Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy
After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospectiv...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-12-01
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| Series: | HemaSphere |
| Online Access: | http://journals.lww.com/10.1097/HS9.0000000000000798 |
| _version_ | 1827333925286969344 |
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| author | Lisa Argnani Alessandro Broccoli Cinzia Pellegrini Alberto Fabbri Benedetta Puccini Riccardo Bruna Maria Chiara Tisi Francesco Masia Leonardo Flenghi Maria Elena Nizzoli Maurizio Musso Marilena Salerno Potito Rosario Scalzulli Daniela Dessi’ Isacco Ferrarini Elsa Pennese Elisa Lucchini Francesca Gaia Rossi Carla Minoia Filippo Gherlinzoni Pellegrino Musto Caterina Patti Vittorio Stefoni Pier Luigi Zinzani |
| author_facet | Lisa Argnani Alessandro Broccoli Cinzia Pellegrini Alberto Fabbri Benedetta Puccini Riccardo Bruna Maria Chiara Tisi Francesco Masia Leonardo Flenghi Maria Elena Nizzoli Maurizio Musso Marilena Salerno Potito Rosario Scalzulli Daniela Dessi’ Isacco Ferrarini Elsa Pennese Elisa Lucchini Francesca Gaia Rossi Carla Minoia Filippo Gherlinzoni Pellegrino Musto Caterina Patti Vittorio Stefoni Pier Luigi Zinzani |
| author_sort | Lisa Argnani |
| collection | DOAJ |
| description | After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospective study was conducted focusing on the effectiveness and safety of PolaBR in everyday clinical practice. Fifty-five patients were enrolled. There were 26 females (47.3%), 32 patients were primary refractory and 45 (81.8%) resulted refractory to their last therapy. The decision to add or not bendamustine was at physician’s discretion. Thirty-six patients underwent PolaBR, and 19 PolaR. The 2 groups did not differ in most of baseline characteristics. The final overall response rate was 32.7% (18.2% complete response rate), with a best response rate of 49.1%. Median disease-free survival was reached at 12 months, median progression-free survival at 4.9 months and median overall survival at 9 months, respectively. Overall, 88 adverse events (AEs) were registered during treatment in 31 patients, 22 of grade ≥3. Eight cases of neuropathy occurred, all of grades 1–2 and all related to polatuzumab. The two groups of treatment did not differ for effectiveness endpoints but presented statistically significant difference in AEs occurrence, especially in hematological AEs, in AEs of grade equal or greater than 3 and in incidence of neuropathy. Our data add useful information on the effectiveness of Pola(B)R in the setting of heavily pretreated DLBCL and may also suggest a better tolerability in absence of bendamustine without compromise of efficacy. |
| first_indexed | 2024-03-07T17:38:38Z |
| format | Article |
| id | doaj.art-1cc1af983bd1486091a4adbd8c7747a9 |
| institution | Directory Open Access Journal |
| issn | 2572-9241 |
| language | English |
| last_indexed | 2024-03-07T17:38:38Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | HemaSphere |
| spelling | doaj.art-1cc1af983bd1486091a4adbd8c7747a92024-03-02T16:11:58ZengWileyHemaSphere2572-92412022-12-01612e79810.1097/HS9.0000000000000798202212000-00003Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based TherapyLisa Argnani0Alessandro Broccoli1Cinzia Pellegrini2Alberto Fabbri3Benedetta Puccini4Riccardo Bruna5Maria Chiara Tisi6Francesco Masia7Leonardo Flenghi8Maria Elena Nizzoli9Maurizio Musso10Marilena Salerno11Potito Rosario Scalzulli12Daniela Dessi’13Isacco Ferrarini14Elsa Pennese15Elisa Lucchini16Francesca Gaia Rossi17Carla Minoia18Filippo Gherlinzoni19Pellegrino Musto20Caterina Patti21Vittorio Stefoni22Pier Luigi Zinzani231 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy1 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy1 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy3 UOC Ematologia, Azienda Ospedaliero-Universitaria Senese, Siena, Italy4 Azienda Ospedaliera Universitaria Careggi, Firenze, Italy5 Division of Hematology, Department of Translational