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奥尼维德(伊立替康脂质体注射液)用于基于吉西他滨的治疗后转移性胰腺癌治疗的安全性和有效性。

The safety and efficacy of Onivyde (irinotecan liposome injection) for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

作者信息

Passero Frank C, Grapsa Dimitra, Syrigos Kostas N, Saif Muhammad Wasif

机构信息

a Division of Hematology/Oncology and Experimental Therapeutics , Tufts Medical Center , Boston , MA , USA.

b Oncology Unit GPP , Sotiria General Hospital , Athens , Greece.

出版信息

Expert Rev Anticancer Ther. 2016 Jul;16(7):697-703. doi: 10.1080/14737140.2016.1192471. Epub 2016 Jun 3.

DOI:10.1080/14737140.2016.1192471
PMID:27219482
Abstract

INTRODUCTION

Patients with advanced and metastatic pancreatic cancer refractory to gemcitabine based therapy have a dismal prognosis and limited therapeutic options. Recently, the FDA approved nanoliposomal irinotecan combined with fluorouracil/folinic acid for such patients based upon results of the NAPOLI-1 study which showed this regimen compared to fluorouracil/folinic acid significantly prolonged progression free survival (3.1 vs. 1.5 months) and overall survival (6.2 vs. 4.1 months).

AREAS COVERED

The pharmacokinetic and pharmacogenetic characteristics of this novel formulation of irinotecan, its safety profile, and use in a clinical context for patients with pancreatic cancer are reviewed. Expert commentary: Nanoliposomal irinotecan, in combination with 5-FU/folinic acid, represents an important step forward in improving second line treatment options in patients with progression of metastatic pancreatic cancer. Furthermore, the novel drug formulation offers pharmacokinetic advantages which serve as a basis for further clinical testing in a various pancreatic cancer settings and other malignancies.

摘要

引言

对基于吉西他滨的治疗难治的晚期和转移性胰腺癌患者预后不佳且治疗选择有限。最近,基于NAPOLI-1研究结果,美国食品药品监督管理局(FDA)批准了纳米脂质体伊立替康联合氟尿嘧啶/亚叶酸用于此类患者,该研究表明该方案与氟尿嘧啶/亚叶酸相比,显著延长了无进展生存期(3.1个月对1.5个月)和总生存期(6.2个月对4.1个月)。

涵盖领域

本文综述了这种新型伊立替康制剂的药代动力学和药物遗传学特征、其安全性概况以及在胰腺癌患者临床中的应用。专家评论:纳米脂质体伊立替康联合5-氟尿嘧啶/亚叶酸是改善转移性胰腺癌进展患者二线治疗选择的重要进展。此外,这种新型药物制剂具有药代动力学优势,可为在各种胰腺癌环境和其他恶性肿瘤中进行进一步临床试验提供依据。

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