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Is Your Patient Eligible for Clinical Trials?

Dr. Paul Sperduto, Director of Minneapolis Radiation Oncology has published new research in the Journal of Clinical Oncology that is transforming the way we think about eligibility for clinical trials. Are your patients eligible?

Visit www.brainmetgpa.com to utilize a free, user-friendly tool to find out.

Abstract: 

Survival in Patients with Brain Metastases: Summary Report on the Updated Diagnosis-Specific Graded Prognostic Assessment (GPA) and Definition of the Eligibility Quotient

Sperduto PW, Mesko S, Li J, et al. Survival in Patients with Brain Metastases: Summary Report on the Updated Diagnosis-Specific Graded Prognostic Assessment and Definition of the Eligibility Quotient.  Journal of Clinical Oncology 2020:38;3773-3784. DOI: https://doi.org/10.1200/JCO.20.01255

Background: 

Conventional wisdom has rendered patients with brain metastases ineligible for clinical trials for fear that poor survival could mask benefit of otherwise promising treatments. Our group previously published the diagnosis-specific Graded Prognostic Assessment (GPA). Updates with larger contemporary cohorts using molecular markers and newly identified prognostic factors have been published. Our purposes are to present all the updated indices in a single report to guide treatment choice, stratify research and to define an Eligibility Quotient (EQ) to expand eligibility.

Methods:

A multi-institutional database of 6984 patients with newly diagnosed brain metastases underwent multivariable analyses of prognostic factors and treatments associated with survival for each primary site.  Significant factors were used to define the updated GPA.  A GPA of 4.0/0.0 correlate with the best/worst prognosis.

Results: 

Significant prognostic factors varied by diagnosis and new prognostic factors were identified.  Those factors were incorporated into the updated GPA with robust separation (p<0.01) between sub-groups. Survival has improved but varies widely by GPA for non-small cell lung, breast, melanoma, gastrointestinal and renal cancer patients with brain metastases from 7-47, 3-36, 5-34, 3-17, 4-35 months, respectively.

Conclusion:

Median survival varies widely and our ability to estimate survival for patients with brain metastases has improved. The updated GPA (available free at brainmetgpa.com) provides an accurate tool to estimate survival, individualize treatment and stratify clinical trials.  Instead of excluding patients with brain metastases, enrollment should be encouraged and those trials should be stratified by the GPA to ensure those trials make appropriate comparisons. Furthermore, we recommend expansion of eligibility to allow enrollment of patients with previously treated brain metastases who have a >50% probability of an additional year of survival (EQ>0.50).