Overview of precision oncology trials: challenges and opportunities

ABSTRACT

Introduction: In recent years, the therapeutic management of selected patients with cancer has shifted toward the ‘precision medicine’ approach based on patient’s mechanisms of tumorigenesis, and their baseline characteristics and comorbidities. Complete tumor and cell-free DNA profiling using next-generation sequencing, proteomic and RNA analysis, and immune mechanisms should to be taken into consideration and accurate bioinformatic analysis is essential to optimize patient’s treatment.

Areas covered: The challenges and opportunities of conducting clinical trials in precision oncology are summarized.

Expert commentary: Precision medicine has significantly changed the diagnostic and therapeutic landscape of cancer. Successful implementation of precision medicine requires translational and bioinformatics infrastructure to support optimization of treatment selection. Targeted therapy, immunotherapy, T-cell therapy alone or in combination with cytotoxic or other effective therapeutic strategies and innovative clinical trials with adaptive design should be offered to all patients. Data sharing and ‘N-of-1’ models hold the promise to optimize the treatment of individual patients and expedite drug approval for rare alterations and tumor types. Artificial intelligence will facilitate accurate utilization of sequencing data to perform algorithm analysis. Collaboration of healthcare providers with pharmaceutical and biotechnical companies, scientific organizations, and governmental regulatory agencies have a crucial role in curing cancer.

KEYWORDS:

• ctDNA
• immunotherapy
• molecular
• mutation
• N-of-1
• personalized
• precision
• targeted
• trial

Acknowledgments

Dr. Fountzilas has received a scholarship from the Hellenic Society of Medical Oncology (10/2017-09/2018).

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript was supported byNIH/NCI, award number P30 CA016672.