随机临床试验的二次分析:年龄是子宫内膜癌的关键预后因素。
Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma.
机构信息
Department of Obstetrics and Gynecology, Sapienza University Hospital, Rome, Italy.
Department of Obstetrics and Gynecology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
出版信息
Am J Obstet Gynecol. 2014 Apr;210(4):363.e1-363.e10. doi: 10.1016/j.ajog.2013.12.025. Epub 2013 Dec 19.
OBJECTIVE
The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer. In the attempt to identify the patients with poorer prognosis, the impact of age and body mass index were also thoroughly investigated by cancer-specific survival (CSS) analyses.
STUDY DESIGN
Survival outcomes of trial patients were analyzed in relation to age (≤65 years and >65 years) in the 2 arms (lymphadenectomy and no lymphadenectomy) and in the whole population of the trial.
RESULTS
Univariate and multivariable analyses of CSS and overall survival (OS) of patients showed that age >65 years is a strong independent poor prognostic factor (5-y OS 92.1% and 78.4% in ≤65 years and >65 years patients, respectively, P < .0001; 5-y CSS 93.8% and 83.5% in ≤65 years and >65 years patients, respectively, P = .003). Among women ≤65 years, node negative patients had 94.4% 5-y OS and 96.3% 5-y CSS vs 74.3% 5-y OS and 74.3% 5-y CSS for node positive patients (P = .009 and P = .002, respectively), while among women >65 y, node negative patients had 75.7% 5-y OS and 83.6% 5-y CSS vs 74.1% 5-y OS and 83.3% 5-y CSS for node positive patients (P = .55 and P = .58, respectively). Univariate and multivariable survival analyses in the whole trial population showed that older age, and higher tumor grade and stage were significantly associated to a worse prognosis.
CONCLUSION
Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy, and, unexpectedly, irrespective of the presence of nodal metastasis. Only in older patients was obesity (body mass index >30) significantly associated with scarce prognosis.
目的
本研究旨在更深入地探讨意大利随机临床试验中探讨盆腔淋巴结清扫术在临床早期子宫内膜癌中的作用的结果。为了确定预后较差的患者,还通过癌症特异性生存(CSS)分析彻底研究了年龄和体重指数的影响。
研究设计
分析了试验患者的生存结果与年龄(≤65 岁和>65 岁)在两个臂(淋巴结清扫术和无淋巴结清扫术)以及试验的全部人群中的关系。
结果
CSS 和患者总生存(OS)的单变量和多变量分析表明,年龄>65 岁是一个强烈的独立不良预后因素(5 年 OS 分别为≤65 岁和>65 岁患者的 92.1%和 78.4%,P<.0001;5 年 CSS 分别为≤65 岁和>65 岁患者的 93.8%和 83.5%,P=.003)。在≤65 岁的女性中,淋巴结阴性患者的 5 年 OS 为 94.4%,5 年 CSS 为 96.3%,而淋巴结阳性患者的 5 年 OS 为 74.3%,5 年 CSS 为 74.3%(P=.009 和 P=.002),而在>65 岁的女性中,淋巴结阴性患者的 5 年 OS 为 75.7%,5 年 CSS 为 83.6%,而淋巴结阳性患者的 5 年 OS 为 74.1%,5 年 CSS 为 83.3%(P=.55 和 P=.58)。整个试验人群的单变量和多变量生存分析表明,年龄较大、肿瘤分级和分期较高与预后较差显著相关。
结论
无论是否进行淋巴结清扫术,老年女性的生存都面临着内在的较差,而且出乎意料的是,与淋巴结转移的存在无关。只有在老年患者中,肥胖(体重指数>30)与预后不佳显著相关。