⁹⁰Y-替伊莫单抗（美罗华）放射性免疫疗法在滤泡性淋巴瘤初始治疗中的应用：一项需要根据 GELF/BNLI 标准进行治疗的国际 II 期研究。
Fractionated ⁹⁰Y-ibritumomab tiuxetan radioimmunotherapy as an initial therapy of follicular lymphoma: an international phase II study in patients requiring treatment according to GELF/BNLI criteria.
机构信息
Tim M. Illidge, Sam Mayes, John A. Radford, W. David J. Ryder, Manchester Academic Health Science Centre, University of Manchester; Jill Tipping, Maureen Zivanovic, Christie Hospital NHS Foundation Trust, Manchester; Ruth Pettengell, St. George's, University of London, London; Andrew T. Bates, Southampton University Hospitals NHS Foundation Trust, Southampton; Mike Bayne, Poole Hospital NHS Foundation Trust, Dorset, United Kingdom; Steven Le Gouill, Centre Hospitalier Universitaire Nantes; Françoise Kraeber-Bodere, Caroline Bodet-Milin, University Hospital-ICO-CRCNA INSERM U892, Nantes; Emmanuel Malek, Damien Huglo, Hospitalier Universitaire Lille; Franck Morschhauser, Centre Hospitalier Universitaire, Lille; Fabrice Jardin, Centre Henri Becquerel, Rouen; Manuel Bardies, Centre de Recherche en Cancérologie de Toulouse, Faculté de Médecine de Toulouse-Rangueil, Toulouse, France.
出版信息
J Clin Oncol. 2014 Jan 20;32(3):212-8. doi: 10.1200/JCO.2013.50.3110. Epub 2013 Dec 2.
PURPOSE
We report an international, multicenter phase II trial to evaluate the efficacy and toxicity of fractionated (90)Y-ibritumomab tiuxetan ((90)Y-IT) as initial therapy of follicular lymphoma (FL).
PATIENTS AND METHODS
A total of 74 patients, with a median age of 61 years (range, 28 to 80 years), were recruited requiring initial therapy by Groupe d'Etude des Lymphomes Folliculaires (GELF)/British National Lymphoma Investigation (BNLI) criteria. Among them, 78% had stage III-IV disease, 32% intermediate, and 44% high-risk (according to FL International Prognostic Index). Treatment consisted of two doses of (90)Y-IT (11.1 MBq/kg) administered 8 to 12 weeks apart. Patients with more than 20% lymphoma infiltration of bone marrow (BM) received one infusion per week for 4 consecutive weeks of rituximab (375 mg/m(2)) and proceeded to fractionated radioimmunotherapy (RIT) only if a repeat BM biopsy demonstrated clearing of lymphoma to less than 20% involvement. The primary end point was end of treatment response of the intention-to-treat population. Secondary objectives were safety and progression-free survival (PFS).
RESULTS
Initial overall response rate (ORR) was 94.4% (68 of 72 patients) with combined complete response (CR/CRu) of 58.3% (42 of 72 patients). Nine patients subsequently improved response making an ORR of 95.8% (69 of 72 patients) and CR/CRu of 69.4% (50 of 72 patients). At a median follow-up of 3.1 years (range, 0.2 to 5.2 years) estimated 3-year PFS is 58%, treatment-free survival 66%, and overall survival 95%. Median PFS is 40.2 months. Thirty patients have experienced disease progression and 24 have required further treatment. The treatment was well tolerated with few (2.8%) grade 3 or 4 infectious episodes or adverse events and manageable hematologic toxicity.
CONCLUSION
Fractionated RIT using (90)Y-IT is an effective initial treatment for advanced-stage FL in patients with higher tumor burden requiring treatment.
目的
我们报告了一项国际多中心 II 期试验，以评估放射性核素标记的单克隆抗体替伊莫单抗（(90)Y-IT）作为滤泡性淋巴瘤（FL）初始治疗的疗效和毒性。
方法
共纳入 74 例中位年龄为 61 岁（范围 28-80 岁）的患者，这些患者均符合 Groupe d'Etude des Lymphomes Folliculaires（GELF）/British National Lymphoma Investigation（BNLI）标准，需要初始治疗。其中，78%的患者为 III-IV 期疾病，32%为中期，44%为高危（根据滤泡性淋巴瘤国际预后指数）。治疗方案包括两次放射性核素标记的替伊莫单抗（11.1 MBq/kg）治疗，间隔 8-12 周。骨髓（BM）淋巴瘤浸润超过 20%的患者每周接受一次利妥昔单抗（375 mg/m2）连续输注 4 周，如果重复 BM 活检显示淋巴瘤清除至小于 20%的受累，则仅进行放射性免疫治疗（RIT）。主要终点为意向治疗人群的治疗结束时的反应。次要目标是安全性和无进展生存期（PFS）。
结果
初始总体缓解率（ORR）为 94.4%（68/72 例），完全缓解（CR/CRu）率为 58.3%（42/72 例）。9 例患者随后改善了反应，ORR 为 95.8%（69/72 例），CR/CRu 为 69.4%（50/72 例）。在中位随访 3.1 年（范围 0.2-5.2 年）时，估计 3 年 PFS 为 58%，无治疗生存期为 66%，总生存期为 95%。中位 PFS 为 40.2 个月。30 例患者疾病进展，24 例需要进一步治疗。治疗耐受性良好，仅有 2.8%的患者发生 3 或 4 级感染或不良事件，血液学毒性可管理。
结论
使用放射性核素标记的替伊莫单抗（(90)Y-IT）进行的分次 RIT 是一种有效的初始治疗方法，适用于需要治疗的高肿瘤负荷的晚期 FL 患者。
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