2020 CCO:张清媛教授:外周T细胞淋巴瘤的治疗进展

2020-11-26 中国抗癌协会 中国抗癌协会

外周T细胞淋巴瘤(PTCL)是一组异质性、侵袭性高的非霍奇金淋巴瘤(NHL),在欧美国家约占非霍奇金淋巴瘤的10-15%左右,而我国为21.4%左右。

外周T细胞淋巴瘤(PTCL)是一组异质性、侵袭性高的非霍奇金淋巴瘤(NHL),在欧美国家约占非霍奇金淋巴瘤的10-15%左右,而我国为21.4%左右。最常见的PTCLs亚型为外周T细胞淋巴瘤非特指型PTCL-NOS、血管免疫母性T细胞淋巴瘤AITL和ALK+或ALK-系统性间变性大T细胞淋巴瘤sALCL。PTCL-NOS在欧洲和北美最常见, 而中国更常见的是NKTCL。

长久以来,这些亚型的治疗通常采用相似的含蒽环类的一线联合化疗方案,即CHOP或CHOP样方案[5]。然而,含蒽环类药物的治疗方案完全缓解率(CR)、无进展生存期(PFS)和总体生存期(OS)较低。即使是预后较好的ALK+sALCL,高龄(>40岁)和不良预后因素(IPI≥2)患者的5年OS<50%。

初治外周T细胞淋巴瘤(PTCL)治疗现状及突破

2020年欧洲血液学年会EHA上一篇口头报告,汇报了北欧淋巴瘤流行病学小组:251例局限性外周T细胞淋巴瘤(PTCL)患者经CHOP(或CHOP样)治疗的预后分析。局限性PTCL患者CHOP治疗以6-8个周期为主,除ALCL,ALK+阳性患者预后较好外,其余亚型使用传统CHOP化疗时的OS和PFS较十年前并未有太大改善。德国一项前瞻性NHL研究对比了CHOEP和CHOP方案,结果表明CHOEP显着改善ALK+ ALCL患者的3年EFS,但对其他亚型患者无显着获益。这些都表明PTCL患者中仍存在较高的尚未满足的治疗需求。

系统性间变性大细胞淋巴瘤中普遍存在CD30表达,并且CD30表达是其特异性表现。在非系统性间变性大细胞淋巴瘤亚型中,CD30的表达情况存在差异,估计范围不等,外周T细胞淋巴瘤非特指型中大约为 58%~64%,血管免疫母细胞性T细胞淋巴瘤中为43%~63%,成人T细胞白血病/淋巴瘤中为55%,肠病相关T细胞淋巴瘤中为0~100%。

维布妥昔单抗是一种抗体-药物偶联物,由一种抗CD30单克隆抗体通过蛋白酶切割型连接键与一种微管破坏剂(单甲基澳瑞他汀E)偶联而成。ECHELON-2是一项双盲、双模拟、随机、安慰剂对照、活性药物比较的Ⅲ期研究。旨在比较维布妥昔单抗、环磷酰胺、阿霉素和泼尼松(A+CHP)方案与环磷酰胺、阿霉素、长春新碱和泼尼松(CHOP)方案用于治疗初治CD30阳性外周T细胞淋巴瘤的疗效和安全性。总共纳入来自17个国家的452名患者,随机分为A+CHP组(n=226)和CHOP组(n=226)。中位随访36.2个月后,与CHOP相比,A+CHP显着改善了中位PFS(48.2 vs 20.8个月;HR 0.71 [95% CI 0.54-0.93];p=0.0110),与CHOP组相比,A+CHP组发生PFS事件的风险降低了29%。对于CD30阳性外周T细胞淋巴瘤患者而言,使用A+CHP进行一线治疗优于 CHOP,可以显着改善无进展生存期和总生存期,并且具有可控的安全性特征。

复发/难治性PTCL患者的治疗

外周T细胞淋巴瘤由于其侵袭性非常高,患者很容易进入到复发难治阶段,除ALCL ALK +外,各PTCL亚型难治/复发患者的结果没有差异,存活率都很低。随着靶向、分子、细胞治疗的不断开展,带给了临床更多的治疗选择。

