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205]
Demographic, clinical, and hematologic characteristics
of patients with chronic myeloid leukemia in Upper Egypt:
association with treatment responses
Safaa A. A. Khaleda,c, Nashwa M.A. Abd El Azizb,d
Background and objectives  Chronic myeloid leukemia
(CML) is a relatively indolent hematologic malignancy
that carries poor prognosis if left untreated. With the
recent advances in treatment options for CML, therapy
could be tailored to each patient based on patient and/or
disease characteristics. This research aimed to study the
characteristics of patients with CML in Upper Egypt and to
investigate their influence on various therapeutic responses.
Patients and methods  A retrospective study was
conducted at the Hematology Unit of Assiut University
Hospital and South Egypt Cancer Institute. The demographic,
clinical, hematologic, and follow-up data of patients with CML
were extracted from hospital records at both Assiut University
Hospital and South Egypt Cancer Institute during the period
from January 2007 to December 2012, representing a total
of 180 patients. Records with incomplete data or unavailable
follow-up were excluded from the study.
Results and conclusion  The median age of participants
was 42 years, and the male-to-female ratio was 1 : 1.7. The
Eastern Cooperative Oncology Group Performance Status
was the most important effector of both hematologic and
therapeutic responses (P = 0.000), followed by the phase
of the disease (P = 0.000 and 0.017, respectively), and
Introduction
Chronic myeloid leukemia (CML) is a clonal
hematopoietic stem cell disorder that possesses a
characteristic cytogenetic profile [1,2]. Treatment of
CML went through a series of discoveries that began
with arsenic and ended in 1998 with the marvelous
discovery of tyrosine kinase inhibitor, which is a
targeted therapeutic agent that markedly changed the
survival of CML patients [3,4].
The first reported case of leukemia was that of a
63-year-old man, with a splenomegaly 20 times
normal and pus in his blood. Since this description,
further studies showed a median age of CML patient
at diagnosis of 55–60 years, and the male population
was predominantly affected compared with the female
population. Clinically, a CML patient is characterized
by huge splenomegaly associated hematologically with
marked leukocytosis, particularly in the chronic phase
of the disease [5]. Women were found to have better
overall survival with interferon therapy [6]. Studies
have also shown that the socioeconomic state of the
patients affects their treatment response, particularly
© 2015 The Egyptian Journal of Haematology | Published by Wolters Kluwer - Medknow
Original article  195
lastly the Philadelphia chromosome (P = 0.07 and 0.000,
respectively). Moreover, leukocytosis was associated with
poor hematologic and cytogenetic responses (r = 0.19,
P = 0.000; r = −0.16, P = 0.05). A small proportion of
patients achieved complete hematologic and cytogenetic
responses (45 and 52%, respectively). These novel findings
may reflect a trend of young age, female-predominant CML
in Upper Egypt and could be attributed to the ethnic and
socioeconomic differences of our patients compared with
those in similar studies. Egyptian J Haematol 40:195–200 ©
2015 The Egyptian Society of Haematology.
Egyptian Journal of Haematology 2015, 40:195–200
Keywords: chronic myeloid leukemia, demographics, Upper Egypt
a
Department of Internal Medicine, Hematology and BMT Unit, Assiut
University Hospital, Faculty of Medicine, Assiut University, bDepartment of
Medical Oncology, South Egypt Cancer Institute, Assiut, Egypt cCollege
of Applied Medical Sciences at Al Dawadmi, Shaqra University, Shaqra,
d
Deparment of Hematology/Oncology, King Khalid University Hospital,
King Saud University, Riyadh, Saudi Arabia
Correspondence to Safaa A.A. Khaled, MD, Department of Internal
Medicine, Hematology and BMT Unit, Assiut University Hospital, Assiut
71111, Egypt
Tel: 002 0882 413940; fax: +20 088233 3327;
e-mails: sa_ah_mh@yahoo.com and safaakhaled2003@gmail.com
Received 24 April 2015 Accepted 23 June 2015
after the introduction of the highly priced tyrosine
kinase inhibitors [7]. Most of these studies were based
on Western Cancer Registry information. Few recent
studies conducted in East Asia and Middle Eastern
countries showed little or no change compared with
the findings of the western ones [8,9]. A recent study
in the Nile delta and a report in Aswan emphasized on
incidence rates and the pattern of incident cancer cases
in an attempt to give clues to the burden and pattern
of cancer in Egypt [10]. This study was conducted in
Upper Egypt to investigate the demographic, clinical,
and hematologic characteristics of CML patients in
Upper Egypt. Another objective was to find out the
diagnostic and prognostic effects of these characteristics
by correlating patient data with various treatment
responses regardless of the stage of the disease or the
type of treatment.
This is an open access article distributed under the terms of the Creative
Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows
others to remix, tweak, and build upon the work non-commercially, as
