Optimum duration of neoadjuvant letrozole to permit breast conserving surgery
Optimum duration of neoadjuvant letrozole to permit breast conserving surgery
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DOI：
10.1007/s10549-014-2835-8
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发表时间：
2014-04-01
影响因子：
3.8
通讯作者：
Skene, Anthony I.
中科院分区：
文献类型：
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作者：
Carpenter, Robert;Doughty, Julie C.;Skene, Anthony I.
这项多中心、前瞻性、纵向IV期研究的目的是确定来曲唑新辅助治疗的最佳持续时间，以便在最初不适合的早期乳腺癌患者中进行保乳手术（BCS）。原发性、侵袭性、雌激素受体和/或孕酮受体阳性乳腺癌患者，伴有大肿瘤（千分之一，即，> 20 mm），最初不适合BCS，口服接受2.5 mg来曲唑。日报患者继续治疗，直到他们有资格接受BCS，进展，不符合BCS标准并因计划的乳房切除术而退出，因其他原因退出，或完成12个月的来曲唑治疗而未做出BCS决定。共入组146例患者; 7例没有有效基线后肿瘤评估的患者从最终疗效分析中排除。在研究结束时，69%的患者（139例中的96例）有资格接受BCS。达到足以允许BCS联合来曲唑新辅助治疗的肿瘤缓解的中位时间为7.5个月（95% CI 6.3-8.5个月）。来曲唑耐受性良好，大多数不良事件为轻度至中度（1-2级）。这项试验的结果表明，与4个月的常规治疗相比，新辅助治疗中延长来曲唑治疗（7.5个月）是最佳的，可以最大限度地减少肿瘤体积，足以实现BCS。
The aim of this multicenter, prospective, longitudinal phase IV study was to establish the optimal duration of neoadjuvant letrozole that would allow breast conservation surgery (BCS) in patients with early breast cancer who were initially unsuitable. Primary, invasive, estrogen-receptor- and/or progesterone-receptor-positive breast cancer patients, with large tumors (a parts per thousand yenT2 i.e., > 20 mm) not initially suitable for BCS, received 2.5 mg letrozole p.o. daily. Patients continued treatment until they became eligible for BCS, progressed, failed to meet criteria for BCS and withdrew for scheduled mastectomy, withdrew for other reasons, or completed 12 months of letrozole treatment without a BCS decision being made. A total of 146 patients were enrolled; seven patients who did not have a valid postbaseline tumor assessment were excluded from the final efficacy analysis. At study closure, 69 % of patients (96 of 139) were eligible for BCS. The median time to achieve a tumor response sufficient to allow BCS with neoadjuvant letrozole was 7.5 months (95 % CI 6.3-8.5 months). Letrozole was well tolerated, and most adverse events were mild-to-moderate (grade 1-2). The results from this trial suggest that extended letrozole therapy in the neoadjuvant setting (7.5 months), as opposed to conventional treatment of 4 months, is optimal to achieve maximum reduction in tumor volume sufficient for BCS.