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The New England Journal of MedicinePerioperative Durvalumab for Resectable Non–Small-Cell Lung Cancer

Durvalumab Enhances Chemotherapy Efficacy in NSCLC

A recent study has shown that perioperative durvalumab, in combination with neoadjuvant chemotherapy, significantly improves event-free survival and pathological complete response in patients with resectable non–small-cell lung cancer (NSCLC).

Study Design

  • The study involved 802 patients with resectable NSCLC (stage II to IIIB [N2 node stage] according to the eighth edition of the AJCC Cancer Staging Manual).
  • Patients were randomly assigned to receive platinum-based chemotherapy plus durvalumab or placebo administered intravenously every 3 weeks for 4 cycles before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles.
  • Randomization was stratified according to disease stage (II or III) and programmed death ligand 1 (PD-L1) expression (≥1% or <1%).

Key Findings

  • The duration of event-free survival was significantly longer with durvalumab than with placebo; the stratified hazard ratio for disease progression, recurrence, or death was 0.68 (95% confidence interval [CI], 0.53 to 0.88; P=0.004) at the first interim analysis.
  • At the 12-month landmark analysis, event-free survival was observed in 73.4% of the patients who received durvalumab (95% CI, 67.9 to 78.1), as compared with 64.5% of the patients who received placebo (95% CI, 58.8 to 69.6).
  • The incidence of pathological complete response was significantly greater with durvalumab than with placebo (17.2% vs. 4.3% at the final analysis; difference, 13.0 percentage points; 95% CI, 8.7 to 17.6; P<0.001 at interim analysis of data from 402 patients).
  • Event-free survival and pathological complete response benefit were observed regardless of stage and PD-L1 expression.
  • Adverse events of maximum grade 3 or 4 occurred in 42.4% of patients with durvalumab and in 43.2% with placebo.

According to the American Cancer Society, lung cancer (both small cell and NSCLC) is the second most common cancer in both men and women (not counting skin cancer). In men, prostate cancer is more common, while in women, breast cancer is more common. About 13% of all new cancers are lung cancers.

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