long as the author is credited and the new creations are licensed under
the identical terms.
DOI: 10.4103/1110-1067.170221
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196  Egyptian Journal of Haematology  2015, Vol 40 No 4
Patients and methods
Patient and data collection
We retrospectively collected the demographic, clinical,
and hematologic data of CML patients who had been
referred to the Hematology Unit of Internal Medicine
Department at Assiut University Hospital and to
South Egypt Cancer Institute, during the period from
January 2007 to December 2012. Data were collected
by reviewing patients’ records and registry; both
computer-based and handwritten patients’ records
were reviewed. Records with incomplete data were
omitted from the study.
The demographic data included patient’s age, sex,
residence, occupation, and social status. Clinically,
symptoms and signs, including the Eastern Cooperative
Oncology Group performance status, splenomegaly,
hepatomegaly, and lymphadenopathy, were recorded.
As regards the hematologic data, they included total
leukocytic count, hemoglobin, and platelet counts. In
addition, the CML phase and the Philadelphia (Ph)
for each case were analyzed; however, for some cases
the Ph was not analyzed.
Follow-up data
Each file was reviewed for a follow-up period of
3  months or more to record the treatment received
and the treatment responses. For some patients both
hematological and cytogenetic responses were available
and for others only the hematologic response was
achieved. This was due to the unavailability of molecular
testing during the period from 2007 to 2009, particularly
at Assiut University Hospital. Files with less than
3-month follow-up were not included in the study.
Treatments and definition of responses
Patients received either hydoxyurea or Gleevec as
first-line or second-line therapy. A small group of
patients was treated with other therapies, mainly
α-interferon. Treatment responses were assessed after
3 months of therapy. Complete hematologic response
(CHR) was defined as a total leukocytic count less
than 10 × 109/l without immature granulocytes, with
less than 5% basophils, and a platelet count less than
450 × 109/l. Cytogenetic response was evaluated on the
basis of fluorescence in-situ hybridization analysis and
categorized as complete (CCyR) (absence of Ph-positive
cells), partial (1–35% Ph-positive cells), minor (36–65%
Ph-positive cells), minimal (66–95% Ph-positive cells),
or no response (>95% Ph-positive cells) [11]. Molecular
responses were unavailable for most of our patients and
thus were not included in analyses.
Statistical methods
The frequency tables and standard descriptive statistics
(mean, median, minimum, and maximum) were used to
summarize patient characteristics. Association between
patients’ characteristics and the various therapeutic
responses was assessed with the c2-test.
Correlations of patients’ data and therapeutic
responses were assessed using Spearman’s correlation
test. Association between quantitative variables and
the obtained therapeutic responses was analyzed with
Pearson’s correlation.
Level of statistical significance was set at 0.05. Analyses
were performed using statistical software SPSS, 0.17
(SPSS Inc., Chicago, Illinois, USA).
Ethical considerations
The study design, method, and objectives were
consistent with the World Medical Association
(WMA) Declaration of Helsinki, 2013. The study
protocol was approved by the University of Assiut,
Faculty of Medicine Research ethical committee.
Results
Patients’ characteristics
A total of 180 CML patients were enrolled in the study;
their ages ranged from 16 to 80 years, with a median
age of 42 years. An overall 57.2% of them were female,
with a male-to-female ratio of 1 : 1.7. An overall 78%
of them were in the chronic phase and 57% were Ph-
positive. Table 1 summarizes the demographic, clinical,
and hematologic characteristics of the study group, the
treatment they received, and the various therapeutic
responses.
Associations between patients’ characteristics
and the obtained therapeutic responses
Overall, the current study showed no sex, age, or social-
based differences in therapeutic responses. In contrast,
a significantly higher proportion of patients with
restricted strenuous activity and/or with chronic phase
diseases achieved both CHR and CCyR (P = 0.001
and 0.017, respectively). Ph positivity was associated
with greater CCyR (P = 0.001). These relations are
presented in Tables 2 and 3.
Effect of patients’ hematologic parameters and the
obtained therapeutic responses
The relationship between patients’ hematologic
parameters and both the HR and CyR was analyzed.
The obtained results showed a significant negative
correlation between TLC and CyR (r = -0.16, P = 0.05).
Also a significant negative correlation between Hb and
both HR and CyR was observed (r = -0.269 and -0.25
respectively, P = 0.00). As depicted in Table 4.
Relationship between the type of CML treatment
and the various therapeutic responses
All patients included in the study were treated and
assessments of their hematologic and cytogenetic
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Chronic myeloid leukemia in Upper Egypt Khaled and Abd El Aziz  197

