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Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies

Nancy L Bartlett1*, Robert Chen2, Michelle A Fanale3, Pauline Brice4, Ajay Gopal5, Scott E Smith6, Ranjana Advani7, Jeffrey V Matous8, Radhakrishnan Ramchandren9, Joseph D Rosenblatt10, Dirk Huebner11, Pamela Levine12, Laurie Grove12 and Andres Forero-Torres13

Author Affiliations

1 Washington University Medical School, St Louis, MO, USA

2 City of Hope, Duarte, CA, USA

3 University of Texas MD Anderson Cancer Center, Houston, TX, USA

4 Hospital Saint-Louis, Paris, France

5 University of Washington/Fred Hutchinson Cancer Center, Seattle, WA, USA

6 Loyola University Medical Center, Maywood, IL, USA

7 Stanford University Medical Center, Stanford, CA, USA

8 Colorado Blood Cancer Institute, Denver, CO, USA

9 Karmanos Cancer Institute, Detroit, MI, USA

10 University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL, USA

11 Takeda Pharmaceuticals International Company, Cambridge, MA, USA

12 Seattle Genetics, Inc, Bothell, WA, USA

13 University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, AL, USA

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Journal of Hematology & Oncology 2014, 7:24  doi:10.1186/1756-8722-7-24

Published: 19 March 2014

Abstract

Background

Brentuximab vedotin is a CD30-directed antibody-drug conjugate. Retreatment with brentuximab vedotin monotherapy was investigated in patients with CD30-positive Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (ALCL) who relapsed after achieving complete or partial remission (CR or PR) with initial brentuximab vedotin therapy in a previous study (ClinicalTrials.gov NCT00947856).

Methods

Twenty-one patients with HL and 8 patients with systemic ALCL were retreated; 3 patients with systemic ALCL were retreated twice. Patients generally received brentuximab vedotin 1.8 mg/kg intravenously approximately every 3 weeks over 30 minutes as an outpatient infusion. The primary objectives of this study were to assess safety and to estimate antitumor activity of brentuximab vedotin retreatment.

Results

The objective response rate was 60% (30% CR) in HL patients and 88% (63% CR) in systemic ALCL patients. The estimated median duration of response for patients with an objective response was 9.5 months (range, 0.0+ to 28.0+ months) at the time of study closure. Of the 19 patients with objective response, 7 patients had not had an event of disease progression or death at the time of study closure; duration of response for these patients ranged from 3.5 to 28 months. Of the 11 patients with CR, 45% had response durations of over 1 year.

Adverse events (AEs) occurring in ≥25% of patients during the retreatment period were generally similar in type and frequency to those observed in the pivotal trials of brentuximab vedotin monotherapy, with the exception of peripheral neuropathy, which is known to have a cumulative effect. Grade 3 or higher events were observed in 48% of patients; these were generally transient and managed by dose modifications or delays. Deaths due to AEs occurred in 3 HL patients; none were considered to be related to brentuximab vedotin retreatment.

Discussion

With the exception of a higher rate of peripheral motor neuropathy, retreatment with brentuximab vedotin was associated with similar side effects seen in the pivotal trials.

Conclusions

Retreatment with brentuximab vedotin monotherapy is associated with response rates in 68% (39% CR) of patients with relapsed HL and systemic ALCL.

Trial registration

United States registry and results database ClinicalTrials.gov NCT00947856.

Keywords:
Hodgkin lymphoma; Systemic anaplastic large cell lymphoma; Brentuximab vedotin; Retreatment; Relapse