Blood Adv:利妥昔单抗时代低级别B细胞淋巴瘤的死亡原因分析-来自一项前瞻性队列研究

2022-08-09 聊聊血液 聊聊血液

作者认为,还需要更多的致力于解决其他死亡原因,同时开发新的治疗策略以及预测早期进展的临床和生物学标志物。

死亡原因分析

低级别B细胞淋巴瘤

惰性B细胞淋巴瘤是一组肿瘤性疾病,在西方约占非霍奇金淋巴瘤 (NHL) 的35-45%。它们在临床上呈惰性,但在病理学上具有多样性,包括滤泡性淋巴瘤 (FL)、边缘区淋巴瘤(MZL,包括淋巴结MZL[NMZL]、结外MZL[EMZL] 和脾MZL[SMZL])、淋巴浆细胞淋巴瘤 (LPL)/华氏巨球蛋白血症 (WM) 和小淋巴细胞淋巴瘤 (SLL)/慢性淋巴细胞白血病 (CLL)。大多数患者的总体预后良好,但也有部分患者的侵袭性病程与早期进展、复发或组织学转化相关,而分子病理学的进展和抗CD20单克隆抗体的引入显著影响了这些患者的结局。

尽管治疗取得了进展,但淋巴瘤仍然是FL患者的主要死亡原因 (cause of death,COD)。同样对于CLL/SLL患者,基础疾病和疾病相关并发症导致也是利妥昔单抗时代的主要死亡原因。而关于其他惰性B细胞淋巴瘤的原因特异性死亡率(cause-specific mortality)的数据有限且存在矛盾。

有研究发现,如果非FL低级别B细胞淋巴瘤(low-grade B-cell lymphomas ,LGBCL) 患者诊断后12个月内无疾病进展、复发或需要再治疗,则生存期与一般人群相仿,而疾病早期进展或再治疗与进展后生存期较差相关;在FIL-NF10研究的MZL患者队列和IELSG-19研究的MALT淋巴瘤患者中也观察到相似结果。此外来自MER和法国里昂的FL患者队列中,早期复发与淋巴瘤相关死亡高度相关,但尚不清楚早期事件如何影响其他惰性B细胞淋巴瘤的死亡原因。尽管已有多种临床病理因素可预测生存率,但与死亡原因相关的因素尚未在LGBCL患者中进行充分研究。此外,描述LGBCL患者的死亡原因,对于提供从咨询到淋巴瘤及其可改善其生存期治疗以外干预的综合治疗非常重要。

基于此,梅奥诊所Matthew J. Maurer教授等对前瞻性入组分子流行病学资源(Molecular Epidemiology Resource,MER)的822例新诊断非FL LGBCL患者进行了死亡原因的详细分析(中位随访107个月,死亡219例),结果近日发表于《Blood Advances》。

本文要点

1、边缘区淋巴瘤和惰性B细胞淋巴瘤患者的死亡率在诊断后的前十年内很大程度上与淋巴瘤不相关

2、诊断后24个月内的早期进展或再治疗与淋巴瘤相关死亡风险增加密切相关

研究设计

MER是2002年建立的淋巴瘤结局的前瞻性队列研究,包括美国新诊断淋巴瘤(诊断后9个月内)的成人患者(≥18岁),纳入的是2002年至2015年间新诊断的患者。

本研究分析了以下组织病理学诊断:1)NMZL;2)EMZL;3)SMZL;4)LPL/WM;5)无法分类的低分级B细胞淋巴瘤 (LGBCL-U),下文提到的LGBCL均为这五类(不含滤泡性淋巴瘤);排除诊断时发生转化和/或伴随DLBCL或其他侵袭性B细胞淋巴瘤的患者。使用标准方案提取人口统计学、临床和病理学数据。

作者通过病历审查验证疾病进展、再治疗、转化和死亡,由MER医生使用标准方案审查死亡证明和/或病历,并将死亡原因分类为淋巴瘤(进展或转化)、治疗、非相关肿瘤、其他原因或未知。治疗相关死亡 (Treatment-related mortality,TRM) 定义较广泛,并进一步分类为感染、心脏、继发MDS/AML。

