Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili and University of Brescia, Italy.
Department of Epidemiological and Molecular Medicine Research, Evaluative Epidemiology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy.
Future Oncol. 2019 Jul;15(21):2543-2553. doi: 10.2217/fon-2018-0772. Epub 2019 Jun 26.
Reporting toxicities of targeted therapies (TTs) and immunotherapy in oncology requires special attention. We identified TTs and immunotherapies approved by the US FDA for solid malignancies in the adult population. Publications were reviewed according to a 24-point score based on the Consolidated Standards of Reporting Trials guidance. We identified 81 trials (>45,000 patients). The experimental drug was studied as single agent in 51% of the cases; setting of disease was mainly (95%) advanced/metastatic. Lowest scores in adverse event (AE) description regarded: reporting recurrent/late toxicities and duration of the AEs (>90%), time of occurrence and indication of all-grade AEs (>75%). Suboptimal reporting of AEs in trials leading to approval of TTs and immunotherapy was shown. Improving AE descriptions should be a priority in ongoing trials.
报告肿瘤学中靶向治疗（TTs）和免疫疗法的毒性需要特别注意。我们确定了美国食品和药物管理局（FDA）批准的用于成人实体恶性肿瘤的 TTs 和免疫疗法。根据临床试验报告的统一标准（CONSORT）指南，根据 24 分制对出版物进行了审查。我们确定了 81 项试验（>45,000 名患者）。在 51%的情况下，实验药物作为单一药物进行了研究；疾病的设置主要是（95%）晚期/转移性。在不良事件（AE）描述中得分最低的是：报告复发/迟发性毒性和 AE 的持续时间（>90%），AE 的发生时间和所有分级 AE 的指示（>75%）。批准 TTs 和免疫疗法的试验中，AE 的报告并不理想。在正在进行的试验中，应优先改进 AE 描述。
Zotero 插件