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BORTEZOMIB TO R-DHAP COMPARED TO R-DHAP IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA ELIGIBLE TO STEM CELL TRANPLANTATION: FINAL RESULTS OF PHASE II RANDOMIZED FIL-VERAL12
Author(s): ,
Annalisa Chiappella
Affiliations:
Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italie;Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italien;Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italia;Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italy;Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italia;Hematology, Fondazione IRCCS,
,
Monica Balzarotti
Affiliations:
Hematology, Humanitas Cancer Center, Istituto Clinico Humanitas,Rozzano,Italie;Hematology, Humanitas Cancer Center, Istituto Clinico Humanitas,Rozzano,Italien;Hematology, Humanitas Cancer Center, Istituto Clinico Humanitas,Rozzano,Italia;Hematology, Humanitas Cancer Center, Istituto Clinico Humanitas,Rozzano,Italy;Hematology, Humanitas Cancer Center, Istituto Clinico Humanitas,Rozzano,Italia;Hemat
,
Barbara Botto
Affiliations:
Hematology, AOU Città della Salute e della Scienza,Torino,Italie;Hematology, AOU Città della Salute e della Scienza,Torino,Italien;Hematology, AOU Città della Salute e della Scienza,Torino,Italia;Hematology, AOU Città della Salute e della Scienza,Torino,Italy;Hematology, AOU Città della Salute e della Scienza,Torino,Italia;Hematology, AOU Città della Salute e della Scienza,Torino,Italië;Hematology
,
Anna Castiglione
Affiliations:
Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italie;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italien;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italia;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italy;Unit
,
Federica Cavallo
Affiliations:
Hematology, Department of Molecular Biotechnologies and Health Sciences, Università degli studi e AOU Città della Salute e della Scienza,Torino,Italie;Hematology, Department of Molecular Biotechnologies and Health Sciences, Università degli studi e AOU Città della Salute e della Scienza,Torino,Italien;Hematology, Department of Molecular Biotechnologies and Health Sciences, Università degli studi e
,
Sara Veronica Usai
Affiliations:
Hematology, Ospedale Businco,Cagliari,Italie;Hematology, Ospedale Businco,Cagliari,Italien;Hematology, Ospedale Businco,Cagliari,Italia;Hematology, Ospedale Businco,Cagliari,Italy;Hematology, Ospedale Businco,Cagliari,Italia;Hematology, Ospedale Businco,Cagliari,Italië;Hematology, Ospedale Businco,Cagliari,Itália;Hematology, Ospedale Businco,Cagliari,Италия;Hematology, Ospedale Businco,Cagliari,It
,
Manuela Zanni
Affiliations:
Hematology, AO SS. Antonio e Biagio e Cesare Arrigo,Alessandria,Italie;Hematology, AO SS. Antonio e Biagio e Cesare Arrigo,Alessandria,Italien;Hematology, AO SS. Antonio e Biagio e Cesare Arrigo,Alessandria,Italia;Hematology, AO SS. Antonio e Biagio e Cesare Arrigo,Alessandria,Italy;Hematology, AO SS. Antonio e Biagio e Cesare Arrigo,Alessandria,Italia;Hematology, AO SS. Antonio e Biagio e Cesare
,
Catello Califano
Affiliations:
Oncology and Hematology, Presidio ospedaliero "A. Tortora",Pagani,Italie;Oncology and Hematology, Presidio ospedaliero "A. Tortora",Pagani,Italien;Oncology and Hematology, Presidio ospedaliero "A. Tortora",Pagani,Italia;Oncology and Hematology, Presidio ospedaliero "A. Tortora",Pagani,Italy;Oncology and Hematology, Presidio ospedaliero "A. Tortora",Pagani,Italia;Oncology and Hematology, Presidio o
,
Francesca Re
Affiliations:
Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Parma,Italie;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Parma,Italien;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Parma,Italia;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Parma,Italy;Hematology, Ospedale Policlinico San
,
Chiara Ghiggi
Affiliations:
Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Genova,Italie;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Genova,Italien;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Genova,Italia;Hematology, Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia,Genova,Italy;Hematology, Ospedale Policlinico
,
Attilio Olivieri
Affiliations:
Hematology, AOU Ospedali Riuniti,Ancona,Italie;Hematology, AOU Ospedali Riuniti,Ancona,Italien;Hematology, AOU Ospedali Riuniti,Ancona,Italia;Hematology, AOU Ospedali Riuniti,Ancona,Italy;Hematology, AOU Ospedali Riuniti,Ancona,Italia;Hematology, AOU Ospedali Riuniti,Ancona,Italië;Hematology, AOU Ospedali Riuniti,Ancona,Itália;Hematology, AOU Ospedali Riuniti,Ancona,Италия;Hematology, AOU Ospedali
,
Paolo Corradini
Affiliations:
Chair of Hematology, Università degli Studi di Milano e Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italie;Chair of Hematology, Università degli Studi di Milano e Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italien;Chair of Hematology, Università degli Studi di Milano e Hematology, Fondazione IRCCS, Istituto Nazionale dei Tumori,Milano,Italia;Chair of
,
Anna Marina Liberati
Affiliations:
Oncology and Hematology, AO. S. Maria,Terni,Italie;Oncology and Hematology, AO. S. Maria,Terni,Italien;Oncology and Hematology, AO. S. Maria,Terni,Italia;Oncology and Hematology, AO. S. Maria,Terni,Italy;Oncology and Hematology, AO. S. Maria,Terni,Italia;Oncology and Hematology, AO. S. Maria,Terni,Italië;Oncology and Hematology, AO. S. Maria,Terni,Itália;Oncology and Hematology, AO. S. Maria,Terni
,
Stefano Volpetti
Affiliations:
Hematology, Azienda Sanitaria Universitaria Friuli Centrale,Udine,Italie;Hematology, Azienda Sanitaria Universitaria Friuli Centrale,Udine,Italien;Hematology, Azienda Sanitaria Universitaria Friuli Centrale,Udine,Italia;Hematology, Azienda Sanitaria Universitaria Friuli Centrale,Udine,Italy;Hematology, Azienda Sanitaria Universitaria Friuli Centrale,Udine,Italia;Hematology, Azienda Sanitaria Unive
,
Maria Grazia Michieli
Affiliations:
Oncology and Hematology, IRCCS Centro di Riferimento Oncologico,Aviano,Italie;Oncology and Hematology, IRCCS Centro di Riferimento Oncologico,Aviano,Italien;Oncology and Hematology, IRCCS Centro di Riferimento Oncologico,Aviano,Italia;Oncology and Hematology, IRCCS Centro di Riferimento Oncologico,Aviano,Italy;Oncology and Hematology, IRCCS Centro di Riferimento Oncologico,Aviano,Italia;Oncology a
,
Alessandra Tucci
Affiliations:
Hematology, ASST Spedali Civili,Brescia,Italie;Hematology, ASST Spedali Civili,Brescia,Italien;Hematology, ASST Spedali Civili,Brescia,Italia;Hematology, ASST Spedali Civili,Brescia,Italy;Hematology, ASST Spedali Civili,Brescia,Italia;Hematology, ASST Spedali Civili,Brescia,Italië;Hematology, ASST Spedali Civili,Brescia,Itália;Hematology, ASST Spedali Civili,Brescia,Италия;Hematology, ASST Spedali
,
Gianluca Gaidano
Affiliations:
Hematology and Department of Translational Medicine, Università del Piemonte Orientale e AOU Maggiore della Carità,Novara,Italie;Hematology and Department of Translational Medicine, Università del Piemonte Orientale e AOU Maggiore della Carità,Novara,Italien;Hematology and Department of Translational Medicine, Università del Piemonte Orientale e AOU Maggiore della Carità,Novara,Italia;Hematology a
,
Monica Tani
Affiliations:
Hematology, Ospedale delle Croci,Ravenna,Italie;Hematology, Ospedale delle Croci,Ravenna,Italien;Hematology, Ospedale delle Croci,Ravenna,Italia;Hematology, Ospedale delle Croci,Ravenna,Italy;Hematology, Ospedale delle Croci,Ravenna,Italia;Hematology, Ospedale delle Croci,Ravenna,Italië;Hematology, Ospedale delle Croci,Ravenna,Itália;Hematology, Ospedale delle Croci,Ravenna,Италия;Hematology, Ospe
,
Fabrizio Ciambelli
Affiliations:
Oncology, AO S. Antonio Abate,Gallarate,Italie;Oncology, AO S. Antonio Abate,Gallarate,Italien;Oncology, AO S. Antonio Abate,Gallarate,Italia;Oncology, AO S. Antonio Abate,Gallarate,Italy;Oncology, AO S. Antonio Abate,Gallarate,Italia;Oncology, AO S. Antonio Abate,Gallarate,Italië;Oncology, AO S. Antonio Abate,Gallarate,Itália;Oncology, AO S. Antonio Abate,Gallarate,Италия;Oncology, AO S. Antonio
,
Gerardo Musuraca
Affiliations:
Hematology, IRCCS Istituto Romagnolo per lo studio dei Tumori 'Dino Amadori' – IRST S.R.L.,Meldola,Italie;Hematology, IRCCS Istituto Romagnolo per lo studio dei Tumori 'Dino Amadori' – IRST S.R.L.,Meldola,Italien;Hematology, IRCCS Istituto Romagnolo per lo studio dei Tumori 'Dino Amadori' – IRST S.R.L.,Meldola,Italia;Hematology, IRCCS Istituto Romagnolo per lo studio dei Tumori 'Dino Amadori' – IR
,
Daniele Vallisa
