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1. Italian Real-Life Experience on the Use of Mogamulizumab in Patients with Cutaneous T-Cell Lymphomas

Author

Caruso L, Castellino A, Dessì D, Flenghi L, Giordano A, Ibatici A, Massone C, Pileri A, Proietti I, Pupo L, Quaglino P, Rupoli S, and Zinzani PL

Subjects
cutaneous t- cell lymphoma, mycosis fungoides, sèzary sindrome, mogamulizumab, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Laura Caruso,1 Alessia Castellino,2 Daniela Dessì,3 Leonardo Flenghi,4 Antonio Giordano,5 Adalberto Ibatici,6 Cesare Massone,7 Alessandro Pileri,8 Ilaria Proietti,9 Livio Pupo,10 Pietro Quaglino,11 Serena Rupoli,12 Pier Luigi Zinzani13,14 1Hematology and Bone Marrow Transplantation Unit, Azienda Ospedaliero Universitaria Policlinico G. Rodolico - San Marco Di Catania, Catania, Italy; 2Department of Hematology, Santa Croce E Carle Hospital, Cuneo, Italy; 3Department of Hematology, Businco Hospital Arnas AOB, Cagliari, Italy; 4Hematology and Bone Marrow Transplantation Unit, Santa Maria Della Misericordia Hospital, Perugia, Italy; 5Department of Hematology, Fondazione Policlinico Universitario Agostino Gemelli—IRCCS, Rome, Italy; 6Hematology and Transplant Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 7Dermatology Unit, Ospedali Galliera, Genova, Italy; 8Dermatology Unit, IRCCS S. Orsola-Malpighi Polyclinic, Bologna, Italy. Department of Specialistic, Diagnostic and Experimental Medicine (DIMES), Alma Mater Studiorum University of Bologna, Bologna, Italy; 9Dermatology Unit”Daniele Innocenzi”, Department of Medical-Surgical Sciences and Bio-Technologies, Sapienza University of Rome, Terracina, Italy; 10UOC Lymphoproliferative Diseases, Fondazione PTV Policlinico Tor Vergata, Rome, Italy; 11Dermatologic Clinic, Department of Medical Sciences University of Turin Medical School, Turin, Italy; 12Clinic of Hematology, Ospedali Riuniti Ancona, Ancona, Italy; 13IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy; 14Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, ItalyCorrespondence: Pier Luigi Zinzani, IRCCS University Hospital of Bologna, Seràgnoli Institute of Hematology, and Department of Specialized, Diagnostic and Experimental Medicine, University of Bologna, via Massarenti 9, Bologna, 40138, Italy, Tel +39 051 2144042, Fax +39 051 2144037, Email pierluigi.zinzani@unibo.itAbstract: Mycosis fungoides and Sèzary syndrome are the most studied subtypes common cutaneous T-cell lymphomas. The current treatment objective is to improve the clinical manifestations of the disease in the affected areas, to relieve symptoms and to halt disease progression. Patients with early-stage mycosis fungoides are usually managed with skin-directed therapies, whereas patients with resistant or advanced-stage mycosis fungoides or Sèzary syndrome often require systemic drugs. Over the last decade, new drugs have been developed, increasing the breadth of treatment options for cutaneous T-cell lymphomas patients. Mogamulizumab is a first-in-class defucosylated humanized IgG1 κ monoclonal antibody, which exerts its anti-tumour action by selectively binding to C-C chemokine receptor 4 and increasing antibody-dependent cellular cytotoxicity activity against malignant T-cells. Several clinical trials showed that mogamulizumab is able to effectively control the cutaneous T-cell lymphomas in each site (skin, blood, lymph nodes and viscera), improving patients’ symptoms, function and overall quality of life with a manageable safety profile. In this report, we discuss 12 cases of patients with mycosis fungoides or Sèzary syndrome successfully treated with mogamulizumab in real-life clinical practice in Italy.Keywords: cutaneous T- cell lymphoma, mycosis fungoides, Sèzary syndrome, mogamulizumab

