Department of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Thorac Cancer. 2021 Feb;12(3):304-313. doi: 10.1111/1759-7714.13725. Epub 2020 Nov 13.
The safety of pembrolizumab monotherapy in treatment-naïve non-small cell lung cancer (NSCLC) patients with high programed death-ligand 1 (PD-L1) expression and pre-existing interstitial lung disease (ILD) has not yet been determined. Here, we aimed to evaluate the prognosis, efficacy and safety associated with pembrolizumab in such settings.
In this single-institution retrospective study conducted from May 2017 to October 2019, pembrolizumab was administered to 72 Japanese patients with treatment-naïve advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥50%. Patients with ILD were assigned to the ILD group, and those without to the non-ILD group. Between-group comparisons were then performed.
Of the 72 patients, 61 (84.7%) were male. The median age was 70 years. A total of 64 patients (88.9%) had a smoking history, median PD-L1 TPS status was 77.5%, and 10 of the 72 patients (13.9%) had ILD on pretreatment computed tomography. The objective response rate (ORR) was 45.8% and disease control rate (DCR) was 75.0%. The ORR was 70.0% and DCR was 90.0% in the ILD group, while the ORR was 41.9% and DCR was 72.6% in the non-ILD group. The median overall survival was 568 days; the value in the non-ILD group was 521 days, while in the ILD group was not reached. There was no significant difference between the two groups (log-lank, P = 0.73).
Pembrolizumab was administered to patients with pre-existing ILD with no difference in prognosis compared to patients without ILD. In patients with ILD, physicians should consider the expected long-term prognosis and risk of adverse events.
对于高程序性死亡配体 1(PD-L1)表达和预先存在的间质性肺病(ILD)的治疗初治非小细胞肺癌(NSCLC)患者,单药派姆单抗的安全性尚未确定。在这里,我们旨在评估派姆单抗在这种情况下的预后、疗效和安全性。
在这项 2017 年 5 月至 2019 年 10 月进行的单机构回顾性研究中,派姆单抗被用于 72 名患有治疗初治晚期 NSCLC 且 PD-L1 肿瘤比例评分(TPS)≥50%的日本患者。ILD 患者被分配到ILD 组,无 ILD 的患者被分配到非 ILD 组。然后对两组之间进行比较。
72 名患者中,61 名(84.7%)为男性。中位年龄为 70 岁。共有 64 名患者(88.9%)有吸烟史,中位 PD-L1 TPS 状态为 77.5%,72 名患者中有 10 名(13.9%)在治疗前 CT 上有 ILD。客观缓解率(ORR)为 45.8%,疾病控制率(DCR)为 75.0%。ILD 组的 ORR 为 70.0%,DCR 为 90.0%,而非 ILD 组的 ORR 为 41.9%,DCR 为 72.6%。中位总生存期为 568 天;非 ILD 组为 521 天,ILD 组未达到。两组之间无显著差异(对数秩,P=0.73)。
对于预先存在的 ILD 患者,给予派姆单抗治疗,与无 ILD 患者的预后无差异。对于患有 ILD 的患者,医生应考虑预期的长期预后和不良事件的风险。