60 research outputs found

    Fotoaferesi extracorporea come terapia di prima linea nel trattamento della GVHD cronica dopo trapianto allogenico di cellule staminali

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    Introduzione. La malattia del trapianto verso l’ospite cronica (cGVHD) è la più importante complicanza dopo trapianto di cellule staminali emopoietiche. La terapia standard è l’associazione di ciclosporina (CyA) e cortisone; le complicanze infettive correlate alla terapia immunosoppressiva (ISS) o la insoddisfacente risposta al trattamento sono la principale causa di mortalità. La fotoaferesi extracorporea (ECP) si è dimostrata efficace nel trattamento della cGVHD, ma il suo utilizzo è stato prevalentemente limitato alla cGVHD resistente a trattamento di prima linea. Scopo dello studio. Il presente studio pilota ha l’obiettivo di valutare la fattibilità di un programma di ECP in associazione a terapia standard per il trattamento di prima linea della cGVHD ad alto rischio. Il rischio elevato si definisce in base alla presenza di parametri che predicono una elevata mortalità cGVHD correlata. Obiettivi secondari sono la risposta e la incidenza di complicanze (sicurezza). Pazienti. Su 10 pazienti che rispettavano i criteri di arruolamento, 2 hanno rifiutato di aderire allo studio per problemi logistici o rifiuto di un protocollo sperimentale, 8 sono stati arruolati. L’età media è stata di 40 anni. Il donatore era un donatore familiare HLA identico in 7 casi e un donatore non familiare in 1 caso. Tutti i pazienti presentavano cGVHD estesa o moderato/severa; lo score prognostico (secondo Akpek) era >0 in 3/8 pazienti. Trattamento. I pazienti hanno iniziato il trattamento con Prednisone (PDN) 1 mg/kg e CyA alla diagnosi di cGVHD; la ECP è stata iniziata con una frequenza di 4 sedute / mese nei primi 3 mesi e 2 / mese per i successivi 9 mesi; PDN e CyA sono stati lentamente scalati sino alla sospensione se possibile, altrimenti modulati. La durata dello studio è stata di 1 anno. I criteri di uscita dallo studio erano la sospensione della ECP, la necessità di inserire altri farmaci immunosoppressivi per progressione della cGVHD o infezioni severe. La risposta è stata valutata secondo criteri standard come progressione, risposta parziale (PR), ottima PR (vgPR) o risposta completa (CR). Risultati. La aderenza al protocollo è stata: 6/8 pazienti a 3 mesi, 4/8 a 6 e 9 mesi, 3/8 a 12 mesi; l’uscita dallo studio è stata determinata da complicanze infettive in 2 pazienti, sospensione della ECP in 1 paziente a acusa di una trombosi correlata al catetere venoso (CV) femorale inserito per le procedure di ECP, in 2 pazienti per chiara progressione della cGVHD. Nei pazienti valutabili la risposta (CR + vgPR / <=PR) per trimestre è stata 4/6, 2/4 and 3/4 al I, II e III trimestre rispettivamente; dopo il IV trimestre di trattemento sono state osservate 1 vgPR, 2 PR e 1 progressione. Complicanze sono state osservate in 4 pazienti per un totale di 9 episodi: 1 caso di polmonite, 1 caso di infezione delle vie urinarie, 3 casi di riattivazione di CMV, 1 caso di condilomatosi, 1 caso di infezione CVC correlata, 1 caso di trombosi CV femorale correlata, 1 caso di sindrome uremicoemolitica. Ad 1 anno 2 pazienti su 8 sono deceduti (1 caso per mortalità trapianto correlata, 1 caso per recidiva). Conclusioni. La ECP in associazione a terapia standard è fattibile; la incidenza di complicanze sembra essere sovrapponibile a quella osservata nei pazienti non sottoposti a ECP. Per valutare adeguatamente la risposta e la sicurezza di questo trattamento sarà necessario un numero più ampio di pazienti.Background. Chronic graft versus host disease (cGVHD) is the major late complication after allogeneic stem cell transplantation. Standard therapy is steroid and Cyclosporine-A (CyA); however, immune suppression (ISS) related infections or unresponsiveness to ISS, are major mortality causes. Extracorporeal photopheresis (ECP) has shown activity in treatment of cGVHD, but its use has been limited to first-line-unresponsive cGVHD. Aim of the study. This is a single center pilot study testing feasibility of a programme of photopheresis in association with standard therapy as first line treatment in high risk cGVHD. High risk was defined as the presence of parameters predicting high cGVHD-related mortality. Secondary objectives were response and complications incidence. Patients. Among 10 pts fitting enrolling criteria, 2 refused due to logistic problem or low compliance with the procedure, 8 were enrolled. Median age was 40. Donor was HLA identical sibling in 7 cases and MUD in 1. All cases presented with extensive/moderate-severe cGVHD; Akpek score was > 0 in 3/8 pts. Treatment plan. Pts started with Prednison (PDN) 1 mg/kg and CyA at cGVHD diagnosis; ECP was started with a frequency of 4 application/month in the first 3 months and 2/month for the subsequent 9 months; PDN and CyA were slowly reduced until suspension, or otherwise modulated. Study duration was 1 year. Pts were ruled out the study in case of ECP suspension, requirement of other ISS drugs in case of GVHD progression unresponsive to standard therapy, or severe infections. Response was evaluated with standard criteria, as progression, partial response (PR), very good PR (vgPR) or complete response (CR). Results. Adherence to protocol was: 6/8 pts at 3 months, 4/8 at 6 and 9 months, 3/8 at 12 mm; exit from the study was due to infectious complications (2), ECP suspension due to venous access related thrombosis (1) and clear cGVHD progression (2). In evaluable pts, response (CR+very good PR / <=PR) per trimester was 4/6, 2/4 and 3/4 at I, II and III respectively; at the IV trimester, 1 very good PR, 2 PR and 1 progression were observed. Complications were observed in 4 pts with : 1 case of pneumonia, 1 case of urinary tract infection, 3 cases of CMV antigenemia activation, 1 case of condilomatosis, 1 case of catheter related infection, 1 case of catheter related thrombosis and 1 case of hemolitic uremic syndrome. At 1 year, 2/8 pts died (1 TRM, 1 relapse). Conclusion. ECP in association with standard therapy is feasible; complications incidence seems to be similar to those observed in patients not treated with ECP; a larger group of patients is needed to evaluate response in this setting

