Table 1.

Characteristics of studies included in review

	Article with OBD		Article without OBD		Total
	N = 22	%	N = 15	%	N = 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