Early whole brain radiotherapy in primary CNS lymphoma: negative impact on quality of life in the randomized G-PCNSL-SG1 trial
Early whole brain radiotherapy in primary CNS lymphoma: negative impact on quality of life in the randomized G-PCNSL-SG1 trial
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DOI：
10.1007/s00432-017-2423-5
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发表时间：
2017-09-01
影响因子：
3.6
通讯作者：
Weller, Michael
中科院分区：
文献类型：
--
作者：
Herrlinger, Ulrich;Schaefer, Niklas;Weller, Michael
目的：在G-PCNSL-SG-1随机试验中，在大剂量甲氨蝶呤(HD-MTX)为主的化疗(早期WBRT组)的基础上加用全脑放疗(45GY)，与单纯HD-MTX为主的化疗(没有早期WBRT组)相比，并不能延长原发CNS淋巴瘤(PCNSL)患者的总生存期(OS)。为了确定WBRT是否可能导致与生活质量(QOL)相关的迟发性神经毒性，本试验前瞻性地监测了QOL。方法采用EORTC-QLQ-C30和BN20问卷进行QOL测量，并结合重复的简易精神状态检查(MMSE)。结果在随机化后的第二年，早期西医组患者的认知功能和整体健康状况较非西医组降低(p=0.004和p=0.022)。此外，疲倦(p=0.037)、食欲不振(p=0.006)和脱发(p=0.002)在西医急救早期更为严重。简易智力状态检查显示，西医急性期早期上肢的数值较低(p=0.002)。纵向数据的混合模型分析还显示，在26个维度中，有15个维度的差异有利于没有早期WBRT的手臂。结论主观QOL问卷和客观MMSE测验的分析表明，没有早期WBRT的手臂的生活质量和认知能力是保守的。因此，尽管这是一个探索性分析，G-PCNSL-SG1的结果挑战了WBRT在PCNSL初级治疗中的地位。
Purpose In the randomized G-PCNSL-SG-1 trial, the addition of whole brain radiotherapy (45 Gy) to high-dose methotrexate (HD-MTX)-based chemotherapy (early WBRT arm) did not prolong overall survival (OS) as compared to HD-MTX-based chemotherapy alone (no early WBRT arm) in primary CNS lymphoma (PCNSL) patients. To determine whether WBRT might lead to quality of life (QoL)-relevant late neurotoxicity, this trial prospectively monitored QoL.Methods QoL measurements were performed using the EORTC-QLQ-C30 and BN20 questionnaires and combined with repeated Mini Mental State Examinations (MMSE). Exploratory data analysis included the 318 patients in the per-protocol population.Results In year 2 after randomization, cognitive functioning and global health status were reduced in the early WBRT arm as compared to the no early WBRT arm (p = 0.004 and p = 0.022, respectively). Also, fatigue (p = 0.037), appetite loss (p = 0.006) and hair loss (p = 0.002) were more intense in the early WBRT arm. MMSE testing revealed lower values (p = 0.002) in the early WBRT arm. A mixed model analysis of longitudinal data additionally showed differences favoring the no early WBRT arm in 15 of 26 dimensions of QoL.Conclusions The analysis of subjective QoL questionnaires and objective MMSE testing revealed that QoL and cognition were conserved in the arm without early WBRT. Thus, even though it was an exploratory analysis, the results of G-PCNSL-SG1 challenge the place of WBRT in the primary therapy of PCNSL.