目的:本研究的主要目的是评估Nivolumab的疗效和安全性,免疫检查点抑制剂抗体,在先进的,以前治疗过,非小细胞肺癌(NSCLC)患者,在现实世界的环境中。
方法:我们进行了回顾性研究,纳入葡萄牙Nivolumab扩展访问计划(EAP)患者的多中心数据分析.合格标准包括组织学或血液学证实的NSCLC,阶段IIIB和IV,可评估的疾病,足够的器官功能和至少一个先前的化疗路线。终点包括总体反应率(ORR),疾病控制率(DCR),无进展生存期(PFS)和总生存期(OS)。使用美国国家癌症研究所不良事件通用术语标准(CTCAE)进行安全性分析。4.0版本和免疫相关不良事件(irAEs)按照方案治疗指南进行治疗.使用实体瘤反应评估标准(RECIST)1.1版评估肿瘤反应。使用SPSS分析数据,版本21.0(IBM统计)。
结果:从2015年6月至2016年12月,在30个葡萄牙中心共纳入229例晚期NSCLC患者。临床数据收集至2018年7月底。基线中位年龄为64岁(范围37-83),大多数患者为男性(70.3%)和以前/现在的吸烟者(69.4%)。非鳞状组织学患者占主导地位(88.1%),67.6%的患者接受过2次或2次以上的化疗.在229名患者中,有219例患者的数据(3例患者未开始治疗,而7例患者的数据不可用);在219例患者中,15.5%未进行放射学肿瘤评估,1.4%有完全缓解(CR),21%部分反应(PR),31%的疾病稳定(SD)和31.1%的疾病进展(PD)。因此,该人群的ORR为22.4%,DCR为53.4%.在生存分析时,中位PFS为4.91个月(95%CI,3.89-6.11),中位OS为13.21个月(95%CI,9.89-16.53)。安全性与临床试验数据一致。
结论:本回顾性分析中观察到的疗效和安全性结果与临床试验和其他中心报告的观察结果一致。
OBJECTIVE: The main aim of the study was to evaluate the efficacy and safety profile of Nivolumab, an immune-checkpoint-inhibitor antibody, in advanced, previously treated, Non-Small Cell Lung Cancer (NSCLC) patients, in a real world setting.
METHODS: We performed a retrospective, multicentre data analysis of patients who were included in the Portuguese Nivolumab Expanded Access Program (EAP). Eligibility criteria included histologically or citologically confirmed NSCLC, stage IIIB and IV, evaluable disease, sufficient organ function and at least one prior line of chemotherapy. The endpoints included Overall Response Rate (ORR), Disease Control Rate (DCR), Progression Free Survival (PFS) and Overall Survival (OS). Safety analysis was performed with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, and immune-related Adverse Events (irAEs) were treated according to protocol treatment guidelines. Tumour response was assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Data was analysed using SPSS, version 21.0 (IBM Statistics).
RESULTS: From June 2015 to December 2016, a total of 229 patients with advanced NSCLC were enrolled at 30 Portuguese centres. Clinical data were collected up to the end of July 2018. The baseline median age was 64 years (range 37-83) and the majority of patients were males (70.3%) and former/current smokers (69.4%). Patients with non-squamous histology predominated (88.1%), and 67.6% of the patients had received 2 or more prior lines of chemotherapy. Out of 229 patients, data was available for 219 patients (3 patients did not start treatment, while data was unavailable in 7 patients); of the 219 patients, 15.5% were not evaluated for radiological tumour assessment, 1.4% had complete response (CR), 21% partial response (PR), 31% stable disease (SD) and 31.1% progressive disease (PD). Thus, the ORR was 22.4% and DCR was 53.4% in this population. At the time of survival analysis the median PFS was 4.91 months (95% CI, 3.89-6.11) and median OS was 13.21 months (95% CI, 9.89-16.53). The safety profile was in line with clinical trial data.
CONCLUSIONS: Efficacy and safety results observed in this retrospective analysis were consistent with observations reported in clinical trials and from other centres.