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

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

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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.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalCancer Chemotherapy and Pharmacology
DOIs
Publication statusAccepted/In press - Dec 1 2017

Keywords

  • Adjuvant therapy
  • Bone metabolism
  • Endocrine therapy
  • Lipid metabolism
  • Postmenopausal

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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  • Cite this

    Shien, T., Doihara, H., Sato, N., Anan, K., Komaki, K., Miyauchi, K., Yanagita, Y., Fujisawa, T., Mitsuyama, S., Kanbayashi, C., Kusama, M., Kimura, M., Jinno, H., Sano, M., & Ikeda, T. (Accepted/In press). 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. Cancer Chemotherapy and Pharmacology, 1-7. https://doi.org/10.1007/s00280-017-3491-6