A phase II study of bortezomib in patients with relapsed or refractory aggressive adult T‐cell leukemia/lymphoma

Cancer Science

Kenji Ishitsuka¹  Atae Utsunomiya⁵  Hiroo Katsuya¹  Shogo Takeuchi⁵  Yoshifusa Takatsuka⁵  Michihiro Hidaka³  Tatsunori Sakai³  Makoto Yoshimitsu⁴  Takashi Ishida² 

[1] Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan;Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan;Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan;Division of Hematology and Immunology, Center for Chronic Viral Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan;Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan

关键词: Adult T‐cell leukemia/lymphoma;    bortezomib;    nuclear factor‐κB;    proteasome inhibitor;    salvage treatment;   

DOI  :  10.1111/cas.12735

来源: Wiley

【 摘 要 】

Abstract

Adult T-cell leukemia/lymphoma (ATL) is a malignancy of peripheral T-lymphocytes with a poor prognosis. This multicenter, two-stage, single-arm, phase II study assessed the efficacy and safety of bortezomib in patients with relapsed/refractory ATL who received at least one regimen of chemotherapy. The primary endpoint was the best overall response rate (ORR), and secondary endpoints included safety, the best response by lesions, and progression-free survival (PFS). Fifteen patients were enrolled in the first stage of this study. One partial remission (PR) and five stable disease (SD) were observed as the best overall responses, and ORR was 6.7% (95% confidence interval (C.I.) 0.17-31.95%). Responses according to disease sites were one complete remission (CR) in peripheral blood, two PR in measurable targeted lesions, and two PR in skin lesions. Progression-free survival (PFS) was 38 (95% CI; 18–106) days. All patients developed ≥1 adverse events (AEs), and 80% of patients had ≥1 grade 3/4 AEs; however, no new safety findings were obtained. Although these results fulfilled the planned settings to proceed to the second stage, the coordinating committee decided to terminate this study because single agent activity did not appear to be very promising for this cohort of patients.

【 授权许可】

CC BY-NC-ND   
© 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

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