Risk-adapted modulation through de-intensification of cancer treatments: an ESMO classification

Area of Science:

• Oncology
• Precision Medicine
• Clinical Trial Design

Background:

• Clinical trials for risk-adapted cancer treatment modulation lack standardized biomarker categorization.
• Existing approaches use diverse trial designs, endpoints, and non-inferiority thresholds, hindering consensus.

Purpose of the Study:

• To develop a tiered classification system for biomarkers guiding cancer treatment de-intensification.
• To establish a common language and harmonized definitions for stakeholders in precision oncology.

Main Methods:

• An international expert subgroup of the European Society for Medical Oncology (ESMO) Precision Medicine Working Group developed the classification.
• A tiered approach was used, incorporating analysis of the status quo, ongoing trials, and expert revisions.

Main Results:

• Treatment de-intensification is defined by reduced treatment intensity with a positive impact on toxicity, quality of life, or costs.
• The ESMO classification categorizes biomarkers into three tiers (A, B, C) based on the level of evidence from clinical validation.

Conclusions:

• The ESMO classification provides evidence-based criteria for categorizing biomarkers to inform risk-guided cancer treatment de-intensification.
• This system aims to harmonize definitions and facilitate communication among clinicians, patients, and decision-makers in oncology.