Published
2022

2. A 3-gene signature based on MYC, BCL-2 and NFKBIA improves risk stratification in diffuse large B-cell lymphoma

Author

Derenzini E, Mazzara S, Melle F, Motta G, Fabbri M, Bruna R, Agostinelli C, Cesano A, Corsini CA, Chen N, Righi S, Sabattini E, Chiappella A, Calleri A, Fiori S, Tabanelli V, Cabras A, Pruneri G, Vitolo U, Gianni AM, Rambaldi A, Corradini P, Zinzani PL, Tarella C, Pileri S., and Derenzini E, Mazzara S, Melle F, Motta G, Fabbri M, Bruna R, Agostinelli C, Cesano A, Corsini CA, Chen N, Righi S, Sabattini E, Chiappella A, Calleri A, Fiori S, Tabanelli V, Cabras A, Pruneri G, Vitolo U, Gianni AM, Rambaldi A, Corradini P, Zinzani PL, Tarella C, Pileri S.

Subjects
NFKBIA, Diffuse Large B-cell Lymphoma, BCL-2, MYC, Gene expression profiling
Abstract

Recent randomized trials focused on gene expression-based determination of the cell of origin in diffuse large B-cell lymphoma could not show significant improvements by adding novel agents to standard chemoimmunotherapy. The aim of this study was the identification of a gene signature able to refine current prognostication algorithms and applicable to clinical practice. Here we used a targeted gene expression profiling panel combining the Lymph2Cx signature for cell of origin classification with additional targets including MYC, BCL-2 and NFKBIA, in 186 patients from 2 randomized trials (discovery cohort) (NCT00355199 and NCT00499018). Data were validated in 3 independent series (2 large public datasets and a real-life cohort). By integrating the cell of origin, MYC/BCL-2 double expressor status and NFKBIA expression, we defined a 3-gene signature combining MYC, BCL-2 and NFKBIA (MBN-signature), which outperformed the MYC/BCL-2 double expressor status in multivariate analysis, and allowed further risk stratification within the germinal center B-cell/unclassified subset. The high-risk (MBN Sig-high) subgroup identified the vast majority of double hit cases and a significant fraction of Activated B-Cell-derived diffuse large B-cell lymphomas. These results were validated in 3 independent series including a cohort from the REMoDL-B trial, where, in an exploratory ad hoc analysis, the addition of bortezomib in the MBN Sig-high subgroup provided a progression free survival advantage compared with standard chemoimmunotherapy. These data indicate that a simple 3-gene signature based on MYC, BCL-2 and NFKBIA could refine the prognostic stratification in diffuse large B-cell lymphoma, and might be the basis for future precision-therapy approaches.

Published
2021

3. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial

Author

Hallek, M, Fischer, K, Fingerle-Rowson, G, Fink, AM, Busch, R, Mayer, J, Hensel, M, Hopfinger, G, Hess, G, von Grünhagen, U, Bergmann, M, Catalano, J, Zinzani, PL, Caligaris-Cappio, F, Seymour, JF, Berrebi, A, Jäger, U, Cazin, B, Trneny, M, Westermann, A, Wendtner, CM, Eichhorst, BF, Staib, P, Bühler, A, Winkler, D, Zenz, T, Böttcher, S, Ritgen, M, Mendila, M, Kneba, M, Döhner, H, and Stilgenbauer, S

Published
2010
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4. BRAF V600E-positive monomorphic epitheliotropic intestinal T-cell lymphoma complicating the course of hairy cell leukemia

Author

Broccoli A, Bertuzzi C, Fiorentino M, Morigi A, Stefoni V, Agostinelli C, Argnani L, Cavo M, and Zinzani PL

Subjects
hairy-cell leukemia, cladribine, monomorphic epitheliotropic intestinal T-cell lymphoma, BRAF V600E mutant, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282
Abstract

