Mazzoni Camilla, Argnani Lisa, Casadei Beatrice, Broccoli Alessandro, Gabrielli Giulia, Fabbri Nicole, Gugliotta Gabriele, Pellegrini Cinzia, Carella Matteo, Bagnato Gianmarco, Gentilini Marianna, Morigi Alice, Maglio Pierluca, Cantelli Martina, Stefoni Vittorio, Zinzani Pier Luigi
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
Eur J Haematol. 2025 Jan;114(1):70-78. doi: 10.1111/ejh.14306. Epub 2024 Sep 18.
First-line therapy for patients with extranodal marginal zone lymphoma (EMZL) is not well established, except for eradication therapy for Helicobacter pylori in early gastric MZL. Various regimens, for example, locoregional treatment and systemic chemo-immunotherapy, can be used depending on the site and stage of disease. Single-agent rituximab is a useful approach in the setting of localized, low-intermediate risk EMZL. The aim our research was to analyze the effectiveness and safety of single-agent rituximab (375 mg/m once weekly for 4 weeks) in naïve EMZL in a real-life setting. The primary endpoint was the overall response rate (ORR), secondary endpoints were progression-free (PFS), overall (OS) and disease-free survivals (DFS), and drug tolerability. Fifty-nine patients were analyzed. Median time between diagnosis and rituximab was 3.6 months. The ORR was 89.9%, with 67.8% complete response (CR). Median DFS and PFS were reached at 6.3 and 5.3 years, respectively. After a median follow-up of 5 years, median OS was not reached. The most common adverse event was infusion reaction, reported in 28 cases, mainly during the first infusion and easily manageable. Single-agent rituximab may represent a valid therapeutic option in the first-line treatment of EMZL, at least for localized disease, with a favorable toxicity profile.
除早期胃黏膜相关淋巴组织淋巴瘤（MZL）的幽门螺杆菌根除治疗外，结外边缘区淋巴瘤（EMZL）患者的一线治疗方案尚未完全确立。根据疾病的部位和分期，可以采用多种治疗方案，例如局部治疗和全身化疗免疫治疗。单药利妥昔单抗是局限性、低中危EMZL的一种有效治疗方法。我们研究的目的是分析单药利妥昔单抗（375mg/m²，每周1次，共4周）在初治EMZL患者真实临床环境中的有效性和安全性。主要终点是总缓解率（ORR），次要终点是无进展生存期（PFS）、总生存期（OS）和无病生存期（DFS）以及药物耐受性。对59例患者进行了分析。诊断与使用利妥昔单抗之间的中位时间为3.6个月。ORR为89.9%，完全缓解（CR）率为67.8%。DFS和PFS的中位数分别为6.3年和5.3年。中位随访5年后，未达到OS的中位数。最常见的不良事件是输注反应，28例患者出现，主要发生在首次输注期间，且易于处理。单药利妥昔单抗可能是EMZL一线治疗的有效选择，至少对于局限性疾病而言，其毒性特征良好。
