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Updated: Dec 2, 2025

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EGFR/ErbB2-Targeting Lapatinib Therapy for Aggressive Prolactinomas.

Odelia Cooper1, Vivien S Bonert1, Jeremy Rudnick2

  • 1Pituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.

The Journal of Clinical Endocrinology and Metabolism
|November 5, 2020
PubMed
Summary

Lapatinib, an oral tyrosine kinase inhibitor, showed potential for aggressive prolactinomas resistant to standard therapy. While not meeting primary endpoints, it offered stable disease in some patients and was generally well-tolerated.

Keywords:
ErbBHER2epidermal growth factor receptorlapatinibprolactinomatyrosine kinase inhibitor

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Area of Science:

  • Endocrinology
  • Oncology
  • Pharmacology

Background:

  • Approximately 10-20% of prolactinomas exhibit resistance to dopamine agonist therapy.
  • The ErbB signaling pathway is implicated in the aggressive behavior of prolactinomas.

Purpose of the Study:

  • To evaluate the efficacy and safety of lapatinib, an ErbB1-EGFR/ErbB2 tyrosine kinase inhibitor (TKI), in patients with aggressive prolactinomas.
  • To assess tumor response, prolactin (PRL) reduction, and correlation with EGFR/HER2 expression.

Main Methods:

  • A prospective, phase 2a, multicenter trial involving adults with aggressive prolactinomas resistant to dopamine agonists.
  • Participants received oral lapatinib 1250 mg/day for 6 months.
  • Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; secondary endpoints included PRL reduction and safety.

Main Results:

  • Due to stringent criteria, only 4 patients were treated; none achieved the primary endpoint of a 40% tumor dimension reduction.
  • Three patients demonstrated stable disease, with tumor diameter changes ranging from a 6% increase to a 16.8% decrease.
  • Lapatinib was generally well-tolerated, with manageable side effects including transaminitis, rash, and bradycardia.

Conclusions:

  • Lapatinib may represent a viable therapeutic option for patients with aggressive prolactinomas refractory to conventional treatments.
  • Further investigation is warranted to establish the role of TKIs in managing difficult-to-treat prolactinomas.