Comprehensive Cancer Center, The Ohio State University, B402 Starling Loving Hall, 320W. 10th Ave, Columbus, OH 43210, USA.
Breast Cancer Res Treat. 2011 Apr;126(2):479-85. doi: 10.1007/s10549-011-1370-0. Epub 2011 Feb 4.
Adjuvant surgical oophorectomy is an effective and remarkably cost effective treatment for premenopausal women with hormone receptor positive operable breast cancer. Previously published secondary analyses indicated a survival benefit for patients whose surgery was performed in the luteal phase of the menstrual cycle as opposed to the follicular. This study utilizes additional follow-up and more fully examines this hypothesis and the general implications of long-term follow-up on trial design. Beginning in 1993 we recruited women to a multicenter randomized clinical trial of adjuvant surgical oophorectomy and tamoxifen for 5 years. We recorded the reported day 1 of the patients' last menstrual cycle on the day of their adjuvant surgery. We conducted secondary analyses of the association of history-estimated luteal or follicular phase oophorectomy surgery with disease-free and overall survival. In multivariable Cox analyses, disease-free survival (DFS) exhibited a positive trend and overall survival (OS) showed a significant improvement in patients whose surgery was estimated to have occurred in the luteal phase of the menstrual cycle compared to the follicular (HR for DFS: 0.66, 95% CI: 0.37-1.16; HR for OS: 0.49, 95% CI: 0.27-0.88). From the hazard function plots, it appears that the luteal phase surgery effect on DFS diminishes after 6 years of follow-up. In conclusion, adjuvant surgical oophorectomy during the luteal phase of the menstrual cycle resulted in a reduced hazard of recurrence as compared to oophorectomy in the follicular phase during the first 5.5 years of follow-up. The practical and biological implications of these findings deserve rigorous evaluation in clinical trials.
辅助手术卵巢切除术是一种有效且具有显著成本效益的治疗方法，适用于激素受体阳性可手术的绝经前乳腺癌患者。先前发表的二次分析表明，对于手术在月经周期黄体期进行的患者，生存获益更高，而非滤泡期。本研究利用了更多的随访数据，并更全面地检验了这一假说以及长期随访对试验设计的普遍影响。从 1993 年开始，我们招募了女性参加一项多中心随机临床试验，比较辅助手术卵巢切除术和他莫昔芬 5 年治疗的效果。我们记录了患者辅助手术当天的最后一次月经周期的报告日 1。我们对黄体期或滤泡期卵巢切除术手术与无病生存和总生存的关联进行了二次分析。在多变量 Cox 分析中，无病生存（DFS）呈正趋势，总生存（OS）显示手术估计发生在黄体期的患者显著改善，与滤泡期相比（DFS 的 HR：0.66，95%CI：0.37-1.16；OS 的 HR：0.49，95%CI：0.27-0.88）。从危险函数图来看，黄体期手术对 DFS 的影响似乎在随访 6 年后减弱。总之，与滤泡期手术相比，月经周期黄体期的辅助手术卵巢切除术可降低复发风险，在随访的前 5.5 年内。这些发现的实际和生物学意义值得在临床试验中进行严格评估。
