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
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
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DOI：
10.1200/jco.2013.50.3110
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发表时间：
2014-01-20
影响因子：
45.3
通讯作者：
Morschhauser, Franck
中科院分区：
文献类型：
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作者：
Illidge, Tim M.;Mayes, Sam;Morschhauser, Franck
目的 我们报告了一项国际多中心 II 期试验，旨在评估分级 Y-90-ibritumomab tiuxetan (Y-90-IT) 作为滤泡性淋巴瘤 (FL) 初始治疗的疗效和毒性。 患者和方法 Groupe d'Etude des Lymphomes Folliculaires 招募了总共 74 名需要初始治疗的患者，中位年龄为 61 岁（范围为 28 至 80 岁） (GELF)/英国国家淋巴瘤调查 (BNLI) 标准。其中，78%为III-IV期疾病，32%为中危，44%为高危（根据FL国际预后指数）。治疗包括两次注射 Y-90-IT (11.1 MBq/kg)，间隔 8 至 12 周。骨髓 (BM) 淋巴瘤浸润超过 20% 的患者连续 4 周每周接受一次利妥昔单抗输注 (375 mg/m(2))，并且仅当重复 BM 活检显示淋巴瘤清除率低于 20% 时才进行分段放射免疫治疗 (RIT)。主要终点是意向治疗人群的治疗反应结束。次要目标是安全性和无进展生存期 (PFS)。结果 初始总缓解率 (ORR) 为 94.4%（72 名患者中的 68 名），综合完全缓解 (CR/CRu) 为 58.3%（72 名患者中的 42 名）。 9 名患者随后改善了反应，ORR 为 95.8%（72 名患者中的 69 名），CR/CRu 为 69.4%（72 名患者中的 50 名）。中位随访时间为 3.1 年（范围为 0.2 至 5.2 年），预计 3 年 PFS 为 58%，无治疗生存率为 66%，总生存率为 95%。中位 PFS 为 40.2 个月。 30 名患者出现疾病进展，24 名患者需要进一步治疗。该治疗耐受性良好，很少 (2.8%) 发生 3 级或 4 级感染事件或不良事件，血液学毒性也可控制。结论 对于需要治疗的肿瘤负荷较高的晚期 FL 患者，使用 Y-90-IT 进行分段 RIT 是一种有效的初始治疗方法。 (C) 2013 年美国临床肿瘤学会
Purpose We report an international, multicenter phase II trial to evaluate the efficacy and toxicity of fractionated Y-90-ibritumomab tiuxetan (Y-90-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 Y-90-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 Y-90-IT is an effective initial treatment for advanced-stage FL in patients with higher tumor burden requiring treatment. (C) 2013 by American Society of Clinical Oncology