Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Italy

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Italy

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Kim T.D.,Charité - Medical University of Berlin | Rea D.,Service des Maladies du Sang | Schwarz M.,Charité - Medical University of Berlin | Grille P.,Charité - Medical University of Berlin | And 12 more authors.
Leukemia | Year: 2013

Several retrospective studies have described the clinical manifestation of peripheral artery occlusive disease (PAOD) in patients receiving nilotinib. We thus prospectively screened for PAOD in patients with chronic phase chronic myeloid leukemia (CP CML) being treated with tyrosine kinase inhibitors (TKI), including imatinib and nilotinib. One hundred and fifty-nine consecutive patients were evaluated for clinical and biochemical risk factors for cardiovascular disease. Non-invasive assessment for PAOD included determination of the ankle-brachial index (ABI) and duplex ultrasonography. A second cohort consisted of patients with clinically manifest PAOD recruited from additional collaborating centers. Pathological ABI were significantly more frequent in patients on first-line nilotinib (7 of 27; 26%) and in patients on second-line nilotinib (10 of 28; 35.7%) as compared with patients on first-line imatinib (3 of 48; 6.3%). Clinically manifest PAOD was identified in five patients, all with current or previous nilotinib exposure only. Relative risk for PAOD determined by a pathological ABI in first-line nilotinib-treated patients as compared with first-line imatinib-treated patients was 10.3. PAOD is more frequently observed in patients receiving nilotinib as compared with imatinib. Owing to the severe nature of clinically manifest PAOD, longitudinal non-invasive monitoring and careful assessment of risk factors is warranted. © 2013 Macmillan Publishers Limited.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio | Polliack A.,Hebrew University of Jerusalem
Leukemia Research | Year: 2016

In the past decade the introduction of targeted therapies has dramatically transformed the landscape of treatment for chronic lymphocytic leukemia (CLL). Whether this new therapeutic scenario will modify the current prevalence statistics and natural history of autoimmune cytopenias complicating CLL is still a matter of debate. Here we present a comprehensive review of the literature on this topic, with special emphasis on the incidence of autoimmune hemolytic anemia (AIHA). The potential to induce autoimmune cytopenia has been studied mostly with ibrutinib, a first- in-class bruton kinase (BTK) inhibitor, licensed for the treatment of relapsed/refractory high-risk CLL. Recent observations suggest that emergent AIHA occurring during therapy with ibrutinib is more an expression of CLL activity than an ibrutinib-mediated process. Since available information on AIHA occurring during and after therapy with small-molecule kinase inhibitors relies mainly on data collected from clinical trials, a close post- marketing surveillance is mandatory in order to improve our understanding of this topic. © 2016 Elsevier Ltd

Efficace F.,Italian Group for Adult Hematologic Diseases GIMEMA | Rosti G.,University of Bologna | Aaronson N.,Netherlands Cancer Institute | Cottone F.,Italian Group for Adult Hematologic Diseases GIMEMA | And 5 more authors.
Haematologica | Year: 2014

The main objective of this study was to compare the reporting of health status and symptom severity, for a set of core symptoms related to imatinib therapy, between chronic myeloid leukemia patients and their treating physicians. Patients were asked to complete a questionnaire including questions on symptom severity and health status. The symptoms assessed were: abdominal discomfort, diarrhea, edema, fatigue, headache, muscle cramps, musculoskeletal pain, nausea and skin problems. The physicians were asked to complete a questionnaire for each of their patients entering the study. Four hundred twenty-two patients were included in the study. All respective paired physicians (n=29) completed the questionnaire, and thus the analyses are based on 422 patient-physician dyads. Agreement on symptom ratings ranged from 34% (for muscle cramps) to 66% (for nausea). For all symptoms, patients reported higher severity more often than their physicians. The three symptoms whose severity was most frequently underestimated by physicians were fatigue (51%), muscle cramps (49%) and musculoskeletal pain (42%). Health status was overestimated by physicians in 67% of the cases. Physicians and their patients with chronic myeloid leukemia often disagree in their ratings of the patients' symptom severity. Most typically, physicians tend to underestimate symptom severity and overestimate the overall health status of their patients. Current findings support the use of patient-reported outcome measures as a possible means to enhance the management of patients with chronic myeloid leukemia. © Ferrata Storti Foundation.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Expert Review of Anticancer Therapy | Year: 2011

