First interim analysis of a randomised trial of whole brain radiotherapy in melanoma brain metastases confirms high data qualityReportar como inadecuado




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BMC Research Notes

, 8:192

First Online: 08 May 2015Received: 27 November 2014Accepted: 27 April 2015DOI: 10.1186-s13104-015-1153-5

Cite this article as: Fogarty, G.B., Hong, A., Dolven-Jacobsen, K. et al. BMC Res Notes 2015 8: 192. doi:10.1186-s13104-015-1153-5

Abstract

BackgroundBrain metastases are a common cause of death in patients with melanoma. The role of adjuvant whole brain radiotherapy WBRT following local treatment of intracranial melanoma metastases is controversial. The Australian and New Zealand Melanoma Trials Group ANZMTG and the Trans-Tasman Radiation Oncology Group TROG are leading the first ever single histology randomised trial investigating this question. The primary endpoint is distant intracranial failure on magnetic resonance imaging MRI within twelve months of randomisation. The first planned interim analysis was performed twelve months after randomisation of the 100 patient. The analysis was an opportunity to review completeness of the trial data to date.

MethodsAll data received up to the end of twelve months after randomisation of the 100th patient was reviewed.

ResultsReview of pathology reports confirmed that all 100 patients had stage IV melanoma and were appropriately entered into the study. Of the 47 distant intracranial events, 34 occurred in isolation i.e. only distant failure was identified, whilst 13 were accompanied by local failure. Data review showed compliance with the protocol mandated MRI schedule and accuracy of intracranial failure reporting was very high. The Quality of Life QoL component of the study achieved a 91% completion rate. For the neurocognitive function NCF assessments, a high completion rate was maintained throughout the 12 month period. Where assessments were not performed at expected time points, valid reasons were noted. Radiotherapy quality was high. Of 50 patients who received WBRT, 32 were reviewed as per protocol design and there was only one major variation out of 308 data points reviewed 0.3%. There were minimal trial related adverse events AEs and no serious adverse events SAEs. Pre-specified protocol stopping rules were not met.

ConclusionsThe Data Safety Monitoring Committee DSMC recommended the trial continue recruitment after reviewing the unblinded data. The data provision and quality to date indicates that a reliable outcome will be obtained when the final analysis is performed. Accrual is ongoing with 156 out of 200 patients randomised to date 26 November 2014.

KeywordsRadiotherapy Metastases Melanoma Brain Whole brain radiotherapy Randomised trial AbbreviationsAEsAdverse events

ANZMTGAustralia and New Zealand Melanoma Trials Group

BMsBrain metastases

CRFsCase report forms

CTComputed tomography

DSMCData Safety Monitoring Committee

ECOGEastern Cooperative Oncology Group

EORTCQLQ BN20 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire brain cancer specific

EORTCQLQ C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire cancer specific

HRHazard ratio

ICHGCPInternational Congress of Harmonization and Good Clinical Practice

MRIMagnetic resonance imaging

NCFNeurocognitive function

OBSObservation

QAQuality assurance

QoLQuality of life

RCTRandomised controlled trial

RTRadiotherapy

SAEsSerious adverse events

SRSStereotactic irradiation

TMC TrialManagement Committee

TROGTrans-Tasman Radiation Oncology Group

TxTreatment

WBRTWhole brain radiotherapy

WBRTMel Wholebrain radiotherapy in melanoma – acronym of this trial

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Autor: Gerald B Fogarty - Angela Hong - Kari Dolven-Jacobsen - Claudius H Reisse - Bryan Burmeister - Lauren H Haydu - Haryana 

Fuente: https://link.springer.com/







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