The role of the molecular tumor board: learnings from the ROME trial

Area of Science:

• Oncology
• Genomics
• Translational Medicine

Background:

• Precision oncology personalizes cancer treatment using tumor molecular data.
• Interpreting complex genomic and multi-omic data presents clinical challenges.
• Molecular Tumor Boards (MTBs) integrate expertise for genomic data interpretation.

Purpose of the Study:

• To compare personalized therapy guided by genomic profiling and MTB review versus standard-of-care (SoC) in advanced solid tumors.
• To evaluate the role of MTBs in selecting patients for precision oncology trials.
• To assess the impact of MTB review on optimizing therapy use.

Main Methods:

• Phase II ROME trial design comparing personalized therapy with SoC.
• Genomic profiling and MTB review for treatment guidance.
• Randomization of 400 patients with advanced solid tumors after MTB discussion of 897 patients.

Main Results:

• Key randomization drivers included high tumor mutational burden (TMB), microsatellite instability (MSI), or actionable alterations, particularly in the PIK3CA/AKT/PTEN pathway.
• Exclusion criteria were primarily lack of actionable alterations or unavailability of trial drugs.
• MTB discussions facilitated the interpretation of complex molecular data for patient selection.

Conclusions:

• MTBs play a substantial role in interpreting complex molecular data and advancing precision oncology.
• Standardization and implementation of MTBs are crucial for improving patient outcomes in precision oncology.
• The ROME trial demonstrates the effectiveness of MTBs in refining patient selection and optimizing therapy in advanced solid tumors.