Alessandro Broccoli,1 Clara Bertuzzi,2 Michelangelo Fiorentino,3 Alice Morigi,1 Vittorio Stefoni,1 Claudio Agostinelli,2 Lisa Argnani,1 Michele Cavo,1 Pier Luigi Zinzani11Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Bologna, Italy; 2Hematopathology Unit, Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Bologna, Italy; 3Pathology Unit, “S.Orsola-Malpighi” Hospital, University of Bologna, Bologna, ItalyAbstract: Hairy cell leukemia (HCL) is an uncommon B-cell chronic lymphoproliferative disorder whose pathogenesis and recurrence are strictly dependent on the presence of the BRAF V600E mutant. A 65-year-old male presented a monomorphic epitheliotropic intestinal T-cell lymphoma (formerly enteropathy-associated T-cell lymphoma, type II) with HCL not responding to first-line induction with cladribine. The intestinal lymphoma bears the BRAF V600E mutant, which is the molecular hallmark of HCL, being implicated in its pathogenesis. The case is of interest, as it provides the first description of a BRAF V600E-positive intestinal T-cell lymphoma, along with immunohistochemical and molecular demonstration, occurring in concomitance with HCL. A novel digital PCR-base method for HCL disease assessment is also suggested.Keywords: hairy-cell leukemia, BRAF V600E mutant, monomorphic epitheliotropic intestinal T-cell lymphoma, cladribine

Published
2019

5. 'MOLTO', A MULTICENTER, OPEN LABEL, UNCONTROLLED, PHASE II CLINICAL TRIAL ON VENETOCLAX, ATEZOLIZUMAB, OBINUTUZUMAB (AVO) COMBINATION IN RICHTER TRANSFORMATION: SAFETY INTERIM ANALYSIS

Author

Frustaci, AM, Tedeschi, A, Zinzani, PL, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, Montillo, M, Frustaci, A, Tedeschi, A, Zinzani, P, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, and Montillo, M

Subjects
Hematology
Published
2021

7. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma

Author

Morschhauser, Franck, Fowler, Nathan H, Feugier, Pierre, Bouabdallah, Reda, Tilly, Hervé, Palomba, M Lia, Fruchart, Christophe, Libby, Edward N, Casasnovas, Rene-Olivier, Flinn, Ian W, Haioun, Corinne, Maisonneuve, Hervé, Ysebaert, Loic, Bartlett, Nancy L, Bouabdallah, Kamal, Brice, Pauline, Ribrag, Vincent, Daguindau, Nicolas, Le Gouill, Steven, Pica, Gian M, Martin Garcia-Sancho, Alejandro, López-Guillermo, Armando, Larouche, Jean-François, Ando, Kiyoshi, Gomes da Silva, Maria, André, Marc, Zachée, Pierre, Sehn, Laurie H, Tobinai, Kensei, Cartron, Guillaume, Liu, David, Wang, Jianming, Xerri, Luc, Salles, Gilles A, Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Morschhauser, Franck, Fowler, Nathan H, Feugier, Pierre, Bouabdallah, Reda, Tilly, Hervé, Palomba, M Lia, Fruchart, Christophe, Libby, Edward N, Casasnovas, Rene-Olivier, Flinn, Ian W, Haioun, Corinne, Maisonneuve, Hervé, Ysebaert, Loic, Bartlett, Nancy L, Bouabdallah, Kamal, Brice, Pauline, Ribrag, Vincent, Daguindau, Nicola, Le Gouill, Steven, Pica, Gian M, Martin Garcia-Sancho, Alejandro, López-Guillermo, Armando, Larouche, Jean-Françoi, Ando, Kiyoshi, Gomes da Silva, Maria, André, Marc, Zachée, Pierre, Sehn, Laurie H, Tobinai, Kensei, Cartron, Guillaume, Liu, David, Wang, Jianming, Xerri, Luc, Salles, Gilles A, Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Department of Lymphoma and Myeloma [Houston, TX, USA], The University of Texas M.D. Anderson Cancer Center [Houston], Service d'Hématologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d’Hématologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Institut d'Hématologie de Basse-Normandie (IHBN), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER, Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Unité des hémopathies lymphoïdes [CHU Henri Mondor], CHU Henri Mondor, Service d’Onco-Hématologie [La Roche sur Yon], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Service Hématologie - IUCT-Oncopole [CHU Toulouse], Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service d'hématologie [CHU Bordeaux], CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Service d'onco-hématologie [AP-HP Hôpital Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département d'hématologie [Gustave Roussy], Institut Gustave Roussy (IGR), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Regulation of Bcl2 and p53 Networks in Multiple Myeloma and Mantle Cell Lymphoma (CRCINA-ÉQUIPE 10), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Service d'Hématologie Clinique [Hôpital Hôtel Dieu, Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Hôtel Dieu, Service Hématologie [CH Métropole Savoie, Chambery], Centre Hospitalier Métropole Savoie [Chambéry], Département d'Hématologie [CHU de Montpellier], Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Département d'Hématologie [CH Lyon-Sud], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), RELEVANCE Trial Investigators : Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Bernardo, Elizabeth, CHU Henri Mondor [Créteil], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), Centre Hospitalier Départemental Vendée, Service d'Hématologie [IUCT Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
Adult, Male, medicine.medical_specialty, Neutropenia, Intention to Treat Analysi, Follicular lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, Gastroenterology, Skin Diseases, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Maintenance therapy, immune system diseases, Internal medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Survival rate, Lenalidomide, Lymphoma, Follicular, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Skin Disease, General Medicine, Middle Aged, medicine.disease, 3. Good health, Intention to Treat Analysis, Thalidomide, Survival Rate, Regimen, 030220 oncology & carcinogenesis, Rituximab, Female, business, Febrile neutropenia, 030215 immunology, medicine.drug, Human
Abstract

