Japanese journal of clinical oncology · 2026
Phase II trial of re-irradiation stereotactic body radiotherapy for painful spinal metastases.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Ito Kei, Ogawa Hiroaki, Nakajima Yujiro, Taguchi Kentaro, Suda Yuhi, Murofushi Keiko Nemoto
Аннотация
OBJECTIVE: To evaluate the palliative efficacy of re-irradiation stereotactic body radiotherapy (SBRT) for painful spinal metastases.
METHODS: In this single-centre, single-arm, phase II study, patients with painful spinal metastases (pain score ≥2 on a 0-10 scale) from solid tumours were enrolled. Eligibility criteria included absence of epidural spinal cord compression, and irradiation history (excluding SBRT) with an interval of ≥3 months. The prescribed dose was 24 Gy in two fractions; the maximum spinal cord dose constraint was 12.2 Gy. The primary endpoint was the pain response rate at 6 months in evaluable patients.
RESULTS: Among 35 spinal lesions in 34 patients registered between July 2019 and June 2024, 11 (31%) lesions were severely painful (score, 8-10), 16 (46%) were radioresistant, and 14 (40%) involved ≥3 consecutive vertebrae. The median prior equivalent dose in 2-Gy fractions (α/β = 10) was 33 (range, 23-70) Gy, and median interval between irradiations was 12 (range, 3-114) months. The median follow-up period was 9 (range, 2-51) months. Among evaluable patients, pain response was 84% at 3 months and 83% at 6 months, whereas complete response (CR) was 48% and 56%, respectively. In the intention-to-treat analysis, pain response was 60% at 3 months and 43% at 6 months, whereas CR was 34% and 29%, respectively. The 6-month local failure rate was 7%. Two (6%) patients experienced grade 3 toxicities.
CONCLUSIONS: Re-irradiation SBRT achieved substantial pain relief with acceptable toxicity, warranting larger randomized trials against conventional radiotherapy.
METHODS: In this single-centre, single-arm, phase II study, patients with painful spinal metastases (pain score ≥2 on a 0-10 scale) from solid tumours were enrolled. Eligibility criteria included absence of epidural spinal cord compression, and irradiation history (excluding SBRT) with an interval of ≥3 months. The prescribed dose was 24 Gy in two fractions; the maximum spinal cord dose constraint was 12.2 Gy. The primary endpoint was the pain response rate at 6 months in evaluable patients.
RESULTS: Among 35 spinal lesions in 34 patients registered between July 2019 and June 2024, 11 (31%) lesions were severely painful (score, 8-10), 16 (46%) were radioresistant, and 14 (40%) involved ≥3 consecutive vertebrae. The median prior equivalent dose in 2-Gy fractions (α/β = 10) was 33 (range, 23-70) Gy, and median interval between irradiations was 12 (range, 3-114) months. The median follow-up period was 9 (range, 2-51) months. Among evaluable patients, pain response was 84% at 3 months and 83% at 6 months, whereas complete response (CR) was 48% and 56%, respectively. In the intention-to-treat analysis, pain response was 60% at 3 months and 43% at 6 months, whereas CR was 34% and 29%, respectively. The 6-month local failure rate was 7%. Two (6%) patients experienced grade 3 toxicities.
CONCLUSIONS: Re-irradiation SBRT achieved substantial pain relief with acceptable toxicity, warranting larger randomized trials against conventional radiotherapy.