Molecular profiling of tumours for precision oncology - high hopes versus reality

Area of Science:

• Oncology
• Genomics
• Clinical Trials

Background:

• Molecular profiling is promoted for guiding cancer therapy.
• Clinical evidence supporting molecular profiling in treatment is scarce.
• Existing data, including the SHIVA trial, show limited success.

Purpose of the Study:

• To review the current clinical data supporting molecular profiling in cancer treatment.
• To identify challenges hindering the clinical implementation of tumor profiling.
• To discuss the implications for patient benefit.

Main Methods:

• Review of published literature and presented data.
• Analysis of the SHIVA randomized clinical trial results.
• Discussion of unpublished series and expert opinions.

Main Results:

• The SHIVA trial, a randomized study, failed to meet its primary endpoint of progression-free survival (PFS).
• Limited clinical data exist to support the efficacy of molecular profiling-guided treatment.
• Several issues, including tumor heterogeneity and therapy access, remain unresolved.

Conclusions:

• Tumor profiling requires further validation before widespread clinical adoption.
• Addressing challenges like tumor heterogeneity and targeted therapy access is crucial.
• Significant patient benefit from molecular profiling is not yet established.