Department of Internal Medicine, University of Michigan Comprehensive Cancer Center, 1500 East Medical Center Drive, C346 Med Inn Building, Ann Arbor, MI 48109-5848, USA.
Breast Cancer Res Treat. 2012 Aug;134(3):1141-7. doi: 10.1007/s10549-012-2147-9. Epub 2012 Jul 5.
Lipid profiles in women with early breast cancer receiving anastrozole with or without risedronate were examined within an international Phase III/IV study to assess for possible treatment related changes. Postmenopausal women with hormone receptor-positive breast cancer were assigned to 1 of 3 strata by risk of fragility fracture. Patients with the highest risk for fracture received anastrozole plus risedronate (A + R). Moderate-risk patients were randomized in a double-blind manner to A + R or anastrozole and placebo (A + P). Lower-risk patients received anastrozole (A) alone. Serial fasting blood samples were assessed for changes in lipid parameters relative to baseline after 12 months of treatment with anastrozole with or without risedronate. Samples were centrally analyzed for low-density lipoprotein cholesterol (LDL-cholesterol), high-density lipoprotein (HDL) cholesterol, total cholesterol (TC) and triglycerides (TG). Analysis was performed as primary analysis population for lipids (A plus A + P), lipid intention to treat population and secondary population (A + R). Of the 119 patients treated with A plus A + P, there were 66 patients eligible for inclusion in the primary analysis population. Of the 115 patients treated with secondary population (A + R) there were 65 patients eligible for lipid profiling. For LDL-cholesterol, HDL-cholesterol, TC and TG there were no significant changes between the baseline and 12 months assessments to suggest that any of these therapies have a negative impact on the lipid profile. In this study of postmenopausal women with early breast cancer receiving adjuvant anastrozole with or without risedronate, there was no adverse effect on LDL-cholesterol, HDL-cholesterol, TC or TG values over the 12 months monitoring period.
在一项国际性的 III/IV 期研究中，对接受阿那曲唑联合或不联合利塞膦酸钠治疗的早期乳腺癌女性的血脂谱进行了检查，以评估可能的治疗相关变化。将激素受体阳性乳腺癌的绝经后女性按脆性骨折风险分为 3 个层次之一。骨折风险最高的患者接受阿那曲唑联合利塞膦酸钠（A+R）治疗。中度风险患者以双盲方式随机分配至 A+R 或阿那曲唑联合安慰剂（A+P）组。低风险患者接受阿那曲唑（A）单药治疗。在接受阿那曲唑联合或不联合利塞膦酸钠治疗 12 个月后，对患者的空腹血样进行了连续检测，以评估相对于基线的血脂参数变化。对低密度脂蛋白胆固醇（LDL-胆固醇）、高密度脂蛋白（HDL）胆固醇、总胆固醇（TC）和甘油三酯（TG）进行了中心分析。对接受 A+A+P 治疗的 119 例患者进行了脂质分析（主要分析人群）、脂质意向治疗人群和次要人群（A+R）的分析。在接受 A+A+P 治疗的 119 例患者中，有 66 例符合主要分析人群的纳入标准。在接受次要人群（A+R）治疗的 115 例患者中，有 65 例有资格进行血脂分析。对于 LDL-胆固醇、HDL-胆固醇、TC 和 TG，从基线到 12 个月的评估没有显著变化，表明这些治疗方案之一对血脂谱没有负面影响。在这项接受辅助性阿那曲唑联合或不联合利塞膦酸钠治疗的早期乳腺癌绝经后女性的研究中，在 12 个月的监测期间，LDL-胆固醇、HDL-胆固醇、TC 或 TG 值没有出现不良反应。
