Trial reports highest-ever 5-year OS in advanced NSCLC

  • Bradley JD & al.
  • J Clin Oncol
  • 16 Dec 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Patients with stage III NSCLC who received a standard dose (SD) of 60 Gy radiation therapy (RT) with concurrent chemotherapy had a 5-year OS of 32.1%, with no survival benefit from the addition of cetuximab.

Why this matters

  • This 5-year OS is the highest ever reported in this patient population, suggesting that a radiation dose of 60 Gy, given in 2-Gy daily fractions, should be the standard of care.

Study design

  • Open-label, randomized, 2-by-2 factorial phase 3 RTOG 0617 trial.
  • 496 patients with stage III NSCLC received a high dose (HD) of 74 Gy vs a SD of 60-Gy radiation therapy with concurrent chemotherapy with or without cetuximab.
  • Funding: National Cancer Institute.

Key results

  • No significant difference between groups in grade ≥3 AEs or overall pulmonary toxicity.
  • At 5 years, the SD group had significantly better:
    • OS: 32.1% vs 23.0% (HR, 1.35; 95% CI, 1.08-1.69).
    • PFS: 18.3% vs 13.0% (HR, 1.22; 95% CI, 1.00-1.51).
  • Adding cetuximab conferred no OS or PFS benefit, and those who received cetuximab had more grade ≥3 AEs than those who did not (87.3% vs 71.2%; P<.0001>

Limitations

  • Randomization limited to patients with completed chemoradiation.