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1. Ibrutinib as a bridge to transplant in high-risk chronic lymphocytic leukemia: A case report and review of the literature

Author

Arcari Annalisa, Bassi Simona, Pochintesta Lara, Trabacchi Elena, Moroni Carlo Filippo, Rossi Angela, Zanlari Luca, and Vallisa Daniele

Subjects
Chronic lymphocytic leukemia, B-cell receptor inhibitors, Allogeneic hematopoietic stem cell transplantation, TP53 mutation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

The treatment landscape of chronic lymphocytic leukemia (CLL) has been challenged by the advent of novel classes of drugs, such as B-cell receptor (BCR)-inhibitors and BCL-2 antagonists. In selected high-risk patients, the choice to start allogeneic hematopoietic stem cell transplantation (alloHCT) or continue these agents is a matter of debate. Furthermore, published data about the impact on the feasibility of alloHCT and the optimal timing of administration are limited. Here we present a case of relapsed TP53 mutated CLL treated with ibrutinib as a bridge to alloHCT, discussing risks and benefits of different treatment options in a “real life” situation.

Published
2017
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2. Busulfan or Treosulfan Conditioning Platform for Allogeneic Stem Cell Transplantation in Patients Aged >60 Y With Acute Myeloid Leukemia/Myelodysplastic Syndrome: A Subanalysis of the GITMO AlloEld Study

Author

Malagola, Michele, Polverelli, Nicola, Martino, Massimo, Patriarca, Francesca, Bruno, Benedetto, Giaccone, Luisa, Grillo, Giovanni, Bramanti, Stefania, Bernasconi, Paolo, De Gobbi, Marco, Natale, Annalisa, Terruzzi, Elisabetta, Olivieri, Attilio, Chiusolo, Patrizia, Carella, Angelo Michele, Casini, Marco, Maffini, Enrico, Nozzoli, Chiara, Mazza, Patrizio, Bassi, Simona, Onida, Francesco, Vacca, Adriana, Falcioni, Sadia, Luppi, Mario, Iori, Anna Paola, Pavone, Vincenzo, Skert, Cristina, Carluccio, Paola, Borghero, Carlo, Proia, Anna, Selleri, Carmine, Rubini, Vicky, Sacchi, Nicoletta, Oldani, Elena, Bonifazi, Francesca, Ciceri, Fabio, Russo, Domenico, Bernardi, Simona, Farina, Mirko, Fiore, Maria, Lupo Stanghellini, Maria Teresa, Fanin, Renato, Faraci, Danilo Giuseppe, Castagna, Luca, Colombo, Anna Amelia, Nicoli, Paolo, Santarone, Stella, Scortechini, Ilaria, Metafuni, Elisabetta, Merla, Emanuela, Cavattoni, Irene, Cutini, Ilaria, Mazzone, Annamaria, Saporiti, Giorgia, Canale, Filippo Antonio, Piras, Eugenia, Galieni, Piero, Debbia, Giulia, Rocca, Ursula La, Mele, Anna, Carobolante, Francesca, Elice, Francesca, and Fanelli, Fulvia

Published
2023
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3. GITMO Registry Study on Allogeneic Transplantation in Patients Aged ≥60 Years from 2000 to 2017: Improvements and Criticisms

Author

Malagola, Michele, Polverelli, Nicola, Rubini, Vicky, Martino, Massimo, Patriarca, Francesca, Bruno, Benedetto, Giaccone, Luisa, Grillo, Giovanni, Bramanti, Stefania, Bernasconi, Paolo, De Gobbi, Marco, Natale, Annalisa, Terruzzi, Elisabetta, Olivieri, Attilio, Chiusolo, Patrizia, Carella, Angelo Michele, Casini, Marco, Nozzoli, Chiara, Mazza, Patrizio, Bassi, Simona, Onida, Francesco, Vacca, Adriana, Falcioni, Sadia, Luppi, Mario, Iori, Anna Paola, Pavone, Vincenzo, Skert, Cristina, Carluccio, Paola, Borghero, Carlo, Proia, Anna, Selleri, Carmine, Sacchi, Nicoletta, Mammoliti, Sonia, Oldani, Elena, Ciceri, Fabio, Russo, Domenico, and Bonifazi, Francesca

Published
2022
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4. Mixed T cell CHIMERISM in bone marrow at day+30 after allogeneic stem cell transplantation: Correlation with acute GVHD grades III–IV and no impact on relapse and overall survival

Author

Guidotti, Samantha, primary, Bassi, Simona, additional, Rossi, Angela, additional, Borotti, Elena, additional, Cortellazzi, Pilade, additional, Ferrarese, Diego, additional, Ronda, Elena, additional, Scarpa, Alice, additional, Schiro, Alice, additional, Merli, Francesco, additional, Prezioso, Lucia, additional, Bonifazi, Francesca, additional, Narni, Franco, additional, Fabrizi, Enrico, additional, and Vallisa, Daniele, additional

Published
2022
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5. A single dose of Pegfilgrastim versus daily Filgrastim to evaluate the mobilization and the engraftment of autologous peripheral hematopoietic progenitors in malignant lymphoma patients candidate for high-dose chemotherapy

Author

Bassi, Simona, Rabascio, Cristina, Nassi, Luca, Steffanoni, Sara, Babic, Aleksandra, Bertazzoni, Paola, Gigli, Federica, Antoniotti, Pierluigi, Orlando, Laura, Sammassimo, Simona, Quarna, Jessica, Negri, Mara, and Martinelli, Giovanni

