23 results on '"Ghione, P."'
Search Results
2. Rituximab and lenalidomide for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma: real-life experience
- Author
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Giulio Cassanello, Esther Drill, Alfredo Rivas-Delgado, Michelle Okwali, Irem Isgor, Philip C. Caron, Zachary Epstein-Peterson, Paola Ghione, Paul Hamlin, Jennifer Lue, Steven M. Horwitz, Andrew M. Intlekofer, William Johnson, Anita Kumar, Alison Moskowitz, Ariela Noy, Colette Owens, Lia M. Palomba, Pallawi Torka, Pallavi Galera, Andrew D. Zelenetz, Gilles Salles, and Lorenzo Falchi
- Subjects
Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
The combination of rituximab and lenalidomide (R-len) stands as an established treatment for relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). However, the reproducibility of clinical trial results in routine clinical practice is unknown. To address this gap in knowledge, we reviewed our experience with patients diagnosed with R/R follicular lymphoma (FL) or marginal zone lymphoma (MZL) treated with this combination. Eighty-four patients underwent treatment with R-len, 69 (82%) affected by FL and 15 (18%) by MZL. The median age at the time of treatment initiation was 65 years (range, 39-94), 38 patients (45%) had a pre-treatment FLIPI score of 3-5, 19 (23%) had a bulky disease, 29 (37%) had a lymphoma refractory to the last treatment line, while in 20 (24%) cases the disease was refractory to rituximab. The best overall response rate (ORR) was 82%, and 52% achieved a complete response (CR). The best CR rates for FL and MZL patients were 55% and 40%, respectively. With a median follow-up of 22 months, the median progression-free survival (mPFS) was 22 months (95% CI 19-36) and the 2-year overall survival (OS) was 83% (95% CI 74-93). The median duration of CR (DoCR) was 46 months (95% CI 22-NR). Factors associated with shorter PFS in multivariate analysis were bulky disease and rituximab refractoriness. The most common adverse events (AE) included hematologic toxicity, fatigue and gastrointestinal disorders, such as diarrhea and constipation. Neutropenia and thrombocytopenia were the most common severe toxicities (grade ≥3 in 25% and 4%, respectively). No new safety signals were reported. Real-life results of R-len in patients with R/R iNHL appear consistent with those reported in prospective studies, and further support its use as comparator arm in controlled clinical trials.
- Published
- 2024
- Full Text
- View/download PDF
3. Spotlight on polatuzumab vedotin: new standards for diffuse large B-cell lymphoma?
- Author
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Paola Ghione and Gilles Salles
- Subjects
Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Despite continuous improvements in the management and treatment of diffuse large B cell lymphoma (DLBCL), approximately 35% of the patients experience relapse or are refractory to frontline chemotherapy. For these patients, outcomes are far from satisfactory, and a real unmet need exists to both improve frontline treatment and create better options for relapsed/refractory disease. Polatuzumab vedotin is an anti-CD79b antibody conjugated to the monomethyl auristatin E (MMAE) microtubule inhibitor. The molecule has recently been under the spotlights for the promising results of the frontline combination with rituximab cyclophosphamide doxorubicin and prednisone (R-CHP) in the phase III POLARIX study, demonstrating improved progression-free survival over standard R-CHOP. A remarkable improvement in terms of complete response rate and overall survival with polatuzumab vedotin has also been achieved by combining polatuzumab with rituximab and bendamustine (pola-BR) over the standard BR for relapsed/refractory patients. Based on the results of these studies, health authorities in several countries granted approval for polatuzumab vedotin both for patients with previously untreated and for relapsed/refractory DLBCL. In this review, we summarize the data of major studies recently concluded with polatuzumab vedotin, and we provide an overview of the ongoing combination trials for frontline and relapsed/refractory DLBCL, outlining reported toxicities.
- Published
- 2024
- Full Text
- View/download PDF
4. Emapalumab as salvage therapy for adults with malignancy-associated hemophagocytic lymphohistiocytosis
- Author
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William T. Johnson, Zachary D. Epstein-Peterson, Nivetha Ganesan, Timothy Pak, Tiffany Chang, Phuong Dao, Alison J. Moskowitz, Robert N. Stuver, Paola Ghione, Natasha Galasso, Niloufer Khan, M. Lia Palomba, Philip C. Caron, Anita Kumar, Roni Tamari, Jennifer K. Lue, Ariela Noy, Lorenzo Falchi, Andrew M. Intlekofer, Boglarka Gyurkocza, Miguel-Angel Perales, Michael Scordo, A. Zara Herskovits, Gilles Salles, Santosha A. Vardhana, and Steven M. Horwitz
- Subjects
Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Not available.
