Afzal Muhammad Zubair, Dragnev Konstantin, Shirai Keisuke
Hospital Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH, USA.
Department of Hematology-Oncology, Norris Cotton Cancer Center, One Medical Center Dr., Lebanon, NH, USA.
J Thorac Dis. 2018 Jun;10(6):3575-3584. doi: 10.21037/jtd.2018.06.08.
Randomized phase II and III studies showed the promising results of the combination of carboplatin/pemetrexed with pembrolizumab in non-squamous non-small cell lung cancer patients. Patients with brain metastases were excluded from the phase II study. After FDA approval, this regimen was adopted early at our institution, including a use in patients with brain metastases. We report real-world use of this regimen in a single medical center.
This is a retrospective cohort study that includes patients with advanced non-squamous non-small cell lung cancer diagnosed and treated with carboplatin/pemetrexed (Cohort A) or carboplatin/pemetrexed plus pembrolizumab (Cohort B) between January 1st, 2016 till December 15th, 2017. Objective response rate (ORR) was the primary endpoint. Progression-free survival (PFS), disease control rate (DCR) were the secondary endpoints.
A total of 54 patients were included (cohort A =37 cohort B =17). ORR was 53.3% in cohort B 40.5% in cohort A (P=0.41). DCR was significantly higher in cohort B (86.7% 54%, P=0.02). PFS was also higher in cohort B (P= 0.009, HR 0.22). Similar proportion of patients had brain metastases in each cohort (A: 32.4% B: 35.3%, P=0.83). ORR was higher in patients with brain metastases from cohort B (B: 80% A: 58.3%, P=0.75). Significantly higher proportion of the patients with brain metastases progressed in cohort A (A: 91.7% B: 33.3%, P=0.009).
The combination of carboplatin and pemetrexed with pembrolizumab showed promising results in a real world setting in patients with NSCLC with and without brain metastases that are in line with the reported results of phase II and III studies. Most significant benefit was observed in preventing progression and achieving the disease control.
随机II期和III期研究显示,卡铂/培美曲塞与帕博利珠单抗联合应用于非鳞状非小细胞肺癌患者取得了令人鼓舞的结果。II期研究排除了脑转移患者。美国食品药品监督管理局(FDA)批准后,我们机构较早采用了该方案,包括用于脑转移患者。我们报告了该方案在单一医疗中心的实际应用情况。
这是一项回顾性队列研究,纳入了2016年1月1日至2017年12月15日期间诊断并接受卡铂/培美曲塞治疗的晚期非鳞状非小细胞肺癌患者(队列A)或卡铂/培美曲塞联合帕博利珠单抗治疗的患者(队列B)。客观缓解率(ORR)是主要终点。无进展生存期(PFS)、疾病控制率(DCR)是次要终点。
共纳入54例患者(队列A = 37例,队列B = 17例)。队列B的ORR为53.3%,队列A为40.5%(P = 0.41)。队列B的DCR显著更高(86.7%对54%,P = 0.02)。队列B的PFS也更高(P = 0.009,风险比0.22)。每个队列中脑转移患者的比例相似(A:32.4%,B:35.3%,P = 0.83)。队列B中脑转移患者的ORR更高(B:80%,A:58.3%,P = 0.75)。队列A中脑转移患者进展的比例显著更高(A:91.7%,B:33.3%,P = 0.009)。
卡铂、培美曲塞与帕博利珠单抗联合应用在伴有和不伴有脑转移的非小细胞肺癌患者的真实世界环境中显示出令人鼓舞的结果,与II期和III期研究报告的结果一致。在预防疾病进展和实现疾病控制方面观察到了最显著的益处。