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1. Thrombopoietin receptor agonists for preparing adult patients with immune thrombocytopenia to splenectomy: results of a retrospective, observational GIMEMA study

Author

Zaja, Francesco, Barcellini, Wilma, Cantoni, Silvia, Carpenedo, Monica, Caparrotti, Giuseppe, Carrai, Valentina, Di Renzo, Nicola, Santoro, Cristina, Di Nicola, Massimo, Veneri, Dino, Simonetti, Federico, Liberati, Anna M., Ferla, Valeria, Paoloni, Francesca, Crea, Enrico, Volpetti, Stefano, Tuniz, Enrica, and Fanin, Renato

Published
2016
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2. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma

Author

Mateos, María-Victoria, Dimopoulos, Meletios A, Cavo, Michele, Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Kaplan, Polina, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna M, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Chiu, Christopher, Wang, Jianping, Carson, Robin, Crist, Wendy, Deraedt, William, Nguyen, Huong, Qi, Ming, San-Miguel, Jesus, ALCYONE Trial Investigators, UCL - (MGD) Service d'hématologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, Clinical sciences, Hematology, Mateos, María-Victoria, Dimopoulos, Meletios A, Cavo, Michele, Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Kaplan, Polina, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna M, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Chiu, Christopher, Wang, Jianping, Carson, Robin, Crist, Wendy, Deraedt, William, Nguyen, Huong, Ming, Qi, and San-Miguel, Jesus for the ALCYONE Trial Investigators

Subjects
Male, Oncology, Melphalan, Kaplan-Meier Estimate, Bortezomib, Prednisone/administration & dosage, 0302 clinical medicine, Prednisone, bortezomib, melphalan, prednisone, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Multiple myeloma, Medicine (all), Standard treatment, antineoplastic agentbortezomibdaratumumabmelphalanmonoclonal antibodyprednisone, Antibodies, Monoclonal, General Medicine, Middle Aged, Intention to Treat Analysis, 3. Good health, Survival Rate, 030220 oncology & carcinogenesis, oncology, Female, Infection, Multiple Myeloma, medicine.drug, Adult, Melphalan/administration & dosage, medicine.medical_specialty, Multiple Myeloma/drug therapy, Infections, Antibodies, Monoclonal/administration & dosage, Antibodies, Disease-Free Survival, 03 medical and health sciences, Internal medicine, medicine, Humans, Survival rate, Aged, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Daratumumab, Infections/chemically induced, medicine.disease, Follow-Up Studies, Transplantation, Bortezomib/administration & dosage, business, 030215 immunology
Abstract

BACKGROUND: The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. RESULTS: At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P

Published
2018

3. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial

Author

Palumbo, Antonio, Bringhen, Sara, Liberati, Anna M., Caravita, Tommaso, Falcone, Antonietta, Callea, Vincenzo, Montanaro, Marco, Ria, Roberto, Capaldi, Antonio, Zambello, Renato, Benevolo, Giulia, Derudas, Daniele, Dore, Fausto, Cavallo, Federica, Gay, Francesca, Falco, Patrizia, Ciccone, Giovannino, Musto, Pellegrino, Cavo, Michele, and Boccadoro, Mario

Published
2008
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5. Thrombopoietin receptor agonists for preparing adult patients with immune thrombocytopenia to splenectomy: results of a retrospective, observational GIMEMA study

Author

Zaja, Francesco, Barcellini, Wilma, Cantoni, Silvia, Carpenedo, Monica, Caparrotti, Giuseppe, Carrai, Valentina, Di Renzo, Nicola, Santoro, Cristina, Di Nicola, Massimo, Veneri, Dino, Simonetti, Federico, Liberati, Anna M., Ferla, Valeria, Paoloni, Francesca, Crea, Enrico, Volpetti, Stefano, Tuniz, Enrica, Fanin, Renato, Zaja, Francesco, Barcellini, Wilma, Cantoni, Silvia, Carpenedo, Monica, Caparrotti, Giuseppe, Carrai, Valentina, Di Renzo, Nicola, Santoro, Cristina, Di Nicola, Massimo, Veneri, Dino, Simonetti, Federico, Liberati, Anna M., Ferla, Valeria, Paoloni, Francesca, Crea, Enrico, Volpetti, Stefano, Tuniz, Enrica, and Fanin, Renato