International audience; BACKGROUND:Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma.METHODS:We conducted this multicenter, international, phase 3 superiority trial to evaluate rituximab plus lenalidomide, as compared with rituximab plus chemotherapy, in patients with previously untreated follicular lymphoma. Patients were randomly assigned to receive one of the two regimens, followed by maintenance monotherapy with rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses). Treatment with rituximab plus chemotherapy consisted of the investigator's choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primary end points were complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival.RESULTS:A total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab-lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab-chemotherapy group (P=0.13). The interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab-chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrile neutropenia of any grade (2% vs. 7%), and a higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%).CONCLUSIONS:Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy). The safety profile differed in the two groups. (Funded by Celgene; RELEVANCE ClinicalTrials.gov numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).

Published
2018

8. New Insights from CAR-T: An Economic and Organizational Perspective

Author

Foglia E., Garagiola E, Ferrario LB, Ladisa V, Scorza A, Rambaldi A, Cairoli R, Medaglia ML, Simona M, Sale EO, Omodeo E, Zinzani PL, Esposti M, Alberti L, Marcias M, Mulas MF, Satta V, Melis E, Onnis S, Croce D, Foglia, E, Garagiola, E, Ferrario, L, Ladisa, V, Scorza, A, Rambaldi, A, Cairoli, R, Medaglia, M, Simona, M, Sale, E, Omodeo, E, Zinzani, P, Esposti, M, Alberti, L, Marcias, M, Mulas, M, Satta, V, Melis, E, Onnis, S, and Croce, D

Subjects
Business Economic, Health Care Sciences Services
Published
2020

13. Outcomes by CD30 expression in patients with CTCL receiving brentuximab vedotin (By) vs physician's choice (PC) in the Phase 3 ALCANZA study

Author

Kim, Yh, Prince, Hm, Whittaker, S, Horwitz, Sm, Duvic, M, Scarisbrick, J, Quaglino, P, Zinzani, Pl, Wolter, P, Bechter, O, Wang, Yh, Corinna, M, Wessels, P, Wood, Kw, Li, M, Liu, V, Lin, Hm, Little, M, Danaee, H, Trepicchio, Wl, and Dummer, R

Subjects
Oncology, Bexarotene, Cancer Research, medicine.medical_specialty, CD30, business.industry, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Methotrexate, In patient, business, Brentuximab vedotin, 030215 immunology, medicine.drug, Conjugate
Abstract

