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Your search keyword '"Fincato, Gianluca"' showing total 8 results
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8 results on '"Fincato, Gianluca"'

1. Imatinib and pegylated human recombinant interferon-α2b in early chronic-phase chronic myeloid leukemia

Author

Baccarani, Michele, Martinelli, Giovanni, Rosti, Gianantonio, Trabacchi, Elena, Testoni, Nicoletta, Bassi, Simona, Amabile, Marilina, Soverini, Simona, Castagnetti, Fausto, Cilloni, Daniela, Izzo, Barbara, de Vivo, Antonio, Messa, Emanuela, Bonifazi, Francesca, Poerio, Angela, Luatti, Simona, Giugliano, Emilia, Alberti, Daniele, Fincato, Gianluca, Russo, Domenico, Pane, Fabrizio, and Saglio, Giuseppe

Published
2004
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2. Imatinib and pegylated human recombinant interferon-alpha2b in early chronic-phase chronic myeloid leukemia

Author

Baccarani, Michele, Martinelli, Giovanni, Rosti, Gianantonio, Trabacchi, Elena, Testoni, Nicoletta, Bassi, Simona, Amabile, Marilina, Soverini, Simona, Castagnetti, Fausto, Cilloni, Daniela, Izzo, Barbara, De Vivo, Antonio, Messa, Emanuela, Bonifazi, Francesca, Poerio, Angela, Luatti, Simona, Giugliano, Emilia, Alberti, Daniele, Fincato, Gianluca, Russo, Domenico, Pane, Fabrizio, Saglio, Giuseppe, GIMEMA CML Working Party, Bocchia, Monica, Baccarani, M, Martinelli, G, Rosti, G, Trabacchi, E, Testoni, N, Bassi, S, Amabile, M, Soverini, S, Castagnetti, F, Cilloni, D, Izzo, Barbara, DE VIVO, A, Messa, E, Bonifazi, F, Poerio, A, Luatti, S, Giugliano, E, Alberti, D, Fincato, G, Russo, D, Pane, Fabrizio, Saglio, G, GIMEMA WORKING PARTY ON CHRONIC MYELOID, L. E. U. K. E. M. I. A., BACCARANI M., MARTINELLI G., ROSTI G., TRABACCHI E., TESTONI N., BASSI S., AMABILE M., SOVERINI S., CASTAGNETTI F., CILLONI D., IZZO B., DE VIVO A., MESSA E., BONIFAZI F., POERIO A., LUATTI S., GIUGLIANO E., ALBERTI D., FINCATO G., RUSSO D., PANE F., SAGLIO G., and GIMEMA WORKING PARTY ON CHRONIC MYELOID LEUKEMIA

Subjects
Male, PHILADELPHIA-CHROMOSOME, Biochemistry, Gastroenterology, Piperazines, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Chronic, BCR-ABL, Leukemia, CLINICAL RESISTANCE, CHRONIC MYELOGENOUS LEUKEMIA, Myeloid leukemia, TYROSINE KINASE INHIBITOR, ABL-POSITIVE CELLS, SEQUENCE BINDING-PROTEIN, FUSION GENE TRANSCRIPTS, CYTOGENETIC RESPONSES, ANTILEUKEMIC AGENTS, Hematology, Middle Aged, Recombinant Proteins, Toxicity, Benzamides, Imatinib Mesylate, Female, Drug, medicine.drug, Adult, medicine.medical_specialty, Immunology, Alpha interferon, Interferon alpha-2, Dose-Response Relationship, chronic myeloid leukemia, Aged, Dose-Response Relationship, Drug, Humans, Interferon-alpha, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Pyrimidines, Internal medicine, medicine, Adverse effect, business.industry, Imatinib, Cell Biology, medicine.disease, Imatinib mesylate, imatinib, BCR-ABL Positive, recombinant alpha2b interferon, business, Chronic myelogenous leukemia, Myelogenous
Abstract

