Evidence map›Paper›PMID 33150390›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2021

EGFR/ErbB2-Targeting Lapatinib Therapy for Aggressive Prolactinomas.

Odelia Cooper, Vivien S Bonert, Jeremy Rudnick, Barry D Pressman, Janet Lo, Roberto Salvatori, Kevin C J Yuen, Maria Fleseriu, Shlomo Melmed

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% 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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Immune Checkpoint Inhibitor Therapy for Aggressive Pituitary Neuroendocrine Tumors.The Journal of clinical endocrinology and metabolism · 2025
    Trial
  3. Review
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  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Approach to the Patient With Prolactinoma.The Journal of clinical endocrinology and metabolism · 2023
    Review
  19. Review
  20. Aggressive Pituitary Tumors and Pituitary Carcinomas: From Pathology to Treatment.The Journal of clinical endocrinology and metabolism · 2023
    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

9 authors at 5 institutions in 1 country.

Odelia CooperPituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
Vivien S BonertPituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
Jeremy RudnickDepartments of Medicine, Neurology, and Neurosurgery, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Barry D PressmanDepartment of Imaging, Cedars-Sinai Medical Center, Los Angeles, California.
Janet LoNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts.
Roberto SalvatoriDivision of Endocrinology, Diabetes, and Metabolism and Pituitary Center, Johns Hopkins Hospital, Baltimore, Maryland.
Kevin C J YuenDepartment of Neuroendocrinology and Neurosurgery, Barrow Pituitary Center, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, Arizona.
Maria FleseriuPituitary Center, Departments of Medicine (Endocrinology) and Neurological Surgery, Oregon Health & Science University, Portland, Oregon.
Shlomo MelmedPituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
Cedars-Sinai Medical Center · USBarrow Neurological Institute · USJohns Hopkins Hospital · USMassachusetts General Hospital · USOregon Health & Science University · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
ErbB receptor tyrosine kinase inhibitor therapy for aggressive prolactinomasR21DK105405 · NIDDK · CEDARS-SINAI MEDICAL CENTER · PI COOPER, ODELIA · 2015 to 2016
$429k
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR001881NIDDK NIH HHS R21 DK105405
6 · The paper itself

Abstract

contextApproximately 10% to 20% of prolactinomas are resistant to dopamine agonist therapy. The ErbB signaling pathway may drive aggressive prolactinoma behavior.

objectiveWe evaluated lapatinib, an ErbB1-epidermal growth factor receptor (EGFR)/ErbB2 or human EGFR2 (HER2) tyrosine kinase inhibitor (TKI), in aggressive prolactinomas.

designA prospective, phase 2a multicenter trial was conducted.

settingThis study took place at a tertiary referral pituitary center. PATIENTS: Study participants included adults with aggressive prolactinomas showing continued tumor growth despite maximally tolerated dopamine agonist therapy.

interventionIntervention included oral lapatinib 1250 mg/day for 6 months.

main outcome measuresThe primary end point was 40% reduction in any tumor dimension assessed by magnetic resonance imaging at study end; tumor response was assessed by Response Evaluation Criteria in Solid Tumors criteria. Secondary end points included prolactin (PRL) reduction, correlation of response with EGFR/HER2 expression, and safety.

resultsOwing to rigorous inclusion criteria, of 24 planned participants, only 7 consented and 4 were treated. None achieved the primary end point but 3 showed stable disease, including 2 with a 6% increase and 1 with a 16.8% decrease in tumor diameter. PRL response was not always concordant with tumor response, as 2 showed 28% and 59% increases in PRL. The fourth participant had a PRL-secreting carcinoma and withdrew after 3 months of lapatinib because of imaging and PRL progression. EGFR/HER2 expression did not correlate with treatment response. Lapatinib was well tolerated overall, with reversible grade 1 transaminitis in 2 patients, grade 2 rash in 2 patients, and grade 1 asymptomatic bradycardia in 2 patients.

conclusionsAn oral TKI such as lapatinib may be an effective option for a difficult-to-treat patient with an aggressive prolactinoma.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsErb-b2 Receptor Tyrosine KinasesErbB ReceptorsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansLapatinibMaleMiddle AgedPituitary NeoplasmsPrognosisAntineoplastic AgentsEGFR protein, humanERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesErbB ReceptorsLapatinibepidermal growth factor receptorErbBHER2lapatinibprolactinomatyrosine kinase inhibitor

Identifiers

PMID33150390
PMCPMC7823257
OpenAlexW3096594071

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.