Document Detail

Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study.
MedLine Citation:
PMID:  22614995     Owner:  NLM     Status:  Publisher    
PURPOSESystemic anaplastic large-cell lymphoma (ALCL) is an aggressive subtype of T-cell lymphoma characterized by the uniform expression of CD30. The antibody-drug conjugate brentuximab vedotin delivers the potent antimicrotubule agent monomethylauristatin E to CD30-positive malignant cells. A phase II multicenter trial was conducted to evaluate the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory systemic ALCL. PATIENTS AND METHODSPatients with systemic ALCL and recurrent disease after at least one prior therapy received brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks over 30 minutes as an outpatient infusion. The primary end point of the study was overall objective response rate as assessed by independent central review.ResultsOf 58 patients treated in the study, 50 patients (86%) achieved an objective response, 33 patients (57%) achieved a complete remission (CR), and 17 patients (29%) achieved a partial remission. The median durations of overall response and CR were 12.6 and 13.2 months, respectively. Grade 3 or 4 adverse events in ≥ 10% of patients were neutropenia (21%), thrombocytopenia (14%), and peripheral sensory neuropathy (12%). CONCLUSIONBrentuximab vedotin induced objective responses in the majority of patients and CRs in more than half of patients with recurrent systemic ALCL. Targeted therapy with this CD30-directed antibody-drug conjugate may be an effective treatment for relapsed or refractory systemic ALCL and warrants further studies in front-line therapy.
Barbara Pro; Ranjana Advani; Pauline Brice; Nancy L Bartlett; Joseph D Rosenblatt; Tim Illidge; Jeffrey Matous; Radhakrishnan Ramchandren; Michelle Fanale; Joseph M Connors; Yin Yang; Eric L Sievers; Dana A Kennedy; Andrei Shustov
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-21
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  -     ISSN:  1527-7755     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Barbara Pro, Fox Chase Cancer Center, Philadelphia, PA; Ranjana Advani, Stanford University Medical Center, Palo Alto, CA; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Joseph D. Rosenblatt, University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL; Tim Illidge, Christie Hospital National Health Service, Manchester, United Kingdom; Jeffrey Matous, Colorado Blood and Cancer Institute, Denver, CO; Radhakrishnan Ramchandren, Karmanos Cancer Institute, Detroit, MI; Michelle Fanale, The University of Texas MD Anderson Cancer Center, Houston, TX; Yin Yang, Eric L. Sievers, and Dana A. Kennedy, Seattle Genetics, Bothell; Andrei Shustov, University of Washington Medical Center, Seattle, WA; Pauline Brice, Hospital Saint Louis, Paris, France; and Joseph M. Connors, British Columbia Cancer Agency Center for Lymphoid Cancer, Vancouver, British Columbia, Canada.
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