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

BMC Research Notes

John F Thompson¹  Catherine Mandel⁶  Richard A Scolyer¹  George Hruby¹  Anna Nowak^1,11  Janette Vardy²  Kate Drummond⁸  Brindha Shivalingam¹  Victoria Steel⁴  Haryana Dhillon²  Lauren H Haydu⁵  Bryan Burmeister^1,10  Claudius H Reisse⁹  Kari Dolven-Jacobsen⁹  Angela Hong⁷  Gerald B Fogarty³ 

[1]Royal Prince Alfred Hospital, Sydney, Australia

[2]Centre for Medical Psychology & Evidence-based Decision-making, Sydney Medical School, The University of Sydney, Camperdown, NSW, Australia

[3]Trans-Tasman Radiation Oncology Group (TROG), Newcastle, Australia

[4]Australia and New Zealand Melanoma Trials Group (ANZMTG), North Sydney, Australia

[5]Melanoma Institute Australia, Sydney, Australia

[6]Peter MacCallum Cancer Centre East Melbourne & University of Melbourne, Parkville, Australia

[7]Sydney Medical School, |The University of Sydney, Sydney, Australia

[8]The Royal Melbourne Hospital & University of Melbourne, Parkville, Australia

[9]Oslo University Hospital HF, The Norwegian Radium Hospital, Oslo, Norway

[10]Princess Alexandra Hospital, Brisbane, Australia

[11]Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia

关键词: Randomised trial;    Whole brain radiotherapy;    Brain;    Melanoma;    Metastases;    Radiotherapy;   

Others  :  1232463
DOI  :  10.1186/s13104-015-1153-5

 received in 2014-11-27, accepted in 2015-04-27,  发布年份 2015

【 摘 要 】

Background

Brain 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^th patient. The analysis was an opportunity to review completeness of the trial data to date.

Methods

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

Results

Review 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.

Conclusions

The 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^th November 2014).

【 授权许可】

   
2015 Fogarty et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

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