Until now, no approach that is able to improve overall survival of chronic lymphocytic leukemia (CLL) patients has been available. In the German CLL Study Group (GCLLSG) CLL8 trial, treatment-naive, physically fit patients (aged 30-81 years) with CD20 + CLL were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m 2 per day) and cyclophosphamide (250 mg/m 2 per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m 2 on day 0 of first course and 500 mg/m 2 on day 1 of second to sixth courses). The two groups were well balanced with respect to baseline characteristics. The study was stopped at the preplanned interim analysis owing to an advantage in the median progression-free survival in the chemoimmunotherapy arm (51.8 vs 32.8 months; hazard ratio: 0.56; 95% CI: 0.46-0.69; p < 0.0001). Furthermore, at 3 years after randomization, 87% of patients in the chemoimmunotherapy group were alive compared with 83% in the chemotherapy group (hazard ratio: 0.67; 95% CI: 0.48-0.92; p = 0.01). In terms of toxicity, chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia (p < 0.0001). There were eight (2%) treatment related-deaths in the chemoimmunotherapy arm compared with ten (3%) in the chemotherapy arm. The CLL8 trial has demonstrated that an association of rituximab, fludarabine and cyclophosphamide is effective in prolonging progression-free survival and overall survival of patients with symptomatic CLL, therefore establishing the new standard of treatment for physically fit patients. © 2011 Expert Reviews Ltd.

Molica S.,Azienda Ospedaliera Pugliese ciaccio
Blood | Year: 2014

In this issue of Blood, Falchi et al present their experience with 2-deoxy-2-[18F] fluoroglucose/positron emission tomography (FDG/PET) in the management of patients with chronic lymphocytic leukemia (CLL) or Richter syndrome (RS) over a 10-year period at a referral center. The results of this study shed light on the potential role of FDG/PET in CLL. © 2014 by The American Society of Hematology.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Expert Review of Anticancer Therapy | Year: 2014

Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia and affects mostly the elderly. Chemoimmunotherapy with fludarabine, cyclophosphamide and rituximab is generally considered a standard treatment for younger fit patients with CLL. In a recent randomized Phase III study of patients with newly diagnosed CLL and coexisting conditions, obinutuzumab, a humanized anti-CD20 glycoenginered type 2 antibody, used in combination with chlorambucil, demonstrated significant improvement in progression-free survival and several other outcome parameters, in comparison to rituximab plus chlorambucil. Grade 3-4 infusion-related reactions and neutropenia occurred more frequently in patients who received obinutuzumab compared with those who received rituximab; however, the rate of serious infections was similar. Results of this trial clearly established that obinutuzumab in combination with chlorambucil represent the new first-line standard of treatment in this setting. A broad range of novel agents with different mechanisms of action have already proven their efficacy in CLL. New drugs targeting specific molecular features, such as ibrutinib, idelalisib or ABT-199, are being tested at present, and their advent is very likely to change the future treatment paradigm of CLL that relies today on chemoimmunotherapy for both fit and elderly/unfit patients. © 2015 Informa UK Ltd.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Expert Review of Hematology | Year: 2015

The latest Annual Meeting of the American Society of Hematology, held in San Francisco, included data on novel-targeted agents active in the treatment of chronic lymphocytic leukemia (CLL). MABTENANCE and PROLONG study suggest that either rituximab or ofatumumab improves progression-free survival in CLL. According to final analysis of CLL-10 trial, rituximab and bendamustine may have a role in the upfront treatment of fit elderly patients. Further insight into the use of ibrutinib, a first-in-class covalent Bruton's tyrosine kinase-inhibitor that is currently approved for patients with relapsed/refractory CLL and with del(17p), was also presented. Idelalisib, a selective inhibitor of PI3K delta, demonstrated its activity with manageable toxicity in previously untreated patients 65 years with CLL or small lymphocytic lymphoma. Finally, a series Phase I/II studies of BCL-2 inhibitor (i.e., venetoclax, GDC-0199) used alone or in combination provide promising results in patients with relapsed/refractory CLL. © Informa UK, Ltd.

