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Pagano L.,Catholic University of the Sacred Heart | Caira M.,Catholic University of the Sacred Heart | Offidani M.,Marche Polytechnic University | Martino B.,Azienda Ospedaliera Bianchi Melacrino Morelli | And 7 more authors.
Journal of Antimicrobial Chemotherapy | Year: 2010

Objectives and methods: In order to assess physicians' compliance with international guidelines for the targeted treatment of invasive aspergillosis, 136 patients with acute myeloid leukaemia and proven/probable invasive aspergillosis were analysed. Results: Compliance with Infectious Diseases Society of America (IDSA) and European Conference on Infections in Leukaemia (ECIL) guidelines was found to be relatively low (28% for ECIL and 55% for IDSA), although no significant differences were found between the two groups (adherence versus non-adherence). In both subgroup analyses (IDSA and ECIL), compliance with the guidelines did not impact the 120 day survival rate. Instead, adherence to guidelines led to a higher response rate to first-line antifungal treatment (76% in the IDSA group and 84% in the ECIL group). Conclusions: Guidelines establish categories of patients with homogeneous characteristics, and suggest optimal diagnostic and therapeutic options for them. Acquisition of good results through adherence to guidelines is confirmed by our series. Unfortunately, there are frequently reasons to deviate from these general recommendations, particularly in patients with acute myeloid leukaemia. Despite evidence-based recommendations, adherence to the guidelines does not constitute the best therapeutic choice in each and every patient. Subjects' clinical conditions and co-morbidities vary widely, and sometimes render the 'recommended' drug a non-applicable strategy. © The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. Source

Merlini L.,Ospedale Civile S | Carteni G.,Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli | Iacobelli S.,Ospedale Clinicizzato SS Annunziata | Stelitano C.,Azienda Ospedaliera Bianchi Melacrino Morelli | And 6 more authors.
Cancer Management and Research | Year: 2013

Purpose: To describe the prevalence and management of anemia in cancer patients. Methods: This cross-sectional, observational survey was conducted in Italy and Austria. Centers prespecified one day, during a 4-month enrollment window, to report specific data collected during normal clinical practice for patients with non-myeloid tumors attending for chemotherapy (±radiotherapy) treatment. The primary endpoint was the prevalence of anemia as determined using a prespecified algorithm: hemoglobin (Hb) ≤10g/dL on/within 3days prior to visit; ongoing anemia treatment; physician diagnosis of anemia, together with ≥1 anemia symptom. Results: Between November 18, 2010 and March 18, 2011, data for 1412 patients were collected (Italy n = 1130; Austria n  = 282). Most patients (n  = 1136; 80%) had solid tumors; 809 (57%) had received ≤3 chemotherapy cycles. The prevalence of anemia was 32% (95% confidence interval: 29.4%-34.2%); 196 patients (14%) were deemed anemic based on Hb ≤10  g/dL, 131 (9%) on ongoing anemia treatment, and 121 (9%) on physician diagnosis/anemia symptom. Overall, 1153 patients (82%) had Hb data; mean (standard deviation [SD]) Hb levels were 11.7  (1.7) g/dL. In total, 456 patients (32%) had anemia symptoms: fatigue (n  = 392; 28%), depression (n  = 122; 9%), and dyspnea (n  = 107; 8%) were most common. Fifty-one patients (4%) had had their current chemotherapy cycle delayed due to anemia. On visit day, or ≤28  days prior, 91 (6%), 188 (13%), and 81 patients (6%) had evidence of whole blood/red blood cell transfusion, erythropoiesis-stimulating agent use, or iron use, respectively. Conclusion: On the prespecified study day, one-third of patients with non-myeloid tumors undergoing chemotherapy were found to be anemic and 13% had evidence of erythropoiesis-stimulating agent use then or in the 28  days prior. © 2013 Merlini et  al, publisher and licensee Dove Medical Press Ltd. Source

Di Renzo N.,U.O. di Ematologia e Trapianto di Cellule Staminali | Montanini A.,University of Modena and Reggio Emilia | Mannina D.,Azienda Ospedaliera Papardo | Dondi A.,University of Modena and Reggio Emilia | And 10 more authors.
Supportive Care in Cancer | Year: 2011

