Pembrolizumab plus Chemotherapy for Squamous Non‑Small‑Cell Lung Cancer
Pembrolizumab added to chemotherapy improves overall survival and progression‑free survival in patients with metastatic squamous NSCLC.
BACKGROUND: Standard first‑line therapy for metastatic, squamous non‑small‑cell lung cancer (NSCLC) is platinum‑based chemotherapy or pembrolizumab (for patients with PD‑L1 expression on >50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC. METHODS: In this double‑blind, phase 3 trial, 559 patients with untreated metastatic, squamous NSCLC were randomly assigned to receive pembrolizumab or saline placebo, together with carboplatin and either paclitaxel or nanoparticle albumin‑bound (nab‑) paclitaxel for the first four cycles. Primary endpoints were overall survival and progression‑free survival. RESULTS: After a median follow‑up of 7.8 months, median overall survival was 15.9 months (95% CI 13.2 to not reached) for the pembrolizumab‑combination group versus 11.3 months (95% CI 9.5 to 14.8) for the placebo‑combination group (hazard ratio 0.64; 95% CI 0.49–0.85; p < 0.001). Median progression‑free survival was 6.4 months (95% CI 6.2–8.3) versus 4.8 months (95% CI 4.3–5.7) (hazard ratio 0.56; 95% CI 0.45–0.70; p < 0.001). Grade 3 or higher adverse events occurred in 69.8% of the pembrolizumab group and 68.2% of the placebo group; discontinuation due to adverse events was more frequent with pembrolizumab (13.3% vs 6.4%). CONCLUSIONS: In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab‑paclitaxel resulted in significantly longer overall survival and progression‑free survival than chemotherapy alone.
This study establishes pembrolizumab plus platinum‑based chemotherapy as a more effective first‑line treatment for metastatic squamous NSCLC, offering clinicians and patients a survival advantage and informing guideline recommendations.
Evidence level: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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