Affiliations:
Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italie;Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italien;Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italia;Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italy;Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italia;Hematology, Ospedale Guglielmo da Saliceto,Piacenza,Italië;Hematology, Ospedale Guglielmo da Saliceto,Pia
,
Francesco Merli
Affiliations:
Hematology, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova,Reggio Emilia,Italie;Hematology, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova,Reggio Emilia,Italien;Hematology, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova,Reggio Emilia,Italia;Hematology, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova,Reggio Emili
,
Anna Lia Molinari
Affiliations:
Hematology, Ospedale degli Infermi,Rimini,Italie;Hematology, Ospedale degli Infermi,Rimini,Italien;Hematology, Ospedale degli Infermi,Rimini,Italia;Hematology, Ospedale degli Infermi,Rimini,Italy;Hematology, Ospedale degli Infermi,Rimini,Italia;Hematology, Ospedale degli Infermi,Rimini,Italië;Hematology, Ospedale degli Infermi,Rimini,Itália;Hematology, Ospedale degli Infermi,Rimini,Италия;Hematolo
,
Agostino Tafuri
Affiliations:
Hematology, AO Sant Andrea,Roma,Italie;Hematology, AO Sant Andrea,Roma,Italien;Hematology, AO Sant Andrea,Roma,Italia;Hematology, AO Sant Andrea,Roma,Italy;Hematology, AO Sant Andrea,Roma,Italia;Hematology, AO Sant Andrea,Roma,Italië;Hematology, AO Sant Andrea,Roma,Itália;Hematology, AO Sant Andrea,Roma,Италия;Hematology, AO Sant Andrea,Roma,Italien
,
Vittorio Ruggero Zilioli
Affiliations:
Hematology, ASST Grande Ospedale Metropolitano Niguarda,Milano,Italie;Hematology, ASST Grande Ospedale Metropolitano Niguarda,Milano,Italien;Hematology, ASST Grande Ospedale Metropolitano Niguarda,Milano,Italia;Hematology, ASST Grande Ospedale Metropolitano Niguarda,Milano,Italy;Hematology, ASST Grande Ospedale Metropolitano Niguarda,Milano,Italia;Hematology, ASST Grande Ospedale Metropolitano Nig
,
Dario Marino
Affiliations:
Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italie;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italien;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italia;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italy;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italia;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Italië;Oncology, IRCCS Istituto Oncologico Veneto,Padova,Itália;O
,
Caterina Stelitano
Affiliations:
Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli,Reggio Calabria,Italie;Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli,Reggio Calabria,Italien;Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli,Reggio Calabria,Italia;Hematology, Grande Ospedale Metropolitano Bianchi Melacrino Morelli,Reggio Calabria,Italy;Hematology, Grande Ospedale Metropol
,
Stefano Aldo Pileri
Affiliations:
Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano,Italie;Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano,Italien;Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano,Italia;Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano,Italy;Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano,Italia;Haematopathology, Istituto Europeo di Oncologia IRCCS,Milano
,
Giovannino Ciccone
Affiliations:
Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italie;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italien;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italia;Unit of Clinical Epidemiology, AOU Città della Salute e della Scienza e CPO Piemonte,Torino,Italy;Unit
Umberto Vitolo
Affiliations:
Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italie;Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italien;Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italia;Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italy;Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italia;Hematology, Candiolo Cancer Institute, FPO-IRCCS,Candiolo,Italië;Hematology
(Abstract release date: 05/12/22) EHA Library. Chiappella A. 06/11/22; 357085; S221
Annalisa Chiappella
Annalisa Chiappella
Contributions
Abstract
Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S221

