BioMed Research International / 2016 / Article / Tab 2

Review Article

Clinically Meaningful Use of Blood Tumor Markers in Oncology

Table 2

Incorporating TMs into clinical trials.
(a) Schematized prospective trial

Baseline TreatmentSurveillanceProgression (PFS)/recurrence (RFS)Death (OS)

ImagingT0T2T3T4T5
TMT0T1T2T3T4T5

(b) Uses of TMs at different clinical endpoints

Clinical endpointPrognostic

Use of clinical dataCorrelate T0 levels with PFS/RFS and/or OS
Potential outcomeTM can be used in future trials as prognostic factor for risk stratification
Example for clinical implicationIn “good risk patients”: consider less intensive treatment, or shorter duration
In “poor risk patients”: consider maintenance after induction chemotherapy

Clinical endpointResponse

Use of clinical dataCorrelate change in T0 to T1 and T2 levels with response per RECIST on imaging at T2
Potential outcomeEarly TM change at T1 predicts progression on first imaging at T2
Early TM change at T2 predicts progression on 2nd imaging at T3 (i.e., in patients with stable disease on 1st imaging at T2)
Example for clinical implicationRandomized trial of continuation of same chemotherapy versus early change to different regimen based on early TM stratification; primary outcome could be ORR, PFS/RFS, or OS

Clinical endpointTreatment monitoring

Use of clinical dataCorrelate change in T0 to T3 levels with best response per RECIST on imaging at T3
Potential outcomeDecline in TM panel correlates with response on imaging
Example for clinical implicationFewer interval scans for patients with declining markers

Clinical endpointDetection of early relapse

Use of clinical dataCorrelate change from nadir of TM at T3 with posttreatment at T4 and T5
Potential outcomeIncrease in levels of TM at T4 compared to T3 will predict progression at T5
Example for clinical implicationTailor surveillance imaging based on TM levels

T0 to T5, various time points for blood draw and/or imaging; PFS, progression-free survival; RFS, recurrence-free survival; OS, overall survival.