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  • 1
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    Latium (Italy) Epidemiology of Philadelphia Chromosome-Negative Myeloproliferative Neoplasms (MPNs) from 2011 to 2015: A Prospective Analysis from Gruppo Laziale of Ph Negative MPN
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 5473-5473
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 5473-5473
    Abstract: Background: MPNs including Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF), are clonal hematopoietic diseases in which the discovery of molecular driver mutations (JAK2, CALR, MPL) has deeply modified diagnostic approach in recent years. To date available data on epidemiology of MPNs and perspective analysis are rare. Our aim is to study the incidence of MPN Ph negative in a specific region of Italy named Latium and its variability across five years. Moreover we prospectively report the general features of our population. Method: We present here the prospective epidemiologic analysis of 1116 adult patients affected by MPNs (PV=289, ET=550, PMF=209) diagnosed according to 2008 WHO criteria, from January 2011 to December 2015 in 15 hematological Centers (5 academic and 10 community-based Hospitals) in Latium. A total of 289 PV, 550 ET and 209PMF were identified. The overall incidence rate of 289PV was 1.0/105 in 2011 and 2012, 1.1/105 in 2013, 0.9/105 in 2014 and 2015. The overall incidence rate of 550ET was 2.0/105 in 2011, 2.4/105 in 2012, 2.2/105 in 2013, 1.8/105 in 2014 and 1,2/105 in 2015 and the overall incidence rate of 209PMF was 0.7/105 in 2011 and 2012, 1.0/105 in 2013, 0.7/105 in 2014 and 0.5/105 in 2015. We have observed also 63 cases of MPNu (36M/32F) and the incidence rate was 0.3/105 in 2011 and 2012, 0.14/105 in 2013, 0.24/105 in 2014 and 0.22/105 in 2015. Baseline features of PV, ET and PMF patients are summarized in table 1. We have also analyzed the presence of comorbidities including obesity, arhythmia and neoplasia observed at the diagnosis in 1.6, 6.2 and 4% of all population, respectively; thirty-five percent of 1116 pts presented other comorbidities such as diabetes, inflammatory bowel disease, renal and liver failure. As thrombotic risk factors we considered diabetes, dislipidemia, smoke, essential hypertension and thrombophilia observed in 11,8, 16,2, 13,2, 51,7 and 3% of total pts, respectively. Conclusions: We confirm in our prospective observational protocol the overall incidence of MPN Ph negative, previously reported in the literature and the major incidence of male gender in PV and PMF, female in of ET. The annual incidence from 2011-2015 in Latium is remained substantially the same during the observation period. The decreasing trend observed in 2015 is probably due to the different update of some Centers that was done in October 2015 not including patients diagnosed in the last two months. Disclosures Latagliata: Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Janssen: Consultancy, Honoraria; Shire: Honoraria. Breccia:Pfizer: Honoraria; Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Ariad: Honoraria. Cimino:Celgene: Honoraria; Bristol-Mayer: Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.5473.5473
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 2
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    Are ET and PV Patients Two Similar Populations As Concern Thrombotic Risk Factors?
