Long-Term Analysis of One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial.
Anurag K Singh, Mark K Farrugia, Kevin L Stephans et al.
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In 30 seconds
This multicentre, randomised phase 2 trial compared long-term outcomes after stereotactic body radiotherapy delivered as 30 Gy in 1 fraction or 60 Gy in 3 fractions. Participants were medically inoperable patients with biopsy-confirmed peripheral clinical T1-T2/N0M0 non-small cell lung cancer. Among 98 randomised patients, median survival was 40.3 months. The investigators reported no differences between regimens in time to local or distant failure, progression-free survival, or overall survival; no new attributable adverse events emerged during additional follow-up. The authors concluded that the regimens were equivalent across the reported outcomes.
Key findings
- Ninety-eight patients were randomised; median survival was 40.3 months.
- No differences were reported in time to local failure, distant failure, progression-free survival, or overall survival (P = .14, .17, .98, and .78, respectively).
- No new attributable adverse events were observed during the additional follow-up period.
Why it matters
For medically inoperable patients with peripheral early-stage disease, the trial provides a randomised comparison of two SBRT schedules with long-term outcome reporting. The absence of reported differences across failure, survival, and toxicity outcomes informs consideration of fractionation, while the phase 2 design and reported results should guide how broadly equivalence is interpreted.
What to keep in mind
The study was a phase 2 trial with 98 randomised patients; the abstract does not provide confidence intervals or detailed estimates for the comparative outcomes.