维布妥昔单抗

一项二期临床研究评估维布妥昔单抗治疗复发难治性系统性ALCL的长期治疗效果,总体患者的预估5年OS为60%、中位OS未达到,预估5年PFS为39%,中位PFS为20个月。法国一项前瞻性、观察性研究最终分析(ODICE研究),评估了霍奇金淋巴瘤(HL)和非霍奇金淋巴瘤(NHL)患者常规诊疗中接受BV治疗情况,其中BV治疗不同PTCL亚型的中位周期数为4-7线,ORR为37%~71%,中位PFS为3.6~8.4个月。

ALCANZA是一项国际性的、开放标签的、随机的3期临床试验,旨在比较维布妥昔单抗与医生选择的标准治疗(PC)——甲氨蝶呤或贝沙罗汀,对曾接受过治疗的MF或pcALCL的疗效。研究结果显示在中位随访时间为22.9个月中,维布妥昔单抗疗效优于PC。显着改善持续至少4个月的客观缓解率(ORR4)(56% vs 13%;P<0.0001),显着提高CR率(16% vs 2%),显着延长PFS(中位16.7个月vs 3.5个月;HR=0.270,95% CI: 0.169-0.430)。

Tipifarnib

AITL和PTCL患者分别有50%和35% CXCL12:CXCR4高表达,这类患者接受标准护理治疗预后较差,Tipifarnib是一种法尼基转移酶FT抑制剂,可以下调CXCL12表达。一项2期、多中心、单臂、开放标签研究,分为两个阶段,旨在评估Tipifarnib 治疗AITL患者中的疗效、安全性和生物标志物。研究共分析了26名AITL患者,20名患者接受了疗效评估,5名CR,5名PR,ORR为50%(PPS分析),临床获益率为65%(PPS分析)。

ALK激酶抑制剂

2020EHA上发表了一项中国研究,旨在评估ALK抑制剂(克唑替尼/阿来替尼/色瑞替尼)±长春花碱VBL治疗儿童R/R ALK+ALCL的有效性和安全性。ALK抑制剂单药治疗(n=6):ORR为83.3%,均为CR,CR平均持续时间为6.9(0-17)个月。ALK抑制剂+VBL(n=13):ORR为100%,均为CR ,CR平均持续时间为13.3(3-23)个月,显示了良好的有效性。

HDACi抑制剂

目前批准上市用于治疗PTCL的组蛋白去乙酰化酶抑制剂(HDACi)有罗米地辛、西达本胺、伏立诺他、贝利司他。在一项关键2期临床研究中,罗米地辛治疗复发难治PTCL患者,ORR为25%,CR15%;在贝利司他的2期研究中,治疗复发难治PTCL的ORR 26%,CR 11%;西达本胺相对于其他药物生存获益更优,中位OS可以达到21.4个月。此外,除了单药用法,还可以考虑联合用药,可很大程度提高患者的生存,比如罗米地辛联合普拉曲沙,ORR可以达到71%,罗米地辛联合5-氮杂胞苷,ORR可以达到73%,带给了临床新的用药选择方案。

移植选择

PTCL患者在一线治疗缓解后是否选择移植?自体移植还是异基因移植?ALK阳性ALCL高危国际预后指数(IPI )患者及其它类型有条件患者,可在一线治疗缓解后接受大剂量化疗联合ASCT巩固,但目前?前瞻性大样本量研究证实该结论。部分PTCL(如肝脾T细胞淋巴瘤)预后极差,可以选择一线异基因造血干细胞移植(allo-SCT)巩固,但也缺乏大样本量研究数据支持。

一项瑞典研究统计了2000年-2009年共755例患者,其中移植组对比未移植组,5年PFS 41% vs 20%,5年OS 48% vs 26%,这项研究是迄今为止报道的真实世界中最大的PTCL研究,它提供了在注册临床试验范围之外的PTCL结果的重要信息,给临床一定的参考。

PTCL患者移植后是否需要巩固治疗,也是目前争议比较大的议题,一项多中心II期试验,评估在新诊断为CD30表达PTCL的患者中,在BV- CHP中添加依托泊苷后接受自体干细胞移植,并接受 BV巩固治疗的安全性和有效性。共入组28例患者,ORR 95%,CR 90%,目前研究仍在进行中,我们可以期待长期的生存数据产生。

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