Table 2
Incorporating TMs into clinical trials.
| (a) Schematized prospective trial |
| | | Baseline | Treatment | Surveillance | Progression (PFS)/recurrence (RFS) | Death (OS) |
| | Imaging | T0 | | T2 | T3 | T4 | T5 | | | TM | T0 | T1 | T2 | T3 | T4 | T5 | |
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| (b) Uses of TMs at different clinical endpoints |
| | Clinical endpoint | Prognostic |
| | Use of clinical data | Correlate T0 levels with PFS/RFS and/or OS | | Potential outcome | TM can be used in future trials as prognostic factor for risk stratification | | Example for clinical implication | In “good risk patients”: consider less intensive treatment, or shorter duration | | In “poor risk patients”: consider maintenance after induction chemotherapy |
| | Clinical endpoint | Response |
| | Use of clinical data | Correlate change in T0 to T1 and T2 levels with response per RECIST on imaging at T2 | | Potential outcome | Early 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 implication | Randomized 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 endpoint | Treatment monitoring |
| | Use of clinical data | Correlate change in T0 to T3 levels with best response per RECIST on imaging at T3 | | Potential outcome | Decline in TM panel correlates with response on imaging | | Example for clinical implication | Fewer interval scans for patients with declining markers |
| | Clinical endpoint | Detection of early relapse |
| | Use of clinical data | Correlate change from nadir of TM at T3 with posttreatment at T4 and T5 | | Potential outcome | Increase in levels of TM at T4 compared to T3 will predict progression at T5 | | Example for clinical implication | Tailor surveillance imaging based on TM levels |
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T0 to T5, various time points for blood draw and/or imaging; PFS, progression-free survival; RFS, recurrence-free survival; OS, overall survival.
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