7517 Background: The Phase 3 ALCANZA study showed significant, durable responses with CD30-directed antibody-drug conjugate BV vs PC of methotrexate (MTX) or bexarotene (Bex) for CD30-positive (CD30+) cutaneous T cell lymphoma (CTCL). Uniform CD30 expression is characteristic of primary cutaneous anaplastic large cell lymphoma (pcALCL), but is variable among other subtypes including mycosis fungoides (MF). We examined activity of BV and MTX / Bex by CD30 expression in pts treated on the ALCANZA study. Methods: Adults with previously treated CD30+ MF or pcALCL were enrolled. MF pts had ≥2 skin biopsies from separate lesions, pcALCL had ≥1. Patients were scored CD30+ if ≥1 biopsy had ≥10% CD30+ lymphoid cells using an investigational Ventana diagnostic test, centrally assessed by one pathologist. We compared the proportion of MF subgroup pts (n=50 per treatment arm) with objective response lasting ≥4 months (ORR4; ALCANZA primary endpoint) and PFS in pts with all biopsies ≥10% CD30+ (CD30min ≥10%) vs ≥1 biopsy min min ≥10% vs min min 20%, 76% vs 7%, respectively). Conclusions: Notable inter-patient or inter-lesional variability in CD30 expression was seen in MF pts. Highly superior ORR4 and PFS endpoints were seen with BV over PC regardless of CD30min expression level. Clinical trial information: NCT01578499. [Table: see text]

Published
2017

14. Randomised phase III study of alisertib or investigator's choice (selected singe agent) in patients with relapsed or refractory peripheral T-cell lymphoma

Author

O'connor, O, Özcan, M, Jacobsen, E, Roncero Vidal, JM, Trotman, J, Demeter, J, Masszi, T, Pereira, J, Ramchandren, R, Beaven, A, Caballero Barringon, D, Horwitz, S, Lennard, A, Turgut, M, Hamerschlak, N, d'Amore, Francesco Annibale, Foss, F, Kim, WS, Leonard, JP, Zinzani, PL, Chiattone, CS, His, ED, Liu, H, Sheldon-Waniga, E, Dansky Ullmann, C, Leonard, EJ, and Shustov, A

Published
2017

15. Italian Real Life Experience with Brentuximab Vedotin: Results of a National Observational Study on Relapsed/Refractory Anaplastic Large Cell Lymphoma

Author

Pellegrini, C, Rigacci, L, Patti, C, Gini, G, Mannina, D, Tani, M, Rusconi, C, Romano, A, Vanazzi, A, Botto, B, Carlo Stella, C, Gravetti, A., Gritti, G, Arcari, A, Tosi, P, Liberati, Anna Marina, Pinto, A, Pavone, V, Gherlinzoni, F, Naso, V, Volpetti, S, Visentin, A, Goldaniga, Mc, Bonfichi, M., De Renzo, A, Schiavotto, C, Spina, M, Storti, S, Carella, Am, Argnani, L., and Zinzani, Pl

Published
2016

16. MAKING THE RIGHT CHOICE: THE ROLE OF FITNESS STATUS IN THE MANAGEMENT OF FIRST-LINE TREATMENT IN CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS (CLL FITNESS STUDY)

Author

Scarfo, L, Quaresmini, G, Mauro, Fr, Orlandi, E, Reda, G, Laurenti, L, Coscia, Marta, Ambrosetti, A, Murru, R, Trentin, L, Guelill, A, Visco, C, Morabito, F, Frustaci, A, Ciolli, S, Rossini, F, Cuneo, A, Gozzetti, A, Scortechini, I, Pane, F, Zinzani, Pl, Ferrara, F, Mannina, D, Marasca, R, Pierri, I, Specchia, G, Chiarenza, A, Zallio, F, Molica, S, De Paoli, L, Torreggiani, A, Brugiatelli, M, Semenzato, G, Innocenti, I, Picardi, P, Pizzolo, G, Foa, R, Rambaldi, A, and Ghia, P.

Published
2015

18. A Molecular Model to Predict Durable Remission after First Line Fludarabine-Cyclophosphamide-Rituximab Treatment in Chronic Lymphocytic Leukemia

Author

Rossi, D, di Bergamo, Lt, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, L, Del Giudice, I, De Paoli, L, Vincelli, I, Rigolin, Gian Matteo, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, Antonio, Foa, R, Gattei, V, and Gaidano, G.

