Classification System May Improve Targeted Therapy Selection in Cancer
ESMO has released a consensus on evidence-based criteria and proposed a classification system to prioritize genomic alterations as markers to select cancer patients for targeted therapies.
The European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of molecular Targets (ESCAT) may standardize and improve patient selection for anticancer targeted therapies, according to a report published in the Annals of Oncology.
The ESMO Translational Research and Precision Medicine Working Group (TR and PM WG) initiated a project to create a unified framework for classifying molecular targets for precision cancer medicine, with the goal of assisting clinicians in selecting effective therapeutic courses for patients based on gene sequencing panels.
A group of experts reached a consensus on grading criteria and proposed a classification system based on collected evidence, which was then approved by the ESMO TR and PM WG.
Six levels were established:
Tier I. Ready for routine use Genomic alteration-drug match has been linked with improved outcome in clinical studies. Therapy should be considered the standard of care.
Tier II. Investigational Genomic alteration-drug match is associated with antitumor activity, but requires further study. Therapy should be considered ‘preferable.'
Tier III. Hypothetical Target Genomic alteration-drug match is suspected to improve clinical outcomes based on data from trials of other tumor types with similar alterations. Enrollment in clinical trials may be discussed with patient.
Tier IV. Hypothetical Target Genomic alteration-drug match has preclinical evidence for efficacy. Enrollment in early clinical trials may be discussed with patient, but the lack of clinical evidence should be stressed to patients.
Tier V. Combination Development Genomic alteration-drug match is associated with objective response but not with clinically significant benefit. Enrollment in clinical trials may be discussed with patient.
Tier X Genomic alteration-drug match has no evidence for actionability, and should not inform clinical decisions.
The authors concluded that “this clinical benefit-centered classification system offers a common language for all the actors involved in clinical cancer drug development. Its implementation in sequencing reports, tumor boards, and scientific communication can enable precise treatment decisions and facilitate discussions with patients about novel therapeutic options.”
Mateo J, Chakravarty D, Dienstmann R, et al. A framework to rank genomic alterations as targets for cancer precision medicine: the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) [published online August 21, 2018]. Ann Oncol. doi: 10.1093/annonc/mdy263