Type: Oral Presentation

Session title: Aggressive Lymphoma - Clinical

Background

The standard treatment in patients with diffuse large-B cell lymphoma (DLBCL) relapsed/refractory (R/R) after first line therapy is a cisplatin-containing regimen followed by consolidation with high-dose chemotherapy and autologous stem cell transplantation (auto-SCT) in responsive ones after induction. Bortezomib had proven activity in aggressive lymphomas.

Aims

On these bases, the Fondazione Italiana Linfomi designed the FIL-VERAL12 trial, aimed at evaluating whether the addition of bortezomib to rituximab-cisplatin-cytarabine-dexametasone (BR-DHAP) increases complete response rate (CR, according to Lugano 2007 criteria) prior auto-SCT compared to standard R-DHAP.

Methods

FIL-VERAL12 was a prospective, multicenter, two-arm randomized phase II trial (NCT01805557).The primary study endpoint was CR after 4 courses of R-DHAP or BR-DHAP, assuming a 30% CR for the standard arm and a 50% CR in experimental arm. Inclusion criteria were: patients aged 18-65 years eligible to high-dose therapy, with R/R DLBCL after first line chemoimmunotherapy. Patients were stratified by relapsed or refractory and randomized 1:1 to receive: a) the standard salvage therapy R-DHAP every 28 days for 4 cycles and b) subcutaneous 1.5 mg/ms bortezomib on days 1 and 4 of each 4-week cycle in addition to the same regimen.

Results

From January 2013 to November 2018, 114 patients were screened, and 107 patients that fulfilled the inclusion criteria were enrolled into the trial and randomized to receive R-DHAP or BR-DHAP (54 patients in R-DHAP, 53 in BR-DHAP). Principal clinical characteristics were: median age 57 years (IQR: 48;62); stage III/IV 83 patients (78%); International Prognostic Index (IPI) risk >2 37 (35%). All patients received rituximab and anthracycline-based regimens as first line treatment. Considering the time at relapse, 53 patients (50%) were registered as relapsed (median time at relapse 10.8 months, IQR: 6.9;20.9) and 54 (50%) as refractory (0.9 months, IQR 0.52;1.3). 52 (49%) patients completed the planned 4 cycles of therapy; 55 did not, due to progressive disease in 42, adverse events or clinician decision in 13. At the end of the 4 courses, the pre-auto-SCT response was: CR 29 (27%), Partial Response (PR) 9 (17%); according to arm of randomization, the primary end point was not met, with CR 28% for R-DHAP and 26% for BR-DHAP (p-value 0.563). Fifty patients (44%) performed a consolidation with SCT, 24 in R-DHAP arm and 26 in BR-DHAP arm; auto-SCT was performed in 39 patients and allo-SCT in 11. The addition of bortezomib to standard R-DHAP did not impact the mobilization, with a median number of CD34+ collected of 6.43 x 10^6 cells CD34/kg (IQR: 4.40;9.11) in R-DHAP and 6.78 x 10^6 cells CD34/kg (IQR: 5.00;9.68) in BR-DHAP. Sixty patients died: 49 (82%) due to lymphoma, 1 due to toxicity, 3 due to transplant related mortality, 7 due to other causes. The incidence of adverse events was similar in the two arms, with grade 3-4 haematological toxicities in 96 patients (90%), g3-4 infection in 5 (5%), g3-4 neurotoxicity in 4 (4%). At a median follow-up of 50 months, 2-years PFS was 29% (95%CI: 19.94;41.83) and 41% (27.67;53.84) for R-DHAP and BR-DHAP, respectively; HR 0.65 (0.41;1.02) p 0.062; 2-years OS was 43% (28.98;56.30) and 52% (37.80;64.56) for R-DHAP and BR-DHAP, respectively; HR 0.74 (0.44;1.23) p 0.244.

Conclusion

In the FIL-VERAL12 phase II randomized trial, the addition of bortezomib to R-DHAP did not improve the CR rate pre-auto-SCT of R/R DLBCL patients eligible to high-dose chemotherapy plus SCT; a numerically higher 2-year PFS rate was observed in BR-DHAP arm.