- Published
- 2024
- Full Text
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5. Exploring Optimal Dark Current Design in HgCdTe Infrared Barrier Detectors: A TCAD and Semianalytic Investigation
- Author
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Marco Vallone, Matteo G. C. Alasio, Alberto Tibaldi, Francesco Bertazzi, Stefan Hanna, Anne Wegmann, Detlef Eich, Heinrich Figgemeier, Giovanni Ghione, and Michele Goano
- Subjects
Modeling ,photodetectors ,semiconductor materials ,theory and design ,Applied optics. Photonics ,TA1501-1820 ,Optics. Light ,QC350-467 - Abstract
The dark current is a fundamental figure of merit to characterize the performance of high-sensitivity, low-noise mid- and far-infrared barrier photodetectors. In the context of HgCdTe barrier photodetectors, the trend is to use very low doping concentrations, in an attempt to minimize recombination processes. In the present work, through TCAD simulations, we delve deeper into the design of low-dark-current $p{\mathrm{B}}n$ detectors, showing the possible existence of an optimum doping. This occurrence is investigated and interpreted also by means of closed-form expressions for the lifetimes, emphasizing the role of the interplay between Auger and Shockley-Read-Hall generation processes.
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- 2024
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6. ASO Author Reflections: Approaching BIA-ACL Diagnosis and Treatment
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Kim, Minji, Vorstenbosch, Joshua, Ghione, Paola, Plitas, George, Horwitz, Steven, Cordeiro, Peter, Nelson, Jonas A., and McCarthy, Colleen
- Published
- 2024
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7. ASO Visual Abstract: Surgical Management and Long-Term Outcomes of BIA-ALCL: A Multidisciplinary Approach
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Vorstenbosch, Joshua, Ghione, Paola, Plitas, George, Horwitz, Steven, Kim, Minji, Cordeiro, Peter, Nelson, Jonas, and McCarthy, Colleen
- Published
- 2024
- Full Text
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8. The wide world of technological telerehabilitation for pediatric neurologic and neurodevelopmental disorders – a systematic review
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Benedetta Del Lucchese, Stefano Parravicini, Silvia Filogna, Gloria Mangani, Elena Beani, Maria Chiara Di Lieto, Alessandra Bardoni, Marta Bertamino, Marta Papini, Chiara Tacchino, Francesca Fedeli, Giovanni Cioni, Giuseppina Sgandurra, the Italian Neuroscience and Neurorehabilitation Network, Arnoldi Maria Teresa, Baglio Francesca, Barzacchi Veronica, Bassi Maria Teresa, Berardinelli Angela, Bombonato Clara, Borgatti Renato, Calabrò Rocco Salvatore, Cardillo Ilaria, Castelli Enrico, Cavallini Anna, Ceragioli Beatrice, Cersosimo Antonella, Condoluci Claudia, Corti Claudia, Di Girolamo Gabriella, Di Giusto Valentina, Elia Maurizio, Favetta Martina, Ferrante Carolina, Ferri Raffaele, Ghione Valeria, Goffredo Michela, Lugari Patrizia, Manzia Carlotta Maria, Martini Giada, Matteucci Elisa, Menici Valentina, Moretti Paolo, Pagliano Emanuela, Perinelli Martina Giorgia, Petrarca Maurizio, Poggi Geraldina, Pulvirenti Francesca, Rizzo Marta, Sgherri Giada, Strazzer Sandra, Striano Pasquale, Tassorelli Cristina, Vannetti Federica, and Viganò Marta
- Subjects
technologies ,telerehabilitation ,pediatric ,neurodevelopmental disorders ,neurological disorders ,children ,Public aspects of medicine ,RA1-1270 - Abstract
IntroductionThe use of Information and Communication Technology (ICT) for assessing and treating cognitive and motor disorders is promoting home-based telerehabilitation. This approach involves ongoing monitoring within a motivating context to help patients generalize their skills. It can also reduce healthcare costs and geographic barriers by minimizing hospitalization. This systematic review focuses on investigating key aspects of telerehabilitation protocols for children with neurodevelopmental or neurological disorders, including technology used, outcomes, caregiver involvement, and dosage, to guide clinical practice and future research.MethodThis systematic review adhered to PRISMA guidelines and was registered in PROSPERO. The PICO framework was followed to define the search strategy for technology-based telerehabilitation interventions targeting the pediatric population (aged 0–18) with neurological or neurodevelopmental disorders. The search encompassed Medline/PubMed, EMBASE, and Web of Science databases. Independent reviewers were responsible for selecting relevant papers and extracting data, while data harmonization and analysis were conducted centrally.ResultsA heterogeneous and evolving situation emerged from our data. Our findings reported that most of the technologies adopted for telerehabilitation are commercial devices; however, research prototypes and clinical software were also employed with a high potential for personalization and treatment efficacy. The efficacy of these protocols on health or health-related domains was also explored by categorizing the outcome measures according to the International Classification of Functioning, Disability, and Health (ICF). Most studies targeted motor and neuropsychological functions, while only a minority of papers explored language or multi-domain protocols. Finally, although caregivers were rarely the direct target of intervention, their role was diffusely highlighted as a critical element of the home-based rehabilitation setting.DiscussionThis systematic review offers insights into the integration of technological devices into telerehabilitation programs for pediatric neurologic and neurodevelopmental disorders. It highlights factors contributing to the effectiveness of these interventions and suggests the need for further development, particularly in creating dynamic and multi-domain rehabilitation protocols. Additionally, it emphasizes the importance of promoting home-based and family-centered care, which could involve caregivers more actively in the treatment, potentially leading to improved clinical outcomes for children with neurological or neurodevelopmental conditions.Systematic review registrationPROSPERO (CRD42020210663).
