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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

3. Multidimensional Results and Reflections on CAR-T: The Italian Evidence

Author

Foglia, E, Garagiola, E, Ladisa, V, Rambaldi, A, Cairoli, R, Sammassimo, S, Salè, E, Zinzani, P, Esposti, M, Alberti, L, Mulas, M, Melis, E, Onnis, S, Marcias, M, Satta, V, Croce, D, Foglia E, Garagiola E, Ladisa V, Rambaldi A, Cairoli R, Sammassimo S, Salè EO, Zinzani PL, Esposti M, Alberti L, Mulas MF, Melis E, Onnis S, Marcias M, Satta V, Croce D, Foglia, E, Garagiola, E, Ladisa, V, Rambaldi, A, Cairoli, R, Sammassimo, S, Salè, E, Zinzani, P, Esposti, M, Alberti, L, Mulas, M, Melis, E, Onnis, S, Marcias, M, Satta, V, Croce, D, Foglia E, Garagiola E, Ladisa V, Rambaldi A, Cairoli R, Sammassimo S, Salè EO, Zinzani PL, Esposti M, Alberti L, Mulas MF, Melis E, Onnis S, Marcias M, Satta V, and Croce D

Abstract

The present study aims at defining the economic and organizational impacts of the introduction of chimeric antigen receptor T-cell therapy (CAR-T) in Italy, for the management of diffuse large B-cell lymphoma (DLBCL) patients in third-line therapy, defining the overall level of sustainability for both hospitals and the National Healthcare System (NHS). The analysis focused on CAR-T and Best Salvage Care (in the following BSC), assuming the Italian hospital and NHS perspectives, over a 36-month time horizon. Process mapping and activity-based costing methodologies were applied to collect the hospital costs related to the BSC and CAR-T pathways, including adverse event management. Anonymous administrative data on services provided (diagnostic and laboratory examinations, hospitalizations, outpatient procedures, and therapies) to 47 third-line patients with lymphoma, as well as any organizational investments required, were collected, in two different Italian Hospitals. The economic results showed that the BSC clinical pathway required less resources in comparison with CAR-T (excluding the cost related to the therapy) (BSC: 29,558.41 vs. CAR-T: EUR 71,220.84, −58.5%). The budget impact analysis depicts that the introduction of CAR-T would generate an increase in costs ranging from 15% to 23%, without considering treatment costs. The assessment of the organizational impact reveals that the introduction of CAR-T therapy would require additional investments equal to a minimum of EUR 15,500 to a maximum of EUR 100,897.49, from the hospital perspective. Results show new economic evidence for healthcare decision makers, to optimize the appropriateness of resource allocation. The present analysis suggests the need to introduce a specific reimbursement tariff, both at the hospital and at NHS levels, since no consensus exists, at least in the Italian setting, concerning the proper remuneration for the hospitals who guarantee this innovative pathway, assuming high risks related t

Published
2023

4. CO67 Tafasitamab Plus Lenalidomide (TAFA+LEN) Versus Pola-BR, R2, and CAR-T in Non-Transplant Eligible (NTE) Relapsed/Refractory (R/R) DLBCL: A Post Hoc Analysis of the RE-MIND2 Study Comparing Multiple Cohort-Balancing Approaches

Author

Córdoba, R, primary, Zinzani, PL, additional, Joffe, E, additional, Yoon, DH, additional, Peters, A, additional, Waltl, EE, additional, Alvero, C, additional, Sabatelli, L, additional, Salles, G, additional, and Nowakowski, GS, additional

Published
2022
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7. Lacutamab in patients with advanced mycosis fungoides according to KIR3DL2 expression: stage 1 results from the TELLOMAK phase 2 trial

Author

Bagot, M, primary, Muller, M, additional, Kim, YH, additional, Ortiz-Romero, PL, additional, Zinzani, PL, additional, Beylot-Barry, M, additional, Dalle, S, additional, Jacobsen, E, additional, Combalia, A, additional, Huen, A, additional, Mehta-Shah, N, additional, Khodadoust, MS, additional, Viotti, J, additional, Paiva, C, additional, and Porcu, P, additional

Published
2022
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9. Quality-of-life analysis of pembrolizumab vs brentuximab vedotin for relapsed/refractory classical Hodgkin lymphoma

Author

Zinzani, PL, Ramchandren, R, Santoro, A, Paszkiewicz-Kozik, E, Gasiorowski, R, Johnson, NA, de Oliveira, JSR, Buccheri, V, Perini, GF, Dickinson, M, McDonald, A, Ozcan, M, Sekiguchi, N, Zhu, Y, Raut, M, Saretsky, TL, Nahar, A, Kuruvilla, J, Zinzani, PL, Ramchandren, R, Santoro, A, Paszkiewicz-Kozik, E, Gasiorowski, R, Johnson, NA, de Oliveira, JSR, Buccheri, V, Perini, GF, Dickinson, M, McDonald, A, Ozcan, M, Sekiguchi, N, Zhu, Y, Raut, M, Saretsky, TL, Nahar, A, and Kuruvilla, J

