title: A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
abstract: Although initial rituximab-containing chemotherapies achieve high response rates, indolent B-cell non-Hodgkin lymphoma (B-NHL), such as follicular lymphoma (FL), is still incurable. Therefore, new effective agents with novel mechanisms are anticipated. In this multicentre phase II study, patients with relapsed/refractory indolent B-NHL and mantle cell lymphoma (MCL) received vorinostat 200 mg twice daily for 14 consecutive days in a 21-d cycle until disease progression or unacceptable toxicity occurred. The primary endpoint was overall response rate (ORR) in FL patients and safety and tolerability in all patients. Secondary endpoints included progression-free survival (PFS). Fifty-six eligible patients were enrolled; 50 patients (39 with FL, seven with other B-NHL, and four with MCL) were evaluable for ORR, and 40 patients had received rituximab-containing prior chemotherapeutic regimens. For the 39 patients with FL, the ORR was 49% [95% confidence interval (CI): 32·4, 65·2] and the median PFS was 20 months (95% CI: 11·2, 29·7). Major toxicities were manageable grade 3/4 thrombocytopenia and neutropenia. Vorinostat offers sustained antitumour activity in patients with relapsed or refractory FL with an acceptable safety profile. Further investigation of vorinostat for clinical efficacy is warranted.
authors.affiliation: Department of Haematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ando
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Suzuki
authors.forename: Kenichi
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Itoh
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Wing Yan
authors.initials: WY
authors.lastname: Au
authors.forename: Hwei-Fang
authors.initials: HF
authors.lastname: Tien
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsuno
authors.forename: Takashi
authors.initials: T
authors.lastname: Terauchi
authors.forename: Keiko
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Masahiko
authors.initials: M
authors.lastname: Mori
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Takashi
authors.initials: T
authors.lastname: Shimamoto
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Won Seog
authors.initials: WS
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D050882:CREB-Binding Protein / Q000235:genetics; D003131:Combined Modality Therapy; D004252:DNA Mutational Analysis; D050881:E1A-Associated p300 Protein / Q000235:genetics; D006801:Humans; D006877:Hydroxamic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology / Q000628:therapy; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology / Q000628:therapy; D008875:Middle Aged; D009154:Mutation; D060787:Neoplasm Grading; D012008:Recurrence; D016896:Treatment Outcome; D000077337:Vorinostat
chemical_list: D000970:Antineoplastic Agents; D006877:Hydroxamic Acids; D000077337:Vorinostat; D050882:CREB-Binding Protein; D050881:E1A-Associated p300 Protein
keywords: HAT mutation; follicular lymphoma; indolent B-cell non-Hodgkin lymphoma; phase II trial; vorinostat