Since interferon-α and imatinib (IM; STI571, Glivec, Gleevec) are effective for the treatment of chronic myeloid leukemia (CML), and their mechanisms of action are different, we designed an exploratory study investigating the effects of a standard IM dose (400 mg/d) and a variable pegylated interferon-α (PegIFN) dose (50 μg/wk, 100 μg/wk, and 150 μg/wk). The criteria for dose adjustment were designed so as to ensure the delivery of the IM dose and to protect life quality. There were 76 patients with previously untreated Philadelphia (Ph)–positive CML enrolled in the study. There were 3 patients who discontinued IM and 45 patients who discontinued PegIFN. The severity of adverse events increased with increasing PegIFN dose. The IM dose could be administered to the patients who were assigned to receive 50 μg/wk or 100 μg/wk PegIFN but not to those who were assigned to receive 150 μg/wk. The median administered dose of PegIFN ranged between 32 μg/wk and 36 μg/wk. The cytogenetic response was 70% complete (Ph-neg 100%) and 83% major (Ph-neg > 65%). The BCR/ABL transcript was reduced by at least 3 logs in 68% of complete cytogenetic responders. These data of toxicity, compliance, and efficacy may assist in the design and preparation of prospective studies.

Published
2004

3. CELSG CML 11 “ISTAHIT” Phase III Study – Planned Interim Analysis: High Doses of Imatinib Mesylate (800mg/day) Significantly Improve Rates of Major and Complete Cytogenetic Remissions (MCR, CCR) in Pretreated Ph+/BCR-ABL+ CML Patients in Chronic Phase.

Author

Petzer, Andreas L., primary, Wolf, Dominik, primary, Fong, Dominic, primary, Lion, Thomas, primary, Dyagil, Irina, primary, Masliak, Zvenyslava, primary, Boskovic, Darinka, primary, Griskevicius, Laimonas, primary, Lejniece, Sandra, primary, Goranov, Stefan, primary, Gercheva, Liana, primary, Stojanovic, Aleksandar, primary, Peytchev, Dontcho, primary, Tzvetkov, Nikolay, primary, Griniute, Rasa, primary, Oucheva, Radka, primary, Ulmer, Hanno, primary, Kwakkelstein, Marthin, primary, Fincato, Gianluca, primary, and Gastl, Guenther, primary

Published
2008
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7. CELSG CML 11 “ISTAHIT” Phase III Study – Planned Interim Analysis: High Doses of Imatinib Mesylate (800mg/day) Significantly Improve Rates of Major and Complete Cytogenetic Remissions (MCR, CCR) in PretreatedPh+/BCR-ABL+CML Patients in Chronic Phase.

Author

Petzer, Andreas L., Wolf, Dominik, Fong, Dominic, Lion, Thomas, Dyagil, Irina, Masliak, Zvenyslava, Boskovic, Darinka, Griskevicius, Laimonas, Lejniece, Sandra, Goranov, Stefan, Gercheva, Liana, Stojanovic, Aleksandar, Peytchev, Dontcho, Tzvetkov, Nikolay, Griniute, Rasa, Oucheva, Radka, Ulmer, Hanno, Kwakkelstein, Marthin, Fincato, Gianluca, and Gastl, Guenther

