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1、1.Background1 背景1.1. History of RECIST criteria1.1 RECIST 標準的歷史Assessment of the change in tumour burden is an important feature of the clinical evaluation ofcancer therapeutics. Both tumour shrinkage (objective response
2、) and time to the development of diseaseprogression are important endpoints in cancer clinical trials. The use of tumour regression as theendpoint for phase II trials screening new agents for evidence of anti-tumour effe
3、ct is supported by yearsof evidence suggesting that, for many solid tumours, agents which produce tumour shrinkage in aproportion of patients have a reasonable (albeit imperfect) chance of subsequently demonstrating anim
4、provement in overall survival or other time to event measures in randomised phase III studies(reviewed in [1], [2], [3] and [4]). At the current time objective response carries with it a body of evidencegreater than for
5、any other biomarker supporting its utility as a measure of promising treatment effect inphase II screening trials.Furthermore, at both the phase II and phase III stage of drug development,clinical trials in advanced dise
6、ase settings are increasingly utilising time to progression (orprogression-free survival) as an endpoint upon which efficacy conclusions are drawn, which is alsobased on anatomical measurement of tumour size.評價腫瘤負荷的改變是癌癥
7、治療的臨床評價的一個重要特征。腫瘤縮小(客觀緩解)和疾病進展時間都是癌癥臨床試驗中的重要終點。為了篩查新的抗腫瘤藥物,腫瘤縮小作為 II 期試驗重點被多年研究的證據(jù)所支持。這些研究提示對于多種實體腫瘤來說,促使部分病人腫瘤縮小的藥物以后都有可能(盡管不完美)被證實可提高在隨機Ⅲ期試驗中病人的總體生存期或進入其他事件評價的可能。目前在Ⅱ期篩查試驗中評價治療效果的指標中,客觀緩解比任何其他生物標記更可靠。而且,在Ⅱ和Ⅲ期藥物試驗中,進展期疾
8、病中的臨床試驗正越來越利用疾病進展的時間(無進展生存)作為得出有治療效果結論的終點,而這些也是建立在腫瘤大小的解剖學測量基礎上。However, both of these tumour endpoints, objective response and time to disease progression, areuseful only if based on widely accepted and readily applied
9、standard criteria based on anatomical tumourburden.In 1981 the World Health Organisation (WHO) first published tumour response criteria, mainly foruse in trials where tumour response was the primary endpoint. The WHO cri
10、teria introduced the conceptof an overall assessment of tumour burden by summing the products of bidimensional lesionmeasurements and determined response to therapy by evaluation of change from baseline while ontreatment
11、.5 However, in the decades that followed their publication, cooperative groups andpharmaceutical companies that used the WHO criteria often ‘modified‘ them to accommodate newtechnologies or to address areas that were unc
12、lear in the original document. This led to confusion ininterpretation of trial results6 and in fact, the application of varying response criteria was shown to lead tovery different conclusions about the efficacy of the s
13、ame regimen.7 In response to these problems, anInternational Working Party was formed in the mid 1990s to standardise and simplify response criteria.New criteria, known as RECIST (Response Evaluation Criteria in Solid Tu
14、mours), were published in2000.8 Key features of the original RECIST include definitions of minimum size of measurable lesions,instructions on how many lesions to follow (up to 10; a maximum five per organ site), and the
15、use ofunidimensional, rather than bidimensional, measures for overall evaluation of tumour burden. Thesecriteria have subsequently been widely adopted by academic institutions, cooperative groups, andunder the leadership
16、 of Jan Bogaerts and Patrick Therasse (co-authors of this guideline), consistsof >6500 patients with >18,000 target lesions and was utilised to investigate the impact of a variety ofquestions (e.g. number of target
17、 lesions required, the need for response confirmation, and lymph nodemeasurement rules) on response and progression-free survival outcomes. The results of this work, whichafter evaluation by the RECIST Working Group led
18、to most of the changes in this revised guideline, arereported in detail in a separate paper in this special issue.10 Larry Schwartz and Robert Ford (alsoco-authors of this guideline) also provided key databases from whic
19、h inferences have been made thatinform these revisions1.11.3 RECIST1.1 形成過程RECIST 工作組,是由來自于學術研究機構、政府和制藥企業(yè)的早期藥物開發(fā)的有經(jīng)驗的臨床醫(yī)生、影像學專家和統(tǒng)計學家組成,他們?yōu)?RECIST 更新定期舉行會議,確定所需的證據(jù),以證明所做的各種更改是合理的,并審查新出現(xiàn)的證據(jù)。修訂過程中一個最重要的方面是建立一個回顧性的數(shù)據(jù)庫,該數(shù)據(jù)庫的資
20、料來自于工業(yè)和學術協(xié)作組試驗中獲得的實體腫瘤相關數(shù)據(jù)。這個數(shù)據(jù)庫在 Jan Bogaerts 和 PatrickTherasse 領導下,在 EORTC 資料中心完成的。該數(shù)據(jù)庫有>6500 病人,病變器官>18000 個,被用來調查各種問題(如需靶病灶的數(shù)量、緩解確認的需要性,淋巴結測量規(guī)則)對緩解和無疾病進展生存期的影響。由 RECIST 工作組做出評價后,這項工作的結果是本版指南中發(fā)生了較大變動,并且在這個專期中做出了
21、具體報道。Larry Schwartz and Robert Ford(該指南的共同作者)也提供了來用于推斷的關鍵的數(shù)據(jù)庫,從而形成了 1.1 版本。The publication of this revised guideline is believed to be timely since it incorporates changes tosimplify, optimise and standardise the assessm
22、ent of tumour burden in clinical trials. A summary of keychanges is found in Appendix I. Because the fundamental approach to assessment remains grounded inthe anatomical, rather than functional, assessment of disease, we
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