Subjects
Male, Premedication, Drug Resistance, Adrenal Cortex Hormones, Adult, Aged, Aged, 80 and over, Benzoates, Combined Modality Therapy, Female, Humans, Hydrazines, Immunoglobulins, Intravenous, Italy, Middle Aged, Platelet Count, Portal Vein, Postoperative Complications, Preoperative Care, Pulmonary Embolism, Purpura, Thrombocytopenic, Idiopathic, Pyrazoles, Receptors, Fc, Receptors, Thrombopoietin, Recombinant Fusion Proteins, Retrospective Studies, Salvage Therapy, Thrombophilia, Thrombopoiesis, Thrombopoietin, Venous Thrombosis, Young Adult, Splenectomy, Hematology, Adrenal Cortex Hormone, Retrospective Studie, Receptors, Hydrazine, 80 and over, CIRRHOSIS, Fc, Idiopathic, LONG-TERM, PLATELET COUNT, ROMIPLOSTIM, ELTROMBOPAG, PURPURA, MANAGEMENT, EFFICACY, SAFETY, Thrombopoiesi, Intravenous, Human, Receptor, Intravenou, Immunoglobulins, Benzoate, Immunoglobulin, Venous Thrombosi, Purpura, Thrombocytopenic, Pyrazole, Postoperative Complication, Recombinant Fusion Protein
Abstract

In patients with immune thrombocytopenia (ITP) refractory to corticosteroids and intravenous immunoglobulins (IVIG), splenectomy may result at higher risk of peri-operative complications and, for this reason, potentially contraindicated. The thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag have shown high therapeutic activity in primary ITP, but data of efficacy and safety regarding their use in preparation for splenectomy are missing. Thirty-one adult patients, median age 50 years, with corticosteroids and/or IVIG refractory persistent and chronic ITP who were treated with TPO-RAs (romiplostim= 24; eltrombopag= 7) with the aim to increase platelet count and allow a safer execution of splenectomy were retrospectively evaluated. Twenty-four patients (77%) responded to the use of TPO-RAs with a median platelet count that increased from 11 × 109/L before starting TPO-RAs to 114 × 109/L pre-splenectomy, but a concomitant treatment with corticosteroids and/or IVIG was required in 19 patients. Twenty-nine patients underwent splenectomy while two patients who responded to TPO-RAs subsequently refused surgery. Post-splenectomy complications were characterized by two Grade 3 thrombotic events (1 portal vein thrombosis in the patient with previous history of HCV hepatitis and 1 pulmonary embolism), with a platelet count at the time of thrombosis of 260 and 167 × 109/L, respectively and one Grade 3 infectious event. TPO-RAs may represent a therapeutic option to improve platelet count and reduce the risk of peri-operative complications in ITP candidates to splenectomy. An increased risk of post-splenectomy thromboembolic events cannot be ruled out and thromboprophylaxis with low-molecular weight heparin is generally recommended. © 2016 Wiley Periodicals, Inc.

Published
2015

6. Second-line rituximab, lenalidomide, and bendamustine in mantle cell lymphoma: a phase II clinical trial of the Fondazione Italiana Linfomi

Author

Zaja, Francesco, primary, Ferrero, Simone, additional, Stelitano, Caterina, additional, Ferrari, Angela, additional, Salvi, Flavia, additional, Arcari, Annalisa, additional, Musuraca, Gerardo, additional, Botto, Barbara, additional, Spina, Michele, additional, Cellini, Claudia, additional, Patti, Caterina, additional, Liberati, Anna M., additional, Minotto, Claudia, additional, Pileri, Stefano A., additional, Ceccarelli, Manuela, additional, Volpetti, Stefano, additional, Ferranti, Antonella, additional, Drandi, Daniela, additional, Montechiarello, Elisa, additional, Ladetto, Marco, additional, Carmichael, James, additional, and Fanin, Renato, additional

Published
2017
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7. Met Over-Expression Is a Prognostic Factor for Myeloma Patients Treated with Novel Agents.