Published
2010
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6. Overall Survival Improvement Following ALLO-SCT in Patients Older THAN 60 YEARS: A Gruppo Italiano Trapianto DI Midollo Osseo (GITMO) Registry Study

Author

Malagola, Michele, primary, Polverelli, Nicola, additional, Martino, Massimo, additional, Rubini, Vicky, additional, Lupo Stanghellini, Maria Teresa, additional, Patriarca, Francesca, additional, Fanin, Renato, additional, Bruno, Benedetto, additional, Giaccone, Luisa, additional, Faraci, Danilo Giuseppe, additional, Grillo, Giovanni, additional, Bramanti, Stefania, additional, Castagna, Luca, additional, Bernasconi, Paolo, additional, Colombo, Anna Amelia, additional, De Gobbi, Marco, additional, Nicoli, Paolo, additional, Natale, Annalisa, additional, Santarone, Stella, additional, Terruzzi, Elisabetta, additional, Olivieri, Attilio, additional, Scortechini, Ilaria, additional, Chiusolo, Patrizia, additional, Metafuni, Elisabetta, additional, Carella, Angelo Michele, additional, Merla, Emanuela, additional, Casini, Marco, additional, Cavattoni, Irene M, additional, Arpinati, Mario, additional, Nozzoli, Chiara, additional, Cutini, Ilaria, additional, Mazza, Patrizio, additional, Mazzone, Annamaria, additional, Bassi, Simona, additional, Onida, Francesco, additional, Saporiti, Giorgia, additional, Canale, Filippo Antonio, additional, Vacca, Adriana, additional, Piras, Eugenia, additional, Galieni, Piero, additional, Falcioni, Sadia, additional, Luppi, Mario, additional, Debbia, Giulia, additional, Iori, Anna Paola, additional, La Rocca, Ursula, additional, Pavone, Vincenzo, additional, Mele, Anna, additional, Skert, Cristina, additional, Carobolante, Francesca, additional, Carluccio, Paola, additional, Borghero, Carlo, additional, Elice, Francesca, additional, Proia, Anna, additional, Fanelli, Fulvia, additional, Selleri, Carmine, additional, Sacchi, Nicoletta, additional, Mammoliti, Sonia, additional, Oldani, Elena, additional, Ciceri, Fabio, additional, Bonifazi, Francesca, additional, and Russo, Domenico, additional

Published
2021
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7. 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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8. ABL Mutations in Late Chronic Phase Chronic Myeloid Leukemia Patients With Up-Front Cytogenetic Resistance to Imatinib Are Associated With a Greater Likelihood of Progression to Blast Crisis and Shorter Survival: A Study by the GIMEMA Working Party on Chronic Myeloid Leukemia

Author

Soverini, Simona, Martinelli, Giovanni, Rosti, Gianantonio, Bassi, Simona, Amabile, Marilina, Poerio, Angela, Giannini, Barbara, Trabacchi, Elena, Castagnetti, Fausto, Testoni, Nicoletta, Luatti, Simona, de Vivo, Antonio, Cilloni, Daniela, Izzo, Barbara, Fava, Milena, Abruzzese, Elisabetta, Alberti, Daniele, Pane, Fabrizio, Saglio, Giuseppe, and Baccarani, Michele

Published
2005
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9. Molecular response to imatinib in late chronic-phase chronic myeloid leukemia

Author

Rosti, Gianantonio, Martinelli, Giovanni, Bassi, Simona, Amabile, Marilina, Trabacchi, Elena, Giannini, Barbara, Cilloni, Daniela, Izzo, Barbara, De Vivo, Antonio, Testoni, Nicoletta, Cambrin, Giovanna Rege, Bonifazi, Francesca, Soverini, Simona, Luatti, Simona, Gottardi, Enrico, Alberti, Daniele, Pane, Fabrizio, Salvatore, Francesco, Saglio, Giuseppe, and Baccarani, Michele

Published
2004
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10. Ibrutinib as a bridge to transplant in high-risk chronic lymphocytic leukemia: A case report and review of the literature

Author

Zanlari Luca, Arcari Annalisa, Pochintesta Lara, Moroni Carlo Filippo, Trabacchi Elena, Bassi Simona, Rossi Angela, and Vallisa Daniele

Subjects
Oncology, medicine.medical_specialty, Chronic lymphocytic leukemia, medicine.medical_treatment, Hematopoietic stem cell transplantation, Tp53 mutation, lcsh:RC254-282, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, medicine, Risks and benefits, Bridge to transplant, business.industry, breakpoint cluster region, TP53 mutation, Treatment options, Hematology, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, chemistry, 030220 oncology & carcinogenesis, Ibrutinib, Immunology, Allogeneic hematopoietic stem cell transplantation, B-cell receptor inhibitors, business, 030215 immunology
Abstract

The treatment landscape of chronic lymphocytic leukemia (CLL) has been challenged by the advent of novel classes of drugs, such as B-cell receptor (BCR)-inhibitors and BCL-2 antagonists. In selected high-risk patients, the choice to start allogeneic hematopoietic stem cell transplantation (alloHCT) or continue these agents is a matter of debate. Furthermore, published data about the impact on the feasibility of alloHCT and the optimal timing of administration are limited. Here we present a case of relapsed TP53 mutated CLL treated with ibrutinib as a bridge to alloHCT, discussing risks and benefits of different treatment options in a “real life” situation.