Abstract

KEYNOTE-204 (NCT02684292) demonstrated a progression-free survival advantage for pembrolizumab over brentuximab vedotin (BV) in patients who had relapsed or refractory classical Hodgkin lymphoma (R/R cHL) following, or who were ineligible for, autologous stem cell transplantation (ASCT). Health-related quality of life (HRQoL), measured by patient-reported outcomes (PROs) from KEYNOTE-204, are reported from patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. The EORTC QoL Questionnaire Core 30 (QLQ-C30) and EuroQoL EQ-5D were administered at baseline, every 6 weeks until week 24, and every 12 weeks thereafter. Prespecified end points included least squares mean (LSM) changes from baseline to week 24 and time to true deterioration (TTD; ≥10-point decline from baseline). Comparisons were evaluated using 2-sided P values uncontrolled for multiplicity. High compliance at baseline (>90%) and through week 24 (>80%) was demonstrated across treatment groups (PRO analysis set: pembrolizumab, n = 146; BV, n = 150). The EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) score improved from baseline to week 24 on pembrolizumab and worsened on BV and demonstrated significant LSM differences at 24 weeks (GHS/QoL: 8.60 [95% confidence interval, 3.89-13.31]; P = .0004). Significant improvements were observed in each QLQ-C30 domain except emotional and cognitive functioning. Compared with BV, pembrolizumab prolonged TTD for GHS/QoL (hazard ratio, 0.40 [95% CI, 0.22-0.74]; P = .003) and each QLQ-C30 domain except cognitive functioning. In conclusion, pembrolizumab demonstrated overall improvements in PROs of HRQoL measures over BV in the KEYNOTE-204 study. These data and previously reported efficacy results support pembrolizumab as the preferred treatment option for patients with R/R cHL who are ineligible for or experience relapse after ASCT.

Published
2022

10. Development of a distributed international patient data registry for hairy cell leukemia

Author

Andritsos, LA, Anghelina, M, Neal, J, Blachly, JS, Mathur, P, Lele, O, Dearden, C, Iyengar, S, Cross, M, Zent, CS, Rogers, KA, Epperla, N, Lozanski, G, Oakes, CC, Kraut, E, Ruppert, AS, Zhao, Q, Bhat, SA, Forconi, F, Banerji, V, Handunnetti, S, Tam, CS, Seymour, JF, Else, M, Kreitman, RJ, Saven, A, Call, T, Parikh, SA, Ravandi, F, Johnston, JB, Tiacci, E, Troussard, X, Tallman, MS, Dietrich, S, Tadmor, T, Gozzetti, A, Zinzani, PL, Robak, T, Quest, G, Demeter, J, Rai, K, Fernandez, SA, Grever, M, Andritsos, LA, Anghelina, M, Neal, J, Blachly, JS, Mathur, P, Lele, O, Dearden, C, Iyengar, S, Cross, M, Zent, CS, Rogers, KA, Epperla, N, Lozanski, G, Oakes, CC, Kraut, E, Ruppert, AS, Zhao, Q, Bhat, SA, Forconi, F, Banerji, V, Handunnetti, S, Tam, CS, Seymour, JF, Else, M, Kreitman, RJ, Saven, A, Call, T, Parikh, SA, Ravandi, F, Johnston, JB, Tiacci, E, Troussard, X, Tallman, MS, Dietrich, S, Tadmor, T, Gozzetti, A, Zinzani, PL, Robak, T, Quest, G, Demeter, J, Rai, K, Fernandez, SA, and Grever, M

Abstract

Hairy cell leukemia (HCL) is a rare lymphoproliferative disorder, comprising only 2% of all leukemias. The Hairy Cell Leukemia Foundation (HCLF) has developed a patient data registry to enable investigators to better study the clinical features, treatment outcomes, and complications of patients with HCL. This system utilizes a centralized registry architecture. Patients are enrolled at HCL Centers of Excellence (COE) or via a web-based portal. All data are de-identified, which reduces regulatory burden and increases opportunities for data access and re-use. To date, 579 patients have been enrolled in the registry. Efforts are underway to engage additional COE's to expand access to patients across the globe. This international PDR will enable researchers to study outcomes in HCL in ways not previously possible due to the rarity of the disease and will serve as a platform for future prospective research.

Published
2022

11. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study

Author

Nowakowski, GS, Yoon, DH, Peters, A, Mondello, P, Joffe, E, Fleury, I, Greil, R, Ku, M, Marks, R, Kim, K, Zinzani, PL, Trotman, J, Huang, D, Waltl, EE, Winderlich, M, Kurukulasuriya, NC, Ambarkhane, S, Hess, G, Salles, G, Nowakowski, GS, Yoon, DH, Peters, A, Mondello, P, Joffe, E, Fleury, I, Greil, R, Ku, M, Marks, R, Kim, K, Zinzani, PL, Trotman, J, Huang, D, Waltl, EE, Winderlich, M, Kurukulasuriya, NC, Ambarkhane, S, Hess, G, and Salles, G

Abstract

PURPOSE: In RE-MIND2 (NCT04697160), patient-level outcomes from the L-MIND study (NCT02399085) of tafasitamab plus lenalidomide were retrospectively compared with patient-level matched observational cohorts treated with National Cancer Care Network (NCCN)/European Society for Medical Oncology (ESMO)-listed systemic therapies for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). PATIENTS AND METHODS: Data were collected from health records of eligible patients aged ≥18 years with histologically confirmed DLBCL who had received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients from L-MIND were matched with patients from the RE-MIND2 observational cohort using estimated propensity score-based 1:1 nearest-neighbor matching, balanced for nine covariates. The primary analysis compared tafasitamab plus lenalidomide with patients who received any systemic therapy for R/R DLBCL (pooled in one cohort) or bendamustine plus rituximab (BR) or rituximab plus gemcitabine and oxaliplatin (R-GemOx; as two distinct cohorts). The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and time-to-event outcomes. RESULTS: In RE-MIND2, 3,454 patients were enrolled from 200 sites in North America, Europe, and Asia-Pacific. Strictly matched pairs of patients consisted of tafasitamab plus lenalidomide versus systemic therapies pooled (n = 76 pairs), versus BR (n = 75 pairs), and versus R-GemOx (n = 74 pairs). Significantly prolonged OS was reported with tafasitamab plus lenalidomide versus systemic pooled therapies [hazard ratios (HR): 0.55; P = 0.0068], BR (HR: 0.42; P < 0.0001), and R-GemOx (HR: 0.47; P = 0.0003). CONCLUSIONS: RE-MIND2, a retrospective observational study, met its primary endpoint, demonstrating prolonged OS with tafasitamab plus lenalidomide versus BR and R-GemOx. See related commentary by Cherng and Westin, p. 3908.

