Preliminary results of a multicenter randomized study on the treatment of acute promyelocytic leukemias
- Authors: Parovichnikova EN1, Savchenko VG1, Demidova IA1, Isaev VG1, Shuravina EN1, Ustinova EN1, Gribanova EO1, Alexanyan MZ.1, Misyurin AV1, Domracheva EV1, Olshanskaya Y.V1, Khoroshko ND1, Kravchenko SK1, Konstantinova TS1, Anchukova LV1, Kaplanov K1, Zagoskina TP1, Volkova SA1, Filatov LВ1, Rekhtman GВ1, Sokolova I1, Mashuk VN1, Milyulina GI1, Lapin VA1, Perekatova TN1, Sviridova EI1, Pristupa AS1, Zyuzgin IS1
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Affiliations:
- Issue: Vol 79, No 7 (2004)
- Pages: 11-18
- Section: Editorial
- URL: https://ter-arkhiv.ru/0040-3660/article/view/29988
- ID: 29988
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Full Text
Abstract
Material and 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 5day courses of cytostatic drugs which alternated or did not altenate 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 (657c) - 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 simitar. 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 lO9/! found no statistical differences by the survival. Patients with hyperleukocytosis had higher early lethality than patients with leukocytes under 10 Iff/I (25% vs 5.3%, p = 0.03).
Conclusion. 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%.
About the authors
E N Parovichnikova
V G Savchenko
I A Demidova
V G Isaev
E N Shuravina
E N Ustinova
E O Gribanova
M Zh Alexanyan
A V Misyurin
E V Domracheva
Yu V Olshanskaya
N D Khoroshko
S K Kravchenko
T S Konstantinova
L V Anchukova
K Kaplanov
T P Zagoskina
S A Volkova
L В Filatov
G В Rekhtman
I Sokolova
V N Mashuk
G I Milyulina
V A Lapin
T N Perekatova
E I Sviridova
A S Pristupa
I S Zyuzgin
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