Published
2017

12. A single dose of Pegfilgrastim versus daily Filgrastim to evaluate the mobilization and the engraftment of autologous peripheral hematopoietic progenitors in malignant lymphoma patients candidate for high-dose chemotherapy

Author

Rabascio Cristina, Steffanoni Sara, Negri Mara, Bassi Simona, Martinelli Giovanni, Gigli Federica, Nassi Luca, Babic Aleksandra, Orlando Laura, Bertazzoni Paola, Antoniotti Pierluigi, Quarna Jessica, and Sammassimo Simona

Subjects
Oncology, medicine.medical_specialty, Filgrastim, Lymphoma, medicine.medical_treatment, Transplantation, Autologous, Polyethylene Glycols, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Hematopoietic Stem Cell Mobilization, Peripheral Blood Stem Cell Transplantation, Chemotherapy, business.industry, Graft Survival, Hematology, medicine.disease, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Transplantation, ESHAP, business, Pegfilgrastim, medicine.drug
Abstract

Pegfilgrastim has equivalent efficacy to daily G-CSF in enhancing neutrophil recovery after chemotherapy, but conclusive data concerning its use for peripheral blood stem cell (PBSC) mobilization are lacking. From 2003 to 2008 we used high-dose chemotherapy in 64 lymphoma patients. At mobilization chemotherapy (ESHAP) the first 26 patients used unconjugated G-CSF, while the remaining 38 patients received Pegfilgrastim. At the time of harvest 25 patients collected stem cells after the use of G-CSF and 36 in the Peg group. No statistical by significant differences were observed in median peripheral CD34+ cells mobilized (77 μL versus 71 μL) and in collected PBSC (12.3 × 10(6)/kg versus 9.4 × 10(6)/kg p = 0.76). In the PEG group all patients collected the target PBSC with a single apheresis with a greater proportion of "optimal" mobilizers (83% versus 64%; p = 0.05). In conclusion a single dose of Pegfilgrastim could be a valid alternative to unconjugated G-CSF to mobilize PBSC in lymphoma patients.

Published
2010

13. Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens

Author

Bassi, Simona, Stroppa, Elisa M., Moroni, Carlo F., Arbasi, Maria C., Trabacchi, Elena, Di Franco, Anna, Lazzaro, Antonio, Bernuzzi, Patrizia, Moretto, Mauro, Arcari, Annalisa, Bosi, Costanza, Riva, Alessandra, Cavanna, Luigi, and Vallisa, Daniele

Subjects
Adult, Male, Transplantation Conditioning, Filgrastim, Lymphoma, Hematopoietic Stem Cell Transplantation, Middle Aged, Costs and Cost Analysis, Humans, Original Article, Female, Autografts, Multiple Myeloma, Biosimilar Pharmaceuticals, Aged, Retrospective Studies
Abstract

Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed.Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim(®) and Zarzio(®) was associated with cost reductions of 56% and of 86%, respectively.Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT.

Published
2015

14. Purging e alte dosi di chemioterapia con reinfusione di cellule staminali autologhe in linfomi non Hodgkin follicolari resistenti/refrattari

Author

Bassi, Simona <1973>

Subjects
MED/15 Malattie del sangue
Abstract

In the era of monoclonal antibodies the role of autologous stem cell transplantation (ASCT) in the management of follicular lymphoma (FL) is still debated. To evaluate the safety and efficacy of myeloablative therapy with rescue of purged or unpurged harvests in FL pts. At our institution form 1997 to 2007 28 pts with refractory/resistant FL were eligible for ASCT. Before high dose therapy they received 2-3 cycles of CHOP-like regimen (ACOD), followed by Cyclophosphamide 4g/mq to mobilize the stem cells (SC). After SC collection the pts underwent 3 cycles of subcutaneous Cladribine at a daily dose of 0,14-0,10 mg/Kg for Day 1-5 every 3-4 weeks. The conditioning regimen was based on Mitoxantrone 60mg/mq + Melphalan 180 mg/mq, followed by SC re-infusion 24-hours later and G-CSF starting 24 hours after re-infusion. In 19 pts the SC underwent purging: in 10 harvests the CD34+ were selected by immunomagnetic beads, while in the other 9 pts, only Rituximab was used as “purging in vivo” agent. The remaining 9 pts received unpurged SC. Before ASCT 11 pts were in complete response (CR), 9 in partial response (PR) and 2 in stable disease. Two pts were not eligible for ASCT because of progressive disease (PD). The remaining 25 pts were eligible for ASCT. The engraftment was at a median of 11 days for leucocytes and 14 days for platelets (>20.000/mmc), with a delay of one day in the pts, who received purged SC. Grade 3-4 mucositis was described in 8 pts. During aplasia a 48% infection rate was reported, without differences between pts with purged or unpurged SC. One patient in CR presented myelodysplastic syndrome at 18 months from ASCT. After ASCT 22 pts were in CR, 2 in PR and one patient were not valuable, because died before response assessment. Nine pts in CR showed PD at a median time of 14 months from ASCT. With a median follow up of 5 years (range 2 months -10 years), 22 pts are alive and 11 (44%) in CR. Ten pts died, 5 for progressive disease and 5 for treatment-related causes; in particular 7 of them received in-vitro purged SC. Conclusions: Our chemotherapy regimen, which included the purine analogue Cladribine in the induction phase, seems safe and feasible. The high rate of CR reported and the sustained freedom from progression up to now, makes such modality of treatment a valid option principally in relapsing FL patients. In our experience, the addition of a monoclonal antibody as part of treatment confirms its role “in vivo purging” without observing an increased incidence of infection.

