Ematologia

Vicenza, Italy

Ematologia

Vicenza, Italy
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BOUDRY, Svizzera--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) ha oggi annunciato i risultati intermedi del programma di studi clinici ABOUND per la valutazione del'uso di ABRAXANE® (particelle di paclitaxel legate alla proteina albumina per sospensione iniettabile) nei pazienti affetti da tumore del polmone non a piccole cellule (NSCLC) in fase avanzata. I dati intermedi degli studi clinici ABOUND presentati durante la 17th World Conference on Lung Cancer (WCLC) della IASLC rafforzano i vantaggi della doppietta chemioterapica ABRAXANE/carboplatino per il trattamento di prima linea del NSCLC. I dati intermedi di ABOUND.70+ su 128 pazienti anziani (≥ 70 anni), sottoposti a trattamento di prima linea con ABRAXANE/carboplatino per NSCLC avanzato, hanno evidenziato che 91 (73%) pazienti presentavano neuropatia periferica di grado ≥2 (NP) o mielosoppressione di grado ≥3 [endpoint primario]. Al momento delle analisi, la sopravvivenza globale mediana era di 14,6 mesi, mentre la sopravvivenza senza progressione mediana era di 6,2 mesi, aggregate tra i due bracci di trattamento [endpoint secondari]. I pazienti sono stati randomizzati per ricevere un trattamento di prima linea con ABRAXANE/carboplatino continuativo a frequenza settimanale oppure settimanale ogni 3 settimane, con una pausa di una settimana.i In tutto, l'80% dei pazienti ha interrotto il trattamento, nella maggior parte dei casi per eventi avversi (24%) o per il progredire della malattia (34%). La NP di grado ≥2 è stata riferita nel 34% dei pazienti, mentre neutropenia, anemia e trombocitopenia di grado ≥3 sono state osservate rispettivamente nel 52%, 21% e 21% dei pazienti. i I dati intermedi ABOUND.sqm su 284 pazienti sottoposti a trattamento di induzione di prima linea con ABRAXANE/carboplatino per NSCLC squamoso di fase IIIB/IV hanno dimostrato che il profilo di sicurezza è stato coerente con quello precedentemente riportato per il sottoinsieme squamoso nell'ambito dello studio pivot di fase III.ii,iii Nel corso della fase di induzione, tutti i pazienti sono stati sottoposti a quattro cicli di 21 giorni di terapia standard a base di ABRAXANE/carboplatino.ii In totale, 119 pazienti (42%) hanno interrotto il trattamento nel corso della fase di induzione, nella maggior parte dei casi per la progressione della malattia (34%) o per eventi avversi (24%). Gli eventi avversi emergenti dal trattamento (TEAE) più comuni di grado 3/4 sono stati di tipo ematologico e comprendevano anemia (26%), neutropenia (43%) e trombocitopenia (15%).ii "Questi primi dati del programma di studi clinici ABOUND sono molto incoraggianti perché rispecchiano i risultati relativi a questi sottogruppi di pazienti affetti da tumore del polmone non a piccole cellule difficili da trattare interessati allo studio clinico pivot di fase III su ABRAXANE", ha dichiarato Michael Pehl, presidente della divisione Ematologia e oncologia di Celgene. "Questi dati, insieme agli studi attualmente in corso su ABRAXANE in combinazione con nuovi agenti e immunoterapie, ci offrono una comprensione più approfondita sulle modalità di trattamento delle popolazioni di pazienti più difficili e ci aiuteranno a proseguire con lo sviluppo di opzioni future di trattamento". Con la rapida evoluzione dei trattamenti contro il tumore del polmone, Celgene resta impegnata nell'esplorazione di nuove combinazioni a tutto vantaggio dei pazienti che convivono con questa malattia, compresi quelli che non possono beneficiare di immunoterapie e terapie mirate. Per questi pazienti ABRAXANE viene valutata attivamente come terapia di