AACR 2020:Durvalumab治疗III期不可切除NSCLC的吸烟状态亚组分析

2020-04-29 MedSci MedSci原创

PACIFIC是第一项证明能够改善无法切除的III期非小细胞肺癌(NSCLC)生存的研究,将改写III期NSCLC的治疗标准。III期无法切除NSCLC的5年生存率为15%~30%左右,在长达几十年中

PACIFIC是第一项证明能够改善无法切除的III期非小细胞肺癌(NSCLC)生存的研究,将改写III期NSCLC的治疗标准。III期无法切除NSCLC的5年生存率为15%~30%左右,在长达几十年中,我们一直僵持在这些数字里面。其标准治疗为以铂类药物为基础的同步放化疗,在相当长的一段时间里面,科学家进行了前赴后继地探索,然而都没能改善患者的结局。PACIFIC研究的出现,打破了这潭死水。在2017ESMO大会首次公布研究数据,在试验中期分析中,研究人员观察到,与安慰剂相比,durvalumab的PFS改善了11.2个月(16.8个月 vs 5.6个月)。两组ORR分别为28.4%和16.0%(P<0.001)。Durvalumab的安全性和耐受性良好。 

截至2018年3月22日,中位随访时间为25.2个月(范围0.2-43.1)。此次更新的PFS结果与之前相似,通过盲法独立中心评价的中位PFS在durvalumab时为17.2个月,在安慰剂组中为5.6个月(HR,0.51; 95%CI,0.41-0.63)。与安慰剂相比,durvalumab显着延长了OS(HR,0.68; 99.73%CI,0.469-0.997; P =0 .00251)。 durvalumab组未达到中位OS,安慰剂组为28.7个月。在OS和PFS森林图中,可以看到不吸烟的患者和常规治疗中使用顺铂的患者更能从durvalumab中受益。 

此次要AACR 2020会议上,进一步对PACIFIC研究的吸烟亚组进行了分析。

该研究共分析了713例患者。结果显示,无论是吸烟或未曾吸烟患者,Durva都能带来PFS及OS的改善。从HR值来看,似乎未曾吸烟患者从Durva的PFS(0.29 vs 0.59)和OS(0.35 vs 0.72)获益要大于吸烟患者。不过,未曾吸烟患者的总肺炎或放射性肺炎发生率都要高于吸烟患者,为durva组中(56% vs 32%,3/4级 7% vs 3%)及安慰剂组(48% vs 23%,3/4级 5% vs 2%)。

不过,从24个月OS来看,吸烟与不吸烟者有背离。在吸烟人群中,durva组中24个月OS为65.5%,而安慰剂组为56.7%;但是,在从未吸烟人群中,durva组中24个月OS为74.1%,而安慰剂组为43.1%;在安慰剂组,从未吸烟人群预后较吸烟人群反而更差。

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    2020-05-07 juliusluan78
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    2020-08-04 tamgche
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    2020-05-16 snf701207
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    2020-05-01 10518094zz
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    2020-05-01 Luyuxie_14
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    2020-04-29 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

    0

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