- 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.
- 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.
- 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>
- Randomization limited to patients with completed chemoradiation.