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【medical-news】【Lancet】MRC ASTEC试验：子宫内膜癌系统性盆腔淋巴结清扫术疗效的随机试验

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http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61766-3/abstract

Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study

Background
Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer. Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy. The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer.

Methods
From 85 centres in four countries, 1408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were randomly allocated by a minimisation method to standard surgery (hysterectomy and BSO, peritoneal washings, and palpation of para-aortic nodes; n=704) or standard surgery plus lymphadenectomy (n=704). The primary outcome measure was overall survival. To control for postsurgical treatment, women with early-stage disease at intermediate or high risk of recurrence were randomised (independent of lymph-node status) into the ASTEC radiotherapy trial. Analysis was by intention to treat. This study is registered, number ISRCTN 16571884.

Findings
After a median follow-up of 37 months (IQR 24—58), 191 women (88 standard surgery group, 103 lymphadenectomy group) had died, with a hazard ratio (HR) of 1·16 (95% CI 0·87—1·54; p=0·31) in favour of standard surgery and an absolute difference in 5-year overall survival of 1% (95% CI −4 to 6). 251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), with an HR of 1·35 (1·06—1·73; p=0·017) in favour of standard surgery and an absolute difference in 5-year recurrence-free survival of 6% (1—12). With adjustment for baseline characteristics and pathology details, the HR for overall survival was 1·04 (0·74—1·45; p=0·83) and for recurrence-free survival was 1·25 (0·93—1·66; p=0·14).

Interpretation
Our results show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early endometrial cancer. Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials.

Funding
Medical Research Council and National Cancer Research Network.

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2009-01-12 00:14 浏览 : 950 回复 : 2

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Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study
MRC ASTEC试验：子宫内膜癌系统性盆腔淋巴结清扫术疗效的随机试验

Background
背景
Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer.
全子宫及双侧附件切除术（BSO）是Ⅰ期子宫内膜癌的标准术式。
Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy.
尽管系统性盆腔淋巴结清扫术也已经常用于明确是否存在宫外病变并作为治疗的一部分，仍需随机化设计的临床试验以评估其疗效。
The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer.
ASTEC外科治疗试验即旨在研究盆腔淋巴结清扫术是否能够改善子宫内膜癌患者的生存率。

Methods
方法
From 85 centres in four countries, 1408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were randomly allocated by a minimisation method to standard surgery (hysterectomy and BSO, peritoneal washings, and palpation of para-aortic nodes; n=704) or standard surgery plus lymphadenectomy (n=704).
研究共纳入4个国家85个中心的1408例术前认为病变限于宫体并最终经组织学证实的子宫内膜癌患者。最小化法随机分组为标准手术组（全子宫切除术+双侧附件切除术+腹膜冲洗+腹主动脉旁淋巴结触诊; n=704例）或标准手术加淋巴结清扫组(n=704例)。
The primary outcome measure was overall survival.
主要终点为总体生存率。
To control for postsurgical treatment, women with early-stage disease at intermediate or high risk of recurrence were randomised (independent of lymph-node status) into the ASTEC radiotherapy trial. 为了消除患者术后治疗的差异，存在中高危复发风险的早期患者随机（即独立于淋巴结的情况）进入ASTEC放疗试验。
Analysis was by intention to treat. This study is registered, number ISRCTN 16571884.
研究采用意向性分析。临床试验注册编号为ISRCTN 16571884。

Findings
结果
After a median follow-up of 37 months (IQR 24—58), 191 women (88 standard surgery group, 103 lymphadenectomy group) had died, with a hazard ratio (HR) of 1·16 (95% CI 0·87—1·54; p=0·31) in favour of standard surgery and an absolute difference in 5-year overall survival of 1% (95% CI −4 to 6).
中位随访37个月(IQR 24—58), 死亡191例(标准手术组88例，淋巴结清扫组103例) ，危险比(HR) 1.16 (95% CI 0.87—1.54; p=0.31) ，结果倾向采用标准手术，5年总体生存率绝对差异为1% (95% CI −4 - 6)。
251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), with an HR of 1·35 (1·06—1·73; p=0·017) in favour of standard surgery and an absolute difference in 5-year recurrence-free survival of 6% (1—12).
死亡或复发共251例(标准手术组107例, 淋巴结清扫组144例), HR 1.35 (1.06—1.73; p=0.017) ，结果倾向采用标准手术，5年无复发生存率绝对差异为 6% (1—12)。
With adjustment for baseline characteristics and pathology details, the HR for overall survival was 1·04 (0·74—1·45; p=0·83) and for recurrence-free survival was 1·25 (0·93—1·66; p=0·14).
根据患者基线特征和病理资料调整后，总体生存率的HR为1.04 (0.74—1.45; p=0.83) ，无复发生存率为1.25 (0.93—1.66; p=0.14).

Interpretation
结论
Our results show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early endometrial cancer. Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials.
我们的研究结果表明，就总体或无复发生存率而言，早期子宫内膜癌患者并不能从盆腔淋巴结清扫术中获益。盆腔淋巴结清扫术不应推荐作为早期子宫内膜癌患者的常规治疗措施。

Funding
资助情况
Medical Research Council and National Cancer Research Network.
研究受医学研究委员会和全美癌症研究协作组资助。

2009-01-12 00:35

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MRC ASTEC试验：子宫内膜癌系统性盆腔淋巴结清扫术疗效的随机试验

背景
全子宫及双侧附件切除术（BSO）是Ⅰ期子宫内膜癌的标准术式。尽管系统性盆腔淋巴结清扫术也已经常用于明确是否存在宫外病变并作为治疗的一部分，仍需随机化设计的临床试验以评估其疗效。ASTEC外科治疗试验即旨在研究盆腔淋巴结清扫术是否能够改善子宫内膜癌患者的生存率。

方法
研究共纳入4个国家85个中心的1408例术前认为病变限于宫体并最终经组织学证实的子宫内膜癌患者。最小化法随机分组为标准手术组（全子宫切除术+双侧附件切除术+腹膜冲洗+腹主动脉旁淋巴结触诊; n=704例）或标准手术加淋巴结清扫组(n=704例)。主要终点为总体生存率。为了消除患者术后治疗的差异，存在中高危复发风险的早期患者随机（即独立于淋巴结的情况）进入ASTEC放疗试验。研究采用意向性分析。临床试验注册编号为ISRCTN 16571884。

结果
中位随访37个月(IQR 24—58), 死亡191例(标准手术组88例，淋巴结清扫组103例) ，危险比(HR) 1.16 (95% CI 0.87—1.54; p=0.31) ，结果倾向采用标准手术，5年总体生存率绝对差异为1% (95% CI −4 - 6)。死亡或复发共251例(标准手术组107例, 淋巴结清扫组144例), HR 1.35 (1.06—1.73; p=0.017) ，结果倾向采用标准手术，5年无复发生存率绝对差异为 6% (1—12)。根据患者基线特征和病理资料调整后，总体生存率的HR为1.04 (0.74—1.45; p=0.83) ，无复发生存率为1.25 (0.93—1.66; p=0.14).

结论
我们的研究结果表明，就总体或无复发生存率而言，早期子宫内膜癌患者并不能从盆腔淋巴结清扫术中获益。盆腔淋巴结清扫术不应推荐作为早期子宫内膜癌患者的常规治疗措施。

资助情况
研究受医学研究委员会和全美癌症研究协作组资助。

2009-01-12 00:37

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