Trial Information

Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)

Acute promielocitic leukaemia (APL) Among all the AML subtypes, APL has the distinction of
being the most curable. The median age at diagnosis is 40 years, which is younger than with
other AML subtypes. The fact that APL is more common in younger patients increases the
likelihood that it may occur during fertile age. The introduction of ATRA and ATO has
substantially modified the outcome of APL: in two successive studies 94% of patients
achieved CR and the 6-yr OS rates (PETHEMA and GIMEMA) were about 80% 2,3,6.

ATRA is highly effective in APL patients, but adverse effects such as retinoic acid
syndrome, arrhythmias, headache, rash, dizziness have been reported. Moreover, retinoids are
known to be potent teratogens and increased rates of spontaneous abortion and major fetal
abnormalities have been reported 10. Most of the cases reported suggest that ATRA is
relatively safe for both mother and fetus when used in the second and third trimesters. By
contrast, when it was used in the first trimester, a negative foetal outcome was reported.
No data have yet been reported on the outcomes of pregnancies in young patients with APL,
occurring during CCR following ATRA-including chemotherapy regimens.

APL therapy AIDA regimen: simultaneous Atra plus IDArubicin (AIDA) combination for induction
treatment, followed by 3 courses of intensive chemotherapy as consolidation2.

Consolidation therapy in the AIDA-0493 trial consisted of 3 chemotherapy courses with Ara-C
and idarubicin3.

Consolidation treatment in the AIDA-2000 was given according to a risk-adapted strategy as
follows: patients with low-/intermediate-risk received the same 3 consolidation courses as
in the AIDA-0493 but with omission of cytarabine; patients in the high-risk group received
the identical 3 cycles as in the AIDA-0493.

Study rationale This is an observational (retrospective) study on number and outcome of
pregnancy in childbearing age female patients treated with chemotherapy for APL. These
patients were enrolled in studies studies AIDA0493, AIDA2000 and were in CR.