"Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer". The New England Journal of Medicine. 2016. 375(19):1823-1833. PubMed
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Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with previously untreated advanced non–small-cell lung cancer (NSCLC) with PD-L1 expression on at least 50% of tumor cells, how does pembrolizumab compare with platinum-based chemotherapy?
In previously untreated advanced NSCLC patients with PD-L1 expression on at least 50% of tumor cells, pembrolizumab significantly improved progression-free and overall survival with fewer adverse events compared to platinum-based chemotherapy.
Advanced NSCLC patients with high PD-L1 expression often have limited treatment options beyond chemotherapy. Pembrolizumab, a PD-1 inhibitor, has shown promising results in such patients.
This study may influence guidelines to consider pembrolizumab for first-line treatment in advanced NSCLC patients with PD-L1 expression on at least 50% of tumor cells.
Open-label, phase 3 randomized controlled trial. N=305 patients. Pembrolizumab vs. investigator's choice of platinum-based chemotherapy.
305 patients with untreated, stage IV NSCLC with PD-L1 expression on ≥50% tumor cells. Inclusion Criteria: Aged ≥18 years, ECOG performance-status score 0 or 1, and life expectancy ≥3 months. No sensitizing EGFR mutations or ALK translocations. Exclusion Criteria: Systemic glucocorticoids or immunosuppressive treatment, untreated brain metastases, active autoimmune disease, interstitial lung disease, pneumonitis history.
Pembrolizumab (200 mg IV every 3 weeks for 35 cycles) vs. investigator's choice of platinum-based chemotherapy (4 to 6 cycles).
Primary Outcome: Progression-free survival assessed by central radiologic review. Secondary Outcomes: Overall survival, objective response rate, safety.
Open-label design could introduce bias. Low number of deaths and confounding effect of crossover design. Limited generalizability to patients with low PD-L1 expression.
The trial was funded by Merck, the developer of pembrolizumab.
Additional sources and research for further reading.