Author

Rocci, Albero, primary, Gay, Francesca, additional, Trusolino, Livio, additional, Omedè, Paola, additional, Bertotti, Andrea, additional, Montefusco, Vittorio, additional, Crippa, Claudia, additional, Patriarca, Francesca, additional, Gilestro, Milena, additional, Liberati, Anna M., additional, Rossini, Fausto, additional, Caravita, Tommaso, additional, Falcone, Antonietta, additional, Rossi, Giuseppe, additional, Drandi, Daniela, additional, Corradini, Paolo, additional, Ladetto, Marco, additional, Comoglio, Paolo M., additional, Boccadoro, Mario, additional, and Palumbo, Antonio, additional

Published
2009
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8. Bortezomib-Doxorubicin-Dexamethasone as Induction Prior to Reduced Intensity Autologous Transplantation Followed by Lenalidomide as Consolidation/Maintenance in Elderly Untreated Myeloma Patients

Author

Palumbo, Antonio, primary, Falco, Patrizia, primary, Gay, Francesca, primary, Montefusco, Vittorio, primary, Crippa, Claudia, primary, Patriarca, Francesca, primary, Gilestro, Milena, primary, Liberati, Anna M., primary, Rossini, Fausto, primary, Caravita, Tommaso, primary, Falcone, Antonietta, primary, Cavallo, Federica, primary, Corradini, Paolo, primary, Rossi, Giuseppe, primary, and Boccadoro, Mario, primary

Published
2008
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9. Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage

Author

Ladetto, Marco, primary, De Marco, Federica, additional, Benedetti, Fabio, additional, Vitolo, Umberto, additional, Patti, Caterina, additional, Rambaldi, Alessandro, additional, Pulsoni, Alessandro, additional, Musso, Maurizio, additional, Liberati, Anna M., additional, Olivieri, Attilio, additional, Gallamini, Andrea, additional, Pogliani, Enrico, additional, Scalabrini, Delia Rota, additional, Callea, Vincenzo, additional, Di Raimondo, Francesco, additional, Pavone, Vincenzo, additional, Tucci, Alessandra, additional, Cortelazzo, Sergio, additional, Levis, Alessandro, additional, Boccadoro, Mario, additional, Majolino, Ignazio, additional, Pileri, Alessandro, additional, Gianni, Alessandro M., additional, Passera, Roberto, additional, Corradini, Paolo, additional, and Tarella, Corrado, additional

Published
2008
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10. Bortezomib, Pegylated-Lyposomal-Doxorubicin and Dexamethasone Followed by Melphalan 100 mg/m2 in Elderly Newly Diagnosed Patients: An Interim Analysis.

Author

Palumbo, Antonio, primary, Avonto, Ilaria, additional, Patriarca, Francesca, additional, Crippa, Claudia, additional, Petrucci, Maria T., additional, Rossini, Fausto, additional, Corradini, Paolo, additional, Liberati, Anna M., additional, Giuliani, Nicola, additional, Pescosta, Norbert, additional, Falco, Patrizia, additional, Larocca, Alessandra, additional, Omedè, Paola, additional, Offidani, Massimo, additional, Fanin, Renato, additional, and Boccadoro, Mario, additional

Published
2007
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11. Long-Term Follow-Up of the Randomized GITMO/IIL Trial Comparing CHOP-Rituximab vs. High-Dose Therapy with Rituximab (R-HDS) in High Risk Follicular Lymphoma (Fl): Updated Results Suggest the Use of R-HDS as Salvage Treatment.

