纳武利尤单抗联合吉西他滨治疗转移性胰腺癌患者的临床结局和安全性：NAPA 研究。

Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study.

机构信息

School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, viale Pieraccini, 6, 50139, Florence, Italy.

出版信息

Curr Cancer Drug Targets. 2020;20(11):887-895. doi: 10.2174/1568009620999200918122426.

DOI:10.2174/1568009620999200918122426

PMID:32957885

Abstract

BACKGROUND

The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice.

METHODS

From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed.

RESULTS

The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients.

CONCLUSION

Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

摘要

背景

III 期 MPACT 试验表明，与单独使用吉西他滨（Gem）相比，在未经治疗的转移性胰腺导管腺癌（PDAC）患者中，吉西他滨联合 Nab-紫杉醇（Nab-P）具有优越性。本研究的目的是评估 Gem/Nab-P 在常规临床实践中的效果。

方法

从 2015 年 1 月至 2018 年 12 月，在一项多中心回顾性观察研究中，纳入了转移性 PDAC 患者，这些患者接受了 Gem 和 Nab-紫杉醇联合一线治疗。对疗效、预后和预测标志物进行了探索性分析。

结果

该队列包括 115 名患者（中位年龄 65 [范围 50-84] 岁），表现状态良好（ECOG PS 0-1）。中位总生存期（OS）为 11 个月（95%CI；9-13），中位无进展生存期（PFS）为 6 个月（95%CI 5-7）。44 名患者和 30 名患者分别获得部分缓解和稳定疾病，总疾病控制率（DCR）为 64.3%。中性粒细胞减少症、贫血和血小板减少症的 3-4 级血液学毒性发生率分别为 22.61%、5.22%和 3.48%。3 级乏力的发生率为 2.61%。未报告 4 级非血液学事件。51.3%的患者需要减少剂量。