PD-1联合培美曲塞治疗晚期难治性肺腺癌的临床研究

A clinical study of PD-1 combined with pemetrexed in the treatment of advanced refractory lung adenocarcinoma

目的:研究PD-1联合培美曲塞治疗晚期难治性肺腺癌的临床疗效和安全性评估。方法:选取33例于2017年11月至2020年1月就诊于我院的肺腺癌患者,所有患者接受培美曲塞联合PD-1治疗,采用iRECIST实体瘤免疫疗效评价标准进行病情评估,同时记录治疗期间的不良反应。评价指标包括近期疗效(ORR、DCR)和远期疗效(PFS、OS),同时分析影响PFS的因素。结果:共30例患者可评价疗效(3例失访),其中14例PR(46.67%),12例SD(40.00%),4例PD(13.33%)。ORR为46.67%,DCR为86.67%,中位PFS为6.2个月,中位OS为11.2个月。30例患者中无治疗相关死亡,12例出现Ⅰ级骨髓抑制,3例出现Ⅱ级骨髓抑制,10例出现Ⅰ级免疫相关性肺炎,1例出现Ⅱ级免疫相关性肠炎,4例出现Ⅰ级皮疹等,无Ⅲ/Ⅳ级不良反应发生。性别、ECOG评分及中性粒细胞与淋巴细胞比值(NLR)水平是联合治疗中患者预后的独立影响因素。结论:PD-1联合培美曲塞治疗复发难治性晚期肺腺癌疗效可期,且耐受性好,不良反应可控;其中性别为女性、ECOG评分0~1分及低NLR水平的患者预后较好。

Objective:To evaluate the clinical efficacy and safety of PD-1 combined with pemetrexed in the treatment of advanced refractory lung adenocarcinoma.Methods:33 patients with lung adenocarcinoma who were admitted to our hospital from November 2017 to January 2020 were selected.All patients were treated with pemetrexed combined with PD-1,and their condition was evaluated using iRECIST immunotherapeutic evaluation criteria for solid tumor,and adverse reactions during treatment were recorded.Evaluation indicators included short-term efficacy(ORR and DCR)and long-term efficacy(PFS and OS).Factors affecting PFS were analyzed.Results:A total of 30 patients were evaluated,and 3 patients lost follow-up.Among them,14 cases achieved PR(46.67%).There were 12 cases of SD(40.00%),and 4 cases of PD(13.33%).The ORR was 46.67%.DCR was 86.67%.The median PFS was 6.2 months,and the median OS was 11.2 months.There were no treatment-related deaths in 30 patients.GradeⅠbone marrow suppression was observed in 12 patients,and 3 patients appeared gradeⅡbone marrow suppression.10 patients appeared gradeⅠimmune associated pneumonia.1 patient appeared gradeⅡimmune associated enteritis and 4 patients appeared gradeⅠrash.No gradeⅢ/Ⅳadverse reactions occurred.Gender,ECOG score and neutrophil-lymphocyte ratio(NLR)were independent factors affecting the prognosis of combined therapy.Conclusion:PD-1 combined with pemetrexed in the treatment of recurrent and refractory advanced lung adenocarcinoma has certain clinical benefits and well tolerance with no obvious adverse reactions,and the patients with gender of female,ECOG score of 0~1 and low NLR have better prognosis.