Published
2022

12. Consensus opinion from an international group of experts on measurable residual disease in hairy cell leukemia

Author

Ravandi, F, Kreitman, RJ, Tiacci, E, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, SA, Blachly, JS, Broccoli, A, Call, T, Chihara, D, Dearden, C, Demeter, J, Dietrich, S, Else, M, Epperla, N, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Jorgensen, J, Juliusson, G, Lauria, F, Lozanski, G, Parikh, SA, Park, JH, Polliack, A, Quest, G, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Thompson, PA, Troussard, X, Zent, CS, Zenz, T, Zinzani, PL, Woermann, B, Rai, K, Grever, M, Ravandi, F, Kreitman, RJ, Tiacci, E, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, SA, Blachly, JS, Broccoli, A, Call, T, Chihara, D, Dearden, C, Demeter, J, Dietrich, S, Else, M, Epperla, N, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Jorgensen, J, Juliusson, G, Lauria, F, Lozanski, G, Parikh, SA, Park, JH, Polliack, A, Quest, G, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Thompson, PA, Troussard, X, Zent, CS, Zenz, T, Zinzani, PL, Woermann, B, Rai, K, and Grever, M

Abstract

A significant body of literature has been generated related to the detection of measurable residual disease (MRD) at the time of achieving complete remission (CR) in patients with hairy cell leukemia (HCL). However, due to the indolent nature of the disease as well as reports suggesting long-term survival in patients treated with a single course of a nucleoside analog albeit without evidence of cure, the merits of detection of MRD and attempts to eradicate it have been debated. Studies utilizing novel strategies in the relapse setting have demonstrated the utility of achieving CR with undetectable MRD (uMRD) in prolonging the duration of remission. Several assays including immunohistochemical analysis of bone marrow specimens, multi-parameter flow cytometry and molecular assays to detect the mutant BRAF V600E gene or the consensus primer for the immunoglobulin heavy chain gene (IGH) rearrangement have been utilized with few comparative studies. Here we provide a consensus report on the available data, the potential merits of MRD assessment in the front-line and relapse settings and recommendations on future role of MRD assessment in HCL.

Published
2022

13. 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

14. 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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15. 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

16. '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

17. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

Author

Kim, YH, Prince, HM, Whittaker, S, Horwitz, SM, Duvic, M, Bechter, O, Sanches, JA, Stadler, R, Scarisbrick, J, Quaglino, P, Zinzani, PL, Wolter, P, Eradat, H, Pinter-Brown, LC, Ortiz-Romero, PL, Akilov, OE, Trotman, J, Taylor, K, Weichenthal, M, Walewski, J, Fisher, D, McNeeley, M, Gru, AA, Brown, L, Palanca-Wessels, MC, Lisano, J, Onsum, M, Bunn, V, Little, M, Trepicchio, WL, Dummer, R, Kim, YH, Prince, HM, Whittaker, S, Horwitz, SM, Duvic, M, Bechter, O, Sanches, JA, Stadler, R, Scarisbrick, J, Quaglino, P, Zinzani, PL, Wolter, P, Eradat, H, Pinter-Brown, LC, Ortiz-Romero, PL, Akilov, OE, Trotman, J, Taylor, K, Weichenthal, M, Walewski, J, Fisher, D, McNeeley, M, Gru, AA, Brown, L, Palanca-Wessels, MC, Lisano, J, Onsum, M, Bunn, V, Little, M, Trepicchio, WL, and Dummer, R

Abstract

INTRODUCTION: Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study. METHODS: Baseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30min < 10% (≥1 biopsy with <10% CD30 expression), or CD30min ≥ 10% (all biopsies with ≥10% CD30 expression) and baseline LCT present or absent. Efficacy analyses were the proportion of patients with objective response lasting ≥4 months (ORR4) and progression-free survival (PFS). RESULTS: Clinical activity with brentuximab vedotin was observed across all CD30 expression levels in patients with ≥1 biopsy showing ≥10% CD30 expression. Superior ORR4 was observed with brentuximab vedotin versus physician's choice in patients: with CD30min < 10% (40.9% versus 9.5%), with CD30min ≥ 10% (57.1% versus 10.3%), with LCT (64.7% versus 17.6%) and without LCT (38.7% versus 6.5%). Brentuximab vedotin improved median PFS versus physician's choice in patients: with CD30min < 10% (16.7 versus 2.3 months), with CD30min ≥ 10% (15.5 versus 3.9 months), with LCT (15.5 versus 2.8 months) and without LCT (16.1 versus 3.5 months). Safety profiles were generally comparable across subgroups. CONCLUSION: These exploratory analyses demonstrated that brentuximab vedotin improved rates of ORR4 and PFS versus physician's choice in patients with CD30-positive MF and ≥1 biopsy showing ≥10% CD30 expression, regardless of LCT status. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT01578499.

Published
2021

18. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data

Author

Horwitz, SM, Scarisbrick, JJ, Dummer, R, Whittaker, S, Duvic, M, Kim, YH, Quaglino, P, Zinzani, PL, Bechter, O, Eradat, H, Pinter-Brown, L, Akilov, OE, Geskin, L, Sanches, JA, Ortiz-Romero, PL, Weichenthal, M, Fisher, DC, Walewski, J, Trotman, J, Taylor, K, Dalle, S, Stadler, R, Lisano, J, Bunn, V, Little, M, Prince, HM, Horwitz, SM, Scarisbrick, JJ, Dummer, R, Whittaker, S, Duvic, M, Kim, YH, Quaglino, P, Zinzani, PL, Bechter, O, Eradat, H, Pinter-Brown, L, Akilov, OE, Geskin, L, Sanches, JA, Ortiz-Romero, PL, Weichenthal, M, Fisher, DC, Walewski, J, Trotman, J, Taylor, K, Dalle, S, Stadler, R, Lisano, J, Bunn, V, Little, M, and Prince, HM

