Department of Internal Medicine V, Hematology & Oncology, Innsbruck Medical University, Innsbruck, Austria.
Wien Klin Wochenschr. 2011 May;123(9-10):269-75. doi: 10.1007/s00508-011-1558-7. Epub 2011 Apr 13.
The objective was to demonstrate feasibility and therapeutic efficacy of routine clinical use of the bendamustine/rituximab combination in lymphoproliferative diseases.
Data were collected retrospectively from 71 patients treated with bendamustine/rituximab combination in Tyrol/Austria. Toxicities, therapeutic response, and survival outcome in the various lymphoma entities were analyzed.
There was considerable hematotoxicity, with neutropenia and thrombocytopenia of grade 3 or 4 in 33% and 18%, respectively. Interestingly, severe infection of grade 3 or 4 was observed in a remarkable percentage of patients with aggressive lymphoma and CLL (21% and 28%, respectively) but not in indolent lymphoma (p = 0.027). Overall, the therapeutic efficacy of bendamustine/rituximab was encouraging. In CLL, an overall response rate (ORR) of 65% was achieved. Notably, in the seven previously untreated CLL patients, ORR was 86%. The therapy was effective across all FISH-cytogenetic subgroups, except for the five patients harboring 17p deletion with unfavorable prognosis (PFS 2.7 months, OS 9.3 months). In indolent lymphoma (n = 25), the bendamustine-rituximab combination induced a remarkable therapeutic effect (ORR 96%, median PFS and OS not reached). In aggressive lymphoma (n = 20), ORR was 50%; in International Prognostic Index high-risk patients (4 or 5 risk factors, n = 10), ORR was only 20%, significantly inferior than in low/intermediate risk patients (ORR 70%; p = 0.025).
In the routine setting aside clinical studies, bendamustine/rituximab therapy resulted in marked clinical responses, especially in CLL and indolent lymphoma. In aggressive lymphoma, the combination of bendamustine and rituximab was effective in favorable risk patients.
本研究旨在展示苯达莫司汀/利妥昔单抗联合方案在淋巴增生性疾病中的常规临床应用的可行性和疗效。
本研究回顾性分析了在奥地利蒂罗尔接受苯达莫司汀/利妥昔单抗联合方案治疗的 71 例患者的数据。分析了各种淋巴瘤实体的毒性、治疗反应和生存结局。
血液学毒性较大,中性粒细胞减少和血小板减少的发生率分别为 3 级或 4 级的占 33%和 18%。有趣的是,侵袭性淋巴瘤和 CLL 患者中严重感染(3 级或 4 级)的发生率较高(分别为 21%和 28%),但惰性淋巴瘤患者中未观察到(p = 0.027)。总体而言,苯达莫司汀/利妥昔单抗的疗效令人鼓舞。在 CLL 中,总缓解率(ORR)为 65%。值得注意的是,7 例初治 CLL 患者的 ORR 为 86%。该疗法在除预后不良的 5 例 17p 缺失患者外的所有 FISH 细胞遗传学亚组中均有效(无进展生存期 2.7 个月,总生存期 9.3 个月)。在惰性淋巴瘤(n = 25)中,苯达莫司汀-利妥昔单抗联合方案诱导了显著的治疗效果(ORR 96%,中位无进展生存期和总生存期未达到)。侵袭性淋巴瘤(n = 20)中 ORR 为 50%;国际预后指数高危患者(4 或 5 个危险因素,n = 10)ORR 仅为 20%,显著低于低/中危患者(ORR 70%;p = 0.025)。
在临床研究之外的常规环境中,苯达莫司汀/利妥昔单抗治疗可产生显著的临床反应,特别是在 CLL 和惰性淋巴瘤中。在侵袭性淋巴瘤中,苯达莫司汀联合利妥昔单抗对预后良好的患者有效。