Department of Hematology, Hospital del Mar, Passeig Maritim, Barcelona, Spain.
Leuk Res. 2012 Jun;36(6):709-14. doi: 10.1016/j.leukres.2011.10.024. Epub 2011 Dec 7.
Bendamustine is a alkylating agent with a purine-like benzamidazole ring currently approved in Europe for indolent non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and multiple myeloma. Our aim was to analyze retrospectively the efficacy and toxicity of bendamustine in NHL and CLL in Spain in the bendamustine Compassionate Use Program. Patients with relapsed/refractory NHL or CLL were eligible. Any regimen containing bendamustine was eligible. 109 patients were included from 22 institutions. Forty-nine patients had indolent NHL, 18 aggressive NHL and 42 CLL, being 44 patients (40%) refractory to previous treatment. 63% of patients had adverse events grade 3-4, mainly hematological. Overall response rate (ORR) was 66%, complete responses 30%. ORR observed in refractory patients was 45%. The median progression-free survival (PFS) was 13 months. Outcome was influenced by histology, number of previous treatments, resistance to previous chemotherapy and type of response achieved with bendamustine. Alone or in combination, bendamustine shows a meaningful clinical antitumor activity in patients with relapsed or refractory NHL or CLL, with an acceptable toxicity profile.
苯达莫司汀是一种烷化剂,具有嘌呤样苯并咪唑环,目前在欧洲被批准用于惰性非霍奇金淋巴瘤(NHL)、慢性淋巴细胞白血病(CLL)和多发性骨髓瘤。我们的目的是在西班牙的苯达莫司汀同情用药项目中回顾性分析苯达莫司汀治疗 NHL 和 CLL 的疗效和毒性。符合条件的患者为复发/难治性 NHL 或 CLL 患者。任何包含苯达莫司汀的方案均符合条件。共纳入了来自 22 个机构的 109 例患者。49 例为惰性 NHL,18 例为侵袭性 NHL,42 例为 CLL,44 例(40%)对先前的治疗有耐药性。63%的患者出现 3-4 级不良事件,主要为血液学毒性。总缓解率(ORR)为 66%,完全缓解率为 30%。在耐药患者中观察到的 ORR 为 45%。无进展生存期(PFS)的中位数为 13 个月。疗效受组织学、先前治疗次数、对先前化疗的耐药性以及苯达莫司汀获得的反应类型影响。苯达莫司汀单独或联合应用,在复发或难治性 NHL 或 CLL 患者中具有显著的临床抗肿瘤活性,且毒性谱可接受。