[Preliminary results of a multicenter randomized study on the treatment of acute promyelocytic leukemias].
OBJECTIVE
To study efficacy of maintenance therapy of patients with acute promyelocytic leukemia (APL) in the APL treatment Russian multicenter trial.


METHODS
The trial was made with participation of 18 hematological departments of clinics in Russia. A total of 68 APL patients entered the trial. The maintenance therapy consisted of 5-day courses of cytostatic drugs which alternated or did not alternate with 5-day courses of ATRA. Cytogenetic tests were made in 31 patients, t(15;17) was detected in 26 of them. Molecular examination conducted in 28 patients discovered chimeric transcript PML/RARa in 26 of them. Of 20 patients examined in Hematological Research Center, 7 (35%) had a bcr 1/2 variant of the transcript PML/RARa, 13 (65%)--bcr 3 variant.


RESULTS
65 patients were eligible for assessment. A complete remission was achieved in 90% cases. No resistance was observed. In follow-up within 30 months the recurrence rate was similar on both treatments. The results of the induction therapy and survival in patients with different variants of the transcripts were also similar. Overall 2.5 year survival for all the patients was 77%, recurrence-free--80%. The survival analysis in patients with leukocytosis higher and lower 10 x 10(9)/l found no statistical differences by the survival. Patients with hyperleukocytosis had higher early lethality than patients with leukocytes under 10 x 10(9)/l (25% vs 5.3%, p = 0.03).


CONCLUSIONS
The APL 06.01 protocol showed high efficacy of the relevant maintenance which provides a complete molecular remission in the majority of patients with probable recurrence-free 2.5 year survival 80%.
Parovichnikova
E N
EN
Savchenko
V G
VG
Demidova
I A
IA
Isaev
V G
VG
Shuravina
E N
EN
Ustinova
E N
EN
Gribanova
E O
EO
Aleksanian
M Zh
MZh
Misiurin
A V
AV
Domracheva
E V
EV
Ol'shanskaia
Iu V
IuV
Khoroshko
N D
ND
Kravchenko
S K
SK
Konstantinova
T S
TS
Anchukova
L V
LV
Kaplanov
K
K
Zagoskina
T P
TP
Volkova
S A
SA
Filatov
L B
LB
Rekhtman
G B
GB
Sokolova
I
I
Mashuk
V N
VN
Miliutina
G I
GI
Lapin
V A
VA
Perekatova
T N
TN
Sviridova
E I
EI
Pristupa
A S
AS
Ziuzgin
I S
IS
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics*; D003561:Cytarabine / Q000008:administration & dosage / Q000627:therapeutic use; D003630:Daunorubicin / Q000008:administration & dosage / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000235:genetics; D015514:Oncogene Proteins, Fusion / Q000235:genetics; D011505:Protein-Tyrosine Kinases / Q000235:genetics; D011518:Proto-Oncogene Proteins / Q000235:genetics; D051562:Proto-Oncogene Proteins c-bcr; D012074:Remission Induction; D014158:Transcription, Genetic; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use
D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins; D015514:Oncogene Proteins, Fusion; D011518:Proto-Oncogene Proteins; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein; D003561:Cytarabine; D014212:Tretinoin; D011505:Protein-Tyrosine Kinases; C496613:BCR protein, human; D051562:Proto-Oncogene Proteins c-bcr; D003630:Daunorubicin
Predvaritel'nye rezul'taty mnogotsentrovogo randomizirovannogo issledovaniia po lecheniiu ostrykh promielotsitarnykh leĭkozov.