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近期专利抗癌药物的安全性概况和药物警戒学考虑因素:甲状腺癌进展期。

Safety Profiles and Pharmacovigilance Considerations for Recently Patented Anticancer Drugs: Advanced Thyroid Cancer.

机构信息

Medical Oncology and Immune-related Tumors, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano 33081, Italy.

Pharmacy Unit, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano 33081, Italy.

出版信息

Recent Pat Anticancer Drug Discov. 2019;14(3):226-241. doi: 10.2174/1574892814666190726143011.

Abstract

BACKGROUND

Thyroid cancer is the most common endocrine neoplasia and represents approximately 1.5% to 2.1% of all cancers diagnosed annually worldwide. Iodine Refractory Differentiated Thyroid Carcinoma (RR-DTC) and advanced/metastatic medullary thyroid carcinoma are relatively uncommon yet prognostically significant thyroid cancers. Gene rearrangements resulting in the aberrant activity of tyrosine kinases have been identified as drivers of oncogenesis in a variety of cancers, including thyroid cancer. Many Multi-Kinase Inhibitors (MKIs) which are now FDA-/EMA approved for thyroid cancer have shown clinical benefit in patients with advanced cancer. Treatment related toxicities occur frequently with these drugs and can be severe or life-threatening.

OBJECTIVES

This review summarizes the role of targeted therapy with MKIs in the management of RRDTC and advanced/metastatic MTC patients, focusing on side-effect profiles of these drugs, with a presentation of several recent patents published in this field.

METHODS

We review the scientific literature on advanced thyroid cancer and analyze the International Pharmacovigilance database (FAERS, Eudravigilance, and WHO Vigibase) for adverse drug reactions.

RESULTS

This systematic analysis highlights the difference in the safety profile of the recent drugs used in the treatment of advanced thyroid cancer and the recent discoveries for diagnosis or treatment of the thyroid cancer.

CONCLUSION

It is essential to investigate the safety profile of recent anticancer drugs for advanced thyroid cancer to allow health professionals to make the best choice for each patient by conducting risk/benefit assessment.

摘要

背景

甲状腺癌是最常见的内分泌肿瘤,约占全球每年诊断出的所有癌症的 1.5%至 2.1%。碘难治性分化型甲状腺癌(RR-DTC)和晚期/转移性甲状腺髓样癌是相对罕见但预后意义重大的甲状腺癌。导致酪氨酸激酶异常活性的基因重排已被确定为包括甲状腺癌在内的多种癌症的致癌驱动因素。许多多激酶抑制剂(MKIs)现已获得美国食品和药物管理局/欧洲药品管理局批准用于甲状腺癌,在晚期癌症患者中显示出临床获益。这些药物常发生治疗相关毒性,且可能严重或危及生命。

目的

本综述总结了 MKI 靶向治疗在 RR-DTC 和晚期/转移性 MTC 患者管理中的作用,重点关注这些药物的副作用特征,并介绍该领域的几项近期专利。

方法

我们回顾了关于晚期甲状腺癌的科学文献,并分析了国际药物警戒数据库(FAERS、Eudravigilance 和 WHO Vigibase)中的药物不良反应报告。

结果

这项系统分析突出了用于治疗晚期甲状腺癌的近期药物的安全性特征与甲状腺癌的诊断或治疗的最新发现之间的差异。

结论

有必要调查晚期甲状腺癌的新型抗癌药物的安全性特征,以便医疗保健专业人员通过风险/获益评估为每位患者做出最佳选择。

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