Published
2008

15. Impact of age on the outcome of patients with chronic myeloid leukemia in late chronic phase: results of a phase II study of the GIMEMA CML Working Party

Author

Rosti, Gianantonio, Iacobucci, Ilaria, Bassi, Simona, Castagnetti, Fausto, Amabile, Marilina, Cilloni, Daniela, Poerio, Angela, Soverini, Simona, Palandri, Francesca, Rege Cambrin, Giovanna, Iuliano, Franco, Alimena, Giuliana, Latagliata, Roberto, Testoni, Nicoletta, Pane, Fabrizio, Saglio, Giuseppe, Baccarani, Michele, Martinelli, Giovanni, GIMEMA CML Working Party, Bocchia, Monica, Rosti G, Iacobucci I, Bassi S, Castagnetti F, Amabile M, Cilloni D, Poerio A, Soverini S, Palandri F, Rege Cambrin G, Iuliano F, Alimena G, Latagliata R, Testoni N, Pane F, Saglio G, Baccarani M, Martinelli G., Rosti, G, Iacobucci, I, Bassi, S, Castagnetti, F, Amabile, M, Cilloni, D, Poerio, A, Soverini, S, Palandri, F, REGE CAMBRIN, G, Iuliano, F, Alimena, G, Latagliata, R, Testoni, N, Pane, Fabrizio, Saglio, G, Baccarani, M, and Martinelli, G.

Subjects
Adult, Male, medicine.medical_specialty, Aging, Adolescent, Phases of clinical research, Antineoplastic Agents, Disease-Free Survival, Piperazines, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, hemic and lymphatic diseases, medicine, 80 and over, Age Factors, Aged, Aged, 80 and over, Benzamides, Female, Humans, Imatinib Mesylate, Middle Aged, Pyrimidines, Treatment Outcome, Chronic, Adverse effect, Hematology, Leukemia, business.industry, Myeloid leukemia, Imatinib, chronic myeloid leukemia, imatinib, older age, medicine.disease, Surgery, Clinical trial, Imatinib mesylate, BCR-ABL Positive, business, medicine.drug, Myelogenous
Abstract

To assess the effect of age on response and compliance to treatment in patients with chronic myeloid leukemia (CML) we performed a sub-analysis within a phase II trial of the GIMEMA CML Working Party (CML/002/STI571). Since the WHO cut-off age to define an older patient is 65 years, among the 284 patients considered, we identified 226 (80%) younger patients (below 65 years) and 58 (20%) older patients (above 65 years) before starting imatinib. Response rates (hematologic and cytogenetic) were lower in the older age group but the probabilities of progression-free survival and overall survival (median observation time 3 years) were the same. Moreover, among complete cytogenetic responders, no differences were found in the level of molecular response between the two age groups. As might be expected, older patients experienced more adverse events, both hematologic and non-hematologic: this worsened compliance did not, however, prevent a long-term outcome similar to that of younger patients.

Published
2007

16. 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

17. Purging e alte dosi di chemioterapia con reinfusione di cellule staminali autologhe in linfomi non Hodgkin follicolari resistenti/refrattari

Author

Zinzani, Pier Luigi, Bassi, Simona <1973>, Zinzani, Pier Luigi, and Bassi, Simona <1973>

Abstract

In the era of monoclonal antibodies the role of autologous stem cell transplantation (ASCT) in the management of follicular lymphoma (FL) is still debated. To evaluate the safety and efficacy of myeloablative therapy with rescue of purged or unpurged harvests in FL pts. At our institution form 1997 to 2007 28 pts with refractory/resistant FL were eligible for ASCT. Before high dose therapy they received 2-3 cycles of CHOP-like regimen (ACOD), followed by Cyclophosphamide 4g/mq to mobilize the stem cells (SC). After SC collection the pts underwent 3 cycles of subcutaneous Cladribine at a daily dose of 0,14-0,10 mg/Kg for Day 1-5 every 3-4 weeks. The conditioning regimen was based on Mitoxantrone 60mg/mq + Melphalan 180 mg/mq, followed by SC re-infusion 24-hours later and G-CSF starting 24 hours after re-infusion. In 19 pts the SC underwent purging: in 10 harvests the CD34+ were selected by immunomagnetic beads, while in the other 9 pts, only Rituximab was used as “purging in vivo” agent. The remaining 9 pts received unpurged SC. Before ASCT 11 pts were in complete response (CR), 9 in partial response (PR) and 2 in stable disease. Two pts were not eligible for ASCT because of progressive disease (PD). The remaining 25 pts were eligible for ASCT. The engraftment was at a median of 11 days for leucocytes and 14 days for platelets (>20.000/mmc), with a delay of one day in the pts, who received purged SC. Grade 3-4 mucositis was described in 8 pts. During aplasia a 48% infection rate was reported, without differences between pts with purged or unpurged SC. One patient in CR presented myelodysplastic syndrome at 18 months from ASCT. After ASCT 22 pts were in CR, 2 in PR and one patient were not valuable, because died before response assessment. Nine pts in CR showed PD at a median time of 14 months from ASCT. With a median follow up of 5 years (range 2 months -10 years), 22 pts are alive and 11 (44%) in CR. Ten pts died, 5 for progressive disease and 5 for treatment-relate

Published
2008

18. Fatherhood during imatinib

Author

Shash, Emad, primary, Bassi, Simona, additional, Cocorocchio, Emilia, additional, Colpi, Giovanni Maria, additional, Cinieri, Saverio, additional, and Peccatori, Fedro Alessandro, additional

Published
2011
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19. Rituximab Plus Chlorambucil Compared with Chlorambucil and Prednisone In Patients with Untreated Follicular Lymphoma