Abstract

We have recently reported results from the first planned interim analysis of a multicenter, randomised, 2-arm - phase III study comparing imatinib standard dose (400 mg/day; arm A) with imatinib high dose (HD) induction (800 mg/day; HD arm B) followed by imatinib standard dose maintenance (400 mg/day) in pretreatedPh+/BCRABL+CML patients in chronic phase (CP; Blood,110,1048a). The first planned interim analysis was performed after 50% of the patients had been treated for 12 months (mo) since randomisation. A total of 227 patients were randomized. Pretreatments included hydroxyurea (96%), interferon (72%), busulfan (17%) and “others” (26%; mainly AraC +/− combinations). Although rates of complete haematological responses did not differ significantly between the 2 arms at 3, 6 and 12 mo, significantly more patients achieved a major (MCR) and a complete cytogenetic response (CCR) at 3 mo (MCR: 21% arm A, 37% arm B, p=0.01; CCR: 6% arm A, 25% arm B, p<0.001) and 6 mo (MCR: 34% arm A, 54% arm B, p=0.009; CCR: 20% arm A, 44% arm B, p<0.001). At 12 mo, following dose reduction of imatinib to 400 mg/d for “maintenance” at mo 6 in the HD arm B, the rates of MCR (the primary endpoint of the study) were comparabel (59% arm A, 57% arm B). Nevertheless, there was still a clear trend to higher rates of CCR (37% arm A, 48% arm B) in the HD arm B, but at the time of the interim analysis these values did not reach statistical significance. In contrast to non-hematological toxicities, grade 3/4 hematological toxicities were significantly more common in the HD arm B (anemia: 2% arm A, 14% arm B; leukopenia: 24% arm A, 46% arm B; thrombocytopenia: 15% arm A, 39% arm B; p≤0.02). Updated results reveal, that the cumulative median doses of imatinib were 400 mg (arm A) and 767 mg (arm B), respectively. The median days of dose interruptions during the first 6 mo were not significantly different (12.5 days arm A, 13 days arm B; p=0.78). Nevertheless, significantly more patients (65.1%) remained on the initial 400mg dose of imatinib in arm A as compared to the initial 800mg dose in the HD arm B (45.6%; p=0.009). 35% of the patients that had to be dose reduced in arm B were reduced to 600mg/day, 63% to 400mg and 2% to 300mg. The cumulative rates of MCR in patients with no dose reduction/interruption were higher in the HD arm B (71%) compared to arm A (59%, p=0.232). Moreover, the cumulative rates of CCR were significantly better for patients with no dose reduction/interruption in the HD arm B (61%) compared to the patients with no dose reduction/interruption in arm A (36%, p=0.014). In addition, in the HD arm B the cumulative rates of CCR were significantly better for patients with no dose reduction/interruption (61%) compared to patients in the HD arm B with an interruption and/or dose reduction (34.9%; p=0.017).

Published
2008
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8. Risk and early cytogenetic response to imatinib and interferon in chronic myeloid leukemia.

Author

Rosti G, Trabacchi E, Bassi S, Bonifazi F, de Vivo A, Martinelli G, Alberti D, Fincato G, Saglio G, and Baccarani M

Subjects
Adolescent, Adult, Aged, Benzamides, Cytogenetic Analysis, Humans, Imatinib Mesylate, Interferon alpha-2, Leukemia, Myelogenous, Chronic, BCR-ABL Positive diagnosis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive genetics, Middle Aged, Piperazines therapeutic use, Pyrimidines therapeutic use, Recombinant Proteins, Risk Assessment, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Interferon-alpha therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Polyethylene Glycols
Abstract

Background and Objectives: We compared the early cytogenetic response (CgR) to a combination of imatinib mesylate (Glivec, Novartis Pharma, Basel, Switzerland) and a pegylated form of human recombinant interferon-alpha2b (pegIFN-alpha2b, PegIntron, Schering Plough, Kenilworth, New Jersey, USA) with the relative risk, either according to Sokal's or Euro scoring systems., Design and Methods: Seventy-seven patients with early chronic phase, previously untreated, Ph-positive chronic myeloid leukemia (CML) received a combination of imatinib mesylate (400 mg/day) and pegIFN-alpha2b (3 consecutive cohorts treated with 50, 100 or 150 mg/weekly). Fifty-seven patients have completed the first 6 months of treatment and are evaluable for CgR., Results: After 6 months of treatment, the overall major CgR rate was 89% and 90% in low risk patients (Sokal's and Euro, respectively), 76 and 59% in intermediate risk and 23% and 17% in high risk patients. These differences were significant (p=0.0001 for Sokal and 0.001 for e)., Interpretation and Conclusions: For the first time, these data suggest that the early CgR rate to a imatinib mesylate-based regimen is significantly risk-related.

Published
2003

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