JCO:局部巩固疗法与维持治疗或观察对低变应性非小细胞肺癌患者的效果

2019-05-12 海北 MedSci原创

之前发表的研究结果报道,局部巩固治疗(LCT)与放射治疗或手术配合可以改善无转移生存(PFS),并延迟一线治疗后没有进展的低转移性非小细胞肺癌(NSCLC)患者新疾病的发生。

之前发表的研究结果报道,局部巩固治疗(LCT)与放射治疗或手术配合可以改善无转移生存(PFS),并延迟一线治疗后没有进展的低转移性非小细胞肺癌NSCLC)患者新疾病的发生。

最近,研究人员进一步检测了长期总体生存(OS)结果以及额外的次要终点。

这项多中心,随机,II期试验纳入了IVNSCLC患者,其具有3种或更少的转移,并且在一线全身治疗后3个月或更长时间没有进展。

患者被随机分配(11)到维持治疗或观察(MT / O)组,或所有活性疾病部位的LCT组。主要终点是PFS,次要终点是OS,毒性和新病变的出现。

所有分析均为双侧,P值小于0.1被认为是显着的。

数据安全和监测委员会建议在49名患者被随机分配后进行早期试验关闭,因为LCT组有显着的PFS益处。更新后的中位随访时间为38.8个月(范围,28.361.4个月),PFS益处持久(中位数,14.2个月[95CI7.423.1个月]LCT v 4.4个月[95CI 2.28.3个月] MT / O; P = .022)。

研究人员还发现了LCT组的OS益处(中位数为41.2个月[95CI18.9个月到未达到]LCT17.0个月[95CI10.1~39.8个月]MT / O; P = .017 )。没有观察到额外的3级或更高的毒性。 LCT组进展后存活时间较长(LCT组为37.6个月,MT / O组为9.4个月; P = .034)。在MT / O组中经历进展的20名患者中,9名在进展后接受所有病变的LCT,并且中位OS17个月(95CI,未达到7.8个月)。

因此,对于在一线全身治疗后没有进展的低转移性NSCLC患者,LCT相对于MT / O延长了PFSOS


原始出处:

Gomez DR et al. Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non-Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study. JCO, 2019; doi: 10.1200/JCO.19.00201.


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    2019-11-20 lidong40
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    2019-05-14 chg122
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    2019-05-12 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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