Instituto Valenciano de Oncología, Valencia, Spain.
Clin Transl Oncol. 2012 Feb;14(2):125-31. doi: 10.1007/s12094-012-0771-9.
Letrozole is superior to tamoxifen in terms of response and breast preservation rates as primary systemic therapy (PST) in postmenopausal women with ER-positive early breast cancer. However, the optimum duration of endocrine PST remains uncertain.
A phase 2 multicentre, open-label trial was conducted to evaluate the efficacy of letrozole over a preoperative period of 4 months to 1 year. Seventy postmenopausal patients (over 65 years) were recruited in four centers. The primary endpoint was to establish the optimal duration of treatment defined as the time required to attain the maximum response by clinical palpation.
The median age of the group was 79 years (66-91) and the median tumour size 35 mm (range 25-100 mm). No severe adverse events were reported. Fifty-six patients were evaluable for the primary objective. A total of 43 patients (76.8%) achieved an objective response; 29 (51.8%) being partial and 14 (25.0%) complete. The median time to objective response was 3.9 months (95% CI, 3.3-4.5) and the median time to maximum response was 4.2 months (95% CI, 4.0-4.5), although 20 (37.1%) patients achieved the maximal response within 6-12 months.
Letrozole shows a high activity and excellent tolerability as neoadjuvant therapy in elderly patients with endocrine-dependent breast cancer. Four to six months of letrozole as PST is an optimum duration with modest benefits thereafter.
来曲唑作为绝经后雌激素受体阳性早期乳腺癌患者的一线全身治疗（PST），在反应率和保乳率方面优于他莫昔芬。然而，内分泌 PST 的最佳持续时间仍不确定。
进行了一项 2 期、多中心、开放性试验，以评估来曲唑在术前 4 个月至 1 年期间的疗效。在四个中心招募了 70 名绝经后患者（年龄超过 65 岁）。主要终点是确定最佳治疗持续时间，定义为通过临床触诊达到最大反应所需的时间。
该组的中位年龄为 79 岁（66-91 岁），中位肿瘤大小为 35 毫米（范围 25-100 毫米）。未报告严重不良事件。56 名患者可评估主要目标。共有 43 名患者（76.8%）达到客观缓解；29 名（51.8%）为部分缓解，14 名（25.0%）为完全缓解。客观缓解的中位时间为 3.9 个月（95%CI，3.3-4.5），最大缓解的中位时间为 4.2 个月（95%CI，4.0-4.5），尽管 20 名（37.1%）患者在 6-12 个月内达到最大缓解。
来曲唑作为内分泌依赖性乳腺癌老年患者的新辅助治疗具有较高的活性和良好的耐受性。作为 PST，来曲唑 4 至 6 个月是最佳持续时间，此后略有获益。