- Published
- 2024
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9. CHRONOS-4: phase 3 study of copanlisib plus rituximab-based immunochemotherapy in relapsed indolent B-cell lymphoma
- Author
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Zinzani, Pier Luigi, Wang, Huaqing, Feng, Jifeng, Kim, Tae Min, Tao, Rong, Zhang, Huilai, Fogliatto, Laura, Maluquer Artigal, Clara, Özcan, Muhit, Yanez, Eduardo, Kim, Won Seog, Kirtbaya, Dmitry, Kriachok, Iryna, Maciel, Felipe, Xue, Hongwei, Bouabdallah, Krimo, Phelps, Charles, Chaturvedi, Shalini, Weispfenning, Anke, Morcos, Peter N., Odongo, Fatuma, Buvaylo, Viktoriya, Childs, Barrett H., Dreyling, Martin, Matasar, Matthew, and Ghione, Paola
- Abstract
•Copanlisib plus R-B did not demonstrate improved PFS or overall survival in patients with relapsed iNHL.•Copanlisib plus R-B was associated with more serious TEAEs, TEAE-related deaths, and discontinuations than placebo plus R-B.
- Published
- 2024
- Full Text
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10. Role of flow cytometric immunophenotyping in the diagnosis of breast implant‐associated anaplastic large cell lymphoma: A 6‐year, single‐institution experience
- Author
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Chan, Alexander, Auclair, Romany, Gao, Qi, Ghione, Paola, Horwitz, Steven, Dogan, Ahmet, Roshal, Mikhail, and Lin, Oscar
- Abstract
Breast implant‐associated anaplastic large cell lymphoma (BIA‐ALCL) is an uncommon mature T‐cell neoplasm occurring in patients with textured breast implants, typically after 7–10 years of exposure. Although cytopathologic or histopathologic assessment is considered the gold standard diagnostic method for BIA‐ALCL, flow cytometry (FC)‐based immunophenotyping is recommended as an adjunct test. However, the diagnostic efficacy of FC is not well reported. We reviewed 290 FC tests from breast implant pericapsular fluid and capsule tissue from 182 patients, including 16 patients with BIA‐ALCL over a 6‐year period, calculating diagnostic rates and test efficacy. FC showed an overall sensitivity of 75.9%, specificity of 100%, and negative and positive predictive values of 95.4% and 100%, respectively. Blinded expert review of false‐negative cases identified diagnostic pitfalls, improving sensitivity to 96.6%. Fluid samples had better rates of adequate samples for FC testing compared with tissue samples. Paired with FC testing of operating room (OR)‐acquired fluid samples, capsulectomy FC specimens added no diagnostic value in patients with concurrent fluid samples; no cases had positive capsule FC with negative fluid FC. Fluid samples are adequate for FC testing more often than tissue. Capsule tissue FC specimens do not improve FC efficacy when paired with OR‐acquired fluid FC samples and are often inadequate samples. FC is 100% specific for BIA‐ALCL and can serve as a confirmatory test but should not be the sole diagnostic method. Awareness of sample‐specific diagnostic pitfalls greatly improves the sensitivity of BIA‐ALCL testing by FC.
