Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies.
Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies.
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DOI：
10.1016/j.ejca.2010.06.002
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发表时间：
2010-09
影响因子：
8.4
通讯作者：
Kristensen, Gunnar
中科院分区：
文献类型：
--
作者：
Hogberg, Thomas;Signorelli, Mauro;de Oliveira, Carlos Freire;Fossati, Roldano;Lissoni, Andrea Alberto;Sorbe, Bengt;Andersson, Hakan;Grenman, Seija;Lundgren, Caroline;Rosenberg, Per;Boman, Karin;Tholander, Bengt;Scambia, Giovanni;Reed, Nicholas;Cormio, Gennaro;Tognon, Germana;Clarke, Jackie;Sawicki, Tomasz;Zola, Paolo;Kristensen, Gunnar
关键词：
肿瘤级别高、肌层深部浸润或疾病处于晚期的子宫内膜癌患者预后较差。随机研究表明，放疗可预防局部复发，但对总生存期没有影响。化疗可能产生的附加效应仍不清楚。进行了两项随机临床试验（NSGO-EC-9501/EORTC-55991 和 MaNGO ILIADE-III），以阐明化疗和放疗的序贯组合是否可以改善高危子宫内膜癌的无进展生存期。这两项研究被合并起来。患有手术后子宫内膜癌FIGO I-III期且无残留肿瘤且预后因素暗示高风险的患者（n=540；534名可评估）被随机分配接受辅助放疗联合或不联合序贯化疗。在 NSGO/EORTC 研究中，联合治疗可将复发或死亡风险降低 36%（HR 0.64，95% CI 0.41-0.99；P=0.04）；使用两侧测试。 MaNGO 研究的结果指向相同的方向（HR 0.61），但并不显着。在综合分析中，复发或死亡风险的估计相似，但置信限较窄（HR 0.63，CI 0.44-0.89；P=0.009）。两项研究均未显示总体生存率存在显着差异。在综合分析中，总生存率接近统计显着性（HR 0.69，CI 0.46-1.03；P = 0.07），癌症特异性生存率显着（HR 0.55，CI 0.35-0.88；p = 0.01）。在放疗中加入辅助化疗可以改善无残留肿瘤和高风险的子宫内膜癌手术患者的无进展生存期。未来研究的一个剩余问题是，在化疗中加入放疗是否可以改善结果。
Endometrial cancer patients with high grade tumours, deep myometrial invasion, or advanced stage disease have a poor prognosis. Randomized studies have demonstrated prevention of loco-regional relapses with radiotherapy with no effect on overall survival. The possible additive effect of chemotherapy remains unclear. Two randomized clinical trials (NSGO-EC-9501/EORTC-55991 and MaNGO ILIADE-III) were undertaken to clarify if sequential combination of chemotherapy and radiotherapy improves progression-free survival in high-risk endometrial cancer. The two studies were pooled. Patients (n=540; 534 evaluable) with operated endometrial cancer FIGO stage I-III with no residual tumour and prognostic factors implying high-risk were randomly allocated to adjuvant radiotherapy with or without sequential chemotherapy. In the NSGO/EORTC study, combined modality treatment was associated with a 36 % reduction in the risk for relapse or death (HR 0.64, 95 % CI 0.41-0.99; P=0.04); two-sided tests were used. The result from the MaNGO-study pointed in the same direction (HR 0.61), but was not significant. In combined analysis, the estimate of risk for relapse or death was similar but with narrower confidence limits (HR 0.63, CI 0.44-0.89; P=0.009). Neither study showed significant differences in overall survival. In combined analysis, overall survival approached statistical significance (HR 0.69, CI 0.46-1.03; P = 0.07) and cancer-specific survival was significant (HR 0.55, CI 0.35-0.88; p=0.01). Addition of adjuvant chemotherapy to radiation improves progression-free survival in operated endometrial cancer patients with no residual tumour and high risk profile. A remaining question for future studies is if addition of radiotherapy to chemotherapy improves the results.
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