Microsoft word - idrossiurea_eha_2011.doc

SIDE EFFECTS OF HYDROXYUREA IN CLASSIC CHRONIC MYELOPROLIFERATIVE NEOPLASMS. A RETROSPECTIVE STUDY OF 3,411 PATIENTS E Antonioli 1, P Guglielmelli 2, L Pieri 2, MC Finazzi 3, E Rumi 4, V Martinelli 5, N Vianelli 6, ML Randi 7, I Bertozzi7 , V De Stefano 8, T Za 8,M Ruggeri 9, F Rodeghiero 9, E Elli 10, E Pogliani 10, R Cacciola 11, E Cacciola 11, G Leone 8, M Baccarani6 , F Passamonti 4, G Finazzi 3, A Rambaldi 3, A Bosi2, T Barbui 3, A Vannucchi 2 1- AOU Careggi, Firenze, Italy
2- University of Florence, Firenze, Italy
3- Ospedali Riuniti, Bergamo, Italy
4- IRCCS, Pavia, Italy
5- Haematology, University of Napoli, Napoli, Italy
6- Haematology Unit, Bologna, Italy
7- Internal medicine, Padova, Italy
8- Hematology, Univ Cattolica, Roma, Italy
9- Haematology, Vicenza, Italy
10- Elli, E, Haematology unit, San Gerardo, Monza, Italy
11- Haematology, Catania, Italy
Backgroud. Hydroxyurea (HU) is the drug of choice for the treatment of patients with high risk
myeloproliferative neoplasms (MPN). Its more frequent side effects are represented by
gastrointestinal toxicity, cutaneous and mucosal toxicity, pulmonary toxicity and fever. A
number of anecdotal cases have been reported in the literature, but epidemiological
information on large series of patients are not yet available.
Aims. To collect information on the rate and characteristics of HU-related side effects, we
examined data from a retrospective survey of ten hematological centers in Italy. To ensure
consistency of data, we only included clinically relevant HU-related manifestations such
cutaneous and mucosal lesions, fever and pneumonitis.
Methods. This study was performed within the GIMEMA (Gruppo Italiano Malattie
Ematologiche Maligne dell'Adulto) MPN Working Party, under the auspices of AGIMM (AIRC-
Gruppo Italiano Malattie Mileoproliferative). Centers were asked to identify, in their own data
base, all subjects with a diagnosis of MPN who had received hydroxyurea and developed one
of the side effects considered above. Diagnosis of PV, ET or PMF was made according to
either the WHO2008 or PVSG/WHO2001 criteria, while diagnosis of post-PV or post-ET MF
was made according to the IWG-MRT plus the histological WHO criteria. Furthermore, for
comparison populations, each participating centre provided information on the total number of
referring patients with matched diagnosis who had been in treatment with HU and had not
developed side effects in the same period of time.
Results. The whole study population was comprised of 3,411 MPN patients, of whom 963
were PV, 1912 ET, 357 PMF, 93 PPV and 86 PET. A total of 184 patients (5%) who developed
HU-related side effects were identified: 16 of them developed fever, 167 muco-cutaneous
lesions and 1 pneumonitis. Pulmonary toxicity attributed to HU was diagnosed in a 68-year-old
male with JAK2V617F negative PMF who was being treated since ten years with 1 g/ daily.
High degree (>39.°C) fever developed in 16 patients: 4 PV, 11 ET and 1 MF. Eight males and
8 females, median age 64 yrs (range 50-79 yrs), 86% were JAK2V617F mutated. Fever was
reported after a median period of 31 days (range, 1-109) of treatment at median dosage of 0.5
g daily (range, 0.15-1 g), for a total HU median dose of 15 g (range, 0.5-52.5 g) for patient.
Muco-cutaneous lesions were referred by 167 patients; 28 patients developed mucosal
lesions, 118 patients presented cutaneous ulcers, while other cutaneous lesions including
keratosis, dyschromia, basalioma and dermatitis developed in 21 patients, as detailed in the
table. Two patients reported both mucosal and cutaneous lesions.
Conclusions. With the intrinsic limitations of the retrospective design, this study provides, for
the first time, an estimate of the rate of HU-related side effects (5%) overall strenghtening the
good tolerability of the drug.


Pentecost 11, 8-4-2013

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