Evidence map›Paper›PMID 29022151›Full record

ArticleTargeted oncology2017

Comparative Safety of Targeted Therapies for Metastatic Colorectal Cancer between Elderly and Younger Patients: a Study Using the International Pharmacovigilance Database.

Amandine Gouverneur, Pauline Claraz, Marine Rousset, Mickaël Arnaud, Annie Fourrier-Réglat, Antoine Pariente, Thomas Aparicio, Ghada Miremont-Salamé, Pernelle Noize

Abstract read
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In one paragraph

Article in Targeted oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Amandine GouverneurUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France. amandine.gouverneur@u-bordeaux.fr.ORCID 0000-0001-6253-1833
Pauline ClarazCHU de Bordeaux, Pôle de Santé Publique, Service de Pharmacologie Médicale, F-33000, Bordeaux, France.
Marine RoussetUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Mickaël ArnaudUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Annie Fourrier-RéglatUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Antoine ParienteUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Thomas AparicioGastroenterology and Digestive Oncology Department, Saint Louis Hospital, APHP, F-75010, Paris, France.
Ghada Miremont-SalaméUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Pernelle NoizeUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, Team, Pharmacoepidemiology, UMR 1219, F-33000, Bordeaux, France.
Université de Bordeaux · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastatic colorectal cancer (mCRC) is increasingly treated using targeted therapies. Post-marketing safety of these agents is understudied, especially in the elderly.

objectiveThis study aimed to compare, according to age, the adverse drug reactions (ADRs) of targeted therapies used for mCRC in real life. PATIENTS AND

methodsAn extraction of VigiBase, which contains World Health Organization individual case safety reports (ICSRs), was performed. All ADR reports with aflibercept, bevacizumab, cetuximab, panitumumab, or regorafenib used in CRC were considered. For all drugs, chi-square tests were used to compare frequencies of serious ADRs between patients aged ≥75 and <75 years. For selected ADRs and each drug, the drug-ADR association compared to other anticancer drugs was estimated through the proportional reporting ratio (PRR) in both age groups.

resultsThere were 21,565 ICSRs included, among which 74% were serious and 11% were fatal. Median age was 64 years (Inter Quartile Range = 56-71) and 15% of patients were aged ≥75; 57% were male. Serious ICSRs accounted for 47,292 ADRs. Neutropenia was not more reported in elderly for all drugs while diarrhea was more reported in elderly for panitumumab. Cardiac disorders were more reported in elderly patients, in particular heart failure, especially for bevacizumab, cetuximab, and regorafenib, as were respiratory, thoracic, and mediastinal disorders. Most of PRR were not different between the two groups, except encephalopathies, which were significantly associated with bevacizumab in the elderly only.

conclusionsADRs related to targeted therapies used for mCRC treatment were different across age groups; yet, not systematically more reported or worse in elderly patients. Selected elderly patients could, therefore, be treated with these targeted therapies.

Indexed as

PharmacovigilanceAgedColorectal NeoplasmsFemaleHumansMaleMiddle AgedNeoplasm Metastasis

Identifiers

PMID29022151
OpenAlexW2761273954

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.