Observational studyPharmaceutical medicine2019
Adverse Drug Reactions Involving Protein Kinase Inhibitors: A French Pharmacovigilance Database Study Comparing Safety in Younger and Older Patients (≥ 75 years) with Cancer.
Observational study in Pharmaceutical medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 5 citations in OpenAlex.
- Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Engineering of Amphiphilic Erlotinib Analogue as Novel Nanomedicine for Non-Small Cell Lung Cancer Therapy.International journal of nanomedicine · 2023Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite the increasing incidence of cancers in elderly people, this population remains under-represented in clinical trials. As a result, data describing the safety and efficacy of protein kinase inhibitors (PKIs) specifically in older patients with cancer are lacking. Advanced age may have a significant impact on drug pharmacology, but data on PKI safety in older patients remain poorly described in "real life".
objectivesWe performed an observational study describing adverse drug reactions (ADRs) related to PKIs and compared the results for younger and older (aged ≥ 75 years) patients.
methodsWe extracted all notifications considered to be related to PKIs from our regional pharmacovigilance database between March 2003 and November 2015. Information about patients, drug exposure, and ADRs were captured. After a descriptive analysis of ADRs, we compared their characteristics between older and younger patients.
resultsIn total, 214 patients experienced 320 ADRs related to PKIs. Slightly over half the patients were male (57%). The mean age was 64.1 years (range 15-90), and 52 (24.3%) patients were aged ≥ 75 years. Cutaneous reactions were the most frequently reported ADRs (22.9%), followed by gastrointestinal (16.8%) and respiratory (12.1%) ADRs. The most often involved PKIs were imatinib [54 patients (25.2%)], dasatinib [25 (11.7%)], sunitinib [25 (11.7%)], erlotinib [25 (11.7%)], and sorafenib [24 (11.2%)], followed by vemurafenib [17 (7.9%)] and everolimus and nilotinib, with 11 patients (5.1%) each. These drugs were administered mostly for three therapeutic indications: chronic myeloid leukemia [56 patients (26.2%)], malignant urinary tract cancer [31 (14.5%)], and bronchial cancer [27 (12.6%)]. Comparison of PKI-related ADRs between older and younger patients showed no significant difference, except for the mean number of coadministered drugs (5.3 vs. 4.2; p = 0.03) and the proportion of vascular ADRs (17.3 vs. 4.3%; p = 0.005), mainly arterial hypertension, which were both significantly more frequent in the older group.
conclusionsOur work showed that PKI-related ADRs in older patients were similar to those in younger adults, except for vascular ADRs, which were significantly more frequent in the older population. Our results require confirmation by larger studies but could lead physicians to be more vigilant about cardiovascular comorbidities during initiation of PKIs in elderly people.
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