- Published
- 2024
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11. TCAD-Assisted Progress on the Cisco Platform Toward Low-Bias 200 Gbit/s vertical-pin Ge- on-Si Waveguide Photodetectors
- Author
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Alasio, Matteo G. C., Vallone, Marco, Tibaldi, Alberto, Namnabat, Soha, Adams, Donald, Gothoskar, Prakash, Forghieri, Fabrizio, Masini, Gianlorenzo, Bertazzi, Francesco, Ghione, Giovanni, Gioannini, Mariangela, and Goano, Michele
- Abstract
We discuss the characterization and numerical simulation of vertical Ge-on-Si waveguide photodetectors (VPIN WPDs) of the Cisco platform for data communications in the O-band (
), with the goal of optimizing their frequency response while integrating them into low-power systems. In a large set of WPDs belonging to 6 different structural variants, at a standard bias voltage of$1.31 \,\mu \mathrm{m}$ the best specimens exhibit an intrinsic electro-optic bandwidth of more than$-2 \,\mathrm{V}$ , which is reduced to about$40 \,\mathrm{G}\mathrm{Hz}$ at zero bias. A comprehensive 3D multiphysics model, validated through the characterization campaign, provides design guidelines towards intrinsic bandwidths not only wider than$10 \,\mathrm{G}\mathrm{Hz}$ at$60 \,\mathrm{G}\mathrm{Hz}$ , directly suitable for application in 200 Gbit/s systems, but also wider than$-2 \,\mathrm{V}$ at zero bias, not including the possible recourse to extrinsic parameter engineering.$40 \,\mathrm{G}\mathrm{Hz}$ - Published
- 2024
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12. GENDER DIFFERENCES IN MORTALITY RISK AFTER TAVI: UNRAVELING THE ENIGMA THROUGH BODY COMPOSITION ANALYSIS
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Casirati, A, Somaschini, A, Cornara, S, Olivotti, L, Giachello, V, Astuti, M, Botta, M, Ghione, M, Buscemi, M, Cereda, E, Caccialanza, R, Bellone, P, and Cordone, S
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- 2024
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13. CNS bridging radiotherapy achieves rapid cytoreduction before CAR T-cell therapy for aggressive B-cell lymphomas
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Cederquist, Gustav Y., Schefflein, Javin, Devlin, Sean M., Shah, Gunjan L., Shouval, Roni, Hubbeling, Harper, Tringale, Kathryn, Alarcon Tomas, Ana, Fregonese, Beatrice, Hajj, Carla, Boardman, Alexander, Luna De Abia, Alejandro, Corona, Magdalena, Cassanello, Giulio, Dahi, Parastoo B., Lin, Richard J., Ghione, Paola, Salles, Gilles, Perales, Miguel-Angel, Palomba, M. Lia, Falchi, Lorenzo, Scordo, Michael, Grommes, Christian, Yahalom, Joachim, and Imber, Brandon S.
- Abstract
•Bridging radiotherapy (BRT) for chemotherapy-refractory CNS lymphoma achieves rapid cytoreduction before CART.•CNS-BRT is associated with a favorable CNS response profile and CART–associated neurotoxicity profile.
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- 2024
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14. The CNS Relapse in T-Cell Lymphoma Index Predicts CNS Relapse in Patients with T- and NK-Cell Lymphomas
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Bhansali, Rahul S., Ellin, Fredrik, Relander, Thomas, Cao, Miao, Li, Wenrui, Long, Qi, Ganesan, Nivetha, Stuver, Robert, Horwitz, Steven M., Wudhikarn, Kitsada, Hwang, Steven R., Bennani, N. Nora, Chavez, Julio, Sokol, Lubomir, Saeed, Hayder, Duan, Frank, Porcu, Pierluigi, Pullarkat, Priyanka, Mehta-Shah, Neha, Zain, Jasmine M., Ruiz, Miguel, Brammer, Jonathan E., Prakash, Rishab, Iyer, Swaminathan P., Olszewski, Adam J., Major, Ajay, Riedell, Peter A., Smith, Sonali M., Goldin, Caroline, Haverkos, Bradley, Hu, Bei, Zhuang, Tony Z., Allen, Pamela B., Toama, Wael, Janakiram, Murali, Brooks, Taylor R., Jagadeesh, Deepa, Hariharan, Nisha, Goodman, Aaron M., Hartman, Gabrielle, Ghione, Paola, Fayyaz, Fatima, Rhodes, Joanna M., Chong, Elise A., Gerson, James N., Landsburg, Daniel J., Nasta, Sunita D., Schuster, Stephen J., Svoboda, Jakub, Jerkeman, Mats, and Barta, Stefan K.
- Abstract
•Tumor histology and number of sites of extranodal involvement are prominent risk factors for CNS relapse.•The CITI score is a validated risk model to predict patients with MTNKN at highest risk of CNS relapse.
