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Nikitina_Ionova_poster presentation_EAFO

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Nikitina_Ionova_poster presentation_EAFO

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

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