base. Anche i risultati intermedi dello studio di fase I sull'agente immunoterapico nivolumab in combinazione con ABRAXANE/carboplatino su 22 pazienti affetti da NSCLC di fase IIIB/IV saranno presentati alla WCLC. I pazienti sono stati sottoposti a quattro cicli di terapia standard a base di ABRAXANE/carboplatino in combinazione con nivolumab, seguito da nivolumab in monoterapia a partire dal ciclo 5. Gli endpoint primari erano il numero di pazienti con tossicità dose-limitante e la percentuale di pazienti con TEAE di grado 3/4 o l'interruzione del trattamento a causa di un TEAE. I dati intermedi indicano che la combinazione ABRAXANE/carboplatino con nivolumab può presentare una promettente attività antitumorale per i pazienti con NSCLC avanzato senza eventi avversi (EA) inaspettati.vi Nel corso della conferenza WCLC sarà organizzata anche una presentazione orale incentrata sui nuovi risultati dello studio registrativo di fase III su ABRAXANE (Abstract 4460), che illustrerà l'impatto della portata della risposta in termini di sopravvivenza sui pazienti affetti da NSCLC in fase avanzata sottoposti a trattamento chemioterapico di prima linea. Sempre al WCLC verranno presentate anche analisi del mondo reale sui veterani degli Stati Uniti, per valutare la prevalenza di NSCLC con istologia squamosa nei veterani rispetto alla popolazione generale (Abstract 4737) (Abstract 4737) e la prevalenza della malattia autoimmune nei veterani affetti da NSCLC (Abstract 4745). Anche ulteriori studi clinici avviati su iniziativa dei ricercatori (IIS, Investigator-Initiated Studies) presentati a WCLC hanno valutato ABRAXANE come trattamento di prima linea (Posters P2.03a-028 e P2.06-018), di seconda linea (Posters P2.03a-040, P2.03a-054 e P2.03a-056) o di terza linea (Poster P2.06-015) per i pazienti affetti da NSCLC in fase avanzata, oltre che come terapia adiuvante (Poster P2.03a-070) e neoadiuvante (Poster P2.04-034) e sui pazienti non precedentemente sottoposti a chemioterapia con mutazione del gene EGFR (Poster P3.02b-061). ABOUND è un programma di studi clinici multifase, in aperto e multicentrici mirati a valutare l'uso di ABRAXANE in combinazione con carboplatino o altri nuovi agenti, tra cui l'immunoterapia, come trattamento di prima o seconda linea per i pazienti affetti da tumore del polmone non a piccole cellule (NSCLC) in stadio avanzato. Gli studi clinici ABOUND hanno interessato pazienti di almeno 70 anni, oltre a quelli in condizioni più critiche o istologia squamosa e ai pazienti sottoposti a trattamento di seconda linea.vii,viii,ix,x Si tratta di uno studio clinico di fase I, in aperto, multicentrico, sulla sicurezza dei regimi chemioterapici a base di ABRAXANE somministrati in precedenza e/o in combinazione con nivolumab per i casi di cancro del pancreas, NSCLC e tumore al seno metastatico. Si tratta di uno studio a sei bracci di pazienti con valutazione del trattamento su due bracci per tipo di tumore/indicazione. ABRAXANE® è indicato per il trattamento di prima linea del tumore del polmone non a piccole cellule localmente avanzato o metastatico, in combinazione con carboplatino, nei pazienti non candidati a chirurgia curativa o a radioterapia. Celgene Corporation, con sede a Summit, New Jersey, è un gruppo farmaceutico integrato globale impegnato principalmente nella ricerca, nello sviluppo e nella commercializzazione di terapie innovative per il trattamento delle neoplasie e delle patologie infiammatorie attraverso soluzioni all'avanguardia nel campo dell'omeostasi delle proteine, di immuno-oncologia, epigenetica, immunologia e neuroinfiammazione. Per ulteriori informazioni visitare www.celgene.com. È possibile seguire Celgene