Mottet Nicolas, Rousmans Sophie, Culine Stéphane
Urologue, Clinique chirurgicale mutualiste, Saint-Etienne, France.
Bull Cancer. 2008 Feb;95(2):205-34.
The "Standards, Options and Recommendations" (SOR)program in oncology, has been initiated in 1993 by the Federation of French Cancer Centres and is realised in collaboration with public and private clinicians,professional federations, scientific societies and since 2005 with National cancer institute. Its aims are to develop clinical practice guidelines (CPG), health technologic assessment reports and systematic reviews. By preparing the latter, it provides support to the scientific societies for the update of their CPG. In this context, the SOR, in collaboration with the French Association of Urology (AFU), has developed a systematic review on the management of nonseminomatous (NSTGC) or seminomatous(STGC) testicular germ cell cancer treated with primary radiotherapy (RT), chemotherapy (CT) or surveillance (SV) after radical orchidectomy. Today, 80 % of patients with testicular germ cell cancer, including metastatic stage, can be cured. Actual challenges are to limit morbidity and late sequels of treatments while maintaining their therapeutic efficacy. Following this goal, surveillance, considered as a therapeutic option, is being broadly developed particularly for localised tumours.
To synthesize outcomes of patients with NSTGC or STGC treated with primary RT, CT or SV after radical orchidectomy.
A systematic literature search has been performed on Medline between 01/2004 and 08/2007 and completed by the consultation of evidence based medicine websites, experts citations and further relevant references identified from trials revealed by electronic searches.
Randomised controlled trial (RCT), systematic reviews, and observational studies (prospective or retrospective cohorts) in patients with locally or advanced NSTGC or STGC treated with primary RT, CT or SV after radical orchidectomy have been included.
Studies have been assessed for eligibility and quality by three independent reviewers. Authors were contacted to provide details of outstanding clinical trials. No quantitative analysis was initially planned because of the heterogeneity of experimental designs researched BIBLIOGRAPHICAL RESULTS: Twenty-nine trials have been included : 1 meta-analysis, 1 pooled analysis of 2 RCT, 4 non-inferiority RCT, 6 comparative studies (1 prospective, 5 retrospective) and 17 observational studies (7 prospective, 10 retrospective). Nineteen references were for NSTGC and 10 for STGC.
The choice of risk-adapted treatment for patients with locally NSTGC of the testis seems to be appropriate: SV for low risk patients and CT for others. For advanced stage, the suppression of bleomycine remains questionable. For local STGC, the choice of SV or CT versus RT needs to be confirmed by RCT with prolonged follow-up according to promising results in term of toxicity obtained with carboplatine or lower irradiation dose (20 Gy instead of 30 Gy). Finally, for advanced STGC, the utility of carboplatine single agent treatment versus cisplatin-based combination chemotherapy has not been proved.
肿瘤学领域的“标准、选项与建议”(SOR)项目由法国癌症中心联合会于1993年发起,并与公立和私立临床医生、专业联合会、科学协会合作开展,自2005年起与国家癌症研究所合作。其目标是制定临床实践指南(CPG)、卫生技术评估报告和系统评价。通过编写后者,它为科学协会更新其CPG提供支持。在此背景下,SOR与法国泌尿外科学会(AFU)合作,对根治性睾丸切除术后采用原发性放疗(RT)、化疗(CT)或监测(SV)治疗的非精原细胞瘤(NSTGC)或精原细胞瘤(STGC)睾丸生殖细胞癌的管理进行了系统评价。如今,80%的睾丸生殖细胞癌患者,包括转移期患者,都可以治愈。当前的挑战是在保持治疗效果的同时,限制治疗的发病率和晚期后遗症。为实现这一目标,作为一种治疗选择的监测正在广泛开展,尤其是针对局限性肿瘤。
综合根治性睾丸切除术后采用原发性RT、CT或SV治疗的NSTGC或STGC患者的治疗结果。
于2004年1月至2007年8月在Medline上进行了系统的文献检索,并通过查阅循证医学网站、专家引用以及从电子检索揭示的试验中识别出的其他相关参考文献加以补充。
纳入了对根治性睾丸切除术后采用原发性RT、CT或SV治疗的局部或晚期NSTGC或STGC患者进行的随机对照试验(RCT)、系统评价和观察性研究(前瞻性或回顾性队列研究)。
由三位独立评审员对研究的入选资格和质量进行评估。与作者联系以获取未发表临床试验的详细信息。由于所研究的实验设计存在异质性,最初未计划进行定量分析。
共纳入29项试验:1项荟萃分析、1项对2项RCT的汇总分析、4项非劣效性RCT、6项比较研究(1项前瞻性、5项回顾性)和17项观察性研究(7项前瞻性、10项回顾性)。19篇参考文献涉及NSTGC,10篇涉及STGC。
对于睾丸局部NSTGC患者,选择风险适应性治疗似乎是合适的:低风险患者采用SV,其他患者采用CT。对于晚期患者,停用博来霉素仍存在疑问。对于局部STGC,根据卡铂或较低照射剂量(20 Gy而非30 Gy)在毒性方面取得的有前景的结果,SV或CT与RT的选择需要通过长期随访的RCT来证实。最后,对于晚期STGC,卡铂单药治疗与基于顺铂的联合化疗的效用尚未得到证实。