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

• Published in: Cancer Research and Treatment Vol. 52; no. 2; pp. 374 - 387
• Main Authors: Kim, Seok Jin, Yoon, Dok Hyun, Kim, Jin Seok, Kang, Hye Jin, Lee, Hye Won, Eom, Hyeon-Seok, Hong, Jung Yong, Cho, Junhun, Ko, Young Hyeh, Huh, Jooryung, Yang, Woo-Ick, Park, Weon Seo, Lee, Seung-Sook, Suh, Cheolwon, Kim, Won Seog
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Cancer Association 01.04.2020; 대한암학회
• Subjects: Adult; Aged; Antineoplastic Agents, Immunological; Antineoplastic Agents, Immunological - therapeutic use; Brentuximab Vedotin; Brentuximab Vedotin - therapeutic use; CD30; Female; Humans; Ki-1 Antigen; Ki-1 Antigen - metabolism; Lymphoma, Non-Hodgkin; Lymphoma, Non-Hodgkin - drug therapy; Male; Middle Aged; Multiple myeloma oncogene-1; Neoplasm Recurrence, Local; Non-Hodgkin lymphoma; Original; Original Article; Treatment Outcome; 의학일반; Non-Hodgkin lymphoma; CD30; Multiple myeloma oncogene-1; Brentuximab vedotin
• ISSN: 1598-2998; 2005-9256; 2005-9256
• DOI: 10.4143/crt.2019.198

PurposeThe 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 MethodsThis 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.ResultsHigh-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).ConclusionBV performance as a single agent was acceptable in terms of disease control rates and toxicity profiles, especially MUM1-negative patients.