Docetaxel in Non-Small Cell Lung Cancer: A Multi-Centre Real-World Evidence Analysis in the Immunotherapy Era

Docetaxel has been a standard second-line or later (2L+) treatment for advanced non-small cell lung cancer (NSCLC) for more than two decades and remains recommended in current treatment algorithms. However, real-world outcomes in the era of immune checkpoint inhibitors (ICI) are limited. This multicenter retrospective study included patients with advanced NSCLC treated with 2L+ docetaxel monotherapy between January 2011 and December 2020. The primary endpoint was median overall survival (mOS) from docetaxel initiation. Subgroup analyses were conducted to identify predictors of OS. A total of 285 patients were analyzed. Median age was 62 years; 43% female, 75% ECOG performance status (PS) 0-1, and 65% adenocarcinoma. Molecular alterations included EGFR (20%) and KRAS (15%). PD-L1 status was available in 66% of patients. Median docetaxel exposure was three cycles, administered as 2L (48%), 3L (35%), or 4L+ (17%). Prior therapies included chemotherapy (96%), ICI (38%), targeted therapy (21%), and chemo-immunotherapy (10%). mOS was 6.5 months (95% CI, 5.9-7.3). On multivariate analysis, KRAS alteration (HR 0.59; 95% CI 0.37-0.94; p = 0.026) and ECOG PS (1 vs. 0 HR 2.26; 95% CI 1.15-4.43; p = 0.018, ≥2 vs. 0 HR 2.62; 95% CI 1.27-5.41; p = 0.0091) remained independent predictors of OS. Real-world OS with docetaxel is consistent with historical trial data, irrespective of prior ICI, targeted therapy, or chemo-immunotherapy. KRAS mutation and a favourable ECOG PS were associated with improved survival.