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Reggio Calabria, Italy

Musto P.,Scientific Institute of Research and Cure | Maurillo L.,S. Eugenio Hospital | Spagnoli A.,S. Eugenio Hospital | Gozzini A.,University of Florence | And 32 more authors.
Cancer | Year: 2010

BACKGROUND: Azacitidine induces responses and prolongs overall survival compared with conventional care regimens in patients who have high-risk myelodysplastic syndromes (MDS). However, limited data are available concerning the efficacy and safety of azacitidine in patients who have lower risk MDS. METHODS: The authors retrospectively evaluated 74 patients with International Prognostic Scoring System low-risk or intermediate 1-risk MDS, who received azacitidine on a national named patient program. At baseline, 84% of patients were transfusion-dependent, 57% had received erythropoietin, and 51% were aged >70 years. Azacitidine was administered subcutaneously for 5 days (n = 29 patients), 7 days (n = 43 patients), or 10 days (n = 2 patients) every month at a dose of 75 mg/m2 daily (n = 45 patients) or at a fixed dose of 100 mg daily (n = 29 patients) and for a median of 7 cycles (range, 1-30 cycles). RESULTS: According to the 2006 International Working Group criteria, overall response rate (ORR) was 45.9%, including complete responses (10.8%), partial responses (9.5%), hematologic improvements (20.3%), and bone marrow complete responses (5.4%). The ORR was 51.6% in 64 patients who completed ≥4 cycles of treatment. The median duration of response was 6 months (range, 1-30 months). After a median follow-up of 15 months, 71% of patients remained alive. A survival benefit was observed in responders versus nonresponders (94% vs 54% of patients projected to be alive at 2.5 years, respectively; P < .0014). The most common grade 3 or 4 adverse events were myelosuppression (21.6%) and infection (6.8%). CONCLUSIONS: The current results indicated that azacitidine may be a feasible and effective treatment for patients with lower risk MDS. © 2010 American Cancer Society.

Pozzi S.,University of Modena and Reggio Emilia | Gentile M.,Cosenza Hospital | Sacchi S.,University of Modena and Reggio Emilia | Marcheselli R.,University of Modena and Reggio Emilia | And 15 more authors.
Leukemia and Lymphoma | Year: 2016

Lenalidomide and dexamethasone are an effective treatment for naïve and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose “level 0”: bendamustine 40 mg/m2 days 1,2; lenalidomide 10 mg days 1–21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM. © 2016 Informa UK Limited, trading as Taylor & Francis Group

Masi F.D.,Pescara General Hospital | Ursini T.,University of Chieti Pescara | Iannece M.D.,D. Cotugno Hospital | Chianura L.,Niguarda Ca Granda Hospital | And 22 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2014

The treatment of visceral leishmaniasis (VL) is poorly standardized in Italy in spite of the existing evidence. All consecutive patients with VL admitted at 15 Italian centers as inpatients or outpatients between January 2004 and December 2008 were retrospectively considered; outcome data at 1 year after treatment were obtained for all but 1 patient. Demographic characteristics, underlying diseases, diagnostic procedures, treatment regimens and outcomes, as well as side effects were recorded. A confirmed diagnosis of VL was reported for 166 patients: 120 (72.3%) immunocompetent, 21 (12.6%) patients with immune deficiencies other than HIV infection, and 25 (15.1%) coinfected with HIV. Liposomal amphotericin B (L-AmB) was the drug almost universally used for treatment, administered to 153 (92.2%) patients. Thirty-seven different regimens, including L-AmB were used. The mean doses were 29.4±7.9 mg/kg in immunocompetent patients, 32.9±8.6 mg/kg in patients with non-HIV-related immunodeficiencies, and 40.8±6.7 mg/kg in HIV-infected patients (P<0.001). The mean numbers of infusion days were 7.8±3.1 in immunocompetent patients, 9.6±3.9 in non-HIV-immunodeficient patients, and 12.0±3.4 in HIV-infected patients (P<0.001). Mild and reversible adverse events were observed in 12.2% of cases. Responsive patients were 154 (93.3%). Successes were 98.4% among immunocompetent patients, 90.5% among non-HIV-immunodeficient patients, and 72.0% among HIV-infected patients. Among predictors of primary response to treatment, HIV infection and age held independent associations in the final multivariate models, whereas the doses and duration of L-AmB treatment were not significantly associated. Longer treatments and higher doses of L-AmB were not able to significantly modify treatment outcomes either in the immunocompetent or in the immunocompromised population. © 2014, American Society for Microbiology. All Rights Reserved.

