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NEJM:早期自体干细胞移植可改善浸润性非霍奇金氏淋巴瘤无进展生存率

2013-11-01 佚名 丁香园

非霍奇金氏淋巴瘤干细胞
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通常情况下，医生会参考国际预后指数（international prognostic index）将治疗高中度恶性风险和高恶性风险的扩散性、侵润性非霍奇金氏淋巴瘤时，首次缓解期间的效果予以界定，而这一效果如何依然存在有争议，且它在利妥昔单抗治疗下的效应也未经检测。日前，Loyola大学医学中心的 Stiff博士等人的一项研究发表于国际权威杂志NEJM 2013年10月最新一期在线版，他们发


通常情况下，医生会参考国际预后指数（international prognostic index）将治疗高中度恶性风险和高恶性风险的扩散性、侵润性非霍奇金氏淋巴瘤时，首次缓解期间的效果予以界定，而这一效果如何依然存在有争议，且它在利妥昔单抗治疗下的效应也未经检测。日前，Loyola大学医学中心的 Stiff博士等人的一项研究发表于国际权威杂志NEJM 2013年10月最新一期在线版，他们发现，对于对诱导治疗有反应的高中危或高危患者而言，早期自体干细胞移植可改善无进展生存率。移植后患者的总生存率无改善，这可能是因为其抢救性移植的作用。【原文下载】

研究者对397例校正年龄后分类为高度恶性风险或高中度恶性风险的患者，分别给予5个周期的环磷酰胺、阿霉素、长春新碱、及强的松(CHOP)或CHOP加利妥昔单抗治疗。有反应的患者随机分组分别追加三轮诱导化疗（对照组）或追加一轮诱导化疗后辅以自体干细胞移植（移植治疗组）。主要有效性终点为2年无进展生存率和总生存率。

结果显示，在370例诱导-合格患者中，有253例经随机分组分别进入移植治疗组（125例）和对照组（128例）。移植治疗组有46例患者、对照组中有69例患者出现疾病进展或死亡，两年无进展生存率分别为69%和55%。

移植治疗组有37例患者、对照组中有47例患者死亡，2年总生存率为74%和71%。探索性分析显示无进展生存率和总生存率的风险水平对应着不同的治疗效应。在高风险患者人群中，移植治疗组的2年总生存率为82%，而对照组则为64%。

研究由此得出结论：对于对诱导治疗有反应的高中危或高危患者而言，早期自体干细胞移植可改善无进展生存率。移植后患者的总生存率无改善，这可能是因为其抢救性移植的作用。

研究背景：

长期以来人们一直认为二次缓解期自体干细胞移植可改善扩散性、侵润性非霍奇金氏淋巴瘤无病生存率和总生存率。根据国际预后指数2(IPI)的定义可在诊断时即可甄别长期缓解机率不到50%的患者，研究者在该组患者人群中进行了移植预试验。

在首先进行的试验LNH-87中，不管IPI风险范畴，患者均接受了全程诱导化疗；其中有完全反应的患者被随机分组为移植治疗组或巩固化疗组。虽然移植组未见生存优势，但一项回顾性分析显示高中危或高危疾病患者的无进展生存率和总生存率得到改善。

2期试验结果显示，高危组巩固移植有获益；然而随后几乎没有一项3期试验发现获益。许多因素导致了这些试验的复杂结果，其中包括因退出率过高而导致样本量不足，这可归因于早期疾病进展或患者自愿退出试验，以及与LNH-87试验不同的设计。15年前，首次报道巩固移植治疗高危疾病患者可能有潜在的获益，然而这项治疗策略的作用至今尚未得到阐明。

鉴于与既往试验相比不满意的数据是由试验设计的不同造成的，研究者利用与LNH-87试验相似的方案评估了自体干细胞移植的效应。对5个周期环磷酰胺、阿霉素、长春新碱、和强的松(CHOP)诱导化疗有反应的高中危或高危疾病患者经随机分组，分别追加一个周期的诱导化疗加移植治疗，或者追加3个周期的诱导化疗。

早期疾病进展的患者和选择不接受移植的患者不进入研究的随机分组，从而使患者的退出率最小化。鼓励出现复发的对照组患者接受抢救性移植，这样就可以评估早期或延迟移植策略的效应。在纳入大约三分之一的CD20+患者后，CHOP加利妥昔单抗(R-CHOP)治疗组优于CHOP单一方案诱导治疗组的趋势已经很明显。因此，2003年4月，R-CHOP方案开始用于这一亚组。

原文出处：

Patrick J. Stiff, M.D., Joseph M. Unger, Ph.D., James R. Cook, M.D., Ph.D., Louis S. Constine, M.D., Stephen Couban, M.D., Douglas A. Stewart, M.D., Thomas C. Shea, M.D., Pierluigi Porcu, M.D., Jane N. Winter, M.D., Brad S. Kahl, M.D., Thomas P. Miller, M.D., Raymond R. Tubbs, D.O., Deborah Marcellus, M.D., Jonathan W. Friedberg, M.D., Kevin P. Barton, M.D., Glenn M. Mills, M.D., Michael LeBlanc, Ph.D., Lisa M. Rimsza, M.D., Stephen J. Forman, M.D., and Richard I. Fisher, M.D.Autologous Transplantation as Consolidation for Aggressive Non-Hodgkin's Lymphoma.N Engl J Med 2013; 369:1681-1690October 31, 2013DOI: 10.1056/NEJMoa1301077【原文下载】

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    2014-01-23 limedical1982

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