Evaluation of Clinical & Haematological Response of Chronic Myeloid Leukemia Patients to Glivec Therapy in Sudan
Evaluation of Clinical & Haematological Response of Chronic Myeloid Leukemia Patients to Glivec Therapy in Sudan
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Date
2015-04-14
Authors
Ali, Rusha
Journal Title
Journal ISSN
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Publisher
UOFK
Abstract
Background:
In the last 20 years Chronic Myeloid Leukemia became one
of the predominant cancer in men and women in Sudan, based on
referral data from the Radiation & Isotopes Centre of Khartoum
(RICK), the only cancer centre in Sudan.
The genetic studies are the building blocks of the future and
the development of Glivec provides a dramatic example of how
the understanding of disease biology and genetic abnormality can
lead to successful molecularly targeted treatments.
In this study the effectiveness of the drug among Sudanese
patients, individual response of patients and factors influencing
the prognosis were examined in order to gain more insight on the
use of Glivec in Sudan as first line treatment of CML.
Design :
A descriptive‐retrospective demographic & cross‐sectional
study.
Setting:
In Radiation and Isotopes Centre of Khartoum (RICK),
Khartoum, Sudan.
Objectives:
The overall aim of this study is to evaluate the effectiveness
of Glivec treatment in Sudanese patients with CML based
on haematologic and clinical remission.
iv
Materials and methods:
The study covered CML (438pts) who took the drug since
2003, was conducted during the period from June 2007 to March
2008.
185 patient were selected randomly and subdivided into 2
groups according to response of therapy, namely to responders
and non
responders or deceased patients. CBC, bone marrow examination,
PCR,
renal and liver functions were assessed in all patients. Responders
were sub‐divided into groups according to duration of therapy: 3
months, 6 months, 1 year, 2 years, 3 years and 4 years.
Results:
• The mean age of all patients was 53years with (46%) Females
and (54%) Males.
• Prognosis of CML patients who took the drug was impressive in
that out of 438 only 51(11.8%) relapsed or died throughout the
period of the study since 2003, while 308 (70.3%) were
regularly taking treatment and coming to follow‐up.
• An incidental diagnosis was made in 22 of the patients (15.8%),
out of whom 12 patients (54.5%) were females.
• The mean duration of illness and symptoms before diagnosis
was 14 months, ranging from 1 ‐ 24months.
• The most common symptoms were fatigue seen in 101
patients (72.6%) and fever in 56 patients (40%). Extramedullary
involvement occurred in the form of splenomegaly in 79
patients (56.8%); hepatomegaly in 29 patients (20.8%) and
lymphadenopathy in 4 patients (2.8%).
• The median WBC of patients at initiation of therapy with Glivec
was 193x109, Median Hb 10.3 g/dl, and median platelet count
was 430x109.
• Complete haematological and clinical response was reported in
(86%) of patients and was achieved within 3 – 6 months from
the start of therapy.
• Glivec in general was well tolerated, only 37.4% experienced
side‐effects
• Out of 438 patients 30 patients (6.8%) died with resistance to
drug; 11 patients of them (36.3%) due to primary resistance, 19
patients of them (63.3%) due to secondary resistance.
• The type of encoded protein (210 or 190) and interruption of
treatment are suggested as factors which can have an impact
on survival of CML patients since (40%) of the deceased
patients took the drug interruptedly and (54.5%) were 190 +ve
patients.
• Reticulin fibrosis was strongly associated with several poor
prognostic features of the disease including huge
splenomegaly, basophilia, anaemia and thrombocytosis.
Conclusion:
Although the results obtained with Glivec to date are truly
impressive, longer follow‐up is necessary to draw definitive
conclusions and to establish whether prevention or delay of blast
crisis can be achieved, and whether an improved over‐all survival
for the majority of patients can be obtained. Also, to help us pave
the way for additional molecular targeted therapies and strategies
in leukemia.
Description
24 page
Keywords
Evaluation,Haematological, Response,Chronic, Myeloid, Leukemia,Glivec, Therapy