- Published
- 2024
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15. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma
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Ghione, Paola, Palomba, M Lia, Patel, Anik R, Bobillo, Sabela, Deighton, Kevin, Jacobson, Caron A, Nahas, Myrna, Hatswell, Anthony J, Jung, A Scott, Kanters, Steve, Snider, Julia Thornton, Neelapu, Sattva S, Ribeiro, Maria Teresa, Brookhart, M Alan, Ghesquieres, Herve, Radford, John, and Gribben, John G
- Abstract
In the pivotal ZUMA-5 trial, axicabtagene ciloleucel (axi-cel; an autologous anti-CD19 chimeric antigen receptor T-cell therapy) demonstrated high rates of durable response in relapsed/refractory (r/r) follicular lymphoma (FL) patients. Here, clinical outcomes from ZUMA-5 are compared to the international SCHOLAR-5 external control cohort, which applied key ZUMA-5 trial eligibility criteria to attempt to simulate RCT conditions. SCHOLAR-5 data were extracted from institutions in five countries, and from one historical clinical trial, for r/r FL patients who initiated a ≥3rdline of therapy after July 2014. Patient characteristics were balanced through propensity scoring on pre-specified prognostic factors using standardized mortality ratio (SMR) weighting. Time-to-event outcomes were evaluated using weighted Kaplan-Meier analysis. Overall response rate (ORR) and complete response (CR) rate were compared using weighted odds ratios. The 143 patients identified in SCHOLAR-5 reduced to an effective sample of 85 patients after SMR weighting, versus 86 patients in ZUMA-5. Median follow-up time was 25.4 and 23.3 months for SCHOLAR-5 and ZUMA-5. The median overall survival (OS) and progression-free survival (PFS) in SCHOLAR-5 were 59.8 months and 12.7 months, and were not reached in ZUMA-5. The hazard ratios for OS and PFS were 0.42 (95% confidence interval [CI]: 0.21-0.83) and 0.30 (95%CI: 0.18-0.49). The ORR and CR rate were 49.9% and 29.9% in SCHOLAR-5 compared to 94.2% and 79.1% in ZUMA-5, for odds ratios of 16.2 (95%CI: 5.6-46.9) and 8.9 (95%CI: 4.3-18.3). Compared to available therapies, axi-cel demonstrated an improvement in meaningful clinical endpoints. This study suggests axi-cel may address an important unmet need for r/r FL patients. Study can be found at NCT03105336 https://www.clinicaltrials.gov/ct2/show/NCT03105336.
- Published
- 2024
- Full Text
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16. Targeted BET inhibition with OPN-51107 synergizes with venetoclax in chronic lymphocytic leukemia.
- Author
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Zablonski KG, Skupa SA, Eiken AP, Sundaram S, Mavis C, Gu JJ, Torka P, Ghione P, El-Gamal D, and Hernandez-Ilizaliturri FJ
- Abstract
Chronic lymphocytic leukemia (CLL) remains incurable and its ability to acquire resistance to front-line therapeutics has proved challenging. Bromodomain and extra-terminal proteins, particularly bromodomain-containing protein 4 (BRD4), are integral to gene expression in CLL and offer a promising therapeutic target. In this study, we examined the activity of the BRD4 inhibitor OPN-51107 alone and in combination with the BCL-2 inhibitor, venetoclax, in CLL cell lines and patient-derived CLL samples. We demonstrate that OPN-51107 induces anti-tumor activity in both CLL cell lines and patient-derived samples, including relapsed/refractory (R/R) samples and those with high-risk features (i.e. ATM and/or TP53 deletions). Importantly, the combination of OPN-51107 and venetoclax exhibited synergistic cytotoxicity in ibrutinib-resistant CLL cells and patient-derived CLL samples regardless of R/R or deletion status. This study establishes the preclinical efficacy of using OPN-51107 and venetoclax in combination in therapy-resistant and/or high-risk CLL, lending support for its further development as a combination therapy.