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2811-2811
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2811-2811
    Abstract: Thrombotic events are major complications in patients (pts) affected by Essential Thrombocytemia (ET) and Polycytemia Vera (PV). To compare thrombotic risk in these 2 groups, we evaluated retrospectively our database of 1249 ET and 623 PV pts diagnosed and followed in 11 hematological centers in the Latium region between 1/1980 and 12/2010: the diagnosis was done according to PVSG, WHO 2001 and 2008criteria based on the time of first observation. Baseline features of ET pts: 797F/452M,median age 62.9 yrs (range 19-96),median WBC count 8.8 x 109/L (range 1.2-57.7), median PLT count 812 x 109/L (range 457-3582), median Hb level 14.0 g/dl (range 6-20.5), JAK-2V617F positivity 59.7% with a median allele burden of 19,6% (range 0.2- 99.9), spleen enlargement in 18.7% of pts, previous thrombosis223/1239 evaluable pts (17.9%) [arterial 176/223 (14.1%), venous 47/223 (3.8%)]. Baseline features of PV pts: 289F/334M, median age 63.0yrs (range 21-91), median WBC count 10.1 x 109/L (range 3.5-37.6), median PLT count 457 x 109/L (range 169-1790), median Hb level 18.2 g/dl (range 10.5-24.8), JAK-2V617F positivity 94.3% with a median allele burden of 59.1% (range 0.3-99.9), spleen enlargement in 42% of patients, previous thrombosis 146/617 evaluable pts (23.7%)[arterial 114/617 (18.5%), venous 32/617 (5,2%)] .in the ET cohort, after a median follow-up of 7.7 yrs, thrombotic complications were seen in 107/1141 evaluable pts (9.4%) [arterial60 (5.25%), venous 47 (4.11%)]; in the PV cohort, after a median follow-up of 8.5 yrs, thrombotic complications were seen in 107/623pts (17.2%) [arterial 67 (10.8%),venous 40 (6.4%)] .All common risk factors for thrombosis were evaluated in multivariate analysis, searching the cut-off number for continuous variables with ROC curves. The significant variables at multivariate analysis for ET and PV pts are shown in the table; age, previous thromboses and spleen enlargement were risk factors in ET pts, while previous thromboses and JAK-2V617F allele burden were risk factors in PV pts. PLT count above ROC value seemed to be a protective factor in both cohorts. In conclusion, in contrast with the tendency to evaluate in a similar manner the thrombotic risk of PV and ET, data from our retrospective database showed that these 2 groups should be considered populations with different risk factors for thrombosis. Table 1.Putative prognostic factorsPolycythemia VeraEssential ThrombocythemiaHR95% C.I.pHR95% C.I .pPrevious thromboses2,311,13 - 4,740,021,871,08 -3,230,026Age ≥ 60 y1,540,79 - 2,990,211,901,18 - 3,060,009JAK2V617FPV: allelic burden ≥ 81% ET: pos1,951,03 - 3,710,040,760,48 - 1,210,25Plt countPV ≥ 452.109/L ET ≥ 944.109/L0,490,25 - 0,950,040,520,31 - 0,890,017Spleen enlargement0,670,34 -1,310,241,711,02 - 2,890,04CV risk factors (at least 1)0,920,41 - 2,030,830,870,51 - 1,490,62WBCPV ≥ 10,175.109/L ET ≥ 9,630.109/L1,090,57 - 2,080,801,410,89 -2,260,15 Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2811.2811
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 3
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    Risk Factors for Thrombosis Vary According to Age in Patients with Essential Thrombocythemia: a Retrospective Analysis of 1090 Patients from the “Gruppo Laziale SMPC Ph Negative “,
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 3854-3854
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 3854-3854
    Abstract: Abstract 3854 Increasing age is a well-recognised risk factor for thrombotic events in patients with Essential Thrombocythemia (ET): however, few data exist on the role of other clinical and biological features in different age groups. To address this issue, we analysed retrospectively 1090 ET patients (M/F 403/687, median age 63 years, IR 17 – 96) diagnosed at 11 Hematological Institutions in the Lazio region from 1980 to 2010 and with a median period of follow-up of 84 months (IR 1 – 371). Based on the commonly adopted age threshold, 480 patients (44 %) were 〈 60 years (Group A) and 610 (56 %) were ≥ 60 years (Group B). Clinical and