sui social media: @Celgene, Pinterest, LinkedIn, FaceBook e YouTube. Questo comunicato stampa contiene dichiarazioni a carattere previsionale, che sono generalmente dichiarazioni e non fatti storici. Le dichiarazioni a carattere previsionale possono essere identificate dalle parole "attendersi", "anticipare", "ritenere", "intendere", "stimare", "programmare", "sarà", "previsione" ed espressioni simili. Le dichiarazioni a carattere previsionale si basano su progetti, stime, ipotesi e proiezioni attuali della dirigenza e hanno valore solo alla data in cui vengono esposte. L'azienda non si assume alcun obbligo di aggiornare le dichiarazioni a carattere previsionale alla luce di nuove informazioni o di eventi futuri, salvo quanto diversamente previsto dalla legge. Le dichiarazioni a carattere previsionale comportano rischi e incertezze, molti dei quali difficilmente prevedibili e generalmente non controllabili dall'azienda. I risultati o gli esiti effettivi possono differire materialmente da quanto suggerito da queste dichiarazioni a carattere previsionale a seguito dell'impatto di una serie di fattori, molti dei quali vengono esposti più dettagliatamente nella relazione annuale presentata dall'azienda sul modulo 10-K e su altri resoconti depositati presso la Securities and Exchange Commission. i Langer C, et al. Safety and Efficacy Results from ABOUND.70+: nab-Paclitaxel + Carboplatin in Elderly Patients with Advanced NSCLC. Abstract 4630. Presentato alla 2016 World Conference of Lung Cancer (WCLC), 4-7 dicembre 2016. ii McCleod M, et al. Interim Results from ABOUND.sqm: Safety of nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer. Abstract 4391. Presentato alla 2016 World Conference of Lung Cancer (WCLC), 4-7 dicembre 2016. iii Socinsky M, et al. Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Annals of Oncology. 24: 314–321, 2013. iv Weiss J, et al. ABOUND.70+: Interim Quality of Life Results of nab-Paclitaxel + Carboplatin Treatment of Elderly Patients with NSCLC. Abstract 4286. Presentato alla 2016 World Conference of Lung Cancer (WCLC), 4-7 dicembre 2016. v Thomas M, et al. nab-Paclitaxel + Carboplatin Induction Therapy in Squamous Non-Small Cell Lung Cancer: Interim Quality of Life Results from ABOUND.sqm. Abstract 4343. Presentato alla 2016 World Conference of Lung Cancer (WCLC), 4-7 dicembre 2016. vi Goldman J, et al. Interim Results from the Phase I Study of Nivolumab + nab-Paclitaxel + Carboplatin in Non-Small Cell Lung Cancer. Abstract 4127. Presentato alla 2016 World Conference of Lung Cancer (WCLC), 4-7 dicembre 2016. vii ClinicalTrials.gov. Safety and Efficacy Study of Nab®Paclitaxel With CC486 or Nab®Paclitaxel With Durvalumab, and Nab®Paclitaxel Monotherapy as Second/Thirdline Treatment for Advanced Nonsmall Cell Lung Cancer (abound2L+). Consultabile alla pagina https://www.clinicaltrials.gov/ct2/show/NCT02250326?term=ABOUNd&rank=3. Ultimo accesso 30 novembre 2016. viii ClinicalTrials.gov. Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (ABOUND 70+). Consultabile alla pagina https://www.clinicaltrials.gov/ct2/show/NCT02151149?term=ABOUNd&rank=2. Ultimo accesso 30 novembre 2016. ix ClinicalTrials.gov. Phase II Safety and Tolerability Trial With NabPaclitaxel Plus Carboplatin Followed by NabPaclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2 (AboundPS2). Consultabile alla pagina https://www.clinicaltrials.gov/ct2/show/NCT02289456?term=ABOUNd&rank=4. Ultimo accesso 30 novembre 2016. x ClinicalTrials.gov. Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer (aboundsqm). Consultabile alla pagina https://www.clinicaltrials.gov/ct2/show/NCT02027428?term=ABOUNd&rank=6. Ultimo accesso 30 novembre 2016.


