免疫治疗相关疗效评价标准在非小细胞肺癌疗效评价中的应用

Clinical exploration of immune-related response criteria in non-small cell lung cancer

目的:评估免疫相关疗效评价标准(immune-related response criteria,irRC)在细胞免疫治疗非小细胞肺癌疗效中的适用性。方法:收集2015年7月至2016年12月于我科行细胞免疫治疗的中晚期非小细胞肺癌患者,入组患者在治疗前完善基线检查,经细胞免疫治疗2疗程后采用WHO标准进行疗效评价,对于评效为完全缓解(complete response,CR)、部分缓解(partial response,PR)、稳定(stable disease,SD)的患者继续治疗,对于评效为进展(progression disease PD)的患者,采用irRC标准再次评效,若评效为irPD,患者出组,否则继续治疗。结果:共90例患者入组,所有患者均至少完成2疗程细胞免疫治疗,2疗程后根据WHO标准进行疗效评估,CR 1例,PR 10例,SD 48例,PD 31例,31例评效PD的患者中,根据irRC评效标准,28例患者为irPD(出组),3例患者为irSD,继续原方案治疗,4周后再次评价疗效,1例患者评效irPR,其余2例患者评效irSD,9.7%(3/31)在WHO标准下PD的患者在后续免疫治疗中继续获益。结论:免疫治疗相关疗效评价标准(irRC)能够捕捉免疫治疗相关的独特反应模式。关于免疫治疗相关评效标准的前瞻性研究是必要的,随着研究的深入,irRC可能成为非小细胞肺癌患者细胞免疫治疗更为适合的疗效评价标准。

Objective:To evaluate the applicability of immune-related response criteria(irRC) in treating non-small cell lung cancer(NSCLC) by cellular immunotherapy.Methods:This study comprised patients with stage III_b-IV NSCLC from July 2015 to December 2016.All the patients received two periods of cellular immunotherapy at least.Curative effects were evaluated by WHO criteria.Patients with CR(complete response),PR(partial response) or SD(stable disease) continued the treatment.For patients with PD(progression disease),irRC was used to evaluate the curative effects.Patients with irPD stopped the treatment,otherwise continued the cellular immunotherapy.Results:A total of 90 patients were collected in the trail.All the patients received two periods of cellular immunotherapy at least.According to the WHO criteria,one patient had CR,ten patients had PR,forty-eight patients had SD,and thirty-one patients had PD.Patients with PD were reassessed according to the irRC evaluation standard,twenty-eight patients had irPD,and three patients had irSD.They continued to perform the original plan of treatment.4 weeks later,the curative effect was evaluated.One patient had irPR.The other two had irSD 9.7%(3/31) PD patients under WHO criteria continued to benefit from subsequent immunotherapy.Conclusion:Immune-related response criteria(irRC),was defined in an attempt to capture additional response patterns observed with immune therapy beyond those described by WHO criteria.Further prospective evaluations of the immune-related response criteria are warranted.irRC may become a more suitable criteria for the evaluation of antitumor responses with cellular immunotherapy in NSCLC.