Perioperative immunotherapy plus chemotherapy versus chemotherapy alone for patients with resectable pulmonary lymphoepithelioma-like carcinoma.

Abstract

Background: Primary pulmonary lymphoepithelioma-like carcinoma (PLELC) is a rare subtype of non-small-cell lung cancer. This study aims to compare the efficacy and safety of perioperative PD-1/PD-L1 inhibitor plus chemotherapy versus chemotherapy alone in stage II-IIIB PLELC patients.

Patients and methods: This retrospective study included stage II-IIIB PLELC patients. Patients received either perioperative immuno-chemotherapy (IO-Chemo) or chemotherapy alone (Chemo). Data on patient characteristics, treatments, efficacy, toxicities, and pathology were collected. Primary endpoints were major pathological response (MPR) and event-free survival (EFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), and adverse events (AEs).

Results: A total of 72 patients were included in this retrospective study. The ORR was 75.0 % in the IO-Chemo group and 58.3 % in the Chemo group (odds ratio [OR] 0.47 [95 % CI 0.15-1.42]; P = 0.200). The percentage of patients achieving major pathological response (MPR) was 54.2 % in the IO-Chemo group and 12.5 % in the Chemo group (OR 1.91 [95 % CI 1.22-2.99]; P < 0.001). Pathological complete response (pCR) was achieved by 33.3 % of patients in the IO-Chemo group compared to 4.2 % in the Chemo group (OR 1.44 [95 % CI 1.08-1.92]; P = 0.002). The median EFS was not reached in the IO-Chemo group, whereas it was 35.0 months in the Chemo group (95 % CI 14.2-55.8; hazard ratio [HR] 0.42 [95 % CI 0.19-0.93]; P = 0.031). Median overall survival (OS) was not reached after a median follow-up of 47.0 months. Multivariate analysis indicated that the PD-1/PD-L1 inhibitor combination was independently associated with longer EFS (HR = 0.32 [95 % CI 0.11-0.95]; P = 0.043). AEs of any grade occurred in 91.7 % of the patients in the IO-Chemo group versus 89.6 % in the Chemo group.

Conclusions: In patients with resectable PLELC, perioperative PD-1/PD-L1 inhibitor plus chemotherapy resulted in significantly longer EFS and a higher percentage of patients achieving MPR and pCR than chemotherapy alone, with a tolerable safety profile.