biological features as well as cardiovascular risk factors analyzed for the impact on the thrombotic risk in the two age groups are reported in the Table.Group A 〈 60 yearsGroup B ≥ 60 yearsPutative risk factorsRisk ratio (95% CI)P valueRisk ratio (95% CI)P valueM/F167/3132.68 (1.03–6.94)0.0029236/3741.12 (0.17–2.59)0.73WBC median (range) x 109/l8.9 (4.29–22.35)0.387 (0.149–1,004)0.06458.9 (1.2–57.7)0.79 (0.41–1.47)0.445PLTS median (range) x 109/l837 (451–3582)0.37 (0.258–1.70)0.66802 (450–3104)0.52 (0.28–0.99)0.0052Hb median, g/dL (range)14.1 (6.0–18.4)0.86 (0.33–2.24)0.76914.0 (7.0–17.8)0.87 (0.45–1.67)0.674*JAK-2 mutational status: wild type/mutated (%)53.2/46.81.57 (0.50–4.87)0.4434.1/65.90.498 (0.17–1.48)0.209Previous thrombotic events: n° (%)· All events72 (15)2.18 (0.59–7.96)0.12149 (24.4)3.01 (1.38–6.57)0.0004· within 24 months from diagnosis48 (10)1.43 (0.19–10.4)0.7464 (10.5)0.506 (0.18–1.39)0.189· within 60 months from diagnosis60 (12.5)NA0.5191 (14.9)0.323 (0.11–0.95)0.023Cardiovascular risk factors: Y/N %○ Arterial hypertension41.7/58.31.68(0.64–4.36)0.2880.7/19.30.96 (0.36–2.57)0.935○ Diabetes10.2/89.81.11 (0.23–5.15)0.8925.0/75.01.09 (0.38–3.11)0.86○ Smoking attitude45.6/54.42.78 (1.01–7.65)0.06758.3/41.71.04 (0.35–3.09)0.94○ Hyperlipidemia31.0/69.03.11(0.917–10.592)0.03951.6/48.42.31 (0.70–7.55)0.203 In Group A, 39 patients (8.1%) had at least one thrombotic event during follow-up; there were 20 (51.3%) arterial thrombosis and 19 (48.7%) venous thrombosis. In Group B, 63 patients (10.3%) had at least one thrombotic event during follow-up; there were 38 (69.4%) arterial thromboses and 25 (39.6%) venous thromboses. In group A univariate analysis for thrombosis-free survival performed by Kaplan-Meier method, disclosed a significant impact of male gender (p=0.0029, CI 1.03–6.94, HR 2.68), 〉 2 cardiovascular risk factors (p=0.0002, CI 1.87 – 190, HR 18.94) and isolated hyperlipidemia (p=0.039, CI 0.917 – 10.59, HR 3.11), while previous thrombotic events had no significant impact (p=0.27). By contrast, the presence of a previous thrombotic event was the only feature with a significant impact on thrombotic risk in Group B (p=0.0004, CI 1.38 – 6.55, HR 3.01). WBC and PLTS values at different cut-off levels as well as JAK-2 mutational status did not have any impact on thrombosis in either age groups. However, in group B, we observed a trend (p=0.052, CI 0.28–0.99, HR 0.52) towards a protective effect of higher PLTS values ( 〉 800 × 109/l). In conclusion, our data seem to reinforce the need of a different thrombotic risk assessment in distinct age groups: in particular, younger patients could benefit from early recognition and treatment of well-known cardiovascular risk factors. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.3854.3854
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 4
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    Clinical Follow-up of Patients with Myeloproliferative Neoplasms Presenting Skin Ulcers During Treatment with Hydroxyurea
    American Society of Hematology ; 2011
    In:  Blood Vol. 118, No. 21 ( 2011-11-18), p. 5157-5157
    Details
    In: Blood, American Society of Hematology, Vol. 118, No. 21 ( 2011-11-18), p. 5157-5157
    Abstract: Abstract 5157 Hydroxyurea (HU) is widely employed in the treatment of Myeloproliferative Neoplasms (MPN); however, painful skin ulcers are a limiting toxicity during HU treatment in 〉 5% of patients. To evaluate the clinical impact of such complication on the outcome of these patients, we retrospectively revised 1001 cases (M/F 437/564, median age 65.6 years, IR 55.6 – 73.7) with MPN consecutively diagnosed at 6 Centers in Rome who received HU treatment during the course of disease. There were 537 patients with Essential Thrombocythemia (ET), 336 with Polycythemia Vera (PV), 102 with Primary Myelofibrosis (PMF) and 26 with unclassifiable Chronic Myeloproliferative Disorders (CMPD-u); 863 patients (86.2%) received HU as 1st line treatment while 138 (13.8%) as 2nd or 3rd line treatment. On the whole, 71 patients (7.1%) developed painful skin ulcers after a median period of 54.1 months (IR 27.7 – 97.6) from HU start; as concerns the site, in 56/71 