This study evaluated quality of life and symptoms in 102 chronic myeloid leukemia patients receiving first- or second-line treatment with dasatinib in real-world clinical settings. For first-line dasatinib patients, quality of life improved in several domains after 12 months, and common symptom severity decreased. For second-line dasatinib patients after imatinib failure, quality of life and symptoms also improved over 12 months. Clinical responses to dasatinib were consistent with previous trials. Real-world data provided additional evidence for dasatinib's effectiveness outside of clinical trials.

1. Quality of life and symptoms in patients with chronic
myeloid leukemia in chronic phase (CP CML)
during first and second line treatment with dasatinib
in a real-world setting
Ionova T.1,2, Bulieva N.3, Vinogradova O.4, Gritsenko T.5, Kozlova L.6, Kurbatova
K.1,2, Kuchma G.6, Lomaia E.7, Machulaytene E.8, Nikitina T.1,2, Novitskaya N.4,
Rodionova A.2, Usacheva E.9, Shneyder T.10
1Saint-Petersburg MultiSpeciality Medical Center, Saint-Petersburg
2Multinational Center for Quality of Life Research, Saint-Petersburg
3 Institute of Medicineof Immanuel Kant Baltic Federal University, Kaliningrad
4Hematological City Center, Botkin City Clinical Hospital, Moscow
5Samara State Medical University, Samara
6Orenburg State Medical University, Orenburg
7Federal Almazov North-West Medical Research Center, Saint-Petersburg
8Policlinic with clinical diagnostic center, Pavlov State Medical University, Saint-Petersburg
9R.M. Gorbacheva Memorial Institute of Children Hematology and Transplantation of Pavlov State
Medical University, Saint-Petersburg
10Leningrad regional clinical hospital, Saint-Petersburg

2. Background
• The efficacy and safety of first- and second line
treatment with dasatinib in CP CML pts as well as
patients’ quality of life (QoL) has been studied in clinical
trials. The above information may differ from that
revealed in a real-world setting.
• Real-world research is made necessary by the variety
of factors that can play an important a role in
modulating effectiveness in real life but are often tightly
controlled in RCTs (age, comorbidities and concomitant
treatments, adherence, strength of doctor–caregiver
communication, and socio-economic and other
organizational factors)*.
*Roche N., Reddel H., Martin R. et al., Ann Am
Thorac Soc. 2014; 11 (Suppl. 2): S99-S104

3. Objectives
• To review QoL and symptom profile data in CP
CML patients receiving first- and second line
treatment with dasatinib in a real-world setting
•«Quality of life, symptom profile and adherence to treatment in
patients with newly-diagnosed chronic myeloid leukemia in
chronic phase during dasatinib treatment» observational study
Primary outcomes – QoL, symptom profile
Secondary outcomes – hematologic response, molecular response, cytogenetic
response, AE frequency and severity
•«Quality of Life and symptom profile in patients with imatinib-
resistant or imatinib-intolerant chronic myeloid leukemia during
second-line treatment» observational study
Primary outcomes – QoL, symptom profile
Secondary outcomes – hematologic response, cytogenetic response, AE frequency and
severity
*Supported by grants of BMS

4. Patients and Methods
Patients’ characteristics
Total number, N 102
Median age (range), years old 49 (20–83)
Male, n (%) 55 (54)
Median disease duration (range), mths 60 (9–204)
Patient groups depending of TKI treatment:
- TKI-naive pts or early switch to dasatinib (less than within 9
months), n (%)
- imatinib-resistant or -intolerant pts, n (%)
27 (26.5)
75 (73.5)
Treatment prescribed – Dasatinib
Dosage 100 mg daily, n (%) - 75 (73.5%)

5. Patients and Methods
Study tools and time-points
 Generic QoL questionnaire – SF-36
•Physical Functioning (PF)
•Role Physical Functioning (RP)
•Bodily Pain (BP)
•General Health (GH)
Study tools
Study time-points
Baseline – before treatment with dasatinib
Follow-up – 1, 3, 6 and 12 mths after dasatinib treatment start
 Symptom assessment instrument – Comprehensive Symptom Profile in Chronic
Myeloid Leukemia Patients (CSP Leuk-CML)
•Consists of 47 symptoms have been experiencing by CML patients;
•Includes Numeric Rating Scale from 0 (no symptoms) to 10 (highest severity of symptoms)
•Vitality (VT)
•Social Functioning (SF)
•Role Emotional Functioning(RE)
•Mental Health (MH)
Integral QoL Index

6. Results
Clinical outcomes and AEs
Real world data about efficacy and safety of dasatinib first- and second-
line treatment in CP CML pts are in line with the results of clinical trials.
Second-line dasatinib treatment
• 92% pts achieved or maintained CHR
• 64% pts achieved MCR (39.4% – CCR)
• 39.4% pts achieved optimal response
(CHR+CCR)
First-line dasatinib treatment
•All pts maintained CHR and
achieved CCR (excluding one
switched patient without CR and
CR);
•M/CMR has been registered in all
the pts excluding one TKI-naive
patient
 AEs were similar to the ones registered within the clinical trials;
• the frequency of hematological and non-hematological AEs was the same as it was
registered in clinical trials, in the most cases AEs were non-severe/moderate;
• no pleural effusion has been revealed during first-line treatment, 6 cases of pleural
effusion were revealed during second-line treatment.
Clinical response at 12 months of dasatinib treatment:

7. Results
QoL changes during dasatinib treatment in TKI-naive CP CML patients
and in early switched patients
0
20
40
60
80
100
PF RP BP GH VT SF RE MH
Base line
12 months after
treatment start
In 12 mths after dasatinib treatment start the improvement of social (63 vs 85)
and role emotional functioning (50 vs 89), mental health (57 vs 74) and vitality
(53 vs 71) was registered (ES=0.88–1.1).
The value of Integral QoL Index increased – 0.36 vs 0.53 (ES=1.8).

8. Results
QoL changes in imatinib-resistant or -intolerant CP CML patients
during second-line treatment with dasatinib
In 12 mths after second-line dasatinib treatment start improvement of
vitality (54 vs 60), social functioning (66 vs 75), mental health (59 vs 65) and
bodily pain (66 vs 73) was observed (p<0.05);
The value of Integral QoL Index increased – 0.34 vs 0.42 (p<0.05).
*p<0,05
*
*
*
*
0
20
40
60
80
100
PF RP BP GH VT SF RE MH
Base line
12 months after
treatment start

9. Results
Changes in the severity of the common symptoms in CP CML
patients receiving first- and second- line treatment with
dasatinib
0 1 2 3 4 5
Fatigue
Feeling of constant tiredness
Easy getting tired after physical
activity
Decreased work energy
Excessive sweat at rest and during
mild physical activity
Palpitation
Shortness of breath with little
exertion
Edema
Patients on first-line dasatinib treatment
0 1 2 3 4 5
12 months after
treatment start
Base line
Patients on second-line dasatinib treatment
Common Symptom Severity Index decreased while treatment: 2.83 vs 1.83 on first-line
(ES=0.9); 2.58 vs 1.94 on second-line treatment (ES=0.26).

10. Conclusions
• Information about efficacy and safety of dasatinib
first- and second-line treatment in CP CML pts from
the real world data is in line with the results of clinical
trials.
• Positive changes in quality of life and symptom profile
in CP CML pts during first- and second-line treatment
with dasatinib from the real world data were verified.
• The information obtained may be useful supplement
to clinical trials data about the effect of first- and
second line treatment of CP CML pts.