Cancer Res Treat.  2020 Apr;52(2):374-387. 10.4143/crt.2019.198.

Efficacy of Brentuximab Vedotin in Relapsed or RefractoryHigh-CD30–Expressing Non-Hodgkin Lymphomas:Results of a Multicenter, Open-Labeled Phase II Trial

Affiliations
  • 1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 2Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 3Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 4Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea
  • 5Center for Hematologic Malignancy, National Cancer Center, Goyang, Korea
  • 6Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 7Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 8Department of Pathology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 9Department of Pathology, National Cancer Center, Goyang, Korea
  • 10Department of Pathology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea

Abstract

Purpose
The treatment outcome of brentuximab vedotin (BV) has not been related with CD30 expression in previous studies enrolling patients with a wide range of CD30 expression level. Thus, this study explored the efficacy of BV in high-CD30–expressing non-Hodgkin lymphoma (NHL) patients most likely to benefit.
Materials and Methods
This phase II study (Clinicaltrials.gov: NCT02280785) enrolled relapsed or refractory high- CD30–expressing NHL, with BV administered intravenously at 1.8 mg/kg every 3 weeks. The primary endpoint was > 40% disease control rate, consisting of complete response (CR), partial response (PR), or stable disease. We defined high CD30 expression as ! 30% tumor cells positive for CD30 by immunohistochemistry.
Results
High-CD30-expressing NHL patients (n=33) were enrolled except anaplastic large cell lymphoma. The disease control rate was 48.5% (16/33) including six CR and six PR; six patients (4CR, 2PR) maintained their response over 16 completed cycles. Response to BV and survival were not associated with CD30 expression levels. Over a median of 29.2 months of follow-up, the median progression-free and overall survival rates were 1.9 months and 6.1 months, respectively. The most common adverse events were fever (39%), neutropenia (30%), fatigue (24%), and peripheral sensory neuropathy (27%). In a post-hoc analysis for the association of multiple myeloma oncogene 1 (MUM1) on treatment outcome, MUM1- negative patients showed a higher response (55.6%, 5/9) than MUM1-positive patients (13.3%, 2/15).
Conclusion
BV performance as a single agent was acceptable in terms of disease control rates and toxicity profiles, especially MUM1-negative patients.

Keyword

Brentuximab vedotin; Non-Hodgkin lymphoma; CD30; Multiple myeloma oncogene-1
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