Hydroxyurea Treatment In 1075 Patients with Essential Thrombocythemia and Occurrence of Extra-Hematological Adverse Events: A Preliminary Report of the Registro Italiano Trombocitemia (RIT)

Author:

Gugliotta Luigi1,Papayannidis Cristina2,Piccin Andrea3,Tieghi Alessia4,Vianelli Nicola5,Scalzulli Potito Rosario6,Candoni Anna7,Dragani Alfredo8,Patriarca Andrea8,Lunghi Monia9,Ciancia Rosanna10,Martinelli Vincenzo11,Liberati Anna Marina12,Specchia Giorgina13,Imovilli Annalisa14,Vannucchi Alessandro M.15,Di Gaetano Rosa16,Randi Maria Luigia17,Passamonti Francesco18,Palmieri Fausto19,Mazzucconi Maria Gabriella20,Mastrullo Lucia21,Cimino Giuseppe22,Pierri Ivana23,Cacciola Emma24,Lucchesi Alessandro25,Luraschi Annalisa26,Martinelli Giovanni2,Baccarani Michele2

Affiliation:

1. S. Orsola-Malpighi Hematology-Oncology, University of Bologna, Bologna, Italy,

2. Department of Hematology-Oncology, University of Bologna, Bologna, Italy,

3. Hematology Unit, Ospedale Civile, Bolzano, Italy,

4. Hematology, Reggio Emilia, Reggio Emilia, Italy,

5. Istituto di Ematologia L. A. Seràgnoli, Policlinico Sant’Orsola Malpighi, Bologna, Italy,

6. Hematology Unit, Casa sollievo della Sofferenza, S. Giovanni Rotondo (FG), Italy,

7. Chair and Division of Haematology, University Hospital of Udine., Chair and Division of Haematology, University Hospital of Udine., Udine,

8. Hematology Unit, Ospedale S. Spirito, Pescara, Italy,

9. Division of Hematology, BRMA - Amedeo Avogadro University of Eastern Piedmont, Novara, Italy,

10. Hematology, Federico II University, Napoli, Italy,

11. Hematology Division, Department of Biochemistry and Medical Biotechnology, University Federico II, Naples, Italy,

12. Hematology Unit, Università, Terni, Italy,

13. University of Bari, Bari, Italy,

14. Ematologia, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy,

15. Hematology, Dept of Medical and Surgical Care, Florence, Italy,

16. Hematology Unit, Ospedale Castelfranco Veneto, Castelfranco Veneto,

17. University of Padua, Italy,

18. Department of Hematology, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy,

19. Hematology Unit, AORN S. Giuseppe Moscsti, Avellino,

20. Department of Cellular Biotechnologies and Hematology, University of Rome, Rome, Italy,

21. Hematology Unit, Ospedale S. Gennaro, Napoli,

22. Univ.Polo Pontino, Latina, Italy,

23. Chair of Hematology, University of Genova, Genova,

24. Biomedical Science, Section of Hematology, University of Catania, Catania, Italy,

25. Hematology Unit, Ospedale, L’Aquila, Italy,

26. Hematology Unit, Ospedale di Verbania, Verbania, Italy

Abstract

Abstract Abstract 1973 Background. Hematological and extra-hematological adverse events associated to Hydroxyurea (HU) treatment in patients with chronic myeloproliferative neoplasms (MPN) are object of particular interest in the Ph-negative MPN since they can significantly limit the HU use. Objective. To evaluate the extra-hematological adverse events associated to HU treayment in a large cohort of Essential Thrombocythemia (ET) patients. Material and Methods. One thousand and seventy-five out of the 2005 ET patients registered in the RIT were treated with HU and are the object of this report. The patients, 641 females (59.6%) and 434 males (40.4%), diagnosed according to the PVSG or WHO criteria in 54 hematological centers of the RIT, started treatment with HU as first (92%) or second (8%) line, at median age of 65 years.The mean duration of HU treatment was 3.3 years. The HU treatment was withdrawn in 221 (20.5%) patients after a mean of 3.0 years.The administered dose of HU was 0.25–3.0 g/day (median 1), and a mean cumulative dose was 1113 g. The extra-hematological adverse events (EHAEs) observed during the HU treatment were distinguished in HU related AEs (HU-EHAEs), ET related AEs (ET-EHAEs) and HU or ET unrelated AEs (U-EHAEs).Results. During the HU treatment (3587 pt-y) 378 EHAEs were reported in 207 (19.3%) patients, being the HU-EHAEs 244 (6.8/100 pt-y) in 170 (15.8%) patients. In detail, the HU-EHAEs were: dermatological in 108 (48.3%) cases (38 hyperpigmentation, 26 leg ulcers, 22 maculo-papular rash, 10 lichenoid eruptions, 5 skin cancer, 4 alopecia); gastro-intestinal in 80 (32.8%) cases (37 nausea/vomiting, 30 diarrhea, 13 gastro-intestinal intolerance); systemic in 35 (14.3%) cases (28 fever, 7 fatigue); neurological in 19 (7.8%) cases (headache); miscellanea in 2 (0.8%) cases. Conclusion. This preliminary analysis in 1075 ET patients of the Registro Italiano Trombocitemia (RIT) treated with HU shows that the extra-hematological adverse events referred to the HU (HU-EHAEs) occurred with not negligible rate (6.8/100 pt-y) and need to be object of attention in the management of ET patients. Disclosures: No relevant conflicts of interest to declare.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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