Objective: Recently, increasing number of lung cancer patients benefit from immune-checkpoint inhibitors (ICIs). However, the data of Chinese small cell lung cancer (SCLC) patients is limited. This study aims to analyze the response and survival data of ICIs treatment in SCLC and to explore the predictive biomarkers. Methods: Forty-seven SCLC patients who received ICIs treatment from Peking University Cancer Hospital from May 2017 to September 2019 was recruited. Clinical characteristics including sex, age, smoking status, ICIs strategy, PD-L1 expression and therapeutic efficacy were collected to explore the clinical predictive biomarkers for SCLC ICIs treatment. Results: Among the 47 patients, 18 (38.3%) cases were partial repose (PR), 11 (23.4%) were stable disease (SD), 18 (38.3%) were progressive disease (PD), and the objective response rate (ORR) was 38.3%, disease control rate (DCR) was 61.7%, the median progression-free survival (PFS) was 5.3 months. ICIs monotherapy accounts for 27.7%, the ORR was 15.4%, DCR was 53.8%, median PFS was 2.7 months. Combined therapy accounts for 72.3%, the ORR was 47.1%, DCR was 64.7%, median PFS was 5.4 months. Fourteen (29.8%) patients received ICIs as the first line treatment, their ORR was 85.7%, DCR was 100%, median PFS was 9.1 month. The ORR was not related to the age, sex, body mass index (BMI), smoking status and programmed death-ligand 1 (PD-L1) expression (P>0.05). The ORRs were higher in patients underwent PD-L1 monotherapy (P=0.001), combined therapy (P=0.002) and received ICIs as the first line treatment (P<0.001). Log-rank analysis indicated that the PFS of female patients were 12.0 months, significantly longer than 4.4 months of male patients in ICIs treatment (P=0.038). Patients who received PD-L1 monotherapy, combined treatment, or ICIs as the first line treatment had longer PFS than their counterparts, though no statistical significant was observed (P>0.05). Cox multivariate analysis showed that, the gender was not an independent predictor for PFS in ICIs treatment (HR=3.777, 95%CI=0.974~30.891, P=0.054). Conclusions: Immunotherapy is an effective treatment strategy for SCLC. Patients who receive combined ICIs treatment, first line ICIs treatment and PD-L1 treatment may get greater benefits. PD-L1 expression cannot predict the response and PFS in SCLC ICIs treatment.
目的： 分析SCLC免疫治疗的疗效，并探索其预测指标。 方法： 回顾性分析2017年5月至2019年9月在北京大学肿瘤医院接受免疫检查点抑制剂(ICIs)治疗的47例晚期小细胞肺癌(SCLC)患者的临床资料，探索疗效相关的临床预测因素。 结果： 47例患者中，部分缓解18例(38.3%)，疾病稳定11例(23.4%)，疾病进展18例(38.3%)，客观缓解率(ORR)为38.3%，疾病控制率(DCR)为61.7%，中位无进展生存时间(PFS)为5.3个月。免疫单药治疗13例(27.7%)，ORR为15.4%，DCR为53.8%，中位PFS为2.7个月。免疫治疗联合其他药物治疗34例(72.3%)，ORR为47.1%，DCR为64.7%中位PFS为5.4个月。一线接受免疫治疗患者14例(29.8%)，ORR为85.7%，DCR为100%，中位PFS为9.1个月。免疫治疗的最佳疗效与患者的年龄、性别、体质指数、吸烟状态和程序性死亡蛋白配体1(PD-L1)的表达均无关(均P>0.05)。使用PD-L1单抗(P＝0.001)、免疫联合其他治疗(P＝0.002)、一线使用免疫治疗(P<0.001)的ORR更高。女性患者接受免疫治疗的中位PFS为12.0个月，明显长于男性患者(4.4个月，P＝0.038)；一线免疫治疗、PD-L1治疗及联合方案治疗患者的中位PFS有延长趋势，但差异均无统计学意义(均P>0.05)。多因素分析显示，性别并不是影响SCLC患者免疫治疗后中位PFS的独立因素(HR＝3.777, 95% CI为0.974～30.891，P＝0.054)。 结论： 免疫治疗在SCLC的治疗中是一种有效的治疗方式；一线尽早使用免疫治疗，采用免疫联合其他治疗方式并使用PD-L1单抗的患者有可能从免疫治疗中获益；PD-L1表达状态对SCLC免疫治疗的预测作用目前证据尚不充分。.
Keywords: Clinical characteristics; Immune-checkpoint inhibitors; Immunotherapy; Neoplasms, small cell lung.