Zayas-Soriano Marta, Bonete-Sánchez Manuel, Campillo-López Juan, Marcos-Ribes Borja, Hernández-Guio Ana, Aznar-Saliente Mª Teresa
Pharmacy Department. San Juan University Hospital. Alicante. Spain..
Farm Hosp. 2020 Dec 3;45(1):22-27. doi: 10.7399/fh.11478.
To evaluate the efficacy and safety of anti-PD-1 and anti-PD-L1 immunotherapy agents as monotherapy in patients with non-small cell lung cancer.
This was a four-year retrospective observational study that included all patients with non-small cell lung cancer treated with nivolumab, pembrolizumab, and atezolizumab in a third level hospital. Demographic, clinical (ECOG status, stage, PD-L1 expression level), therapeutic (drug, start date, line of treatment and number of cycles), efficacy (date and status at the end of follow-up) and toxicity variables were collected. Data was extracted from the patient's electronic medical record. Overall survival and progression-free survival rates for different monitoring times were calculated.
The study included 80 patients, 35 on nivolumab, 32 on pembrolizumab and 13 on atezolizumab. The median overall survival was not achieved. Overall survival at 6, 12, 18 and 49 months in patients treated with nivolumab was 79.7%, 74.0%, 65.8% and 65.8%, respectively. Median progression-free survival was 15 months. Adverse events were observed in 85.7% of cases, the most common being asthenia (45.7%), hypothyroidism (25.7%) and cough (20.0%). For pembrolizumab, the overall survival rate at the end of follow-up for first- and second-line treatment was 100% and 70.9%, respectively. Median progression-free survival was 17 months in the first-line and 24 months in the second-line setting. Adverse events were observed in 84.4% of subjects, the most common ones being dyspnea (31.3%), arthralgia (28.1%) and asthenia (25.0%). The overall survival rate from 3 to 7 months remained at 75.8% for atezolizumab. Median progression-free survival could not be determined. At 3 and 6 months, 49.5% of subjects had made some progress. The most frequent adverse events included toxicity (69.2%), asthenia (30.8%), and cough, dyspnea, and skin toxicity (15.4% each).
Subjects showed a trend toward stabilization and chronification of the disease. A positive and considerable survival rate was observed, as compared with previous studies. Further studies are required with larger sample sizes and longer follow-up times to confirm these findings.
评估抗程序性死亡蛋白1（PD-1）和抗程序性死亡配体1（PD-L1）免疫治疗药物单药治疗非小细胞肺癌患者的疗效和安全性。
这是一项为期四年的回顾性观察研究，纳入了在一家三级医院接受纳武利尤单抗、帕博利珠单抗和阿替利珠单抗治疗的所有非小细胞肺癌患者。收集了人口统计学、临床（东部肿瘤协作组[ECOG]状态、分期、PD-L1表达水平）、治疗（药物、开始日期、治疗线数和周期数）、疗效（随访结束时的日期和状态）及毒性变量。数据从患者的电子病历中提取。计算了不同监测时间的总生存率和无进展生存率。
该研究纳入80例患者，其中35例接受纳武利尤单抗治疗，32例接受帕博利珠单抗治疗，13例接受阿替利珠单抗治疗。未达到中位总生存期。接受纳武利尤单抗治疗的患者在6、12、18和49个月时的总生存率分别为79.7%、74.0%、65.8%和65.8%。中位无进展生存期为15个月。85.7%的病例观察到不良事件，最常见的是乏力（45.7%）、甲状腺功能减退（）和咳嗽（20.0%）。对于帕博利珠单抗，一线和二线治疗随访结束时的总生存率分别为100%和70.9%。一线治疗的中位无进展生存期为17个月，二线治疗为24个月。84.4%的受试者观察到不良事件，最常见的是呼吸困难（31.3%）、关节痛（28.1%）和乏力（25.0%）。阿替利珠单抗从3至7个月的总生存率保持在75.8%。无法确定中位无进展生存期。在3和6个月时，49.5%的受试者出现了一些进展。最常见的不良事件包括毒性（69.2%）、乏力（30.8%）以及咳嗽、呼吸困难和皮肤毒性（各15.4%）。
受试者显示出疾病稳定和慢性化的趋势。与既往研究相比，观察到了积极且可观的生存率。需要进一步开展更大样本量、更长随访时间的研究来证实这些发现。