    A prospective study comparing quantitative Cytomegalovirus (CMV) polymerase chain reaction in plasma and pp65 antigenemia assay in monitoring patients after allogeneic stem cell transplantation

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    BACKGROUND: Low levels of Cytomegalovirus (CMV) viral load are frequently detected following allogeneic stem cell transplantation (SCT) and CMV disease may still develop in some allogeneic SCT patients who have negative pp65-antigenemia (pp65-Ag) or undetectable DNA. Pp65Ag is a sensitive method to diagnose CMV infection. Quantitative CMV-DNA PCR assay in plasma has been proposed to monitor CMV infection in SCT patients. We evaluated the clinical utility of pp65Ag and PCR assay in plasma of SCT recipients. METHODS: In a prospective longitudinal study, 38 consecutive patients at risk of CMV infection (donor and/or recipient CMV seropositive) were weekly monitored for CMV infection by both quantitative CMV-PCR in plasma (COBAS AMPLICOR CMV MONITOR) and pp65 Ag, during the first 100 days after SCT. RESULTS: A total of 534 blood samples were simultaneously analysed for pp65Ag and PCR. Overall, 28/38 patients (74%) had active CMV infection within 100 days from SCT. In 16 patients, CMV was first detected by pp65 Ag alone; in 5 patients by both methods and in 6 by PCR assay alone; one patient had CMV biopsy-proven intestinal disease without pp65Ag and PCR assays positivity before CMV disease. Overall, three patients developed intestinal CMV disease (7.9%): one had negative both pp65Ag and PCR assays before CMV disease, one had disease and concomitant positivity of both methods, while in the remaining patient, only pp65Ag was positive before CMV disease. CONCLUSION: Plasma PCR(COBAS AMPLICOR CMV MONITOR) and pp65Ag assays were effective in detecting CMV infection, however, discordance between both methods were frequently observed. Plasma PCR and pp65Ag assays may be complementary for diagnosis and management of CMV infection

    Cidofovir for BK Virus-Associated Hemorrhagic Cystitis: A Retrospective Study

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    Background.BK virus-associated hemorrhagic cystitis (BKV-HC) is a severe complication after allogeneic hematopoietic stem cell transplantation (HSCT), but antiviral treatment for this condition has not been evaluated. Methods.We conducted a retrospective survey on the safety and outcome of cidofovir treatment for patients with BKV-HC in centers affiliated with the European Group for Blood and Marrow Transplantation. Results.From 1 April 2004 to 31 December 2007, 62 patients received a diagnosis of BKV-HC after a median interval of 35 days after HSCT (range, 3-577 days). Fifty-seven patients (92%) received intravenous cidofovir, whereas 5 patients received cidofovir intravesically. Complete response (CR) was recorded in 38 (67%) of 57 patients with HC treated with intravenous cidofovir, whereas partial response (PR) was documented in 7 patients (12%). CR was documented in 3 patients and PR in 1 patient with HC treated with intravesical cidofovir. A reduction of 1-3 logs in BKV load was documented in 8 of the 10 patients achieving CR. Mild-to-moderate toxic effects were recorded in 18 of 57 patients who received intravenous cidofovir administration. In a multivariate analysis, the factors significantly associated with response to cidofovir were the stem cell source (P=.01) and the use of total body irradiation (P=.03). After a median follow-up of 287 days, overall survival and total treatment-related mortality rates were 63% and 40% for patients achieving CR, compared with 14% and 72% for patients with PR or no response to cidofovir, respectively (P<.001 and P=.001, respectively). Conclusions.Cidofovir may be a potentially effective therapy for BKV-HC, but evidence supporting its use requires randomized controlled trial

    Pain in Blood Cancers

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    Patients with blood-related cancers (BRC) suffer from a substantial symptom burden, including several pain syndromes sustained by different causes and pathogenetic mechanisms. So, with regard to pain, a multifaceted clinical scenario may be observed in this setting. Indeed, pain may be correlated to disease itself, to disease-associated complications, to iatrogenic causes or may be due to unrelated clinical conditions. A close diagnostic procedure for the assessment of the underlying causes of the pain and of its pathogenetic mechanisms may direct the treatment approach which should be based on a multidisciplinary management and requires the integration of etiology-targeted interventions and painkilling drugs. The World Health Organization's three-step analgesic ladder for cancer pain relief can provide adequate pain control using oral drugs in most patients with BRC on pain, although more complex interventions may be necessary for many difficult-to-treat pain syndromes which are not infrequently encountered in this setting
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