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利妥昔单抗联合环磷酰胺、长春新碱、非聚乙二醇化脂质体阿霉素及泼尼松作为脾边缘区淋巴瘤一线治疗方案:意大利淋巴瘤基金会II期研究

Rituximab with cyclophosphamide, vincristine, non-pegylated liposomal doxorubicin and prednisone as first-line treatment for splenic marginal zone lymphoma: a Fondazione Italiana Linfomi phase II study.

作者信息

Iannitto Emilio, Luminari Stefano, Tripodo Claudio, Mancuso Salvatrice, Cesaretti Marina, Marcheselli Luigi, Merli Francesco, Stelitano Caterina, Carella Angelo Michele, Fragasso Alberto, Montechiarello Elisa, Ricciuti Giuseppina, Pulsoni Alessandro, Paulli Marco, Franco Vito, Federico Massimo

机构信息

a A.O.U. Policlinico Paolo Giaccone , Palermo , Italy.

b University of Modena and Reggio Emilia , Modena , Italy.

出版信息

Leuk Lymphoma. 2015;56(12):3281-7. doi: 10.3109/10428194.2015.1029925. Epub 2015 Jul 18.

DOI:10.3109/10428194.2015.1029925
PMID:25791121
Abstract

Rituximab® provides high response rates and effective disease palliation in patients with splenic marginal zone lymphoma (SMZL). We conducted a phase II trial in patients with SMZL who were either untreated or were splenectomized but had shown disease progression within 1 year after splenectomy. Treatment consisted of six courses of Rituximab with cyclophosphamide, vincristine, non-pegylated liposomal doxorubicin and prednisone (R-COMP). Fifty-one patients were eligible for the analysis. The overall response rate was 84%. The 6-year progression-free survival and overall survival were 54% and 72%, respectively. Toxicity was substantial (grade≥3 neutropenia: 26%; grade≥3 infections: 8%). Of the 15 deaths, two occurred on treatment (one sepsis and one pneumonia). Six deaths were due to lymphoma progression, four to secondary neoplasia, one to sepsis, one to pneumonia and one to splenectomy complications. R-COMP should be restricted to patients with bulky disease associated with symptoms or to patients with possible histological transformation.

摘要

利妥昔单抗(Rituximab®)在脾边缘区淋巴瘤(SMZL)患者中具有高缓解率并能有效缓解疾病。我们对未经治疗或已行脾切除术但在脾切除术后1年内出现疾病进展的SMZL患者进行了一项II期试验。治疗方案为六个疗程的利妥昔单抗联合环磷酰胺、长春新碱、非聚乙二醇化脂质体阿霉素和泼尼松(R-COMP)。51例患者符合分析条件。总缓解率为84%。6年无进展生存率和总生存率分别为54%和72%。毒性反应较为严重(≥3级中性粒细胞减少:26%;≥3级感染:8%)。15例死亡病例中,2例在治疗期间死亡(1例败血症和1例肺炎)。6例死亡归因于淋巴瘤进展,4例归因于继发肿瘤,1例归因于败血症,1例归因于肺炎,1例归因于脾切除术后并发症。R-COMP应仅限于有症状的肿块性疾病患者或可能发生组织学转化的患者。

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