Systematic Pelvic Lymphadenectomy vs No Lymphadenectomy in Early-Stage Endometrial Carcinoma: Randomized Clinical Trial
Systematic Pelvic Lymphadenectomy vs No Lymphadenectomy in Early-Stage Endometrial Carcinoma: Randomized Clinical Trial
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DOI：
10.1093/jnci/djn397
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发表时间：
2008-12-03
影响因子：
10.3
通讯作者：
Mangioni, Costantino
中科院分区：
文献类型：
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作者：
Panici, Pierluigi Benedetti;Basile, Stefano;Mangioni, Costantino
盆腔淋巴结是早期子宫内膜癌中最常见的宫外肿瘤扩散部位，但淋巴结切除术的临床影响尚未在随机研究中得到解决。我们进行了一项随机临床试验，以确定在标准子宫切除术和双侧输卵管卵巢切除术的基础上增加盆腔系统性淋巴结切除术是否能提高总生存率和无病生存率。514例符合条件的术前国际妇产科联合会I期子宫内膜癌患者被随机分配接受盆腔系统治疗，淋巴结清扫术（n = 264）或无淋巴结清扫术（n = 250）。出院时记录患者的临床资料、病理肿瘤特征、手术和术后早期资料。术后6个月收集晚期术后并发症、辅助治疗和随访数据。采用对数秩检验和考克斯多变量回归分析分析生存率。所有的统计学检验都是双侧的，盆腔系统性淋巴结清扫组的中位淋巴结清扫数为30（四分位距= 22-42），而非淋巴结清扫组为0（四分位距= 0-0）（P < .001）。早期和晚期术后并发症在接受盆腔系统性淋巴结切除术的患者中发生率更高，具有统计学意义（淋巴结切除术组81例患者和非淋巴结切除术组34例患者，P = 0.001）。盆腔系统性淋巴结切除术改善了手术分期，因为淋巴结切除术组发现淋巴结转移的患者比非淋巴结切除术组有统计学显著性差异（13.3% vs 3.2%，差异= 10.1%，95%置信区间[CI] = 5.3%至14.9%，P <0.001）。在中位随访49个月时，观察到78起事件（即复发或死亡），53例患者死亡。两组间首次事件和死亡的未校正风险相似（首次事件的风险比[HR]= 1.10，95% CI = 0.70至1.71，P = 0.68，死亡的HR = 1.20，95% CI = 0.70至2.07，P = 0.50）。在意向性治疗分析中，两组的5年无病生存率和总生存率相似（淋巴结清扫组分别为81.0%和85.9%，非淋巴结清扫组分别为81.7%和90.0%），尽管系统性盆腔淋巴结清扫术显著改善了手术分期，但并未改善无病生存率或总生存率。
Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival.From October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients' clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided.The median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively).Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.