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Lancet haemat:R-CHOP、放疗、利妥昔单抗维持的序贯疗法治疗晚期滤泡性淋巴瘤的效果和安全性

2018-01-25 MedSci MedSci原创

虽然目前有多种治疗方案,但晚期滤泡性淋巴瘤仍不能被治愈。而且,后诱导治疗的理想顺利和绝对优势也不清楚。现有研究人员对联合放射免疫疗法和化疗后用利妥昔单抗序贯维持治疗的效果和安全性进行评估。本研究为单臂、多中心的II期研究(SWOGS0801),从美国的20个医疗中心招募年满18岁的确诊为III-IV期或II1、II2和II3a期的既往未接受过治疗的滤泡性淋巴瘤患者。受试患者接受5年的治疗计划:R-

虽然目前有多种治疗方案,但晚期滤泡性淋巴瘤仍不能被治愈。而且,后诱导治疗的理想顺利和绝对优势也不清楚。现有研究人员对联合放射免疫疗法和化疗后用利妥昔单抗序贯维持治疗的效果和安全性进行评估。

本研究为单臂、多中心的II期研究(SWOGS0801),从美国的20个医疗中心招募年满18岁的确诊为III-IV期或II1、II2和II3a期的既往未接受过治疗的滤泡性淋巴瘤患者。受试患者接受5年的治疗计划:R-CHOP(利妥昔单抗+环磷酰胺[750mg/m2]、阿霉素[50mg/m2]、长春新碱[1.4mg/m2]和强的松龙[100mg]),12天一疗程,6个疗程;1-4疗程的第1天予以利妥昔单抗375mg/m2,随后予以I131放射治疗;6个疗程的R-CHOP治疗后12周内,开始予以利妥昔单抗375mg/2维持治疗,每3个月一次,持续4年。主要评估指标:3年无进展存活期。

2009年4月1日-2010年12月15日期间,共招募84位符合要求的患者,其中73位完成R-CHOP和放疗。69位登记进行维持治疗的患者,只有41位完成4年的利妥昔单抗维持治疗。3年无进展存活期达到90%(95%CI82-95)。最常见的3级及以上副反应事件有中性粒细胞减少(48例[57%])、白细胞减少(34例[40%])、血小板减少(17例[20%])和发热性中性粒细胞减少(12例[17%])。研究期间有9例可能治疗相关的死亡(次发或不明原因3例、肝硬化1例、心脏骤停1例、次生恶性肿瘤4例)。7位患者出现2次恶性肿瘤,包括2例肉瘤、2例结直肠癌、2例急性髓系白血病和1例肾细胞癌。

本研究结果显示,联合放化疗后患者普遍获得缓解。但是,在维持治疗期间,很多人中断治疗,表明用利妥昔单抗维持治疗4年对多数患者来说都不可行。虽然如此,但该顺利的治疗策略可为患者带来良好的总体预后。

原始出处:

PaulMBarr,eta.R-CHOP,radioimmunotherapy,andmaintenancerituximabinuntreatedfollicularlymphoma(SWOGS0801):asingle-arm,phase2,multicentrestudy.TheLancetHaematology.January24,2018.http://dx.doi.org/10.1016/S2352-3026(18)30001-2

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    2018-03-28 changfy
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    2018-02-17 howi
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    2018-01-27 fengyi812
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