- Published
- 2024
- Full Text
- View/download PDF
17. Rituximab and lenalidomide for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma: real-life experience.
- Author
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Cassanello G, Drill E, Rivas-Delgado A, Okwali M, Isgor I, Caron PC, Epstein-Peterson Z, Ghione P, Hamlin P, Lue J, Horwitz SM, Intlekofer AM, Johnson W, Kumar A, Moskowitz A, Noy A, Owens C, Palomba LM, Torka P, Galera P, Zelenetz AD, Salles G, and Falchi L
- Abstract
The combination of rituximab and lenalidomide (R-len) stands as an established treatment for relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). However, the reproducibility of clinical trial results in routine clinical practice is unknown. To address this gap in knowledge, we reviewed our experience with patients diagnosed with R/R follicular lymphoma (FL) or marginal zone lymphoma (MZL) treated with this combination. Eighty-four patients underwent treatment with R-len, 69 (82%) affected by FL and 15 (18%) by MZL. The median age at the time of treatment initiation was 65 years (range, 39-94), 38 patients (45%) had a pre-treatment FLIPI score of 3-5, 19 (23%) had a bulky disease, 29 (37%) had a lymphoma refractory to the last treatment line, while in 20 (24%) cases the disease was refractory to rituximab. The best overall response rate (ORR) was 82%, and 52% achieved a complete response (CR). The best CR rates for FL and MZL patients were 55% and 40%, respectively. With a median follow-up of 22 months, the median progression-free survival (mPFS) was 22 months (95% CI 19-36) and the 2-year overall survival (OS) was 83% (95% CI 74-93). The median duration of CR (DoCR) was 46 months (95% CI 22-NR). Factors associated with shorter PFS in multivariate analysis were bulky disease and rituximab refractoriness. The most common adverse events (AE) included hematologic toxicity, fatigue and gastrointestinal disorders, such as diarrhea and constipation. Neutropenia and thrombocytopenia were the most common severe toxicities (grade ≥3 in 25% and 4%, respectively). No new safety signals were reported. Real-life results of R-len in patients with R/R iNHL appear consistent with those reported in prospective studies, and further support its use as comparator arm in controlled clinical trials.
- Published
- 2024
- Full Text
- View/download PDF
18. Emapalumab as salvage therapy for adults with malignancy-associated hemophagocytic lymphohistiocytosis.
- Author
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Johnson WT, Epstein-Peterson ZD, Ganesan N, Pak T, Chang T, Dao P, Moskowitz AJ, Stuver RN, Ghione P, Galasso N, Khan N, Palomba ML, Caron PC, Kumar A, Tamari R, Lue JK, Noy A, Falchi L, Intlekofer AM, Gyurkocza B, Perales MA, Scordo M, Herskovits AZ, Salles G, Vardhana SA, and Horwitz SM
- Subjects
- Humans, Adult, Male, Female, Middle Aged, Aged, Treatment Outcome, Neoplasms drug therapy, Neoplasms complications, Antibodies, Neutralizing, Lymphohistiocytosis, Hemophagocytic drug therapy, Lymphohistiocytosis, Hemophagocytic etiology, Lymphohistiocytosis, Hemophagocytic diagnosis, Salvage Therapy, Antibodies, Monoclonal therapeutic use
- Published
- 2024
- Full Text
- View/download PDF
19. Spotlight on polatuzumab vedotin: new standards for diffuse large B-cell lymphoma?
- Author
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Ghione P and Salles G
- Subjects
- Humans, Immunoconjugates therapeutic use, Immunoconjugates adverse effects, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal adverse effects, Treatment Outcome, Clinical Trials as Topic, Lymphoma, Large B-Cell, Diffuse drug therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects
- Abstract
Despite continuous improvements in the management and treatment of diffuse large B-cell lymphoma (DLBCL), approximately 35% of affected patients experience relapse or are refractory to frontline chemotherapy. For these patients, outcomes are far from satisfactory, and a real unmet need exists both to improve frontline treatment and to create better options for relapsed/refractory disease. Polatuzumab vedotin is an anti-CD79b antibody conjugated to the monomethyl auristatin E microtubule inhibitor. The molecule has recently been under the spotlight for the promising results of the frontline combination with rituximab, cyclophosphamide, doxorubicin and prednisone in the phase III POLARIX study, demonstrating improved progression-free survival over standard rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. Remarkable improvements in terms of complete response rate and overall survival have also been achieved with polatuzumab vedotin by combining the antibody with the standard rituximab and bendamustine regimen for relapsed/refractory patients. Based on the results of these studies, health authorities in several countries granted approval for polatuzumab vedotin to be used as treatment both for patients with previously untreated DLBCL and for those with relapsed/refractory DLBCL. In this review, we summarize the data of major studies recently concluded with polatuzumab vedotin, and we provide an overview of the ongoing combination trials for frontline and relapsed/refractory DLBCL, outlining reported toxicities.
- Published
- 2024
- Full Text
- View/download PDF
20. Cutaneous T-cell lymphoma and dupilumab use: A retrospective matched cohort study of clinical characteristics and treatment outcomes.
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Stuver R, Dusza S, Epstein-Peterson ZD, Ghione P, Horwitz SM, Johnson W, Moskowitz AJ, Myskowski P, Pulitzer M, and Geller S
- Published
- 2024
- Full Text
- View/download PDF
21. A Comparison of 3-Year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) With SCHOLAR-5 in Relapsed/Refractory Follicular Lymphoma.
