[CML] article about pregnancy during gleevec

Giora Fri, 25 Nov 2005 11:55:02 -0800

here is a case story of 1 indian patient. it only strengthen the caution that should be exercised if a woman wants to become pregnant on gleevec

shalom

gior

Annals of Oncology letter to the editor

Pregnancy on imatinib: fatal

outcome with meningocele

We read with interest a recent letter by Prabhash et al. [1]

showing a successful outcome of pregnancy in two patients on

imatinib. There have also been a few other recent reports where

no adverse effects have been reported [2–4]. However, we

would suggest extreme caution, based on our experience in

a patient who conceived while on imatinib with an adverse

outcome.

A 25-year-old female was diagnosed as having chronic

myeloid leukemia in chronic phase in July 2004. She had no

significant past medical history and was nulliparous.

Examination revealed spleen palpable 10 cm below costal

margin. Hematological parameters (hemoglobin 7.8 g/dl, white

blood cell count 23.4 · 109/l and platelet count 383 · 109/l) and

RT–PCR revealed positive BCR-ABL translocation. Her

biochemical parameters, including liver, renal functions and

uric acid, were within normal limits. Therapy was started with

imatinib (Glivec; Novartis, Basel, Switzerland) 400 mg/day as

part of a research project where the drug was provided free. She

was counseled to avoid pregnancy. Complete hematological

remission was achieved at the end of 1 month and molecular

remission after 3 months. Imatinib was continued at the same

dosage. The patient reported to the clinic with history of

amenorrhea of one and half months’ duration in January 2005

and a pregnancy test was positive. After counseling, she

declined termination of pregnancy, but imatinib was stopped.

No drug was administered until completion of the first

trimester. As the patient could not afford interferon,

hydroxyurea was administered to control the blood counts and

symptoms. At 30 weeks, ultrasound abdomen revealed the

presence of a meningocele. She delivered a dead fetus with the

meningocele at the 34th week of pregnancy. She was restarted

on imatinib with further advice for strict contraception and to

stop the drug before any planned pregnancy.

The limited published literature suggests that imatinib is

safe in pregnancy [1–4]. However, animal experiments suggest

it is unsafe. Imatinib, an inhibitor of abl-tyrosine kinase, is

teratogenic in mouse and rats when administered during

organogenesis at doses of >100 mg/kg, causing exencephaly or

encephalocele, and absent or reduced frontal and absent

parietal bones [5]. The most critical period for teratogenicity is

the first trimester as this period correlates with active

organogenesis. Our patient had been exposed to imatinib

during conception and for 6 weeks thereafter with development

of a meningocele and a fatal outcome. The few reports of

delivery of a normal fetus, even with intake of imitanib during

pregnancy, should not suggest that the drug is safe. Our case

clearly highlights that the drug is potentially teratogenic. To the

best of our knowledge this is the first such complication

reported in humans. We strongly recommend effective

contraception for all patients who are on imatinib.

D. R. Choudhary, P. Mishra, R. Kumar*, M. Mahapatra &

V. P. Choudhry

All India Institute of Medical Sciences, Department of Hematology,

AIIMS, 110029 New Delhi, India

(*E-mail: [EMAIL PROTECTED] or [EMAIL PROTECTED])

references

1. Prabhash K, Sastry PS, Biswas G et al. Pregnancy outcome of two patients

treated with imatinib. Ann Oncol 2005; doi:10.1093/annonc/mdi398.

2. Ali R, Ozkalemkas F, Ozcelik T et al. Pregnancy under treatment of imatinib

and successful labor in a patient with chronic myelogenous leukemia (CML).

Outcome of discontinuation of imatinib therapy after achieving a molecular

remission. Leuk Res 2005; 29: 971–973.

3. AlKindi S, Dennison D, Pathare A. Imatinib in pregnancy. Eur J Haematol 2005;

74: 535–537.

4. Heartin E, Walkinshaw S, Clark RE. Successful outcome of pregnancy in

chronic myeloid leukaemia treated with imatinib. Leuk Lymphoma 2004; 45:

1307–1308.

5. Hensley ML, Ford JM. Imatinib treatment: specific issues related to safety, fertility,

and pregnancy. Semin Hematol 2003; 40: 21–25.

doi:10.1093/annonc/mdj065

letter to

the editor

× 2005 European Society for Medical Oncology

Annals of Oncology Advance Access published November 15, 2005
a

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[CML] article about pregnancy during gleevec

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