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首页> 外文期刊>International journal of hematology >Combined rituximab, bendamustine, and dexamethasone chemotherapy for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma: a multicenter phase II study
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Combined rituximab, bendamustine, and dexamethasone chemotherapy for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma: a multicenter phase II study

机译：用于复发或难治性惰性B细胞非霍奇金淋巴瘤和地幔细胞淋巴瘤的rituximab，Bendamustine和地塞米松化学疗法：多中心二期研究

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This multicenter phase II study (UMIN000008145) aims to investigate the efficacy and safety of six cycles of combination therapy (RBD) comprising rituximab, bendamustine, and dexamethasone (DEX) for relapsed or refractory (RR) indolent B-cell non-Hodgkin lymphoma (B-NHL) and mantle cell lymphoma (MCL). Although the initial study protocol comprised 20mg/body DEX on days 1 and 2, and 10mg/body on days 3-5 [high-dose (HD-) DEX group], the dose of DEX was later decreased to 8mg/body on days 1 and 2 [low-dose (LD-) DEX group] due to frequent cytomegalovirus (CMV) antigenemia and recurrent retinitis. We enrolled 33 patients, and LD-DEX and HD-DEX were administered in 15 and 18 patients, respectively. The overall response and the 3-year progression-free survival rates were 88% and 75.5%, respectively. The leading adverse event was myelosuppression. Incidence of grade 3-4 leukocytopenia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively). Incidence of CMV antigenemia over 10/100,000 white blood cells was significantly lower with LD-DEX than that with HD-DEX (P=0.0127). In conclusion, RBD showed significant effectiveness for RR indolent B-NHL and MCL.
机译：该多中心期II研究（UMIN000008145）旨在探讨六个组合治疗（RBD）的疗效和安全性，所述联合治疗（RBD）包含Rituximab，Bendamustine和地塞米松（DEX），用于复发或难治性（RR）惰性B细胞非霍奇金淋巴瘤（ B-NHL）和地幔细胞淋巴瘤（MCL）。虽然初始研究方案在第1天和第2天和第2天（High-Deose（HD-）Dex Group）上包含20mg /体DEX和10mg /体，但在几天后，DEX的剂量后来降至8mg /体1和2 [低剂量（LD-）DEX组]由于频繁的巨细胞病毒（CMV）抗原血症和复发性视网膜炎。我们注册了33名患者，分别在15例和18名患者中施用LD-DEX和HD-DEX。总体反应和3年的无进展生存率分别为88％和75.5％。领先的不良事件是骨髓抑制。 3-4级白细胞减少症，中性粒细胞病和淋巴细胞病的发病率分别为55％，67％和91％。最常见的非热神经不良事件是CMV抗原血症和皮疹（分别为33％和30％）。在10 / 100,000白细胞上，CMV抗原血症的发病率与HD-DEX的LD-DEX显着降低（P = 0.0127）。总之，RBD对RR惰性B-NHL和MCL显示出显着的有效性。

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