Author

Bassi, Simona, primary, Sammassimo, Simona, additional, Gigli, Federica, additional, Pruneri, Giancarlo, additional, Bertazzoni, Paola, additional, Quarna, Jessica, additional, Cocorocchio, Emilia, additional, Laszlo, Daniele, additional, Negri, Mara, additional, Lionetti, Maria, additional, Vanazzi, Anna, additional, Alietti, Alessandra, additional, Agazzi, Alberto, additional, Gardellini, Angelo, additional, Andreola, Giovanna, additional, Preda, Lorenzo, additional, Pastano, Rocco, additional, and Martinelli, Giovanni, additional

Published
2010
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22. Long-Term Follow-Up of Patients With Follicular Lymphoma Receiving Single-Agent Rituximab at Two Different Schedules in Trial SAKK 35/98

Author

Martinelli, Giovanni, primary, Hsu Schmitz, Shu-Fang, additional, Utiger, Urs, additional, Cerny, Thomas, additional, Hess, Urs, additional, Bassi, Simona, additional, Okkinga, Emmie, additional, Stupp, Roger, additional, Stahel, Rolf, additional, Heizmann, Marc, additional, Vorobiof, Daniel, additional, Lohri, Andreas, additional, Dietrich, Pierre-Yves, additional, Zucca, Emanuele, additional, and Ghielmini, Michele, additional

Published
2010
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23. Rituximab and subcutaneous cladribine in chronic lymphocytic leukemia for newly diagnosed and relapsed patients

Author

Bertazzoni, Paola, primary, Rabascio, Cristina, additional, Gigli, Federica, additional, Calabrese, Liliana, additional, Radice, Davide, additional, Calleri, Angelica, additional, Gregato, Giuliana, additional, Negri, Mara, additional, Liptrott, Sarah J., additional, Bassi, Simona, additional, Nassi, Luca, additional, Sammassimo, Simona, additional, Laszlo, Daniele, additional, Preda, Lorenzo, additional, Pruneri, Giancarlo, additional, Orlando, Laura, additional, and Martinelli, Giovanni, additional

Published
2010
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24. Rituximab and Chlorambucil as Front-Line Treatment in Untreated Follicular Lymphoma: a Combination with a Durable Response and Low Toxicity Profile.

Author

Bassi, Simona, primary, Nassi, Luca, additional, Pruneri, Giancarlo, additional, Sammassimo, Simona, additional, Bertazzoni, Paola, additional, Gigli, Federica, additional, Vanazzi, Anna, additional, Cocorocchio, Emilia, additional, Mancuso, Patrizia, additional, Rabascio, Cristina, additional, Lionetti, Maria Teresa, additional, Laszlo, Daniele, additional, and Martinelli, Giovanni, additional

Published
2009
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25. Rituximab in Lymphocyte-Predominant Hodgkin Disease

Author

Azim Jr., Hatem A., primary, Pruneri, Giancarlo, additional, Cocorocchio, Emilia, additional, Cinieri, Saverio, additional, Raviele, Paola R., additional, Bassi, Simona, additional, Preda, Lorenzo, additional, Martinelli, Giovanni, additional, and Peccatori, Fedro A., additional

Published
2008
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26. Rituximab and 2-Cda Activity in CLL/SLL Patients: An Update of Pharmacogenomic and Clinical Results

Author

Bertazzoni, Paola, primary, Rabascio, Cristina, primary, Calabrese, Liliana, primary, Gigli, Federica, primary, Bassi, Simona, primary, Nassi, Luca, primary, Sammassimo, Simona, primary, Steffanoni, Sara, primary, Radice, Davide, primary, Calleri, Angelica, primary, Cocorocchio, Emilia, primary, Laszlo, Daniele, primary, and Martinelli, Giovanni, primary

Published
2008
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27. Evolving First-Line Treatments -from Chemotherapy to Immunotherapy Alone- in 143 Consecutive Follicular Lymphoma Patients Treated in the Last 14 Years at the European Institute of Oncology, Milano

Author

Bassi, Simona, primary, Gigli, Federica, primary, Rabascio, Cristina, primary, Sammassimo, Simona, primary, Mancuso, Patrizia, primary, Cocorocchio, Emilia, primary, Bertazzoni, Paola, primary, Laszlo, Daniele, primary, Pruneri, Giancarlo, primary, Calabrese, Liliana, primary, Lionetti, Maria Teresa, primary, Vanazzi, Anna, primary, Alietti, Alessandra, primary, Nassi, Luca, primary, Agazzi, Alberto, primary, Pastano, Rocco, primary, Peccatori, Fedro Alessandro, primary, and Martinelli, Giovanni, primary

Published
2008
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28. Interim 18f[FDG] Positron Emission Tomography in Patients with Diffuse Large B-Cell Lymphoma

Author

Gigli, Federica, primary, Nassi, Luca, additional, Negri, Mara, additional, Travaini, Laura, additional, Steffanoni, Sara, additional, Liptrott, Sarah Jane, additional, Mancuso, Patrizia, additional, Bertazzoni, Paola, additional, Bassi, Simona, additional, Calabrese, Liliana, additional, Cocorocchio, Emilia, additional, and Martinelli, Giovanni, additional

Published
2008
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29. Combined VBM Chemotherapy and Involved Field (IF) Radiotherapy in Early Stage Hodgkin’s Lymphoma (HL): A Single Centre Experience.

Author

Cocorocchio, Emilia, primary, Peccatori, Fedro A., additional, Gigli, Federica, additional, Bassi, Simona, additional, Nassi, Luca, additional, Calabrese, Liliana, additional, Travaini, Laura, additional, Piperno, Gaia, additional, Preda, Lorenzo, additional, Pruneri, Giancarlo, additional, Liptrott, Sarah J., additional, Alietti, Alessandra, additional, and Martinelli, Giovanni, additional

Published
2007
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30. Continuous Immuno-Chemotherapy Followed by High Dose and Autologous Cell Transplantation May Improve the Event-Free-Survival in Mantle Cell Lymphoma Patients. Experience at the European Institute of Oncology in Milan.