研究结果

患者基线特征和初始治疗策略

本研究共纳入2002-2015年 MER 入组的822例新诊断LGBCL患者。研究人群的基线特征见表1。最常见的亚型为结外边缘区淋巴瘤EMZL(n= 363;44%),其次为低分级B细胞淋巴瘤-无法分类LGBCL-U(n= 204;25%)、淋巴浆细胞淋巴瘤/华氏巨球蛋白血症LPL/WM(n= 91;11%)、脾边缘区淋巴瘤SMZL(n= 85;10%) 和NMZL(n= 79;10%)。诊断时的中位年龄为64岁,60% (n= 490) 的患者年龄> 60岁。大多数患者 (n= 501;63%) 为 III-IV 期疾病。375例(46%)患者为FLIPI风险分层低危,而195例患者 (24%) 为高危FLIPI。MALT-IPI 对患者的分类略有不同,208例患者 (25%) 为低危,238例患者 (29%) 为高危。

LGBCL患者的一线治疗策略见表1,不同亚型之间存在差异。最常见的方案是观察 (38%),范围从LPL/WM的26%至SMZL的48%;19%(n= 155) 的患者使用了联合免疫化疗,范围从 SMZL的9%至LPL/WM 的40%;110例研究患者 (13%) 最初接受利妥昔单抗 (R) 单药治疗,从SMZL的8%至LPL/WM的20%;总体而言,12%(n= 101) 的患者仅接受放疗,其中EMZL患者的频率最高 (23%),而SMZL患者的频率最低 (1%)。

中位随访8.9年,31例 (3.8%) 发生转化,219例 (27%) 死亡。Kaplan-Meier法测定的EFS24为79%。其中65例患者为淋巴瘤相关死亡(58例因进行性淋巴瘤,7例因治疗相关原因);7例治疗相关死亡的亚型包括LPL(N= 3)、结外MZL(N= 3) 和低级别B细胞淋巴瘤无法分类型(N= 1);死亡时的治疗类别为R-CHOP (N= 2)、CD20-苯达莫司汀 (N= 2)、BTK抑制剂 (N= 1)、mTOR抑制剂 (N= 1) 和蛋白酶体抑制剂 (N= 1)。此外112例 (51.1%) 患者为非淋巴瘤相关死亡,42例 (19.2%) 患者的死亡原因未知;非淋巴瘤相关死亡的最常见原因为医学合并症 (35%) 和其他恶性肿瘤 (35%)。

总体/各亚型死亡原因的累积发生率和分布

队列的10年全因OS为73.8%(图1A),范围介于SMZL的59.6%至NMZL的83.3%(图1B)。219例死亡中51%(112/219) 为非淋巴瘤相关,30%(65/219) 为淋巴瘤相关原因;19%(42/219) 的死亡原因未知。

总体人群中淋巴瘤相关死亡的10年估计值为8.0%,低于非淋巴瘤相关死亡率(13.6%)(图 2A)。按亚型列出的死亡原因见图2(B-F),淋巴瘤相关死亡率最高的是LPL/WM(10年估计值19.3%)和LGBCL-U(10年估计值11.0%),淋巴瘤相关死亡率最低的是EMZL(10年估计值3.7%)。非淋巴瘤相关死亡的发生率最高的是SMZL(10年估计值23.0%),其次是LGBCL-U(10年估计值18.5%);LPL/WM的发生率最低(10年估计值8.9%)。

按关键人口统计学和临床特征列出的死亡原因模式见表2。

淋巴瘤相关和非淋巴瘤相关死亡的发生率均随诊断时年龄的增加而增加。在年龄≤60岁vs 61-70 岁vs > 70岁时诊断的患者中,淋巴瘤相关死亡的10年估计值分别为4.1% vs 5.0% vs 14.8% (p< 0.001),而非淋巴瘤相关死亡率的10年估计值分别为5.0% vs 13.7% vs 24.5% (p< 0.001)(图3 A-C)。且值得注意的是,在所有年龄组中非淋巴瘤相关死亡的累积发生率均高于淋巴瘤相关死亡。

此外,不同性别中淋巴瘤相关死亡(男性10年估计值9.7% vs.女性6.4%,p= 0.12)或非淋巴瘤相关死亡(男性10年估计值14.6% vs.女性12.7%,p= 0.06)均无临床显著差异,2002-2008年诊断的患者亚组和2009-2015年诊断的患者亚组之间的死亡原因模式相似。