Table 1 Demographic, clinical, and hematologic responses were carried out over 3 months thereafter.
characteristics of the study group (N = 180)
An overall 50.6% of patients received hydroxyurea as
Patients’ characteristics Estimated results
first-line therapy and 37.2% received Gleevec either as
Demographic first-line or second-line therapy. Only 12.2% of patients
Age (mean ± SD) (years) 41.89 ± 14.77 received other therapies, mainly interferon alpha.
Sex: male 77 (48.2)
Despite the curative effect of the hematopoietic stem
Residence
cell transplantation (HSCT), none of our patients had
Urban 72 (40)
undergone HSCT. This was due to the unavailability
Rural 108 (60)
Occupation
of suitable donors and the decreased needs to perform
Farmer 28 (15.6)
HSCT after the introduction of the tyrosine kinase
Housewife 98 (54.4) inhibitors. An overall 71.6 and 67.2% of patients treated
Employed 10 (5.6) with Gleevec achieved complete hematologic and
Unemployed 44 (24.4) cytogenetic responses, respectively. For those treated
Clinical with hydoxyurea, only 34.1 and 31.9% reached to
ECOG PS complete therapeutic responses. Failure of hematologic
Restricted strenuous activity 100 (55.6) and cytogenetic responses was observed in 6 and 13.4%,
Self-care but no work 49 (27.2) and 14.3 and 18.7% of patients treated with Gleevec
Limited self-care 31 (17.2) and hydoxyurea, respectively. Disease progression
Spleen was noted in 21.7% of the study group. Figs. 1 and 2
Huge 164 (91.1)
illustrate the influence of the type of treatment on the
Mild to moderate 16 (8.9)
obtained therapeutic responses.
Liver
Hepatomegaly 137 (76.1)
Impalpable 43 (23.9)
Discussion
Lymph nodes
Lymphadenopathy 29 (16.1)
CML is a chronic myeloproliferative disorder that
Impalpable 151 (83.9) ranges clinically from a quiescent to rapidly fatal
Type of treatment disease  [12]. This study analyzed the demographic,
Hydroxyurea 91 (50.6) clinical, and hematologic characteristics of CML
Gleevec 67 (37.2) patients in Upper Egypt.The associations between these
Others 22 (12.2) characteristics and the various therapeutic responses
Hematologic were also investigated. The study included 180 CML
TLC (≥100 × 103/ml) 97 (53.9) patients who were originally from Al-Menia, Assiut,
Hb (mean ± SD) 9.24 ± 2.04 Sohag, Qena, and Aswan governorates of Upper Egypt.
Plt count (mean ± SD) 406.61 ± 411.80 The study revealed lower median age of CML patients
Phase of CML and higher affection of female patients and rural-
Chronic 138 (76.7)
resident patients, compared with that reported in other
Accelerated 24 (13.3)
studies in other eastern and western countries [8–10].
Blastic crisis 18 (10)
Ph chromosome
Positive 103 (57.2) Fig. 1
Negative 69 (38.3)
Not done 8 (4.4)
Therapeutic response
Hematologic response
Complete response 81 (45)
Partial response 38 (21.1)
Stable disease 22 (12.2)
Progressive disease 39 (21.7)
Cytogenetic response (N = 144)
Complete 75 (52.1)
Partial 17 (9.4)
Minimal 13 (7.2)
No response 39 (21.7)

