Acute promyelocytic leukemia (MS) is, as one of the FAB subtypes of AM
L, included in the EORTC/GIMEMA AML-8A and 8B randomized trials. In th
ese trials 1519 patients were included, 477 of them in non Italian EOR
TC-LCG centers and 1042 in GIMEMA centers. A total of 80 patients were
classified as MS including 18 patients with MS-variant. Thirty-nine w
ere male and 41 female. Ages ranged from 15 to 59 years; 25 (31.3%) of
them were younger than 30, 34 (42.5%) between 30 and 45, and 21 (26.3
%) older than 45 years of age. 56.3% of the patients had leukocytes le
ss than 5 x 10(9)/l at the time of diagnosis vs. 24.9% of the patients
belonging to the other FAB subtypes. Remission induction consisted of
a standard protocol with 3 days daunorubicin and 7 days of cytosine a
rabinoside. Forty-three patients (53.8%) achieved a complete remission
compared to 64.6% of the remaining AML patients. After salvage treatm
ent this percentage increased to 70%, which is the same as for the oth
er AML subtypes. Thirteen (16.3%) patients died during remission induc
tion, mainly due to hemorrhagic complications. This percentage is sign
ificantly higher than the death rate (9.1%) in the other FAB subtypes
of AML. All patients received one course of consolidation treatment. P
ost consolidation treatment could be either standard maintenance, inte
nsive consolidation courses, autologous or allogeneic transplantation,
according to the guidelines of the treatment protocols. At present, r
elapses almost all in the bone marrow, are seen in only 34.9% of the M
S patients, compared to 48.4% in the remaining AML patients. Disease-f
ree survival for patients less than 45 years of age with the M2 and M3
subtypes was approximately 50% at 3 years compared to 30-40% for the
other FAB subtypes. Despite the higher death rate during induction, th
e long-term survival results were better for M3 patients in comparison
with the remaining AML patients. The projected survival at 3 years wa
s 50% for M3 patients vs. 38% for remaining patients.