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

被引：101

作者：

Ogura, Michinori ^{[1
]}

Ando, Kiyoshi ^{[2
]}

Suzuki, Tatsuya ^{[1
]}

Ishizawa, Kenichi ^{[3
]}

Oh, Sung Yong ^{[4
]}

Itoh, Kuniaki ^{[5
]}

Yamamoto, Kazuhito ^{[6
]}

Au, Wing Yan ^{[7
]}

Tien, Hwei-Fang ^{[8
]}

Matsuno, Yoshihiro ^{[9
]}

Terauchi, Takashi ^{[10
]}

Yamamoto, Keiko ^{[11
]}

Mori, Masahiko ^{[11
]}

Tanaka, Yoshinobu ^{[11
]}

Shimamoto, Takashi ^{[11
]}

Tobinai, Kensei ^{[12
]}

Kim, Won Seog ^{[13
]}

机构：

[1] Nagoya Daini Red Cross Hosp, Dept Haematol & Oncol, Nagoya, Aichi 4668650, Japan

[2] Tokai Univ, Sch Med, Dept Haematol & Oncol, Isehara, Kanagawa 25911, Japan

[3] Tohoku Univ Hosp, Clin Res Innovat & Educ Ctr, Sendai, Miyagi, Japan

[4] Dong A Univ, Dept Internal Med, Coll Med, Pusan, South Korea

[5] Natl Canc Ctr Hosp East, Div Haematol Oncol, Kashiwa, Chiba, Japan

[6] Aichi Canc Ctr Hosp, Dept Haematol & Cell Therapy, Dept Clin Trials, Nagoya, Aichi 464, Japan

[7] Queen Mary Hosp, Univ Med Unit, Hong Kong, Hong Kong, Peoples R China

[8] Natl Taiwan Univ Hosp, Dept Internal Med, Taipei 100, Taiwan

[9] Hokkaido Univ Hosp, Dept Surg Pathol, Sapporo, Hokkaido 060, Japan

[10] Natl Canc Ctr, Div Diagnost Radiol, Tokyo, Japan

[11] MSD KK, Japan Dev, Tokyo, Japan

[12] Natl Canc Ctr, Dept Haematol, Tokyo, Japan

[13] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Div Haematol Oncol,Dept Med, Seoul, South Korea

来源：

BRITISH JOURNAL OF HAEMATOLOGY | 2014年 / 165卷 / 06期

关键词：

vorinostat; indolent B-cell non-Hodgkin lymphoma; follicular lymphoma; phase II trial; HAT mutation; HISTONE DEACETYLASE INHIBITORS; TRIAL; RITUXIMAB; BENDAMUSTINE; ACETYLATION; GENES;

D O I：

10.1111/bjh.12819

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 200mg 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): 324, 652] and the median PFS was 20months (95% CI: 112, 297). 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.

引用

页码：768 / 776

页数：9

共 20 条

[1] Activity of suberoylanilide hydroxamic acid against human breast cancer cells with amplification of Her-2 [J].

Bali, P ;

Pranpat, M ;

Swaby, R ;

Fiskus, W ;

Yamaguchi, H ;

Balasis, M ;

Rocha, K ;

Wang, HG ;

Richon, V ;

Bhalla, K .

CLINICAL CANCER RESEARCH, 2005, 11 (17) :6382-6389

[2]

Carlisi D, 2008, INT J ONCOL, V32, P177

[3] Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas [J].

Cheson, BD ;

Horning, SJ ;

Coiffier, B ;

Shipp, MA ;

Fisher, RI ;

Connors, JM ;

Lister, TA ;

Vose, J ;

Grillo-López, A ;

Hagenbeek, A ;

Cabanillas, F ;

Klippensten, D ;

Hiddemann, W ;

Castellino, R ;

Harris, NL ;

Armitage, JO ;

Carter, W ;

Hoppe, R ;

Canellos, GP .

JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (04) :1244-1253

[4] Differential protein acetylation induced by novel histone deacetylase inhibitors [J].

Glaser, KB ;

Li, J ;

Pease, LJ ;

Staver, MJ ;

Marcotte, PA ;

Guo, J ;

Frey, RR ;

Garland, RB ;

Heyman, HR ;

Wada, CK ;

Vasudevan, A ;

Michaelides, MR ;

Davidsen, SK ;

Curtin, ML .

BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, 2004, 325 (03) :683-690

[5] Bendamustine Is Effective Therapy in Patients With Rituximab-Refractory, Indolent B-cell Non-Hodgkin Lymphoma Results From a Multicenter Study [J].