Data was expressed as mean ± SD, or as percentage from the

total number as appropriate; CML, chronic myeloid leukemia;
ECOG PS, Eastern Cooperative Oncology Group Performance Relationship between the type of chronic myeloid leukemia treatment
Status; Hb, hemoglobin; Ph, Philadelphia; Plt, platelets; TLC, total and the obtained hematologic response.
leukocytic count.
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198  Egyptian Journal of Haematology  2015, Vol 40 No 4

Consistent with other studies, the vast majorities of adverse hematological features such as leukocytosis
our patients were presented with huge splenomegaly, and anemia were identified in a significant proportion
chronic phase, and were Ph-positive [13]. Moreover, of the study group [14].

Fig. 2 Unlike other studies, most of our patients failed to

achieve CHR at 3 months. This could be attributed to
tyrosine kinase inhibitor being the main treatment [15],
unlike the current study in which different treatment
methods were used.

In this study both the hematologic and cytogenetic

Relationship between the type of chronic myeloid leukemia treatment
and the obtained cytogenetic response.
responses of patients revealed the superior efficacy of
Gleevec compared with other treatment modalities.
These responses were similar to those observed by
Kantarjian et al. [16]. However, the current study
showed higher disease progression and response
failure in those treated with Gleevec. This could be
attributed to treatment interruption of the highly
priced Gleevec therapy. Another major cause of
treatment interruption is development of adverse
events. This explanation is supported by the work of

Table 2 Crosstabulation results of patient characteristics and hematologic therapeutic response

Patient’s characteristics Hematologic response (N = 180) [n (%)]
Complete Partial Stable disease Progressive disease P value
Sex
Male 35 (45.5) 16 (20.8) 10 (13.0) 16 (20.8) 0.98
Female 46 (44.7) 22 (21.4) 12 (11.7) 23 (22.3)
Residence
Urban 29 (40.3) 17 (23.6) 9 (12.5) 17 (23.6) 0.76
Rural 52 (48.1) 21 (44.7) 13 (12.0) 22 (20.4)
Occupation
Farmer 14 (50.0) 3 (10.7) 4 (14.3) 7 (25.0) 0.62
Housewife 44 (44.9) 25 (25.5) 10 (10.2) 19 (19.4)
Employed 6 (60.0) 0 (0.0) 2 (20.0) 2 (20.0)
Unemployed 17 (38.6) 10 (22.7) 6 (13.6) 11 (25.0)
ECOG PS
Restricted strenuous activity 52 (52.0) 28 (28.0) 10 (10.0) 10 (10.0) 0.000*
Self-care but no work 22 (46.9) 9 (18.4) 9 (18.4) 8 (16.3)
Limited self-care 6 (19.4) 1 (3.2) 4 (12.6) 20 (64.5)
Spleen
Huge 75 (45.7) 33 (20.1) 20 (12.2) 36 (22.0) 0.76
Mild to moderate 6 (37.5) 5 (31.2) 2 (12.5) 3 (18.8)
Liver
Hepatomegaly 61 (44.5) 28 (20.4) 16 (11.7) 32 (23.4) 0.79
No hepatomegaly 20 (46.5) 10 (23.3) 6 (14.0) 7 (16.3)
Lymph nodes
Lymphadenopathy 12 (41.4) 7 (24.1) 3 (10.3) 7 (24.1) 0.93
No lymphadenopathy 69 (45.7) 31 (20.5) 19 (12.6) 32 (21.2)
Phase of CML
Chronic 69 (50.0) 33 (23.9) 18 (13.0) 18 (13.0) 0.000*
Accelerated 7 (38.6) 3 (12.5) 2 (8.3) 12 (50.0)
Blastic crisis 5 (27.8) 2 (11.1) 2 (11.1) 9 (50.0)
Ph chromosome (N = 172)
Positive 53 (67.1) 9 (11.4) 5 (6.3) 12 (15.2) 0.07
Negative 22 (36.1) 8 (13.1) 6 (9.8) 25 (41.0)
CML, chronic myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group Performance Status; Ph, Philadelphia chromosome;
*P value is significant at the 0.01 level.
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Chronic myeloid leukemia in Upper Egypt Khaled and Abd El Aziz  199