Bringhen S.,Myeloma Unit | Petrucci M.T.,University of Rome La Sapienza | Larocca A.,Myeloma Unit | Conticello C.,Ospedale Ferrarotto | And 16 more authors.
Blood | Year: 2014

This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N 5 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787. © 2014 by The American Society of Hematology.


Olivieri A.,Marche Polytechnic University | Cimminiello M.,Uo Of Ematologia Centro Trapianto Of Cellule Staminali | Corradini P.,University of Milan | Mordini N.,Azienda Ospedaliera S. Croce e Carle | And 15 more authors.
Blood | Year: 2013

Forty adults aged 28 to 73 years were entered into a prospective trial of imatinib for the treatment of steroid-refractory chronic graft-versus-host disease (SR-cGVHD). After 6 months, intention-to-treat (ITT) analysis of 39 patients who received the drug, regardless of the duration of treatment, revealed 14 partial responses (PR), 4 minor responses (MR) with relevant steroid sparing (46%) according to Couriel criteria, and 20 ≥ PR (51.3%), as per the National Institutes of Health (NIH) criteria and NIH severity score changes. The best responses were seen in the lungs, gut, and skin (35%, 50%, and 32%, respectively). After a median follow-up of 40 months, 28 patients were alive, with a 3-year overall survival (OS) and event-free survival of 72% and 46%, respectively. The 3-year OS was 94% for patients responding at 6 months and 58% for nonresponders according to NIH response, suggesting that these criteria represent a reliable tool for predicting OS after second-line treatment. Monitoring of anti-platelet-derived growth factor receptor (PDGF-R) antibodies showed a significant decrease in PDGF-R stimulatory activity in 7 responders, whereas it remained high in 4 nonresponders. This study confirms the efficacy of imatinib against SR-cGVHD and suggests that the response at 6 months significantly predicts long-term survival. © 2013 by The American Society of Hematology.


PubMed | University of Turin, Ematologia e Medicina Trasfusionale, Ematologia, University of Cagliari and 10 more.
Type: | Journal: Leukemia research | Year: 2016

Dasatinib was approved for the treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients in first line therapy based on the demonstration of efficacy and safety reported in patients enrolled in clinical trials. We describe a multicentric Italian real-life experience of dasatinib used as frontline treatment outside clinical trials. One hundred and nine patients (median age 54 years) were treated from January 2012 to December 2013. Increased incidence of high risk patients were detected according to stratification (26% according to Sokal score, 19% according to Euro score and 16% according to EUTOS) when compared to company sponsored studies. Median time from diagnosis to start of dasatinib was 18 days. Ten patients received unscheduled starting dose (6 patients 50mg and 4 patients 80 mg QD), whereas 99 patients started with 100mg QD. At 3 months, 92% of patients achieved a BCR-ABL ratio less than 10%. At 6 months, the rate of CCyR was 91% and the rate of MR3 was 40%, with 8% of the patients reaching MR4.5. Ninety-three patients were evaluable at 12 months: the rate of MR3 was 62%, with MR4.5 being achieved by 19% of the patients. At a median follow-up of 12 months, 27 patients (24.7%) were receiving the drug at reduced dose. Two patients (1.8%) experienced a lymphoid blast crisis and the overall incidence of resistance was 8%. As regards safety, the major side effects recorded were thrombocytopenia, neutropenia and pleural effusions, which occurred in 22%, 10% and 8% of patients, respectively. Present results, achieved in a large cohort of patients treated outside clinical trials, further confirm the efficacy and safety of dasatinib as firstline treatment in CML.