Author

Bassi, Simona, primary, Alietti, Alessandra, additional, Corsini, Chiara, additional, Gigli, Federica, additional, Bertazzoni, Paola, additional, Rabascio, Cristina, additional, Mancuso, Patrizia, additional, Cocorocchio, Emilia, additional, Laszlo, Daniele, additional, Pruneri, Giancarlo, additional, Preda, Lorenzo, additional, Liptrott, Sarah J., additional, Cascio, Rosaria, additional, Bertolini, Francesco, additional, and Martinelli, Giovanni, additional

Published
2007
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31. Impact of Age in the Outcome of Patients with Chronic Myeloid Leukemia in Late Chronic Phase: Clinical and Molecular Results of a Phase II Study of the GIMEMA CML Working Party.

Author

Martinelli, Giovanni, primary, Palandri, Francesca, primary, Iacobucci, Ilaria, primary, Bassi, Simona, primary, Castagnetti, Fausto, primary, Amabile, Marilina, primary, Cilloni, Daniela, primary, Poerio, Angela, primary, Soverini, Simona, primary, Rege-Cambrin, Giovanna, primary, Iuliano, Franco, primary, Alimena, Giuliana, primary, Latagliata, Roberto, primary, Testoni, Nicoletta, primary, Pane, Fabrizio, primary, Saglio, Giuseppe, primary, Rosti, Gianantonio, primary, and Baccarani, Michele, primary

Published
2006
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32. Achieving a Major Molecular Response at the Time of a Complete Cytogenetic Response (CCgR) Predicts a Better Duration of CCgR in Imatinib-Treated Chronic Myeloid Leukemia Patients

Author

Iacobucci, Ilaria, primary, Saglio, Giuseppe, additional, Rosti, Gianantonio, additional, Testoni, Nicoletta, additional, Pane, Fabrizio, additional, Amabile, Marilina, additional, Poerio, Angela, additional, Soverini, Simona, additional, Bassi, Simona, additional, Cilloni, Daniela, additional, Bassan, Renato, additional, Breccia, Massimo, additional, Lauria, Francesco, additional, Izzo, Barbara, additional, Merante, Serena, additional, Frassoni, Francesco, additional, Paolini, Stefania, additional, Montefusco, Enrico, additional, Baccarani, Michele, additional, and Martinelli, Giovanni, additional

Published
2006
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34. Down Regulation of TOPK, PBX3, SRPK, DDX21 and CLC Genes in Newly Diagnosed, Early-Chronic Phase Chronic Myeloid Leukemia Patients Treated with Imatinib Mesylate.

Author

Poerio, Angela, primary, Amabile, Marilina, primary, Soverini, Simona, primary, Renzulli, Matteo, primary, Rosti, Gianantonio, primary, Bassi, Simona, primary, Ottaviani, Emanuela, primary, Grafone, Tiziana, primary, Terragna, Carolina, primary, Taccioli, Cristian, primary, Rondoni, Michela, primary, Bosi, Costanza, primary, Testoni, Nicoletta, primary, Luatti, Simona, primary, Castagnetti, Fausto, primary, Malagola, Michele, primary, Pane, Fabrizio, primary, Saglio, Giuseppe, primary, Baccarani, Michele, primary, and Martinelli, Giovanni, primary

Published
2004
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35. A New Abl Kinase Inhibitor (AMN107) Has In Vitro Activity on CML Ph+Blast Cells Resistant to Imatinib.

Author

Martinelli, Giovanni, primary, Martelli, Alberto M., primary, Grafone, Tiziana, primary, Rosti, Gianantonio, primary, Mantovani, Irina, primary, Cappellini, Alessandra, primary, Tazzari, Pier Luigi, primary, Ottaviani, Emanuela, primary, Renzulli, Matteo, primary, Amabile, Marilina, primary, Poerio, Angela, primary, Soverini, Simona, primary, Terragna, Carolina, primary, Taccioli, Cristian, primary, Bassi, Simona, primary, and Baccarani, Michele, primary

Published
2004
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36. Imatinib in the Treatment of CML Patients ≥ 65 Years Old in Late Chronic Phase: Results of a Phase II Study of the GIMEMA CML Working Party.

Author

Bassi, Simona, primary, Castagnetti, Fausto, primary, Amabile, Marilina, primary, Giannini, Barbara, primary, Cilloni, Daniela, primary, Izzo, Barbara, primary, De Vivo, Antonio, primary, Luatti, Simona, primary, Testoni, Nicoletta, primary, Rege-Cambrin, Giovanna, primary, Iacobucci, Ilaria, primary, Gottardi, Enrico, primary, Pane, Fabrizio, primary, Salvatore, Francesco, primary, Dorigo, Alessandra, primary, Saglio, Giuseppe, primary, Martinelli, Giovanni, primary, Rosti, Gianantonio, primary, and Baccarani, Michele, primary

Published
2004
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37. Prediction of Response to Imatinib by Prospective Quantitation of BCR-ABL Transcript in Late Chronic Phase Chronic Myeloid Leukemia PatientsBy GIMEMA Working Party on CML.