不良临床特征与淋巴瘤相关死亡的增加广泛相关。诊断时乳酸脱氢酶 (LDH) 升高的患者的淋巴瘤相关死亡率(10年估计值15.8%)显著高于无LDH升高的患者 (6.5%,p= 0.001),非淋巴瘤相关死亡率同样如此(10年时15.4% vs 14.4%,p= 0.97)。血红蛋白 (HGB) < 12 g/dL的患者淋巴瘤相关死亡(10年估计值13.6%)和非淋巴瘤相关死亡(10年估计值19.9%)的发生率高于HGB≥12 g/dL的患者(10年估计值分别为6.5%,p= 0.001和11.5%,p= 0.009)。同样,与I/II期疾病患者(10年估计值2.2%和9.4%,p= 0.013)相比,III–IV期疾病患者的淋巴瘤相关死亡(10年估计值11.4%,p< 0.001)和非淋巴瘤相关死亡(10年估计值15.1%,p=0.013)发生率也更高。

按基线预后指数列出的死亡原因模式

滤泡性淋巴瘤国际预后指数(FLIPI)评分越高(评分0-1 vs 2 vs 3-5),则淋巴瘤相关和非淋巴瘤相关死亡的累积发生率均越高,10年淋巴瘤相关死亡率分别为2.3% vs 9.8% vs 16.8% ,10年非淋巴瘤相关死亡率分别为8.5% vs 14.5% vs 22.3%,p均< 0.0001(表2和图4)。

随着评分的增加,MALT-IPI评分在淋巴瘤和非淋巴瘤相关死亡率中的累积发生率增加模式也相似,但累积发生率不同。MALT-IPI 0 vs 1 vs 2-3分患者淋巴瘤相关死亡的10年累积发生率为1.3% vs 5.4% vs 16.8% (p < 0.001),非淋巴瘤相关死亡的10年累积发生率分别为3.3% vs 16.0% vs 19.0%(p < 0.001;表2)。IPI 评分也存在相似的模式(表2)。值得注意的是,在所有IPI、FLIPI和 MALT-IPI 组中,非淋巴瘤相关死亡的累积发生率均高于淋巴瘤相关死亡。

按临床结局列出的死亡原因模式

作者基于转化和EFS24情况评估了死亡原因的模式。在疾病转化的患者中,淋巴瘤相关死亡率高于非淋巴瘤相关死亡率。在随访期间发生转化的31例患者中,转化日期后淋巴瘤相关死亡的5年估计值为34%,而转化后5年时非淋巴瘤相关死亡为6.5%。达到EFS24的621例患者(从达到EFS24计算)淋巴瘤相关死亡率非常低,10年时为5.1%(图5A);相比之下,139例未达到EFS24患者淋巴瘤相关死亡率显著增加,早期事件后10年淋巴瘤相关死亡率为19.1%(p< 0.001;表2,图5B)。未达到EFS24的患者与达到EFS24的患者(10年时11.0% vs 15.3%,p= 0.37)之间非淋巴瘤相关死亡率无显著差异。并且值得注意的是,未达到EFS24患者中,淋巴瘤相关死亡率高于非淋巴瘤相关死亡(10年时19.1% vs 11.0%)(图5)。

结论

本研究是利妥昔单抗时代,具有完整临床特征、治疗和结局数据的边缘区淋巴瘤、淋巴浆细胞性淋巴瘤和低级别恶性B细胞淋巴瘤无法分类型患者中,关于死亡原因的最大规模前瞻性队列研究,有助于患者的咨询和预后判断。

总的来说,10年时低级别B细胞淋巴瘤中最常见的死亡原因与淋巴瘤不相关,与之前关于FL和CLL/SLL的数据相反,之前数据报告淋巴瘤是10年时最常见的死亡原因。然而与FL一样的是,未能达到EFS24的低级别B细胞淋巴瘤患者发生淋巴瘤相关死亡的风险显著增加。作者认为,还需要更多的致力于解决其他死亡原因,同时开发新的治疗策略以及预测早期进展的临床和生物学标志物。

参考文献

Aung Tun ,et al. Causes of Death in Low Grade B-Cell Lymphomas in the Rituximab Era: A Prospective Cohort Study. Blood Adv . 2022 Jul 18;bloodadvances.2022007990. doi: 10.1182/bloodadvances.2022007990.

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    2022-08-10 ms2428646620762205

    好好学习

    0

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