Article |
expression at diagnosis characterize a high-risk subgroup of acute promyelocytic leukemia patients.
1 Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain
2 Unidad de Genómica, Servicio de Investigación, Hospital Universitario de Salamanca, Salamanca, Spain
3 Centro de Investigación del Cáncer-IBMCC (USAL-CSIC), Salamanca, Spain
4 Complejo Hospitalario de León and Ibiomed, Universidad de León, León, Spain
5 Hospital Central de Asturias, Oviedo, Spain
6 Hospital Clínico San Carlos, Madrid, Spain
7 Hospital Clínico de Valladolid, Valladolid, Spain
8 Hospital Río Hortega, Valladolid, Spain
9 Hospital General de Segovia, Segovia, Spain
10 Hospital Miguel Servet, Zaragoza, Spain
CORRESPONDENCE: María del Carmen Chillón Santos, PhD, Department of Hematology, University Hospital of Salamanca, Paseo San Vicente 58-182, Salamanca, 37007, Spain. Phone +34-923291384. Fax +34-923294624. E-mail: chillon{at}usal.es
ABSTRACT
Background: Internal tandem duplications of the FLT3 gene (FLT3-ITDs) are frequent in patients with acute promyelocytic leukemia (APL), however its clinical impact remains controversial.
Design and Methods: We analyzed the prognostic significance of FLT3-ITD mutant level and size, as well as FLT3-D835 point mutations, PML-RAR
expression and other predictive factors in 129 APL patients at diagnosis enrolled on the Spanish LPA96 (n=43) or LPA99 (n=86) PETHEMA trials.
Results: FLT3-ITDs and D835 mutations were detected in 21% and 9% of patients, respectively. Patients with increased ITD mutant/wild type ratio or longer ITD size displayed shorter 5-year relapse-free survival (RFS) (p=0.048 and p<0.0001, respectively). However, patients with D835 mutations did not show differences in RFS or overall survival (OS). Moreover, patients with initial normalized copy number (NCN) of PML-RAR
transcripts less than the 25th percentile had adverse clinical features and shorter 5-year RFS (p<0.0001) and OS (p=0.004) compared to patients with higher NCN. Patients with low NCN showed increased incidence of ITDs (p=0.001), with higher ratios (p<0.0001) and/or longer sizes (p=0.007). Multivariate analysis showed that long FLT3-ITD (p=0.001), low PML-RAR
levels (p=0.004) and elevated WBC counts (>10 x 109/L) (p=0.018) were independent predictors for shorter RFS. We identified a subgroup of patients with high WBC, long FLT3-ITD and low NCN of transcripts that showed an extremely bad prognosis (5-year RFS 23.4%, p<0.0001).
Conclusions: In conclusion, FLT3-ITD size and PML-RAR
transcripts levels at diagnosis could contribute to improve the risk stratification in APL.
Key words: acute promyelocytic leukemia, FLT3- ITD size, PML-RAR
level, prognosis.