- Author
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Ghione P, Palomba ML, Ray MD, Limbrick-Oldfield EH, Owen J, Kanters S, Bobillo S, Ribiero MT, Jacobson CA, Neelapu SS, Ghesquieres H, Nahas M, Beygi S, Patel AR, and Gribben JG
- Subjects
- Humans, Male, Follow-Up Studies, Female, Middle Aged, Immunotherapy, Adoptive methods, Aged, Adult, Antigens, CD19 therapeutic use, Antigens, CD19 immunology, Treatment Outcome, Neoplasm Recurrence, Local drug therapy, Lymphoma, Follicular drug therapy, Lymphoma, Follicular mortality, Biological Products therapeutic use, Biological Products pharmacology
- Abstract
In the pivotal ZUMA-5 trial, axicabtagene ciloleucel (axi-cel; an autologous anti-CD19 chimeric antigen receptor T-cell therapy) demonstrated high rates of durable response in relapsed/refractory follicular lymphoma patients. SCHOLAR-5 is an external control cohort designed to act as a comparator to ZUMA-5. Here, we present an updated comparative analysis of ZUMA-5 and SCHOLAR-5, using the 36-month follow-up data and the intent-to-treat population of ZUMA-5. Using propensity-score methods, 127 patients in ZUMA-5 were compared to 129 patients in SCHOLAR-5. At this extended follow-up, axi-cel continues to demonstrate clinically meaningful benefits in survival compared to historically available treatments in this population., Competing Interests: Disclosures PG has received consultancy fees from AstraZeneca Pharmaceuticals, Kyowa Hakko Kirin and Secura Bio, and research funding from Kite, a Gilead Company. MLP has received consultancy fees from BMS, honoraria from BeiGene, Novartis, Sythekine, Kite, a Gilead Company, MustangBio, Vor Biopharma, Rheos, Frazier Healthcare Partners, Nectar Therapeutics, Ceramedix, Lygenesis, GSK, Da Volterra, Thymofox, Notch Therapeutics, Pluto Therapeutics, and Garuda, is a current holder of stock options in Notch Therapeutics, Pluto Therapeutics, and has served on a board or committee for BeiGene. MDR current employment at and holding stock and stock options from Kite, a Gilead company. ELO: current employment at RainCity Analytics; JO: current employment at Delta Hat; SK: current employment at RainCity Analytics. SBo has no conflicts of interest to declare. MTR has no conflicts of interest to declare. CAJ has received consultancy fees and honoraria from Kite, a Gilead Company, Novartis, BMS/Celgene, Lonza,Ispen, Epizyme, Bluebird Bio, Instil Bio, ImmPACT Bio, Daiichi Sanko, AbbVie, Humanigen, Nkarta, and Precision BioSciences, has received travel support from Novartis, Lonza, Humanigen, Celgene, and Precision BioSciences, has received research funding from Kite, a Gilead Company, and has received speakers bureau from Clinical Care Options and Axis. SSN received research support from Kite, a Gilead Company, BMS, Allogene, Precision Biosciences, Adicet Bio, and Sana Biotechnology; served as Advisory Board Member/Consultant for Kite, a Gilead Company, Merck, Sellas Life Sciences, Athenex, Allogene, Incyte, Adicet Bio, BMS, Bluebird Bio, Fosun, Kite, a Gilead Company, Sana Biotechnology, Caribou, Astellas Pharma, Morphosys, Janssen, Chimagen, ImmunoACT, Orna Therapeutics, Takeda, and Synthekine; has stock options from Longbow Immunotherapy, Inc; and has intellectual property related to cell therapy. HG has received consultancy fees and honoraria from Gilead and Roche, and honoraria from BMS and AbbVie. MN, current employment at and holding stock and stock options from Kite, a Gilead company. SBe, current employment at and holding stock and stock options from Kite, a Gilead company. AP, current employment at and holding stock and stock options from Kite, a Gilead company. JG received honoraria from Janssen, AbbVie, AtraZeneca, Amgen, BMS, Kite, a Gilead Company, and Novartis and research funding from AstraZeneca, Bristol Myers Squibb, Celgene Corporation, and Janssen., (Copyright © 2024. Published by Elsevier Inc.)
- Published
- 2024
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22. Diffuse large B-cell lymphoma involving osseous sites: utility of response assessment by PET/CT and good longterm outcomes.
