Prognostic Models Phase 1 Clinical Trial | Medical Algorithm

Description

Olmos et al reported 2 models for selecting patients for Phase I trials of cancer therapy. The authors are from the European Drug Development Network (EDDN).

Selection criteria: ECOG 0 to 2 for model A, ECOG 0 or 1 for model B

Parameters:

(1) ECOG performance status

(2) serum albumin in g/dL

(3) serum LDH in IU/L relative to upper limit of normal (ULN)

(4) number of metastatic sites

(5) number of weeks per treatment (time per treatment index)

(6) serum alkaline phosphatase in IU/L relative to ULN

(7) percent lymphocytes in the peripheral blood differential

(8) white blood cell count per µL

Model A

Parameter	Finding	Points
ECOG	ECOG 0	0
	ECOG 1	1
	ECOG 2	3
serum albumin	< 3.5 g/dL	1
	>= 3.5 g/dL	0
serum LDH	normal (<= ULN)	0
	elevated (> ULN)	1
number of metastatic sites	0 to 2	0
	>= 3	1
number of weeks per treatment	< 24 weeks per treatment	1
	>= 24 weeks per treatment	0
serum alkaline phosphatase	normal (<= ULN)	0
	elevated (> ULN)	1

total score =

= SUM(points for all 6 parameters)

Model B

Parameter	Finding	Points
serum albumin	< 3.5 g/dL	1
	>= 3.5 g/dL	0
serum LDH	normal (<= ULN)	0
	elevated (> ULN)	1
number of metastatic sites	0 to 2	0
	>= 3	1
number of weeks per treatment	< 24 weeks per treatment	1
	>= 24 weeks per treatment	0
serum alkaline phosphatase	normal (<= ULN)	0
	elevated (> ULN)	1
percent lymphocytes	>= 18%	0
	< 18%	1
white blood cell count	<= 10,500 per µL	0
	> 10,500 per µL	1

total score =

= SUM(points for all 7 parameters)

Interpretation:

• minimum scores: 0

• maximum score for model A: 8

• maximum score for model B: 7

• The higher the score the worse the prognosis.

Total Score	Median Survival Model A	Median Survival Model B
0	141 weeks	141 weeks
1	76 weeks	61 weeks
2	53 weeks	54 weeks
3	39 weeks	37 weeks
4	27 weeks	29 weeks
5	15 weeks	21 weeks
6	11 weeks	11 weeks
7	NA	10 weeks

To read more or access our algorithms and calculators, please log in or register.

Description

Specialty

Objective

ICD-10

Prognostic Models for Phase I Clinical Trials

Purpose: To evaluate a cancer patient for participation in a Phase I clinical trial using the models of Olmos et al (EDDN models).

Description

Specialty

Objective

ICD-10