Preoperative and long-term efficacy and safety of lanreotide autogel in patients with thyrotropin-secreting pituitary adenoma: a multicenter, single-arm, phase 3 study in Japan

Akira Shimatsu; Akinobu Nakamura; Yutaka Takahashi; Shingo Fujio; Fumitoshi Satoh; Shigeyuki Tahara; Hiroshi Nishioka; Koji Takano; Miho Yamashita; Hiroshi Arima; Atsushi Tominaga; Shohei Tateishi; Yusaku Matsushita

doi:10.1507/endocrj.EJ20-0707

ORIGINAL

Preoperative and long-term efficacy and safety of lanreotide autogel in patients with thyrotropin-secreting pituitary adenoma: a multicenter, single-arm, phase 3 study in Japan

Akira Shimatsu, Akinobu Nakamura, Yutaka Takahashi, Shingo Fujio, Fumitoshi Satoh, Shigeyuki Tahara, Hiroshi Nishioka, Koji Takano, Miho Yamashita, Hiroshi Arima, Atsushi Tominaga, Shohei Tateishi, Yusaku Matsushita

Author information

Akira Shimatsu
Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan
Advanced Medical Care Center, Kusatsu General Hospital, Kusatsu 525-8585, Japan
Akinobu Nakamura
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, Japan
Yutaka Takahashi
Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan
Department of Diabetes and Endocrinology, Nara Medical University, Kashihara 634-8522, Japan
Shingo Fujio
Department of Neurosurgery, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima 890-8520, Japan
Fumitoshi Satoh
Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Hospital, Sendai 980-8577, Japan
Shigeyuki Tahara
Department of Neurological Surgery, Nippon Medical School, Tokyo 113-8603, Japan
Hiroshi Nishioka
Department of Hypothalamic and Pituitary Surgery, Toranomon Hospital, Tokyo 105-8470, Japan
Koji Takano
Department of Endocrinology, Diabetes & Metabolism, Kitasato University School of Medicine, Sagamihara 252-0374, Japan
Miho Yamashita
Second Division, Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan
International Center, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan
Hiroshi Arima
Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya 466-8550, Japan
Atsushi Tominaga
Department of Neurosurgery, Hiroshima Prefectural Hospital, Hiroshima 734-8530, Japan
Shohei Tateishi
Teijin Pharma Limited, Tokyo 100-8585, Japan
Yusaku Matsushita
Teijin Pharma Limited, Tokyo 100-8585, Japan

Keywords: Clinical study, Lanreotide, Thyroid-stimulating hormone-secreting pituitary adenoma, Somatostatin analog, Preoperative treatment

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2021 Volume 68 Issue 7 Pages 791-805

DOI https://doi.org/10.1507/endocrj.EJ20-0707

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Abstract

Somatostatin analogs are recommended for pharmacotherapy of TSH-secreting pituitary adenoma (TSHoma). A multicenter clinical trial was conducted to evaluate the efficacy and safety of lanreotide autogel treatment for TSHoma. A total of 13 Japanese patients with TSHoma were enrolled from February to December 2018 and treated with lanreotide autogel 90 mg every 4 weeks, with dose adjustments to 60 mg or 120 mg. Analysis was performed on data from patients receiving preoperative treatment (n = 6) up to 24 weeks and from those receiving primary or postoperative treatment (n = 7) up to 52 weeks. The primary efficacy endpoints were serum concentrations of TSH, free triiodothyronine (FT3), and free thyroxine (FT4). The secondary efficacy endpoints were pituitary tumor size and clinical symptoms. The serum concentrations of TSH, FT3, and FT4 decreased with treatment, and euthyroid status was maintained until final assessment. FT4 at final assessment was within reference ranges in 10/13 patients. The median (interquartile range) percent change in pituitary tumor size from baseline at final assessment was –23.8% (–38.1, –19.8). The clinical symptoms were also improved. The patients receiving preoperative treatment did not develop perioperative thyroid storm. Regarding safety, adverse events were observed in 12/13 patients, but none discontinued treatment. The common adverse events were gastrointestinal disorders (12/13 patients) and administration site reactions (5/13 patients). Lanreotide autogel may be effective for controlling thyroid function and reducing the pituitary tumor size, and is tolerable in patients with TSHoma (Japic Clinical Trials Information; JapicCTI-173772).

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