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Title
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Stereotactic ablative radiation therapy to all lesions in patients with oligometastatic cancers : a phase 1 dose-escalation trial
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Author
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Abstract
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| Purpose: Increasing evidence suggests that patients with a limited number of metastases benefit from SABR to all lesions. However, the optimal dose and fractionation remain unknown. This is particularly true for bone and lymph node metastases. Therefore, a prospective, single-center, dose-escalation trial was initiated. Methods: Dose-Escalation trial of STereotactic ablative body RadiOtherapY for non-spine bone and lymph node metastases (DESTROY) was an open-label phase 1 trial evaluating SABR to nonspine bone and lymph node lesions in patients with up to 3 metastases. Patients with European Cooperative Oncology Group performance status <= 1, an estimated life expectancy of at least 6 months, and histologically confirmed nonhematological malignancy were eligible. Three SABR fractionation regimens, ie, 5 fractions of 7.0 Gy versus 3 fractions of 10.0 Gy versus a single fraction of 20.0 Gy, were applied in 3 consecutive patient cohorts. The rate of >= grade 3 toxicity, scored according to the Common Toxicity Criteria for Adverse Events v. 4.03, up to 6 months after SABR, was the primary endpoint. The trial was registered on clinicaltrials.gov (NCT03486431). Results: Between July 2017 and December 2018, 90 patients were enrolled. In total 101 metastases were treated. No >= grade 3 toxicity was observed in any of the enrolled patients (95% CI 0.0%- 12.3% for the first cohort with 28 analyzable patients; 95% CI 0.0%-11.6% for the second and third cohort with 30 analyzable patients each). Treatment-related grade 2 toxicities occurred in 4 out of 30 versus 2 out of 30 versus 2 out of 30 patients for the 5, 3 and 1 fraction schedule, respectively. Actuarial local control rate at 12 months was 94.5%. Conclusion: All 3 treatment schedules were feasible and effective with remarkably low toxicity rates and high local control rates. From a patient and resource point of view, the single-fraction schedule is undoubtedly most convenient. (C) 2020 The Authors. Published by Elsevier Inc. |
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Language
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English
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Source (journal)
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International journal of radiation oncology, biology, physics. - Bedford
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Publication
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Bedford
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2021
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ISSN
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0360-3016
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DOI
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10.1016/J.IJROBP.2020.11.066
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Volume/pages
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109
:5
(2021)
, p. 1195-1205
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ISI
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000631998800011
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Pubmed ID
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33307151
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Full text (Publisher's DOI)
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Full text (open access)
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