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Lancet oncol:VR-CAP疗法相比R-CHOP可显著延长套细胞淋巴瘤患者的总体存活期

2018-10-29 MedSci MedSci原创

LYM-3002研究,在不适合进行移植的未治疗过的新确诊的套细胞淋巴瘤患者中对比硼替佐米联合利妥昔单抗、环磷酰胺、阿霉素和强的松(VR-CAP)和利妥昔单抗、环磷酰胺、阿霉素、长春新碱和强的松(R-CHOP)两种一线疗法的疗效和安全性。现研究人员对达到主要的无进展存活期结点后,长期随访阶段患者的最终总体存活期和安全预后结果进行报告。LYM-3002是在28个国家的128个临床中心开展的一项随机化的

LYM-3002研究,在不适合进行移植的未治疗过的新确诊的套细胞淋巴瘤患者中对比硼替佐米联合利妥昔单抗、环磷酰胺、阿霉素和强的松(VR-CAP)和利妥昔单抗、环磷酰胺、阿霉素、长春新碱和强的松(R-CHOP)两种一线疗法的疗效和安全性。现研究人员对达到主要的无进展存活期结点后,长期随访阶段患者的最终总体存活期和安全预后结果进行报告。

LYM-3002是在28个国家的128个临床中心开展的一项随机化的开放性的3期研究。招募确诊的II-IV期未治疗过的、不适合进行骨髓移植的套细胞淋巴瘤成年患者,ECOG状态评分≤2分,被随机(按1:1)分至VR-CAP组(静滴 利妥昔单抗 375mg/m2、环磷酰胺 750mg/m2、阿霉素 50mg/m2和硼替佐米 1.3mg/m2,联合口服强的松100mg/m2)或R-CHOP组(静滴 长春新碱1.4mg/m2[最大剂量2mg]、利妥昔单抗 375mg/m2、环磷酰胺 750mg/m2和阿霉素 50mg/m2,联合口服强的松100m/m2),21天一疗程,6或8个疗程。本次分析的主要结点是总体存活期。

2008年5月22日-2011年12月5日,共招募了487位患者,其中268位(VR-CAP组140位、R-CHOP组128位)被纳入随访分析,随访截止2013年12月2日。中位随访82.0个月(IQR 74.1-94.2),VR-CAP组的中位总体存活期明显长于R-CHOP组(90.7个月[95% CI 71.4-未达到] vs 55.7个月[47.2-68.9];风险比0.66[95% CI 0.51-0.85];p=0.001)。随访期间出现3种新的副反应事件(两种各1例4期肺腺癌、VR-CAP组1例4期癌、R-CHOP组1例2期肺炎)。VR-CAP组243位患者死亡103位(42%),R-CHOP组244位患者死亡138位(57%),最常见的死因是病程进展。

与R-CHOP相比,VR-CAP疗法可明显延长患者存活期,而且安全性可接受。


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    2019-06-16 minlingfeng
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    2019-07-23 howi
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    2018-11-24 smlt2008
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