Table 3 Cross tabulation results of patient characteristics and cytogenetic therapeutic response
Patient’s characteristics Cytogenetic response (N = 180) [n (%)]
Complete Partial Minimal No response P value
Sex
Male 33 (49.3) 9 (13.4) 7 (10.4) 18 (26.9) 0.89
Female 42 (54.5) 8 (10.4) 6 (7.8) 21 (27.3)
Residence
Urban 31 (55.4) 9 (16.1) 3 (5.4) 13 (23.2) 0.32
Rural 52 (48.1) 21 (44.7) 13 (12.0) 22 (20.4)
Occupation
Farmer 11 (52.4) 1 (4.8) 3 (14.3) 6 (28.6) 0.87
Housewife 44 (44.9) 25 (25.5) 10 (10.2) 19 (19.4)
Employed 6 (60.0) 0 (0.0) 2 (20.0) 2 (20.0)
Unemployed 17 (38.6) 10 (22.7) 6 (13.6) 11 (25.0)
ECOG PS
Restricted strenuous activity 48 (64.0) 10 (13.3) 7 (9.3) 10 (13.3) 0.000*
Self-care but no work 21 (48.8) 6 (14.0) 3 (7.0) 13 (30.2)
Limited self-care 6 (23.1) 1 (3.2) 3 (11.5) 16 (61.5)
Spleen
Huge 69 (52.7) 14 (10.7) 12 (9.2) 36 (27.5) 0.62
Mild to moderate 6 (37.5) 3 (23.1) 1 (7.7) 3 (23.1)
Liver
Hepatomegaly 57 (51.4) 13 (11.7) 10 (9.0) 31 (25.4) 0.98
No hepatomegaly 18 (54.5) 4 (12.1) 3 (9.1) 8 (24.2)
Lymph nodes
Lymphadenopathy 12 (51.5) 1 (4.5) 1 (4.5) 8 (36.4) 0.45
No lymphadenopathy 63 (51.6) 16 (13.1) 12 (9.8) 31 (25.4)
Phase of CML
Chronic 64 (59.8) 11 (10.3) 8 (7.5) 24 (22.4) 0.017*
Accelerated 8 (36.4) 4 (18.2) 4 (18.2) 6 (27.3)
Blastic crisis 3 (20.0) 2 (13.3) 1 (6.7) 9 (60.0)
Ph chromosome (N = 172)
Positive 54 (37.7) 23 (22.3) 10 (9.7) 16 (15.5) 0.000*
Negative 26 (37.5) 12 (17.4) 10 (14.5) 21 (30.4)
CML, chronic myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group Performance Status; Ph, Philadelphia chromosome;
*P value is significant at the 0.01 level.

Table 4 Correlations between patient characteristics and the responses. These results could be possibly due to ethnic
hematologic and cytogenetic therapeutic responses
and socioeconomic effects.
Patient Hematologic response Cytogenetic response
characteristics
r P value r P value Acknowledgements
Age −0.008 0.91 0.03 0.64 The authors thank Professor Yousseryia A. Ahmed and
TLC 0.195 **0.00 −0.16 0.05 Professor Esam A.S. ElBieh – Internal Medicine Department,
Hb −0.269 **0.00 −0.25 **0.00 Hematology and BMT Unit, Assiut University Hospital,
Plt −0.057 0.45 0.03 0.65 Assiut, Egypt – for their continuous scientific guidance.
Hb, hemoglobin; Plt, platelets; r, Spearman’s rank correlation
coefficient; TLC, total leukocytic count; **Correlations is significant Financial support and sponsorship
at the 0.01 level.
Nil.

others who demonstrated that treatment interruption Conflicts of interest

leads to loss of the gained therapeutic responses and There are no conflicts of interest.
even to disease progression [17–19].

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