Kahl, Brad S. ;

Bartlett, Nancy L. ;

Leonard, John P. ;

Chen, Ling ;

Ganjoo, Kristen ;

Williams, Michael E. ;

Czuczman, Myron S. ;

Robinson, K. Sue ;

Joyce, Robin ;

van der Jagt, Richard H. ;

Cheson, Bruce D. .

CANCER, 2010, 116 (01) :106-114

[6] Phase II Study of Vorinostat for Treatment of Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma [J].

Kirschbaum, Mark ;

Frankel, Paul ;

Popplewell, Leslie ;

Zain, Jasmine ;

Delioukina, Maria ;

Pullarkat, Vinod ;

Matsuoka, Deron ;

Pulone, Bernadette ;

Rotter, Arnold J. ;

Espinoza-Delgado, Igor ;

Nademanee, Auayporn ;

Forman, Stephen J. ;

Gandara, David ;

Newman, Edward .

JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (09) :1198-1203

[7] Frequent mutation of histone-modifying genes in non-Hodgkin lymphoma [J].

Morin, Ryan D. ;

Mendez-Lago, Maria ;

Mungall, Andrew J. ;

Goya, Rodrigo ;

Mungall, Karen L. ;

Corbett, Richard D. ;

Johnson, Nathalie A. ;

Severson, Tesa M. ;

Chiu, Readman ;

Field, Matthew ;

Jackman, Shaun ;

Krzywinski, Martin ;

Scott, David W. ;

Trinh, Diane L. ;

Tamura-Wells, Jessica ;

Li, Sa ;

Firme, Marlo R. ;

Rogic, Sanja ;

Griffith, Malachi ;

Chan, Susanna ;

Yakovenko, Oleksandr ;

Meyer, Irmtraud M. ;

Zhao, Eric Y. ;

Smailus, Duane ;

Moksa, Michelle ;

Chittaranjan, Suganthi ;

Rimsza, Lisa ;

Brooks-Wilson, Angela ;

Spinelli, John J. ;

Ben-Neriah, Susana ;

Meissner, Barbara ;

Woolcock, Bruce ;

Boyle, Merrill ;

McDonald, Helen ;

Tam, Angela ;

Zhao, Yongjun ;

Delaney, Allen ;

Zeng, Thomas ;

Tse, Kane ;

Butterfield, Yaron ;

Birol, Inanc ;

Holt, Rob ;

Schein, Jacqueline ;

Horsman, Douglas E. ;

Moore, Richard ;

Jones, Steven J. M. ;

Connors, Joseph M. ;

Hirst, Martin ;

Gascoyne, Randy D. ;

Marra, Marco A. .

NATURE, 2011, 476 (7360) :298-303

[8] Durable response but prolonged cytopenia after cladribine treatment in relapsed patients with indolent non-Hodgkin's lymphomas: Results of a Japanese phase II study [J].

Ogura, M ;

Morishima, Y ;

Kobayashi, Y ;

Uike, N ;

Sugai, S ;

Chou, T ;

Kasai, M ;

Miura, I ;

Murayama, T ;

Matsuno, Y ;

Nakamura, S ;

Mori, S ;

Ohashi, Y ;

Tobinai, K .

INTERNATIONAL JOURNAL OF HEMATOLOGY, 2004, 80 (03) :267-277

[9] Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma [J].

Ohmachi, Ken ;

Ando, Kiyoshi ;

Ogura, Michinori ;

Uchida, Toshiki ;

Itoh, Kuniaki ;

Kubota, Nobuko ;

Ishizawa, Kenichi ;

Yamamoto, Joji ;

Watanabe, Takashi ;

Uike, Naokuni ;

Choi, Ilseung ;

Terui, Yasuhito ;

Usuki, Kensuke ;

Nagai, Hirokazu ;

Uoshima, Nobuhiko ;

Tobinai, Kensei .

CANCER SCIENCE, 2010, 101 (09) :2059-2064

[10] Phase IIB multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma [J].

Olsen, Elise A. ;

Kim, Youn H. ;

Kuzel, Timothy M. ;

Pacheco, Theresa R. ;

Foss, Francine M. ;

Parker, Sareeta ;

Frankel, Stanley R. ;

Chen, Cong ;

Ricker, Justin L. ;

Arduino, Jean Marie ;

Duvic, Madeleine .

JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (21) :3109-3115

← 1 2 →