patients (78.8%) skin ulcers were located in the perimalleolar area while in the remaining 15 patients in other skin areas (localized to the head or to the extremities in 8 and 7 patients, respectively). When the skin ulcers occurred, HU treatment was continued at the same dosage in 11 patients (15.4%), was reduced in 13 patients (18.4%) and temporarily interrupted in 11 patients (15.4%): the remaining 36 patients (50.8%) needed a permanent drug discontinuation. Among these latter patients, pipobroman was started in 20 patients, anagrelide in 5, alpha-interferon in 3, melphalan in 3; in addition, no further treatment was given in 1 patient and 4 patients were lost to follow-up. As to ulcer resolution, 11/71 patients were not evaluable (2 too early, 9 lost to follow-up). Among the 60 evaluable patients, after a median period of 6.3 months (IR 3.6 – 11.3) from the onset of the skin ulcers, 43 patients (71.6%) had a complete resolution and 17 patients (28.4%) had an improvement without complete resolution. The incidence of 2nd neoplasia [3/71 (4.2%) patients with skin ulcers vs 73/930 (7.8%) patients without skin ulcers] and blastic phase evolution [2/71 (2.8%) patients with skin ulcers vs 41/930 (4.4%) patients without skin ulcers] were not increased after the skin ulcer occurrence. After a median period from skin toxicity of 30.7 months (IR 14.3 – 63.6), 9 patients were lost to follow-up, 11 patients died and 51 patients are still alive. In conclusion, painful skin ulcers during HU treatment are a relatively common complication in MPN patients, require HU discontinuation in 〉 50% of cases and in a sizable rate of patients there is only a partial healing of skin lesion: however, this complication and the requested treatment changes do not seem to impact on the subsequent clinical follow-up of MPN patients. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V118.21.5157.5157
    RVK:
    XA 33000
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    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2011
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  • 5
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    Thrombosis and survival in essential thrombocythemia: A regional study of 1,144 patients
    Wiley ; 2014
    In:  American Journal of Hematology Vol. 89, No. 5 ( 2014-05), p. 542-546
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    In: American Journal of Hematology, Wiley, Vol. 89, No. 5 ( 2014-05), p. 542-546
    Abstract: To identify prognostic factors affecting thrombosis‐free survival (TFS) and overall survival (OS), we report the experience of a Regional cooperative group in a real‐life cohort of 1,144 patients with essential thrombocythemia (ET) diagnosed from January 1979 to December 2010. There were 107 thrombotic events (9.4%) during follow‐up [60 (5.3%) arterial and 47 (4.1%) venous thromboses]. At univariate analysis, risk factors for a shorter TFS were: age 〉 60 years ( P   〈  0.0054, 95% CI 1.18–2.6), previous thrombosis ( P   〈  0.0001, 95% CI 1.58–4.52) and the presence of at least one cardiovascular risk factor ( P  = 0.036, 95% CI 1.15–3.13). Patients with a previous thrombosis occurred ≥24 months before ET diagnosis had a shorter TFS compared to patients with a previous thrombosis occurred 〈 24 months ( P  = 0.0029, 95% CI 1.5–6.1); furthermore, patients with previous thrombosis occurred 〈 24 months did not show a shorter TFS compared with patients without previous thrombosis ( P  = 0.303, 95% CI 0.64–3.21). At multivariate analysis for TFS, only the occurrence of a previous thrombosis maintained its prognostic impact ( P  = 0.0004, 95% CI 1.48–3.79, RR 2.36). The 10‐year OS was 89.9% (95% CI 87.3–92.5): at multivariate analysis for OS, age 〉 60 years ( P   〈  0.0001), anemia ( P   〈  0.0001), male gender ( P  = 0.0019), previous thromboses ( P  = 0.0344), and white blood cell 〉 15 × 10 9 /l ( P  = 0.0370) were independent risk factors. Previous thrombotic events in ET patients are crucial for TFS but their importance seems related not to the occurrence per se but mainly to the interval between the event and the diagnosis. Am. J. Hematol. 89:542–546, 2014. © 2014 Wiley Periodicals, Inc.