Author

Ladetto, Marco, primary, De Marco, Federica, primary, Benedetti, Fabio, primary, Vitolo, Umberto, primary, Patti, Caterina, primary, Rambaldi, Alessandro, primary, Pulsoni, Alessandro, primary, Musso, Maurizio, primary, Liberati, Anna M., primary, Olivieri, Attilio, primary, Gallamini, Andrea, primary, Pogliani, Enrico, primary, Scalabrini, Delia Rota, primary, Callea, Vincenzo, primary, Di Raimondo, Francesco, primary, Pavone, Vincenzo, primary, Tucci, Alessandra, primary, Cortelazzo, Sergio, primary, Levis, Alessandro, primary, Boccadoro, Mario, primary, Majolino, Ignazio, primary, Pileri, Alessandro, primary, Gianni, Alessandro M., primary, Passera, Roberto, primary, Corradini, Paolo, primary, and Tarella, Corrado, primary

Published
2007
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16. Interferon Alpha-2b as Therapy for Ph'-Positive Chronic Myelogenous Leukemia: A Study of 82 Patients Treated With Intermittent or Daily Administration

Author

Alimena, Giuliana, Morra, Enrica, Lazzarino, Mario, Liberati, Anna M., Montefusco, Enrico, Inverardi, Daniela, Bernasconi, Paolo, Mancini, Marco, Donti, Emilio, Grignani, Fausto, Bernasconi, Carlo, Dianzani, Ferdinando, and Mandelli, Franco

Abstract

The authors treated a total of 82 patients with Ph-positive chronic myelogenous leukemia (CML) with recombinant interferon alpha-2b (IFN α-2b). Sixty-five patients in chronic phase (CP), 28 of whom were untreated and 37 pretreated, and nine patients in accelerated phase (AP), were started on IFN three times a week. Patients in CP were randomized to receive 2 or 5 x 106IU/m , while patients in AP were all given the dose of 5 x 106IU/m2, in addition to concomitant chemotherapy. Patients in CP who were unresponsive to the lower dose were crossed to the higher dose. Of 63 evaluable patients in CP, 43 (68%) responded, 29 (46%) achieved complete hematologic response (CHR), and 14 (22%) achieved partial hematologic response (PHR). The response rate appeared to be significantly influenced by the IFN dose in pretreated patients. Of the nine patients in AP, two attained PHR and one CHR. More recently, eight previously untreated CP cases were submitted to daily IFN administration at doses from 2 to 5 x 106IU/m2. This daily schedule was also applied to patients who had obtained, with the intermittent treatment, a PHR persisting unmodified for six months (nine patients) or an unstable CHR (five patients). Seven of the eight previously untreated patients, and five of the nine PHR patients crossed to daily IFN reached CHR. In the total series of previously untreated patients, the response rate proved to be significantly influenced by the initial risk status. Cytogenetic improvement was seen in 37 of 53 responders (70%) treated for more than 3 months, the median of Ph‘-positive cells declining from 100% to 65% (range 0% to 95%). Complete suppression of Ph’ chromosome was observed in one case. The cytogenetic response was persistent for over 6 months in 21 patients, but the lowest value of Ph' positivity was usually unstable. At a median follow-up of 56 weeks, 23 of 36 (64%) CHR patients remain in continued disease control with IFN. A blastic transformation (BT) occurred in seven of 21 unresponsive patients and in one of the 36 CHR patients. The authors' data confirm that IFN a-2b, especially at daily doses, is effective in inducing clinical and cytogenetic response in a good proportion of patients with CML in the benign phase. Longer follow-ups will define the exact influence of this agent on the natural course of the disease. © 1988 by Grune & Stratton, Inc.

Published
1988
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17. Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi

Author

Anna Marina Liberati, Dario Marino, Francesco Merli, Andrés José Maria Ferreri, Francesco Zaja, Angela Ferrari, Monica Tani, Stefano Luminari, Emanuela Anna Pesce, Monica Balzarotti, Antonio Spadea, Maria Bruno-Ventre, Stefano Volpetti, Alessandra Tucci, Gerardo Musuraca, Elda Viel, Emanuela Chimienti, Francesca Salvi, Chiara Bottelli, Michele Spina, Elena Ravaioli, Luminari, Stefano, Viel, Elda, Ferreri, Andrés José Maria, Zaja, Francesco, Chimienti, Emanuela, Musuraca, Gerardo, Tucci, Alessandra, Balzarotti, Monica, Tani, Monica, Salvi, Francesca, Pesce, Emanuela A., Ferrari, Angela, Liberati, Anna M., Spadea, Antonio, Marino, Dario, Bruno-Ventre, Maria, Volpetti, Stefano, Bottelli, Chiara, Ravaioli, Elena, Merli, Francesco, and Spina, Michele

