TY - JOUR
T1 - Brentuximab vedotin plus bendamustine
T2 - a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma
AU - LaCasce, Ann S.
AU - Gregory Bociek, R.
AU - Sawas, Ahmed
AU - Caimi, Paolo
AU - Agura, Edward
AU - Matous, Jeffrey
AU - Ansell, Stephen M.
AU - Crosswell, Howland E.
AU - Islas-Ohlmayer, Miguel
AU - Behler, Caroline
AU - Cheung, Eric
AU - Forero-Torres, Andres
AU - Vose, Julie
AU - O’Connor, Owen A.
AU - Josephson, Neil
AU - Wang, Yinghui
AU - Advani, Ranjana
N1 - Funding Information:
The authors thank the patients and clinical study teams who participated in this research. Medical writing and editorial support were provided by Eric Bertelsen, an employee of Seattle Genetics, Inc. This work was supported by research funding from Seattle Genetics, Inc.
Publisher Copyright:
© 2018 by The American Society of Hematology.
PY - 2018/7/5
Y1 - 2018/7/5
N2 - Autologous stem cell transplantation (ASCT) is standard of care for patients with Hodgkin lymphoma (HL) who have relapsed/refractory disease after frontline chemotherapy. Achievement of complete remission (CR) with pre-ASCT salvage chemotherapy predicts favorable outcomes post-ASCT. This phase 1/2 study evaluated the combination of brentuximab vedotin (BV) plus bendamustine as a first salvage regimen in relapsed/ refractory HL. A total of 55 patients (28 primary refractory and 27 relapsed) were enrolled. Patients received BV (1.8 mg/kg) on day 1 and bendamustine (90 mg/m2) on days 1 and 2 of a 21-day cycle for up to 6 cycles. Patients could undergo ASCT any time after cycle 2. Following ASCT or completion of combination therapy if not proceeding to ASCT, patients could receive BV monotherapy for up to 16 cycles of total therapy. After a median of 2 cycles of combination therapy (range, 1-6), the objective response rate among 53 efficacy-evaluable patients was 92.5%, with 39 patients (73.6%) achieving CR. Forty patients underwent ASCT. Thirty-one patients (25 of whom underwent ASCT) received BV monotherapy (median, 10 cycles; range, 1-14). After a median of 20.9 months of follow-up, the estimated 2-year progression-free survival was 69.8% and 62.6% for patients who received ASCT and all patients, respectively. Thirty-one patients (56.4%) experienced infusion-related reactions (IRRs), with a majority occurring during cycle 2 of combination therapy. A protocol amendment requiring premedication reduced IRR severity. BV plus bendamustine as first salvage therapy in relapsed/refractory HL is highly active with a manageable toxicity profile. This trial was registered at www.clinicaltrials.gov as #NCT01874054.
AB - Autologous stem cell transplantation (ASCT) is standard of care for patients with Hodgkin lymphoma (HL) who have relapsed/refractory disease after frontline chemotherapy. Achievement of complete remission (CR) with pre-ASCT salvage chemotherapy predicts favorable outcomes post-ASCT. This phase 1/2 study evaluated the combination of brentuximab vedotin (BV) plus bendamustine as a first salvage regimen in relapsed/ refractory HL. A total of 55 patients (28 primary refractory and 27 relapsed) were enrolled. Patients received BV (1.8 mg/kg) on day 1 and bendamustine (90 mg/m2) on days 1 and 2 of a 21-day cycle for up to 6 cycles. Patients could undergo ASCT any time after cycle 2. Following ASCT or completion of combination therapy if not proceeding to ASCT, patients could receive BV monotherapy for up to 16 cycles of total therapy. After a median of 2 cycles of combination therapy (range, 1-6), the objective response rate among 53 efficacy-evaluable patients was 92.5%, with 39 patients (73.6%) achieving CR. Forty patients underwent ASCT. Thirty-one patients (25 of whom underwent ASCT) received BV monotherapy (median, 10 cycles; range, 1-14). After a median of 20.9 months of follow-up, the estimated 2-year progression-free survival was 69.8% and 62.6% for patients who received ASCT and all patients, respectively. Thirty-one patients (56.4%) experienced infusion-related reactions (IRRs), with a majority occurring during cycle 2 of combination therapy. A protocol amendment requiring premedication reduced IRR severity. BV plus bendamustine as first salvage therapy in relapsed/refractory HL is highly active with a manageable toxicity profile. This trial was registered at www.clinicaltrials.gov as #NCT01874054.
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U2 - 10.1182/blood-2017-11-815183
DO - 10.1182/blood-2017-11-815183
M3 - Article
C2 - 29703778
AN - SCOPUS:85048635308
SN - 0006-4971
VL - 132
SP - 40
EP - 48
JO - Blood
JF - Blood
IS - 1
ER -