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您所在的位置:首頁 > 血液科醫(yī)學(xué)進(jìn)展 > [ASCO2015]CLL患者的國際預(yù)后指標(biāo)

[ASCO2015]CLL患者的國際預(yù)后指標(biāo)

2015-05-26 17:37 閱讀:2942 來源:醫(yī)脈通 作者:林* 責(zé)任編輯:林夕
[導(dǎo)讀] 在慢性淋巴細(xì)胞白血病(CLL)治療越來越有效的時代,建立臨床分期系統(tǒng)不能準(zhǔn)確區(qū)分預(yù)后組。目前有很多新的預(yù)后標(biāo)志,但是沒有系統(tǒng)將主要的臨床,生物和基因變量整合至廣泛接受的評分中。

    在慢性淋巴細(xì)胞白血?。–LL)治療越來越有效的時代,建立臨床分期系統(tǒng)不能準(zhǔn)確區(qū)分預(yù)后組。目前有很多新的預(yù)后標(biāo)志,但是沒有系統(tǒng)將主要的臨床,生物和基因變量整合至廣泛接受的評分中。因此,研究者進(jìn)行了一項綜合分析,分析用于發(fā)展CLL患者國際預(yù)后指標(biāo)的26種預(yù)后因素。(摘要ID:7002)【方法】

    我們的全分析集收集了來自法國,德國,英國,美國和波蘭的8項3期試驗(3472名早期或晚期疾病患者;中位年齡61歲[范圍27-86];中位觀察時間[OT]80個月)。FAS隨機(jī)分為訓(xùn)練集和內(nèi)部驗證集(TD, 2308[67%]; IVD, 1164 [33%])。研究使用多變量統(tǒng)計方法,主要終點(diǎn)是總生存期(OS)。通過完整病歷分析來處理缺失數(shù)據(jù)。這一模型通過第三個數(shù)據(jù)集(包含梅約診所的845名新診斷CLL患者,中位年齡62歲[范圍25-89];中位OT為63個月)進(jìn)行驗證。

    【結(jié)果】

    基于1192(52%)名TD的患者,研究者鑒定了5個OS的***預(yù)測因素:年齡,臨床分期,17p缺失和/或TP53突變,IGHV突變狀態(tài)和β2-微球蛋白(B2M)水平。使用重量分級,一種預(yù)后指標(biāo)可以衍生出4個不同患者組:低危(評分0-1),中危(評分2-3),高危(評分4-6)和極高危(評分7-10),他們的OS顯著不同(5年的OS分別為93%,79%,64%和23%,p < 0.001;曲線下面積c=0.72[95% CI, 0.69-0.76])。梅約診所數(shù)據(jù)集中4個風(fēng)險組的5年OS分別為97%,91%,68%和21%(p < 0.001, c = 0.79 [0.74-0.85])。

    【結(jié)論】

    CLL-IPI聯(lián)合最重要的基因風(fēng)險因素——臨床分期,年齡和B2M可列入適用CLL患者的預(yù)后評分。此外,它可以區(qū)分不同預(yù)后組,有利于目前的治療建議。

    編譯自:The international Prognostic Index for patients with CLL (CLL-IPI): An international meta-**ysis. ASCO. 2015.5

    英文摘要:

    Background: Inthe era of more effective treatments for CLL, the established clinical staging systems [Rai/Binet] do not accurately discriminate between prognostic groups.There are several new prognostic markers, but no system integrates the major clinical, biological and genetic variables into one widely accepted score.Therefore we performed a comprehensive **ysis of 26 prognostic factors todevelop an internationally applicable prognostic index for CLL patients (pts)[CLL-IPI].

    Methods: Our full **ysis set (FAS) was collected from 8 phase 3 trials from France,Germany, UK, USA and Poland [3472 pts at early & advanced stage; median age61 years (yr) (range 27 - 86); median observation time (OT) 80 months (ms)].The FAS was randomly divided into training and internal validation datasets[TD, 2308 (67%); IVD, 1164 (33%)]. Methods of multivariable statistics wereapplied and the main end point was overall survival (OS)。 Handling of missingdata was performed by complete case **ysis. The model was externally validated in a third dataset comprised of 845 newly diagnosed CLL pts from Mayo Clinic [median age 62 yr (range 25 - 89); median OT 63 ms].

    Results: Basedon 1192 (52%) pts from the TD, 5 independent predictors for OS were identified:age, clinical stage, del(17p) and/or TP53 mutation, IGHV mutation status and β2-microglobulin (B2M) level. Using weighted grading, a prognostic index wasderived separating 4 different pt groups: low (score 0-1), intermediate (score2-3), high (score 4-6) and very high risk (score 7-10) with significantly differentOS [93%, 79%, 64% and 23% OS at 5 yr for the low to very high risk groupre spectively, p < 0.001; C-statistic c = 0.72 (95% CI, 0.69-0.76)]. This multivariable model was confirmed on the IVD [575 (49%) pts; c = 0.777(0.73-0.82)] and the 4 risk groups were reproduced with 97%, 91%, 68% and 21%5-yr OS [(p < 0.001), c = 0.79 (0.74-0.85)] on the Mayo set.

    Conclusions:The resulting CLL-IPI combines the most important genetic risk factors (IGHV, del(17p)/TP53 mutation) with clinical stage, age,and B2M into an easily applicable prognostic score for CLL pts. Moreover, itboth discriminates between prognostic groups and is ***rmative regarding current treatment recommendations.


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