    Type of Medium: Online Resource
    ISSN: 0361-8609 , 1096-8652
    URL: Issue
    URL: Article
    DOI: 10.1002/ajh.v89.5
    DOI: 10.1002/ajh.23685
    Language: English
    Publisher: Wiley
    Publication Date: 2014
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  • 6
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    Role of treatment on the development of secondary malignancies in patients with essential thrombocythemia
    Wiley ; 2017
    In:  Cancer Medicine Vol. 6, No. 6 ( 2017-06), p. 1233-1239
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    In: Cancer Medicine, Wiley, Vol. 6, No. 6 ( 2017-06), p. 1233-1239
    Abstract: Aim of this study is to explore the role of different treatments on the development of secondary malignancies ( SM s) in a large cohort of essential thrombocythemia ( ET ) patients. We report the experience of a regional cooperative group in a real‐life cohort of 1026 patients with ET . We divided our population into five different groups: group 0, no treatment; group 1, hydroxyurea ( HU ); group 2, alkylating agents ( ALK ); group 3, ALK  +  HU sequentially or in combination; and group 4, anagrelide ( ANA ) and/or α ‐interferon ( IFN ) only. Patients from groups 1, 2, and 3 could also have been treated either with ANA and/or IFN in their medical history, considering these drugs not to have an additional cytotoxic potential. In all, 63 of the 1026 patients (6%) developed 64 SM during the follow‐up, after a median time of 50 months (range: 2–158) from diagnosis. In univariate analysis, a statistically significant difference was found only for gender ( P  = 0.035) and age ( P  = 0.0001). In multivariate analysis, a statistically significant difference was maintained for both gender and age (gender HR 1.7 [ CI 95% 1.037–2.818] P  = 0.035; age HR 4.190 [ CI 95% 2.308–7.607] P  = 0.0001). The impact of different treatments on SM s development was not statistically significant. In our series of 1026 ET patients, diagnosed and followed during a 30‐year period, the different therapies administered, comprising HU and ALK , do not appear to have impacted on the development of SM . A similar rate of SM s was observed also in untreated patients. The only two variables which showed a statistical significance were male gender and age 〉 60 years.
    Type of Medium: Online Resource
    ISSN: 2045-7634 , 2045-7634
    URL: Issue
    URL: Article
    DOI: 10.1002/cam4.2017.6.issue-6
    DOI: 10.1002/cam4.1081
    Language: English
    Publisher: Wiley
    Publication Date: 2017
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  • 7
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    Application of the International Prognostic Score of Thrombosis for Essential Thrombocytemia(ET) (IPSET-Thrombosis) in a Cohort of ET Patients: Experience from Gruppo Laziale for Myeloproliferative Ph Negative Neoplasms
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2821-2821
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    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2821-2821
    Abstract: INTRODUCTION: Essential Thrombocytemia (ET) is the most common of the myeloproliferative neoplasms, vascular complications contribute mostly to both morbidity and mortality. The ability to identify thrombotic risk of the individual patient is necessary for a correct therapeutic management. Traditionally, risk stratification for thrombosis in ET pts was based on the respective absence and/or presence of either age 〉 60 years or history of thrombosis. Recently, the IPSET score (International Prognostic Score Of Thrombosis for ET) was developed to better predict the occurrence of thrombotic events in ET patients. Risk factors included in the new score were: age, cardiovascular risk factors, previous thrombosis, presence of JAK 2 V617F mutation. AIM: to evaluate the validity of IPSET-thrombosis score in a cohort of ET patients from "Gruppo Laziale for Myeloproliferative Ph negative Neoplasms" in predicting thrombosis incidence. METHODS: