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

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.

Lipid Changes During Endocrine Therapy in Breast Cancer Patients: The Results of a 5-Year Real-World Retrospective Analysis

“…( 36 ) demonstrated that LET had no significant effects on TC, LDL or HDL levels following 3 and 6 months of therapy. Similarly, a multicentre open randomized study containing 27 patients in the LET and TOR groups, respectively reported that after 2 years of follow-up, lipid profiles were essentially unchanged in the LET group ( 37 ). Additionally, a sub-study of the MA.17 trial (183 in the LET group and 164 in the placebo group with a 3-year follow-up) demonstrated that after 5 years of TAM treatment, LET therapy did not significantly alter TG, HDL, LDL, or TC levels, and the frequency of hypercholesterolemia was comparable between patients treated with LET and those treated with placebo ( 38 ).…”

Влияние Эндокринотерапии Рака Молочной Железы На Липидный Профиль Сыворотки Крови Женщин В Постменопаузе

“…У проспективному рандомізованому дослідженні у II фазі в Японії [34] розглянутий вплив летрозолу порівняно з тореміфеном в ад'ювантному режимі на ліпідний профіль та метаболізм кісток у жінок у постменопаузі з гормончутливим раком молочної залози I-II cтадії.…”

Comparison of dyslipidemia incidence in Chinese early-stage breast cancer patients following different endocrine therapies: A population-based cohort study

“…The ATAC trial compared the adverse reactions of anastrozole and tamoxifen in postmenopausal patients with BC, and the results of a 100-month follow-up showed that the incidence of hypercholesterolemia in patients treated with anastrozole was significantly higher than that in patients treated with tamoxifen (12). In a previous prospective clinical trial, Shien et al found that TC and LDL-C levels at 12 and 24 months after toremifene treatment were lower than those in the letrozole group (13). A retrospective study found that the level of TGs in postmenopausal BC patients treated with letrozole for 24 months was higher than that in patients treated with exemestane (14).…”

“…In a previous prospective clinical trial, Shien et al. found that TC and LDL-C levels at 12 and 24 months after toremifene treatment were lower than those in the letrozole group ( 13 ). A retrospective study found that the level of TGs in postmenopausal BC patients treated with letrozole for 24 months was higher than that in patients treated with exemestane ( 14 ).…”