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EFFICACY AND SAFETY OF RUXOLITINIB IN 132 TURKISH PATIENTS WITH CHRONIC MYELOPROLIFERATIVE NEOPLASMS: A MULTICENTER AND RETROSPECTIVE ANALYSIS
Author(s): ,
Guray Saydam
Affiliations:
Hematology,Ege University Faculty Of Medicine,IZMIR,Turkey
,
Nur Soyer
Affiliations:
Hematology,Ege University Faculty Of Medicine,IZMIR,Turkey
,
Mehmet Turgut
Affiliations:
Hematology,OMU Faculty of Medicine,Samsun,Turkey
,
Ibrahim C. Haznedaroglu
Affiliations:
Hematology,Hacettepe Medical Faculty, Internal Medicine,Ankara,Turkey
,
Yilmaz Fergun
Affiliations:
Hematology,Ataturk Research and Training Hospital,IZMIR,Turkey
,
Ismet Aydogdu
Affiliations:
Hematology,CBU Medical Faculty,Manisa,Turkey
,
Ali Pir
Affiliations:
Hematology,KaTU Medical Faculty, Internal Medicine,Trabzon,Turkey
,
Volkan Karakus
Affiliations:
Hematology,Sitki Kocman Mugla University,Mugla,Turkey
,
Gokhan Ozgur
Affiliations:
Hematology,GATA,Ankara,Turkey
,
Cem Kis
Affiliations:
Hematology,Cukurova University,Adana,Turkey
,
Funda Ceran
Affiliations:
Hematology,Numune Research and Training Hospital,Ankara,Turkey
,
Gul Ilhan
Affiliations:
Hematology,Mustafa Kemal Univ,Hatay,Turkey
,
Melda Ozkan
Affiliations:
Hematology,Inonu Univ. Medical Faculty,Malatya,Turkey
,
Muzeyyen Arslaner
Affiliations:
Hematology,Dr Ersin Arslan Research and Training Hospital,Gaziantep,Turkey
,
Idris Ince
Affiliations:
Hematology,Dr Ersin Arslan Research and Training Hospital,Gaziantep,Turkey
,
Irfan Yavasoglu
Affiliations:
Hematology,AMU Internal Medicine,Aydin,Turkey
,
Fusun Gediz
Affiliations:
Hematology,Ataturk Research and Training Hospital,IZMIR,Turkey
,
Mehmet Sonmez
Affiliations:
Hematology,KaTU Medical Faculty, Internal Medicine,Trabzon,Turkey
,
Birol Guvenc
Affiliations:
Hematology,Cukurova University,Adana,Turkey
,
Gulsum Ozet
Affiliations:
Hematology,Numune Research and Training Hospital,Ankara,Turkey
,
Emin Kaya
Affiliations:
Hematology,Inonu Univ. Medical Faculty,Malatya,Turkey
,
Mahmut Tobu
Affiliations:
Hematology,Ege University Faculty Of Medicine,IZMIR,Turkey
,
Filiz Vural
Affiliations:
Hematology,Ege University Faculty Of Medicine,IZMIR,Turkey
Fahri Sahin
Affiliations:
Hematology,Ege University Faculty Of Medicine,IZMIR,Turkey
(Abstract release date: 05/17/18) EHA Library. Saydam G. 06/14/18; 216536; PB2293
Prof. Dr. Guray Saydam
Prof. Dr. Guray Saydam
Contributions
Abstract

Abstract: PB2293

Type: Publication Only

Background

Ruxolitinib has been approved for the treatment of patients with high- or intermediate-risk myelofibrosis with symptomatic splenomegaly. The aim of this study is to assess the efficacy and safety of ruxolitinib in patients with chronic myeloproliferative neoplasms.

Aims

The aim of this study is to assess the efficacy and safety of ruxolitinib in patients with chronic myeloproliferative neoplasms and clarify the existing treatment strategies of these patients.

Methods

Across all of Turkey, 14 centers were enrolled in the study. We retrospectively evaluated 132 patients who treated with ruxolitinib. Ethical committee aproval was obtained. 

Results
Among 132 MPN patients, 72 (54.5%) of them were male, 60 (45.5%) cases were female. The median age of the patients at the time of diagnosis was 58 (26- 83). Twenty (15.2%) of the patients were post- ET MF, 32 were (24.2%) post-PV MF and 80 (60.6%) were diagnosed as PMF. There was thrombosis and bleeding history before diagnosis in 15.2% and 8.3% of the patients, respectively. Only two patients had concomitant cancer history. Antiplatelet, androgen, steroid and erythrocyte stimulating agent treatments were present in 59.9%, 12.1%, 7.6% and 2.3% patients, respectively. Splenectomy was performed only in 3.8% of the patients.  There was JAK2 mutation and MPL mutation positivity in 66.9% and 14.6% of patients, respectively. Conventional cytogenetic analysis was applied in 31 patients. Twenty three patients had normal karyotype and 8 patients had complex karyotype. Leukemic transformation was observed in 6 (4.5%) patients. Only one patient was undergone hematopoietic stem cell transplantation. The median white blood cell, platelet and hemoglobin (x103/µl) counts were 10.75 (0.8- 61.3), 346 (42- 1920) and 10.8 (6. 6- 20.7), respectively.