from January 1978 to December 2011 we observed 1249 ET patients, median follow up was 105 months (range 12.1-417.7). We were able to retrospectively evaluate all the IPSET risk factors in 680 ET patients and estimated the clinical implication of the IPSET-thrombosis score system. According to the score 27.3 %, 19.1% and 53.5% of pts were stratified in low, intermediate and high risk group respectively. RESULTS: median age at the time of diagnosis was 61.8 yrs (range 19.9 -94; 64% females), median hemoglobin was 14 g/dl (range 6-20); median leukocyte count was 8.8 x 109/L (range 1,2-57); median platelets count was 812x 109/L (range 108-3582). We observed, during a median follow-up of 200 months, 82 thrombotic events (total incidence 17,89 %). According IPSET-thrombosis risk, in our ET population was documented a statistically different thrombosis free survival (TFS) (Gray test 0.1316): 85%, 78%, 77% in low,intermediate and high risk group respectively. During all the observation period the intermediate and high risk group showed a similar probability of thrombotic events. CONCLUSIONS: in our retrospective study the IPSET score was able to differentiate the rate of thrombosis events in low-risk (0-1 risk factors) from that of intermediate ( 〉 = 2 risk factors) and high risk ( 〉 = 3 risk factors) ET pts. Unfortunately the intermediate and high risk groups show a similar incidence of thrombotic events during the whole observation period. We were not able to verify the clinical benefit resulting from the different treatment strategies. Because treatment options in ET pts are tailored according to thrombotic risk, and since we have specified therapeutic indications for patients with low and high risk, it is necessary to validate the score IPSET in a large prospective, long term study to discriminate a true "intermediate" subset of patients for which there are no currently defined therapeutic guidelines. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2821.2821
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    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 8
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    The Role of Previous Thrombotic Events in Patients with Essential Thrombocythemia: The Earlier the Worse?
    American Society of Hematology ; 2012
    In:  Blood Vol. 120, No. 21 ( 2012-11-16), p. 5062-5062
    Details
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 5062-5062
    Abstract: Abstract 5062 Thrombotic events occurring before or at diagnosis of Essential Thrombocythemia (ET) are a worldwide recognized prognostic factor for the incidence of thrombosis during the follow-up of ET patients: however, these previous thrombotic events have been considered on the whole in the vast majority of studies, without further characterization. Among 1063 ET patients collected in the retrospective database of the “Gruppo Laziale SMPC Ph-”, we revised 186 cases with a previous thrombosis and a known data of occurrence, to evaluate the role of the interval from previous thrombotic episode and the diagnosis of ET. In 95 patients (51. 1%) previous thrombotic event occurred 〈 24 months before diagnosis of ET (group A) while in 91 patients (48. 9%) thrombosis occurred ≥ 24 months before diagnosis of ET (group B). Clinical features of patients at diagnosis are shown in the Table: GROUP A GROUP B p Gender (M/F) 40/55 42/49 0.636 Median age (yrs) (Interquartile range) (IR) 64.1 (52.7–71.8) 70.9 (61.0 – 78.0) 0.001 Hb median (g/dl) (IR) 13.9 (12.5 – 14.7) 14.2 (13.0 – 15.2) 0.136 PLT median (x 109/l) (IR) 800 (669 – 1066) 778 (652 – 926) 0.453 WBC median (x 109/l) (IR) 9.2 (7.8 – 11.3) 8.6 (7.1 – 10.8) 0.121 Median interval diagnosis – CHT (mos) (IR) 0.9 (0 – 7.0) 1.7 (0.4 – 5.6) 0.194 *CV risk factors (n°/%): 0.454     0 20 (21.0) 17 (18.6)     1 42 (44.2) 44 (48.3)     ≥ 2 33 (34.8) 30 (33.1) Type of previous thrombosis (n°/%): 0.873     Arterial 78 (82.1) 67 (73.6)     Venous 17 (17.9) 24 (26.4) * Cardiovascular (CV) risk factors at diagnosis were considered the presence of arterial hypertension, diabetes, smoking attitude, and hypercholesterolemia. In the group A, 9 out 95 patients (9. 