- Author
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Ghione P, Ahsanuddin S, Luttwak E, Varela SB, Nakajima R, Michaud L, Gupta K, Navitski A, Straus D, Palomba ML, Moskowitz A, Noy A, Hamlin P, Matasar M, Kumar A, Falchi L, Yahalom J, Horwitz S, Zelenetz A, Younes A, Salles G, Schöder H, and Joffe E
- Subjects
- Humans, Prognosis, Fluorodeoxyglucose F18 therapeutic use, Positron-Emission Tomography, Retrospective Studies, Positron Emission Tomography Computed Tomography methods, Lymphoma, Large B-Cell, Diffuse diagnostic imaging, Lymphoma, Large B-Cell, Diffuse therapy
- Abstract
Osseous involvement by diffuse large B-cell lymphoma (DLBCL-bone) is a heterogeneous disease. There is limited data regarding response assessment by positron emission tomography with fluorodeoxyglucose, which may demonstrate residual avidity despite a complete response. We analyzed clinical data of patients with newly diagnosed DLBCL and identified all cases with DLBCL-bone. End of treatment scans were reviewed by two independent experts classifying osseous lesions into Deauville (DV) ≤3; DV ≥4, or reactive uptake in the bone marrow (M), site of fracture (F) or surgery (S). We compared outcomes of DLBCL-bone to other extranodal sites (EN) matched on International Prognotic Index features and regimen. Of 1,860 patients with DLBCL (bone 16%; EN 45%; nodal 39%), 41% had localized disease and 59% advanced. Only 9% (n=27) of patients with initial bone involvement had residual fluorodeoxyglucose avidity at the osseous site. In half of these cases, the uptake was attributed to F/S/M, and of the remaining 13, only two were truly refractory (both with persistent disease at other sites). Overall survival and progression-free survival (PFS) were found to be similar for early- stage nodal DLBCL and DLBCL-bone, but inferior in EN-DLBCL. Advanced-stage disease involving the bone had a similar 5-year PFS to nodal disease and EN-DLBCL. After matching for International Prognotic Index and treatment regiments, PFS between bone and other EN sites was similar. Osseous involvement in DLBCL does not portend a worse prognosis. End of treatment DV ≥4 can be expected in 5-10% of cases, but in the absence of other signs of refractory disease, may be followed expectantly.
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- 2024
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23. Safety and efficacy of tenalisib in combination with romidepsin in patients with relapsed/refractory T-cell lymphoma: results from a phase I/II open-label multicenter study.
- Author
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Iyer SP, Huen A, Ai WZ, Jagadeesh D, Lechowicz MJ, Okada C, Feldman TA, Ghione P, Alderuccio JP, Champion R, Kim SH, Mohrbacher A, Routhu KV, Barde P, Nair AM, and Haverkos BM
- Subjects
- Adult, Humans, Neoplasm Recurrence, Local drug therapy, Treatment Outcome, Lymphoma, T-Cell drug therapy, Lymphoma, T-Cell, Peripheral drug therapy, Skin Neoplasms
- Abstract
Tenalisib, a selective phosphoinositide-3-kinase δ/γ, and salt-inducible-kinase-3 inhibitor has shown efficacy and was well-tolerated in patients with T-cell lymphoma (TCL). In vitro studies suggest a synergistic anti-tumor potential for the combination of tenalisib with the histone-deacetylase inhibitor, romidepsin. This multicenter, open-label, phase I/II study was designed to characterize the safety, efficacy and pharmacokinetics of oral tenalisib twice-daily and intravenous romidepsin administered on days 1, 8 and 15 in 28-day cycles in adults with relapsed/refractory TCL. Phase I/dose escalation determined the maximum tolerated dose (MTD)/optimal doses of tenalisib and romidepsin. The phase II/dose expansion assessed the safety and anti-tumor activity of the combination at MTD/optimal dose. Overall, 33 patients were enrolled. In dose escalation, no dose-limiting toxicity was identified. Hence, the recommended doses for dose expansion were tenalisib 800 mg twice daily orally, and romidepsin 14 mg/m2 intravenous. Overall treatment-emergent adverse events of any grade reported in >15% of patients were nausea, thrombocytopenia, increased aspartate aminotransferase, increased alanine aminotransferase, decreased appetite, neutropenia, vomiting, fatigue, anemia, dysgeusia, weight loss, diarrhea, and hypokalemia. Twenty-three patients (69.7%) had related grade ≥3 treatment-emergent adverse events. The overall objective response rate in evaluable patients was 63.0% (peripheral TCL: 75% and cutaneous TCL: 53.3%), with a complete response and partial response of 25.9% and 37.0% respectively. The median duration of response was 5.03 months. Co-administration of tenalisib and romidepsin did not significantly alter the pharmacokinetics of romidepsin. Overall, tenalisib and romidepsin combination demonstrated a favorable safety and efficacy profile supporting its further development for relapsed/refractory TCL (clinicaltrials gov. Identifier: NCT03770000).
- Published
- 2024
- Full Text
- View/download PDF
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