Author

Martinelli, Giovanni, primary, Rosti, Gianantonio, primary, Pane, Fabrizio, primary, Amabile, Marilina, primary, Bassi, Simona, primary, Izzo, Barbara, primary, Poerio, Angela, primary, Giannini, Barbara, primary, Cilloni, Daniela, primary, Soverini, Simona, primary, Terragna, Carolina, primary, Ottaviani, Emanuela, primary, Grafone, Tiziana, primary, De Vivo, Antonio, primary, Testoni, Nicoletta, primary, Trabacchi, Elena, primary, Alberti, Daniele, primary, Salvatore, Francesco, primary, Saglio, Giuseppe, primary, and Baccarani, Michele, primary

Published
2004
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38. ABL Mutations in Late-Chronic Phase Chronic Myeloid Leukemia Patients with Cytogenetic Refractoriness to Imatinib Are Associated with a Greater Likelihood of Progression to Blast Crisis and Shorter Survival. on behalf of the GIMEMA Working Party on Chronic Myeloid Leukemia.

Author

Soverini, Simona, primary, Martinelli, Giovanni, additional, Rosti, Gianantonio, additional, Bassi, Simona, additional, Amabile, Marilina, additional, Poerio, Angela, additional, Giannini5, Barbara, additional, Trabacchi, Elena, additional, Ottaviani, Emanuela, additional, Grafone, Tiziana, additional, Terragna, Carolina, additional, Renzulli, Matteo, additional, Testoni, Nicoletta, additional, Luatti, Simona, additional, Castagnetti, Fausto, additional, Cilloni, Daniela, additional, Fava, Milena, additional, Izzo, Barbara, additional, Pane, Fabrizio, additional, Saglio, Giuseppe, additional, and Baccarani, Michele, additional

Published
2004
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39. High-Dose Therapy with Autologous Transplantation for Aggressive Non-Hodgkin's Lymphoma: The Bologna Experience

Author

Zinzani, Pier Luigi, primary, Tani, Monica, additional, Gabriele, Annalisa, additional, Gherlinzoni, Filippo, additional, de Vivo, Antonello, additional, Ricci, Paolo, additional, Bandini, Giuseppe, additional, Lemoli, Roberto Massimo, additional, Motta, Maria Rosa, additional, Rizzi, Simonetta, additional, Guidice, Valeria, additional, Zompatori, Maurizio, additional, Stefoni, Vittorio, additional, Alinari, Lapo, additional, Musuraca, Gerardo, additional, Marchi, Enrica, additional, Bassi, Simona, additional, Conte, Roberto, additional, Pileri, Stefano, additional, Tura, Sante, additional, and Baccarani, Michele, additional

Published
2004
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40. Rituximab in Lymphocyte-Predominant Hodgkin Disease.

Author

Azim Jr., Hatem A., Pruneri, Giancarlo, Cocorocchio, Emilia, Cinieri, Saverio, Raviele, Paola R., Bassi, Simona, Preda, Lorenzo, Martinelli, Giovanni, and Peccatori, Fedro A.

Subjects
RITUXIMAB, ANTINEOPLASTIC agents, LYMPHOCYTES, LEUCOCYTES, HODGKIN'S disease
Abstract

Background: Lymphocyte-predominant Hodgkin disease (LPHD) differs in biology and clinical behaviour from classic Hodgkin disease. Almost 100% of LPHD neoplastic cells express CD20 and thus rituximab could be effective; yet limited data are available. Patients and Methods: We performed a retrospective analysis on patients with LPHD who were treated with rituximab at our institution to determine the magnitude of benefit offered by this drug. Results: Seven patients were identified; 4 received the drug as single agent while the rest received it in combination with chemotherapy. All except 2 received the drug in the salvage setting. Response rate was 100% with 6 of 7 patients achieving complete remission. At a median follow-up of 2 years, 4 patients are still disease free while the rest relapsed at a median time of 27 months. Conclusion: Rituximab is effective in LPHD and should be considered; however, the optimal schedule remains to be determined. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2009
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41. Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens.

Author

Bassi S, Stroppa EM, Moroni CF, Arbasi MC, Trabacchi E, Di Franco A, Lazzaro A, Bernuzzi P, Moretto M, Arcari A, Bosi C, Riva A, Cavanna L, and Vallisa D

Subjects
Adult, Aged, Autografts, Biosimilar Pharmaceuticals adverse effects, Biosimilar Pharmaceuticals economics, Costs and Cost Analysis, Female, Filgrastim adverse effects, Filgrastim economics, Humans, Lymphoma economics, Male, Middle Aged, Multiple Myeloma economics, Retrospective Studies, Biosimilar Pharmaceuticals administration & dosage, Filgrastim administration & dosage, Hematopoietic Stem Cell Transplantation, Lymphoma therapy, Multiple Myeloma therapy, Transplantation Conditioning
Abstract

Background: Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients., Materials and Methods: With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed., Results: Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim(®) and Zarzio(®) was associated with cost reductions of 56% and of 86%, respectively., Discussion: Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT.

Published
2015
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42. Chronic myeloid leukemia in blast crisis treated with imatinib 600 mg: outcome of the patients alive after a 6-year follow-up.