4%) reported thrombotic episodes (5 arterial and 4 venous) during follow-up compared to 23 out 91 patients (25. 2%) (13 arterial and 10 venous) in the group B (p=0. 004). Consequently, patients of group B had a significantly higher cumulative risk of thrombosis compared to patients of group A (p=0. 0029, CI95% 1. 5 – 6. 1, RR 3. 04). In addition, it is worth of note that there was no difference in the cumulative risk of thrombosis between the patients of group A and the 877 patients without previous thrombotic events (p=0. 303, CI95% 0. 64 – 3. 21, RR 1. 24) In conclusion, the prognostic role of a previous thrombotic event in ET patients seems to be related not to the occurrence per se of the event but mainly to the interval between the event and the diagnosis of ET. Disclosures: Tafuri: Sigma Tau Pharmaceuticals: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V120.21.5062.5062
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
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  • 9
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    The Platelet COUNT at Diagnosis of Essential Thrombocythemia Is a Prognostic Factor for Thrombosis-Free Survival: Retrospective Analysis on 1201 Patients
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2815-2815
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2815-2815
    Abstract: The protective effect of higher platelet count at diagnosis of Essential Thrombocythemia (ET) was reported in some papers (Carobbio A. 2011, Palandri F. 2012, Montanaro M., 2014). As at our knowledge, there is no study specifically addressing this point; in this retrospective analysis we have examined 1201 ET patients (pts) followed in 11 Hematological centers of our region from 1/1978 to 12/2010. The diagnosis of ET was made with PVSG, WHO 2001 and WHO 2008 criteria, respectively, according to the period of 1st observation. The main features of our cohort were as follows: median age 62,9 yrs (19-96), male/female 435/766 (36.2%/63.8%), median WBC count 8,8 x 106/L (1.2-57.7), median Hb level 14.0 g/dl (6.0-20.5), median platelet count 813 x 106/L (457-3582), JAK-2V617F mutation in 498/834 performed pts (59,7 %) with a median allele burden of 19.6% (0.2-99.9%), spleen enlargement in 226 pts (18.7%), previous thrombosis in 17.9% of pts (arterial 14.1%, venous 3.8%). The median follow-up of the entire cohort was 7.75 yrs. Thrombosis-free survival curves were plotted according to Kaplan-Meier method and independent risk factors were identified with the Cox proportional-hazards method. At the multivariate analysis, negative prognostic factors for TFS resulted: previous thrombotic events (p= 0.012), age ≥60 yrs (p= 0.008) and spleen enlargement (p= 0.039): on the contrary, platelet count ≥ 944.109/L resulted a protective factor for TFS [p= 0.031 with an HR 0,57 (C.I. 95% 0,35-0,95)]. Receiver operating characteristic (ROC) analyses based on thrombotic events during follow-up were used to identify the baseline platelet count of 944 x 109/L as the best threshold for predicting thrombotic events. Thrombotic events according to this cutoff were 40/384 (10.3%) in pts with platelet count ≥ 944 x 109/L and 109/817 (13.3%) in pts with platelet count 〈 944 x 109/L. The sites of thrombosis are reported in the table. A comparison of the main features in these two populations showed that pts with PLT count 〈 944 x 109/L were older (median age 60.4 yrs vs 57.1 yrs, p= 0.016), had a lower median WBC count (8.8 x 109/L vs 10.6 x 109/L, p 〈 0.0001), an higher median Hb level (14.1 g/dL vs 13.6 g/dL, p 〈 0.0001) and an higher rate of JAK-2V617F mutation (67.2% vs 41.6%, p 〈 0.0001); no differences were observed between the two groups as to thrombotic events before diagnosis, spleen enlargement and cardiovascular risk factor (p=NS). As to the treatment, both groups resulted equally treated with anti-aggregant