PubMed | Ematologia, UOC Ematologia, University Cattolica Sacro Cuore, Presidio and 3 more.
Type: Journal Article | Journal: European journal of haematology | Year: 2015

Deferasirox (DFX) is an orally administered iron chelator approved for use in patients with transfusion-dependent iron overload due to myelodysplastic syndromes (MDS). The safety and efficacy of DFX has been explored in clinical trial settings, but there is little data on unselected patients with MDS. The aim of this study was to retrospectively evaluate the safety, compliance, efficacy and effect on haematopoiesis of DFX in a large real-world MDS population. One hundred and eighteen patients with transfusion-dependent MDS were treated with DFX across 11 centres in Italy. Serum ferritin levels, haematological response, dosing, adverse events and transfusion dependence were recorded at baseline, 3, 6, 12 and 24 months following initiation of treatment. DFX reduced mean serum ferritin levels from 1790 to 1140 ng/mL (P < 0.001), with 7.1% of patients achieving transfusion independence. Significant haematological improvement was seen in erythroid (17.6%), platelet (5.9%) and neutrophil counts (7.1%). Adverse events were reported in 47.5% of patients, including gastrointestinal and renal toxicity. Regression analysis showed that higher starting doses of DFX are associated with transfusion independence at 24 months. DFX is a safe, effective treatment for transfusion-dependent MDS that can lead to transfusion independence and haematological improvement in a subset of patients.


Barcellini W.,U.O. Ematologia e CTMO | Zaja F.,Clinica Ematologica | Zaninoni A.,U.O. Ematologia e CTMO | Imperiali F.G.,U.O. Ematologia e CTMO | And 6 more authors.
European Journal of Haematology | Year: 2013

Objectives: To evaluate the sustained response to low-dose (LD) rituximab in autoimmune hemolytic anemia (AIHA), the ex vivo effect on anti-RBC antibody production by mitogen-stimulated direct antiglobulin test (MS-DAT), and the in vitro dose effect of the drug on the production of anti-RBC antibodies. Methods: Thirty two patients, 18 warm (W) AIHA and 14 cold hemagglutinin disease (CHD), were treated with LD rituximab (100 mg fixed dose ×4 weekly infusions) along with a short course of oral prednisone. Complete clinical examination, blood counts, and hemolytic markers were performed at enrollment and at month 6, 12, 24, and 36. Results: Hematological parameters significantly improved at all time points compared to enrollment. The overall response was 90%, 100%, 100%, and 89% and the relapse-free survival 87%, 79%, 68%, and 68% at 6, 12, 24, and 36 months, respectively. Response rates were slightly better in WAIHA than in CHD, and relapse risk was greater in cold than warm forms (HR 2.1, 95% CI 0.6-7.9). Four patients were retreated (one patient twice), all achieving a response, lasting a median of 18 months (range 9-30). Treatment was well tolerated without adverse events or infections. Anti-RBC antibody production by MS-DAT significantly decreased over time. In vitro studies showed that rituximab effectively inhibited anti-RBC antibody production at 50 μg/mL, 1/6 of the drug concentration after therapy with standard doses. Conclusions: These data confirm that LD rituximab treatment is effective and induces sustained responses in AIHA, and that a lower dose of the drug is enough to down-regulate autoantibody production. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.


Larocca A.,University of Turin | Cavallo F.,University of Turin | Bringhen S.,University of Turin | Di Raimondo F.,University of Catania | And 21 more authors.
Blood | Year: 2012

Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma (MM) but is associated with an increased risk of venous thromboembolism (VTE). This prospective, open-label, randomized substudy of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin (ASA) or low-molecular-weight heparin (LMWH) in patients with newly diagnosed MM, treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were randomly assigned to receive ASA 100 mg/d (n = 176) or LMWH enoxaparin 40 mg/d (n = 166). The incidence of VTE was 2.27% in the ASA group and 1.20% in the LMWH group. Compared with LMWH, the absolute difference in the proportion of VTE was 1.07% (95% confidence interval, -1.69-3.83; P = .452) in the ASA group. Pulmonary embolism was observed in 1.70% of patients in the ASA group and none in the LMWH group. No arterial thrombosis, acute cardiovascular events, or sudden deaths were reported. No major hemorrhagic complications were reported. In previously untreated patients with MM receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis. This study was registered at www.clinicaltrials.gov as #NCT00551928. © 2012 by The American Society of Hematology.


