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Serious adverse effects occurring after chemotherapy: A general cancer registry‐based incidence survey

机译:化疗后发生的严重不良反应:基于癌症的一般性癌症注册率调查

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Aims Pharmaco‐epidemiological surveys enable the frequency of serious adverse effects—and also the determining factors of their occurrence and seriousness—to be quantified. Few studies systematically gathering post‐chemotherapy adverse effects data have been conducted. The objective was to assess the incidence of post‐chemotherapy serious adverse effects on the basis of cancer registry data. Methods The population was composed of new invasive cancer cases, with the exception of haematopoietic tumours and cutaneous carcinomas. These cancers were identified in 2012 among patients living at the time of diagnosis in a region covered by a general cancer registry and by a French regional pharmacovigilance centre, and treated with neo‐adjuvant and/or adjuvant first‐intention chemotherapy, followed or not by radiotherapy. The study was based on a sample of 1000 patients from the registry, followed by the collection of serious adverse effects and the required information to constitute a pharmacovigilance file. Results Chemotherapy was associated with a particularly high incidence of serious adverse effects, affecting 44.5% (41.4–47.5%) of the patients. The highest incidence rates were observed when patients were exposed to topo‐isomerase II inhibitors such as etoposide and bleomycin (69.2%), vinca‐alkaloids (66.7%), topo‐isomerase I inhibitors (54.5%) and platinum derivatives (52.0%). The clinical context was also linked to incidence, especially in case of metastases (53.3%) and comorbidities (51.3%). Substantial differences were found according to localisation, with a particularly high incidence in bronchial–pulmonary cancers (59.0%). Conclusion The high overall incidence rate of serious adverse effects should motivate a reinforcement of information about drug toxicities and improve knowledge by drawing on patient reporting.
机译:目的药物流行病学调查使得频率是严重不利影响 - 以及确定其发生和严重性的决定因素 - 以量化。已经进行了很少的研究,系统地收集化疗后的不良反应数据。目标是根据癌症登记数据评估化疗后的化疗后严重不利影响的发病率。方法群体由新的侵入性癌症病例组成,除血包血肿瘤和皮肤癌外。这些癌症于2012年鉴定在一般癌症登记处和法国区域药物检测中心涵盖的区域诊断时患者,并用新辅助剂和/或佐剂首先 - 意图化疗,遵循或不遵守放射疗法。该研究基于来自登记处的1000名患者的样本,其次是收集严重的不利影响和所需信息,以构成药物检定文件。结果化疗与严重不良影响的特别高,影响患者的44.5%(41.4-47.5%)。当患者暴露于Topo-异构酶II抑制剂(如etposide和Bleomycin(69.2%),vinca-生物碱(66.7%),Topo-异构酶I抑制剂(54.5%)和铂衍生物(52.0%)时,观察到最高发病率。临床上下文也与发病率有关,特别是在转移(53.3%)和合并症(51.3%)的情况下。根据本地化发现显着差异,在支气管 - 肺癌中具有特别高的发病率(59.0%)。结论严重不利影响的高总体发病率应激励有关药物毒性的信息,并通过绘制患者报告来提高知识。

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