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Cabergoline in the Management of Residual Nonfunctioning Pituitary Adenoma

A Single-Center, Open-Label, 2-Year Randomized Clinical Trial

Batista, Rafael L., MD, PhD*; Musolino, Nina R.C., MD, PhD*; Cescato, Valter A.S., MD, PhD*; da Silva, Gilberto O., MD, PhD*; Medeiros, Raphael S.S., MD, PhD; Herkenhoff, Clarissa G.B., MD*; Trarbach, Ericka B., PhD; Cunha-Neto, Malebranche B., MD, PhD*

American Journal of Clinical Oncology: February 2019 - Volume 42 - Issue 2 - p 221–227
doi: 10.1097/COC.0000000000000505
Original Articles: Central Nervous System

Background: Complete tumor removal by transsphenoidal surgery is usually difficult for large nonfunctioning pituitary adenomas (NFPAs). A validated medical treatment may be useful for their management. This study evaluates the clinical efficacy of the dopaminergic agonist cabergoline for residual NFPA.

Design, Setting, and Participants: We conducted a randomized, parallel, open-label clinical trial that compared cabergoline with nonintervention in patients with residual NFPA after transsphenoidal surgery over 2 years. The primary outcome was clinical efficacy (tumor reduction). The secondary outcome was the relationship between tumor dopamine D2 receptor (D2R) expression and clinical responsiveness. Tumor measurements and clinical evaluations were performed every 6 months.

Results: In total, 59 and 57 individuals were randomly assigned to the study and control groups, respectively. At the end of the study, residual tumor shrinkage, stabilization, and enlargement were observed in 28.8%, 66.1%, and 5.1% of patients, respectively, in the medical-therapy group and in 10.5%, 73.7%, and 15.8% of patients, respectively, in the control group (P=0.01). The progression-free survival rate was 23.2 and 20.8 months for the study and control groups, respectively (P=0.01). D2R was not associated with cabergoline responsiveness. No major side effects were related to cabergoline use.

Conclusions: Cabergoline was an effective drug for treating residual NFPA, and its use was associated with a high rate of tumor shrinkage (ClinicalTrials.gov NCT03271918).

*Division of Functional Neurosurgery, Institute of Psychiatry—IPq, Hospital das Clinicas, FMUSP

Division of Pathological Anatomy, Hospital das Clinicas, FMUSP

Laboratory of Cellular and Molecular Endocrinology, LIM25, Discipline of Endocrinology, Hospital das Clinicas, FMUSP, Sao Paulo, SP, Brasil

E.B.T and M.B.C.N share the last authorship of this manuscript.

This work was supported in part by Fundacao de Amparo a Pesquisa do Estado de Sao Paulo—FAPESP (2014/16327-1) to E.B.T.

The authors declare no conflicts of interest.

Reprints: Ericka B. Trarbach, PhD, Rua Dr. Arnaldo, 455–LIM25, 4o andar, sala 4345, Cerqueira César, Sao Paulo, SP CEP 01246-903, Brasil. E-mail: ericka.trarbach@hc.fm.usp.br.

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