A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer.

IF 2.3 Q3 ONCOLOGY Prostate Cancer Pub Date : 2020-11-24 eCollection Date: 2020-01-01 DOI:10.1155/2020/4242989

Aseem Samar, Srikant Tiwari, Sundaram Subramanian, Nisarg Joshi, Jaykumar Sejpal, Mujtaba A Khan, Imran Ahmad

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引用次数: 1

Abstract

Purpose: To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Materials and methods: In this multicenter, retrospective study, we analyzed the medical charts of mCRPC patients, who were treated with NDLS administered as 2-weekly (50 mg/m²) or 3-weekly regimens (75 mg/m²). The study endpoints were prostate-specific antigen (PSA) response (>50% PSA decline from baseline), PSA progression (PSA increase from baseline beyond 12 weeks: ≥25% and ≥2 ng/mL), median PSA decline, and time-to-treatment failure (TTF). Overall survival (OS) and safety were also evaluated.

Results: Data of 24 patients with mCRPC were analyzed in this study. NDLS was administered as a 2-weekly regimen in 37.5% (9/24; all first-line) patients and as a 3-weekly regimen in 62.5% patients (15/24; first-line: 20% (3/15), second-line: 80% (12/15)). Overall, PSA response was reported in 66.7% (16/24) patients. The PSA response was 77.8% (7/9 patients) in the 2-weekly group and 60% (9/15 patients) in the 3-weekly group. The median decline in PSA was 96.31% in the 2-weekly group and 83.29% in the 3-weekly group; the median TTF was 6.7 and 6.5 months in the 2 weekly group and 3-weekly group, respectively. The median OS was 14.6 months (follow-up: 5.5-25.8 months) in the 2-weekly group whereas it was not reached in the 3-weekly group (follow-up: 7.9-15.6 months). The most common hematological AEs were anemia, lymphopenia, thrombocytopenia, and neutropenia whereas nausea, weakness, constipation, vomiting, and diarrhea were the most common (≥10%) nonhematological AEs. Overall, NDLS treatment was well tolerated without any new safety concerns.

Conclusions: Nanosomal docetaxel lipid suspension (2-weekly or 3-weekly) was effective and well tolerated in patients with metastatic castration-resistant prostate cancer.

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多西紫杉醇纳米体脂质悬浮液治疗转移性去势抵抗性前列腺癌的多中心回顾性疗效和安全性研究

目的:评价纳米体多西紫杉醇脂质悬浮液(NDLS, DoceAqualip)治疗转移性去势抵抗性前列腺癌(mCRPC)的疗效和安全性。材料和方法:在这项多中心的回顾性研究中，我们分析了mCRPC患者的医疗图表，这些患者接受NDLS治疗，分为2周(50 mg/m2)或3周(75 mg/m2)。研究终点为前列腺特异性抗原(PSA)应答(PSA比基线下降>50%)、PSA进展(PSA比基线增加超过12周:≥25%和≥2 ng/mL)、中位PSA下降和治疗失败时间(TTF)。总生存期(OS)和安全性也进行了评估。结果:本研究分析了24例mCRPC患者的资料。37.5% (9/24;62.5%的患者采用3周方案(15/24;一线:20%(3/15)，二线:80%(12/15)。总体而言，66.7%(16/24)的患者报告了PSA反应。2周治疗组PSA应答率为77.8%(7/9例)，3周治疗组为60%(9/15例)。2周治疗组PSA中位下降率为96.31%，3周治疗组为83.29%;2周治疗组和3周治疗组的中位TTF分别为6.7和6.5个月。2周治疗组的中位OS为14.6个月(随访时间:5.5-25.8个月)，而3周治疗组(随访时间:7.9-15.6个月)未达到中位OS。最常见的血液学不良反应是贫血、淋巴细胞减少、血小板减少和中性粒细胞减少，而恶心、虚弱、便秘、呕吐和腹泻是最常见的(≥10%)非血液学不良反应。总体而言，NDLS治疗耐受性良好，没有任何新的安全问题。结论:纳米体多西紫杉醇脂质悬浮液(2周或3周)对转移性去势抵抗性前列腺癌患者有效且耐受性良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Prostate Cancer ONCOLOGY-

CiteScore

2.70

自引率

0.00%

发文量

审稿时长

13 weeks

期刊介绍： Prostate Cancer is a peer-reviewed, Open Access journal that provides a multidisciplinary platform for scientists, surgeons, oncologists and clinicians working on prostate cancer. The journal publishes original research articles, review articles, and clinical studies related to the diagnosis, surgery, radiotherapy, drug discovery and medical management of the disease.