Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel.
Statistical Consulting Unit, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel.
Lung Cancer. 2020 May;143:40-46. doi: 10.1016/j.lungcan.2020.03.008. Epub 2020 Mar 12.
Little is known regarding the ICPi efficacy in LCNEC. We explored the efficacy and safety of ICPi in LCNEC and assessed its impact on OS.
Thirty-seven consecutive patients with advanced LCNEC were selected from the Davidoff Cancer Center database. These were divided into groups A1 (patients treated with ICPi, n-23) and A2 (patients not treated with ICPi, n-14). Additionally, group A1* was introduced (patients treated with ICPi as a monotherapy, n-21). Another cohort of advanced non-LCNEC lung cancer patients treated with nivolumab at five Israeli cancer centers was chosen as a comparator (group B, n-270). ORR, PFS with ICPi in group A1* were assessed (RECIST 1.1), OS with ICPi was compared between groups A1* and B. OS since advanced disease diagnosis (OSDx) was compared between groups A1 and A2.
In group A1*, ORR and median PFS with ICPi were 33 %, and 4.2 months (95 % CI, 2.4-8.1), respectively. With median follow-up since start of ICPi of 6.2 months [IQR 2.2-12.1] and 4.9 months [IQR 2.3-8.9] in groups A1* and B, respectively, 52 % and 64 % of patients died in groups A1* and B, respectively. Median OS with ICPi comprised 11.8 months (95 % CI, 3.7-NR) and 6.9 months (95 % CI, 5.5-8.1) in groups A1* and B, respectively (p-0.23). Median OSDx was 14.5 months (95 % CI, 10.1-38.9) and 10.3 months (95 % CI, 2.6-NR), in groups A1 and A2, respectively (p-0.54).
In advanced LCNEC, ICPi outcomes are comparable to the outcomes observed in advanced NSCLC. Future research is needed to clarify the impact of ICPi on OS, and to correlate its benefit with tumor mutational landscape.
关于 ICPi 在 LCNEC 中的疗效知之甚少。我们探讨了 ICPi 在 LCNEC 中的疗效和安全性,并评估了其对 OS 的影响。
从 Davidoff 癌症中心数据库中选择了 37 例晚期 LCNEC 患者。这些患者分为 A1 组(接受 ICPi 治疗的患者,n=23)和 A2 组(未接受 ICPi 治疗的患者,n=14)。此外,引入了 A1组(接受 ICPi 单药治疗的患者,n=21)。选择了在以色列五家癌症中心接受 nivolumab 治疗的晚期非 LCNEC 肺癌患者的另一队列作为对照组(B 组,n=270)。评估了 A1组中 ICPi 的客观缓解率(ORR)和无进展生存期(根据 RECIST 1.1),并比较了 A1*组和 B 组之间 ICPi 的总生存期(OS)。比较了 A1 组和 A2 组的晚期疾病诊断后总生存期(OSDx)。
在 A1组中,ORR 和 ICPi 的中位 PFS 分别为 33%和 4.2 个月(95%CI,2.4-8.1)。在 A1组和 B 组中,分别从开始 ICPi 治疗的中位随访时间为 6.2 个月(IQR,2.2-12.1)和 4.9 个月(IQR,2.3-8.9),分别有 52%和 64%的患者在 A1组和 B 组死亡。A1组和 B 组的中位 OS 分别为 11.8 个月(95%CI,3.7-NR)和 6.9 个月(95%CI,5.5-8.1)(p=0.23)。A1 组和 A2 组的中位 OSDx 分别为 14.5 个月(95%CI,10.1-38.9)和 10.3 个月(95%CI,2.6-NR)(p=0.54)。
在晚期 LCNEC 中,ICPi 的疗效与晚期 NSCLC 观察到的疗效相当。需要进一步的研究来阐明 ICPi 对 OS 的影响,并将其益处与肿瘤突变景观相关联。