All patients had first line cytoreductive treatment. Hydroxyurea (85.2%) was the most common drug as first line treatment. Anagrelide (n=18) and interferon (n=14) were the most common drugs as second line treatment. Eight patients were used third line treatment. Interferon was the most common drug.

Twenty patients were lost. Exitus reasons were pneumonia/sepsis in 10 patients, myocardial infarction (n=1), acute respiratory distress syndrome (n=1), bleeding (n=1), and cholangiocellular carcinoma (n=1) in other patients.

The median dose of ruxolitinib was 30 (10- 40) mg at the beginning of the therapy. Dose change was made in 39 (43.8%) of 89 patients. Forty one (39%) of 105 patients had adverse events. Thirty five (33.3%) of 105 had hematological adverse events (n=21, anemia and n=19, thrombocytopenia). Eighteen (17.1%) of 105 patients had non-hematological adverse events. The most common events were infection (n=4), elevated liver enzymes (n=4) and fatigue (n=4). Others were zona zoster (n=2), abdominal discomfort (n=2), rash (n=1) and dizziness (n=1).

Eighty eight (82.2%) of 107 patients who had constitutional symptoms were improved. The median spleen sizes before and after ruxolitinib treatment were 220 (110-350) mm versus 193 (110-270), respectively.

Conclusion
 

We observed a reduction in spleen size after ruxolitinib treatment in Turkish patients with MPN and constitutional symptoms were improved. Ruxolitinib is both safe and efficacious in Turkish patients with MPNs.

Session topic: 16. Myeloproliferative neoplasms - Clinical

Keyword(s): Chronic, Myeloproliferative disorder, Ruxolitinib

Abstract: PB2293

Type: Publication Only

Background

Ruxolitinib has been approved for the treatment of patients with high- or intermediate-risk myelofibrosis with symptomatic splenomegaly. The aim of this study is to assess the efficacy and safety of ruxolitinib in patients with chronic myeloproliferative neoplasms.

Aims

The aim of this study is to assess the efficacy and safety of ruxolitinib in patients with chronic myeloproliferative neoplasms and clarify the existing treatment strategies of these patients.

Methods

Across all of Turkey, 14 centers were enrolled in the study. We retrospectively evaluated 132 patients who treated with ruxolitinib. Ethical committee aproval was obtained. 

Results
Among 132 MPN patients, 72 (54.5%) of them were male, 60 (45.5%) cases were female. The median age of the patients at the time of diagnosis was 58 (26- 83). Twenty (15.2%) of the patients were post- ET MF, 32 were (24.2%) post-PV MF and 80 (60.6%) were diagnosed as PMF. There was thrombosis and bleeding history before diagnosis in 15.2% and 8.3% of the patients, respectively. Only two patients had concomitant cancer history. Antiplatelet, androgen, steroid and erythrocyte stimulating agent treatments were present in 59.9%, 12.1%, 7.6% and 2.3% patients, respectively. Splenectomy was performed only in 3.8% of the patients.  There was JAK2 mutation and MPL mutation positivity in 66.9% and 14.6% of patients, respectively. Conventional cytogenetic analysis was applied in 31 patients. Twenty three patients had normal karyotype and 8 patients had complex karyotype. Leukemic transformation was observed in 6 (4.5%) patients. Only one patient was undergone hematopoietic stem cell transplantation. The median white blood cell, platelet and hemoglobin (x103/µl) counts were 10.75 (0.8- 61.3), 346 (42- 1920) and 10.8 (6. 6- 20.7), respectively.

All patients had first line cytoreductive treatment. Hydroxyurea (85.2%) was the most common drug as first line treatment. Anagrelide (n=18) and interferon (n=14) were the most common drugs as second line treatment. Eight patients were used third line treatment. Interferon was the most common drug.

Twenty patients were lost. Exitus reasons were pneumonia/sepsis in 10 patients, myocardial infarction (n=1), acute respiratory distress syndrome (n=1), bleeding (n=1), and cholangiocellular carcinoma (n=1) in other patients.

The median dose of ruxolitinib was 30 (10- 40) mg at the beginning of the therapy. Dose change was made in 39 (43.8%) of 89 patients. Forty one (39%) of 105 patients had adverse events. Thirty five (33.3%) of 105 had hematological adverse events (n=21, anemia and n=19, thrombocytopenia). Eighteen (17.1%) of 105 patients had non-hematological adverse events. The most common events were infection (n=4), elevated liver enzymes (n=4) and fatigue (n=4). Others were zona zoster (n=2), abdominal discomfort (n=2), rash (n=1) and dizziness (n=1).

Eighty eight (82.2%) of 107 patients who had constitutional symptoms were improved. The median spleen sizes before and after ruxolitinib treatment were 220 (110-350) mm versus 193 (110-270), respectively.

Conclusion
 

We observed a reduction in spleen size after ruxolitinib treatment in Turkish patients with MPN and constitutional symptoms were improved. Ruxolitinib is both safe and efficacious in Turkish patients with MPNs.

Session topic: 16. Myeloproliferative neoplasms - Clinical

Keyword(s): Chronic, Myeloproliferative disorder, Ruxolitinib

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