Abstract

The primary analysis of the phase 3 ALCANZA trial showed significantly improved objective responses lasting ≥4 months (ORR4; primary endpoint) and progression-free survival (PFS) with brentuximab vedotin vs physician's choice (methotrexate or bexarotene) in CD30-expressing mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (C-ALCL). Cutaneous T-cell lymphomas often cause pruritus and pain; brentuximab vedotin improved skin symptom burden with no negative effects on quality of life. We report final data from ALCANZA (median follow-up, 45.9 months). Adults with previously treated CD30-expressing MF/C-ALCL were randomly assigned to brentuximab vedotin (n = 64) or physician's choice (n = 64). Final data demonstrated improved responses per independent review facility with brentuximab vedotin vs physician's choice: ORR4; 54.7% vs 12.5% (P < .001); complete response, 17.2% vs 1.6% (P = .002). Median PFS with brentuximab vedotin vs physician's choice was 16.7 months vs 3.5 months (P < .001). Median time to the next treatment was significantly longer with brentuximab vedotin than with physician's choice (14.2 vs 5.6 months; hazard ratio, 0.27; 95% confidence interval, 0.17-0.42; P < .001). Of 44 patients in the brentuximab vedotin arm who experienced any-grade peripheral neuropathy, (grade 3, n = 6; grade 4, n = 0), 86% (38 of 44) had complete resolution (26 of 44) or improvement to grades 1 and 2 (12 of 44). Peripheral neuropathy was ongoing in 18 patients (all grades 1-2). These final analyses confirm improved, clinically meaningful, durable responses and longer PFS with brentuximab vedotin vs physician's choice in CD30-expressing MF or C-ALCL. This trial was registered at https://www.clinicaltrials.gov as #NCT01578499.

Published
2021

19. Hairy cell leukemia and COVID-19 adaptation of treatment guidelines

Author

Grever, M, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, S, Blachly, JS, Call, T, Cross, M, Dearden, C, Demeter, J, Dietrich, S, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Juliusson, G, Kraut, E, Kreitman, RJ, Lauria, F, Lozanski, G, Parikh, SA, Park, J, Polliack, A, Ravandi, F, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Tiacci, E, Troussard, X, Zent, C, Zenz, T, Zinzani, PL, Wormann, B, Grever, M, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, S, Blachly, JS, Call, T, Cross, M, Dearden, C, Demeter, J, Dietrich, S, Falini, B, Forconi, F, Gladstone, DE, Gozzetti, A, Iyengar, S, Johnston, JB, Juliusson, G, Kraut, E, Kreitman, RJ, Lauria, F, Lozanski, G, Parikh, SA, Park, J, Polliack, A, Ravandi, F, Robak, T, Rogers, KA, Saven, A, Seymour, JF, Tadmor, T, Tallman, MS, Tam, CS, Tiacci, E, Troussard, X, Zent, C, Zenz, T, Zinzani, PL, and Wormann, B

Abstract

Standard treatment options in classic HCL (cHCL) result in high response rates and near normal life expectancy. However, the disease itself and the recommended standard treatment are associated with profound and prolonged immunosuppression, increasing susceptibility to infections and the risk for a severe course of COVID-19. The Hairy Cell Leukemia Foundation (HCLF) has recently convened experts and discussed different clinical strategies for the management of these patients. The new recommendations adapt the 2017 consensus for the diagnosis and management with cHCL to the current COVID-19 pandemic. They underline the option of active surveillance in patients with low but stable blood counts, consider the use of targeted and non-immunosuppressive agents as first-line treatment for cHCL, and give recommendations on preventive measures against COVID-19.

Published
2021

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

Author

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, Montillo, M, Frustaci, AM, Zinzani, PL, 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, Montillo, M, Frustaci, AM, and Zinzani, PL

Published
2021

21. 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

22. Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas

Author

Sancho JM, Navarro B, Soler Campos JA, de Oteyza JP, de Barrenetxea Lekue C, Bregni M, Grasso Cicala S, Spione M, Mombiedro C, Soler B, and Zinzani PL

Subjects
immune system diseases, hemic and lymphatic diseases, aggressive B-cell lymphoma, pixantrone, relapse, survival
Abstract

Few treatment options exist for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who fail first- and second-line therapies. Pixantrone is a novel aza-anthracenedione agent with reduced potential for cardiotoxicity but maintained anti-tumour activity relative to anthracyclines. The current retrospective, observational, real-life study was undertaken in 79 patients who received pixantrone monotherapy for multiply R/R aggressive B-cell NHL in Spain and Italy.

Published
2020

23. 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

24. Zanubrutinib for the treatment of MYD88 wild-type Waldenstrom macroglobulinemia: a substudy of the phase 3 ASPEN trial

Author

Dimopoulos, M, Garcia Sanz, R, Lee, H-P, Trneny, M, Varettoni, M, Opat, S, D'Sa, S, Owen, RG, Cull, G, Mulligan, S, Czyz, J, Castillo, JJ, Motta, M, Siddiqi, T, Gironella Mesa, M, Granell Gorrochategui, M, Talaulikar, D, Zinzani, PL, Askari, E, Grosicki, S, Oriol, A, Rule, S, Kloczko, J, Tedeschi, A, Buske, C, Leblond, V, Trotman, J, Chan, WY, Michel, J, Schneider, J, Tan, Z, Cohen, A, Huang, J, Tam, CS, Dimopoulos, M, Garcia Sanz, R, Lee, H-P, Trneny, M, Varettoni, M, Opat, S, D'Sa, S, Owen, RG, Cull, G, Mulligan, S, Czyz, J, Castillo, JJ, Motta, M, Siddiqi, T, Gironella Mesa, M, Granell Gorrochategui, M, Talaulikar, D, Zinzani, PL, Askari, E, Grosicki, S, Oriol, A, Rule, S, Kloczko, J, Tedeschi, A, Buske, C, Leblond, V, Trotman, J, Chan, WY, Michel, J, Schneider, J, Tan, Z, Cohen, A, Huang, J, and Tam, CS