Keyword(s): Bortezomib, Diffuse large B cell lymphoma, Relapsed lymphoma, Stem cell transplant

Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S221

Type: Oral Presentation

Session title: Aggressive Lymphoma - Clinical

Background

The standard treatment in patients with diffuse large-B cell lymphoma (DLBCL) relapsed/refractory (R/R) after first line therapy is a cisplatin-containing regimen followed by consolidation with high-dose chemotherapy and autologous stem cell transplantation (auto-SCT) in responsive ones after induction. Bortezomib had proven activity in aggressive lymphomas.

Aims

On these bases, the Fondazione Italiana Linfomi designed the FIL-VERAL12 trial, aimed at evaluating whether the addition of bortezomib to rituximab-cisplatin-cytarabine-dexametasone (BR-DHAP) increases complete response rate (CR, according to Lugano 2007 criteria) prior auto-SCT compared to standard R-DHAP.

Methods

FIL-VERAL12 was a prospective, multicenter, two-arm randomized phase II trial (NCT01805557).The primary study endpoint was CR after 4 courses of R-DHAP or BR-DHAP, assuming a 30% CR for the standard arm and a 50% CR in experimental arm. Inclusion criteria were: patients aged 18-65 years eligible to high-dose therapy, with R/R DLBCL after first line chemoimmunotherapy. Patients were stratified by relapsed or refractory and randomized 1:1 to receive: a) the standard salvage therapy R-DHAP every 28 days for 4 cycles and b) subcutaneous 1.5 mg/ms bortezomib on days 1 and 4 of each 4-week cycle in addition to the same regimen.

Results

From January 2013 to November 2018, 114 patients were screened, and 107 patients that fulfilled the inclusion criteria were enrolled into the trial and randomized to receive R-DHAP or BR-DHAP (54 patients in R-DHAP, 53 in BR-DHAP). Principal clinical characteristics were: median age 57 years (IQR: 48;62); stage III/IV 83 patients (78%); International Prognostic Index (IPI) risk >2 37 (35%). All patients received rituximab and anthracycline-based regimens as first line treatment. Considering the time at relapse, 53 patients (50%) were registered as relapsed (median time at relapse 10.8 months, IQR: 6.9;20.9) and 54 (50%) as refractory (0.9 months, IQR 0.52;1.3). 52 (49%) patients completed the planned 4 cycles of therapy; 55 did not, due to progressive disease in 42, adverse events or clinician decision in 13. At the end of the 4 courses, the pre-auto-SCT response was: CR 29 (27%), Partial Response (PR) 9 (17%); according to arm of randomization, the primary end point was not met, with CR 28% for R-DHAP and 26% for BR-DHAP (p-value 0.563). Fifty patients (44%) performed a consolidation with SCT, 24 in R-DHAP arm and 26 in BR-DHAP arm; auto-SCT was performed in 39 patients and allo-SCT in 11. The addition of bortezomib to standard R-DHAP did not impact the mobilization, with a median number of CD34+ collected of 6.43 x 10^6 cells CD34/kg (IQR: 4.40;9.11) in R-DHAP and 6.78 x 10^6 cells CD34/kg (IQR: 5.00;9.68) in BR-DHAP. Sixty patients died: 49 (82%) due to lymphoma, 1 due to toxicity, 3 due to transplant related mortality, 7 due to other causes. The incidence of adverse events was similar in the two arms, with grade 3-4 haematological toxicities in 96 patients (90%), g3-4 infection in 5 (5%), g3-4 neurotoxicity in 4 (4%). At a median follow-up of 50 months, 2-years PFS was 29% (95%CI: 19.94;41.83) and 41% (27.67;53.84) for R-DHAP and BR-DHAP, respectively; HR 0.65 (0.41;1.02) p 0.062; 2-years OS was 43% (28.98;56.30) and 52% (37.80;64.56) for R-DHAP and BR-DHAP, respectively; HR 0.74 (0.44;1.23) p 0.244.

Conclusion

In the FIL-VERAL12 phase II randomized trial, the addition of bortezomib to R-DHAP did not improve the CR rate pre-auto-SCT of R/R DLBCL patients eligible to high-dose chemotherapy plus SCT; a numerically higher 2-year PFS rate was observed in BR-DHAP arm.

Keyword(s): Bortezomib, Diffuse large B cell lymphoma, Relapsed lymphoma, Stem cell transplant

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