Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin's Lymphoma

被引：1165

作者：

Younes, Anas ^{[1
]}

Gopal, Ajay K. ^{[2
]}

Smith, Scott E. ^{[4
]}

Ansell, Stephen M. ^{[5
]}

Rosenblatt, Joseph D. ^{[6
]}

Savage, Kerry J. ^{[14
]}

Ramchandren, Radhakrishnan ^{[7
]}

Bartlett, Nancy L. ^{[8
]}

Cheson, Bruce D. ^{[9
]}

de Vos, Sven ^{[10
]}

Forero-Torres, Andres ^{[12
]}

Moskowitz, Craig H. ^{[13
]}

Connors, Joseph M. ^{[14
]}

Engert, Andreas ^{[15
]}

Larsen, Emily K. ^{[3
]}

Kennedy, Dana A. ^{[3
]}

Sievers, Eric L. ^{[3
]}

Chen, Robert ^{[11
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[2] Univ Washington, Fred Hutchinson Canc Res Ctr, Seattle, WA 98195 USA

[3] Seattle Genet, Bothell, WA USA

[4] Loyola Univ, Med Ctr, Maywood, IL 60153 USA

[5] Mayo Clin, Rochester, MN USA

[6] Univ Miami, Miami, FL USA

[7] Karmanos Canc Inst, Detroit, MI USA

[8] Washington Univ, Sch Med, St Louis, MO USA

[9] Georgetown Univ, Lombardi Comprehens Canc Ctr, Washington, DC USA

[10] Univ Calif Los Angeles, Med Ctr, Los Angeles, CA 90024 USA

[11] City Hope Natl Med Ctr, Duarte, CA 91010 USA

[12] Univ Alabama Birmingham, Birmingham, AL USA

[13] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

[14] British Columbia Canc Agcy, Ctr Lymphoid Canc, Vancouver, BC V5Z 4E6, Canada

[15] Univ Hosp Cologne, Cologne, Germany

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2012年 / 30卷 / 18期

关键词：

STEM-CELL TRANSPLANTATION; RECEPTOR; REGIMEN;

D O I：

10.1200/JCO.2011.38.0410

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. Patients and Methods In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility. Results The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. Conclusion The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy. J Clin Oncol 30:2183-2189. (c) 2012 by American Society of Clinical Oncology

引用

页码：2183 / 2189

页数：7

共 21 条

[21] Brentuximab Vedotin (SGN-35) for Relapsed CD30-Positive Lymphomas. [J].

Younes, Anas ;

Bartlett, Nancy L. ;

Leonard, John P. ;

Kennedy, Dana A. ;

Lynch, Carmel M. ;

Sievers, Eric L. ;

Forero-Torres, Andres .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (19) :1812-1821

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