培美曲塞（Alvopem）在非小细胞肺癌或恶性胸膜间皮瘤患者中的安全性评估：一项上市后监测。

Alvopem (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance.

作者信息

Seifi Sharareh, Salimi Babak, Monfared Zahra Esfahani, Sabahi Cyrus, Kafi Hamidreza, Khosravi Adnan

机构信息

Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar Roundabout, Tehran, 1956944413, Iran.

出版信息

J Pharm Policy Pract. 2023 Jan 25;16(1):16. doi: 10.1186/s40545-023-00524-5.

DOI:10.1186/s40545-023-00524-5

PMID:36698207

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9878795/

Abstract

BACKGROUND

Lung cancer is the leading cause of cancer deaths worldwide in both men and women, and non-small cell lung cancer (NSCLC) accounts for the majority (~ 85%) of lung cancers. This post-marketing surveillance (PMS) study aimed to evaluate the safety of Pemetrexed (Alvopem, NanoAlvand, Iran) in Iranian patients with lung cancer or mesothelioma.

METHODS

The present study is an observational, single-center, open-label, and post-authorization study. All eligible non-squamous NSCLC and malignant pleural mesothelioma (MPM) patients who received pemetrexed based on the physicians' decision, were enrolled.

RESULTS

A total of 199 patients with non-squamous NSCLC [186 patients (93.47%) or MPM (12 patients (6.03%)] were enrolled from March 2016 to February 2020. The most common reported adverse event (AE) was anemia (89.39%), followed by neutropenia (28.79%) and leukopenia (24.75%). The most important grade 3 AEs were anemia and neutropenia, with the incidence rate of 3.54% and 7.58%, respectively. No grade 4 AEs were reported. Moreover, the results of our study showed negative statistically significant correlations between patients' age and mean neutrophil count (r = - 0.17; P = 0.0156) and hemoglobin (r = - 0.16; P = 0.0201) in all six visits.

CONCLUSIONS

The results of this open-label, observational PMS showed that Pemetrexed (Alvopem) is safe in patients with non-squamous NSCLC patients receiving pemetrexed-containing regimens.

TRIAL REGISTRATION

The trial was registered at ClinicalTrials.gov (NCT04843007) in April 13th, 2021.

摘要

背景

肺癌是全球男性和女性癌症死亡的主要原因，非小细胞肺癌（NSCLC）占肺癌的大多数（约85%）。这项上市后监测（PMS）研究旨在评估培美曲塞（Alvopem，NanoAlvand，伊朗）在伊朗肺癌或间皮瘤患者中的安全性。

方法

本研究是一项观察性、单中心、开放标签和上市后授权研究。所有符合条件的非鳞状NSCLC和恶性胸膜间皮瘤（MPM）患者，根据医生的决定接受培美曲塞治疗，均被纳入研究。

结果

2016年3月至2020年2月，共纳入199例非鳞状NSCLC患者[186例（93.47%）或MPM患者（12例（6.03%）]。报告的最常见不良事件（AE）是贫血（89.39%），其次是中性粒细胞减少（28.79%）和白细胞减少（24.75%）。最重要的3级AE是贫血和中性粒细胞减少，发生率分别为3.54%和7.58%。未报告4级AE。此外，我们的研究结果显示，在所有六次就诊中，患者年龄与平均中性粒细胞计数（r = -0.17；P = 0.0156）和血红蛋白（r = -0.16；P = 0.0201）之间存在负相关且具有统计学意义。