Abstract
IntroductionThe spine represents the site which is most frequently affected by bone metastases in patients with systemic cancer. Of all local treatment options, combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provides both, instantaneous stabilization and immediate pain relief. We here report on the long-term outcomes of the largest cohort treated with Kypho-IORT to date.MethodsBetween 2009 and 2019 a total of 104 patients underwent Kypho-IORT to vertebral tumors in the thoracic, lumbar, or sacral spine with transpedicular kyphoplasty and intraoperative irradiation with a needle-shaped electronic brachytherapy source at our center. Patients were treated either on trial, within the prospective Kypho-IORT studies (NCT01280032 and NCT02773966), or, after completion of the study, off trial but compliant with the study protocol. Follow-up and imaging with computed tomography (CT) or magnetic resonance imaging was scheduled after 3 and 6 months and then bi-annually.ResultsA total of 143 vertebrae (89 thoracic spine, 53 lumbar spine, and 1 sacral spine) were treated in 104 patients. The median follow-up was 14.5 months (range 0.4–109). Local progression occurred in 10 patients (10 vertebrae) after a median time of 22.3 months (range 1.5–73) resulting in local control rates of 97.1, 95.9, and 94.2% at 6, 12, and 24 months, respectively. Overall survival was 74.6, 61.7, and 50.3% at 6, 12, and 24 months, respectively. A single serious adverse event was reported.ConclusionIn addition to immediate pain reduction and stabilization, Kypho-IORT shows excellent long-term local control with minimal side effects.
Highlights
The spine represents the site which is most frequently affected by bone metastases in patients with systemic cancer
In a recent dose escalation and cohort expansion phase I/II trial with a total of 61 patients we showed a significant median pain reduction at the first postoperative day and a subsequent sustained pain reduction
All vertebral bodies were intraoperatively irradiated with 8 Gy, which were prescribed to a distance from the isocenter of 8, 11, or 13 mm in 48, 20, and 75 vertebrae, accounting for 33.6, 14.0, and 52.4% of the vertebrae treated, respectively
Summary
The spine represents the site which is most frequently affected by bone metastases in patients with systemic cancer. Of all local treatment options, combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provides both, instantaneous stabilization and immediate pain relief. Treatment should focus on palliation of pain, stabilization and local tumor control with therapeutic options including radiation therapy, surgical intervention or radiofrequency ablation [3,4,5]. Kypho-IORT consists of cement augmentation kyphoplasty and intraoperative irradiation as a “one-stop-shop” intervention for the treatment of tumors in vertebral bodies of the thoracic, lumbar, and sacral spine. The 3-, 6-, and 12-month local progression free survival (L-PFS without considering death as an endpoint) was 97.5, 93.8, and 93.8% [9] To further investigate this combined approach, a multicentric randomized phase III trial (NCT02773966) was designed to test Kypho-IORT against external beam radiotherapy (EBRT) as standard-of-care for painful vertebral metastases [10]. We here report our long-term experience of 10 years with patients treated at our institution as the largest single-center cohort analysis to date
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