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Open Access 01-02-2018 | Original Article

Serum lipid and bone metabolism effects of Toremifene vs. Letrozole as adjuvant therapy for postmenopausal early breast cancer patients: results of a multicenter open randomized study

Authors: Tadahiko Shien, Hiroyoshi Doihara, Nobuaki Sato, Keisei Anan, Kansei Komaki, Keisuke Miyauchi, Yasuhiro Yanagita, Tomomi Fujisawa, Shoshu Mitsuyama, Chizuko Kanbayashi, Mikihiro Kusama, Morihiko Kimura, Hiromitsu Jinno, Muneaki Sano, Tadashi Ikeda

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2018

Abstract

A prospective randomized phase II trial was conducted to evaluate the time course effects of toremifene (TOR) and letrozole (LET), as adjuvant hormone therapy, on serum lipid profiles and bone metabolism in estrogen receptor (ER)-positive, postmenopausal breast cancer patients.Fifty-four postmenopausal breast cancer patients [ER positive, HER2 negative, T1–2, node metastases (n = 0–3), M0] who had undergone curative resection were enrolled. They were randomized to receive either TOR 40 mg/day or LET 2.5 mg/day as adjuvant hormone therapy. Serum lipids and bone markers were measured prior to, and again at 6, 12, and 24 months after initiation of treatment. Changes in serum lipids and bone markers were compared. Serum levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) were decreased compared with the baseline values at 6 months in 6.5 and 14.0% of patients, respectively, receiving TOR. Lipid levels did not change in patients administered LET. Significant differences were observed in TC and LDL-C between the two groups at 12 and 24 months. In the TOR group, serum bone-specific alkaline phosphatase (BAP) was decreased by 25.0% at 12 months, and serum cross-linked N-telopeptide of type-I collagen (NTx) was decreased by 13.6% at 6 months, and these reductions were maintained for at least 24 months. In contrast, in the LET group, serum BAP did not change and NTx was increased by 16.0% at 6 months and by 18.6% at 24 months, as compared with the baseline.TOR and LET exert different effects on serum lipid profiles and bone metabolism markers. The effects of TOR, as adjuvant hormone therapy, on both lipids and bone metabolism in postmenopausal breast cancer patients are superior to those of LET.

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Title: Serum lipid and bone metabolism effects of Toremifene vs. Letrozole as adjuvant therapy for postmenopausal early breast cancer patients: results of a multicenter open randomized study
Authors: Tadahiko Shien
Hiroyoshi Doihara
Nobuaki Sato
Keisei Anan
Kansei Komaki
Keisuke Miyauchi
Yasuhiro Yanagita
Tomomi Fujisawa
Shoshu Mitsuyama
Chizuko Kanbayashi
Mikihiro Kusama
Morihiko Kimura
Hiromitsu Jinno
Muneaki Sano
Tadashi Ikeda
Publication date: 01-02-2018
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 2/2018
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-017-3491-6

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