Purpose: The control of nausea and vomiting induced by chemotherapy is paramount for overall treatment success in cancer patients. Antiemetic therapy during chemotherapy in lymphoma patients generally consists of anti-serotoninergic drugs and dexamethasone. The aim of this trial was to evaluate the efficacy of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT 3) receptor antagonist, in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy (MEC) containing steroids. Methods: Patients received a single intravenous bolus of palonosetron (0.25 mg) before administration of chemotherapy. Complete response (CR) defined as no vomiting and no rescue therapy during overall phase (0-120 h) was the primary endpoint. Complete control (CC) defined as CR and only mild nausea was a secondary endpoint. Results: Eighty-six evaluable patients entered in the study. A CR was observed in 74 patients (86.0%) during the overall phase; the CR during the acute (0-24 h) and delayed (24-120 h) phases was 90.7% and 88.4%, respectively. CC was 89.5% during the acute and 84.9% during the delayed phase; the overall CC was 82.6%. Conclusions: This was the first trial, which demonstrated the efficacy of a single dose of palonosetron in control CINV in patients with aggressive non-Hodgkin's lymphoma receiving MEC regimen containing steroids. © 2010 The Author(s). Source

Martelli M.,University of Rome La Sapienza | Ceriani L.,Oncology Institute of Southern Switzerland | Zucca E.,Oncology Institute of Southern Switzerland | Zinzani P.L.,Policlinico S. Orsola Malpighi | And 15 more authors.
Journal of Clinical Oncology | Year: 2014

Purpose: To assess the role of [18F]fluorodeoxyglucose ([ 18F]FDG) positron emission tomography/computed tomography (PET/CT) after rituximab and anthracycline-containing chemoimmunotherapy in patients with primary mediastinal large B-cell lymphoma (PMLBCL). Patients and Methods: Among 125 patients prospectively enrolled, 115 were eligible for central review of PET/CT scans at the completion of standard chemoimmunotherapy, by using a five-point scale. Consolidation radiotherapy (RT) was permitted and given to 102 patients. Results: Fifty-four patients (47%) achieved a complete metabolic response (CMR), defined as a completely negative scan or with residual [ 18F] FDG activity below the mediastinal blood pool (MBP) uptake. In the remaining 61 patients (53%), the residual uptake was higher than MBP uptake but below the liver uptake in 27 (23%), slightly higher than the liver uptake in 24 (21%), and markedly higher in 10 (9%). CMR after chemoimmunotherapy predicted higher 5-year progression-free survival (PFS; 98% v 82%; P = .0044) and overall survival (OS; 100% v 91%; P = .0298). Patients with residual uptake higher than MBP uptake but below liver uptake had equally good outcomes without any recurrence. Using the liver uptake as cutoff for PET positivity (boundary of score, 3 to 4) discriminated most effectively between high or low risk of failure, with 5-year PFS of 99% versus 68% (P < .001) and 5-year OS of 100% versus 83% (P < .001). Conclusion: More than 90% of patients are projected to be alive and progression-free at 5 years, despite a low CMR rate (47%) after chemoimmunotherapy. This study provides a basis for using PET/CT to define the role of RT in PMLBCL. © 2014 by American Society of Clinical Oncology. Source

Pagano L.,Catholic University of the Sacred Heart | Verga L.,University of Milan Bicocca | Martino B.,Azienda Ospedaliera Bianchi Melacrino Morelli | Mitra M.E.,Policlinico di Palermo | And 11 more authors.
The Journal of antimicrobial chemotherapy | Year: 2014

OBJECTIVES: To investigate the incidence, treatment and outcome of breakthrough invasive fungal infections (IFIs) in adult acute myeloid leukaemia (AML) patients after posaconazole prophylaxis.METHODS: From January 2010 to April 2012, all consecutive patients with newly diagnosed AML were prospectively registered at 33 participating Italian centres. All cases of IFIs occurring within 30 days after the end of the first induction chemotherapy were recorded. The strategy of antifungal treatment (empirical, pre-emptive or targeted) and the drugs used were analysed. ClinicalTrials.gov code: NCT01315925.RESULTS: In total, 1192 patients with newly diagnosed AML were enrolled in the study, of whom 510 received posaconazole prophylaxis and were included in the present analysis. Of these patients, 140 (27%) needed systemic antifungal treatment. Among the 127 evaluable cases, an empirical approach was utilized in 102 patients (80%), a pre-emptive approach in 19 patients (15%) and targeted therapy in 6 patients (5%). Only five patients died of IFIs (three in the empirical group and two in the targeted group; 4%). A critical review of IFI diagnoses at 30 days demonstrated that among the patients treated empirically, ∼30% were not affected by IFIs but rather only by fever of unidentified origin. A comparison between the empirical and the pre-emptive groups showed no significant differences regarding the attributable and overall mortalities.CONCLUSIONS: This study confirms that posaconazole prophylaxis reduces the incidence of breakthrough IFIs and does not modify the efficacy of subsequent systemic antifungal treatment, regardless of the approach (empirical or pre-emptive) or the antifungal drug used. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. Source

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