Abstract
Purpose/ObjectivePublished preclinical and phase I clinical trial data suggest that fractionated lesional radiotherapy with 60 Gy in 10 fractions can serve as an alternative approach to single fraction radiosurgical boost for brain oligometastases. Methods and MaterialsA phase II clinical trial (NCT01543542) of a total of 60 Gy in 10 fractions of lesional (one to three) radiotherapy (given simultaneously with whole-brain helical tomotherapy with 30 Gy in 10 fractions) was conducted at five institutions. We hypothesized that fractionated radiotherapy would be considered unsuitable if the median overall survival (OS) was degraded by two months or if six-month intracranial control (ICC) and intracranial lesion (ILC) were inferior by 10% compared with the published RTOG 9508 results.ResultsA total of 87 patients were enrolled over a 4.5-year accrual period. Radiological lesion and extralesional central nervous system progression were documented in 15/87 (17%) and 11/87 (13%) patients, respectively. Median OS for all patients was 5.4 months. Six-month actuarial estimates of ICC and ILC were 78% and 89%, respectively. However, only the ILC estimate achieved statistical significance (p=0.02), demonstrating non-inferiority to the a priori historical controls (OS: p=0.09, ICC=0.31). Two patients developed suspected asymptomatic radionecrosis.ConclusionsThe phase II estimates of ILC were demonstrated to be non-inferior to the results of the RTOG 9508.
Highlights
The radiotherapeutic treatment of brain metastases has shifted considerably in the last two decades in response to clinical trial evidence [1,2]
Published preclinical and phase I clinical trial data suggest that fractionated lesional radiotherapy with 60 Gy in 10 fractions can serve as an alternative approach to single fraction radiosurgical boost for brain oligometastases
The primary objective of this clinical trial is to assess the median overall survival (OS), intralesional control ([ILC] local control of index lesions treated to 60 Gy on protocol) at six months, and intracranial control (ICC) at six months for a course of fractionated SRT (fSRT) given at a total dose of 60 Gy in 10 fractions for one to three brain metastases
Summary
The radiotherapeutic treatment of brain metastases has shifted considerably in the last two decades in response to clinical trial evidence [1,2]. Treatment of brain metastases was often limited to palliative whole-brain radiotherapy (WBRT); clinical trial investigations of treatment intensification of index brain lesions with surgery and radiosurgery have demonstrated improvements in various clinical endpoints such as overall survival (OS), intracranial cancer control, and steroid dependency. The combination of image-guided procedures and advanced, highly conformal treatment planning paradigms has allowed for the development of non-invasive fractionated alternatives to SRS [16,17]. This fractionated alternative has been reviewed and it suggested that fractionated SRT (fSRT) may be associated with “clinical benefits including overall survival, local control and acceptable toxicity” [18]. There is optimism that fSRT may prove to be beneficial, the clinical benefits have not been firmly established and require further evaluation in wellconducted prospective clinical trials
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