PD-1 inhibition plus platinum-based chemotherapy (PBC) or PBC alone in the first-line treatment of locally advanced or metastatic pulmonary lymphoepithelioma-like carcinoma

BackgroundPulmonary lymphoepithelioma-like carcinoma (PLELC) is a distinctive subtype of non-small cell lung carcinoma that was not well presented in clinical studies. The management of advanced PLELC remains an important, unmet need due to the paucity of high-grade evidence. Herein, we carried out a multicenter, retrospective study to assess the effectiveness and tolerability of PD-1/PD-L1 inhibitor plus chemotherapy versus chemotherapy alone for patients with advanced PLELC in the first-line setting. Patients and MethodsThis retrospective study enrolled patients with advanced PLELC receiving first-line treatment with PD-1 inhibition plus chemotherapy (IO-Chemo group) or chemotherapy alone (Chemo group) in three medical centers in China. The survival outcomes, efficacy, and safety profile were investigated. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), and adverse events (AEs). ResultsA total of 133 patients were enrolled. PFS was significantly longer in the IO-Chemo group (median 12.8 months [95% CI 5.2-20.4]) than that in the Chemo group (median 7.7 months [95% CI 6.8-8.6]; hazard ratio [HR] 0.48 [95% CI 0.31-0.74]; P=0.001). ORR was 74.5% (95% CI, 63.0-86.1) in the IO-Chemo group and 34.6% (95% CI, 24.1-45.2) in the Chemo group (P<0.001). The median OS was not reached in the IO-Chemo group versus 35.7 months (95% CI 26.7-44.8) in the Chemo group (HR 0.47 [95% CI 0.20-1.07]; P=0.065). Multivariate analysis revealed that PD-1/PD-L1 inhibitor combination was independently associated with longer PFS (HR 0.40 [95% CI 0.25-0.63]; P<0.001). Grade 3 or higher AEs occurred in 36 (65.5%) patients in the IO-Chemo group and 56 (71.8%) patients in the Chemo group, respectively. ConclusionsIn patients with advanced PLELC, adding PD-1/PD-L1 inhibitor to platinum-based chemotherapy significantly increased PFS and ORR with a tolerable safety profile.

Automated summary

In patients with advanced PLELC, adding PD-1/PD-L1 inhibitor to platinum-based chemotherapy significantly increased PFS and ORR with a tolerable safety profile.