Mori S.,University of Milan Bicocca | Vagge E.,University of Milan Bicocca | Vagge E.,Justus Liebig University | Le Coutre P.,Humboldt University of Berlin | And 23 more authors.
American Journal of Hematology | Year: 2015

Imatinib is effective for the treatment of chronic myeloid leukemia (CML). However even undetectable BCR-ABL1 by Q-RT-PCR does not equate to eradication of the disease. Digital-PCR (dPCR), able to detect 1 BCR-ABL1 positive cell out of 107, has been recently developed. The ISAV study is a multicentre trial aimed at validating dPCR to predict relapses after imatinib discontinuation in CML patients with undetectable Q-RT-PCR. CML patients under imatinib therapy since more than 2 years and with undetectable PCR for at least 18 months were eligible. Patients were monitored by standard Q-RT-PCR for 36 months. Patients losing molecular remission (two consecutive positive Q-RT-PCR with at least 1 BCR-ABL1/ABL1 value above 0.1%) resumed imatinib. The study enrolled 112 patients, with a median follow-up of 21.6 months. Fifty-two of the 108 evaluable patients (48.1%), relapsed; 73.1% relapsed in the first 9 months but 14 late relapses were observed between 10 and 22 months. Among the 56 not-relapsed patients, 40 (37.0% of total) regained Q-RT-PCR positivity but never lost MMR. dPCR results showed a significant negative predictive value ratio of 1.115 [95% CI: 1.013-1.227]. An inverse relationship between patients age and risk of relapse was evident: 95% of patients <45 years relapsed versus 42% in the class ≥45 to <65 years and 33% of patients ≥65 years [P(χ2)<0.0001]. Relapse rates ranged between 100% (<45 years, dPCR+) and 36% (>45 years, dPCR-). Imatinib can be safely discontinued in the setting of continued PCR negativity; age and dPCR results can predict relapse. © 2015 Wiley Periodicals, Inc.

Veneziano D.,Bianchi Melacrino Morelli Hospital | Minervini A.,University of Florence | Beatty J.,Northampton General Hospital NHS Trust | Fornara P.,Martin Luther University of Halle Wittenberg | And 16 more authors.
World Journal of Urology | Year: 2016

Purpose: Assessing construct, face and content validity of the camera handling trainer (CHT), a novel low-fidelity training device for 30° laparoscope navigation skills. Methods: We developed a custom-designed box trainer with clinically based graphic targets. A total of 117 participants, stratified according to their previous experience (novice, competent, expert), took part to a CHT session and subsequently were asked to fill out a survey to assess the impact of the CHT on their 30° laparoscope navigation skills. Sixty of them were also studied for task performance during a 1-h session, with multiple time measurements. Results: All participants, regardless of the previous experience, significantly improved their performance after the CHT session. Regarding construct validity, the mean task performance on the last measurement for novice group was found to be comparable to the mean first attempt of both competent (p = 0.12) and expert (p = 0.24) participants. All participants agreed that “the CHT is a valid training tool” and that “the CHT should be part of the regular dry laboratory training sessions”, assessing both face and content validity. Limitations include the need for assessment of predictive validity. Conclusions: The CHT is a valid training tool for 30° laparoscope navigation and thus should be considered as one of the fundamental exercises during basic laparoscopic hands-on training sessions for urologists. © 2015, Springer-Verlag Berlin Heidelberg.

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