Phase 2 trial of high-dose thoracic reirradiation shows 30-month median OS for recurrent lung cancer
This prospective phase 2 clinical trial evaluated high-dose thoracic reirradiation in 60 analyzed patients with recurrent lung cancer in the thorax, specifically tumors located <5 cm from the 50 Gy EQD isodose line of previous radiation therapy. The intervention involved reirradiation to ≥45 Gy EQD using image-guided intensity modulated radiation therapy or volumetric modulated arc therapy, delivered via conventional fractionation (63% of patients, median dose 53 Gy) or stereotactic body radiation treatment (37%, median dose 77 Gy). No comparator group was included.
The primary outcome was median overall survival (OS), which was 30.1 months, exceeding the study's 12-month goal. Median local control (LC) was 28.2 months, and median disease-free survival (DFS) was 13.6 months. Statistical measures like p-values or confidence intervals were not reported for these outcomes.
Regarding safety, grade 3 toxicities occurred in 12 patients (20%), with pneumonitis being the most common (12%). No grade 4 or 5 toxicities were registered, indicating a low-toxicity profile. Discontinuation rates were not reported.
Key limitations include the single-arm, non-randomized phase 2 design with no comparator, a limited sample size of 60 analyzed patients, and the absence of reported statistical confidence intervals. The study design shows association, not causation. Practice relevance is not reported, and these findings should be interpreted as preliminary evidence requiring validation in larger, controlled studies before influencing clinical standards.