Subjects
CLL, FCR, molecular analysis, FCR, molecular analysis, CLL, NO
Published
2014

19. Practice guidelines for the management of extranodal non-Hodgkin's lymphomas of adult non-immunodeficient patients. Part I: primary lung and mediastinal lymphomas. A project of the Italian Society of Hematology, the Italian Society of Experimental Hematology and the Italian Group for Bone Marrow Transplantation

Author

Zinzani, Pl, Martelli, M, Poletti, V, Vitolo, U, Gobbi, Pg, Chisesi, T, Barosi, G, Ferreri, Aj, Marchetti, M, Pimpinelli, Nicola, Tura, S, Italian Society of Hematology, Italian Society of Experimental Hematology, Italian Group for Bone Marrow Transplantation, Zinzani PL, Martelli M, Poletti V, Vitolo U, Gobbi PG, Chisesi T, Barosi G, Ferreri AJ, Marchetti M, Pimpinelli N, Tura S, Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation.

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, CHOP, chemotherapy, Mediastinal Neoplasms, Autologous stem-cell transplantation, systematic review, Recurrence, immune system diseases, hemic and lymphatic diseases, Internal medicine, medicine, Humans, non-hodgkin's lymphoma, Societies, Medical, Bone Marrow Transplantation, Neoplasm Staging, Chlorambucil, business.industry, Lymphoma, Non-Hodgkin, clinical practice guidelines, Immunologic Deficiency Syndromes, Hematology, Middle Aged, medicine.disease, Debulking, Combined Modality Therapy, Surgery, Lymphoma, Non-Hodgkin's lymphoma, Radiation therapy, Italy, Practice Guidelines as Topic, Female, Rituximab, business, medicine.drug
Abstract

Extranodal non-Hodgkin's lymphomas constitute 20-25% of overall non-Hodgkin's lymphomas cases and can be managed with very different therapeutic strategies. Therefore, the Italian Society of Hematology and the two affiliate societies (the Italian Society of Experimental Hematology and the Italian Group of Bone Marrow Transplantation) appointed a panel of experts to produce clinical practice-guidelines for the management of these conditions. Primary lung and mediastinal lymphomas were the objective of this part of the project. The panel of experts produced the following key recommendations that were graded according to the strength of evidence and clinical judgement. The first-line therapy for non-MALT primary lung non-Hodgkin's lymphomas should include anthracycline-based chemotherapy with CHOP or CHOP-like, MACOP-B or MACOP-B-like regimens (grade D). Rituximab association with chemotherapy needs to be evaluated within approved clinical trials. Second-line therapy with high-dose chemotherapy and autologous stem cell transplantation is recommended (grade B). In patients with MALT primary lung non-Hodgkin's lymphomas, the recommended first-line therapy should include chlorambucil, CHOP, CHOP-like or fludarabine-containing regimens (grade B). Radiotherapy is to be reserved for patients with a unique, small lesion in a poorly mobile site and with contraindication to surgery (grade D). Rituximab should be administered only within approved clinical trials. For treatment of primary mediastinal large B-cell lymphomas, the recommended first-line therapy is a chemotherapy and radiotherapy association (grade B). An anthracycline-based chemotherapy with CHOP, MACOP-B or VACOP-B is recommended (grade B). Rituximab combination with chemotherapy is highly suggested but only for patients enrolled into approved clinical trials. Patients with an inadequate early response should be candidates for early intensification with high-dose chemotherapy (grade C). Patients with refractory or relapsed disease should undergo rescue programs including intensive, non-cross-resistant debulking treatment followed, in chemosensitive patients, by high-dose chemotherapy and autologous stem cell transplantation (grade B).

Published
2008

20. Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients

Author

Zinzani, Pl, Martelli, M, Bertini, M, Gianni, Am, Devizzi, L, Federico, M, Pangalis, G, Michels, J, Zucca, E, Cantonetti, M, Cortelazzo, S, Wotherspoon, A, Ferreri, Aj, Zaja, Francesco, Lauria, F, De Renzo, A, Liberati, Ma, Falini, B, Balzarotti, M, Calderoni, A, Zaccaria, A, Gentilini, P, Fattori, Pp, Pavone, E, Angelopoulou, Mk, Alinari, L, Brugiatelli, M, Di Renzo, N, Bonifazi, F, Pileri, Sa, Cavalli, F, International Extranodal Lymphoma Study Group, Zinzani, Pl, Martelli, M, Bertini, M, Gianni, Am, Devizzi, L, Federico, M, Pangalis, G, Michels, J, Zucca, E, Cantonetti, M, Cortelazzo, S, Wotherspoon, A, Ferreri, Aj, Zaja, Francesco, Lauria, F, De Renzo, A, Liberati, Ma, Falini, B, Balzarotti, M, Calderoni, A, Zaccaria, A, Gentilini, P, Fattori, Pp, Pavone, E, Angelopoulou, Mk, Alinari, L, Brugiatelli, M, Di Renzo, N, Bonifazi, F, Pileri, Sa, Cavalli, F, and International Extranodal Lymphoma Study, Group

