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

Abstract

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.

Are severe adverse events commonly observed in dogs during cancer chemotherapy? A retrospective study on 155 dogs

“…In human medicine, sAE are defined as any AE resulting in hospitalisation, permanent disability, life‐threatening situation or death and congenital malformation 40 . Sometimes, it also includes sAE leading to chemotherapy delay or arrest 41 . In veterinary medicine, there is no consensual definition and sAE is mostly considered as an AE leading to hospitalisation, chemotherapy arrest or death 42 .…”

Genetic Therapy and Molecular Targeted Therapy in Oncology: Safety, Pharmacovigilance, and Perspectives for Research and Clinical Practice

“…For example, oncolytic viruses can affect only viral antigens, limiting the effectiveness of OV therapy; the reaction and the immune response have significant individual variability, and a relevant problem is the rapid viral elimination of OVs from the organism [ 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 ]. In addition, CAR-T therapy requires a very complex lymphodepletion process, implemented with chemotherapy before infusion; the consequent risk of serious adverse events such as cytokine release syndrome calls for immediate management and advanced clinical skills [ 72 ]. Therefore, clinical trials to investigate these treatment strategies must be designed and planned for both the follow-up of patients and the available technologies, which require advanced clinical and hospital settings and vast investments of economic resources [ 73 , 74 ].…”

Toxicities associated with chemotherapy regimens containing a fluoropyrimidine: A real-life evaluation in France

“…Data were extracted from the SIRCADE study cohort (22). The objective was to assess the incidence of post-chemotherapy SAEs in patients diagnosed receiving first-line chemotherapy.…”