University Breast Center, Department of Gynecology and Obstetrics, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
BMC Cancer. 2014 Feb 5;14:66. doi: 10.1186/1471-2407-14-66.
The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL).
Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data.
Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm.
No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid.
本前瞻性随机 II 期试验（试验注册：EUCTR2004-004007-37-DE）的目的是比较单独使用来曲唑（LET）或来曲唑联合唑来膦酸（LET+ZOL）进行新辅助治疗的原发性乳腺癌患者的临床反应。
患者随机分为两组，分别接受来曲唑 2.5mg/天（n=79）或来曲唑 2.5mg/天联合唑来膦酸共 7 次，每 4 周 1 次，共 6 个月。主要终点是通过乳房 X 线摄影评估的临床反应率。由于招募不足，该研究提前终止。我们在此报告对该数据的探索性分析。
在治疗期间，中心评估了 131 例患者的肿瘤大小（LET 组 66 例，LET+ZOL 组 65 例）。LET 组中 54.5%（95%CI：41.8-66.9）的患者和 LET+ZOL 组中 69.2%（95%CI：56.6-80.1）的患者出现临床反应（完全或部分）（P=0.106）。多变量模型显示实验组的 OR 为 1.72（95%CI：0.83-3.59）。
在来曲唑新辅助治疗方案中加入唑来膦酸并未观察到临床反应率增加。然而，LET+ZOL 组的反应可能更好。这种趋势与先前研究一致，这些研究表明唑来膦酸联合化疗可提高疗效，并且可能支持唑来膦酸具有直接抗肿瘤作用的证据。