Medicine University of Eastern Piedmont and AOU Maggiore della Carità di Novara, Italy6 Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy7 Department of Medicine and Surgery, University of Perugia, Italy8 Ematologia, Azienda Ospedaliera di Perugia, Italy9 Ematologia, AUSL/IRCSS Reggio Emilia, Italy10 Oncoematologia e TMO, Dip. Oncologico La Maddalena, Palermo, Italy11 UOC Ematologia ARNAS Garibaldi, Catania, Italy12 IRCCS “Casa Sollievo della Sofferenza” Hospital, SC Ematologia e Trapianto di Cellule Staminali, San Giovanni Rotondo, Italy13 Unità operativa di Ematologia e CTMO ospedale Businco Arnas AOB, Cagliari, Italy14 Department of Medicine, Section of Hematology, University of Verona, Italy15 UOSD Centro Diagnosi e Terapia dei Linfomi, Dipartimento Oncologico-Ematologico, Presidio Ospedaliero Santo Spirito, Pescara, Italy16 SC Ematologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy17 Division of Hematology, Fondazione IRCCS Ospedale Maggiore Policlinico, Università degli Studi di Milano, Italy18 Hematology Unit-IRCCS Istituto Tumori “Giovanni Paolo II” Bari, Italy19 Azienda ULSS 2 Marca Trevigiana Ospedale Ca’ Foncello, Treviso, Italy20 Dipartimento dell’Emergenza e dei Trapianti di Organi (DETO) Scuola di Medicina, Università degli Studi “Aldo Moro”, Bari, Italy21 Division of Onco-Hematology, Azienda Villa Sofia-Cervello, Palermo, Italy1 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy1 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, ItalyAfter FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospective study was conducted focusing on the effectiveness and safety of PolaBR in everyday clinical practice. Fifty-five patients were enrolled. There were 26 females (47.3%), 32 patients were primary refractory and 45 (81.8%) resulted refractory to their last therapy. The decision to add or not bendamustine was at physician’s discretion. Thirty-six patients underwent PolaBR, and 19 PolaR. The 2 groups did not differ in most of baseline characteristics. The final overall response rate was 32.7% (18.2% complete response rate), with a best response rate of 49.1%. Median disease-free survival was reached at 12 months, median progression-free survival at 4.9 months and median overall survival at 9 months, respectively. Overall, 88 adverse events (AEs) were registered during treatment in 31 patients, 22 of grade ≥3. Eight cases of neuropathy occurred, all of grades 1–2 and all related to polatuzumab. The two groups of treatment did not differ for effectiveness endpoints but presented statistically significant difference in AEs occurrence, especially in hematological AEs, in AEs of grade equal or greater than 3 and in incidence of neuropathy. Our data add useful information on the effectiveness of Pola(B)R in the setting of heavily pretreated DLBCL and may also suggest a better tolerability in absence of bendamustine without compromise of efficacy.http://journals.lww.com/10.1097/HS9.0000000000000798 |
| spellingShingle | Lisa Argnani Alessandro Broccoli Cinzia Pellegrini Alberto Fabbri Benedetta Puccini Riccardo Bruna Maria Chiara Tisi Francesco Masia Leonardo Flenghi Maria Elena Nizzoli Maurizio Musso Marilena Salerno Potito Rosario Scalzulli Daniela Dessi’ Isacco Ferrarini Elsa Pennese Elisa Lucchini Francesca Gaia Rossi Carla Minoia Filippo Gherlinzoni Pellegrino Musto Caterina Patti Vittorio Stefoni Pier Luigi Zinzani Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy HemaSphere |
| title | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
| title_full | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
| title_fullStr | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
| title_full_unstemmed | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
| title_short | Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy |
| title_sort | real world outcomes of relapsed refractory diffuse large b cell lymphoma treated with polatuzumab vedotin based therapy |
| url | http://journals.lww.com/10.1097/HS9.0000000000000798 |
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