Efficacy of Brentuximab Vedotin in Relapsed or RefractoryHigh-CD30–Expressing Non-Hodgkin Lymphomas:Results of a Multicenter, Open-Labeled Phase II Trial
- Author:
Seok Jin KIM
1
;
Dok Hyun YOON
;
Jin Seok KIM
;
Hye Jin KANG
;
Hye Won LEE
;
Hyeon-Seok EOM
;
Jung Yong HONG
;
Junhun CHO
;
Young Hyeh KO
;
Jooryung HUH
;
Woo-Ick YANG
;
Weon Seo PARK
;
Seung-Sook LEE
;
Cheolwon SUH
;
Won Seog KIM
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2020;52(2):374-387
- CountryRepublic of Korea
- Language:0
-
Abstract:
Purpose:The treatment outcome of brentuximab vedotin (BV) has not been related with CD30 expressionin 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 survivalwere not associated with CD30 expression levels. Over a median of 29.2 months offollow-up, the median progression-free and overall survival rates were 1.9 months and 6.1months, respectively. The most common adverse events were fever (39%), neutropenia(30%), fatigue (24%), and peripheral sensory neuropathy (27%). In a post-hoc analysis forthe 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 toxicityprofiles, especially MUM1-negative patients.
