Conclusion
In summary, although numerous studies provide a clear rationale for
monitoring drug levels of oral small molecule anticancer drugs, the lack
of trials clearly showing significant improvement in outcomes with TDM
prevents this approach from being embraced by the oncology community.
Well-designed randomized controlled trials comparing drug level
monitoring with the standard of care, which are sufficiently powered to
demonstrate an effect on survival are desperately needed. Numerous
completed and ongoing studies on TDM of oral small molecule anticancer
drugs have prepared the precision oncology field for such a trial. The
time has come to take the next step.