PMID- 36398133 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221119 IS - 2572-9241 (Electronic) IS - 2572-9241 (Linking) VI - 6 IP - 12 DP - 2022 Dec TI - Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy. PG - e798 LID - 10.1097/HS9.0000000000000798 [doi] LID - e798 AB - 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. CI - Copyright (c) 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. FAU - Argnani, Lisa AU - Argnani L AD - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seragnoli", Bologna, Italy. AD - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Universita di Bologna, Italy. FAU - Broccoli, Alessandro AU - Broccoli A AD - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seragnoli", Bologna, Italy. AD - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Universita di Bologna, Italy. FAU - Pellegrini, Cinzia AU - Pellegrini C AD - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seragnoli", Bologna, Italy. FAU - Fabbri, Alberto AU - Fabbri A AD - UOC Ematologia, Azienda Ospedaliero-Universitaria Senese, Siena, Italy. FAU - Puccini, Benedetta AU - Puccini B AD - Azienda Ospedaliera Universitaria Careggi, Firenze, Italy. FAU - Bruna, Riccardo AU - Bruna R AD - Division of Hematology, Department of Translational Medicine University of Eastern Piedmont and AOU Maggiore della Carita di Novara, Italy. FAU - Tisi, Maria Chiara AU - Tisi MC AD - Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy. FAU - Masia, Francesco AU - Masia F AD - Department of Medicine and Surgery, University of Perugia, Italy. FAU - Flenghi, Leonardo AU - Flenghi L AD - Ematologia, Azienda Ospedaliera di Perugia, Italy. FAU - Nizzoli, Maria Elena AU - Nizzoli ME AD - Ematologia, AUSL/IRCSS Reggio Emilia, Italy. FAU - Musso, Maurizio AU - Musso M AD - Oncoematologia e TMO, Dip. Oncologico La Maddalena, Palermo, Italy. FAU - Salerno, Marilena AU - Salerno M AD - UOC Ematologia ARNAS Garibaldi, Catania, Italy. FAU - Scalzulli, Potito Rosario AU - Scalzulli PR AD - IRCCS "Casa Sollievo della Sofferenza" Hospital, SC Ematologia e Trapianto di Cellule Staminali, San Giovanni Rotondo, Italy. FAU - Dessi', Daniela AU - Dessi' D AD - Unita operativa di Ematologia e CTMO ospedale Businco Arnas AOB, Cagliari, Italy. FAU - Ferrarini, Isacco AU - Ferrarini I AD - Department of Medicine, Section of Hematology, University of Verona, Italy. FAU - Pennese, Elsa AU - Pennese E AD - UOSD Centro Diagnosi e Terapia dei Linfomi, Dipartimento Oncologico-Ematologico, Presidio Ospedaliero Santo Spirito, Pescara, Italy. FAU - Lucchini, Elisa AU - Lucchini E AD - SC Ematologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy. FAU - Rossi, Francesca Gaia AU - Rossi FG AD - Division of Hematology, Fondazione IRCCS Ospedale Maggiore Policlinico, Universita degli Studi di Milano, Italy. FAU - Minoia, Carla AU - Minoia C AD - Hematology Unit-IRCCS Istituto Tumori "Giovanni Paolo II" Bari, Italy. FAU - Gherlinzoni, Filippo AU - Gherlinzoni F AD - Azienda ULSS 2 Marca Trevigiana Ospedale Ca' Foncello, Treviso, Italy. FAU - Musto, Pellegrino AU - Musto P AD - Dipartimento dell'Emergenza e dei Trapianti di Organi (DETO) Scuola di Medicina, Universita degli Studi "Aldo Moro", Bari, Italy. FAU - Patti, Caterina AU - Patti C AD - Division of Onco-Hematology, Azienda Villa Sofia-Cervello, Palermo, Italy. FAU - Stefoni, Vittorio AU - Stefoni V AD - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seragnoli", Bologna, Italy. AD - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Universita di Bologna, Italy. FAU - Zinzani, Pier Luigi AU - Zinzani PL AD - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seragnoli", Bologna, Italy. AD - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Universita di Bologna, Italy. LA - eng PT - Journal Article DEP - 20221111 PL - United States TA - Hemasphere JT - HemaSphere JID - 101740619 PMC - PMC9663137 EDAT- 2022/11/19 06:00 MHDA- 2022/11/19 06:01 PMCR- 2022/11/11 CRDT- 2022/11/18 02:12 PHST- 2022/07/19 00:00 [received] PHST- 2022/10/03 00:00 [accepted] PHST- 2022/11/18 02:12 [entrez] PHST- 2022/11/19 06:00 [pubmed] PHST- 2022/11/19 06:01 [medline] PHST- 2022/11/11 00:00 [pmc-release] AID - 10.1097/HS9.0000000000000798 [doi] PST - epublish SO - Hemasphere. 2022 Nov 11;6(12):e798. doi: 10.1097/HS9.0000000000000798. eCollection 2022 Dec.