therapy effectiveness

Dasatinib in First- and Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life

MYELOID TUMORS , , , , ,

TI Ionova1,2, NB Bulieva3, OYu Vinogradova4,5,6, TA Gritsenko7, LK Kozlova8, GB Kuchma8, EG Lomaia9, ER Machyulaitene10, TP Nikitina1,2, NV Novitskaya4, AYu Rodionova2, EI Usacheva11, TV Shneider12

1 Saint Petersburg Multifield Medical Center under the Ministry of Health of Russia, 154 Nabereznaya Reki Fontanki, Saint Petersburg, Russian Federation, 198103

2 Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., office 152, Saint Petersburg, Russian Federation, 191014

3 I Kant Baltic Federal University, 14 A Nevskogo str., Kaliningrad, Russian Federation, 236041

4 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-zd, Moscow, Russian Federation, 125284

5 Dmitrii Rogachev Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology under the Ministry of Health of the Russian Federation, 1 Samory Mashela str., Moscow, Russian Federation, 117198

6 NI Pirogov Russian National Research Medical University under the Ministry of Health of the Russian Federation, 1 Ostrovityanova str., Moscow, Russian Federation, 117997

7 Samara State Medical University under the Ministry of Health of the Russian Federation, 89 Chapaevskaya str., Samara, Russian Federation, 443099

8 Orenburg State Medical University, 6 Sovetskaya str., Orenburg, Russian Federation, 460000

9 Federal Almazov North-West Medical Research Centre, 2 Akkuratova str., Saint Petersburg, Russian Federation, 197341

10 Outpatient Department, Academician IP Pavlov First St. Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022

11 RM Gorbacheva Scientific Research Institute of Pediatric Hematology and Transplantation; Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022

12 Leningrad District Clinical Hospital, 43/49 Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291

For correspondence: Tat’yana Ivanovna Ionova, DSci, 1 office 152 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; Tel: +7(812)579-61-38; e-mail: qlife@rambler.ru

For citation: Ionova TI, Bulieva NB, Vinogradova OYu, et al. Dasatinib in First- and Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life. Clinical oncohematology. 2017;10(2):206–17 (In Russ).

DOI: 10.21320/2500-2139-2017-10-2-206-217

ABSTRACT

Background & Aims. The article presents results of two observational, prospective, multicenter studies “Quality of Life, Symptom Profile, and Adherence to Treatment in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia Receiving Dasatinib” (2012–2015) and “Quality of Life and Symptom Profile in Imatinib-Resistant or Intolerant Patients with Chronic Myeloid Leukemia” (2011–2014).

Methods. Data of 107 patients with chronic myeloid leukemia in chronic phase were involved in the real-world analysis — 32 newly diagnosed patients on first-line treatment with dasatinib or after yearly switch to dasatinib after imatinib treatment failure and 75 imatinib-resistant or intolerant patients on second-line treatment with dasatinib. Treatment effectiveness and safety of dasatinib were assessed during first and second-line dasatinib treatment using clinical outcomes as well as quality of life and symptom profile assessment.

Results. The real-world data obtained during observational study in limited population of CML patients conform the results of clinical trials devoted to evaluation of treatment efficacy and safety of dasatinib treatment in first and second-line treatment and demonstrate the importance of patient-reported outcomes. Patient’s quality of life improved within 12 months of the first-line dasatinib therapy according to the following scales: role physical functioning, pain, vitality, social functioning and role emotional functioning. The most pronounced and clinically significant improvement was observed for the role emotional functioning (51.1 vs. 68.9). During the second-line dasatinib treatment, stabilization of quality of life parameters was registered for the following scales: vitality, social functioning, mental health, and pain. Significant improvement of the Integral Quality of Life Index was observed (p < 0.05). Positive dynamics of relevant symptoms was registered. The symptom severity decreased during both the first and second-line therapy.

Conclusion. Quality of life and symptom assessment in CML patients contribute to a better disease control in accordance with the principles of risk-adaptive therapy.

Keywords: quality of life, chronic myeloid leukemia, dasatinib, therapy effectiveness, therapy safety, routine clinical practice.

Received: November 10, 2016

Accepted: February 10, 2017

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