Evidence map›Paper›PMID 27796680›Full record

Trial reportInvestigational new drugs2017

Erlotinib pharmacokinetics: a critical parameter influencing acute toxicity in elderly patients over 75 years-old.

Frederic Bigot, Pascaline Boudou-Rouquette, Jennifer Arrondeau, Audrey Thomas-Schoemann, Camille Tlemsani, Jeanne Chapron, Olivier Huillard, Anatole Cessot, Michel Vidal, Jerome Alexandre and 2 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. KScientific reports · 2021
    Article
  4. Article
  5. Article
  6. Review
  7. Review
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

12 authors.

Frederic BigotDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Pascaline Boudou-RouquetteDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France. pascaline.boudou@aphp.fr.
Jennifer ArrondeauDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Audrey Thomas-SchoemannDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Camille TlemsaniDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Jeanne ChapronDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Olivier HuillardDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Anatole CessotDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Michel VidalDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Jerome AlexandreDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Benoit BlanchetDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.
Francois GoldwasserDepartment of Medical Oncology, Cochin - Port Royal Hospital, AP-HP, Paris Descartes University, Sorbonne Paris Cité 123, Boulevard de Port-Royal, 75014, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Older non-small cell lung cancer (NSCLC) patients under erlotinib are reported to experience more acute toxicity. We hypothesized that modifications in erlotinib pharmacokinetics might explain this observation. Methods A monocentric prospective clinico-pharmacological study included stage IIIb/IV NSCLC consecutive pts. treated with erlotinib. The plasma concentration of erlotinib (Ce) was measured at steady state on day 15. We studied the relationship between age > 75 years, and Ce, using the Mann-Whitney U test and with the occurrence of acute toxicity, using a Fisher's test. Results A total of 53 pts. were analyzed. Median age was 68 years (31-83), 56 % were female. All pts. > 75 years experienced toxicity: all grade acute adverse events were 1.6 fold more frequent (100 % vs 61 %; OR 95 % CI [1.9-INF]; p = 0.003). At day 15, Ce increased with age. Over 75 years old, the mean Ce was 1.5 fold higher: 2091 ng/mL (95 % CI [1476; 2706]) vs 1359 (95 % CI [1029; 1689]; p = 0.024). In pts. over 80 years old, the mean Ce was doubled: 2729 (95 % CI [1961; 3497]) vs 1358 ng/mL (95 % CI [1070; 1646]; p = 0.0019). Reduced lean body mass over 75 years (median 36.6 kg versus 49.1 kg) might account for these differences. Finally, the risk of early erlotinib discontinuation was increased by 11 in older pts. (33 % vs 3 % OR 17.2; 95 % CI [1.7; 892.5] p = .005). Conclusion The risk of overexposure to erlotinib increases with age. Reduced lean body mass may explain erlotinib pharmacokinetics and excessive acute toxicity in the elderly.

Indexed as

AgedAged, 80 and overAgingAntineoplastic AgentsBody HeightBody Mass IndexBody WeightCarcinoma, Non-Small-Cell LungErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleProtein Kinase InhibitorsAntineoplastic AgentsErlotinib HydrochlorideProtein Kinase InhibitorsElderlyErlotinibPharmacokineticPlasma monitoringToxicity

Identifiers

PMID27796680

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.