Martin-Hirsch Pierre Pl, Bryant Andrew, Keep Sarah L, Kitchener Henry C, Lilford Richard
Gynaecological Oncology Unit, Royal Preston Hospital, Lancashire Teaching Hospital NHS Trust, Sharoe Green Lane, Fullwood, Preston, Lancashire, UK, PR2 9HT.
Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD001040. doi: 10.1002/14651858.CD001040.pub2.
Endometrial cancer is the most common genital tract carcinoma among women in developed countries, with most women presenting with stage 1 disease. Adjuvant progestagen therapy has been advocated following primary surgery to reduce the risk of recurrence of disease.
To evaluate the effectiveness and safety of adjuvant progestagen therapy for the treatment of endometrial cancer.
We searched the Cochrane Gynaecological Cancer Group Trials Specilaised Register, Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2009. MEDLINE and EMBASE up to April 2009.
Randomised controlled trials (RCTs) of progestagen therapy in women who have had surgery for endometrial cancer.
Two review authors independently abstracted data and assessed risk of bias. Risk ratios (RRs) comparing survival in women who did and did not receive progestagen were pooled in random effects meta-analyses. .
Seven trials assessing 4556 women were identified. Three trials included women with stage one disease only, whereas four included women with more advanced disease. Meta-analysis of four trials showed that there was no significant difference in the risk of death at five years between adjuvant progestagen therapy and no further treatment (RR = 1.00, 95% CI 0.85 to 1.18). This conclusion is also robust to single trial analyses at 4 and 7 years and in one trial across all points in time using a hazard ratio (HR). There was also no significant difference between progestagen therapy and control in terms of the risk of death from endometrial cancer, cardiovascular disease and intercurrent disease. Relapse of disease appeared to be reduced by progestagen therapy in one trial (HR = 0.71, 95% CI 0.52 to 0.97 and 5 year RR = 0.74, 95% CI 0.58 to 0.96), but there was no evidence of a difference in disease recurrence in another trial at 7 years (RR = 1.34, 95% CI 0.79 to 2.27).
AUTHORS' CONCLUSIONS: There is no evidence to support the use of adjuvant progestagen therapy in the primary treatment of endometrial cancer.
子宫内膜癌是发达国家女性中最常见的生殖道癌,大多数女性为Ⅰ期疾病。在初次手术后提倡辅助孕激素治疗以降低疾病复发风险。
评估辅助孕激素治疗子宫内膜癌的有效性和安全性。
我们检索了Cochrane妇科癌症小组试验专门注册库、Cochrane对照试验中心注册库(CENTRAL)2009年第2期。检索了截至2009年4月的MEDLINE和EMBASE。
对接受过子宫内膜癌手术的女性进行孕激素治疗的随机对照试验(RCT)。
两位综述作者独立提取数据并评估偏倚风险。在随机效应荟萃分析中汇总比较接受和未接受孕激素治疗的女性生存率的风险比(RR)。
共纳入7项评估4556名女性的试验。3项试验仅纳入Ⅰ期疾病的女性,而4项试验纳入疾病分期更晚的女性。对4项试验的荟萃分析表明,辅助孕激素治疗与不进行进一步治疗相比,5年死亡风险无显著差异(RR = 1.00,95%CI 0.85至1.18)。该结论在4年和7年的单试验分析以及一项使用风险比(HR)对所有时间点进行分析的试验中同样可靠。在子宫内膜癌、心血管疾病和并发疾病的死亡风险方面,孕激素治疗与对照组之间也无显著差异。在一项试验中,孕激素治疗似乎降低了疾病复发率(HR = 0.71,95%CI 0.52至0.97;5年RR = 0.74,95%CI 0.58至0.96),但在另一项7年试验中没有证据表明疾病复发存在差异(RR = 1.34,95%CI 0.79至2.27)。
没有证据支持在子宫内膜癌的初始治疗中使用辅助孕激素治疗。