A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
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DOI：
10.1111/bjh.12819
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发表时间：
2014-06
影响因子：
6.5
通讯作者：
Kim WS
中科院分区：
文献类型：
--
作者：
Ogura M;Ando K;Suzuki T;Ishizawa K;Oh SY;Itoh K;Yamamoto K;Au WY;Tien HF;Matsuno Y;Terauchi T;Yamamoto K;Mori M;Tanaka Y;Shimamoto T;Tobinai K;Kim WS
虽然最初的含利妥昔单抗的化疗达到高反应率，惰性B细胞非霍奇金淋巴瘤（B-NHL），如滤泡性淋巴瘤（FL），仍然是不可治愈的。因此，具有新机制的新的有效药物被期待。在这项多中心II期研究中，复发性/难治性惰性B-NHL和套细胞淋巴瘤（MCL）患者接受伏立诺他200 mg，每日两次，连续14天，21天为一个周期，直至疾病进展或出现不可接受的毒性。主要终点是FL患者的总体缓解率（ORR）以及所有患者的安全性和耐受性。次要终点包括无进展生存期（PFS）。入组了五十六例符合条件的患者; 50例患者（39例FL，7例其他B-NHL，4例MCL）可评价ORR，40例患者既往接受过含利妥昔单抗的化疗方案。对于39例FL患者，ORR为49% [95%置信区间（CI）：32.4，65.2]，中位PFS为20个月（95% CI：11.2，29.7）。主要毒性为可管理的3/4级血小板减少和中性粒细胞减少。伏立诺他在复发性或难治性FL患者中提供持续的抗肿瘤活性，具有可接受的安全性。需要进一步研究伏立诺他的临床疗效。
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.
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影响因子：
6.2
作者：
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.
通讯作者：
Cheson, Bruce D.
影响因子：
2.1
作者：
Ogura, M;Morishima, Y;Tobinai, K
通讯作者：
Tobinai, K
影响因子：
11.5
作者：
Bali, P;Pranpat, M;Bhalla, K
通讯作者：
Bhalla, K
影响因子：
64.8
作者：
Pasqualucci, Laura;Dominguez-Sola, David;Chiarenza, Annalisa;Fabbri, Giulia;Grunn, Adina;Trifonov, Vladimir;Kasper, Lawryn H.;Lerach, Stephanie;Tang, Hongyan;Ma, Jing;Rossi, Davide;Chadburn, Amy;Murty, Vundavalli V.;Mullighan, Charles G.;Gaidano, Gianluca;Rabadan, Raul;Brindle, Paul K.;Dalla-Favera, Riccardo
通讯作者：
Dalla-Favera, Riccardo
影响因子：
45.3
作者：
Watanabe, Takashi;Tobinai, Kensei;Hotta, Tomomitsu
通讯作者：
Hotta, Tomomitsu