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Multicenter Real-World Data on First-Line Chemoimmunotherapy in Patients With Advanced Non-Small Cell Lung Cancer and
Shunichi Kataoka1, Takehito Shukuya1, Hiroshi Ohtsu2
1Department of Respiratory Medicine, Juntendo University, Graduate School of Medicine, Tokyo, Japan.
Background:
Immune checkpoint inhibitors (ICIs) with platinum-doublet chemotherapy (Chemo-ICIs) are used as the standard treatment for advanced non-small cell lung cancer (NSCLC) with performance status (PS) 0 to 1. However, patients with PS2 are often excluded from clinical trials, leading to an evidence gap that makes it difficult to select the optimal treatment strategy. The efficacy and safety of first-line Chemo-ICIs in PS2 remain unclear.
Patients And Methods:
This multicenter retrospective cohort study analyzed real-world data of 2425 patients with stage IV NSCLC and PS0 to 2 without driver oncogenes. Propensity score matching was used to compare outcomes between patients receiving Chemo and those receiving Chemo-ICIs. Primary endpoints included progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), and the incidence of grade ≥ 3 adverse events.
Results:
Among 424 patients with PS2 (median age 71 years; 73% men), 56 received Chemo-ICIs and 117 received Chemo. After matching, median PFS was significantly longer in the Chemo-ICIs group (5.7 vs. 2.3 months; hazard ratio [HR] 0.58 [0.36-0.93]; P = .025), and ORR was higher (43% vs. 21%; P = .02). OS showed a non-significant trend toward improvement (8.0 vs. 6.0 months; HR 0.75 [0.47-1.19]; P = .219). Rates of grade ≥ 3 adverse events were comparable (50.0% vs. 43.6%; P = .514).
Conclusions:
Chemo-ICIs significantly improved PFS and ORR compared to Chemo in patients with NSCLC with PS2 without higher toxicity. These findings highlight the clinical relevance of chemoimmunotherapy in patients with PS2 and may help bridge the evidence gap in existing treatment guidelines.