agents (84,6% vs 87,4%, p= 0,76) while in pts with platelet count 〈 944 x 109/L the oral anticoagulants (7.1% vs. 3.1%, p= 0.01) were more often used. Pts with higher platelet count were more frequently treated with cyto-reductive drugs (90,4 % vs 76,4 %, p 〈 0.0001). No significant difference resulted for Hydroxyurea (70,8 % vs 64,3%, p= 0,34) and Interferon ( 11,7% vs 6,9%, p= 0,07); on the contrary, more pts with higher platelet count were treated with anagrelide (10.7% vs 5.0%, p= 0.001) and alkylating agents (8.9% vs 5.1%, p= 0.03). In conclusion, our retrospective analysis confirmed the protective role for thrombosis of an higher platelet count at diagnosis. Pts with platelet count ≥ 944 x 109/L were more frequently treated with cyto-reductive drugs and this could possibly explain the better TFS, even if the platelet count closer to the occurrence of a thrombotic event resulted near the normal values in both groups. On the other hand, the higher rate of JAK-2V617F mutation in the group of pts with a baseline lower platelet count could be responsible of this counterintuitive finding: it is worth of note, however, that in our series the JAK-2V617F mutation did not result a significant factor for TFS. Table 1.TYPESITEPLTs ≥ 944PLTs 〈 944ARTERIALCardiac10 (2.6%)20 (2.5%)CNS*9 (2.3%)39 (4.8%)Peripheral2 (0.5%)6 (0.7%)Splanchnic1 (0.3%)1 (0.1%)Total22/384 (5.7%)66/817 (8.1%)VENOUSPeripheral17 (4.4%)32 (3.9%)Atypical03 (0.4%)Splanchnic1 (0.2%)7 (0.9%)Total18/384(4.6%)42/817(5.2%)*Central Nervous System; ° Non tested Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2815.2815
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 10
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    Spleen enlargement is a risk factor for thrombosis in essential thrombocythemia: Evaluation on 1,297 patients
    Wiley ; 2016
    In:  American Journal of Hematology Vol. 91, No. 3 ( 2016-03), p. 318-321
    Details
    In: American Journal of Hematology, Wiley, Vol. 91, No. 3 ( 2016-03), p. 318-321
    Abstract: Spleen enlargement, present in 10–20% of Essential Thrombocythemia (ET) patients at diagnosis, is a feature clinically easy to assess, confirmable by echography with a very low chance of misinterpretation. Nonetheless, the clinical and prognostic role of splenomegaly has been seldom evaluated. From 1979 to 2013, 1297 ET patients retrospectively collected in the database of the Lazio Cooperative Group and Bologna University Hospital were evaluable for spleen enlargement at diagnosis and included in the analysis. On the whole, spleen was enlarged in 172/1297 (13.0%) patients; in most cases (94.8%) splenomegaly was mild (≤5 cm). Patients with splenomegaly were younger, predominantly male, presented higher platelet count and JAK2 V617F allele burden and had a lower incidence of concomitant cardiovascular risk factors. At least one thrombotic event during follow‐up occurred in 97/1,125 (8.6%) patients without spleen enlargement compared to 27/172 (15.7%) patients with spleen enlargement ( P  = 0.003). Despite comparable use of cytoreductive/antiplatelet therapies in the two groups, the cumulative risk of thrombosis at 5 years was significantly higher in patients with baseline splenomegaly (9.8% versus 4.4% in patients without splenomegaly, P  = 0.012). In multivariate analysis exploring risk factors for thrombosis, splenomegaly retained its negative prognostic role, together with previous thrombosis, leucocyte count and male gender. Baseline splenomegaly seems to be an independent additional risk factor for thrombosis in nonstrictly WHO‐defined ET patients. This data could be useful in the real‐life clinical management of these patients. Am. J. Hematol. 91:318–321, 2016. © 2016 Wiley Periodicals, Inc.
    Type of Medium: Online Resource
    ISSN: 0361-8609 , 1096-8652
    URL: Issue
    URL: Article
    DOI: 10.1002/ajh.v91.3
    DOI: 10.1002/ajh.24269
    Language: English
    Publisher: Wiley
    Publication Date: 2016
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