A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma

Michinori Ogura, Kiyoshi Ando, Tatsuya Suzuki, Kenichi Ishizawa, Sung Yong Oh, Kuniaki Itoh, Kazuhito Yamamoto, Wing Yan Au, Hwei Fang Tien, Yoshihiro Matsuno, Takashi Terauchi, Keiko Yamamoto, Masahiko Mori, Yoshinobu Tanaka, Takashi Shimamoto, Kensei Tobinai, Won Seog Kim

    Research output: Contribution to journalArticlepeer-review

    70 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)768-776
    Number of pages9
    JournalBritish Journal of Haematology
    Volume165
    Issue number6
    DOIs
    Publication statusPublished - 2014 Jun

    Keywords

    • Follicular lymphoma
    • HAT mutation
    • Indolent B-cell non-Hodgkin lymphoma
    • Phase II trial
    • Vorinostat

    ASJC Scopus subject areas

    • Hematology

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