Sintilimab with chemotherapy as first-line treatment for locally advanced or metastatic squamous non-small-cell lung cancer: a real-world data study

Purpose The ORIENT-12 study demonstrated the promising results of sintilimab combined with gemcitabine and platinum (GP) therapy in squamous non-small-cell lung cancer (sqNSCLC) patients. However, the efficacy of sintilimab plus paclitaxel/nab-paclitaxel and platinum (TP) in sqNSCLC is not yet known. Methods Real-life data were retrospectively collected from patients with untreated locally advanced or metastatic sqNSCLC who were treated with sintilimab plus TP (arm A) or sintilimab plus GP (arm B) between January 2019 and January 2021. Baseline characteristics, the efficacy of sintilimab, and adverse events were analyzed. Results A total of 52 patients were included (arm A, n = 32 and arm B, n = 20). The overall response rate was 59.4% in arm A and 40.0% in arm B. The median progression-free survival was 13.9 months (95% confidence interval [CI], 6.9–21.0) in arm A and 8.5 months (95% CI, 6.9–10.2) in arm B (hazard ratio [HR], 0.61; 95% CI, 0.30 to 1.25; p = 0.18). The median overall survival was 21.3 months (95% CI, 13.4–29.3) in arm A and 13.3 months (95% CI, 9.1–17.5) in arm B (HR, 0.62; 95% CI, 0.28–1.36; p = 0.23). Adverse events of grade 3 or higher occurred in 37.5% of the patients in arm A and 55.0% of the patients in arm B. Conclusions Sintilimab-TP may have similar clinical benefits compared with sintilimab-GP in patients with untreated advanced or metastatic sqNSCLC. These results require further validation by prospective randomized controlled studies.