Piro E.,Azienda Ospedaliera Pugliese Ciaccio | Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Acta Haematologica | Year: 2011

This report presents the totality of evidence through a systematic review that assessed either the efficacy or safety of bortezomib-based regimens in multiple myeloma with renal impairment. A systematic and comprehensive search of the literature was performed using MEDLINE databases from 1978 to December 1, 2010, and a hand search of references. We used the following medical subject headings (MESH) to identify potential studies: 'myeloma renal failure' (1,225 hits) and 'bortezomib' (2,554 hits). An additional search performed by combining the MESH terms 'myeloma renal failure' and 'bortezomib' yielded 50 citations. Five additional case-control studies judged relevant for the purpose of study were also included. In total, 6 case reports, 9 case series and 9 case-control studies were identified that reported on myeloma, renal failure and bortezomib. In this review, only the case series and case-control studies were considered. The results of our search led to the following conclusions: (1) bortezomib is feasible and well tolerated and its efficacy and safety are not substantially modified by renal failure patients, (2) renal failure should not induce physicians to reduce doses, since the efficacy of bortezomib is attained also in dialyzed patients who may achieve dialysis independence, and (3) standard doses of bortezomib (i.e. 1.3 mg/m2 on days 1, 4, 8, 11) associated with dexamethasone yield satisfactory tumor response, generally obtained shortly after starting therapy. Although many questions remain unanswered, our effort should be considered a relevant scientific and practical address for generating a diagnostic and therapeutic algorithm to be used in patients with renal impairment related to multiple myeloma. Copyright © 2011 S. Karger AG, Basel.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Expert Opinion on Drug Safety | Year: 2015

Introduction: Ibrutinib, a targeted inhibitor of B-cell receptor signaling, achieved impressive clinical results for patients with chronic lymphocytic leukemia (CLL). These results allowed the approval of ibrutinib for the treatment of patients with CLL who have received at least one prior therapy and those with a 17p deletion regardless of line of therapy.Areas covered: Comprehensive data from either Phase I-II or randomized Phase III studies are analyzed in this article. In addition, we reviewed data on the prevalence and the clinical management of some peculiar toxicities ibrutinib related such as lymphocytosis, major bleeding and atrial fibrillation.Expert opinion: Ibrutinib has radically changed the scenery of relapsed/refractory CLL treatment and established an important paradigm in the molecularly targeted approach of this disease. Discontinuation of ibrutinib is rarely due to adverse events related to the drug. Patients who discontinue treatment represent a challenge to the physicians because treatment options are very limited. © 2015 Informa UK, Ltd.

Molica S.,Azienda Ospedaliera Pugliese Ciaccio
Leukemia and Lymphoma | Year: 2010

A systematic and comprehensive search of literature was performed using MEDLINE databases from 1st January 1978 to 2nd November 2009 and hand search of references. A search performed by combining the Medical Subject Headings (MESH) terms 'Richter's syndrome' and 'chronic lymphocytic leukemia' (CLL) yielded 143 citations. Ten additional casecontrol studies judged relevant for the purpose of study were also included. In total, 45 case reports, 18 case series, and 9 casecontrol studies were identified. For the purpose of this review, only case series and casecontrol studies were considered. The following conclusions could be drawn from the studies analyzed in this review: (i) some biological markers (i.e. CD38 expression and genotype, absence of del13q) or clinical features (i.e. bulky lymph node involvement), although not validated in prospective trials, may be considered for close monitoring and a careful biopsy policy; (ii) PET, is not yet standardized in RS, however, it may be useful in the diagnosis and to choose the site for biopsy; (iii) when diagnosed RS should be treated with a combination of rituximab and polychemotherapy; (iii) younger patients who respond to initial therapy should be offered allogeneic SCT, if feasible. Despite the paucity of data, it is important to note that this article represents the first systematic review of the entire body of available clinical evidence useful for an appropriate management of Richter transformation. © 2010 Informa Healthcare USA, Inc.

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