Scholten Astrid N, van Putten Wim L J, Beerman Henk, Smit Vincent T H B M, Koper Peter C M, Lybeert Marnix L M, Jobsen Jan J, Wárlám-Rodenhuis Carla C, De Winter Karin A J, Lutgens Ludy C H W, van Lent Mat, Creutzberg Carien L
Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):834-8. doi: 10.1016/j.ijrobp.2005.03.007. Epub 2005 May 31.
In 2000, the results of the multicenter Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial were published. This trial included 714 Stage I endometrial carcinoma patients randomly assigned to postoperative pelvic radiotherapy (RT) or no further treatment, excluding those with Stage IC, Grade 3, or Stage IB, Grade 1 lesions. Radiotherapy significantly decreased the risk of locoregional recurrence (4% vs. 14%), without affecting overall survival. In this report the long-term outcome and results with central pathology review are presented.
The slides of 569 patients (80%) could be obtained for pathology review. Median follow-up for patients alive was 97 months. Analysis was done according to the intention-to-treat principle. The primary study endpoints were locoregional recurrence and death.
Ten-year locoregional relapse rates were 5% (RT) and 14% (controls; p < 0.0001), and 10-year overall survival was 66% and 73%, respectively (p = 0.09). Endometrial cancer related death rates were 11% (RT) and 9% (controls; p = 0.47). Pathology review showed a substantial shift from Grade 2 to Grade 1, but no significant difference for Grade 3. When cases diagnosed at review as Grade 1 with superficial myometrial invasion were excluded from the analysis, the results remained essentially the same, with 10-year locoregional recurrence rates of 5% (RT) and 17% (controls; p < 0.0001).
In view of the significant locoregional control benefit, radiotherapy remains indicated in Stage I endometrial carcinoma patients with high-risk features for locoregional relapse.
2000年,多中心子宫内膜癌术后放射治疗(PORTEC)试验结果发表。该试验纳入了714例I期子宫内膜癌患者,随机分为术后盆腔放疗(RT)组或不再接受进一步治疗组,排除IC期、3级或IB期1级病变患者。放疗显著降低了局部区域复发风险(4%对14%),且不影响总生存期。本报告呈现了长期结局及中心病理复查结果。
可获取569例患者(80%)的切片用于病理复查。存活患者的中位随访时间为97个月。根据意向性治疗原则进行分析。主要研究终点为局部区域复发和死亡。
10年局部区域复发率分别为5%(放疗组)和14%(对照组;p<0.0001),10年总生存率分别为66%和73%(p=0.09)。子宫内膜癌相关死亡率分别为11%(放疗组)和9%(对照组;p=0.47)。病理复查显示从2级到1级有显著转变,但3级无显著差异。当将复查诊断为1级且有浅肌层浸润的病例排除在分析之外时,结果基本相同,10年局部区域复发率分别为5%(放疗组)和17%(对照组;p<0.0001)。
鉴于显著的局部区域控制获益,对于有局部区域复发高危特征的I期子宫内膜癌患者,放疗仍有必要。