Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II:: An European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874)
Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II:: An European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874)
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DOI：
10.1016/j.ejca.2008.01.019
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发表时间：
2008-04-01
影响因子：
8.4
通讯作者：
Vermorken, J. B.
中科院分区：
文献类型：
--
作者：
Reed, N. S.;Mangioni, C.;Vermorken, J. B.
子宫肉瘤的管理仍然存在许多困难。初次手术是最佳治疗方法，但术后放疗的作用仍不确定。在20世纪80年代中期，欧洲癌症研究和治疗组织妇科癌症组研究提出了一项评估辅助放疗的试验，因为以前的非随机研究表明，术后放疗具有生存优势并改善了局部控制。该研究于1987年开始，历时13年，招募了224名患者。允许所有子宫肉瘤亚型。要求患者至少接受TAH、BSO和wahsings（166例患者），但淋巴结采样是可选的。平滑肌瘤103例，癌性肉瘤91例，子宫内膜间质肉瘤28例。患者随机接受观察或盆腔放疗，51戈伊，分28次，持续5周。初始分析显示局部复发减少（14对24，p = 0.004），但对OS或PFS无影响。在放疗组中未观察到意外的毒性反应，总体或无病生存率均无差异，但接受放疗的CS患者局部控制率增加，但LMS无任何获益。预后因素分析表明，阶段，年龄和组织学亚型是重要的预测因素的行为，这可能解释CS和LMS之间的差异。CS表现出更多的亲属关系，低分化子宫内膜癌的行为。LMS没有显示出同样的辐射益处。这些结果将有助于塑造未来的管理和子宫肉瘤的临床试验。(c)2008爱思唯尔有限公司保留所有权利。
The management of uterine sarcomas continues to present many difficulties. Primary surgery is the optimal treatment but the role of post-operative radiation remains uncertain. In the mid-1980s, the European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study proposed a trial to evaluate adjuvant radiotherapy, as previous non-randomised studies had suggested a survival advantage and improved local control when post-operative radiation was administered. The study opened in 1987 taking 13 years to accrue 224 patients. All uterine sarcoma subtypes were permitted. Patients were required to have undergone as a minimum, TAH and BSO and wahsings (166 patients) but nodal sampling was optional. There were 103 leiomyosarcomas (LMS), 91 carcinosarcomas (CS) and 28 endometrial stromal sarcomas (ESS). Patients were randomised to either observation or pelvic radiation, 51 Gy in 28 fractions over 5 weeks. Hundred and twelve were recruited to each arm. The initial analysis has shown a reduction in local relapse (14 versus 24, p = 0.004) but no effect on either OS or PFS. No unexpected toxicity was seen in the radiation arm. No difference in either overall or disease-free survival was demonstrated but there is an increased local control for the CS patients receiving radiation but without any benefit for LMS. Prognostic factor analysis shows that stage, age and histological subtype were important predictors of behaviour which may explain differences between CS and LMS. CS appears to show more kinship to poorly differentiated endometrial carcinomas in behaviour. LMS did not show the same benefit from radiation. These results will help shape future management and clinical trials in uterine sarcomas. (c) 2008 Elsevier Ltd. All rights reserved.