Subjects
response rate, Author Keywords:PMLBCL, chemotherapy, radiotherapy, combined modality treatment KeyWords Plus:HIGH-DOSE CHEMOTHERAPY, NON-HODGKINS-LYMPHOMA, MACOP-B, COMBINATION CHEMOTHERAPY, MALIGNANT-LYMPHOMA, RADIATION-THERAPY, CLINICAL-TRIALS, TRANSPLANTATION, CLASSIFICATION, MANAGEMENT
Abstract

BACKGROUND AND OBJECTIVES: This multinational retrospective study compares the outcomes of patients with primary mediastinal large B-cell lymphoma (PMLBCL) with sclerosis after first-generation (dose-intensive regimens), third-generation (alternating regimens) and high-dose chemotherapy strategies, frequently with adjuvant radiation therapy. DESIGN AND METHODS: Between August 1981 and December 1999, a total of 426 previously untreated patients with confirmed diagnosis were enrolled in 20 institutions to receive combination chemotherapy with either first generation (CHOP or CHOP-like) regimens, third generation (MACOP-B, VACOP-B, ProMACE CytaBOM) regimens or high-dose chemotherapy (HDS/ABMT). RESULTS: With chemotherapy, complete response (CR) rates were 49% (50/105), 51% (142/277) and 53% (23/44) with first generation, third generation and high-dose chemotherapy strategies, respectively; partial response (PR) rates were 32%, 36% and 35%, respectively. All patients who achieved CR and 124/142 (84%) with PR had radiation therapy on the mediastinum. The final CR rates became 61% for CHOP/CHOP-like regimens, 79% for MACOP-B and other regimens, and 75% for HDS/ABMT. After median follow-ups from attaining CR of 48.5 months for CHOP/CHOP-like regimens, 51.7 months for MACOP-B type regimens and 32.4 months for HDS/ABMT, relapses occurred in 15/64 (23%), 27/218 (12%) and 0/33 (0%) patients, respectively. Projected 10-year progression-free survival rates were 35%, 67% and 78%, respectively (p=0.0000). Projected 10-year overall survival rates were 44%, 71% and 77%, respectively (p=0.0000), after median follow-ups from diagnosis of 52.3 months, 54.9 months and 35.8 months, respectively. INTERPRETATION AND CONCLUSIONS: In patients with PMLBCL with sclerosis, MACOP-B plus radiation therapy may be a better strategy than other treatments; these retrospective data need to be confirmed by prospective studies. The encouraging survival results after high dose chemotherapy require confirmation in selected high-risk patients.

Published
2002

24. Bortezomib plus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 Trial

Author

Coiffier, B, Osmanov, Ea, Hong, X, Scheliga, A, Mayer, J, Offner, F, Rule, S, Teixeira, A, Walewski, J, de Vos, S, Crump, M, Shpilberg, O, Esseltine, Dl, Zhu, E, Enny, C, Theocharous, P, van de Velde H, Elsayed YA, Zinzani, Pl, LYM 3001 study investigators, and Liberati, Anna Marina

Subjects
rituximab, drug terms: bortezomib
Published
2011

28. Risk-assessment in diffuse large cell lymphoma at first relapse. A study by the Italian Intergroup for Lymphomas

Author

Guglielmi, C., Martelli, M., Federico, M., Zinzani, Pl, Vitolo, U., Bellesi, G., Santini, G., Tarella, Corrado, Zallio, F., Pregno, P., DI RENZO, N., and Resegotti, L.

