Markopoulos C, Polychronis A, Zobolas V, Xepapadakis G, Papadiamantis J, Koukouras D, Lappas H, Gogas H
Hellenic Breast Surgeons Society (HBSS), 8 Iassiou Street, Athens, Attica 11521, Greece.
Breast Cancer Res Treat. 2005 Sep;93(1):61-6. doi: 10.1007/s10549-005-3783-0.
INTRODUCTION: Long-term endocrine therapy for breast cancer may have clinical implications as drugs that potentially alter the lipid profile may increase the risk of developing cardiovascular disease. In this study, a companion sub-protocol to the TEAM (Tamoxifen and Exemestane Adjuvant Multicenter) International trial, we compared the effect of the steroidal aromatase inactivator exemestane on the lipid profile of postmenopausal women with early breast cancer in the adjuvant setting to that of tamoxifen. PATIENTS AND METHODS: In this open-label, randomized, parallel group study, 176 postmenopausal patients with estrogen and/or progesterone receptor positive early breast cancer were randomized to either adjuvant exemestane (25 mg/day; n = 90) or tamoxifen (20 mg/day; n = 86). Assessments of total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and serum triglycerides (TRG) were performed at baseline and every 3 months for the first 12 months. RESULTS: Serum triglyceride levels were consistently increased above baseline throughout the study in the tamoxifen arm, while there was a trend towards reduction in the exemestane arm. There was also an overall trend for tamoxifen to decrease the levels of LDL throughout the study period. Exemestane did not demonstrate any other significant change in HDL levels; however, there was a consistent trend for a reduction in total cholesterol in both treatment arms. The atherogenic risk determined by the TC:HDL ratio remained stable in both arms throughout the treatment period. CONCLUSIONS: Exemestane appears to have a neutral effect on total cholesterol and HDL levels. Unlike tamoxifen's positive effect on LDL levels, exemestane does not significantly alter LDL levels. Tamoxifen on the other hand increases triglyceride levels, while exemestane results in a beneficial reduction in TRG levels. These data offer additional information with regard to the safety and tolerability of exemestane in postmenopausal breast cancer patients and support further investigation of its potential usefulness in the adjuvant setting.
引言：乳腺癌的长期内分泌治疗可能具有临床意义，因为那些可能改变血脂谱的药物可能会增加患心血管疾病的风险。在本研究中，作为TEAM（他莫昔芬与依西美坦辅助治疗多中心研究）国际试验的一项配套子方案，我们比较了甾体类芳香化酶抑制剂依西美坦与他莫昔芬在辅助治疗环境下对绝经后早期乳腺癌女性血脂谱的影响。 患者与方法：在这项开放标签、随机、平行组研究中，176例雌激素和/或孕激素受体阳性的绝经后早期乳腺癌患者被随机分为接受辅助依西美坦治疗组（25毫克/天；n = 90）或他莫昔芬治疗组（20毫克/天；n = 86）。在基线时以及治疗的前12个月中每3个月对总胆固醇、高密度脂蛋白（HDL）、低密度脂蛋白（LDL）和血清甘油三酯（TRG）进行评估。 结果：在整个研究过程中，他莫昔芬治疗组的血清甘油三酯水平持续高于基线水平，而依西美坦治疗组则有下降趋势。在整个研究期间，他莫昔芬还有使LDL水平降低的总体趋势。依西美坦未显示出HDL水平有任何其他显著变化；然而，两个治疗组的总胆固醇均有持续下降趋势。在整个治疗期间，由TC:HDL比值确定的致动脉粥样硬化风险在两个治疗组中均保持稳定。 结论：依西美坦似乎对总胆固醇和HDL水平具有中性作用。与他莫昔芬对LDL水平的积极作用不同，依西美坦不会显著改变LDL水平。另一方面，他莫昔芬会使甘油三酯水平升高，而依西美坦则会使TRG水平有益地降低。这些数据提供了关于依西美坦在绝经后乳腺癌患者中的安全性和耐受性的更多信息，并支持进一步研究其在辅助治疗环境中的潜在效用。
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