PubMed | University of Modena and Reggio Emilia, Unita Operativa Complessa di Ematologia, University Cattolica ore, Ematologia and 7 more.
Type: | Journal: Blood reviews | Year: 2016

Invasive fungal infections (IFIs) are an important cause of morbidity and mortality in immunocompromised patients. Patients with hematological malignancies undergoing conventional chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation are considered at high risk, and Aspergillus spp. represents the most frequently isolated micro-organisms. In the last years, attention has also been focused on other rare molds (e.g., Zygomycetes, Fusarium spp.) responsible for devastating clinical manifestations. The extensive use of antifungal prophylaxis has reduced the infections from yeasts (e.g., candidemia) even though they are still associated with high mortality rates. This paper analyzes concurrent multiple predisposing factors that could favor the onset of fungal infections. Although neutropenia is common to almost all hematologic patients, other factors play a key role in specific patients, in particular in patients with AML or allogeneic HSCT recipients. Defining those patients at higher risk of IFIs may help to design the most appropriate diagnostic work-up and antifungal strategy.


Barcellini W.,Unita Operativa Ematologia 2 | Zaja F.,Clinica Ematologica | Zaninoni A.,Unita Operativa Ematologia 2 | Imperiali F.G.,Unita Operativa Ematologia 2 | And 7 more authors.
Blood | Year: 2012

This prospective study investigated the efficacy, safety, and response duration of low-dose rituximab (100 mg fixed dose for 4 weekly infusions) together with a short course of steroids as first- or second-line therapy in 23 patients with primary autoimmune hemolytic anemia (AIHA). The overall response was 82.6% at month +2, and subsequently stabilized to ∼90% at months +6 and +12; the response was better in warm autoimmune hemolytic anemia (WAIHA; overall response, 100% at all time points) than in cold hemagglutinin disease (CHD; average, 60%); the relapse-free survival was 100% for WAIHA at +6 and +12 months versus 89% and 59% in CHD, respectively, and the estimated relapse-free survival at 2 years was 81% and 40% for the warm and cold forms, respectively. The risk of relapse was higher in CHD and in patients with a longer interval between diagnosis and enrollment. Steroid administration was reduced both as cumulative dose (∼50%) and duration compared with the patient's past history. Treatment was well tolerated and no adverse events or infections were recorded; retreatment was also effective. The clinical response was correlated with amelioration biologic markers such as cytokine production (IFN-γ, IL-12, TNF-α, and IL-17), suggesting that low-dose rituximab exerts an immu-nomodulating activity. This study is registered at www.clinicaltrials.gov as NCT01345708. © 2012 by The American Society of Hematology.


Merli F.,Ematologia | Luminari S.,University of Modena and Reggio Emilia | Ilariucci F.,Ematologia | Petrini M.,Ematologia | And 11 more authors.
British Journal of Haematology | Year: 2012

This study investigated the clinical activity and toxicity of R-HCVAD-AM [rituximab plus HyperCVAD (R-HCVAD) alternating with high-dose cytarabine and methotrexate (AM)] in patients with newly diagnosed Mantle Cell Lymphoma (MCL). Patients aged ≤70years with confirmed MCL received four alternating cycles each of R-HCVAD and AM. Patients who obtained a partial response proceeded to autologous stem cell transplant. Sixty-three patients were enrolled and 60 were fully eligible. Median age was 57years (22-66); 60%, 33% and 7% were classified at low (L)-, intermediate (I)- or high (H)-risk, respectively, according to the MCL International Prognostic Index (MIPI). Only 22 patients (37%) completed the four cycles and three patients died during therapy. Overall response and complete response rates were 83% and 72% respectively. After a median follow-up of 46months (range 1-72) the estimated 5-year overall survival (OS) and progression-free survival rates were 73% [95% confidence interval (CI) 59-83%], and 61% (95%CI 45-73%) respectively. MIPI maintained the prognostic value with an estimated 5-year OS of 89%, 80% and 24% for L, I, and H groups respectively (P<0·001). This multicentre study confirms that R-HCVAD-AM is an active regimen for the initial treatment of patients with MCL, but is associated with significant toxicity. © 2011 Blackwell Publishing Ltd.

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