Abstract

Patients with Waldenström macroglobulinemia (WM) lacking activating mutations in the MYD88 gene (MYD88WT) have demonstrated relatively poor outcomes to ibrutinib monotherapy, with no major responses reported in a phase 2 pivotal study. Zanubrutinib is a novel, selective Bruton tyrosine kinase (BTK) inhibitor designed to maximize BTK occupancy and minimize off-target activity. The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a separate cohort of patients without MYD88 mutation (MYD88WT) or with unknown mutational status who received zanubrutinib. Results from the latter single-arm cohort are reported herein. Efficacy endpoints included overall, major and complete (CR) or very good partial response (VGPR) rates, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Twenty-eight patients (23 relapsed/refractory; 5 treatment-naïve) were enrolled, including 26 with centrally confirmed MYD88WT disease and 2 with unknown MYD88 mutational status. At a median follow-up of 17.9 months, 7 of 26 MYD88WT patients (27%) had achieved a VGPR and 50% a major response (partial response or better); there were no CRs. At 18 months, the estimated PFS and OS rates were 68% and 88%, respectively, while the median DOR had not been reached. Two patients discontinued zanubrutinib due to adverse events. Treatment-emergent hypertension, atrial fibrillation, and major hemorrhages were reported in 3, 1 and 2 patients (including 1 concurrent with enoxaparin therapy), respectively. Results of this substudy demonstrate that zanubrutinib monotherapy can induce high quality responses in patients with MYD88WT WM. This trial is registered on www.clinicaltrials.gov as NCT #03053440.

Published
2020

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

Author

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, Croce, D, 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, Croce, D, 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, and Croce D

Published
2020

26. Lung lymphoma

Author

Pileri, Stefano A, primary, Poletti, V, additional, Campidelli, C, additional, Zinzani, PL, additional, and Martelli, Maurizio, additional

Published
2008
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29. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma

Author

Wang, M, Rule, S, Zinzani, PL, Goy, A, Casasnovas, O, Smith, SD, Damaj, G, Doorduijn, Jeanette, Lamy, T, Morschhauser, F, Panizo, C, Shah, B, Davies, A, Eek, R, Dupuis, J, Jacobsen, E, Kater, AP, Le Gouill, S, Oberic, L, Robak, T, Jain, P, Frigault, MM, Izumi, R, Nguyen, D, Patel, P, Yin, M, Dlugosz-Danecka, M, Wang, M, Rule, S, Zinzani, PL, Goy, A, Casasnovas, O, Smith, SD, Damaj, G, Doorduijn, Jeanette, Lamy, T, Morschhauser, F, Panizo, C, Shah, B, Davies, A, Eek, R, Dupuis, J, Jacobsen, E, Kater, AP, Le Gouill, S, Oberic, L, Robak, T, Jain, P, Frigault, MM, Izumi, R, Nguyen, D, Patel, P, Yin, M, and Dlugosz-Danecka, M

Published
2019

30. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma

Author

Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J, and ECHELON-1 Study Group

Published
2018

31. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding

Author

Boriani, G, Corradini, P, Cuneo, A, Falanga, A, Foà, R, Gaidano, G, Ghia, P, Martelli, M, Marasca, R, Massaia, M, Mauro, F, Minotti, G, Molica, S, Montillo, M, Pinto, A, Tedeschi, A, Vitolo, U, Zinzani, P, Boriani G, Corradini P, Cuneo A, Falanga A, Foà R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL, Boriani, G, Corradini, P, Cuneo, A, Falanga, A, Foà, R, Gaidano, G, Ghia, P, Martelli, M, Marasca, R, Massaia, M, Mauro, F, Minotti, G, Molica, S, Montillo, M, Pinto, A, Tedeschi, A, Vitolo, U, Zinzani, P, Boriani G, Corradini P, Cuneo A, Falanga A, Foà R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, and Zinzani PL

Abstract

The Bruton tyrosine kinase inhibitor ibrutinib (IB) has attained an important role in the treatment of patients with chronic lymphocytic leukaemia, mantle cell lymphoma, and Waldenström macroglobulinemia, significantly improving clinical outcomes. However, IB therapy has been associated with an increased risk of atrial fibrillation (AF) and bleeding. We report on the expert opinion that a group of Italian haematologists, cardiologists, and pharmacologists jointly released to improve the practical management of patients at risk for AF and bleeding during treatment with IB. A proper pretreatment assessment to identify patients who are at a higher risk, careful choice of concomitant drugs, regular monitoring, and multispecialist approach were characterized as the main principles of clinical management of these patients. For patients developing AF, anticoagulant and antiarrhythmic therapy must be guided by considerations about efficacy, safety, and risk of pharmacokinetic interactions with IB. For patients experiencing bleeding or requiring procedures that increase the risk of bleeding, considerations about platelet turnover, IB-related platelet dysfunctions, and bleeding worsening by concomitant anticoagulants or antiplatelet agents provide clues to manage bleeding. Overall, AF and bleeding are manageable clinical events in patients receiving IB, not requiring drug interruption in most cases. Preexisting AF should not represent an absolute contraindication to IB therapy. For each patient candidate for IB, strategies of risk assessment and mitigation may allow to exploit the life-saving effects of in chronic lymphocytic leukaemia and mantle cell lymphoma

Published
2018

33. 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

34. 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

35. Survival in HIV‐infected patients with lymphoma according to the choice of antiretroviral treatment: an observational multicentre study

Author

Focà, E, primary, Cavaglià, G, additional, Rusconi, S, additional, Cascavilla, A, additional, Cenderello, G, additional, Re, A, additional, Casari, S, additional, van den Bogaart, L, additional, Zinzani, PL, additional, Caracciolo, D, additional, Di Perri, G, additional, Bonito, A, additional, Lucchini, A, additional, Cassola, G, additional, Viale, P, additional, and Calcagno, A, additional

