Phase III randomised trialA phase III study of accelerated versus conventional hypofractionated whole brain irradiation in patients of good performance status with brain metastases not suitable for surgical excision
Section snippets
Patients and methods
The main purpose of this trial was to determine whether a course of accelerated WBI resulted in an increased overall survival time for patients. A secondary endpoint was to determine the duration of the control of the growth of intracranial metastases by measuring the time from initial treatment to the time salvage therapy was delivered for intracranial tumour progression. The acute side effects of treatment were studied by applying the WHO epilation score. This scale was selected in order to
Results
Ninety patients were entered into this study between 2nd October 1996 and 5th November 2003; 76 at Centre A and 14 at Centre B. There were 45 patients in each arm. There were 4 protocol violations comprising 1 patient who was ineligible (ECOG 3) and 1 patient who withdrew from the study before treatment. In addition, radiotherapy was discontinued in 2 patients: 1 in the control arm and 1 in the investigational arm. All 90 randomized patients are included in the results for overall survival. The
Conclusions
This is a randomized study that failed to demonstrate an overall survival advantage for accelerated WBI over conventional hypofractionated treatment. The dataset did validate RTOG RPA classes of features prognostic for survival as well as the adverse survival outcome in patients with colorectal cancer. Retrospective subset analysis did raise the possibility that accelerated WBI improves local control using time to retreatment as a surrogate endpoint. (It would seem unlikely that patients in the
Acknowledgements
The original statistician for this study was Dr. Gerrit DeBoer who passed away in 2005. The authors are grateful to the following physicians who entered patients on this study: Dr. E. Chow (1), Dr. C. Danjoux (3), Dr. M. Doherty (6), Dr. C. Hayter (3), Dr. J. Kamra (3), and Dr. M. Tsao (2). Funding for this study was provided by the CNS Site Group at the Odette Cancer Centre.
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Radiation Therapy for Brain Metastases: A Systematic Review
2021, Practical Radiation OncologyCitation Excerpt :Deaths due to brain metastases showed no difference across studies (RR, 1.02; 95% CI, 0.13%-8.24%; 2 RCTs). Seven RCTs compared different doses in head-to-head trials.14-20 Metaregressions across studies did not detect systematic dose-repose effects for the analyzable outcomes overall survival (P = .97), disease-free survival (P = .65), or deaths due to brain metastases (P = .09).
Brain metastases in non-small-cell lung cancer
2014, Clinical Lung CancerCitation Excerpt :Changes in radiation technology and dosing have occurred, enhancing the challenges of interpreting historical data. At least 9 RCTs have addressed different dosing schedules for WBRT since 1980.52-60 Two specifically addressed the treatment of brain metastases in patients with lung cancer.53,54
Radiotherapy plus concomitant systemic therapies for patients with brain metastases from breast cancer
2014, Cancer/RadiotherapieRadiotherapeutic and surgical management for newly diagnosed brain metastasis(es): An American Society for Radiation Oncology evidence-based guideline
2012, Practical Radiation OncologyCitation Excerpt :This interpretation is consistent with the AANS guideline on whole brain radiotherapy.4 Numerous trials have examined various dose fractionation schedules of WBRT.60-69 No altered dose fractionation scheme has shown improvement in either survival or symptom control (neurologic functional status, neurologic symptom relief, palliative index, or performance status) as compared with 20 Gy in 5 fractions or 30 Gy in 10 fractions of daily WBRT.