Long term results of a phase I dose escalation trial of ablative stereotactic body radiation therapy - International Journal of Radiation Oncology, Biology, Physics

Long term results of a phase I dose escalation trial of ablative stereotactic body radiation therapy - International Journal of Radiation Oncology, Biology, Physics

redjournal.org

Abstract

Stereotactic body radiation therapy (SBRT) is increasingly used for oligometastatic disease as well as palliation, but treatment protocols for non-spine bone and nodal metastases are lacking, with a wide variety of schedules applied. Therefore, a prospective dose-escalation trial was initiated, involving 90 patients, among whom 52 (58%) had primary prostate tumors, 13 had breast tumors (14%), and 25 (28%) had other primary tumor types. 

All visible lymph node and/or non-spine bone oligometastases were treated in three consecutive cohorts: 5×7.0 Gy, 3×10.0 Gy, or 1×20.0 Gy. Initial results revealed no dose-limiting toxicity after a median follow-up of 17.2 months. This update provides information on long-term toxicity, local failure (LF), and progression-free survival (PFS). After a median follow-up of 50 months, no new safety signals were observed. Grade 2 toxicity was 13%, 7% and 10% in the respective cohorts (p=0.9), without grade 3-5 toxicities. LF rates were 9%, 3%, and 6% (P=.5) for the respective treatment groups, with an overall cumulative risk of LF of 7% (95% CI 2-12) at 4 years. 

Median PFS was 16.5 months (95% CI 9.8-21.5), and 4-year PFS was 21% (95% CI 14-32). Median overall survival across groups was not reached (95% CI 52.8 – not reached), 4-year OS was 68% (95% CI 59-78). A subset of patients (23%) remained long-term disease-free, 37% had oligoprogressive disease at first recurrence and 40% developed polymetastatic relapse. 

In conclusion, the safe and effective use of dose-escalated single-fraction SBRT for bone and lymph node metastases is supported by this trial, especially considering patient-convenience and cost-effectiveness. Caution is needed when generalizing these outcomes beyond breast and prostate cancer, given their underrepresentation in our study.

 

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