Subjects
Adult, Aged, 80 and over, Male, Salvage Therapy, relapse, Antibiotics, Antineoplastic, lymphoma, Middle Aged, Risk Assessment, Survival Analysis, Cohort Studies, Italy, Recurrence, lymphoma, relapse, prognosis, adults, transplantation, Antineoplastic Combined Chemotherapy Protocols, adults, Humans, Female, Lymphoma, Large B-Cell, Diffuse, Prospective Studies, prognosis, Aged, transplantation
Abstract

Our aim was to identify risk factors in adults with diffuse large cell lymphoma at first relapse.We studied 474 patients observed at 45 centers in Italy. Median time from diagnosis to relapse was 395 days, median age at relapse was 55 years and median follow-up from relapse was 3.3 years. Salvage therapy consisted of polychemotherapy in 79% of patients, monochemotherapy and/or radiotherapy and/or surgery alone in 16%, and palliative therapy in 5%. Salvage treatment was intensified with high-dose chemotherapy + stem cell transplant in 20% of patients. OS and PFS were compared by sex, International Prognostic Index at diagnosis, histology, B/T phenotype, initial treatment, salvage therapy, and features at relapse: time from diagnosis, LDH, stage, performance status and bone marrow involvement. Cox models, adjusted for salvage therapy, were performed with factors related to overall survival (OS) and progression-free survival (PFS).Overall response (complete + partial) was 63%, OS at 3 years 35% and PFS at 3 years 26%. Relapse within 12 months from diagnosis, elevated serum lactic dehydrogenase (LDH), advanced stage and poor performance status were independent adverse factors for OS and PFS. The cumulative number of adverse factors is proposed as prognostic index for DLCL at first relapse since it identifies risk groups (p0.0001) and has been validated (p=0.01). Moreover, it predicts OS and PFS in the selected group of patients with a responsive relapse (p0.0001).Delay from initial diagnosis, LDH, stage and performance status at relapse should be balanced in comparative studies of salvage therapy of adults with DLCL. Patients with more than 2 adverse factors are one third of all cases and deserve more effective salvage treatments.

Published
2001

29. ALK+ lymphoma: clinico-pathological findings and outcome

Author

Santucci, A., Martelli, Mf, Flenghi, L., Pelicci, Pg, Fizzotti, M., Araujo, I., Foss, Hd, Aiello, A., Giardini, R., Lazzarino, M., Marco Paulli, Todeschini, G., Menestrina, F., Verhoef, G., Wolf-Peeters, C., Zagonel, V., Carbone, A., Zinzani, Pl, Pileri, S., and Falini, B.

Published
1999

37. Phase III comparative trial using CHOP vs CIOP in the treatment of advanced intermediate-grade non-Hodgkin's lymph

Author

Zinzani, Pl, Martelli, M, Storti, S, Musso, M, Cantonetti, M, Leone, G, Cajozzo, A, Papa, G, Iannitto, E, Perrotti, A, Bendandi, M, Gherlinzoni, F, Gentilini, P, Rossi, G, Aitini, E, Mandelli, E, and Tura, S

Subjects
survival rate, Male, Heart Diseases, Lymphoma, Settore MED/06 - Oncologia Medica, cardiotoxicity, Non-Hodgkin, dexamethasone, antineoplastic activity, idarubicin, heart disease, doxorubicin, vincristine EMTREE medical terms: adult, vomiting MeSH: Adult, cancer combination chemotherapy, neurotoxicity, Antineoplastic Combined Chemotherapy Protocols, neutropenia, Humans, controlled study, human, Cyclophosphamide, controlled clinical trial, phase 3 clinical trial, nonhodgkin lymphoma, drug comparison, article, clinical trial, Middle Aged, alopecia, nausea, major clinical study, Survival Analysis, liver toxicity, EMTREE drug terms: antileukemic agent, cyclophosphamide, aged, cancer grading, female, male, mouth mucosa, mucosa inflammation, priority journal, randomized controlled trial, Aged, Doxorubicin, Female, Idarubicin, Lymphoma, Non-Hodgkin, Prednisone, Vincristine, Settore MED/15 - Malattie del Sangue
Published
1995

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