Table 1 Characteristics of studies included in review
From: Optimal biological dose: a systematic review in cancer phase I clinical trials
| Â | Article with OBD | Article without OBD | Total | |||
|---|---|---|---|---|---|---|
NÂ =Â 22 | % | NÂ =Â 15 | % | NÂ =Â 37 | % | |
Trial | ||||||
 Phase I | 16 | 72.7 | 13 | 86.7 | 29 | 78.4 |
 Phase I/II | 6 | 27.3 | 2 | 13.3 | 8 | 21.6 |
Location | ||||||
 Hematologic cancer | 2 | 9.1 | 2 | 13.3 | 4 | 10.8 |
 Solid tumor | 17 | 77.3 | 11 | 73.3 | 28 | 75.7 |
 Melanoma | 3 | 13.6 | 0 |  | 3 | 8.1 |
 Solid tumor + Melanoma | 0 |  | 1 | 6.7 | 1 | 2.7 |
 Solid tumor + Hematologic cancer | 0 |  | 1 | 6.7 | 1 | 2.7 |
Therapeutic schedule | ||||||
 Molecule | 11 | 50.0 | 12 | 80.0 | 23 | 62.2 |
 Association of molecules | 11 | 50.0 | 3 | 20.0 | 14 | 37.8 |
Principal objective | ||||||
 MTD | 7 | 31.8 | 15 | 100 | 22 | 59.5 |
 OBD | 11 | 50.0 | 0 |  | 11 | 29.7 |
 OBD/MTD | 4 | 18.2 | 0 |  | 4 | 10.8 |
Primary endpoint | ||||||
 DLT | 7 | 31.8 | 15 | 100 | 22 | 59.5 |
 DLT + (PK + clinical response) | 1 | 4.5 | 0 |  | 1 | 2.7 |
 DLT + biological target | 8 | 36.4 | 0 |  | 8 | 21.6 |
 DLT + clinical response | 3 | 13.6 | 0 |  | 3 | 8.1 |
 Biological target | 2 | 9.1 | 0 |  | 2 | 5.4 |
 Toxicity + biological target | 1 | 4.5 | 0 |  | 1 | 2.7 |
Observation period | ||||||
 Not defined | 5 | 25.0 | 2 | 13.3 | 7 | 20.0 |
 First cycle | 11 | 55.0 | 13 | 86.7 | 24 | 68.6 |
 Other | 4 | 20.0 | 0 |  | 4 | 11.4 |
 Missing | 2 |  | 0 |  | 2 |  |
Dose-escalation method | ||||||
 3 + 3 | 6 | 27.3 | 7 | 46.7 | 13 | 35.1 |
 Modified fibonacci | 2 | 9.1 | 3 | 20.0 | 5 | 13.5 |
 CRM | 2 | 9.1 | 0 |  | 2 | 5.4 |
 Consecutive / Sequential cohorts | 9 | 40.9 | 3 | 20.0 | 12 | 32.4 |
 Other | 3 | 13.6 | 2 | 13.3 | 5 | 13.5 |
DRP2 | ||||||
 No | 16 | 72.7 | 10 | 66.7 | 26 | 70.3 |
 Yes | 6 | 27.3 | 5 | 33.3 | 11 | 29.7 |
Secondary objective | ||||||
 OBD | 7 | 31.8 | 0 |  | 7 | 18.9 |
 Other | 15 | 68.2 | 15 | 100 | 30 | 81.1 |
Secondary endpoint associated with OBD | ||||||
 DLT + biological target | 1 | 14.3 | 0 |  | 1 | 14.3 |
 DLT + clinical response | 4 | 57.1 | 0 |  | 4 | 57.1 |
 Toxicity + biological target | 2 | 28.6 | 0 |  | 2 | 28.6 |
Secondary endpoint: PK/PD | ||||||
 No | 10 | 45.5 | 3 | 20.0 | 13 | 35.1 |
 PK | 4 | 18.2 | 5 | 33.3 | 9 | 24.3 |
 PD | 0 |  | 1 | 6.7 | 1 | 2.7 |
 PK/PD | 8 | 36.4 | 6 | 40.0 | 14 | 37.8 |
Secondary endpoint: Clinical response | ||||||
 No | 6 | 27.3 | 1 | 6.7 | 7 | 18.9 |
 Yes | 16 | 72.7 | 14 | 93.3 | 30 | 81.1 |
Secondary endpoint: Immune response | ||||||
 No | 18 | 81.8 | 13 | 86.7 | 31 | 83.8 |
 Yes | 4 | 18.2 | 2 | 13.3 | 6 | 16.2 |
Secondary endpoint: Survival outcome | ||||||
 No | 13 | 59.1 | 10 | 66.7 | 23 | 62.2 |
 Yes | 9 | 40.9 | 5 | 33.3 | 14 | 37.8 |