Author

Palandri F, Castagnetti F, Testoni N, Luatti S, Marzocchi G, Bassi S, Breccia M, Alimena G, Pungolino E, Rege-Cambrin G, Varaldo R, Miglino M, Specchia G, Zuffa E, Ferrara F, Bocchia M, Saglio G, Pane F, Alberti D, Martinelli G, Baccarani M, and Rosti G

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Benzamides, Blast Crisis, Female, Follow-Up Studies, Hematopoietic Stem Cell Transplantation, Humans, Imatinib Mesylate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive mortality, Leukemia, Myelogenous, Chronic, BCR-ABL Positive therapy, Male, Middle Aged, Survival Rate, Time Factors, Transplantation, Homologous, Treatment Outcome, Young Adult, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Piperazines administration & dosage, Pyrimidines administration & dosage
Abstract

Background: Imatinib mesylate is the first line treatment for chronic myeloid leukemia. In patients with advanced phase of the disease, the advent of imatinib significantly increased survival. However, few long-term data, based on large, prospective and controlled trials are available on the outcome of these patients., Design and Methods: We conducted a phase II trial of imatinib 600 mg daily in patients with chronic myeloid leukemia in blast crisis. The return to chronic phase was defined as <15% blasts and <30% blasts plus promyelocytes in blood or bone marrow and <20% peripheral basophils. A complete hematologic response required the normalization of platelet and white cell differential counts and absence of extramedullary involvement. Cytogenetic response was assessed by the standard banding technique and rated as usual., Results: Ninety-two patients were enrolled (20 with lymphoid blast crisis and 72 with myeloid blast crisis). Forty-six patients (50%) returned to chronic phase, and 24 patients (26%) achieved also a complete hematologic response. Sixteen patients (17%) had a cytogenetic response (9 complete, 1 partial, and 6 minor or minimal). The complete cytogenetic response was subsequently lost by all but two patients between 2 and 12 months after first having achieved it: the median duration of complete cytogenetic response was 7 months. All responses were sustained for a minimum of 4 weeks. The median survival of all the patients was 7 months. After a median observation time of 66 months, seven (8%) patients are alive. Three of these patients are on imatinib treatment (1 in complete hematologic remission, 1 in partial cytogenetic response and 1 in complete cytogenetic remission). Three patients are in complete remission after allogeneic stem cell transplantation. One patient is alive in blast crisis, on therapy with a second-generation tyrosine kinase inhibitor., Conclusions: Imatinib was effective and safe in the short-term treatment of chronic myeloid leukemia in blast crisis, but longer-term outcome was not significantly influenced (ClinicalTrials.gov identifier: NCT00514969).

Published
2008
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43. Impact of age on the outcome of patients with chronic myeloid leukemia in late chronic phase: results of a phase II study of the GIMEMA CML Working Party.

Author

Rosti G, Iacobucci I, Bassi S, Castagnetti F, Amabile M, Cilloni D, Poerio A, Soverini S, Palandri F, Rege Cambrin G, Iuliano F, Alimena G, Latagliata R, Testoni N, Pane F, Saglio G, Baccarani M, and Martinelli G

Subjects
Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Aging, Benzamides, Disease-Free Survival, Female, Humans, Imatinib Mesylate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive epidemiology, Leukemia, Myelogenous, Chronic, BCR-ABL Positive mortality, Male, Middle Aged, Treatment Outcome, Antineoplastic Agents therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive therapy, Piperazines therapeutic use, Pyrimidines therapeutic use
Abstract

To assess the effect of age on response and compliance to treatment in patients with chronic myeloid leukemia (CML) we performed a sub-analysis within a phase II trial of the GIMEMA CML Working Party (CML/002/STI571). Since the WHO cut-off age to define an older patient is 65 years, among the 284 patients considered, we identified 226 (80%) younger patients (below 65 years) and 58 (20%) older patients (above 65 years) before starting imatinib. Response rates (hematologic and cytogenetic) were lower in the older age group but the probabilities of progression-free survival and overall survival (median observation time 3 years) were the same. Moreover, among complete cytogenetic responders, no differences were found in the level of molecular response between the two age groups. As might be expected, older patients experienced more adverse events, both hematologic and non-hematologic: this worsened compliance did not, however, prevent a long-term outcome similar to that of younger patients.

Published
2007
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44. High-dose therapy with autologous transplantation for Hodgkin's disease: the Bologna experience.

Author

Zinzani PL, Tani M, Gabriele A, Gherlinzoni F, de Vivo A, Ricci P, Bandini G, Lemoli RM, Motta MR, Rizzi S, Giudice V, Zompatori M, Stefoni V, Alinari L, Musuraca G, Bassi S, Conte R, Pileri S, Tura S, and Baccarani M

Subjects
Adolescent, Adult, Bone Marrow Transplantation, Child, Combined Modality Therapy, Female, Hodgkin Disease diagnosis, Humans, Male, Middle Aged, Radiotherapy Dosage, Recurrence, Retrospective Studies, Spain, Survival Analysis, Treatment Outcome, Hematopoietic Stem Cell Transplantation, Hodgkin Disease radiotherapy, Hodgkin Disease therapy
Abstract

Background and Objectives: In this work we examine the characteristics and outcome of patients with Hodgkin's disease (HD) treated with high-dose therapy (HDT) and autologous transplantation at our Institute between 1982 to 2000., Design and Methods: A retrospective analysis was performed examining patients' characteristics, prior chemotherapy regimens, pre-transplant disease status, HDT regimen, source of stem cells, time for hematopoietic recovery, complications of transplantation, response rates, overall survival (OS) and relapse-free survival (RFS)., Results: Ninety-seven patients with HD were treated and had estimated 10-year OS and RFS rates of 32% and 60%, respectively. Disease status (sensitive vs. refractory) before HDT was the most powerful predictive parameter for OS and RFS in both univariate and multivariate analyses. The rate of transplant-related mortality in the whole cohort was only 1% whereas the rate of second malignancies was 3%., Interpretation and Conclusions: Our results confirm that HDT with autologous transplantation is associated with a durable RFS in a remarkable proportion of HD patients and that the procedure has a very low global early and late toxicity.

Published
2003

45. 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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