Published
2018
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36. 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

37. Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis

Author

Eichhorst, Barbara F, Fischer, Kirsten, Fink, Anna Maria, Elter, Thomas, Wendtner, Clemens M, Goede, Valentin, Bergmann, Manuela, Stilgenbauer, Stephan, Hopfinger, Georg, Ritgen, Matthias, Bahlo, Jasmin, Busch, Raymonde, Hallek, Michael, Oduncu, F, Dreyling, M, Forstpointner, R, Schneller, F, Bogner, C, Peschel, C, Ringshausen, I, Götze, K, Goebeler, Me, Rückle, Lanz, Ritgen, M, Schawitzke, A, Heydrich, B, Kern, K, Böttcher, S, Irmer, S, Strack, U, Borries, V, Klima, Km, Scholz, C, Herold, M, Härtwig, K, Dürig, J, Dührsen, U, Müller Beissenhirtz, H, Noppeney, R, Schüttrumpf, S, Hohloch, K, Binder, C, Hasenkamp, J, Trümper, L, Bäsecke, J, Rieger, M, Witzens Harig, M, Friedrichs, B, Rieger, K, Uharek, L, Kubuschok, B, Murawski, N, Held, G, Zwick, C, Pfreundschuh, M, Fingerle Rowson, G, Reiser, M, Elter, T, Eichhorst, B, Pallasch, C, Hallek, M, Borchmann, P, Hacker, U, Schinkel, S, Wieker, K, Sökler, M, Wolf, Hh, Eucker, J, Staib, P, Schlegel, F, Kropff, M, Kahl, C, Hess, G, Beck, J, Wölfel, T, Bokemeyer, C, Schilling, G, Dierlamm, J, Schüler, F, Busemann, C, Dölken, G, Trendelenburg, Tk, Bühler, A, Stilgenbauer, S, Viardot, A, Greiner, J, Zenz, T, Gaidzik, V, Langer, C, Döhner, H, Werner, I, Dienst, A, Habersang, K, Härtel, N, Leitner, A, Kehrer, G, Middeke, H, Heinisch, K, Adorf, D, Ismer, B, Hering Schubert, C, Jäckle, J, Aulmann, C, Söllner, S, Majunke, P, Fuss, H, Käfer, G, Potenberg, J, Dietrich, G, Hartung, E, Pronath, A, Riedhammer, Fj, Zehrfeld, T, Prümmer, O, Gatter, J, Meier, A, Wattad, M, Heit, W, Sauer, I, Hilgers, K, Geissler, M, Bauer, J, Stein, W, Voigtmann, R, Natt, F, Nickelsen, M, Zeis, M, Schmitz, N, Lange, E, Stoltefuss, A, Schubert, J, Dürk, Ha, Kloke, O, Fauser, A, Roemer, E, Kraut, L, Musch, E, Kohl, S, Link, H, Kirsch, Jf, Schatz, M, Mezger, J, Kempf, B, Heil, G, Derigs, Hg, Roll, C, Kettner, E, Dübbers, Hw, Lutz, L, Hentrich, M, Hoffmann, U, Ibe, M, Falge, C, Schäfer Eckart, K, Rothmann, F, Raghavachar, A, Beckmann, K, Behringer, D, Stauder, H, Hempfling, C, Matzdorff, A, Hähling, D, Kaesberger, Kj, Mück, R, Waladkhani, Ar, Clemens, M, Kraft, J, Ehlert, T, N. N., Schloen, A, Sandritter, B, Scholz, Diekmann, C, Pflüger, Kh, Hausner, G, Fetscher, S, Aulitzky, W, Brugger, W, Frickhofen, N, Fuhr, Lange, C, Lambertz, H, Schulz, L, Schmier, M, Bentz, M, Tauchmann, Gm, Schmidt, M, Meiler, J, Sandmann, M, Kürschner, D, Maier Bay, B, Lindemann, W, Diers, J, Riemeier Sievers, C, Daun, M, Mergenthaler, Hg, Hiller, S, Schirmer, V, Kirchner, H, Langer, W, Günther, B, Gassmann, W, Franke, K, Burghardt, F, Abele, U, Celikel Becker, D, von Weikersthal LF, Brög, G, Hauch, U, Heinrich, B, Brudler, O, Häcker, B, Eckart, Mj, Bolouri, H, Göttler, B, Kindler, M, Zuchold, K, Strohbach, F, Plingen, Ml, Seibt Jung, H, Kirsch, A, Herrenberger, J, Doering, G, von Grünhagen, U, Franke, H, Weniger, J, Kerzel, W, Schmalfeld, M, Rohrberg, R, Hurtz, Hj, Gehbauer, G, Hahnfeld, S, Vehling Kaiser, U, Abenhardt, W, Bosse, D, Böning, L, Schmidt, B, Schick, Hd, Jacobs, G, Stauch, M, Hoffmann, R, Müller, S, Hahn, M, Freier, W, Dietzfelbinger, H, Rassmann, I, Söling, U, Siehl, S, Rudolph, R, Weinert, R, Sauer, A, Meyer, B, Eschenburg, H, Schadeck Gressel, C, Grabenhorst, U, Perker, M, Otremba, B, Reschke, D, Hinrichs, Hf, Zirpel, I, Höring, E, Respondek, M, Köppler, H, Heymanns, J, Weide, R, Hünermund, K, Thiel, C, Reiber, T, Spohn, C, Springer, G, Fiechtner, H, Hübner, A, Kurschel, E, Weiss, J, Schlag, R, Schäfer, E, Hartwich, G, Schmitz, S, Steinmetz, T, Kim, Ts, Lerchenmüller, C, Wehmeyer, J, Laubenstein, Hp, Rendenbach, B, Lebahn, H, Kröning, H, Uhle, R, Balló, H, Gaede, B, Zumbrink, S, Eckert, R, Kamp, T, Reimann, B, Burkhard, O, Mittermüller, J, Hansen, R, Hitz, H, Schliesser, G, Schmitt, Hr, Forstbauer, H, Grundeis, M, Schulze, M, Baldus, M, Lakner, V, Haen, M, Müller, C, Dörfel, S, Göhler, T, Welslau, M, Achtzehn, V, Culmann, H, Gerhardt, S, Ulshöfer, T, Koschuth, A, Schmidt, P, Müller, L, Schneider, M, Koniczek, K, Porowski, P, Glados, M, Knoblich, J, Ben Yehuda, D, Jäger, U, Gaiger, A, Schwarzmeier, J, Nösslinger, T, Smith, M, Patton, N, Gibbons, S, Bouabdallah, R, Gandhi, M, Marlton, P, Mills, T, Angelucci, E, Sorano, Gg, Casula, P, Berneman, Z, Kohser, P, Hudcova Burgetova, A, Machová, R, Papajik, T, Kubová, Z, Fineman, R, Mayer, J, Doubek, M, Brychtova, Y, Ciceri, F, Caligaris Cappio, F, Crocchiolo, R, Dauriac, C, Bernard, M, Escoffre Barbe, M, Lamy, T, Zikesova, E, Karban, J, Salkova, J, Trnený, M, Pytlik, R, Tiley, C, Forsyth, C, Vokurka, S, Koza, V, Van Hoof, A, Selleslag, D, Sebban, C, Baker, B, Belada, D, Jebavy, L, Smolej, L, Pavel, Z, Di Ianni, M, Castaigne, S, Del Poeta, G, Amadori, S, Catalano, J, Ganju, V, Hertzberg, M, Laurenti, L, Dalseg, Am, Bron, D, Morton, J, Durrant, S, Casado, Lf, Theunissen, K, Atias, D, Berkhan, L, Seymour, J, Wolf, M, Bosly, A, Osma Cordoba MM, Portois, C, Jaubert, J, Ferrant, A, Lambert, C, Maerevoet, E, Van den Neste, E, Gadeberg, O, Carney, B, Cannell, P, Eghbali, H, Legouffe, E, Bordessoule, D, Chaury, M, Moreau, S, Pierri, I, Gobbi, M, Berrebi, A, Lishner, M, Yerushazim, R, Yermiaku, T, Kosolov, V, Ambrosetti, Achille, Andreoli, Al, Huguet, F, Laurent, G, Orsucci, L, Forconi, F, Musuraca, G, Zinzani, Pl, Loscertales, J, Mcquillan, A, Cordingley, F, Leahy, M, Cazin, B, Taylor, Mulligan, S, Herbrecht, Cull, G, Seldon, M, Rowlings, P, Ludwig, H, Zojer, N, Solal Céligny, P, Pomponi, F, Savdkova, L, Kozák, T, Christiansen, I, Pérez, I, Campbell, P, Canales Albendea, M, De Paz, R, Arthur, C, Gisselbrecht, C., Eichhorst B.F., Fischer K., Fink A.M., Elter T., Wendtner C.M., Goede V., Bergmann M., Stilgenbauer S., Hopfinger G., Ritgen M., Bahlo J., Busch R., Hallek M., and Zinzani P.L.

