title: A phase II study of bortezomib in patients with relapsed or refractory aggressive adult T-cell leukemia/lymphoma.
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.
authors.affiliation: Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishitsuka
authors.affiliation: Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
authors.forename: Atae
authors.initials: A
authors.lastname: Utsunomiya
authors.affiliation: Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
authors.forename: Hiroo
authors.initials: H
authors.lastname: Katsuya
authors.affiliation: Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Takeuchi
authors.affiliation: Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
authors.forename: Yoshifusa
authors.initials: Y
authors.lastname: Takatsuka
authors.affiliation: Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hidaka
authors.affiliation: Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
authors.forename: Tatsunori
authors.initials: T
authors.lastname: Sakai
authors.affiliation: Division of Hematology and Immunology, Center for Chronic Viral Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Yoshimitsu
authors.affiliation: Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Division of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015459:Leukemia-Lymphoma, Adult T-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods
chemical_list: D000970:Antineoplastic Agents; D000069286:Bortezomib
keywords: Adult T-cell leukemia/lymphoma; bortezomib; nuclear factor-κB; proteasome inhibitor; salvage treatment