Nomogram of Pond et al for Predicting a Serious Adverse Event During Cycle One of a Phase II Clinical Trial for a Molecularly Targeted Agent

 

Patient selection: age 25 to 85 years, ECOG score <= 2, Charlson score <= 6, number of target lesions <=10, ratio LDH to ULN from 0.2 to 20

 

Parameters:

(1) ratio of serum albumin to upper limit of normal (ULN)

(2) ratio of serum LDH to upper limit of normal (ULN)

(3) number of target lesions

(4) prior radiation therapy

(5) Charlson score

(6) age in years

(7) ECOG performance status

 

points for albumin ratio =

= 152.5 - (118.3 * (ratio of albumin to ULN))

 

NOTE: The paper uses the ratio of the upper limit of normal (ULN) but the ratio to the LLN may be intended. Hypoalbuminemia is a recognized risk factor. As written a patient could get high points for an albumin within the normal reference range.

 

points for LDH to ULN ratio for ratio 0.2 to 2.5 =

= (-6.145 * ((ratios)^2)) + (39.07 * (ratio)) - 5.186

 

points for LDH to ULN ratio for ratio 2.5 to 20 =

= (1.738 * (ratio)) + 51.91

 

points for target lesions =

= (3.1111 * (number of lesions)) - 3.111

 

points for Charlson score =

= (9.5 * (Charlson score))

 

points for age =

= (-0.5666 * (age)) + 48.1667

Parameter	Finding	Points
ECOG performance status	0	0
	1	37
	2	74
prior radiation therapy	no	14
	yes	0

total score =

= SUM(points for all 7 parameters)

 

Interpretation:

• minimum score: 0

• maximum score: 292

• The higher the score the greater the likelihood of a serious adverse event.

 

Score	Odds Ratio
< 80	< 0.33
80 to 142	(0.000109 * ((points)^2)) - (0.01378 * (points)) + 0.7324
142 to 245	(0.000478 * ((points)^2)) - (0.01372 * (points)) + 10.91
> 245	> 6