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A prospective study on the efficacy of oral estrogen in female patients with acromegaly

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Abstract

Purpose

To evaluate the efficacy and safety of oral estrogen therapy in female patients of childbearing age with uncontrolled acromegaly and to verify the significance of the presence of estrogen receptor α (ER-α) in somatotropinomas.

Methods

Prospective study in which biochemical and radiological evaluations were performed at baseline and after six months of treatment with an oral formulation of ethinyl-estradiol 0.03 mg and levonorgestrel 0.15 mg. ER-α was assessed by immunohistochemistry and immunopositivity was considered when it was present in ≥ 1% of cells.

Results

Eight patients with uncontrolled acromegaly were selected. All patients underwent surgery. Four patients were on octreotide LAR 30 mg, two patients were on lanreotide autogel 120 mg, and two patients had active disease after surgery. At the end of follow-up, IGF-I normalized in 3/8 (37%), 2/8 (25%) patients presented with mean IGF-I reduction of 25% but without IGF-I normalization, and 2/8 (25%) did not respond—one had a 13% increase in IGF-I and IGF-I level remained unchanged after treatment in the other. In one patient, treatment was discontinued after 3 months due to side effects (headache), with an IGF-I reduction of 28% but without normalization. Tumor volume increase (41%) was observed in only one patient (the only tumor with positive ER-α expression).

Conclusions

In uncontrolled patients with acromegaly, a trial with oral estrogen can be an option for young women. Oral estrogen was well tolerated, but the somatotropinoma that presented ER-α expression was the only somatotropinoma that presented growth during treatment.

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Acknowledgements

This work is dedicated to all those who have made it possible: patients, endocrinologists, biotechnicians, radiologists, pathologists, and employees of the Instituto Estadual do Cérebro Paulo Niemeyer and the Hospital Universitario Clementino Fraga Filho.

Funding

This study received funding from CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico), Process Number 171144/2017–1.

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Correspondence to L. Kasuki.

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The authors declare that they have no competing interests.

Ethics approval

The study was approved by the Ethics Committee of Instituto Estadual do Cérebro Paulo Niemeyer (Approval number: CAAE: 72415017.2.0000.8110).

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Informed consent was obtained from all participants included in study.

Research involving human participants and/or animals

The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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Magalhães, J., Ventura, N., Lamback, E.B. et al. A prospective study on the efficacy of oral estrogen in female patients with acromegaly. Pituitary 25, 433–443 (2022). https://doi.org/10.1007/s11102-021-01204-w

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