Subjects
Male, Vincristine, medicine.medical_specialty, Cancer Research, Heart Diseases, cardiotoxicity, diffuse large B-cell lymphoma, Comorbidity, Gastroenterology, Polyethylene Glycols, 03 medical and health sciences, 0302 clinical medicine, Prednisone, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Aged, non-pegylated liposomal doxorubicin, Ejection fraction, business.industry, Hematology, Oncology, Atrial fibrillation, General Medicine, medicine.disease, Surgery, Regimen, Treatment Outcome, Italy, Doxorubicin, 030220 oncology & carcinogenesis, Concomitant, cardiovascular system, Rituximab, Female, Lymphoma, Large B-Cell, Diffuse, business, Diffuse large B-cell lymphoma, 030215 immunology, medicine.drug
Abstract

The purpose of this phase 2, multicenter study was to determine the activity and safety of nonpegylated liposomal doxorubicin as part of "R-COMP" combination in patients with diffuse large B-cell lymphoma and coexisting cardiac disorders. The study was conducted using a Bayesian continuing assessment method using complete remission rate and rate of cardiac events as study endpoints. Between November 2009 and October 2011, 50 evaluable patients were enrolled (median age, 76 years). Median baseline left ventricular ejection fraction (LVEF) was 60%. Ischemic cardiopathy was the most frequent preexisting cardiac disorder (35%), followed by atrial fibrillation (15%), left ventricular hypertrophy (13%), and baseline LVEF

Published
2018

18. Second-line rituximab, lenalidomide, and bendamustine in mantle cell lymphoma: A phase II clinical trial of the fondazione italiana linfomi

Author

Claudia Cellini, Francesco Zaja, Annalisa Arcari, Stefano Volpetti, Angela Ferrari, Caterina Stelitano, Simone Ferrero, James Carmichael, Stefano Pileri, Gerardo Musuraca, Caterina Patti, Flavia Salvi, Manuela Ceccarelli, Renato Fanin, Barbara Botto, Michele Spina, Elisa Montechiarello, Anna Marina Liberati, Marco Ladetto, Antonella Ferranti, Daniela Drandi, Claudia Minotto, Zaja, Francesco, Ferrero, Simone, Stelitano, Caterina, Ferrari, Angela, Salvi, Flavia, Arcari, Annalisa, Musuraca, Gerardo, Botto, Barbara, Spina, Michele, Cellini, Claudia, Patti, Caterina, Liberati, Anna M., Minotto, Claudia, Pileri, Stefano A., Ceccarelli, Manuela, Volpetti, Stefano, Ferranti, Antonella, Drandi, Daniela, Montechiarello, Elisa, Ladetto, Marco, Carmichael, Jame, and Fanin, Renato

Subjects
Bendamustine, Oncology, medicine.medical_specialty, MULTICENTER, MINIMAL RESIDUAL DISEASE, NON-HODGKINS-LYMPHOMA, PLUS RITUXIMAB, FOLLOW-UP, RELAPSES, Combination chemotherapy, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, International Prognostic Index, Autologous stem-cell transplantation, immune system diseases, hemic and lymphatic diseases, Internal medicine, Medicine, Online Only Articles, Lenalidomide, Mantle cell lymphoma, business.industry, Gene rearrangement, Hematology, medicine.disease, chemistry, 030220 oncology & carcinogenesis, Ibrutinib, Immunology, Rituximab, business, 030215 immunology, medicine.drug
Abstract

In this past decade, new therapeutic approaches based on the use of rituximab, high-dose cytosine-arabinoside, and autologous stem cell transplantation (ASCT) have changed the paradigm of mantle cell lymphoma (MCL) treatment, significantly improving the quality and duration of response and

Published
2017

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