Subjects
Male, medicine.medical_specialty, Cyclophosphamide, Chronic lymphocytic leukemia, Immunology, Medizin, Antineoplastic Combined Chemotherapy Protocols, Blood Cell Count, Disease Progression, Disease-Free Survival, Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Middle Aged, Prognosis, Recurrence, Remission Induction, Tomography, X-Ray Computed, Physical examination, Biochemistry, Chemoimmunotherapy, medicine, Chronic, Tomography, Leukemia, medicine.diagnostic_test, business.industry, B-Cell, Cancer, Cell Biology, Hematology, medicine.disease, Lymphocytic, imaging techniques, X-Ray Computed, Fludarabine, Surgery, chronic lymphocytic leukemia, Radiology, business, Progressive disease, medicine.drug
Abstract

The clinical value of imaging is well established for the follow-up of many lymphoid malignancies but not for chronic lymphocytic leukemia (CLL). A meta-analysis was performed with the dataset of 3 German CLL Study Group phase 3 trials (CLL4, CLL5, and CLL8) that included 1372 patients receiving first-line therapy for CLL. Response as well as progression during follow-up was reassessed according to the National Cancer Institute Working Group1996 criteria. A total of 481 events were counted as progressive disease during treatment or follow-up. Of these, 372 progressions (77%) were detected by clinical symptoms or blood counts. Computed tomography (CT) scans or ultrasound were relevant in 44 and 29 cases (9% and 6%), respectively. The decision for relapse treatment was determined by CT scan or ultrasound results in only 2 of 176 patients (1%). CT scan results had an impact on the prognosis of patients in complete remission only after the administration of conventional chemotherapy but not after chemoimmunotherapy. In conclusion, physical examination and blood count remain the methods of choice for staging and clinical follow-up of patients with CLL as recommended by the International Workshop on Chronic Lymphocytic Leukemia 2008 guidelines. These trials are registered at http://www.isrctn.org as ISRCTN 75653261 and ISRCTN 36294212 and at http://www.clinicaltrials.gov as NCT00281918.

