Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial
Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial
复制标题
DOI：
10.1200/jco.2010.33.0738
复制
发表时间：
2011-07-20
影响因子：
45.3
通讯作者：
Mittra, Indraneel
中科院分区：
文献类型：
--
作者：
Badwe, Rajendra;Hawaldar, Rohini;Mittra, Indraneel
许多非随机研究表明，在月经周期的黄体期（孕激素期）进行手术的乳腺癌患者预后更好，但这是有争议的。我们调查了一个单一的术前注射羟孕酮的妇女与可手术的乳腺癌（OBC）在一项随机对照试验（ClinicalTrials.gov标识符，NCT 00123669）的效果。患者和方法1000例OBC患者被随机分配到接受手术或肌肉注射贮库羟孕酮500毫克5至14天手术前。主要和次要终点分别为无病生存期（DFS）和总生存期（OS）。腋窝淋巴结状态的分析是预先planned.ResultsAt中位随访65个月的976名符合条件的患者，273复发和202死亡记录。孕酮组与对照组相比，5年DFS和OS率分别为73.9%和70.2%（风险比[HR]，0.87; 95% CI，0.68至1.09; P = 0.23）和80.2%和78.4%（HR，0.92; 95% CI，0.69至1.21; P = 0.53）。在471例淋巴结阳性患者中，孕酮组与对照组的5年DFS和OS率分别为65.3%和54.7%（HR，0.72; 95% CI，0.54至0.97; P = 0.02）和75.7%和66.8%（HR，0.70; 95% CI，0.49至0.99; P = 0.04）。在多变量分析中，DFS显着改善与孕激素在淋巴结阳性患者（调整后的HR，0.71; 95%CI，0.53至0.95; P = 0.02），而没有显着影响在淋巴结阴性patients（P = 0.04）。这种干预措施显示，淋巴结阳性的妇女，可能被认为是假设生成显着改善。如果在其他研究中重复，这可能是一种简单而廉价的干预措施，特别是在淋巴结转移发生率高的发展中国家。J Clin Oncol 29：2845-2851. (C)2011年美国临床肿瘤学会
PurposeMany nonrandomized studies have suggested better outcome for patients with breast cancer who undergo surgery during the luteal (progestogenic) phase of their menstrual cycle, but this is controversial. We investigated the effect of a single preoperative injection of hydroxyprogesterone in women with operable breast cancer (OBC) in a randomized controlled trial (ClinicalTrials.gov identifier, NCT00123669).Patients and MethodsOne thousand patients with OBC were randomly assigned to receive surgery or an intramuscular injection of depot hydroxyprogesterone 500 mg 5 to 14 days before surgery. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), respectively. An analysis by axillary lymph node status was preplanned.ResultsAt a median follow-up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In the progesterone group versus control group, 5-year DFS and OS rates were 73.9% v 70.2% (hazard ratio [HR], 0.87; 95% CI, 0.68 to 1.09; P = .23) and 80.2% v 78.4% (HR, 0.92; 95% CI, 0.69 to 1.21; P = .53), respectively. In 471 node-positive patients, the 5-year DFS and OS rates in the progesterone group versus control group were 65.3% v 54.7% (HR, 0.72; 95% CI, 0.54 to 0.97; P = .02) and 75.7% v 66.8% (HR, 0.70; 95% CI, 0.49 to 0.99; P = .04), respectively. In multivariate analysis, DFS was significantly improved with progesterone in node-positive patients (adjusted HR, 0.71; 95% CI, 0.53 to 0.95; P = .02), whereas there was no significant effect in node-negative patients (P for interaction = .04).ConclusionA single injection of hydroxyprogesterone before surgery did not improve outcomes in all women with OBC. This intervention showed significant improvement in node-positive women that may be considered hypothesis generating. If replicated in other studies, this could be a simple and inexpensive intervention, especially in developing countries where the incidence of lymph node metastasis is high. J Clin Oncol 29: 2845-2851. (C) 2011 by American Society of Clinical Oncology