio did not show conclusive results for overall survival. Safety profile was similar to that observed in clinical trials, with a single case of treatment discontinuation due to grade 3 neuropathy.

CONCLUSION

The studied schedule for locally advanced or metastatic pancreatic adenocarcinoma seems to be an effective therapeutic option, with an easy to manage toxicity profile, similar to other schedules used in pancreatic adenocarcinoma.

摘要

背景

基于纳米白蛋白结合型紫杉醇联合吉西他滨的治疗是局部晚期或转移性胰腺腺癌的标准治疗方法之一。关于其在临床实践中的应用,目前可用信息不多。寻找预后标志物可能有助于改善患者的治疗方案。

目的

描述纳米白蛋白结合型紫杉醇/吉西他滨在局部晚期或转移性胰腺腺癌中的有效性和安全性。我们还试图评估治疗反应的预后标志物。

地点

在西班牙一家三级医院进行的回顾性描述性研究。

方法

纳入2014年1月至2017年12月期间接受纳米白蛋白结合型紫杉醇/吉西他滨治疗的局部晚期或转移性胰腺腺癌患者进行分析。

主要观察指标

有效性通过总生存期、无进展生存期和缓解率来衡量。为了评估安全性,记录从治疗开始到治疗结束后10天内的每一次不良事件。

结果

纳入50例患者。33例(66%)患有转移性疾病。中位总生存期为8.8个月(95%置信区间:5.1-12.5),中位无进展生存期为5.6个月(95%置信区间:4.3-6.9)。碳水化合物抗原19-9基线水平作为预后反应标志物的相关性得到证实,而中性粒细胞与淋巴细胞比值在总生存期方面未显示出确凿结果。安全性与临床试验中观察到的相似,有1例因3级神经病变而停药。

结论

研究的局部晚期或转移性胰腺腺癌治疗方案似乎是一种有效的治疗选择,毒性易于管理,与用于胰腺腺癌的其他方案相似。

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