Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2026
FAST-02: Results from the second in-human prospective evaluation of single-fraction proton FLASH for symptomatic thoracic bone metastases.
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Daugherty Emily C, Zhang Yongbin, Xiao Zhiyan, Backus Lori, McDonald Julie M, Stockman Beth, Woo Jennifer, McCann Claire, Russell Ken, Sharma Ricky, Khuntia Dee, McGee James, Bradley Jeffrey D, Simone Charles B, Breneman John, Perentesis John P, Mascia Anthony E
Аннотация
BACKGROUND AND PURPOSE: FAST-01 demonstrated that proton FLASH radiotherapy (FLASH-RT) is clinically feasible and has an acceptable safety profile in patients with painful bone metastases of the extremities. FAST-02 expanded the investigation of FLASH-RT to patients whose treatment sites lie closer to critical normal structures.
MATERIALS AND METHODS: FAST-02 was a prospective, single-arm clinical trial (FDA IDE G220086) in which adult patients with 1-3 painful non-vertebral thoracic bone metastases were treated with FLASH-RT (8 Gy, ≥40 Gy/second). The co-primary objectives of FAST-02 were patient-reported toxicity and efficacy of pain relief. The trial's secondary objective was to evaluate FLASH-RT workflow metrics. Patients reported adverse events as well as overall pain, treatment site pain, and pain flare. Time-on-table and device-related treatment malfunctions were recorded.
RESULTS: Twelve patients were enrolled, and 10 patients were treated with FLASH-RT. Histologic diagnoses spanned lung, prostate, and kidney cancers. One site was treated per patient in the rib or scapula. All patients completed treatment per protocol. Average time-on-table was 14.6 min. At a median follow-up of 189 days, there were no ≥ grade 2 acute or late adverse events at least possibly related to FLASH-RT. Three-month pain was available in 8 patients; 1-month pain was available in 2 patients. A complete response was observed in 6 patients, a partial response in 3 patients, and stable response in 1 patient. Three patients reported pain flares by day 11 of follow-up.
CONCLUSION: FAST-02, the first prospective clinical study of FLASH adjacent to thoracic critical organs, supported that FLASH-RT can be effective and has an acceptable safety profile in study patients with painful thoracic bony metastases.
MATERIALS AND METHODS: FAST-02 was a prospective, single-arm clinical trial (FDA IDE G220086) in which adult patients with 1-3 painful non-vertebral thoracic bone metastases were treated with FLASH-RT (8 Gy, ≥40 Gy/second). The co-primary objectives of FAST-02 were patient-reported toxicity and efficacy of pain relief. The trial's secondary objective was to evaluate FLASH-RT workflow metrics. Patients reported adverse events as well as overall pain, treatment site pain, and pain flare. Time-on-table and device-related treatment malfunctions were recorded.
RESULTS: Twelve patients were enrolled, and 10 patients were treated with FLASH-RT. Histologic diagnoses spanned lung, prostate, and kidney cancers. One site was treated per patient in the rib or scapula. All patients completed treatment per protocol. Average time-on-table was 14.6 min. At a median follow-up of 189 days, there were no ≥ grade 2 acute or late adverse events at least possibly related to FLASH-RT. Three-month pain was available in 8 patients; 1-month pain was available in 2 patients. A complete response was observed in 6 patients, a partial response in 3 patients, and stable response in 1 patient. Three patients reported pain flares by day 11 of follow-up.
CONCLUSION: FAST-02, the first prospective clinical study of FLASH adjacent to thoracic critical organs, supported that FLASH-RT can be effective and has an acceptable safety profile in study patients with painful thoracic bony metastases.