Published
2011

38. 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

39. Cyclophosphamide, doxorubicin, vincristine, methotrexate, bleomicin and prednisone plus rituximab in untreated young patients with low-risk (age-adjusted international prognostic index 0-1) diffuse large B-cell lymphoma

Author

Derenzini, E, Stefoni, V, Pellegrini, C, Fina, Mp, Broccoli, A, Venturini, F, Gandolfi, L, Pileri, S. A., Martelli, M, Petti, Mc, Perrotti, A, DE RENZO, A, Zaja, Francesco, Zinzani, Pl, Derenzini, E, Stefoni, V, Pellegrini, C, Fina, Mp, Broccoli, A, Venturini, F, Gandolfi, L, PILERI S., A, Martelli, M, Petti, Mc, Perrotti, A, DE RENZO, A, Zaja, Francesco, and Zinzani, Pl

Abstract

Young patients (aged 1860 years) with good-prognosis diffuse large B-cell lymphoma (DLBCL) [0 and 1 risk factor according to age-adjusted international prognostic index (aa-IPI)] are distinguished from patients with poor-prognosis. Six cycles of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) in combination with rituximab achieved best results in young patients with low-risk DLBCL. We retrospectively analyzed the data of 82 patients (1860 years) with untreated aa-IPI 01 DLBCL, from six Italian institutions, who underwent, between January 2002 and January 2007, rituximab-cyclophosphamide, doxorubicin, vincristine, methotrexate, bleomicin and prednisone (R-MACOP-B) therapy followed, in patients with bulky presentation, by 3036 Gy involved-field radiation therapy (34 patients). An overall response rate was noted in 77 out of 82 (94) patients (75 patients had a complete response (91), 2 patients had a partial response). With a median follow-up of 46 months, 7-year progression-free and overall survival were estimated to be 91 and 94, respectively. R-MACOP-B regimen followed by involved-field radiation on bulky presentation is safe and very effective in the treatment of young patients with low-risk DLBCL. © 2009 Informa Healthcare USA, Inc.

Published
2009

41. 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

42. 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

43. Molecular prediction of durable remission after first-line fludarabine-cyclophosphamide-rituximab in chronic lymphocytic leukemia.

Author

Rossi, D, Terzi-di-Bergamo, L, De Paoli, Luigi, Cerri, Marco Vittorio, Ghilardi, Giampaolo, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, Luca, Del Giudice, I, Gentile, M, Vincelli, I, Motta, M, Coscia, M, Rigolin, Gm, Tedeschi, Alessandra, Neri, A, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, A, Gattei, V, Foà, R, Gaidano, G, Laurenti L (ORCID:0000-0002-8327-1396), Rossi, D, Terzi-di-Bergamo, L, De Paoli, Luigi, Cerri, Marco Vittorio, Ghilardi, Giampaolo, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, Luca, Del Giudice, I, Gentile, M, Vincelli, I, Motta, M, Coscia, M, Rigolin, Gm, Tedeschi, Alessandra, Neri, A, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, A, Gattei, V, Foà, R, Gaidano, G, and Laurenti L (ORCID:0000-0002-8327-1396)

Abstract

X

Published
2015

44. Safety and efficacy of single-agent bendamustine after failure of brentuximab vedotin in patients with relapsed or refractory hodgkin's lymphoma: experience with 27 patients

Author

Zinzani, Pl, Vitolo, U, Viviani, S, Corradini, P, Motta, G, Tani, M, Cascavilla, N, Hohaus, Stefan, Merli, F, Argnani, L, Broccoli, A, Hohaus, S (ORCID:0000-0002-5534-7197), Zinzani, Pl, Vitolo, U, Viviani, S, Corradini, P, Motta, G, Tani, M, Cascavilla, N, Hohaus, Stefan, Merli, F, Argnani, L, Broccoli, A, and Hohaus, S (ORCID:0000-0002-5534-7197)

Abstract

The optimal treatment of patients with heavily pretreated Hodgkin's lymphoma is controversial. Brentuximab vedotin is an active single agent in this context. Also, bendamustine can be regarded as a safe and effective alternative for patients with relapse after autologous transplantation and as an interesting cytoreductive strategy before allogeneic transplantation.

Published
2015

45. Randomized trial of 8-week versus 12-week VNCOP-b puls G-CSF regimens as front - line treatment in elderly aggressive non-Hodgkin's lymphoma patients

Author

DE RENZO, A, Falini, B, Fattori, Pp, Gentilini, P, Gherlinzoni, F, Guardigni, L, Lauta, Vm, Mannina, D, Mazza, P, Moretti, L, Pavone, E, Storti, S, Volpe, E, Zaccaria, A, Zaja, Francesco, Zinzani, Pl, DE RENZO, A, Falini, B, Fattori, Pp, Gentilini, P, Gherlinzoni, F, Guardigni, L, Lauta, Vm, Mannina, D, Mazza, P, Moretti, L, Pavone, E, Storti, S, Volpe, E, Zaccaria, A, Zaja, Francesco, and Zinzani, Pl

Abstract

BACKGROUND: Among the third-generation chemotherapy regimens specifically adapted in the last decade for elderly aggressive non-Hodgkin's lymphoma (NHL) patients, we designed an 8-week cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin and prednisone (VNCOP-B) plus granulocyte colony-stimulating factor (G-CSF) regimen which, in a national multicenter trial, induced good complete response (CR) and relapse-free survival rates with only moderate toxic effects. Here we report a prospective, multicenter, randomized trial comparing the efficacy and toxicity of 8- and 12-week regimens of VNCOP-B plus G-CSF. PATIENTS AND METHODS: From February 1996 to June 2001, 306 consecutive previously untreated stage II-IV aggressive NHL patients > or =60 years of age were enrolled from 12 Italian cooperative institutions. Of the 297 evaluable patients, 149 and 148 received 8- and 12-week regimens, respectively, of VNCOP-B. RESULTS: The CR rates were 63% and 56% in the 8- and 12-week groups; at a median of 32 months (range 3-62 months), relapse-free survival rates were 59% and 55%, respectively. Hematological and non-hematological toxicities were similar in both treatment groups. CONCLUSIONS: Our data show that extending induction treatment with the VNCOP-B plus G-CSF regimen from 8 to 12 weeks does not raise the CR rate or provide a more durable remission.

Published
2002

46. 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

50. 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

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