Du He, Song Xinyu, Wu Fengying
Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People's Republic of China.
Lung Cancer (Auckl). 2025 Jun 9;16:73-83. doi: 10.2147/LCTT.S494990. eCollection 2025.
Pulmonary sarcomatoid carcinoma (PSC) represents a rare subtype of non-small cell lung cancer (NSCLC), and it has poor pathologic differentiation, aggressive progression, and early metastasis. Conventional antitumor therapies demonstrate limited efficacy against PSC, which is frequently associated with unfavorable clinical outcomes.
We conducted an open-label, single-arm Phase II trial. This study has been registered with Clinical Trials (ChiCTR2000031478). Patients received immune checkpoint inhibitor (ICI) combination with chemotherapy, the treatment continued until disease progression, unacceptable toxicity, patient withdrawal, or death. The primary endpoint was objective response rate (ORR), with secondary endpoints comprising progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and treatment-emergent adverse events.
From March 2021 through August 2023, a total of 38 patients were enrolled. The study comprised predominantly male participants (91%, n=34) with a median age of 65.4 years. Notably, 86.8% (n=33) had smoking histories. The ORR and DCR were 73.7% and 94.7%, respectively. The median PFS was 13.3 months (95% CI, 10.2-15.7) and median OS was not reached. The most common immune-related adverse events were pneumonitis, the incidence of which was 13.2%. The majority of observed AEs were grades 1 or 2 and all AEs were manageable. Only two patients discontinued treatment due to grade 3 immune-related pneumonitis during the study.
In our trial, we found that ICI combination with chemotherapy showed robust efficacy alongside acceptable toxicity in advanced-stage PSC. Taken together, ICI combination with chemotherapy could be a better option for PSC.
肺肉瘤样癌（PSC）是一种罕见的非小细胞肺癌（NSCLC）亚型，其病理分化差、进展迅速且早期转移。传统抗肿瘤疗法对PSC疗效有限，常导致不良临床结局。
我们开展了一项开放标签、单臂II期试验。本研究已在临床试验注册中心注册（注册号：ChiCTR2000031478）。患者接受免疫检查点抑制剂（ICI）联合化疗，治疗持续至疾病进展、出现不可接受的毒性、患者退出或死亡。主要终点为客观缓解率（ORR），次要终点包括无进展生存期（PFS）、疾病控制率（DCR）、总生存期（OS）以及治疗期间出现的不良事件。
2021年3月至2023年8月，共纳入38例患者。该研究主要为男性参与者（91%，n = 34），中位年龄65.4岁。值得注意的是，86.8%（n = 33）有吸烟史。ORR和DCR分别为73.7%和94.7%。中位PFS为13.3个月（95%CI，10.2 - 15.7），中位OS未达到。最常见的免疫相关不良事件是肺炎，发生率为13.2%。观察到的大多数不良事件为1级或2级，所有不良事件均可管理。研究期间仅有2例患者因3级免疫相关肺炎停止治疗。
在我们的试验中，发现ICI联合化疗在晚期PSC中显示出强大疗效且毒性可接受。综上所述，ICI联合化疗可能是PSC的更好选择。
