Evidence map›Paper›PMID 33530147›Full record

ReviewCardio-oncology (London, England)2015

Cardiac safety of afatinib: a review of data from clinical trials.

Michael S Ewer, Kalpesh Patel, Dennis O'Brien, Robert M Lorence

Open access · goldAbstract readReview
In one paragraph

Review in Cardio-oncology (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 29% 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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Cardiovascular disease and lung cancer.Frontiers in oncology · 2024
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Cardio-Oncology: Mechanisms, Drug Combinations, and Reverse Cardio-Oncology.International journal of molecular sciences · 2022
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Cardiac Safety of Osimertinib: A Review of Data.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Review
  20. Article
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

4 authors at 2 institutions in 1 country.

Michael S EwerDepartment of Cardiology, Division of Medical Specialties, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA. mewer@mdanderson.org.
Kalpesh PatelBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Dennis O'BrienBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Robert M LorenceBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Boehringer Ingelheim (United States) · USThe University of Texas MD Anderson Cancer Center · US

Funding

Boehringer Ingelheim ID0EAGAE16
6 · The paper itself

Abstract

backgroundAfatinib is an oral irreversible ErbB family blocker that targets epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (HER2/ErbB2), and HER4 (ErbB4) and is approved for the first-line treatment of advanced non-small cell lung cancer (NSCLC) with certain sensitizing EGFR mutations. As anti-HER2 therapies have been associated with cardiac dysfunction, we report cardiac safety data for afatinib.

methodsCardiac data were analyzed from phase III trials of afatinib 40 mg in treatment-naive patients with EGFR mutation-positive NSCLC (LUX-Lung 3 [LL3]; n = 229 afatinib, n = 111 chemotherapy) and afatinib 50 mg in EGFR tyrosine kinase inhibitor-pretreated NSCLC patients (LUX-Lung 1 [LL1]; n = 390 afatinib, n = 195 placebo). Additional pooled data from 49 trials (n = 3865 afatinib-treated patients) is reported. Cardiac failure adverse events (CF-AEs), including symptomatic cardiac failure and depressed left ventricular ejection fraction (LVEF), were analyzed.

resultsTime at risk-adjusted CF-AE rates (events/100 patient-years) were similar for afatinib versus placebo in LL1 (2.40 vs 2.23) and versus chemotherapy in LL3 (2.28 vs 2.92); the pooled afatinib CF-AE rate (2.88) was consistent with that for both trials. The frequency of clinically significant LVEF reductions was higher for chemotherapy in LL3 (2/15 [13.3 %], afatinib 13/208 [6.3 %]; p = 0.267) and similar to placebo in LL1 (5/122 [4.1 %], afatinib 14/304 [4.6 %]; p = 1.000).

conclusionAfatinib was not associated with cardiac failure or LVEF reductions in the afatinib clinical trial program.

Indexed as

AfatinibCardiac safetyNon–small cell lung cancerTyrosine kinase inhibitor

Identifiers

PMID33530147
PMCPMC7837143
OpenAlexW2179573379

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.