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Clinical Trials |
Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris [P. d. L. S., Cl. C.]; Service de Dermatologie, Hôpital Sainte Marguerite, Marseille [J-J. G.]; Service de Dermatologie, Hôpital Hôtel-Dieu, Nantes [B. D.]; and Service de Dermatologie, Hôpital Pellegrin, Bordeaux [M. D.], France.
IFNhas recently been recognized as an adjuvant therapy to surgery in
melanoma patients. A major issue is to select patients who will benefit
from this therapy and to avoid toxicity in those who will not respond.
The aim of this exploratory analysis was to identify the predictive
factors of response to
IFN.
The French cooperative group has recently shown that adjuvant therapy
of melanoma patients with low-dose
IFN provides a benefit on
disease-free interval (DFI). Using this database, predictors of DFI
were investigated using Cox models and treatment-covariate interactions
were sought.
Gender, age, Breslow thickness, and baseline WBC count, given an
IFN-WBC interaction, were independent predictors of DFI. Baseline
WBC count was the only variable for which there was an interaction with
IFN, whatever the Breslow: patients with low WBC count (<6.8 x 109/liter = median) did not benefit from
IFN
(HR=1.27(95%CI: 0.841.91); P = 0.26) whereas the
DFI of patients with high WBC was prolonged (P =
0.0001) with a hazard ratio of 0.50 (95% confidence interval,
0.350.71). The estimated values of WBC count for which IFN was
significantly superior to no-treatment were those
7.2 x
109/liter. The baseline WBC count was correlated to
baseline neutrophils but not to Breslow thickness or to time since last
melanoma surgery.
IFN prolonged DFI in patients with a high WBC count but not in those
with a low WBC count. The results of this exploratory analysis, if
confirmed by other studies, may help to identify patients who are most
likely to benefit from
IFN.
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