Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma.
Ann S LaCasce, R Gregory Bociek, Ahmed Sawas, Paolo Caimi, Edward Agura, Jeffrey Matous, Stephen M Ansell, Howland E Crosswell, Miguel Islas-Ohlmayer, Caroline Behler, Eric Cheung, Andres Forero-Torres, Julie Vose, Owen A O'Connor, Neil Josephson, Yinghui Wang, Ranjana Advani
Author Information
Ann S LaCasce: Dana-Farber Cancer Institute, Boston, MA.
R Gregory Bociek: Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.
Ahmed Sawas: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY.
Paolo Caimi: Seidman Cancer Center, University Hospitals, Cleveland, OH.
Edward Agura: Charles A. Sammons Cancer Center, Dallas, TX.
Jeffrey Matous: Colorado Blood Cancer Institute, Denver, CO.
Stephen M Ansell: Mayo Clinic, Rochester, MN.
Howland E Crosswell: St. Francis Hospital, Greenville, SC.
Miguel Islas-Ohlmayer: The Jewish Hospital-Mercy Health, Cincinnati, OH.
Caroline Behler: Pacific Hematology Oncology Associates, San Francisco, CA.
Eric Cheung: The Oncology Institute of Hope & Innovation, Whittier, CA.
Andres Forero-Torres: Division of Hematology & Oncology, University of Alabama at Birmingham, Birmingham, AL.
Julie Vose: Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.
Owen A O'Connor: Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY.
Neil Josephson: Seattle Genetics, Inc, Bothell, WA; and.
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/m) 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.
Associated Data
ClinicalTrials.gov | NCT01874054
References
J Clin Oncol. 2007 Feb 10;25(5):579-86
[PMID: 17242396]
