Bachelot et al identified prognostic factors for a patient with advanced cancer who is enrolled in a phase I clinical trial. The authors are from Centre Leon Berard in Lyon, France.
NOTE: The second author (Ray-Coquard) is first author on a similar study for predicting early death following conventional chemotherapy.
Patient selection: advanced cancer, ECOG <= 3, in Phase I clinical trial (Phase I trials study new agents and investigate the maximum tolerated dose).
Risk factors for Grade 3 or 4 toxicity:
(1) age > 65 years
(2) higher dose of chemotherapeutic agent
Parameters affecting survival from multivariate analysis:
(1) ECOG performance status at start of trial
(2) serum LDH in IU/L (method and normal reference range not stated but the upper limit of normal may have been 350 U/L)
|
Parameter
|
Finding
|
Points
|
|
ECOG Performance
|
0 or 1
|
0
|
|
|
2 or 3
|
1
|
|
serum LDH
|
<= 600 IU/L
|
0
|
|
|
> 600 IU/L
|
|
number of poor prognostic features =
= SUM(points for the 2 parameters)
Interpretation:
• minimum score: 0
• maximum score: 2
• The higher the score the worse the survival.
|
Total Score
|
6 Month Survival
|
12 Month Survival
|
|
0
|
64%
|
33%
|
|
1
|
34%
|
10%
|
|
2
|
5%
|
0%
|
Additional factors associated with poor survival in univariate analysis:
(1) serum albumin <= 35 g/L
(2) thrombocytosis (platelet count > 450,000 per µL)
(3) absolute neutrophil count > 7 * 10^9/L
(4) age >= 65 years
